| Page Range | 60281-60503 | |
| FR Document |
| Page and Subject | |
|---|---|
| 82 FR 60306 - Medical Devices; General Hospital and Personal Use Devices; Classification of the Image Processing Device for Estimation of External Blood Loss | |
| 82 FR 60382 - Request for Information on Obtaining Input From Rural Schools and Local Educational Agencies | |
| 82 FR 60416 - Draft Habitat Conservation Plan for the Desert Tortoise and Mohave Ground Squirrel and Draft Environmental Assessment; Hinkley Groundwater Remediation Project; San Bernardino County, California | |
| 82 FR 60420 - AREVA, Inc.; Richland, Washington; Indirect Transfer of License; Order | |
| 82 FR 60402 - Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases; Draft Guidance for Industry; Availability | |
| 82 FR 60350 - Authorizing Permissive Use of the “Next Generation” Broadcast Television Standard | |
| 82 FR 60348 - Approval of California Air Plan Revisions, San Diego County Air Pollution Control District | |
| 82 FR 60463 - Consulting Group Capital Markets Funds and Consulting Group Advisory Services LLC | |
| 82 FR 60327 - Fisheries of the Exclusive Economic Zone Off Alaska; Inseason Adjustment to the 2018 Gulf of Alaska Pollock and Pacific Cod Total Allowable Catch Amounts | |
| 82 FR 60329 - Fisheries of the Exclusive Economic Zone Off Alaska; Inseason Adjustment to the 2018 Bering Sea and Aleutian Islands Pollock, Atka Mackerel, and Pacific Cod Total Allowable Catch Amounts | |
| 82 FR 60325 - Fisheries of the Exclusive Economic Zone Off Alaska; Reallocation of Atka Mackerel in the Bering Sea and Aleutian Islands Management Area | |
| 82 FR 60396 - Agency Information Collection Activities; Proposed Collection (EPA ICR No. 1710.08); Comment Request | |
| 82 FR 60335 - Retail Commodity Transactions Involving Virtual Currency | |
| 82 FR 60467 - Notice of Opportunity for Public Comment on the Release of Deed Restrictions at the Yellowstone Airport, West Yellowstone, MT | |
| 82 FR 60466 - CSX Transportation, Inc.-Abandonment Exemption-in Greenbrier County, W. Va. | |
| 82 FR 60399 - Notice of Request for Comment on the Exposure Draft of a Proposed Statement of Federal Financial Accounting Standards (SFFAS), Classified Activities | |
| 82 FR 60408 - Government-Owned Inventions; Availability for Licensing | |
| 82 FR 60406 - Prospective Grant of an Exclusive Patent License: The Development of an Anti-CD30 Chimeric Antigen Receptor (CAR) for the Treatment of Human Cancer | |
| 82 FR 60407 - Proposed Collection; 60-Day Comment Request Division of Cancer Epidemiology and Genetics Fellowship Program and Summer Student Applications (DCEG) (National Cancer Institute) | |
| 82 FR 60417 - Notice of Realty Action: Proposed Non-Competitive (Direct) Sale of Public Land in Santa Barbara County, CA | |
| 82 FR 60320 - Final Supplementary Rules for Guffey Gorge in Park County, Colorado | |
| 82 FR 60290 - Agency Reorganization | |
| 82 FR 60283 - Emergency Mergers-Chartering and Field of Membership | |
| 82 FR 60314 - 2016 Quarterly Listings; Safety Zones, Security Zones, Special Local Regulations, Drawbridge Operation Regulations and Regulated Navigation Areas | |
| 82 FR 60401 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company | |
| 82 FR 60422 - Information Collection: Registration Certificate-In Vitro Testing With Byproduct Material Under General License | |
| 82 FR 60369 - Foreign-Trade Zone (FTZ) 41-Milwaukee, Wisconsin; Notification of Proposed Production Activity; AFE, Inc. (Monitors/Displays/Televisions); Mount Pleasant, Wisconsin | |
| 82 FR 60370 - Certain Crystalline Silicon Photovoltaic Products From Taiwan: Preliminary Results of Antidumping Duty Administrative Review and Partial Rescission of Antidumping Duty Administrative Review; 2016-2017 | |
| 82 FR 60312 - 2016 Quarterly Listings; Safety Zones, Security Zones, Special Local Regulations, Drawbridge Operation Regulations and Regulated Navigation Areas | |
| 82 FR 60316 - Drawbridge Operation Regulation; Quantuck Canal, Westhampton Beach, NY | |
| 82 FR 60409 - Removal of Conditions of Entry for Certain Vessels Arriving to the United States From Two Port Facilities in Côte d'Ivoire | |
| 82 FR 60281 - Rules of Practice and Procedures To Formulate or Amend a Marketing Agreement or a Marketing Order, or Certain Research and Promotion Orders; Correction | |
| 82 FR 60419 - Notice of Lodging of Proposed Consent Decree Under the Comprehensive Environmental Response, Compensation, and Liability Act | |
| 82 FR 60405 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery | |
| 82 FR 60414 - U.S. Endangered Species; Receipt of Recovery Permit Applications | |
| 82 FR 60383 - Notice of Filing of Self-Certification of Coal Capability Under the Powerplant and Industrial Fuel Use Act | |
| 82 FR 60384 - Agency Information Collection Activity; Extension | |
| 82 FR 60384 - Revision of a Currently Approved Information Collection for the Energy Efficiency and Conservation Block Grant Financing Programs | |
| 82 FR 60282 - Regulation D: Reserve Requirements of Depository Institutions | |
| 82 FR 60281 - Regulation A: Extensions of Credit by Federal Reserve Banks | |
| 82 FR 60419 - Stainless Steel Butt-Weld Pipe Fittings From Italy, Malaysia, and the Philippines | |
| 82 FR 60401 - Notice of Agreements Filed | |
| 82 FR 60362 - Endangered and Threatened Wildlife and Plants; 90-Day Findings for Five Species | |
| 82 FR 60304 - Addition of Certain Entities to the Entity List | |
| 82 FR 60382 - Environmental Assessment (EA) for the Proposed New Space Lease for the Geophysical Fluid Dynamics Laboratory in Princeton, NJ | |
| 82 FR 60315 - Drawbridge Operation Regulation; San Leandro Bay, Between Alameda and Bay Farm Island, CA | |
| 82 FR 60420 - Notice of Permits Issued Under the Antarctic Conservation Act of 1978 | |
| 82 FR 60466 - 30-Day Notice of Proposed Information Collection: Training/Internship Placement Plan | |
| 82 FR 60423 - Information Collection: Request for Approval of Official Foreign Travel | |
| 82 FR 60318 - Safety Zone; Spa Creek, Annapolis, MD | |
| 82 FR 60470 - Advisory Committee on the Readjustment of Veterans, Notice of Meeting | |
| 82 FR 60369 - Proposed Information Collection; Comment Request; Survey of Residential Building or Zoning Permit Systems | |
| 82 FR 60470 - Publication of the Date on Which All Amounts Deposited in the Veterans Choice Fund Will Be Exhausted | |
| 82 FR 60412 - Foreign Endangered and Threatened Species; Receipt of Applications for Permit | |
| 82 FR 60334 - Test Procedures and Labeling Standards for Recycled Oil | |
| 82 FR 60390 - Combined Notice of Filings #1 | |
| 82 FR 60387 - Idaho Power Company; Notice of Application for Amendment of License and Soliciting Comments, Motions To Intervene, and Protests | |
| 82 FR 60386 - City of Radford; Notice Soliciting Scoping Comments | |
| 82 FR 60388 - Gregory R. and Beverly F. Swecker v. Midland Power Cooperative, Central Iowa Power Cooperative Swecker, Gregory and Beverly; Notice of Petition for Enforcement | |
| 82 FR 60393 - Gulf South Pipeline Company, LP ; Notice of Schedule for Environmental Review of the Westlake Expansion Project | |
| 82 FR 60389 - Combined Notice of Filings #1 | |
| 82 FR 60386 - Notice of Request for Waiver: Empire Pipeline, Inc. | |
| 82 FR 60464 - Administrative Declaration of an Economic Injury Disaster for the State of MONTANA | |
| 82 FR 60399 - Filing Dates for the Michigan Special Election in the 13th Congressional District | |
| 82 FR 60400 - Filing Dates for the Arizona Special Election in the 8th Congressional District | |
| 82 FR 60374 - Marine Mammals; Issuance of Permits | |
| 82 FR 60308 - Allocation of Assets in Single-Employer Plans; Valuation of Benefits and Assets; Expected Retirement Age | |
| 82 FR 60392 - Combined Notice of Filings #1 | |
| 82 FR 60424 - Product Change-Priority Mail Express Negotiated Service Agreement | |
| 82 FR 60424 - Product Change-Priority Mail Negotiated Service Agreement | |
| 82 FR 60373 - Accurate Fluorescence Measurements Consortium | |
| 82 FR 60376 - Fisheries of the South Atlantic; South Atlantic Fishery Management Council-Public Meetings | |
| 82 FR 60442 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Designation of Longer Period for Commission Action on Proceedings To Determine Whether To Approve or Disapprove a Proposed Rule Change, as Modified by Amendment No. 3, To Amend Section 102.01B of the NYSE Listed Company Manual To Provide for the Listing of Companies That List Without a Prior Exchange Act Registration and That Are Not Listing in Connection With an Underwritten Initial Public Offering and Related Changes to Rules 15, 104, and 123D | |
| 82 FR 60424 - Self-Regulatory Organizations; Cboe EDGX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend Rule 19.6, Series of Options Contracts Open for Trading | |
| 82 FR 60443 - Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of Filing of a Proposed Rule Change To List and Trade the Common Shares of Beneficial Interest of the PowerShares Income Builder Portfolio, a Series of PowerShares Exchange-Traded Fund Trust II | |
| 82 FR 60429 - Self-Regulatory Organizations; The Nasdaq Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Rule 4120 (Limit Up-Limit Down Plan and Trading Halts) To Reduce the Length of the “Display-Only Period” for the Initial Pricing on Nasdaq of a Security That Is the Subject of an Initial Public Offering | |
| 82 FR 60439 - Self-Regulatory Organizations; Nasdaq GEMX, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Relating to Primary Market Maker Obligations | |
| 82 FR 60451 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Rule 300 | |
| 82 FR 60460 - Self-Regulatory Organizations; Nasdaq MRX, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Relating to Primary Market Maker Obligations | |
| 82 FR 60455 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Designation of a Longer Period for Commission Action on Proposed Rule Change, as Modified by Amendment No. 1, To List and Trade Shares of the Hartford Schroders Tax-Aware Bond ETF Under NYSE Arca Rule 8.600-E | |
| 82 FR 60458 - Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Relating to Specialist Obligations | |
| 82 FR 60433 - Self-Regulatory Organizations; Municipal Securities Rulemaking Board; Order Granting Accelerated Approval of a Proposed Rule Change, as Modified by Amendment No. 1, Consisting of Proposed Amendments to MSRB Rule G-34, on CUSIP Numbers, New Issue, and Market Information Requirements | |
| 82 FR 60464 - Notice of Issuance of a Presidential Permit to the State of North Dakota | |
| 82 FR 60455 - Self-Regulatory Organizations; Nasdaq ISE, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the Calculation of the Member Order Routing Program | |
| 82 FR 60431 - Self-Regulatory Organizations; Nasdaq GEMX, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the Market Access and Routing Subsidy Program | |
| 82 FR 60453 - Self-Regulatory Organizations; Nasdaq ISE, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Relating to Primary Market Maker Obligations | |
| 82 FR 60426 - Ausdal Financial Partners, Inc. and Ausdal Unit Investment Trust | |
| 82 FR 60379 - Fisheries of the Exclusive Economic Zone Off Alaska; North Pacific Halibut and Sablefish Individual Fishing Quota Cost Recovery Programs | |
| 82 FR 60394 - Carroll County Energy, LLC; Notice of Institution of Section 206 Proceeding and Refund Effective Date | |
| 82 FR 60391 - Records Governing Off-the-Record Communications; Public Notice | |
| 82 FR 60385 - Mad River Power Associates LP; Notice of Intent To File License Application, Filing of Pre-Application Document, Approving Use of the Traditional Licensing Process | |
| 82 FR 60394 - Flambeau Hydro, LLC; Notice of Application Accepted for Filing, Soliciting Motions To Intervene and Protests, Ready for Environmental Analysis, and Soliciting Comments, Recommendations, Terms and Conditions, and Prescriptions | |
| 82 FR 60392 - Duke Energy Carolinas, LLC; Notice of Application Accepted for Filing, Soliciting Comments, Motions To Intervene, and Protests | |
| 82 FR 60394 - Notice of Petition for Declaratory Order; Blue Racer NGL Pipelines, LLC | |
| 82 FR 60407 - National Institute of Neurological Disorders and Stroke Notice of Closed Meetings | |
| 82 FR 60468 - Agency Information Collection Requirements: Information Collection Renewal; Submission for OMB Review; Debt Cancellation Contracts and Debt Suspension Agreements | |
| 82 FR 60410 - 60-Day Notice of Proposed Information Collection: Comment Request: Agency Information Collection Activities: Consolidated Discretionary Grant Programs Solicitations (Funding Opportunities) Templates and Forms | |
| 82 FR 60402 - Notice of Closed Meeting | |
| 82 FR 60316 - Drawbridge Operation Regulation; Sacramento River, Sacramento, CA | |
| 82 FR 60366 - Pacific Island Fisheries; 2017 Hawaii Kona Crab Annual Catch Limit and Accountability Measure | |
| 82 FR 60418 - Certain Color Intraoral Scanners and Related Hardware and Software; Institution of Investigation | |
| 82 FR 60474 - Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use | |
| 82 FR 60323 - Hours of Service; Electronic Logging Devices; Limited 90-Day Waiver for the Transportation of Agricultural Commodities | |
| 82 FR 60360 - Hours of Service of Drivers of Commercial Motor Vehicles; Proposed Regulatory Guidance Concerning the Transportation of Agricultural Commodities | |
| 82 FR 60341 - Safety Zone; Pacific Ocean, Kilauea Lava Flow Ocean Entry on Southeast Side of Island of Hawaii, HI | |
| 82 FR 60377 - Notice of Availability of the Deepwater Horizon Oil Spill Louisiana Trustee Implementation Group Draft Strategic Restoration Plan and Environmental Assessment #3: Restoration of Wetlands, Coastal and Nearshore Habitats in the Barataria Basin, Louisiana | |
| 82 FR 60292 - Airworthiness Directives; Airbus Helicopters (Previously Eurocopter France) | |
| 82 FR 60355 - Training, Qualification, and Oversight for Safety-Related Railroad Employees | |
| 82 FR 60295 - Airworthiness Directives; The Enstrom Helicopter Corporation Helicopters | |
| 82 FR 60298 - Airworthiness Directives; Agusta S.p.A. Helicopters | |
| 82 FR 60302 - Change to Automatic Dependent Surveillance Broadcast Services | |
| 82 FR 60300 - Airworthiness Directives; The Boeing Company Airplanes | |
| 82 FR 60403 - Drug Products Labeled as Homeopathic; Draft Guidance for Food and Drug Administration Staff and Industry; Availability | |
| 82 FR 60309 - Exchange of Coin | |
| 82 FR 60397 - Notice of Availability of the Deepwater Horizon Oil Spill Louisiana Trustee Implementation Group Draft Restoration Plan and Environmental Assessment #2: Provide and Enhance Recreational Opportunities |
Agricultural Marketing Service
Census Bureau
Foreign-Trade Zones Board
Industry and Security Bureau
International Trade Administration
National Institute of Standards and Technology
National Oceanic and Atmospheric Administration
Energy Information Administration
Federal Energy Regulatory Commission
Centers for Disease Control and Prevention
Food and Drug Administration
National Institutes of Health
Coast Guard
Fish and Wildlife Service
Land Management Bureau
Federal Aviation Administration
Federal Motor Carrier Safety Administration
Federal Railroad Administration
Comptroller of the Currency
United States Mint
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
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Agricultural Marketing Service, USDA.
Final rule; correction.
This document contains a correction to the final rule which was published on December 11, 2017. In the final rule, the Regulatory Information Number (RIN) appears as RIN 0581-AD74. This number is incorrect. The correct number is 0581-AD76. This document corrects the final rule.
Effective December 20, 2017.
William Richmond, Acting Chief of Staff, AMS, 1400 Independence Avenue SW, Washington, DC 20250, (202) 720-5115.
In final rule FR Doc. 2017-26718, beginning at page 58097 of the issue December 11, 2017, make the following corrections:
On page 58097, in the first column in the heading, correct the RIN to read “0581-AD76”.
Board of Governors of the Federal Reserve System.
Final rule.
The Board of Governors of the Federal Reserve System (“Board”) has adopted final amendments to its Regulation A to reflect the Board's approval of an increase in the rate for primary credit at each Federal Reserve Bank. The secondary credit rate at each Reserve Bank automatically increased by formula as a result of the Board's primary credit rate action.
The amendments to part 201 (Regulation A) are effective December 20, 2017. The rate changes for primary and secondary credit were applicable on December 14, 2017.
Clinton Chen, Senior Attorney (202-452-3952), or Sophia Allison, Special Counsel (202-452-3565), Legal Division, or Lyle Kumasaka, Senior Financial Analyst (202-452-2382); for users of Telecommunications Device for the Deaf (TDD) only, contact 202-263-4869; Board of Governors of the Federal Reserve System, 20th and C Streets NW, Washington, DC 20551.
The Federal Reserve Banks make primary and secondary credit available to depository institutions as a backup source of funding on a short-term basis, usually overnight. The primary and secondary credit rates are the interest rates that the twelve Federal Reserve Banks charge for extensions of credit under these programs. In accordance with the Federal Reserve Act, the primary and secondary credit rates are established by the boards of directors of the Federal Reserve Banks, subject to the review and determination of the Board.
On December 13, 2017, the Board voted to approve a
The
In general, the Administrative Procedure Act (12 U.S.C. 551
Regulation A establishes the interest rates that the twelve Reserve Banks charge for extensions of primary credit and secondary credit. The Board has determined that the notice, public comment, and delayed effective date requirements of the APA do not apply to these final amendments to Regulation A for several reasons. The amendments involve a matter relating to loans, and are therefore exempt under the terms of the APA. In addition, the Board has determined that notice, public comment, and delayed effective date would be unnecessary and contrary to the public interest because delay in implementation of changes to the rates charged on primary credit and secondary credit would permit insured depository institutions to profit improperly from the difference in the current rate and the announced increased rate. Finally, because delay would undermine the Board's action in responding to economic data and conditions, the Board has determined that “good cause” exists within the meaning of the APA to dispense with the notice, public comment, and delayed effective date procedures of the APA with respect to the final amendments to Regulation A.
The Regulatory Flexibility Act (“RFA”) does not apply to a rulemaking where a general notice of proposed rulemaking is not required.
In accordance with the Paperwork Reduction Act (“PRA”) of 1995 (44 U.S.C. 3506; 5 CFR 1320 Appendix A.1), the Board reviewed the final rule under the authority delegated to the Board by the Office of Management and Budget. The final rule contains no requirements subject to the PRA.
Banks, Banking, Federal Reserve System, Reporting and recordkeeping.
For the reasons set forth in the preamble, the Board is amending 12 CFR chapter II to read as follows:
12 U.S.C. 248(i)-(j), 343
(a)
(b)
By order of the Board of Governors of the Federal Reserve System.
Board of Governors of the Federal Reserve System.
Final rule.
The Board of Governors of the Federal Reserve System (“Board”) is amending Regulation D (Reserve Requirements of Depository Institutions) to revise the rate of interest paid on balances maintained to satisfy reserve balance requirements (“IORR”) and the rate of interest paid on excess balances (“IOER”) maintained at Federal Reserve Banks by or on behalf of eligible institutions. The final amendments specify that IORR is 1.50 percent and IOER is 1.50 percent, a 0.25 percentage point increase from their prior levels. The amendments are intended to enhance the role of such rates of interest in moving the Federal funds rate into the target range established by the Federal Open Market Committee (“FOMC” or “Committee”).
The amendments to part 204 (Regulation D) are effective December 20, 2017. The IORR and IOER rate changes were applicable on December 14, 2017.
Clinton Chen, Senior Attorney (202-452-3952), or Sophia Allison, Special Counsel (202-452-3198), Legal Division, or Kristen Payne, Financial Analyst (202-452-2872), or Heather Wiggins, Section Chief (202-452-3674), Division of Monetary Affairs; for users of Telecommunications Device for the Deaf (TDD) only, contact 202-263-4869; Board of Governors of the Federal Reserve System, 20th and C Streets NW, Washington, DC 20551.
For monetary policy purposes, section 19 of the Federal Reserve Act (“the Act”) imposes reserve requirements on certain types of deposits and other liabilities of depository institutions. Regulation D, which implements section 19 of the Act, requires that a depository institution meet reserve requirements by holding cash in its vault, or if vault cash is insufficient, by maintaining a balance in an account at a Federal Reserve Bank (“Reserve Bank”).
The Board is amending § 204.10(b)(5) of Regulation D to specify that IORR is 1.50 percent and IOER is 1.50 percent.
Information received since the Federal Open Market Committee met in November indicates that the labor market has continued to strengthen and that economic activity has been rising at a solid rate. Averaging through hurricane-related fluctuations, job gains have been solid, and the unemployment rate declined further. Household spending has been expanding at a moderate rate, and growth in business fixed investment has picked up in recent quarters. On a 12-month basis, both overall inflation and inflation for items other than food and energy have declined this year and are running below 2 percent. Market-based measures of inflation compensation remain low; survey-based measures of longer-term inflation expectations are little changed, on balance.
Consistent with its statutory mandate, the Committee seeks to foster maximum employment and price stability. Hurricane-related disruptions and rebuilding have affected economic activity, employment, and inflation in recent months but have not materially altered the outlook for the national economy. Consequently, the Committee continues to expect that, with gradual adjustments in the stance of monetary policy, economic activity will expand at a moderate pace and labor market conditions will remain strong. Inflation on a 12-month basis is expected to remain somewhat below 2 percent in the near term but to stabilize around the Committee's 2 percent objective over the medium term. Near-term risks to the economic outlook appear roughly balanced, but the Committee is monitoring inflation developments closely.
In view of realized and expected labor market conditions and inflation, the Committee decided to raise the target range for the federal funds rate to 1
A Federal Reserve Implementation note released simultaneously with the announcement stated that:
The Board of Governors of the Federal Reserve System voted unanimously to raise the interest rate paid on required and excess reserve balances to 1.50 percent, effective December 14, 2017.
As a result, the Board is amending section 204.10(b)(5) of Regulation D to change IORR to 1.50 percent and IOER to 1.50 percent.
In general, the Administrative Procedure Act (12 U.S.C. 551
The Board has determined that good cause exists for finding that the notice, public comment, and delayed effective date provisions of the APA are unnecessary, impracticable, or contrary to the public interest with respect to these final amendments to Regulation D. The rate increases for IORR and IOER that are reflected in the final amendments to Regulation D were made with a view towards accommodating commerce and business and with regard to their bearing upon the general credit situation of the country. Notice and public comment would prevent the Board's action from being effective as promptly as necessary in the public interest, and would not otherwise serve any useful purpose. Notice, public comment, and a delayed effective date would create uncertainty about the finality and effectiveness of the Board's action and undermine the effectiveness of that action. Accordingly, the Board has determined that good cause exists to dispense with the notice, public comment, and delayed effective date procedures of the APA with respect to these final amendments to Regulation D.
The Regulatory Flexibility Act (“RFA”) does not apply to a rulemaking where a general notice of proposed rulemaking is not required.
In accordance with the Paperwork Reduction Act (“PRA”) of 1995 (44 U.S.C. 3506; 5 CFR 1320 Appendix A.1), the Board reviewed the final rule under the authority delegated to the Board by the Office of Management and Budget. The final rule contains no requirements subject to the PRA.
Banks, Banking, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Board amends
12 CFR part 204 as follows:
12 U.S.C. 248(a), 248(c), 461, 601, 611, and 3105.
(b) * * *
(5) The rates for IORR and IOER are:
By order of the Board of Governors of the Federal Reserve System.
National Credit Union Administration (NCUA).
Final rule.
The NCUA Board (Board) is issuing this final rule to amend, in its Chartering and Field of Membership
The effective date for this rule is January 19, 2018.
Thomas I. Zells, Staff Attorney, Office of General Counsel, or Amanda Parkhill, Loss/Risk Analysis Officer, Office of Examination and Insurance, at 1775 Duke Street, Alexandria, VA 22314 or telephone: (703) 548-2478 (Mr. Zells) or (703) 518-6385 (Ms. Parkhill).
Credit unions that experience a sharp decline in net worth have a much higher likelihood of failing. From the second quarter of 1996 through the second quarter of 2016, there were 11,734 federally insured credit unions. As shown in the table below, 2,502 of these credit unions fell below the well-capitalized threshold (7 percent net worth ratio) after having a net worth ratio above that threshold for at least one quarter. The net worth ratios of 490 of these 2,502 credit unions eventually declined to below two percent. Importantly, only 15 percent of those credit unions whose net worth dropped below two percent sometime in this period remain currently active.
Credit union failures are costly to the entire credit union system through their effect on the National Credit Union Share Insurance Fund (NCUSIF). The NCUA, as a prudential safety and soundness regulator, is charged with protecting the safety and soundness of the credit union system and, in turn, the NCUSIF through regulation and supervision.
Under the emergency merger provision of section 205(h) of the FCU Act, the Board may allow a credit union that is either insolvent or in danger of insolvency to merge with another credit union if the Board finds that: (1) An emergency requiring expeditious action exists; (2) no other reasonable alternatives are available; and (3) the action is in the public interest.
To take such action, the NCUA must first determine that a credit union is either insolvent or in danger of insolvency before the agency can make the additional findings that an emergency exists, other alternatives are not reasonably available, and the public interest would be served by the merger. The FCU Act, however, does not define when a credit union is “in danger of insolvency.”
In 2009, the NCUA proposed a definition of in danger of insolvency to establish an objective standard to aid it in making in danger of insolvency determinations.
Experience gained since 2010, including the analysis of Call Reports and other NCUA internal data, led the Board to conclude that an update to the 2010 definition of in danger of insolvency is needed. For these reasons, the Board published proposed changes to the definition in the
The NCUA received 12 comments on the 2017 proposal to amend the definition of in danger of insolvency for emergency merger purposes (the Proposal). The comments were overwhelmingly supportive of the proposed definition and generally agreed with the NCUA's rationale for amending the definition. No commenters specifically opposed the proposed amendments to the definition. However, the commenters did raise several issues and made several suggestions. Specifically, commenters: Raised concerns about the impact on small credit unions and the impact of mergers on the federal charter generally; asked the NCUA to continue to study
After reviewing and considering the comments, the Board is issuing this final rule to implement the changes as proposed in the Proposal. The 2010 definition of in danger of insolvency required a credit union to fall into at least one of three net worth categories to be found to be in danger of insolvency. Consistent with the Proposal, this final rule amends the 2010 definition in three ways.
First, the final rule lengthens by six months the “forecast horizons,” the time periods in which the NCUA projects a credit union's net worth for determining if it is in danger of insolvency. This change applies to two of the three current categories. It results in forecast horizons of 30 months for the insolvency (zero net worth) category, up from 24 months, and 18 months for the critically undercapitalized (under two percent net worth) category, up from 12 months. The third category of the 2010 definition, in which a credit union is significantly undercapitalized and the NCUA determines there is no reasonable prospect of the credit union becoming adequately capitalized in the succeeding 36 months, remains unchanged.
The second change the final rule makes is the addition of a fourth category to the definition. Specifically, a credit union will be considered in danger of insolvency if it has been granted or received assistance under section 208 of the FCU Act in the 15 months prior to the NCUA regional office's determination that the credit union is in danger of insolvency.
Third, the final rule makes a technical spelling correction to the first category of the definition to replace the word “relay” with the word “rely”.
The Board believes these changes to the 2010 definition provide the NCUA with a more appropriate degree of flexibility and better allow the NCUA to act when the statutory criteria for an emergency merger are met, namely an emergency requiring expeditious action exists, no other reasonable alternatives are available, and the action is in the public interest.
In some instances, the rigidity of the 2010 regulatory definition unnecessarily limited the NCUA's ability to resolve failing institutions. This came at a greater cost to a credit union's members and the NCUSIF, particularly in the case of an eventual liquidation. The FCU Act grants the Board broad authority to define the term “in danger of insolvency” for emergency merger purposes. The new definition increases agency flexibility and will enable the NCUA to act more timely to preserve credit union services and credit union assets and to protect the safety and soundness of the credit union system and the NCUSIF. Specifically, commenters agreed that the changes will: (1) Modernize and provide increased flexibility to the emergency merger process; (2) improve merger prospects and help the NCUA and credit unions find appropriate merger partners for declining credit unions; (3) allow the NCUA to capture more credit unions that are in danger of insolvency earlier in their decline; (4) help to preserve and protect assets, liquidity, and net worth; (5) protect and mitigate costs to the NCUSIF; and (6) preserve continuity in services to members. One commenter also specifically agreed that identifying struggling credit unions and allowing them to merge is more desirable than total liquidation.
The Proposal amended the definition of in danger of insolvency in the glossary to appendix B to part 701 to extend the forecast horizons. Under the 2010 definition, to be deemed in danger of insolvency under the definition's first two categories, the NCUA had to project that a credit union's future net worth would decline at a rate that would either render the credit union insolvent within 24 months or drop below two percent (critically undercapitalized) within 12 months. In the Proposal, the Board proposed extending these periods to 30 months and 18 months, respectively. The Proposal left as is the forecast horizon of the third category of the definition pertaining to significantly undercapitalized credit unions that NCUA projects have no reasonable prospect of becoming adequately capitalized in the succeeding 36 months. After reviewing the data and considering the overwhelmingly supportive comments, the Board is finalizing these amendments to the forecast horizons as proposed.
As noted in the Proposal, the Board believes that these changes to the definition will capture more credit unions that are in danger of insolvency earlier in their decline, before their net worth declines most rapidly, and will provide value to both the members of the credit union being merged and the NCUSIF. Increasing the likelihood that a distressed credit union would be eligible for an emergency merger earlier could help to protect net worth, reduce payouts on deposit insurance or merger assistance, and improve merger prospects. The changes also provide the NCUA with additional flexibility to resolve the distressed credit union through a merger and help to better ensure continuity of financial services for members. This additional flexibility is especially beneficial when circumstances deplete a credit union's capital slowly and steadily rather than abruptly, such as in the case of an institution with a large portfolio of declining illiquid assets.
As provided in the Proposal, the NCUA used a simple forecast of the net worth ratios of 46 credit unions that underwent an emergency merger between the second quarter of 2010, when the 2010 definition of in danger of insolvency was put into place, and the fourth quarter of 2016 to evaluate the benefit of shifting the critically undercapitalized threshold from 12 to 18 months and the insolvency threshold from 24 to 30 months.
Also, the longer forecast horizon allows the NCUA to identify a significant number of additional potential credit union emergency merger candidates. The largest diagnostic improvements from extending the forecast horizon occur in the two quarters prior to an emergency merger. Instead of 31% of the credit unions estimated to be below the critically undercapitalized threshold within 12 months two quarters before the emergency merger and 50% one quarter before, 42% and 58% of the credit unions are estimated to be below the critically undercapitalized threshold within 18 months. The identification of these additional credit unions represent an opportunity for the NCUA to preserve services to members and member assets through the emergency merger process prior to the quarters when the net worth of these credit unions declines the most. As the chart below illustrates, credit union net worth generally declines the most in the quarters leading up to an emergency merger.
The data closely aligns with the views and experiences of the NCUA. The agency found that the 2010 definition's forecast horizons for these two categories could result in the unnecessary delay or even rejection of emergency merger requests that did not meet the 2010 regulatory definition of in danger of insolvency, but would otherwise meet the statutory criteria for an emergency merger. The NCUA believes that extending these forecast horizons will lessen the potential for such occurrences. When a credit union cannot be timely merged through an emergency merger and no other credit unions with compatible fields of membership submit a merger proposal, the NCUA must consider alternative and usually less desirable means of resolution. These less desirable means of resolution could even include the liquidation of the credit union. In general, merging a credit union into another institution is more desirable than liquidating the credit union because a merger is generally lower cost to the NCUSIF and provides continued and, in most cases, expanded service to the membership.
The NCUA believes that the delay associated with waiting for an institution to deteriorate to the point where it satisfies the 2010 regulatory definition of in danger of insolvency has too frequently resulted in struggling institutions being allowed to deteriorate over time to the point where they are no longer viable merger partners and have to be resolved by means that are more costly to the NCUSIF and more disruptive to the members. Rather than continue to operate under the 2010 definition, which hampered the NCUA's ability to take responsible supervisory action on a timely basis and ensure the safety and soundness of the credit union system, the Board is adopting the Proposal's amendments to the forecast horizons of the regulatory definition of in danger of insolvency to facilitate those mergers that satisfy the statutory requirements.
The vast majority of commenters specifically expressed support for the extended forecast horizons. No commenters opposed the change. Commenters' reasons for supporting the extended forecast horizons mirrored those expressed by the NCUA in the Proposal. Commenters specifically stated that the change will: (1) Improve merger prospects as credit unions will not continue to deteriorate until they are no longer viable merger partners; (2) allow undercapitalized institutions, where merited, to sooner be eligible for emergency mergers; (3) allow the NCUA to act more timely to preserve credit union services, liquidity, and assets for the benefit of members; (4) protect the NCUSIF; and (5) allow for continued (and often expanded) service to the membership. Additionally, one commenter specifically noted that the desire to preserve the NCUSIF will help federally insured credit unions avoid additional premium cost due to NCUSIF depletion. Another commenter stated that because of how expensive and draining mergers are to the acquiring organization, particularly when there is limited capital remaining or the membership base has departed, earlier identification and action by the NCUA to preserve the capital and membership base will make finding a merger partner for the merging credit union easier.
One commenter described how its credit union's experiences support the changes. The commenter stated that, as the continuing credit union, their members would have benefited greatly from an extra six months of cushion before the merging credit union deteriorated further. The commenter reiterated that mergers require months or years of due diligence and that, under the current rule, strong credit unions are reluctant to consider mergers with safety and soundness concerns because qualifying in danger of insolvency credit unions are often too far gone to allow sufficient time for proper due diligence. The commenter opined that on a few occasions they had to turn down emergency merger opportunities presented by the NCUA regional office
Commenters' support for the extended forecast horizons and their description of their own real world experiences bolsters the need for the extended forecast horizons. As such, the Board is finalizing the 30-month insolvency and 18-month critically undercapitalized forecast horizons as proposed.
As proposed, the final rule leaves the forecast horizon for the third category of the current definition as is. Rather than establishing a time period in which credit unions are projected to decline to a certain point, as the other two categories do, the third category only allows the NCUA to find that a credit union is in danger of insolvency if the credit union has no reasonable prospect of improving its net worth from the significantly undercapitalized level to the adequately capitalized level in the succeeding 36 months. The Board believes that the forecast horizon for this category adopted in 2010 already provides credit unions significant time to become adequately capitalized and is concerned that any extension to the forecast horizon would make it exceedingly difficult to accurately determine if a credit union has a reasonable possibility of returning its net worth to the adequately capitalized level.
In the Proposal, the Board proposed expanding the definition of in danger of insolvency in the glossary to appendix B to part 701 to add a fourth category that provides that a credit union will satisfy the definition of in danger of insolvency if the credit union has been granted or received assistance under section 208 of the FCU Act in the 15 months prior to the NCUA regional office making such a determination. Section 208 allows the Board to provide special assistance to credit unions to avoid liquidation. After reviewing the data and the comments, the Board has decided to adopt this change as proposed.
In the Proposal the Board noted that, in analyzing credit union Call Reports and other internal NCUA data, the NCUA has found that an overwhelming number of credit unions that received section 208 assistance eventually left the credit union system. Specifically, between the first quarter of 2001 and the fourth quarter of 2016, 181 credit unions received at least one type of section 208 assistance. Since then, 165, or 91.2%, of these credit unions have stopped filing Call Reports.
Further, the data shows that not only did the overwhelming majority of the credit unions that received section 208 assistance stop filing Call Reports, but did so not long after, or prior to, receiving the assistance. Notably, 13.9% of the total number of credit unions that received section 208 assistance began receiving such assistance after they filed their final Call Report. An additional 37.0% of these 165 credit unions filed their final Call Report in the same quarter in which they first began receiving section 208 assistance. Another 41.2% of these credit unions filed their final Call Report within the four quarters after the quarter they first received section 208 assistance. In total, 152 of the 165 credit unions, or 92.1%, stopped filing Call Reports prior to or within 15 months of receiving the section 208 assistance.
The quantitative evidence, along with the NCUA's experiences and observations, demonstrate that credit unions receiving section 208 assistance within the last 15 months are in danger of insolvency for emergency merger purposes.
The majority of commenters explicitly supported the proposed fourth category and felt the NCUA's data clearly showed that credit unions receiving 208 assistance are in danger of insolvency. While no commenter opposed the addition of the fourth category, a number did provide suggestions and feedback. However, much of this feedback falls outside the scope of this rulemaking.
Specifically, one commenter who supported the change also argued that the data shows problems with 208 assistance generally and that the current process covers up foundational problems inherent in credit unions approaching insolvency. The commenter urged the NCUA to explore ways to either improve the success of 208 assistance or to seek more effective remedies to help struggling credit unions. Additionally, four commenters requested that the NCUA further analyze the credit unions that survived after receiving 208 assistance to ensure the success of future recipients. One of these commenters specifically asked the NCUA to consider whether more stringent criteria is warranted when receiving 208 assistance. Another of these commenters recommended that the NCUA continue to collect and analyze the 208 assistance data. Another commenter specifically asked that the NCUA exhaust all efforts to assist credit unions receiving 208 assistance to regain strength.
The Proposal sought comment on amendments to the in danger of insolvency standard for purposes of determining credit unions' eligibility for emergency mergers. This included whether the addition of the fourth category is proper. The comments received addressing section 208 assistance in a capacity other than its merits as an indication that a credit union is in danger of insolvency for emergency merger purposes, while generally helpful and appreciated, fall outside the scope of this rulemaking. However, the Board does note that the NCUA has previously and will continue to evaluate the 208 assistance program and the data the agency collects on it on an ongoing basis.
One commenter noted the delicate balance the NCUA must strike between the public policy behind 208 assistance and the implementation of this fourth category. The commenter stressed that the in danger of insolvency determination should be holistic and not based solely or primarily on a credit union's request or acceptance of 208 assistance. A separate commenter supported the addition of the fourth category, but cautioned that adding 208 assistance to the definition could deter credit unions from seeking 208 assistance.
The Board agrees that the determination that a credit union is eligible for an emergency merger must be made holistically rather than just based on a credit union's request for or acceptance of 208 assistance. The Board reiterates that it is not proposing that every credit union that receives section 208 assistance, thus meeting the new definition of in danger of insolvency, is destined for an emergency merger. In fact, the Board cannot authorize an emergency merger on this determination alone. Credit unions to be merged on an emergency basis still must meet the statutory requirements that an emergency exists, other alternatives are
For similar reasons, the Board does not believe that using section 208 assistance to determine that a credit union is in danger of insolvency is likely to deter credit unions from seeking 208 assistance. The Board's determination that an emergency merger is necessary is a holistic one and subject to the above strict statutory requirements. Further, credit unions that receive section 208 assistance typically do so only when necessary to avoid liquidation or reduce risk to the NCUSIF. Whether they would potentially be part of an emergency merger down the line should they survive seems a minor concern.
The final rule replaces the word “relay” with the word “rely” as proposed. One commenter specifically supported this change.
Two commenters specifically cautioned against any regime that would result in rigid guidelines forcing credit union mergers. One of the commenters cited data in the Proposal that showed that roughly 73 credit unions that fell below two percent net worth during the last 20 years remain active today as evidence of the need to avoid “impos[ing] an inflexible, one-size-fits-all rubric to resolve financially-challenged institutions.” The Board understands this concern, and reiterates that the aim of this rulemaking is to return flexibility to the in danger of insolvency definition, not to force credit unions that meet the definition into emergency mergers. Further, credit unions are not forced into emergency mergers. While it is true that fledgling institutions may be left with limited options, including liquidation, a credit union's Board of Directors must consent to an emergency merger for it to occur.
One commenter argued for a more transparent emergency merger process. The commenter suggested prospective merger partners be fully apprised of important information regarding the selection process and have the opportunity to make their case for the merger. To increase transparency and guide future emergency mergers, the commenter asked the NCUA to provide prospective merger partners with a written explanation of the reasons for its decision. The emergency merger process is a collaborative one between the merging credit union, the potential acquiring credit unions, the state regulator if applicable, and the NCUA. The Board believes that potential acquiring credit unions are currently provided with a transparent view of the emergency merger process. Further, this rulemaking focuses on the in danger of insolvency definition rather than the emergency merger process generally. As such, this comment is beyond the scope of this rulemaking but nevertheless appreciated.
One commenter said that small credit unions' lack of resources often frustrates the merger process and requested the NCUA try to alleviate these potential issues by providing more streamlined procedures for merger of small institutions. The commenter noted that even with the increased forecast horizons, there may still be delays in the actual emergency merger process. The commenters did not specify how the procedures for emergency mergers could be streamlined to assist small institutions. This rulemaking relates only to the in danger of insolvency definition. As such, comments relating to procedures governing other aspects of the emergency merger process are beyond the scope of this rulemaking but still appreciated.
Another commenter read the proposal's Paperwork Reduction Act and Regulatory Flexibility Act sections to mean that the NCUA believed the proposed changes focused on regulating larger credit unions and did not impact a significant number of smaller credit unions. The commenter advised the NCUA to review how the proposal will actually impact smaller credit unions. Specifically, the commenter suggested the NCUA research whether the Proposal affects small credit unions through evaluation forecasts, prompt corrective action, and net worth restoration plans. The commenter requested that the NCUA analyze and explain whether subjective application of the definition will disproportionately affect small credit unions, as examiners may be more likely to accept (or even push for) a forecast for small credit unions that reflects a danger of insolvency.
The Proposal's Paperwork Reduction Act and Regulatory Flexibility Act analyses do not state that the changes to the in danger of insolvency definition are focused on regulating larger institutions. Instead, they convey that the changes do not have a significant economic impact on a substantial number of small credit unions and do not require additional information collection requirements. The analyses state that the proposed amendments instead are intended to return flexibility to the NCUA in making the in danger of insolvency determination.
One commenter was particularly concerned that the NCUA “emphasize and uphold the importance and viability of the credit union charter.” The commenter said the NCUA has a dual obligation to preserve and protect the NCUSIF and the federal credit union system. The commenter stressed the value federal credit union charters hold and asserted that while a strong emphasis on finances is important in the emergency merger context, a more holistic evaluation that includes the three other statutory criteria should be incorporated to preserve the value of FCU charters.
The Board appreciates its responsibility to serve both as the charterer and prudential regulator of federal credit unions and the insurer of all federally insured credit unions. As the Board has noted both in the Proposal and above, it appreciates that the emergency merger evaluation is a holistic one that, in addition to the insolvent or in danger of insolvency determination, includes the Board's determination that the credit union meets the three other statutory criteria that: Exigent circumstances exist; there are no other reasonable alternatives available; and the emergency merger is in the public interest.
Another commenter suggested that “the Board consider standardizing timeframes contained both within this final rule as well as throughout all regulations relative to capitalization and net worth.” The commenter noted that for risk-based capital purposes, the NCUA uses a 24-month look-back period and that for the in danger of insolvency determination the timelines would now be: 30 months for the
The Regulatory Flexibility Act requires the NCUA to prepare an analysis of any significant economic impact a regulation may have on a substantial number of small entities (primarily those under $100 million in assets).
The Paperwork Reduction Act of 1995 (PRA) applies to rulemakings in which an agency creates new or amends existing information collection requirements.
Executive Order 13132 encourages independent regulatory agencies to consider the impact of their actions on state and local interests. In adherence to fundamental federalism principles, the NCUA, an independent regulatory agency as defined in 44 U.S.C. 3502(5), voluntarily complies with the executive order. This rulemaking will not have a substantial direct effect on the states, on the connection between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. The NCUA has therefore determined that this final rule does not constitute a policy that has federalism implications for purposes of the executive order.
The NCUA has determined that this final rule will not affect family well-being within the meaning of Section 654 of the Treasury and General Government Appropriations Act, 1999.
The Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121) (SBREFA) provides generally for congressional review of agency rules. A reporting requirement is triggered in instances where the NCUA issues a final rule as defined by Section 551 of the Administrative Procedure Act. The NCUA does not believe this final rule is a “major rule” within the meaning of the relevant sections of SBREFA. As required by SBREFA, the NCUA has filed the appropriate reports so that this final rule may be reviewed.
Credit, Credit unions, Reporting and recordkeeping requirements.
For the reasons discussed above, the NCUA Board amends 12 CFR part 701 as follows:
12 U.S.C. 1752(5), 1755, 1756, 1757, 1758, 1759, 1761a, 1761b, 1766, 1767, 1782, 1784, 1785, 1786, 1787, 1788, 1789. Section 701.6 is also authorized by 15 U.S.C. 3717. Section 701.31 is also authorized by 15 U.S.C. 1601
1. The credit union's net worth is declining at a rate that will render it insolvent within 30 months. In projecting future net worth, NCUA may rely on data in addition to Call Report data. The trend must be supported by at least 12 months of historic data.
2. The credit union's net worth is declining at a rate that will take it under two percent (2%) net worth within 18 months. In projecting future net worth, NCUA may rely on data in addition to Call Report data. The trend must be supported by at least 12 months of historic data.
3. The credit union's net worth, as self-reported on its Call Report, is significantly undercapitalized, and NCUA determines that there is no reasonable prospect of the credit union becoming adequately capitalized in the succeeding 36 months. In making its determination on the prospect of achieving adequate capitalization, NCUA will assume that, if adverse economic conditions are affecting the value of the credit union's assets and liabilities, including property values and loan delinquencies related to unemployment, these adverse conditions will not further deteriorate.
4. The credit union has been granted or received assistance under section 208 of the Federal Credit Union Act, 12 U.S.C. 1788, in the 15 months prior to the Region's determination that the credit union is in danger of insolvency.
National Credit Union Administration (NCUA).
Final rule.
The NCUA Board (“Board”) is issuing a final rule to implement certain features of the NCUA reorganization that the Board announced earlier this year. This rule amends the NCUA's regulations related to the organization of the NCUA's Central Office.
This rule is effective January 6, 2018.
Elizabeth Wirick, Senior Staff Attorney,
In July 2017, the Board announced a plan to streamline and consolidate certain of the NCUA's functions and offices in an effort to reduce the NCUA's budget and increase efficiency. The portions of the Board's reorganization plan reflected in this rule will:
• Eliminate the Office of Small Credit Union Initiatives;
• Rename the Office of Consumer Financial Protection and Access the “Office of Consumer Financial Protection;” and
• Create a new office named the “Office of Credit Union Resources and Expansion” to absorb: (1) Most of the current functions of the Office of Small Credit Union Initiatives; (2) the federal credit union chartering and field of membership functions of the Office of Consumer Financial Protection; and (3) the minority depository institution preservation program of the Office of Minority and Women Inclusion.
Other aspects of the Board's reorganization plan, such as changes affecting the Office of Examination and Insurance, do not require regulatory changes.
The rule also makes a technical correction to the definition of “Regional Director” in the NCUA's voluntary merger regulation to reflect the fact that the Office of National Examinations and Supervision supervises natural person credit unions with assets of $10 billion or more as well as corporate credit unions.
Additionally, the changes articulated in this rulemaking relate only to changes in the organization of the NCUA's Central Office, which become effective January 6, 2018. The two NCUA Regional Offices that are to be eliminated under the reorganization plan will not be closed until December 31, 2018. The Board will issue another rule in 2018 to reflect the reduction in the number of NCUA Regional Offices beginning in 2019.
Generally, the APA requires a federal agency to provide the public with notice and an opportunity to comment on agency rulemakings.
The APA also generally requires publication of a rule in the
The Small Business Regulatory Enforcement Fairness Act of 1996
The Regulatory Flexibility Act requires the NCUA to prepare an analysis of any significant economic impact a regulation may have on a substantial number of small entities (primarily those under $100 million in assets).
The Paperwork Reduction Act of 1995 (PRA) applies to rulemakings in which an agency by rule creates a new paperwork burden on regulated entities or increases an existing burden.
Executive Order 13132 encourages independent regulatory agencies to consider the impact of their actions on state and local interests. The NCUA, an independent regulatory agency as defined in 44 U.S.C. 3502(5), voluntarily complies with the executive order to adhere to fundamental federalism principles. The final rule does not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. The NCUA has therefore determined that this final rule does not constitute a policy that has federalism implications for purposes of the executive order.
The NCUA has determined that this rule will not affect family well-being within the meaning of § 654 of the Treasury and General Government Appropriations Act, 1999, Public Law 105-277, 112 Stat. 2681 (1998).
Credit unions, Chartering, Field of membership.
Credit unions, Grants, Loans, Low-income credit unions, Revolving fund.
Credit unions, Charter conversions.
Credit unions, Mergers of credit unions.
Organization and functions (Government agencies).
For the reasons discussed above, the National Credit Union Administration amends 12 CFR parts 701, 705, 708a, 708b, and 790 as follows:
12 U.S.C. 1752(5), 1755, 1756, 1757, 1758, 1759, 1761a, 1761b, 1766, 1767, 1782, 1784, 1786, 1787, 1789. Section 701.6 is also authorized by 15 U.S.C. 3717. Section 701.31 is also authorized by 15 U.S.C. 1601
12 U.S.C. 1756, 1757, 1766, 1782, 1784, 1785, 1786.
12 U.S.C. 1766, 1785(b), and 1785(c).
12 U.S.C. 1752(7), 1766, 1785, 1786, and 1789.
12 U.S.C. 1766, 1789, 1795f.
(b) * * *
(6) * * * The Executive Director translates the NCUA Board policy decisions into workable programs, delegates responsibility for these programs to appropriate staff members, and coordinates the activities of the senior executive staff, which includes: The General Counsel; the Regional Directors; and the Office Directors for the Asset Management and Assistance Center, Chief Economist, Chief Financial Officer, Chief Information Officer, Consumer Financial Protection, Continuity and Security Management, Credit Union Resources and Expansion, Examination and Insurance, Human Resources, Minority and Women Inclusion, National Examinations and Supervision, and Public and Congressional Affairs. * * *
(12)
(13)
(15)
(A) The Division of Consumer Compliance Policy and Outreach; and
(B) The Division of Consumer Affairs;
(ii) The Office provides consumer financial services, including consumer education and complaint resolution; establishes, consolidates, and coordinates consumer financial protections within the agency; oversees the agency's fair lending examination program; and acts as the central liaison on consumer financial protection with other federal agencies.
Federal Aviation Administration (FAA), DOT.
Final rule.
We are superseding Airworthiness Directive (AD) 2009-25-07 for Airbus Helicopters Model EC120B helicopters. AD 2009-25-07 required amending the rotorcraft flight manual supplement (RFMS) and pre-flight checking the emergency flotation gear before each flight over water. Since we issued AD 2009-25-07, Airbus Helicopters developed a terminating action and identified an additional part-
This AD is effective January 24, 2018.
For service information identified in this final 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 examine the AD docket on the internet at
George Schwab, Aviation Safety Engineer, Safety Management Section, Rotorcraft Standards Branch, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone (817) 222-5110; email
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to remove AD 2009-25-07 (74 FR 65682, December 11, 2009) (2009-25-07), and add a new AD. AD 2009-25-07 applied to Eurocopter France (now Airbus Helicopters) Model EC120B helicopters. AD 2009-25-07 required amending the limitations section of RFMS to prohibit flight over water if the “float arm” pushbutton does not remain lit, conducting a pilot check to determine whether the “float arm” pushbutton remains lit before any flight over water, and placarding the “float arm” pushbutton as inoperative if the functional check is unsuccessful.
The NPRM published in the
Accordingly, the NPRM proposed to retain the RFMS amendment and repetitive functional check requirements of AD 2009-25-07, add LACU P/N 040101BA to the applicability paragraph, require replacing the float arm pushbutton P/N 045004A111A with float arm pushbutton P/N 304-2500-00 within 300 hours time-in-service (TIS), and prohibit installing float arm pushbutton P/N 045004A111A on any helicopter. Replacing the float arm pushbutton was also proposed as a terminating action for the repetitive functional checks prior to flight overwater. An owner/operator (pilot) may perform the functional check required by this AD and must enter compliance with that paragraph into the helicopter maintenance records in accordance with 14 CFR 43.9(a)(1) through (4) and 91.417(a)(2)(v). A pilot may perform this check because it involves only a functional check to determine whether the emergency flotation gear has been armed and can be performed equally well by a pilot or a mechanic. This check is an exception to our standard maintenance regulations.
The proposed requirements were intended to prohibit flight over water if a functional test indicates that the emergency flotation gear cannot be armed, which would preclude deployment of the floats in an emergency water ditching, resulting in subsequent damage to the helicopter and injury to occupants.
Since the NPRM was issued, the FAA's Aircraft Certification Service has changed its organization structure. The new structure replaces product directorates with functional divisions. We have revised some of the office titles and nomenclature throughout this Final rule to reflect the new organizational changes. Additional information about the new structure can be found in the Notice published on July 25, 2017 (82 FR 34564).
We gave the public the opportunity to participate in developing this AD, but we did not receive any comments on the NPRM.
We have reviewed the relevant information and determined that an unsafe condition exists and is likely to exist or develop on other helicopters of these same type designs and that air safety and the public interest require adopting the AD requirements as proposed.
The EASA AD requires installing the LACU float arm pushbutton within 13 months; this AD requires the installation within 300 hours TIS.
We reviewed Airbus Helicopters Emergency Alert Service Bulletin No. 04A007, Revision 1, dated June 30, 2016 (EASB), for Airbus Helicopters Model EC120B helicopters. The EASB describes procedures for a pre-flight check of the float arm pushbutton while arming the emergency flotation gear and prohibits operators from flight over water if the float arm pushbutton fails.
We also reviewed Airbus Helicopters Alert Service Bulletin No. EC120-31A008, Revision 0, dated June 30, 2016 (ASB), for Airbus Helicopters Model EC120B helicopters. The ASB describes procedures for replacing the float arm pushbutton with a new design pushbutton and for re-labeling the modified LACU with a new P/N label.
We estimate this AD will affect 53 helicopters of U.S. Registry.
We estimate that operators may incur the following costs in order to comply with this AD. At an average labor rate of $85 per hour, the cost of revising the limitations section of the RFMS and of the pre-flight functional check is negligible. Replacing the float arm pushbutton will require about 2 work-hours, and required parts cost about $311, for a cost per helicopter of $481 and a total cost of $25,493 to the U.S. fleet.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I,
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 helicopters identified in this rulemaking action.
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 that this AD:
(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);
(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 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 amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD applies to Airbus Helicopters (previously Eurocopter France) Model EC120B helicopters, certificated in any category, with a Lighting and Ancillary Control Unit (LACU) part-number (P/N) 040101AB or 040101BA with a float arm pushbutton P/N 045004A111A installed.
This AD defines the unsafe condition as failure of a “float arm” pushbutton, which could result in inoperative floats being used in an emergency water ditching, causing damage to the helicopter or injury to occupants.
This AD supersedes AD 2009-25-07, Amendment 39-16126 (74 FR 65682, December 11, 2009).
This AD becomes effective January 24, 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) Before further flight, amend the EC120B Rotorcraft Flight Manual Supplement (RFMS) for the Aerazur emergency flotation gear, by inserting a copy of this AD into the Limitations section of the RFMS or by making pen and ink changes to that section to add the information in Figure 1 to paragraph (f)(1) of this AD:
(2) Before each flight over water:
(i) Perform a functional check to determine whether flight over water is permitted under the Limitations section in paragraph (f)(1) of this AD. For purposes of this AD, “flight over water” means flight beyond the power-off gliding distance from shore. “Shore” is an area of land adjacent to the water and above the high water mark but does not include land area that is intermittently under water. The actions required by this paragraph may be performed by the owner/operator (pilot) holding at least a private pilot certificate, and must be entered into the aircraft records showing compliance with this AD in accordance with 14 CFR 43.9(a)(1) through (4) and 14 CFR 91.417(a)(2)(v). The record must be maintained as required by 14 CFR 91.417, 121.380, or 135.439.
(ii) If the LACU fails the functional check required by paragraph (f)(2)(i) of this AD, place a placard over the “float arm” pushbutton that reads “INOP.”
(3) Within 300 hours time-in-service, replace float arm pushbutton P/N 045004A111A with float arm pushbutton P/N 304-2500-00. Installing float arm pushbutton P/N 304-2500-00 is terminating action for the functional check and placard required by paragraphs (f)(2)(i) and (f)(2)(ii) of this AD.
(4) Do not install float arm pushbutton P/N 045004A111A on any helicopter.
(1) The Manager, Safety Management Section, Rotorcraft Standards Branch, FAA, may approve AMOCs for this AD. Send your proposal to: George Schwab, 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.
(1) Airbus Helicopters Emergency Alert Service Bulletin No. 04A007, Revision 1, dated June 30, 2016, and Airbus Helicopters Alert Service Bulletin No. EC120-31A008, Revision 0, dated June 30, 2016, which are not incorporated by reference, contain additional information about the subject of this AD. For service information identified in this AD, 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
(2) The subject of this AD is addressed in European Aviation Safety Agency (EASA) AD No. 2016-0180, dated September 13, 2016. You may view the EASA AD on the internet at
Joint Aircraft Service Component (JASC) Code: 2560 Emergency Equipment.
Federal Aviation Administration (FAA), DOT.
Final rule; request for comments.
We are adopting a new airworthiness directive (AD) for the Enstrom Helicopter Corporation (Enstrom) Model F-28, F-28A, F-28C, F-28C-2, F-28C-2R, F-28F, F-28F-R, TH-28, 280, 280C, 280F, 280FX, 480, and 480B helicopters. This AD requires inspecting certain rod end bearing assemblies. This AD is prompted by an accident. The actions of this AD are intended to prevent an unsafe condition on these helicopters.
This AD becomes effective January 4, 2018.
The Director of the Federal Register approved the incorporation by reference of certain documents listed in this AD as of January 4, 2018.
We must receive comments on this AD by February 20, 2018.
You may send comments by any of the following methods:
•
•
•
•
You may examine the AD docket on the internet at
For service information identified in this final rule, contact Enstrom Helicopter Corporation, 2209 22nd Street, Menominee, MI; telephone (906) 863-1200; fax (906) 863-6821; or at
Manzoor Javed, Senior Aerospace Engineer, Chicago ACO Branch, Compliance and Airworthiness Division, Aircraft Certification Service, FAA, 2300 East Devon Ave., Des Plaines, IL 60018; telephone (847) 294-8112; email
This AD is a final rule that involves requirements affecting flight safety, and we did not provide you with notice and an opportunity to provide your comments prior to it becoming effective. However, 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 resulted from adopting this AD. The most helpful comments reference a specific portion of the AD, 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 them 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 rulemaking during the comment period. We will consider all the comments we receive and may conduct additional rulemaking based on those comments.
We are adopting a new AD for Enstrom Model F-28, F-28A, F-28C, F-28C-2, F-28C-2R, F-28F, F-28F-R, TH-28, 280, 280C, 280F, 280FX, 480, and 480B helicopters with a rod end bearing assembly (bearing assembly) part number (P/N) 01-824-08E-011, 09455-01-824-08E-011, ECD091-1, ASMK8T, M81935/1-08K, MS21242S8K, or MTK8 installed. We received a report of an accident involving an Enstrom Model 480B helicopter in which one of the main rotor (M/R) blades departed in-flight. The preliminary investigation indicated that failure of a rod end bearing assembly of one of the M/R hydraulic damper assemblies may have caused the M/R blade to depart from the helicopter. Based on a partially visible marking, the FAA believes the failed part is assembly P/N ECD091-1, vendor P/N 09455-01-824-08E-011. Analysis of the failed assembly revealed corrosion in the root of the threaded portion of the rod end. Enstrom identified a potential failure mode whereby failure of the rod end bearing assembly may result in the loss of the M/R blade. Because there is no indication of a specific manufacturing or design issue that would limit the potential for this corrosion to have occurred on other similarly-designed rod ends, the FAA determined it necessary to require an inspection of all approved rod end P/Ns.
Accordingly, this AD requires, within 5 hours time-in-service (TIS), a one-time inspection of the bearing assemblies for corrosion on the threaded portion of the rod end. If there is any corrosion, this AD requires replacing the bearing assembly before further flight. This AD also requires reporting information about the inspection to the FAA within 10 days.
The actions specified by this AD are intended to detect corrosion in the bearing assembly to prevent failure of the rod end, loss of an M/R blade, and subsequent loss of control of the helicopter. Additional inspections at longer intervals may also be necessary.
We are issuing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other helicopters of these same type designs.
Enstrom has issued Service Directive Bulletin (SDB) No. 0127, Revision 1, dated October 6, 2017, for Model F-28, F-28A, F-28C, F-28C-2, F-28C-2R, F-28F, F-28F-R, 280, 280C, 280F, and 280FX helicopters and SDB No. T-058, dated August 2, 2017, for Model TH-28, 480, and 480B helicopters. This service information provides procedures for inspecting certain vendor specific bearing assemblies P/N ECD091-1 for corrosion on the threaded portion of the rod end.
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 AD requires, within 5 hours TIS, inspecting each M/R hydraulic damper bearing assembly P/N ECD091-1, and for model F-28, F-28A, F-28C, F-28C-2, F-28C-2R, F-28F, F-28F-R, 280, 280C, 280F, and 280FX helicopters each belt tension shaft bearing assembly P/N 01-824-08E-011, 09455-01-824-08E-011, ASMK8T, ECD091-1, MTK8, M81935/1-08K, and MS21242S8K, for corrosion at the root of the thread on the rod end with a 5X or higher power magnifying glass. If there is any corrosion, this AD requires replacing the bearing assembly before further flight.
This AD also requires, within 10 days after completing each inspection, reporting the findings of the inspection to the FAA's Chicago ACO Branch, including: The owner's contact information, helicopter registration number and model, date of the inspection, total hours of the bearing assembly and helicopter, bearing assembly serial number, the location of any corrosion, and a description of any corrosion.
The service information specifies repeating the visual inspection for corrosion at every 100 hour or annual inspection, while this AD does not, as this time interval would allow for sufficient time for notice and comment.
Also, the service information only applies to bearing assembly P/N ECD091-1 and only specifies performing an inspection if marked with vendor P/N 09455-01-824-08E-011 or if the marking is missing or illegible. This AD applies to all P/N ECD091-1, 09455-01-824-08E-011, MTK8, ASMK8T, 01-824-08E-011, M81935/1-08K, and MS21242S8K bearing assemblies. Because the FAA does not have any data that positively confirms the root cause as a manufacturing batch, the AD requires inspections on all P/Ns of the same type design. The data received about the initial inspections will be used to determine the effectivity of any follow-on actions.
Finally, the service information specifies reporting the inspection findings to Enstrom, while this AD requires reporting the findings to the FAA.
We consider this AD interim action. The inspection reports that are required by this AD will enable us to obtain better insight into the nature of the corrosion and to develop final action to address the unsafe condition. Once final action has been identified, we might consider further rulemaking.
We estimate that this AD affects 513 helicopters of U.S. Registry.
At an average labor rate of $85 per work-hour, we estimate that operators may incur the following costs in order to comply with this AD.
Inspecting the bearing assemblies will require 5 work-hours, for a cost per helicopter of $425 and a total cost of $218,025 to the U.S. fleet.
Reporting the inspection results required by this AD will require about 0.5 work-hour, for a cost per helicopter of $43, and a total cost of $22,059 to the U.S. fleet.
If required, replacing one bearing assembly will not incur any additional work-hours, and required parts will cost $410, for a cost per helicopter of $410.
A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a current valid OMB control number. The control number for the collection of information required by this AD is 2120-0056. The paperwork cost associated with this AD has been detailed in the Costs of Compliance section of this document and includes time for reviewing instructions, as well as completing and reviewing the collection of information. Therefore, all reporting required by this AD is mandatory. Comments concerning the accuracy of this burden and suggestions for reducing the burden should be directed to the FAA at 800 Independence Ave. SW, Washington, DC 20591. ATTN: Information Collection Clearance Officer, AES-200.
An unsafe condition exists that requires the immediate adoption of this AD without providing an opportunity for public comments prior to adoption. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because the bearing assembly inspection required by this AD must be accomplished within 5 hours TIS. Therefore, we find good cause that notice and opportunity for prior public comment are impracticable. In addition, for the reason(s) stated above, we find that good cause exists for making this amendment effective in less than 30 days.
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 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
For the reasons discussed, I certify that this AD:
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);
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 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 amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD applies to the Enstrom Helicopter Corporation (Enstrom) Model F-28, F-28A, F-28C, F-28C-2, F-28C-2R, F-28F, F-28F-R, TH-28, 280, 280C, 280F, 280FX, 480, and 480B helicopters, certificated in any category, with a rod end bearing assembly (bearing assembly) P/N 01-824-08E-011, 09455-01-824-08E-011, ECD091-1, ASMK8T, M81935/1-08K, MS21242S8K, or MTK8 installed.
This AD defines the unsafe condition as corrosion on a bearing assembly rod end thread. This condition could result in a crack in the bearing assembly, failure of the rod end resulting in loss of a main rotor blade, and loss of control of the helicopter.
This AD becomes effective January 4, 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 5 hours time-in-service (TIS), using a 5X or higher power magnifying glass, inspect each main rotor damper bearing assembly for corrosion on the threaded portion of the rod end as shown in Figure 1 of Enstrom Service Directive Bulletin (SDB) No. 0127, Revision 1, dated October 6, 2017 (SDB 0127), for Model F-28, F-28A, F-28C, F-28C-2, F-28C-2R, F-28F, F-28F-R, 280, 280C, 280F, and 280FX helicopters or Enstrom SDB No. T-058, dated August 2, 2017 (SDB T-058), for model TH-28, 480, and 480B helicopters, as appropriate for your model helicopter. If there is any corrosion, before further flight, replace the bearing assembly.
(2) For Model F-28, F-28A, F-28C, F-28C-2, F-28C-2R, F-28F, F-28F-R, 280, 280C, 280F, and 280FX helicopters, within 5 hours TIS, using a 5X or higher power magnifying glass, inspect each belt tension shaft rod end bearing assembly for corrosion on the threaded portion of the rod end as shown in Figure 1 of SDB 0127. If there is any corrosion, before further flight, replace the bearing assembly.
(3) Within 10 days after completing the inspections required by paragraph (e)(1) and (e)(2) of this AD, report the findings of each inspection, including the helicopter owner, address, telephone number, email address, helicopter model, helicopter registration number, date of inspection, total hours TIS of the helicopter, total hours TIS of the bearing, bearing assembly serial number, location of any corrosion, and a description of any corrosion, by mail or email to the individual listed in paragraph (g)(1) of this AD.
A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to a penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a current valid OMB Control Number. The OMB Control Number for this information collection is 2120-0056. Public reporting for this collection of information is estimated to be approximately 30 minutes per response, including the time for reviewing instructions, completing and reviewing the collection of information. All responses to this collection of information are mandatory. Comments concerning the accuracy of this burden and suggestions for reducing the burden should be directed to the FAA at: 800 Independence Ave. SW, Washington, DC 20591, Attn: Information Collection Clearance Officer, AES-200.
(1) The Manager, Chicago ACO Branch, Compliance and Airworthiness Division, Aircraft Certification Service, FAA, may approve AMOCs for this AD. Send your proposal to: Manzoor Javed, Senior Aerospace Engineer, Chicago ACO Branch, Compliance and Airworthiness Division, Aircraft Certification Service, FAA, 2300 East Devon Ave., Des Plaines, IL 60018; telephone (847) 294-8112; 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.
Joint Aircraft Service Component (JASC) Code: 6200 Main Rotor System.
(1) The Director of the Federal Register approved the incorporation by reference 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.
(i) Enstrom Service Directive Bulletin No. 0127, Revision 1, dated October 6, 2017.
(ii) Enstrom Service Directive Bulletin No. T-058, dated August 2, 2017.
(3) For Enstrom service information identified in this AD, contact Enstrom Helicopter Corporation, 2209 22nd Street, Menominee, MI; telephone (906) 863-1200; fax (906) 863-6821; or at
(4) You may view this service information at FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy, Room 6N-321, Fort Worth, TX 76177. For information on the availability of this material at the FAA, call (817) 222-5110.
(5) 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), Department of Transportation (DOT).
Final rule; request for comments.
We are superseding airworthiness directive (AD) 2011-27-08 for Agusta S.p.A. (Agusta) Model A109S and AW109SP helicopters. AD 2011-27-08 required repetitively inspecting each elevator assembly for a crack. This new AD retains the initial inspection interval and adds a repetitive borescope inspection. This AD is prompted by the discovery of another crack on an elevator assembly since AD 2011-27-08 was issued. The actions of this AD are intended to prevent an unsafe condition on these helicopters.
This AD becomes effective January 4, 2018.
The Director of the Federal Register approved the incorporation by reference of certain documents listed in this AD as of January 4, 2018.
We must receive comments on this AD by February 20, 2018.
You may send comments by any of the following methods:
•
•
•
•
You may examine the AD docket on the internet at
For service information identified in this final rule, contact Leonardo S.p.A. Helicopters, Matteo Ragazzi, Head of Airworthiness, Viale G.Agusta 520, 21017 C.Costa di Samarate (Va) Italy; telephone +39-0331-711756; fax +39-0331-229046; or at
David Hatfield, Aviation Safety Engineer, Safety Management Section, Rotorcraft Standards Branch, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone (817) 222-5110; email
This AD is a final rule that involves requirements affecting flight safety, and we did not provide you with notice and an opportunity to provide your comments prior to it becoming effective. However, 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 resulted from adopting this AD. The most helpful comments reference a specific portion of the AD, 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 them 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 rulemaking during the comment period. We will consider all the comments we receive and may conduct additional rulemaking based on those comments.
We issued AD 2011-27-08 (77 FR 3382, January 24, 2012) (2011-27-08), for Agusta Model A109S and AW109SP helicopters with elevator assemblies, part number (P/N) 109-0200-02-601, 109-0200-02-801, 109-0200-02-602, 109-0200-02-802, 109-0200-02-803, or 109-0200-02-804 installed. AD 2011-27-08 required repetitively inspecting the left and right elevator assemblies for a crack and replacing the elevator assembly before further flight if there is a crack. AD 2011-27-08 was prompted by AD No. 2011-0150, dated August 9, 2011 (AD 2011-0150), issued by EASA, which is the Technical Agent for the Member States of the European Union, to correct an unsafe condition for Agusta Model A109S and AW109SP helicopters. EASA advised of a fracture of the left elevator assembly along the riveting of the upper skin to the fourth rib due to fatigue.
Since we issued AD 2011-27-08, EASA has issued Emergency AD No. 2017-0085-E, dated May 12, 2017 (EAD 2017-0085-E), which supersedes AD 2011-0150. EASA advises that since AD 2011-0150 was issued, another crack was found in an elevator assembly during a post-flight inspection on an A109S helicopter. EAD 2017-0085-E requires a one-time visual or dye-penetrant inspection of the elevator upper skin in the area of the fourth rib, and also requires drilling an access hole in each elevator and performing repetitive inspections of the internal areas with an endoscope. If there is a crack, EAD 2017-0085-E requires replacing the cracked elevator assembly or contacting Agusta for an approved repair.
Also, the FAA is in the process of updating Agusta's name change to Leonardo Helicopters S.p.A. on its FAA type certificate. Because this name change is not yet effective, this AD specifies Agusta.
These helicopters have been approved by the aviation authority of Italy and are approved for operation in the United States. Pursuant to our bilateral agreement with Italy, EASA, its technical representative, has notified us of the unsafe condition described in the EASA AD. We are issuing this AD because we evaluated all information provided by EASA and determined the unsafe condition exists and is likely to exist or develop on other helicopters of these same type designs.
Leonardo Helicopters has issued Emergency Alert Service Bulletin (EASB) No. 109S-076 for Model A109S helicopters, and EASB No. 109SP-113 for Model AW109SP helicopters, both Revision A and dated May 12, 2017. Each EASB specifies procedures for visually inspecting the elevator assembly skin for a crack, adding an inspection hole to the elevator assembly, and inspecting the interior of the elevator assembly with an endoscope.
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 AD retains the initial visual inspection of AD 2011-27-08, but changes the compliance time to before further flight or before the elevator assembly exceeds 400 hours TIS, whichever occurs later.
The AD also requires, within 10 hours TIS or before the elevator assembly exceeds 400 hours TIS, whichever occurs later, drilling an access hole on the lower face of each elevator assembly and performing a borescope inspection of the internal areas of the elevator assembly leading edge and trailing edge longerons and upper web for a crack. If there is a crack, the AD requires replacing the elevator assembly before further flight. Lastly, this AD requires repeating the borescope inspection every 25 hours TIS.
The EASA AD allows a dye-penetrant inspection of the elevator assembly as an option, while this AD does not.
We estimate that this AD will affect 14 helicopters of U.S. Registry.
At an average labor rate of $85 per hour, we estimate that operators may incur the following costs in order to comply with this AD. Inspecting the elevator assemblies with a magnifying glass will require 3 work-hours for a cost of $255 per helicopter and $3,570 for the U.S. fleet.
Drilling an access hole will require 1 work-hour and required parts cost would be minimal, for a cost of $85 per helicopter and $1,190 for the U.S. fleet.
Inspecting with a borescope will require 1 work-hour for a cost of $85 per helicopter and $1,190 for the U.S. fleet per inspection cycle.
If required, replacing a cracked elevator assembly will require 10 work-hours and required parts will cost $23,905 for a cost per helicopter of $24,755.
An unsafe condition exists that requires the immediate adoption of this AD without providing an opportunity for public comments prior to adoption. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because some of the corrective actions must be accomplished before further flight. Therefore, we find good cause that notice and opportunity for prior public comment are impracticable. In addition, for the reason stated above, we find that good cause exists for making this amendment effective in less than 30 days.
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 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, I certify that this AD:
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);
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 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 amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD applies to Model A109S and AW109SP helicopters with elevator assemblies, part number (P/N) 109-0200-02-601, 109-0200-02-801, 109-0200-02-602, 109-0200-02-802, 109-0200-02-803, or 109-0200-02-804 installed, certificated in any category.
This AD defines the unsafe condition as a fatigue crack on the elevator assembly. This condition could result in failure of the elevator, reduced maneuverability of the helicopter, and subsequent loss of control of the helicopter.
This AD supersedes AD 2011-27-08, Amendment 39-16910 (77 FR 3382, January 24, 2012).
This AD becomes effective January 4, 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) Before further flight or before the elevator assembly accumulates 400 hours time-in-service (TIS), whichever occurs later, inspect the left and right elevator upper skin along the 4th rib station rivet line from the leading edge to 200 mm aft with a 10X or higher power magnifying glass for a crack in the area depicted in Figure 1 of Leonardo Helicopters Emergency Alert Service Bulletin (EASB) No. 109S-076, Revision A, dated May 12, 2017 (EASB 109S-076), or EASB No. 109SP-113, Revision A, dated May 12, 2017 (EASB 109SP-113), as appropriate for your model helicopter. If there is a crack, before further flight, replace the elevator assembly.
(2) Within 10 hours TIS or before the elevator assembly accumulates 400 hours TIS, whichever occurs later:
(i) Drill a 19.05 mm access hole on the lower face of each elevator assembly as depicted in Figure 2 of EASB 109S-076 or EASB 109SP-113, as appropriate for your model helicopter. Apply Alodine or equivalent coating and epoxy polyamide primer to the hole surface.
(ii) Using a borescope, inspect the internal area of each elevator assembly for a crack along the leading edge and trailing edge longerons and upper web as depicted in Figure 3 of EASB 109S-076 or EASB 109SP-113, as appropriate for your model helicopter. If there is a crack, before further flight, replace the elevator assembly. Repeat this inspection at intervals not to exceed 25 hours TIS.
(1) The Manager, Safety Management Section, Rotorcraft Standards Branch, FAA, may approve AMOCs for this AD. Send your proposal to: David Hatfield, 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. 2017-0085-E, dated May 12, 2017. You may view the EASA AD on the internet at
Joint Aircraft Service Component (JASC) Code: 5520 Elevator Structure.
(1) The Director of the Federal Register approved the incorporation by reference 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.
(i) Leonardo Helicopters Emergency Alert Service Bulletin No. 109S-076, Revision A, dated May 12, 2017.
(ii) Leonardo Helicopters Emergency Alert Service Bulletin No. 109SP-113, Revision A, dated May 12, 2017.
(3) For Leonardo Helicopters service information identified in this AD, contact Leonardo S.p.A. Helicopters, Matteo Ragazzi, Head of Airworthiness, Viale G. Agusta 520, 21017 C. Costa di Samarate (Va) Italy; telephone +39-0331-711756; fax +39-0331-229046; or at
(4) You may view this service information at FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy, Room 6N-321, Fort Worth, TX 76177. For information on the availability of this material at the FAA, call (817) 222-5110.
(5) 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.
We are adopting a new airworthiness directive (AD) for certain The Boeing Company Model 757-200 series airplanes. This AD was prompted by a report indicating that the main cargo door (MCD) forward-most cam latch on the forward center cam latch pair broke during flight. This AD requires repetitive inspections for discrepancies of cam latches, latch pins, and latch pin cross bolts of the MCD; replacement of all alloy steel latch pin cross bolts with corrosion-resistant steel (CRES) latch pin cross bolts of the MCD; and related investigative and corrective actions if necessary. We are issuing this AD to address the unsafe condition on these products.
This AD is effective January 24, 2018.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of January 24, 2018.
For service information identified in this final rule, contact VT Mobile Aerospace Engineering Inc., 2100 9th Street, Brookley Aeroplex, Mobile, AL 36615; telephone: 251-379-0112; email:
You may examine the AD docket on the internet at
Samuel Belete, Aerospace Engineer, Systems and Equipment Section, FAA, Atlanta ACO Branch, 1701 Columbia Avenue, College Park, GA 30337; telephone: 404-474-5580; fax: 404-474-5605; email:
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain The Boeing Company Model 757-200 series airplanes. The NPRM published in the
We are issuing this AD to detect and correct discrepancies of the MCD cam latches, latch pins, and latch pin cross bolts, which, if left undetected, could reduce the structural integrity of the MCD and result in potential loss of the cargo door and rapid decompression of the airplane.
We gave the public the opportunity to participate in developing this final rule. We have considered the comments received. Air Line Pilots Association, International, FedEx Express, and VT Mobile Aerospace Engineering Inc. supported the NPRM.
We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this final rule 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 VT Mobile Aerospace Engineering Inc. Service Bulletin MAE757SF-SB-52-12/02, Revision 3, dated July 22, 2016. This service information describes procedures for doing inspections for discrepancies of cam latches, latch pins, and latch pin cross bolts of the MCD; replacement of all alloy steel latch pin cross bolts with CRES latch pin cross bolts of the MCD; and related investigative and corrective actions. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
We estimate that this AD affects 119 airplanes of U.S. registry.
We estimate the following costs to comply with this AD:
We estimate the following costs to do any necessary replacement of latch pin cross bolts and related investigative and corrective actions that would be required based on the results of the inspection. We have no way of determining the number of aircraft that might need these actions:
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 transport category airplanes to the Director of the System Oversight Division.
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 that this AD:
(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),
(3) Will not affect intrastate aviation in Alaska, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD is effective January 24, 2018.
None.
This AD applies to The Boeing Company Model 757-200 series airplanes, certificated in any category, that have been converted from passenger to freighter configuration as specified in any of the VT Mobile Aerospace Engineering Inc. supplemental type certificates (STCs) identified in paragraphs (c)(1), (c)(2), and (c)(3) of this AD.
(1) STC ST03562AT (14 pallet) (
(2) STC ST04242AT (15 pallet) (
(3) STC ST03952AT (combi—airplanes that can carry passenger, freight, or both in the cabin) (
Air Transport Association (ATA) of America Code 52, Doors.
This AD was prompted by a report indicating that the main cargo door (MCD) forward-most cam latch on the forward center cam latch pair broke during flight. We are issuing this AD to detect and correct discrepancies of the MCD cam latches, latch pins, and latch pin cross bolts, which, if left undetected, could reduce the structural integrity of the MCD and result in potential loss of the MCD and rapid decompression of the airplane.
Comply with this AD within the compliance times specified, unless already done.
At the applicable time specified in paragraph I.D., “Compliance,” of VT Mobile Aerospace Engineering Inc. Service Bulletin MAE757SF-SB-52-12/02, Revision 3, dated July 22, 2016 (“SB MAE757SF-SB-52-12/02, R3”), except as required by paragraph (h)(1) of this AD; or within 30 days after the effective date of this AD, whichever occurs later: Do the actions specified in paragraphs (g)(1) through (g)(4) of this AD, and do all applicable related investigative and corrective actions, in accordance with the Accomplishment Instructions of SB MAE757SF-SB-52-12/02, R3, except as specified in paragraph (h)(2) of this AD. Do all applicable related investigative and corrective actions before further flight. Repeat the inspections specified in paragraphs (g)(1), (g)(2), and (g)(4) of this AD thereafter at the applicable intervals specified in paragraph I.D., “Compliance,” of SB MAE757SF-SB-52-12/02, R3.
(1) Do a general visual inspection for any broken or missing cam latches, latch pins, and latch pin cross bolts of the MCD.
(2) Do a detailed inspection for any cracks or gouges in critical areas of the cam latches and latch pins of the MCD and for any cam latches with lip deformation.
(3) Replace all previously unreplaced alloy steel latch pin cross bolts with corrosion resistant steel (CRES) latch pin cross bolts of the MCD.
(4) Do a high frequency eddy current (HFEC) or magnetic particle inspection for any cracks in the critical areas of cam latch 1 and cam latch 2 of the MCD.
(1) Where the “Condition” column of table 1 of paragraph I.D., “Compliance,” of SB MAE757SF-SB-52-12/02, R3, refers to airplanes meeting certain conditions identified in “Condition 1,” for this AD, “Condition 1” applies to all airplanes.
(2) Where the Accomplishment Instructions of SB MAE757SF-SB-52-12/02, R3, specify doing actions only for airplanes that have completed a certain rig and check of the MCD, this AD requires doing those actions on all airplanes.
This paragraph provides credit for the actions specified in paragraph (g) of this AD, if those actions were performed before the effective date of this AD using VT Mobile Aerospace Engineering Inc. Service Bulletin MAE757SF-SB-52-12/02, Revision 2, dated February 18, 2016.
A special flight permit may be issued in accordance with sections 21.197 and 21.199 of the Federal Aviation Regulations (14 CFR 21.197 and 21.199) to operate the airplane, for a single unpressurized flight, to a location where the requirements of this AD can be accomplished.
(1) The Manager, Atlanta ACO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the ACO, send it to the attention of the person identified in paragraph (l) of this AD.
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
For more information about this AD, contact Samuel Belete, Aerospace Engineer, Systems and Equipment Section, Atlanta ACO Branch, 1701 Columbia Avenue, College Park, GA 30337; telephone 404-474-5580; fax 404-474-5605; email:
(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.
(i) VT Mobile Aerospace Engineering Inc. Service Bulletin MAE757SF-SB-52-12/02, Revision 3, dated July 22, 2016. The date appears only on pages 1 and 3 of this document.
(ii) Reserved.
(3) For service information identified in this AD, contact VT Mobile Aerospace Engineering Inc., 2100 9th Street, Brookley Aeroplex, Mobile, AL 36615; telephone: 251-379-0112; email:
(4) You may view this service information at the FAA, Transport Standards Branch, 1601 Lind Avenue SW, Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.
(5) 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.
Notification of changes in ADS-B services.
This action announces changes in ADS-B services, including Traffic Information Service—Broadcast (TIS-B), for a small number of aircraft. The FAA is implementing a filter for certain ADS-B equipped aircraft
The action described herein is implemented January 2, 2018.
For technical questions concerning this action, contact: David E. Gray, Program Manager, Surveillance and Broadcast Services, AJM-232, Air Traffic Organization, Federal Aviation Administration, 600 Independence Ave. SW, Wilbur Wright Building, Washington, DC 20597; telephone: 202-267-3615; email:
In 2010, the FAA issued a final rule mandating equipage requirements and performance standards for Automatic Dependent Surveillance—Broadcast (ADS-B) Out avionics on aircraft operating in certain airspace after December 31, 2019. 75 FR 30160, May 28, 2010. Use of ADS-B Out will move air traffic control from a radar-based system to a satellite-derived aircraft location system and enhance aircraft surveillance by FAA and Department of Defense (DOD) air traffic controllers. Equipage with ADS-B avionics also provides aircraft operators with a platform for additional flight applications and services, including TIS-B,
In deploying the ADS-B surveillance infrastructure, the FAA implemented a capability to monitor compliance with § 91.227 requirements for aircraft operating within the U.S. National Airspace System (NAS). Over the past three years, this monitoring has identified some ADS-B Out aircraft with non-performing equipment (NPE) transmitting data used by ATC and ADS-B-In-equipped aircraft that present a potential safety hazard to NAS operations, including but not limited to: Unassigned/invalid 24-bit ICAO addresses; incorrect flight identification codes; erroneous position reports; improper avionics integrity and accuracy levels; and missing data required by applicable regulations.
To reduce the potential hazard presented by NPE aircraft, the FAA is filtering individual 24-bit ICAO address codes (also known as Mode S codes) for certain aircraft from the FAA's operational ADS-B network. The FAA is implementing an ATC filtering capability on January 2, 2018. This filtering prevents processing of data transmitted by uniquely identified NPE aircraft within FAA air traffic control systems and by the FAA TIS-B service. ATC will continue to receive transponder replies to secondary radar interrogations and will be able to provide ATC services within radar coverage to aircraft subject to the filter, using secondary radar information. Also, any aircraft with a filtered ICAO address code will continue to appear as a “target” to nearby aircraft with ADS-B-In equipment.
The FAA will always filter ICAO address codes from aircraft that are transmitting the hexadecimal values “000000” and “FFFFFF.” Per ICAO technical standards which FAA surveillance systems meet, neither of these ICAO address codes should be used by any aircraft ADS-B Out transmitter or Mode S transponder. However, FAA ADS-B monitoring over the last three years indicates that approximately once per day, on average, there is a flight in the NAS using one of these incorrect ICAO address codes and indicating that the aircraft is equipped with an ADS-B-In system. Because these non-compliant codes are not unique to a single aircraft, the potential for multiple aircraft to transmit the same code could create confusion inside ADS-B and TCAS avionics, Mode S interrogators, and ATC automation systems. This confusion could cause an aircraft's position to be incorrectly displayed or not displayed at all, thereby creating an unsafe condition in the NAS. To mitigate this risk and discourage violation of ICAO technical standards, the FAA will filter the ADS-B information from any aircraft transmitting a non-compliant address code from the FAA's operational ATC systems. Therefore, aircraft broadcasting these incorrect ICAO address codes will be unable to receive TIS-B services.
The FAA also intends to utilize the filter for other ICAO codes that are being improperly broadcast or for aircraft whose ADS-B Out equipment has exhibited erroneous position reports that could affect the safe provision of air traffic services. The FAA may also utilize the filter for aircraft that have a known issue that could reasonably result in erroneous ADS-B reports that could affect the safe provision of ATC services.
The FAA has initiated the filtering capability described in this document for aircraft transmitting non-compliant codes. For other aircraft, the FAA intends when possible to provide individual notice to owners/operators prior to utilizing the filter. This notification would describe the reason for applying the filter and steps that must be taken before an aircraft may be removed from the filter. If an aircraft owner/operator does not respond to an FAA notice of finding regarding an ADS-B avionics issue, FAA at its option may subject that aircraft to the filter without further notice.
Owners and operators can identify the ICAO address filtering status of their aircraft by requesting a Public ADS-B Performance Report (PAPR) at the following web address:
Operators should check to insure that the ICAO address code (Mode S code) broadcast by their ADS-B equipment matches the assigned ICAO address code for their aircraft. This ICAO address code (Mode S code) can be found at:
Bureau of Industry and Security, Commerce.
Final rule.
This rule amends the Export Administration Regulations (EAR) by adding two entities to the Entity List. The two entities being added to the Entity List have been determined by the U.S. Government to be acting contrary to the national security or foreign policy interests of the United States. These two entities will be listed on the Entity List under the destination of Russia.
This rule is effective December 20, 2017.
Chair, End-User Review Committee, Office of the Assistant Secretary, Export Administration, Bureau of Industry and Security, Department of Commerce, Phone: (202) 482-5991, Email:
The Entity List (Supplement No. 4 to part 744 of the Export Administration Regulations (EAR)) identifies entities and other persons reasonably believed to be involved, or to pose a significant risk of being or becoming involved, in activities contrary to the national security or foreign policy interests of the United States. The EAR imposes additional license requirements on, and limits the availability of most license exceptions for, exports, reexports, and transfers (in-country) to those listed. The “license review policy” for each listed entity or other person is identified in the License Review Policy column on the Entity List and the impact on the availability of license exceptions is described in the
The End-User Review Committee (ERC), composed of representatives of the Departments of Commerce (Chair), State, Defense, Energy and, where appropriate, the Treasury, makes all decisions regarding additions to, removals from, or other modifications to the Entity List. The ERC makes decisions to add an entry to the Entity List by majority vote and decisions to remove or modify an entry by unanimous vote. The Departments represented on the ERC have approved these changes to the Entity List.
This rule implements the decision of the ERC to add two entities to the Entity List. These two entities are being added on the basis of § 744.11 (License requirements that apply to entities acting contrary to the national security or foreign policy interests of the United States) of the EAR. The two entries added to the Entity List consist of two entities located in Russia.
Under § 744.11(b) (Criteria for revising the Entity List) of the EAR, persons for whom there is reasonable cause to believe, based on specific and articulable facts, that they have been involved, are involved, or pose a significant risk of being or becoming involved in, activities that are contrary to the national security or foreign policy interests of the United States and those acting on behalf of such persons may be added to the Entity List. Paragraphs (b)(1) through (b)(5) of § 744.11 provide an illustrative list of activities that could be contrary to the national security or foreign policy interests of the United States.
BIS, pursuant to Section 744.11(b) of the EAR, and in consultation with the Departments of State, Defense, Energy and the Treasury, has designated the two persons, located in the Russian Federation, to be added to the Entity List for actions contrary to the national security or foreign policy interests of the United States. Specifically, these entities produced, for the Russian Federation Ministry of Defense, a ground-launched cruise missile system, and associated transporter-erector-launcher, with a range prohibited by the Intermediate-Range Nuclear Forces Treaty. Both the Russian Federation and the United States are party to the INF Treaty. Therefore, there is reasonable cause to believe, based on specific and articulable facts, that Joint Stock Company Experimental Design Bureau Novator, and Joint Stock Company Federal Scientific and Production Center Titan-Barrikady have been involved in actions contrary to the national security or foreign policy interests of the United States.
The prior review of exports, reexports or transfers (in-country) of all items subject to the EAR involving these persons, and the possible imposition of license conditions or license denials on shipments to the persons, will enhance BIS's ability to prevent use of items subject to the EAR contrary to U.S. national security or foreign policy interests.
For the two persons added to the Entity List, BIS imposes a license requirement for all items subject to the EAR, and a license review policy of presumption of denial. The license requirements apply to any transaction in which items are to be exported, reexported, or transferred (in-country) to either of the persons or in which such persons act as purchaser, intermediate consignee, ultimate consignee, or end-user. In addition, no license exceptions are available for exports, reexports, or transfers (in-country) to the persons being added to the Entity List in this rule. The acronym “a.k.a.” (also known as) is used in entries on the Entity List to identify aliases and help exporters, reexporters and transferors to better identify persons on the Entity List.
This final rule adds the following two entities to the Entity List:
(1)
18 Prospekt Kosmonavtov, 620017 Yekaterinburg, Russia;
(2)
Prospekt Imeni V.I. Lenina, b/n 400071, Volgograd, Russia.
Although the Export Administration Act of 1979 expired on August 20, 2001, the President, through Executive Order 13222 of August 17, 2001, 3 CFR, 2001 Comp., p. 783 (2002), as amended by Executive Order 13637 of March 8, 2013, 78 FR 16129 (March 13, 2013) and as extended by the Notice of August 15, 2017, 82 FR 39005 (August 16, 2017), has continued the Export Administration Regulations in effect under the International Emergency Economic Powers Act. BIS continues to carry out the provisions of the Export Administration Act of 1979, as appropriate and to the extent permitted by law, pursuant to Executive Order
1. Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been determined to be not significant for purposes of Executive Order 12866. This rule is not an Executive Order 13771 regulatory action because this rule is not significant under Executive Order 12866.
2. Notwithstanding any other provision of law, no person is required to respond to nor be subject to a penalty for failure to comply with a collection of information, subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Total burden hours associated with the PRA and OMB control number 0694-0088 are not expected to increase as a result of this rule. You may send comments regarding the collection of information associated with this rule, including suggestions for reducing the burden, to Jasmeet K. Seehra, Office of Management and Budget (OMB), by email to
3. This rule does not contain policies with Federalism implications as that term is defined in Executive Order 13132.
4. For the two persons added to the Entity List in this final rule, the provisions of the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, the opportunity for public participation and a 30-day delay in effective date are inapplicable because this regulation involves a military or foreign affairs function of the United States (5 U.S.C. 553(a)(1)). BIS implementation of this rule is necessary to protect U.S. national security or foreign policy interests by preventing items from being exported, reexported, or transferred (in-country) to the persons being added to the Entity List. If this rule were delayed to allow for notice and comment and a delay in effective date, the entities being added to the Entity List by this action would continue to be able to receive items without a license and to conduct activities contrary to the national security or foreign policy interests of the United States. In addition, publishing a proposed rule would give these parties notice of the U.S. Government's intention to place them on the Entity List, which could create an incentive for these persons to accelerate receiving items subject to the EAR to conduct activities that are contrary to the national security or foreign policy interests of the United States, including taking steps to set up additional aliases, change addresses, and other measures to try to limit the impact of the listing on the Entity List once a final rule is published. Further, no other law requires that a notice of proposed rulemaking and an opportunity for public comment be given for this rule. Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule by 5 U.S.C. 553, or by any other law, the analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601
Exports, Reporting and recordkeeping requirements, Terrorism.
Accordingly, part 744 of the Export Administration Regulations (15 CFR parts 730-774) is amended as follows:
50 U.S.C. 4601
The additions read as follows:
Food and Drug Administration, HHS.
Final order.
The Food and Drug Administration (FDA or we) is classifying the image processing device for estimation of external blood loss into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the image processing device for estimation of external blood loss' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
This order is effective December 20, 2017. The classification was applicable on May 9, 2014.
Jitendra Virani, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G459, Silver Spring, MD 20993-0002, 301-796-6398,
Upon request, FDA has classified the image processing device for estimation of external blood loss as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment.
The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).
FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate by means of the procedures for premarket notification under section 510(k) of the FD&C Act and part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively).
FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 established the first procedure for De Novo classification (Pub. L. 105-115). Section 607 of the Food and Drug Administration Safety and Innovation Act modified the De Novo application process by adding a second procedure (Pub. L. 112-144). A device sponsor may utilize either procedure for De Novo classification.
Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).
Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.
Under either procedure for De Novo classification, FDA shall classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device.
We believe this De Novo classification will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application (PMA) in order to market a substantially equivalent device (see 21 U.S.C. 360c(i), defining
For this device, FDA issued an order on November 13, 2012, finding the Gauss Surgical Pixel 3 Application not substantially equivalent to a predicate not subject to PMA. Thus, the device remained in class III in accordance with section 513(f)(1) of the FD&C Act when we issued the order.
On February 4, 2013, Gauss Surgical, Inc., submitted a request for De Novo classification of the PIXEL 3 SYSTEM. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.
We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.
Therefore, on May 9, 2014, FDA issued an order to the requester classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 880.2750. We have named the generic type of device image processing device for estimation of external blood loss, and it is identified as a device to be used as an aid in estimation of patient external blood loss. The device may include software and/or hardware that is used to process images capturing externally lost blood to estimate the hemoglobin mass and/or the blood volume present in the images.
FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1.
FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act.
The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in the guidance document “De Novo Classification Process (Evaluation of Automatic Class III Designation)” have been approved under OMB control number 0910-0844; the collections of information in part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; and the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910-0485.
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 880 is amended as follows:
21 U.S.C. 351, 360, 360c, 360e, 360j, 360
(a)
(b)
(1) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. Demonstration of the performance characteristics must include a comparison to a scientifically valid alternative method for measuring deposited hemoglobin mass. The following use conditions must be tested:
(i) Lighting conditions;
(ii) Range of expected hemoglobin concentrations;
(iii) Range of expected blood volume absorption; and
(iv) Presence of other non-sanguineous fluids (
(2) Human factors testing and analysis must validate that the device design and labeling are sufficient for appropriate use by intended users of the device.
(3) Appropriate analysis and non-clinical testing must validate the electromagnetic compatibility (EMC) and wireless performance of the device.
(4) Appropriate software verification, validation, and hazard analysis must be performed.
(5) Software display must include an estimate of the cumulative error associated with estimated blood loss values.
(6) Labeling must include:
(i) Warnings, cautions, and limitations needed for safe use of the device;
(ii) A detailed summary of the performance testing pertinent to use of the device, including a description of the bias and variance the device exhibited during testing;
(iii) The validated surgical materials, range of hemoglobin mass, software, hardware, and accessories that the device is intended to be used with; and
(iv) EMC and wireless technology instructions and information.
Pension Benefit Guaranty Corporation.
Final rule.
This rule amends the Pension Benefit Guaranty Corporation's regulation on Allocation of Assets in Single-Employer Plans by substituting a new table for determining expected retirement ages for participants in pension plans undergoing distress or involuntary termination with valuation dates falling in 2018. This table is needed to compute the value of early retirement benefits and, thus, the total value of benefits under a plan.
This rule is effective January 1, 2018.
Hilary Duke (
The Pension Benefit Guaranty Corporation (PBGC) administers the pension plan termination insurance program under Title IV of the Employee Retirement Income Security Act of 1974 (ERISA). PBGC's regulation on Allocation of Assets in Single-Employer Plans (29 CFR part 4044) sets forth (in subpart B) the methods for valuing plan benefits of terminating single-employer plans covered under Title IV. Guaranteed benefits and benefit liabilities under a plan that is undergoing a distress termination must be valued in accordance with subpart B of part 4044. In addition, when PBGC terminates an underfunded plan involuntarily pursuant to ERISA section 4042(a), it uses the subpart B valuation rules to determine the amount of the plan's underfunding.
Under § 4044.51(b) of the asset allocation regulation, early retirement benefits are valued based on the annuity starting date, if a retirement date has been selected, or the expected retirement age, if the annuity starting date is not known on the valuation date. Sections 4044.55 through 4044.57 set forth rules for determining the expected retirement ages for plan participants entitled to early retirement benefits. Appendix D of part 4044 contains tables to be used in determining the expected early retirement ages.
Table I in appendix D (Selection of Retirement Rate Category) is used to determine whether a participant has a low, medium, or high probability of retiring early. The determination is based on the year a participant would reach “unreduced retirement age” (
Tables II-A, II-B, and II-C (Expected Retirement Ages for Individuals in the Low, Medium, and High Categories respectively) are used to determine the expected retirement age after the probability of early retirement has been determined using Table I. These tables establish, by probability category, the expected retirement age based on both the earliest age a participant could retire under the plan and the unreduced retirement age. This expected retirement age is used to compute the value of the early retirement benefit and, thus, the total value of benefits under the plan.
This document amends appendix D to replace Table I-17 with Table I-18 to provide an updated correlation, appropriate for calendar year 2018, between the amount of a participant's benefit and the probability that the participant will elect early retirement. Table I-18 will be used to value benefits in plans with valuation dates during calendar year 2018.
PBGC has determined that notice of, and public comment on, this rule are impracticable and contrary to the public interest. Plan administrators need to be able to estimate accurately the value of plan benefits as early as possible before initiating the termination process. For that purpose, if a plan has a valuation date in 2018, the plan administrator needs the updated table being promulgated in this rule. Accordingly, PBGC finds that the public interest is best served by issuing this table expeditiously, without an opportunity for notice and comment, and that good cause exists for making the table set forth in this amendment effective less than 30 days after publication to allow as much time as possible to estimate the value of plan benefits with the proper table for plans with valuation dates in early 2018.
PBGC has determined that this action is not a “significant regulatory action” under the criteria set forth in Executive Order 12866 and Executive Order 13771.
Because no general notice of proposed rulemaking is required for this regulation, the Regulatory Flexibility Act of 1980 does not apply (5 U.S.C. 601(2)).
Employee benefit plans, Pension insurance.
In consideration of the foregoing, 29 CFR part 4044 is amended as follows:
29 U.S.C. 1301(a), 1302(b)(3), 1341, 1344, 1362.
Issued in Washington, DC, by:
United States Mint, Treasury.
Final rule.
This final rule revises Treasury regulations relating to the exchange of uncurrent, bent, partial, fused, and mixed coins, and to update the regulations to comply with the requirement for orderly codification. The revisions include updates to redemption rates and procedures that will enhance the integrity of the acceptance and processing of bent and partial United States coins.
Sheila Barnett, Legal Counsel; Office of the Chief Counsel; United States Mint; at (202) 354-7624 or
The Treasury Regulations appearing at 31 CFR part 100, subpart C, are promulgated under 31 U.S.C. 5120, and relate to the exchange of uncurrent, bent, partial, fused, and mixed coins. The last amendment to 31 CFR part 100, subpart C, was on August 23, 1999. Since then, the United States Mint identified portions of the regulations in need of revision to update redemption rates and procedures, and to enhance the integrity of the acceptance and processing of bent and partial United States coins.
The first category of revisions updates and improves the redemption process of bent and partial coins to enhance security and ensure the integrity of United States coinage. The revisions establish procedures for certifying participants based on submission amounts and frequency, sampling submissions to authenticate material, conducting site visits for certain participants, and requiring information on how the submission came to be bent or partial. The revisions also inform submitters of required banking information. Lastly, the revisions provide the United States Mint discretion to cease processing submissions that appear to be part of an illegal scheme, or contain material that is not identifiable as bent or partial United States coinage.
The second category of revisions relates to the redemption rates for uncurrent coins and bent and partial coins that have been withdrawn from circulation. For uncurrent coins, the revisions clarify the procedure for redemption by instructing the public to deposit the uncurrent coins with a financial institution that will accept them, or with a depository institution that has a direct relationship with a Federal Reserve Bank. The revisions make clear that a Federal Reserve Bank will redeem uncurrent coins based on the policies described in the Federal Reserve's Operating Circular 2.
For bent or partial coins, the revisions update the redemption rates of certain coins to reflect the current values and compositions of coins being redeemed. For example, in the prior regulation, the redemption rate for one-cent coins was $1.4585 per pound; this redemption rate was derived from the weight of bronze one-cent coins (3.11 grams or 0.1097 ounces each), which the United States Mint has not minted and issued since 1982. In 1983, the United States Mint began minting and issuing only copper-plated zinc one-cent coins, which weigh 2.50 grams or 0.0882 ounces each. Due to the weight difference, a pound (the minimum weight for redemption) of copper-plated zinc one-cent coins contains a higher quantity of coins than a pound of bronze one-cent coins. The revisions make the redemption rate $1.8100 for a pound consisting solely of copper-plated zinc one-cent coins. For bronze one-cent coins, or a mix of both bronze and copper-plated zinc one-cent coins, the lower redemption rate of $1.4585 will apply. A similar update is made to the redemption rate for $1 coins.
The third category of revisions clarifies that the United States Mint will not accept fused coins. The United States Mint will also not accept mixed coins (coins of several alloy categories presented together) for redemption, with the exception of bent or partial one-cent coins and $1 coins that are presented in mixed years.
The fourth category of revisions puts the public on notice that the Director of the United States Mint may provide information pertaining to any bent or partial coin submission to law enforcement officials or other third parties for purposes of investigating related criminal activity or for purposes of seeking civil judgment. The revisions also notify potential participants that they may be held criminally and/or civilly liable, fined, and/or imprisoned for fraudulent submissions.
Finally, the United States Mint clarifies which of the various offices and bureaus within the Department of the Treasury has authorization to update the different subparts within part 100.
In 82 FR 43730, Sep. 19, 2017, the United States Mint issued a notice of proposed rulemaking (NPRM) to revise redemption rates and procedures relating to the exchange of uncurrent, bent, partial, fused, and mixed coins, and requested comments on the proposed revisions. The United States Mint received fourteen comments. The majority of comments were from individuals and businesses who previously participated in the exchange program. One comment was from a trade association representing the private, for-profit recycling industry.
Most comments expressed support for the revisions. Many of the comments raised questions about details of the exchange program that specifically relate to operating procedures. Those instructions and other details relating to the exchange of bent and partial coins will be provided to the public on the United States Mint's website. Instructions and other details related to the exchange of uncurrent coins will be described in the Federal Reserve's Operating Circular 2. If a comment is not addressed in the summary below, it is because the comment was more specific to those operating procedures and details, or the comment was not responsive to the proposed revisions.
The majority of comments supported a participant certification process. A few comments expressed confusion or dissatisfaction with certification occurring prior to submission of coins. One comment said it would be logically inconsistent to require certification prior to submission because the thresholds related to certification are related to the submission. The United States Mint does not believe it is inconsistent to require certification prior to submission. Participants who will exceed or plan to exceed the annual weight threshold will be required to be certified by the United States Mint prior to submission. The annual weight threshold, along with other certification instructions, will be provided on the United States Mint's website.
One comment asked whether a participant would be required to go through the certification process prior to
Two comments expressed concern with the regulations applying equally to domestic and foreign recycling companies. Foreign individuals and businesses will be given the same opportunity to participate in the exchange program. The requirement to provide payment information for a bank or other financial institution in the United States applies equally to domestic and foreign participants.
One comment requested clarity on how to separate bent or partial coins for redemption. Specifically, the comment cited the requirement of the prior regulation to separate bent or partial coins into the following denomination categories of at least one pound: One-cent coins; 5-cent coins; dime, quarter-dollar, and half-dollar coins; and $1 coins. The United States Mint is only revising the redemption rates, not the denomination categories themselves. Paragraph (d) is revised to clarify that lots of at least one pound must still be separated into the denomination categories of one-cent coins; 5-cent coins; dime, quarter-dollar, and half-dollar coins; and $1 coins.
After reviewing and considering all timely comments received in response to the NPRM, the United States Mint decided to move forward with the proposed regulatory text, with a minor editorial change to clarify the denomination categories. The United States Mint has determined that this minor editorial change is consistent with the intent that was proposed in the NPRM and does not add any additional burden upon the public than was already proposed in the NPRM.
The Office of Management and Budget determined that this rule does not constitute a “significant regulatory action” under Executive Order 12866 or Executive Order 13771.
It is hereby certified that the revisions will not have a significant economic impact on a substantial number of small entities. Accordingly, a regulatory flexibility analysis under the Regulatory Flexibility Act, 5 U.S.C. 601
Coins.
For the reasons set forth in the preamble, the United States Mint amends 31 CFR part 100 as follows:
31 U.S.C. 321.
(b) The Department of the Treasury has authorized amendments to this part by the following bureaus and offices:
(1) This section—Office of the Secretary.
(2) Subpart A—Office of the Secretary.
(3) Subpart B—Bureau of Engraving and Printing.
(4) Subpart C—United States Mint.
(5) Subpart D—Office of the Secretary.
(a)
(b)
(c)
(d)
(a)
(b)
(2) Partial coins are U.S. coins which are not whole; partial coins must be readily and clearly identifiable as to genuineness and denomination.
(3) Participants are individuals or businesses that submit coins through the redemption process.
(c)
(2) All submissions for review shall include an estimate of the value of the coins and an explanation of how the submission came to be bent or partial. The submission should also contain the bank account number and routing number for a checking or savings account at a bank or other financial institution (such as a mutual fund, brokerage firm, or credit union) in the United States.
(3) Participants may be required to provide documentation for how the participant came into custody of the bent or partial coins.
(4) The United States Mint reserves the right to test samples from any submission to authenticate the material. The size of the sample will be limited to the amount necessary for authentication. Testing may result in partial or complete destruction of the sample.
(5) The United States Mint reserves the right to conduct site visits for participants over a certain volume threshold to verify information provided to the United States Mint.
(6) No redemption will be made when:
(i) A submission, or any portion of a submission, demonstrates a pattern of intentional mutilation or an attempt to defraud the United States;
(ii) A submission appears to be part of, or intended to further, any criminal activity;
(iii) A submission contains a material misrepresentation of facts;
(iv) Material presented is not identifiable as United States coins. In such instances, the participant will be notified to retrieve the entire submission, at the participant's sole expense, within 30 days. If the submission is not retrieved in a timely manner, the entire submission will be treated as voluntarily abandoned property, pursuant to 41 CFR 102-41.80, and will be retained or disposed of by the United States Mint;
(v) A submission contains any contaminant that could render the coins unsuitable for coinage metal. In such instances, the participant will be notified to retrieve the entire submission, at the participant's sole expense, within 30 days. If the submission is not retrieved in a timely manner, the entire submission will be treated as voluntarily abandoned property, pursuant to 41 CFR 102-41.80, and will be retained or disposed of by the United States Mint; or
(vi) A submission contains more than a nominal amount of uncurrent coins. In such instances, the participant may be notified to retrieve the entire submission, at the participant's sole expense, within 30 days. If the submission is not retrieved in a timely manner, the entire submission will be treated as voluntarily abandoned property, pursuant to 41 CFR 102-41.80, and will be retained or disposed of by the United States Mint.
(7) The Director of the United States Mint, or designee, shall have final authority with respect to all aspects of redemptions of bent or partial coin submissions.
(d)
(i) One-Cent Coins: $1.4585 per pound.
(ii) 5-Cent Coins: $4.5359 per pound.
(iii) Dime, Quarter-Dollar, and Half-Dollar Coins: $20.00 per pound.
(iv) $1 Coins: $20.00 per pound.
(2)
(ii) The United States Mint will redeem $1 coins inscribed with a year after 1978 at the rate set forth at paragraph (d)(1)(iv) of this section unless such $1 coins are presented
(e)
(1) Bent and partial coins submitted in quantities less than or equal to a threshold established annually will be redeemed only at the United States Mint at Philadelphia, P.O. Box 400, Philadelphia, PA 19105.
(2) Bent and partial coins submitted in quantities greater than a threshold established annually should be scheduled with the United States Mint to be sent directly to the authorized recycler(s) of the United States Mint.
(a)
(2) Mixed coins are U.S. coins of several alloy categories which are presented together, but are readily and clearly identifiable as U.S. coins.
(b)
(a) Additional information and procedures about the United States Mint's redemption of bent or partial coins can be found on the United States Mint's website.
(b) Criminal penalties connected with the defacement or mutilation of U.S. coins are provided in 18 U.S.C. 331.
(c) The Director of the United States Mint may provide information pertaining to any bent or partial coin submissions to law enforcement officials or other third parties for purposes of investigating related criminal activity or for purposes of seeking a civil judgment.
(d) Whoever intentionally files a false claim seeking reimbursement for uncurrent, bent or partial coins may be held criminally liable under a number of statutes including 18 U.S.C. 287 and 18 U.S.C. 1341 and may be held civilly liable under 31 U.S.C. 3729,
Coast Guard, DHS.
Notification of expired temporary rules issued.
This document provides notice of substantive rules issued by the Coast Guard that were made temporarily effective but expired before they could be published in the
This document lists temporary Coast Guard rules that became effective, primarily between July 2016 and September 2016, unless otherwise indicated, and were terminated before they could be published in the
Temporary rules listed in this document may be viewed online, under their respective docket numbers, using the Federal eRulemaking Portal at
For questions on this notice contact Yeoman First Class David Hager, Office of Regulations and Administrative Law, telephone (202) 372-3862.
Coast Guard District Commanders and Captains of the Port (COTP) must be immediately responsive to the safety and security needs within their jurisdiction; therefore, District Commanders and COTPs have been delegated the authority to issue certain local regulations.
Timely publication of these rules in the
The following unpublished rules were placed in effect temporarily during the period between May 2013-October 2016 unless otherwise indicated. To view copies of these rules, visit
Coast Guard, DHS.
Notice of expired temporary rules issued.
This document provides notice of substantive rules issued by the Coast Guard that were made temporarily effective but expired before they could be published in the
This document lists temporary Coast Guard rules that became effective, primarily between October 2016 and December 2016, unless otherwise indicated, and were terminated before they could be published in the
Temporary rules listed in this document may be viewed online, under their respective docket numbers, using the Federal eRulemaking Portal at
For questions on this notice contact Yeoman First Class David Hager, Office of Regulations and Administrative Law, telephone (202) 372-3862.
Coast Guard District Commanders and Captains of the Port (COTP) must be immediately responsive to the safety and security needs within their jurisdiction; therefore, District Commanders and COTPs have been delegated the authority to issue certain local regulations.
Timely publication of these rules in the
The following unpublished rules were placed in effect temporarily during the period between October 2016 and December 2016 unless otherwise indicated. To view copies of these rules, visit
Coast Guard, DHS.
Notice of deviation from drawbridge regulation.
The Coast Guard has issued a temporary deviation from the operating schedule that governs the California Department of Transportation Highway and Bicycle drawbridges across San Leandro Bay, mile 0.0 and mile 0.1, between Alameda and Bay Farm Island, CA. The deviation is necessary to allow the bridge owner to perform major rehabilitation and maintenance. This deviation allows the bridges to remain
This deviation is effective from 6 a.m. on January 2, 2018 through 6 p.m. on May 27, 2018.
The docket for this deviation, USCG-2017-1074, is available at
If you have questions on this temporary deviation, call or email Carl T. Hausner, Chief, Bridge Section, Eleventh Coast Guard District; telephone 510-437-3516; email
The California Department of Transportation has requested a temporary change to the operation of the Highway and Bicycle drawbridges over San Leandro Bay, mile 0.0 and mile 0.1, between Alameda and Bay Farm Island, CA. The highway drawbridge navigation span provides a vertical clearance of 20 feet above Mean High Water in the closed-to-navigation position. The bicycle drawbridge navigation span provides a vertical clearance of 26 feet above Mean High Water in the closed-to-navigation position. The draws operate as required by 33 CFR 117.193. Navigation on the waterway is commercial and recreational.
The drawspans will be secured in the closed-to-navigation position from 6 a.m. on January 2, 2018 through 6 p.m. on May 27, 2018 to allow the bridge owner to perform major rehabilitation and maintenance work, including repainting the structural steel of the highway drawbridge. A temporary platform will be installed beneath the drawspan of the highway drawbridge, reducing the vertical clearance by 3 feet. This temporary deviation has been coordinated with the waterway users. No objections to the proposed temporary deviation were raised.
Vessels able to pass through the bridges in the closed position may do so at anytime. If necessary, the draws can open on signal if at least 30 days notice is given to the bridge owner. Oakland Inner Harbor Tidal Canal can be used an alternate route for vessels unable to pass through the bridges in the closed position. The Coast Guard will also inform the users of the waterway through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridges 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), both drawbridges must return to their 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 Tower Drawbridge across the Sacramento River, mile 59.0, at Sacramento, CA. The deviation is necessary to allow the community to participate in the New Year's Eve Sky Spectacular fireworks show. This deviation allows the bridge to remain in the closed-to-navigation position during the deviation period.
This deviation is effective from 8 p.m. through 11 p.m. on December 31, 2017.
The docket for this deviation, USCG-2017-1027, is available at
If you have questions on this temporary deviation, call or email Carl T. Hausner, Chief, Bridge Section, Eleventh Coast Guard District; telephone 510-437-3516; email
The California Department of Transportation has requested a temporary change to the operation of the Tower Drawbridge over the Sacramento River, mile 59.0, at Sacramento, CA. The drawbridge navigation span provides a vertical clearance of 30 feet above Mean High Water in the closed-to-navigation position. The draw operates as required by 33 CFR 117.189(a). Navigation on the waterway is commercial and recreational.
The drawspan will be secured in the closed-to-navigation position from 8 p.m. through 11 p.m. on December 31, 2017, to allow the community to participate in the New Year's Eve Sky Spectacular fireworks show. This temporary deviation has been coordinated with the waterway users. No objections to the proposed temporary deviation were raised. Vessels able to pass through the bridge in the closed position may do so at anytime. In the event of an emergency the draw can open on signal if at least one hour notice is given to the bridge operator. There are no immediate alternate routes for vessels to pass. The Coast Guard will also inform the users of the waterway through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.
In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is modifying the operating schedule that governs the Beach Lane Bridge across Quantuck Canal, mile 1.1, at Westhampton Beach, New York. This action is necessary to allow for an unexpected delay in the rehabilitation of the bascule leaves and painting of the bridge. A temporary deviation was previously granted for a length of 180 days. As the Coast Guard
This rule is effective without actual notice from December 20, 2017 until 11:59 p.m. on January 11, 2018. For the purposes of enforcement, actual notice will be used from 12:01 on December 1, 2017 until December 20, 2017.”
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this interim rule, call or email Judy Leung-Yee, Bridge Management Specialist, U.S. Coast Guard; telephone 212-514-4336, email
On September 13, 2017, we published a temporary deviation entitled, “Drawbridge Operation Regulation; Beach Lane Bridge, Quantuck Canal, Westhampton Beach, NY” in the
The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable. Due to unanticipated difficulties and delays impacting the schedule and pace of rehabilitation of the bascule leaves and painting of the bridge additional time is required to finalize and complete the work necessary in order to restore the bridge to full operational capacity. We must modify the operation schedule of the bridge by December 1, 2017 to allow the completion of rehabilitation of the bascule leaves and painting of the bridge. We therefore lack sufficient time to provide a reasonable comment period and then consider those comments before issuing the modification.
We are issuing this rule and under 5 U.S.C. 553(d)(3), and for the reasons stated above, the Coast Guard finds that good cause exists for making it effective in less than 30 days after publication in the
The Coast Guard is issuing this rule under authority 33 U.S.C. 499. The Coast Guard is modifying the operating schedule that governs the Beach Lane Bridge across Quantuck Canal, mile 1.1, at Westhampton Beach, New York. The Beach Lane Bridge is a double-leaf bascule bridge offering mariners a vertical clearance of 13.9 feet at mean high water and 16.2 feet at mean low water in the closed position.
The existing drawbridge regulations are listed at 33 CFR 117.799(d). The Suffolk County Department of Public Works, the bridge owner, has requested this modification as additional time is required to complete the final rehabilitation of the bascule leaves and painting of the bridge.
The Suffolk County Department of Public Works has also requested that the Beach Lane Bridge be allowed to open on signal only one of two bascule spans for bridge openings with the understanding that dual lift-span operations will occur for vessels requiring such an opening provided a 48 hour advance notice was furnished to the owner of the bridge.
The bridge generally opens for seasonal recreational craft and small scale tug/barge combinations occasionally transit the waterway. Vessels that can pass under the bridge without an opening may do so at all times. The bridge will be able to open for emergencies and there is no alternate route for vessels unable to pass through the bridge when in the closed position.
The Coast Guard is issuing this rule, which permits a temporary deviation from the operating schedule that governs the Beach Lane Bridge across Quantuck Canal, mile 1.1, at Westhampton Beach, New York. The rule is necessary to accommodate the completion of rehabilitation of the bascule leaves and painting of the bridge. This rule allows for single-leaf operations upon signal and dual lift-span operations will be provided for vessels requiring such an opening given 48 hours of advance notice.
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 protesters.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget (OMB) and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771. This regulatory action determination is based on the ability of the majority of vessels to successfully transit through the draw of the bridge with a single-leaf opening. Vessels requiring dual lift-span operations may continue to transit the draw provided submission of advance notice.
The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the bridge may be small entities, for the reasons stated in section V.A above, this interim rule will not have a significant
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 calls for no 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.
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have made a determination that this action is one of a category of actions which do not individually or cumulatively have a significant effect on the human environment. This rule simply promulgates the operating regulations or procedures for drawbridges. This action is categorically excluded from further review, under figure 2-1, paragraph (32)(e), of the Instruction. A preliminary Record of Environmental Consideration and a Memorandum for the Record are not required for this rule.
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Bridges.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 117 as follows:
33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland Security Delegation No. 0170.1.
(j) The draws of the West Bay bridge, mile 0.1, across Quantuck Canal, Quoque bridge, mile 1.1, across Quoque Canal and the Smith Point bridge, mile 6.1, across Narrow Bay shall open on signal from October 1 through April 30 from 8 a.m. to 4 p.m. and from May 1 through September 30 from 6 a.m. to 10 p.m. At all other times during these periods, the draws shall open as soon as possible but no more than one hour after a request to open is received.
(1) The draw of the Beach Lane bridge, mile 1.1, across Quantuck Canal shall open only one of two bascule spans on signal for bridge openings. Dual lift-span operations will occur for vessels requiring such an opening provided a 48 hour advance to the owner of the bridge.
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone for certain waters of Spa Creek. This action is necessary to provide for the safety of life on navigable waters during a fireworks display in Anne Arundel County at Annapolis, MD, on December 31, 2017. This rulemaking prohibits 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 December 31, 2017 through 1 a.m. on January 1, 2018.
To view documents mentioned in this preamble as being
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 August 29, 2017, the City of Annapolis, MD, notified the Coast Guard that it will be conducting an aerial fireworks display at 11:55 p.m. on December 31, 2017. The fireworks display will be conducted by Pyrotecnico of New Castle, PA and launched from a barge located in Spa Creek, in Anne Arundel County at Annapolis, MD. There is no rain date planned for this fireworks display. In response, on November 21, 2017, the Coast Guard published a notice of proposed rulemaking (NPRM) titled “Safety Zone; Spa Creek, Annapolis, MD” (82 FR 55336). 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 November 28, 2017, we received no 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 COTP has determined that potential hazards associated with the fireworks to be used in this December 31, 2017 display will be a safety concern for anyone within 133 yards of the fireworks barge. 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 no comments on our NPRM published November 21, 2017. There are no changes in the regulatory text of this rule from the proposed rule in the NPRM.
This rule establishes a safety zone from 11 p.m. on December 31, 2017 through 1 a.m. on January 1, 2018. The safety zone will cover all navigable waters of Spa Creek within 133 yards of a fireworks barge in approximate position latitude 38°58′33.01″ N, longitude 076°28′58.00″ W, located at Annapolis, MD. The duration of the zone is intended to ensure the safety of vessels and these navigable waters before, during, and after the scheduled 11:55 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 duration, time-of-year, and time-of-day of the safety zone. Although vessel traffic will not be able to safely transit around this safety zone, the impact would be for only 2 hours during the late evening when vessel traffic in Spa Creek is normally low. Moreover, the Coast Guard will issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard received no comments from the Small Business Administration on this rulemaking. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 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
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone lasting less than two hours that would prohibit entry within 133 yards of a fireworks barge. It is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; and Department of Homeland Security Delegation No. 0170.1.
(a)
(b)
(c)
(1) All persons are required to comply with the general regulations governing safety zones found in § 165.23.
(2) Entry into or remaining in this zone is prohibited unless authorized by the Captain of the Port (COTP) or designated representative. 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 must first obtain authorization from the COTP or designated representative. To request permission to transit the area, the COTP 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). If permission is granted, persons and vessels must comply with the instructions of the COTP or designated representative and proceed as directed while within the zone.
(4) The U.S. Coast Guard may be assisted in the patrol and enforcement of the safety zone by Federal, State, and local agencies.
(d)
Bureau of Land Management, Interior.
Final supplementary rules.
The Bureau of Land Management (BLM) Royal Gorge Field Office is implementing supplementary rules to regulate certain activities on public lands within Guffey Gorge in Park County, Colorado. These supplementary rules are necessary to implement decisions found in the Guffey Gorge Management Plan approved on June 29, 2015, to provide for the protection of persons, property, and public lands and resources located within the 80-acre site. These supplementary rules will result in changes to some currently authorized activities related to the possession or use of alcohol, amplified music, vehicle parking, and visitors with dogs.
These supplementary rules are effective January 19, 2018.
You may send inquiries by mail or hand delivery to Linda Skinner, Outdoor Recreation Planner, BLM Royal Gorge Field Office, 3028 E. Main Street,
Linda Skinner, Outdoor Recreation Planner; see address in the
Guffey Gorge is an 80 acre tract of public land in Park County, Colorado. It is surrounded by private land with Park County Road 102 providing legal public access. Until ten years ago, recreational use of this area was light, and the area was used primarily by local residents for picnicking, hiking, and swimming. Recreational use of the area has increased significantly over the past five years, resulting in resource damage, user conflicts, and safety hazards for visitors and surrounding private landowners. In 2013, the BLM began the public process for developing a management plan for the 80 acre parcel to manage the increasing visitor use and associated issues. This process included presentations and site tours with the Rocky Mountain (formerly Front Range) Resource Advisory Council (RAC) and collaboration with stakeholders and concerned citizens. On August 11, 2014, the BLM initiated a 30-day public scoping period. Based on feedback received during this process, the BLM developed a proposed action and released a preliminary Environmental Assessment (EA) for a 30-day public review on November 20, 2014. The BLM incorporated comments into the Final EA and corresponding Decision Record, signed on June 29, 2015.
The proposed supplementary rules were published in the
These final supplementary rules implement certain decisions from the Guffey Gorge Management Plan on lands administered by the Royal Gorge Field Office. The planning area consists of approximately 80 acres of public lands within Park County, Colorado, in the following described townships:
These final supplementary rules are needed to address significant public safety concerns and resource protection issues resulting from increased and unsafe public use on public lands known as Guffey Gorge. The authority for these supplementary rules is set forth at section 310 of the Federal Land Policy and Management Act (FLPMA), 43 U.S.C. 1740, and 43 CFR 8365.1-6. This notice, with a detailed map, will be posted at the Royal Gorge Field Office.
These final supplementary rules will help the BLM achieve management objectives for the area in the following ways:
• Supplementary rule number one prohibits possession and consumption of alcoholic beverages. As visitation at Guffey Gorge has increased, alcohol and drug use has also increased, leading to public health and safety concerns. This supplementary rule will help reduce disruptive behavior associated with alcohol use, improve public safety, and reduce litter in the area.
• Supplementary rule number two prohibits visitors from parking a motor vehicle outside of designated parking areas. Visitor parking is limited at Guffey Gorge and frequently overflows onto the shoulder of Park County Road 102. Park County Road 102 is a narrow, two-lane road with limited visibility near the Guffey Gorge trailhead. Restricting parking to designated parking areas only is essential for public health and safety.
• Supplementary rule number three requires animals brought into the area to be on a leash and under the control of a person, or otherwise physically restricted. This rule will help reduce problems associated with unrestrained dogs observed by staff in recent years. Currently, BLM regulations only require dogs to be restrained in developed recreation sites. Guffey Gorge is not a developed site, so existing BLM regulations do not apply. This supplementary rule will help reduce conflicts between visitors; reduce conflicts between domestic animals and wildlife; and control domestic animal waste.
• Supplementary rule number four prohibits the operation of any device producing amplified sound, such as stereos, speakers, and public address systems. This supplementary rule will help restore opportunities for quiet recreational activities recognized as one of Guffey Gorge's attributes.
These supplementary rules are not significant regulatory actions and not subject to review by the Office of Management and Budget under Executive Order 12866. These supplementary rules will not have an annual effect of $100 million or more on the economy. They will not adversely affect in a material way the economy; productivity; competition; jobs; environment; public health or safety; or State, local or tribal governments or communities. These supplementary rules do not create a serious inconsistency or otherwise interfere with an action taken or planned by another agency. These supplementary rules do not materially alter the budgetary effects of entitlements, grants, user fees, or loan programs or the rights or obligations of their recipients; nor do they raise novel legal or policy issues. These supplementary rules merely establish rules of conduct for public use of a limited area of public lands.
During the National Environmental Policy Act (NEPA) review for the Guffey Gorge Management Plan, the BLM fully analyzed the substance of these supplementary rules in an EA, DOI-BLM-CO-200-2013-040 EA. The BLM signed the Decision Record for the EA on June 29, 2015, and found that these supplementary rules would not constitute a major Federal action
Congress enacted the Regulatory Flexibility Act of 1980 (RFA), as amended, 5 U.S.C. 601-612, to ensure that government regulations do not unnecessarily or disproportionately burden small entities. The RFA requires a regulatory flexibility analysis if a rule would have a significant economic impact, either detrimental or beneficial, on a substantial number of small entities. These supplementary rules will have no effect on business entities of any size. These supplementary rules merely impose reasonable restrictions on certain recreational activities on certain public lands to protect natural resources and the environment and human health and safety. Therefore, the BLM has determined under the RFA that these supplementary rules will not have a significant economic impact on a substantial number of small entities.
These supplementary rules are not a “major rule” as defined at 5 U.S.C. 804(2). These supplementary rules merely impose reasonable restrictions on certain recreational activities on certain public lands to protect natural resources and the environment and human health and safety. These supplementary rules will not:
(1) Have an annual effect on the economy of $100 million or more;
(2) Cause a major increase in costs or prices for consumers; individual industries; Federal, State, or local agencies; or geographic regions; or
(3) Have significant adverse effects on competition, employment, investment, productivity, or innovation; or on the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets.
These supplementary rules do not impose an unfunded mandate on the private sector; or State, local, or tribal governments of more than $100 million per year, nor will these supplementary rules have a significant or unique effect on State, local, or tribal governments or the private sector. These supplementary rules merely impose reasonable restrictions on certain recreational activities on certain public lands to protect natural resources and the environment and human health and safety. Therefore, the BLM is not required to prepare a statement containing the information required by the Unfunded Mandates Reform Act (2 U.S.C. 1531
These supplementary rules do not constitute a government action capable of interfering with constitutionally protected property rights. These supplementary rules will not address property rights in any form, and will not cause the impairment of constitutionally protected property rights. Therefore, the BLM has determined that these supplementary rules will not cause a “taking” of private property or require further discussion of takings implications under this Executive Order.
These supplementary rules 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. Therefore, in accordance with Executive Order 13132, the BLM has determined that these supplementary rules will not have sufficient Federalism implications to warrant preparation of a Federalism Assessment.
Under Executive Order 12988, the BLM Colorado State Director has determined that these supplementary rules will not unduly burden the judicial system, and that they meet the requirements of Sections 3(a) and 3(b) (2) of the Order.
In accordance with Executive Order 13175, the BLM has found that these supplementary rules do not include policies that have tribal implications, and will have no bearing on trust lands or on lands for which title is held in fee status by Indian Tribes or U.S. Government-owned lands managed by the Bureau of Indian Affairs.
In developing these supplementary rules, the BLM did not conduct or use a study, experiment or survey requiring peer review under the Information Quality Act (Section 515 of Pub. L. 106-554).
These supplementary rules do not constitute a significant energy action. These supplementary rules will not have an adverse effect on energy supply, production, or consumption and have no connection with energy policy.
In accordance with Executive Order 13352, the BLM has determined that these supplementary rules will not impede facilitating cooperative conservation; will take appropriate account of and consider the interests of persons with ownership or other legally recognized interests in land or other natural resources; will properly accommodate local participation in the Federal decision-making process; and will provide that the programs, projects, and activities are consistent with protecting public health and safety.
These supplementary rules do not contain information collection requirements that the Office of Management and Budget must approve under the Paperwork Reduction Act of 1995, 44 U.S.C. 3501-3521.
The principal author of these final supplementary rules is Linda Skinner, Outdoor Recreation Planner, BLM, Royal Gorge Field Office.
For the reasons stated in the preamble, and under the authorities for supplementary rules found at 43 U.S.C. 1740 and 43 CFR 8365.1-6, the BLM Colorado State Director establishes supplementary rules for approximately 80 acres of public lands in Guffey Gorge, to read as follows:
Unless otherwise authorized, the following acts are prohibited on all public lands, roads, trails, and waterways administered by the BLM within the Guffey Gorge Management Area:
1. You must not possess or consume alcoholic beverages;
2. You must not park a motor vehicle outside of designated parking areas;
3. You must not bring an animal into the area, unless the animal is on a leash not longer than six feet and secured to a fixed object or under control of a person, or is otherwise physically restricted at all times; and
4. You must not operate any device producing amplified sound such as a stereo, speaker, public address system, or other similar device.
The following persons are exempt from these supplementary rules: Any Federal, State, local and/or military persons acting within the scope of their duties; members of any organized rescue or fire-fighting force in performance of an official duty; or individuals expressly authorized by the BLM.
Any person who violates any of these supplementary rules may be tried before a United States Magistrate and fined in accordance with 18 U.S.C. 3571, imprisoned no more than 12 months under 43 U.S.C. 1733(a) and 43 CFR 8360.0-7, or both. In accordance with 43 CFR 8365.1-7, State or local officials may also impose penalties for violations of Colorado law.
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notification; grant of waiver.
FMCSA grants a limited 90-day waiver from the Federal hours-of-service (HOS) regulations pertaining to electronic logging devices (ELDs) for the transportation of agricultural commodities as defined in the Federal Motor Carrier Safety Regulations (FMCSRs). The Agency takes this action in response to a waiver request from the National Pork Producers Council (NPPC) on behalf of eight organizations representing transporters of livestock and other agricultural commodities, as defined in the FMCSRs. The Agency has determined that the waiver is in the public interest and would likely achieve a level of safety that is equivalent to, or greater than, the level that would be achieved absent such exemption, based on the terms and conditions imposed. The waiver will also through notice and public comment, provide FMCSA with time to consider certain exemption applications from segments of the agricultural industry concerning the use of ELDs to document drivers' hours of service and clarify applicability of the requirements and the need for certain carriers to begin using ELDs by the December 18, 2017, deadline.
This waiver is applicable beginning December 18, 2017, and expires on March 18, 2018.
Thomas L. Yager, Chief, Driver and Carrier Operations Division, Office of Bus and Truck Standards and Operations, Federal Motor Carrier Safety Administration, 1200 New Jersey Ave. SE, Washington, DC 20590. Email:
The Transportation Equity Act for the 21st Century (TEA-21) (Pub. L. 105-178, 112 Stat. 107, June 9, 1998) provides the Secretary of Transportation (the Secretary) the authority to grant waivers from any of the FMCSRs issued under Chapter 313 of Title 49 of the United States Code or 49 U.S.C. 31136, to a person(s) seeking regulatory relief. (49 U.S.C. 31136(e), 31315(a)). The Secretary must make a determination that the waiver is in the public interest, and that it is likely to achieve a level of safety that is equivalent to, or greater than, the level of safety that would be obtained in the absence of the waiver. Individual waivers may be granted only for a specific unique, non-emergency event, for a period up to three months. TEA-21 authorizes the Secretary to grant waivers without requesting public comment, and without providing public notice.
The Administrator of FMCSA has been delegated authority under 49 CFR 1.87(e) to carry out the functions vested in the Secretary by 49 U.S.C. chapter 311, subchapters I and III, relating to commercial motor vehicle programs and safety regulation.
The FMCSA received an application for an exemption and waiver from the NPPC on behalf of eight organizations that represent transporters of livestock and other agricultural commodities. Notice of the request for exemption from the requirement that a motor carrier require each of its drivers to use an electronic logging device (ELD) no later than December 18, 2017, to record the driver's hours-of-service (HOS), was published in the
The NPPC focused on the impact of the ELD requirement on its members, given unique aspects of its industry, including “exposed incompatibilities between the HOS rules and the . . . industry . . . causing disruption . . . and endangering the health and welfare of . . . animals transported . . .”
FMCSA has also received from the Agricultural Retailers Association (ARA) an exemption, waiver, and petition document dated October 25, 2017, requesting that transporters of agricultural commodities and farm supplies not be required to use ELDs during an exemption period. That exemption request has not yet been published for comment. While this waiver is issued in response to the application submitted by the NPPC, it also applies to other eligible motor carriers, including ARA members, to the extent they are handling agricultural commodities as defined under 49 CFR 395.2, as discussed in the Terms and Conditions of the Waiver section below.
In addition to NPPC's request, FMCSA received numerous inquiries from parties involved in the transport of agricultural commodities about the correct application of the HOS agricultural exception in 49 CFR 395.1(k)(1), leading to an ongoing review of the exception. FMCSA is considering providing new guidance on the agricultural exception in the near future.
In an October 6, 2010,
The study was conducted in two phases. Phase 1 compared the safety performance of agricultural and non-agricultural carriers for the period 2005 through 2008, and also examined two additional industries, livestock and utility carriers, whose operations were not exempt from HOS regulations prior to the passage of SAFETEA-LU. The Phase 1 analysis used carrier registration, inspection and crash data from FMCSA's Motor Carrier Management Information System (MCMIS). The study used cargo classification information on the FMCSA Motor Carrier Identification Report (Form MCS-150)
For the Phase 2 analysis, inspection data of agricultural commodity and utility carriers (which are also exempt from HOS regulations) were collected during an FMCSA special study of a sample of States. These data included only those inspections occurring during the States' planting and harvesting seasons and indicated both the commodity being transported and whether the driver was operating within or beyond the 100-air-mile radius exempt from HOS regulations. The Phase 2 analysis assessed the safety performance of the HOS exempt agricultural commodity and utility service carriers identified in the survey in comparison with non-HOS exempt carriers based on their out of service (OOS) violation rates and crash rates.
For the purposes of considering whether to issue a limited waiver, FMCSA focused on the crash rate data from the study. The Agency placed less emphasis on the out-of-service (OOS) rates because there were no HOS violation data to consider given that the agricultural carriers for which data were available were operating under a statutory exemption from the HOS rule. Differences between the OOS rates for other issues such as driver qualifications and vehicle defects and deficiencies, while important in considering overall safety management controls of the carriers, were not necessarily related to the potential safety impact of the waiver.
The Phase 1 analysis indicated that nationally, agricultural carriers operating within a 100-air-mile radius had lower crash rates per 100 power units than those operating beyond this radius, except in 2008, when there was no difference in the crash rates.
To provide additional validation of the crash analysis, which uses power unit data reported on the Form MCS-150, a separate analysis was performed using data only for carriers domiciled in States participating in the Performance and Registration Information Systems Management (PRISM) program that enforces MCS-150 updating. PRISM links State motor vehicle registration systems with carrier safety data in order to identify unsafe commercial motor carriers. The PRISM State carriers are required to update their MCS-150 annually. By contrast, non-PRISM State carriers are required by FMCSA to update their MCS-150 biennially. As a result, the PRISM State data are considered more current and reliable than non-PRISM State data where there is no direct implication for not updating the data. Data from PRISM States that enforce MCS-150 updating show that agricultural carriers operating within a 100-air-mile radius had more varied results, with crash rates higher than carriers operating beyond a 100-air-mile radius in 2008, lower in 2006 and 2007, and nearly the same in 2005.
The Phase 2 analysis indicated that in the four States participating in the survey (ID, KS, MD, MI), agricultural carriers that were subject to the HOS requirements had higher crash rates per 100 power units than agricultural carriers exempt from the HOS requirements.
Although this study was conducted in 2010 and relied upon data from 2005 through 2008, FMCSA has no reason to believe that the conclusions would be different if updated using more recent data. Although these studies did not focus on benefits achieved by use of ELDS, given the limited population of motor carriers affected by the waiver and the brief period of time a waiver is in effect, FMCSA believes that the level of safety maintained by haulers of agricultural commodities will be equivalent to the safety of operations that would be obtained absent the granting of a waiver. Furthermore, the Agency believes the sense of urgency in this matter requires a decision based on the best available data, albeit dated, rather than delaying a decision until a new study can be conducted.
Considering the above study, the ongoing review of the HOS agricultural commodities exception, and the pending exemption request from NPPC, FMCSA has determined that it is in the public interest to provide a limited waiver from the use of ELDs for interstate motor carriers engaged in the transportation of agricultural commodities as defined in 49 CFR 395.2. This waiver will allow FMCSA time to evaluate the HOS exception applicable to the transport of agricultural commodities and review the concerns unique to the agricultural industry identified by NPPC and others. FMCSA grants the waiver requested by NPPC, but also extends it to all motor carriers transporting an agricultural commodity.
(1)
(2) Motor carriers transporting agricultural commodities under the provisions of 49 CFR 395.1(k)(1), are exempt from the ELD requirements in 49 CFR 395.8(a) during the period of this waiver, regardless of the distance traveled.
(3) Carriers operating under this waiver must comply with all other applicable requirements of the Federal Motor Carrier Safety Regulations (49 CFR parts 390 through 399), including the preparation of records of duty status (RODS) for operations which are currently considered to be subject to the HOS rules and the record retention requirements associated with those RODs and supporting documents.
(4) Motor carriers operating under this waiver must have a “satisfactory” safety rating from FMCSA or be unrated; motor carriers with “conditional” or “unsatisfactory” safety ratings are prohibited from taking advantage of the waiver.
(5) Drivers operating under this waiver must carry a copy of this
(6)
Carriers operating under this waiver must notify FMCSA within 5 business days of any accident (as defined in 49 CFR 390.5), involving any of the motor carrier's drivers operating under the terms of this waiver. The notification must include the following information:
(a) Identity of Waiver: “AG”
(b) Date of the accident,
(c) City or town, and State, in which the accident occurred, or closest to the accident scene,
(d) Driver's name and license number,
(e) Co-driver's name and license number (if applicable),
(f) Vehicle number and State license number,
(g) Number of individuals suffering physical injury,
(h) Number of fatalities,
(i) The police-reported cause of the accident,
(j) Whether the driver was cited for violation of any traffic laws, motor carrier safety regulations, and
(k) The total driving time and total on-duty time period prior to the accident.
Accident notifications must be emailed to
Considering the limited period of this waiver and that it does not alter any of the HOS regulations other than the method of recording HOS, and the Agency's previous review of data concerning the safety performance of motor carriers engaged in the transportation of agricultural commodities, the Agency has determined that the waiver from the ELD requirements for 90 days is likely achieve a level of safety equivalent to, or greater than, the level that would be achieved by the current regulation.
FMCSA expects that any drivers and their employing motor carrier operating under the terms and conditions of the exemption will maintain their safety record. Should any safety problems be discovered, however, FMCSA will take all steps necessary to protect the public interest. Use of this waiver is voluntary, and FMCSA will immediately revoke the waiver for any interstate driver or motor carrier for failure to comply with the terms and conditions of the waiver.
Consistent with 49 U.S.C. 31315(d), this waiver preempts inconsistent State or local requirements applicable to interstate commerce.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; reallocation.
NMFS is reallocating the projected unused amount of the 2017 Bering Sea subarea and Eastern Aleutian Island District (BS/EAI) Atka mackerel total allowable catch (TAC) assigned to the Bering Sea and Aleutian Islands (BSAI) trawl limited access sector to the Amendment 80 cooperative in the BS/EAI of the BSAI. This action is necessary to allow the 2017 TAC of Atka mackerel in the BSAI to be fully harvested.
Effective 1200 hrs Alaska local time (A.l.t.), December 15, 2017, through 2400 hrs, A.l.t., December 31, 2017.
Steve Whitney, 907-586-7228.
NMFS manages the groundfish fishery in the BSAI according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.
The 2017 Atka mackerel TAC in the BS/EAI assigned to the BSAI trawl limited access sector is 2,966 metric tons (mt) and 2017 Atka mackerel TAC assigned to the Amendment 80 cooperatives is 27,594 mt as established by the final 2017 and 2018 harvest specifications for groundfish in the BSAI (82 FR 11826, February 27, 2017) and reallocation (82 FR 45740, October 2, 2017.)
The Administrator, Alaska Region, NMFS, has determined that 6 mt of the Atka mackerel TAC for the BS/EAI assigned to the BSAI trawl limited access sector will not be harvested. Therefore, in accordance with § 679.91(f), NMFS reallocates 6 mt of Atka mackerel in the BS/EAI from the BSAI trawl limited access sector to the Amendment 80 cooperatives in the BSAI. In accordance with § 679.91(f), NMFS will reissue cooperative quota permits for the reallocated Atka mackerel following the procedures set forth in § 679.91(f)(3).
The harvest specifications for Atka mackerel included in the harvest specifications for groundfish in the BSAI (82 FR 11826, February 27, 2017) and reallocation (82 FR 45740, October 2, 2017) are revised as follows: 2,960 mt of Atka mackerel in the BS/EAI for the BSAI trawl limited access sector and 27,600 mt for the Amendment 80 cooperative allocations in the BS/EAI. Table 6 is revised and republished in its entirety as follows:
Seasonal or sector apportionments may not total precisely due to rounding.
This will enhance the socioeconomic well-being of harvesters dependent upon Atka mackerel in this area. The Regional Administrator considered the following factors in reaching this decision: (1) The current catch of Atka mackerel by the BSAI trawl limited access sector in the BS/EAI, and (2) the harvest capacity and stated intent on future harvesting patterns of the Amendment 80 cooperatives that participate in this BS/EAI fishery.
This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the reallocation of Atka mackerel in the BS/EAI from the BSAI trawl limited access sector to the Amendment 80 cooperatives in the BSAI. Since the fishery is currently open, it is important to immediately inform the industry as to the revised allocations. Immediate notification is necessary to allow for the orderly conduct and efficient operation of this fishery, to allow the industry to plan for the fishing season, and to avoid potential disruption to the fishing fleet as well as processors. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of December 11, 2017.
The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.
This action is required by § 679.91 and is exempt from review under Executive Order 12866.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; inseason adjustment; request for comments.
NMFS is adjusting the 2018 total allowable catch (TAC) amounts for the Gulf of Alaska (GOA) pollock and Pacific cod fisheries. This action is necessary because NMFS has determined these TACs are incorrectly specified, and will ensure the GOA pollock and Pacific cod TACs are the appropriate amounts based on the best available scientific information for pollock and Pacific cod in the GOA. This action is consistent with the goals and objectives of the Fishery Management Plan for Groundfish of the Gulf of Alaska.
Effective 0000 hours, Alaska local time (A.l.t.), January 1, 2018, until the effective date of the final 2018 and 2019 harvest specifications for GOA groundfish, unless otherwise modified or superseded through publication of a notification in the
Comments must be received at the following address no later than 4:30 p.m., A.l.t., January 4, 2018.
You may submit comments on this document, identified by FDMS Docket Number NOAA-NMFS-2016-0127 by any of the following methods:
•
•
Obren Davis, 907-586-7228.
NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP) prepared by the North Pacific Fishery Management Council (Council) under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.
The final 2017 and 2018 harvest specifications for groundfish in the GOA (82 FR 12032, February 27, 2017) set the 2018 pollock TAC at 163,479 metric tons (mt) and the 2018 Pacific cod TAC at 57,825 mt in the GOA. In December 2017, the North Pacific Fishery Management Council (Council) recommended a 2018 pollock TAC of 166,228 mt for the GOA, which is more than the 163,479 mt established by the final 2017 and 2018 harvest specifications for groundfish in the GOA. The Council also recommended a 2018 Pacific cod TAC of 13,096 mt for the GOA, which is less than the 57,825 mt established by the final 2017 and 2018 harvest specifications for groundfish in the GOA. The Council's recommended 2018 TACs, and the area and seasonal apportionments, are based on the Stock Assessment and Fishery Evaluation report (SAFE), dated November 2017, which NMFS has determined is the best available scientific information for these fisheries.
Steller sea lions occur in the same location as the pollock and Pacific cod fisheries and are listed as endangered under the Endangered Species Act (ESA). Pollock and Pacific cod are a principal prey species for Steller sea lions in the GOA. The seasonal apportionment of pollock and Pacific cod harvest is necessary to ensure the groundfish fisheries are not likely to cause jeopardy of extinction or adverse modification of critical habitat for Steller sea lions. The regulations at § 679.20(a)(5)(iv) specify how the pollock TAC will be apportioned. The regulations at § 679.20(a)(6)(ii) and § 679.20(a)(12)(i) specify how the Pacific cod TAC will be apportioned.
In accordance with § 679.25(a)(1)(iii), (a)(2)(i)(B), and (a)(2)(iv) the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that, based on the November 2017 SAFE report for this fishery, the current GOA pollock and Pacific cod TACs are incorrectly specified. Consequently, pursuant to § 679.25(a)(1)(iii), the Regional Administrator is adjusting the 2018 GOA pollock TAC to 166,228 mt and the 2018 GOA Pacific cod TAC to 13,096 mt. Therefore, Table 2 of the final 2017 and 2018 harvest specifications for groundfish in the GOA (82 FR 12032, February 27, 2017) is revised consistent with this adjustment.
Pursuant to § 679.20(a)(5)(iv), Table 4 of the final 2017 and 2018 harvest specifications for groundfish in the GOA (82 FR 12032, February 27, 2017) is revised for the 2018 TACs of pollock in the Central and Western Regulatory Area of the GOA.
Pursuant to § 679.20(a)(6)(ii) and § 679.20(a)(12)(i), Table 6 of the final 2017 and 2018 harvest specifications for groundfish in the GOA (82 FR 12032, February 27, 2017) is revised for the 2018 seasonal apportionments and allocation of Pacific cod TAC in the GOA consistent with this adjustment.
This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would allow for harvests that exceed the appropriate allocations for pollock and Pacific cod based on the best scientific information available. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of December 13, 2017, and additional time for prior public comment would result in conservation concerns for the ESA-listed Steller sea lions.
The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of
Under § 679.25(c)(2), interested persons are invited to submit written comments on this action to the above address until January 4, 2018.
This action is required by § 679.20 and § 679.25 and is exempt from review under Executive Order 12866.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; inseason adjustment; request for comments.
NMFS is adjusting the 2018 total allowable catch (TAC) amounts for the Bering Sea and Aleutian Islands (BSAI) pollock, Atka mackerel, and Pacific cod fisheries. This action is necessary because NMFS has determined these TACs are incorrectly specified, and will ensure the BSAI pollock, Atka mackerel, and Pacific cod TACs are the appropriate amounts based on the best available scientific information. Also, NMFS is announcing the Aleutian Islands Catcher Vessel (CV) Harvest Set-Aside and Bering Sea Trawl CV A-Season Sector Limitation will be in effect for 2018, and TACs in this inseason adjustment will apply for 2018. This action is consistent with the goals and objectives of the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area.
Effective 0000 hours, Alaska local time (A.l.t.), January 1, 2018, until the effective date of the final 2018 and 2019 harvest specifications for BSAI groundfish, unless otherwise modified or superseded through publication of a notification in the
Comments must be received at the following address no later than 4:30 p.m., A.l.t., January 4, 2018.
You may submit comments on this document, identified by
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Mary Furuness, 907-586-7228.
NMFS manages the groundfish fishery in the BSAI exclusive economic zone according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.
The final 2017 and 2018 harvest specifications for groundfish in the BSAI (82 FR 11826, February 27, 2017) set the 2018 Bering Sea (BS) pollock TAC at 1,345,000 mt, the 2018 BSAI Atka mackerel TAC at 65,000 mt, the 2018 BS Pacific cod TAC at 223,704 mt, and the 2018 AI Pacific cod TAC at 15,695 mt. In December 2017, the North Pacific Fishery Management Council (Council) recommended a 2018 BS pollock TAC of 1,364,341 mt, which is more than the 1,345,000 mt TAC established by the final 2017 and 2018 harvest specifications for groundfish in the BSAI. The Council also recommended a 2018 BSAI Atka mackerel TAC of 71,000 mt, which is more than the 65,000 mt TAC established by the final 2017 and 2018 harvest specifications for groundfish in the BSAI. The Council recommended a 2018 BS Pacific cod TAC of 188,136 mt, and an AI Pacific cod TAC of 15,695 mt, which is less than the BS Pacific cod TAC of 223,704 mt, and the same as the AI Pacific cod TAC of 15,695 mt established by the final 2017 and 2018 harvest specifications for groundfish in the BSAI. The Council's recommended 2018 TACs, and the area and seasonal apportionments, are based on the Stock Assessment and Fishery Evaluation report (SAFE), dated November 2017, which NMFS has determined is the best available scientific information for these fisheries.
Amendment 113 to the FMP (81 FR 84434, November 23, 2016) and regulations at § 679.20(a)(7)(viii) require NMFS to announce whether the Aleutian Islands incidental catch allowance, directed fishing allowance, CV Harvest Set-Aside, and Unrestricted Fishery, as well as the Bering Sea Trawl CV A-Season Sector Limitation will be in effect for 2018. NMFS received notification from Adak that a shoreplant will be processing Aleutian Islands Pacific cod in 2018. Therefore, the Pacific cod TACs in Table 9A of this inseason adjustment will be effective for 2018 and the harvest limits will apply in 2018.
Steller sea lions occur in the same location as the pollock, Atka mackerel, and Pacific cod fisheries and are listed as endangered under the Endangered Species Act (ESA). Pollock, Atka mackerel, and Pacific cod are a principal prey species for Steller sea lions in the BSAI. The seasonal apportionment of pollock, Atka mackerel, and Pacific cod harvest is necessary to ensure the groundfish fisheries are not likely to cause jeopardy of extinction or adverse modification of critical habitat for Steller sea lions. NMFS published regulations and the revised harvest limit amounts for Atka mackerel, Pacific cod, and pollock fisheries to implement Steller sea lion protection measures to insure that groundfish fisheries of the BSAI are not likely to jeopardize the continued existence of the western distinct population segment of Steller sea lions or destroy or adversely modify their designated critical habitat (79 FR 70286, November 25, 2014). The regulations at
In accordance with § 679.25(a)(1)(iii), (a)(2)(i)(B), and (a)(2)(iv), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that, based on the November 2017 SAFE report for this fishery, the current BSAI pollock, Atka mackerel, and Pacific cod TACs are incorrectly specified. Pursuant to § 679.25(a)(1)(iii), the Regional Administrator is adjusting the 2018 BS pollock TAC to 1,364,341 mt, the 2018 BSAI Atka mackerel TAC to 71,000 mt, and the 2018 BS Pacific cod TAC to 188,136 mt. Therefore, Table 2 of the final 2017 and 2018 harvest specifications for groundfish in the BSAI (82 FR 11826, February 27, 2017) is revised consistent with this adjustment.
Pursuant to § 679.20(a)(5)(i), Table 5 of the final 2017 and 2018 harvest specifications for groundfish in the BSAI (82 FR 11826, February 27, 2017) is revised for the 2018 BS allocations of pollock TAC to the directed pollock fisheries and to the Community Development Quota (CDQ) directed fishing allowances consistent with this adjustment. The Steller sea lion protection measure final rule (79 FR 70286, November 25, 2014), sets harvest limits for pollock in the A season (January 20 to June 10) in Areas 543, 542, and 541, see § 679.20(a)(5)(iii)(B)(
Pursuant to § 679.20(a)(8), Table 7 of the final 2017 and 2018 harvest specifications for groundfish in the BSAI (82 FR 11826, February 27, 2017) is revised for the 2018 seasonal and spatial allowances, gear shares, CDQ reserve, incidental catch allowance, and Amendment 80 allocation of the BSAI
Pursuant to § 679.20(a)(7), Table 9 of the final 2017 and 2018 harvest specifications for groundfish in the BSAI (82 FR 11826, February 27, 2017) is revised for the 2018 gear shares and seasonal allowances of the BSAI Pacific cod TAC consistent with this adjustment.
Pursuant to § 679.20(a)(7)(viii), the Pacific cod TACs in Table 9A of this inseason adjustment will be effective for 2018 and the harvest limits will apply in 2018.
This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would allow for harvests that exceed the appropriate allocations for pollock, Atka mackerel, and Pacific cod in the BSAI based on the best scientific information available. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of December 20, 2017, and additional time for prior public comment would result in conservation concerns for the ESA-listed Steller sea lions.
The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.
Under § 679.25(c)(2), interested persons are invited to submit written comments on this action to the above address until January 4, 2018.
This action is required by § 679.20 and § 679.25 and is exempt from review under Executive Order 12866.
16 U.S.C. 1801
Federal Trade Commission (“FTC” or “Commission”).
Advance notice of proposed rulemaking; request for public comment.
The Federal Trade Commission (“FTC” or “Commission”) requests public comment on the overall costs, benefits, and regulatory and economic impact of its rule specifying Test Procedures and Labeling Standards for Recycled Oil (“Recycled Oil Rule” or “Rule”), as part of the Commission's systematic review of all current FTC rules and guides.
Comments must be received on or before February 12, 2018.
Interested parties may file a comment online or on paper, by following the instructions in the Request for Comment part of the
Hampton Newsome, (202) 326-2889, Attorney, Division of Enforcement, Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue NW, CC-9528, Washington, DC 20580.
The Recycled Oil Rule, mandated by the Energy Policy and Conservation Act (“EPCA”) (42 U.S.C. 6363), contains testing and labeling requirements for recycled engine oil. As indicated in the statute, the Rule's purpose is to encourage used oil recycling, promote recycled oil use, reduce new oil consumption, and reduce environmental hazards and wasteful practices associated with used oil disposal.
The Commission reviews its rules and guides periodically to seek information about their costs and benefits, regulatory and economic impact, and general effectiveness in protecting consumers and helping industry avoid deceptive claims. These reviews assist the Commission in identifying rules and guides that warrant modification or rescission. As part of its last review in 2007, the Commission determined to retain the Rule and updated the reference to API Publication 1509, Fifteenth Edition, and added an explanation of incorporation by reference in § 311.4.
With the present Notice, the Commission initiates a new review. The Commission solicits comments on, among other things, the economic impact of, and the continuing need for, the Recycled Oil Rule; the Rule's benefits to consumers; and the burdens it places on industry members subject to the Rule's requirements, including small businesses.
To aid commenters in submitting information, the Commission has prepared the following specific questions related to the Recycled Oil Rule. The Commission seeks comments on these and any other issues related to the Rule's current requirements. In their replies, commenters should provide any available evidence and data that supports their position, such as empirical data, consumer perception studies, and consumer complaints.
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You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before February 12, 2018. Write “16 CFR part 311—Recycled Oil, Matter No. R811006” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the public Commission website, at
If you prefer to file your comment on paper, write “16 CFR part 311—Recycled Oil, Matter No. R811006” on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW, Suite CC-5610 (Annex A), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW, 5th Floor, Suite 5610 (Annex A), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service.
Because your comment will be placed on the publicly accessible FTC website at
Comments containing material for which confidential treatment is requested must be filed in paper form, must be clearly labeled “Confidential,” and must comply with FTC Rule 4.9(c), 16 CFR 4.9(c). In particular, the written request for confidential treatment that accompanies the comment must include the factual and legal basis for the request, and must identify the specific portions of the comment to be withheld from the public record.
Visit the FTC website to read this Notice and the news release describing it. The FTC Act and other laws that the Commission administers permit the collection of public comments to consider and use in this proceeding, as appropriate. The Commission will consider all timely and responsive public comments that it receives on or before February 12, 2018. For information on the Commission's privacy policy, including routine uses permitted by the Privacy Act, see
By direction of the Commission.
Commodity Futures Trading Commission.
Proposed interpretation; request for comment.
The Commodity Futures Trading Commission (the “Commission” or “CFTC”) is issuing this proposed interpretation of the term “actual delivery” as set forth in a certain provision of the Commodity Exchange Act (“CEA”) pursuant to the Dodd-Frank Wall Street Reform and Consumer Protection Act (the “Dodd-Frank Act”). Specifically, this proposed interpretation is being issued to inform the public of the Commission's views as to the meaning of actual delivery within the specific context of retail commodity transactions in virtual currency. The Commission requests comment on this proposed interpretation and further invites comment on specific questions related to the Commission's treatment of virtual currency transactions.
Comments must be received on or before March 20, 2018.
You may submit comments, identified by RIN 3038-AE62, by any of the following methods:
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All comments must be submitted in English or, if not, accompanied by an English translation. Comments will be posted as received to
The Commission reserves the right, but shall have no obligation, to review, pre-screen, filter, redact, refuse or remove any or all of your submission from
Philip W. Raimondi, Special Counsel, (202) 418-5717,
With certain exceptions, the CFTC has been granted exclusive jurisdiction over commodity futures, options, and all other derivatives that fall within the definition of a swap.
Pursuant to CEA section 2(c)(2)(D),
The Dodd-Frank Act added CEA section 2(c)(2)(D) to address certain judicial uncertainty involving the Commission's regulatory oversight capabilities. The Commission has long held that certain speculative commodity transactions involving leverage or margin may have indicia of futures contracts, subjecting them to Commission oversight.
In connection with its retail commodity transaction oversight, the Commission previously issued a proposed interpretation of the term “actual delivery” in the context of CEA section 2(c)(2)(D), accompanied by a request for comment.
The 2013 Guidance explained that the Commission will consider evidence “beyond the four corners of contract documents” to assess whether actual delivery of the commodity occurred.
Within a year after the 2013 Guidance was released, the Eleventh Circuit issued an opinion affirming a preliminary injunction obtained by the Commission in
Soon after the
After
As noted previously, the Commission considers virtual currency to be a commodity,
The Commission interprets the term virtual currency broadly. In the context of this interpretation, virtual or digital currency:
The Commission recognizes that certain virtual currencies and their underlying blockchain technologies have the potential to yield notable advancements in applications of financial technology (“FinTech”). Indeed, as part of its efforts to facilitate beneficial FinTech innovation and help ensure market integrity, the Commission launched the LabCFTC initiative.
Moreover, since virtual currency can serve as an underlying component of derivatives transactions, the Commission maintains a close interest in the development of the virtual currency marketplace generally. As a practical matter, virtual currency, by virtue of its name, represents a digital medium of exchange for goods and services, similar to fiat currency.
Some of these centralized platforms also attempt to cater to those that wish to speculate on the price movements of a virtual currency against other currencies. For example, a speculator may purchase virtual currency using borrowed money in the hopes of covering any outstanding balance owed through profits from favorable price movements in the future. This interpretation is specifically focused on such “retail commodity transactions,” whereby an entity or platform: (i) Offers margin trading or otherwise facilitates
Beyond their practical and speculative functions, the emergence of these nascent markets has also been negatively marked by a variety of retail customer harm that warrants the Commission's attention, including, among other things, flash crashes and other market disruptions,
As underscored by its efforts to engage the FinTech community, the Commission emphasizes that it does not intend to impede market-enhancing innovation or otherwise harm the evolving virtual currency marketplace with this interpretation. To the contrary, the Commission believes this interpretation can help advance a healthy ecosystem and support further market-enhancing innovation. Additionally, the Commission takes seriously its goal of protecting U.S. retail market participants engaged in the virtual currency marketplace that falls within the Commission's jurisdiction—as it would with respect to retail market participants trading in any other retail commodity marketplace that falls within its jurisdiction. The Commission drafted this interpretation with such a balance in mind.
As discussed above, a retail commodity transaction may be excepted from CEA section 2(c)(2)(D) (and thus not subject to CEA sections 4(a), 4(b), and 4b) if actual delivery of the commodity occurs within 28 days of the transaction.
The Commission, in interpreting the term actual delivery for the purposes of CEA section 2(c)(2)(D)(ii)(III)(aa), will continue to follow the 2013 Guidance and “employ a functional approach and examine how the agreement, contract, or transaction is marketed, managed, and performed, instead of relying solely on language used by the parties in the agreement, contract, or transaction.”
Further, the Commission will continue to assess all relevant factors
(1) A customer having the ability to: (i) Take possession and control of the entire quantity of the commodity, whether it was purchased on margin, or using leverage, or any other financing arrangement, and (ii) use it freely in commerce (both within and away from any particular platform) no later than 28 days from the date of the transaction; and
(2) The offeror and counterparty seller (including any of their respective affiliates or other persons acting in concert with the offeror or counterparty seller on a similar basis)
Consistent with the 2013 Guidance, a sham delivery does not constitute actual delivery for purposes of this interpretation. The offeror and counterparty seller, including their agents, must retain no interest or control whatsoever in the virtual currency acquired by the purchaser at the expiration of 28 days from the date of entering into the transaction. Indeed, in its simplest form, actual delivery of virtual currency connotes the ability of a purchaser to utilize the virtual currency purchased “on the spot” to immediately purchase goods or services with the currency elsewhere.
In the context of an “actual delivery” determination in virtual currency, physical settlement of the commodity must occur. A cash settlement or offset mechanism, as described in Example 4 below, will not satisfy the actual delivery exception of CEA section 2(c)(2)(D). The distinction between physical settlement and cash settlement in this context is akin to settlement of a spot foreign currency transaction at a commercial bank or hotel in a foreign nation—the customer receives physical foreign currency, not U.S. dollars. As mentioned, such physical settlement must occur within 28 days from the date on which the “agreement, contract, or transaction is entered into” to constitute “actual delivery.”
Consistent with the interpretation above, the Commission provides the following non-exclusive examples to further clarify the meaning of actual delivery in the virtual currency context:
The Commission requests comment from the public regarding the Commission's proposed interpretation of “actual delivery” in the context of virtual currency and further invites comments on specific questions related to the Commission's treatment of virtual currency transactions. The Commission encourages all comments including background information, actual market examples, best practice principles, expectations for the possible impact on further innovation, and estimates of any asserted costs and expenses. Specifically, the Commission requests comment on the following questions:
On this matter, Chairman Giancarlo and Commissioners Quintenz and Behnam voted in the affirmative. No Commissioner voted in the negative.
Coast Guard, DHS.
Supplemental notice of proposed rulemaking.
On April 3, 2017, the Coast Guard published a notice of proposed rulemaking to establish a permanent safety zone surrounding the entry of lava from the Kilauea volcano into the Pacific Ocean on the southeast side of the Island of Hawaii, HI. The safety zone is needed to protect persons and vessels from the potential hazards associated with molten lava entering the ocean. After considering comments received from the public, the Coast Guard analyzed the economic impact of the proposed rule and made minor modifications to the proposed rule. This supplemental notice requests comments on the analysis and revised proposal.
Comments and related material must be received by the Coast Guard on or before February 20, 2018.
You may submit and view comments identified by docket number USCG-2017-0234 using the Federal eRulemaking Portal at
If you have questions about this proposed rulemaking, call or email Lieutenant Commander John Bannon, Waterways Management Division, Coast Guard; telephone 808-541-4359, email
Lava flow that enters the ocean is potentially hazardous to anyone near it, particularly when lava deltas collapse. A lava delta is new land that forms when lava accumulates above sea level, and extends from the existing base of a sea cliff. Persons and vessels near active lava flow ocean-entry sites face potential hazards, which include, but are not limited to: Plumes of hot, corrosive seawater laden with hydrochloric acid and fine volcanic particles that can irritate the skin, eyes, and lungs; explosions of debris and eruptions of scalding water from hot rock entering the ocean; sudden lava delta collapses; and waves associated with these explosions and collapses.
Lava has been entering the ocean at the Kamokuna lava delta on Kilauea volcano's south coast since July 2016. On December 31, 2016, a large portion of the new lava delta collapsed into the ocean, producing waves and explosions of debris near 19°19′12″ N, 155°02′24″ W at the Kamokuna entry point. Following this collapse, portions of the adjacent sea cliff continued to collapse into the ocean, producing localized waves and showers of debris. The lava delta continues to undergo a series of formation and subsequent collapses as lava pours into the Pacific Ocean. Additionally, cracks parallel to the sea cliff in the surrounding area persist, indicating further collapses with very little or no warning are possible. As of March 2017, a new delta began to form at the Kamokuna ocean-entry point. As it continues to grow and collapse, cracks parallel to the sea cliff surrounding it persist, indicating the possibility of further collapses.
On March 28, 2017, the Captain of the Port (COTP) Honolulu issued a temporary final rule (TFR) under docket USCG-2017-0172. The TFR was published in the
In addition to the TFR, the Coast Guard also published a notice of proposed rulemaking (NPRM) on April 3, 2017, proposing to make the temporary safety zone a final rule. Its purpose was to mitigate the potential threats that molten lava posed to the maritime public when it entered the ocean by implementing the safety zone as a permanent control measure for vessels operating near the lava entry points. The NPRM addressed these concerns, and invited the public to comment during the comment period, which ended June 2, 2017. Subsequently, the Coast Guard extended the TFR to allow the Coast Guard to analyze the economic impact of the safety zone and allow for public comments on this supplemental NPRM. The TFR will remain in effect through March 28, 2018, unless the COTP Honolulu cancels or modifies the TFR.
The Coast Guard is proposing this SNPRM under authority in 33 U.S.C. 1231. The COTP Honolulu has determined that there are potential hazards associated with the molten lava at the Kamokuna lava delta, which pose potential safety concerns for anyone within 300 meters of the ocean-entry point. The purpose of this proposed rule is to clarify the regulatory language for the entry requirements of the safety zone, and emphasize the safety concerns related to boating near lava ocean-entry points. The regulatory text we are proposing appears at the end of this document. It differs from the text proposed in the NPRM, primarily in its discussion of enforcement and how to gain permission to enter the safety zone.
This proposed rule would establish a permanent safety zone around the lava flow at the Kamokuna lava delta. Additionally, this proposed rule would allow the Coast Guard to impose and enforce restrictions on vessels operating near the lava flow that enters the ocean. This action is necessary to promote safe navigation, and to preserve the safety of life and property. Vessels capable of safely operating inside the safety zone may be authorized to enter by the COTP Honolulu, or his designated representative. Vessels approved for transiting within the safety zone, such as approved lava tour-boat operations, are required to adhere to specific conditions set by the COTP Honolulu. Mariners who seek first time authorization to enter the safety zone must submit a written request, by email or letter. The request must explain how the vessel will operate safely in proximity to lava. A typical request should note the vessel's condition, the operator's familiarity with the surrounding waters, and any specific safety practices for operating near the lava ocean-entry points. Once initial authorization is received, a vessel owner or operator only needs to contact COTP Honolulu by phone or radio to request permission to enter the safety zone.
In response to the NPRM, the Coast Guard received 67 public comments. On May 8, 2017, at a public meeting held in Hilo, HI, meeting participants discussed the proposed rule as well as the dangers associated with lava ocean-
The Coast Guard received nine comments in support of the proposed rule. One commenter noted that he had taken a lava boat tour and felt that the vessel got too close to the entry point and that he experienced adverse health symptoms from being in the lava plume. Several commenters agreed that the safety zone should be consistent with that of the landside restriction of 300 meters. Other commenters supported the safety zone due to the hazards resulting from the entry of volcanic lava into the ocean.
The Coast Guard received 18 comments regarding the safety zone's size and location. These comments ranged from being in favor of the 300-meter safety zone as well as opposed. Nine opposing views stated that 300 meters is excessively restrictive. One comment from the National Oceanic Atmospheric Administration stated that the Coast Guard should “provide definitive bounding coordinates for the safety zone, instead of a general statement that the safety zone will encompass all waters extending 300 meters in all directions around the entry point of lava flow into the ocean associated with the lava flow at the Kamokuna lava delta.”
We believe that because of the unpredictable and varying nature of the active lava flowing into the ocean at this area, the Coast Guard cannot issue specific geographic coordinates of the safety zone in the final rulemaking, but will discuss the current entry site in the final rule. We have noted, with the concurrence of NOAA's Nautical Data Branch, Marine Chart Division, the position 19°19′08″ N, 155°02′36″ W for their charting systems. That is the coordinate provided for Kamokuna Beach in the U.S. Geological Survey's Geographic Names Information System.
Additionally, because of the varying dangers of the lava entry and fragile bench shelf development, the Coast Guard cannot provide a specific distance at which a vessel can safely operate. However, the COTP Honolulu has permitted vessels to operate within the 300-meter safety zone under certain conditions.
The Coast Guard received one comment from Hawaii Volcanoes National Park supporting a safety zone “that is flexible to account for whatever location the lava may occur since it is not a static event in time or space. As such, we recommend that the proposed rule apply not just to the Kamokuna ocean-entry point, but any location in the future where lava enters the ocean.”
We agree, and the proposed final rule includes language stating that all locations associated with the Kilauea lava flow entering the Pacific Ocean on the eastern side of the Island of Hawaii, HI, are included under the safety zone.
Sixteen commenters recommended that the Coast Guard reduce the 300-meter radius of the safety zone.
We believe that based on Sector Honolulu's review of the historical observations of delta collapses and ejecta distances from the Hawaii Volcano Observatory (HVO) records, a radius of 300 meters remains a safe and reasonable distance for a high-hazard zone for the general boating public. The Hawaiian Volcano Observatory reports that explosions from delta collapses “have hurled hot rocks nearly a meter (yard) in size as far as about 250 m (273 yards) inland from the collapsed delta and scattered rock debris onshore over an area the size of several football fields. These explosions also hurl rocks seaward, probably to similar distances.”
The 300-meter safety zone also mirrors land and air restrictions for lava flow viewing. Furthermore, the 300 meter restriction was discussed at the public meeting held on this rulemaking and staff from the Hawaiian Volcano Observatory reiterated the need for a 300 meter restriction. Accordingly, the Coast Guard proposes to maintain the safety zone's 300-meter radius, with the option of allowing operators to request authorization to enter the safety zone from the COTP Honolulu.
The Coast Guard received 30 comments in favor of allowing the lava tour-boat owners and operators to enter and operate in the safety zone.
Prior to the NPRM, the Coast Guard promulgated a TFR for a 300-meter safety zone at the Kamokuna lava delta. Pursuant to the TFR, the COTP Honolulu granted four lava tour-boat owners and operators and one photographer access to operate within the safety zone. We believe that because of the potential hazards associated with the active lava flow and cliff fragility at lava ocean-entry points, specific distances from the lava flow a vessel can safely operate cannot be provided. Under this proposed final rule, any vessel owner or operator may submit a written request to the COTP Honolulu, or his designated representative, for authorization to enter the safety zone. Such written requests must explain how the vessel will operate safely in proximity to lava. A typical request should note the vessel's condition, the operator's familiarity with the surrounding waters, and any specific safety practices for operating near the lava ocean-entry points. Once initial authorization is received, a vessel owner or operator only needs to contact COTP Honolulu by phone or radio to request permission to enter the safety zone.
The Coast Guard received three comments regarding access or exclusive access to the lava flow by Hawaiian natives. This rule is concerned with the safety aspect of access to the lava flow area. Mandating exclusive access to the lava flow is outside the scope of this rulemaking and is outside the Coast Guard's authority. This proposed rule provides for access after requesting permission from the COTP to enter the zone. We encourage persons or vessel owners and operators seeking access to the safety zone to make their request by following the guidance above.
The Coast Guard received one comment regarding the lack of reliable VHF radio communications near the lava flow area, thereby, preventing lava tour-boat owners and operators from hailing the Coast Guard via VHF radio.
We are aware of the VHF radio limitations in this area, and are currently researching how to improve radio coverage. The COTP Honolulu and Coast Guard Base Honolulu are attempting to install equipment in the vicinity to enhance communications in this area. In the meantime, vessel owners and operators are encouraged to use alternate means to communicate effectively near the lava flow ocean-entry points. They are also encouraged to contact the Coast Guard in advance of their transits to the lava ocean-entry points in order to facilitate effective communications as well as timely processing any written request for authorization to enter the safety zone.
The Coast Guard received four comments regarding general unsafe conditions at the boat ramp where tour operators launch.
Boat ramps and associated safe boating concerns are a state management issue. We have forwarded
One comment proposed the safety zone be stationary, and move with the lava shelf, essentially creating a moving safety zone.
Title 33 CFR 165.20 defines a safety zone as a water area to which, for safety purposes, access is limited to authorized persons or vessels. It further states that a safety zone may be stationary and described by fixed limits. We believe that in this situation, the entry point of the lava changes based on flow, and as such, the safety zone would encompass all waters extending 300 meters (984 feet) in all directions around the entry point of lava flow into the ocean. The Coast Guard does not define this as a moving safety zone around a moving object, but rather as a necessary adjustment to a dynamic environmental occurrence, which may have multiple lava entry points.
The Coast Guard also received a comment stating that our certification under 5 U.S.C. 605(b), concerning the economic impact on small entities, was potentially arbitrary as it lacked any factual basis for the certification. This SNPRM includes an Initial Regulatory Flexibility Analysis (IRFA) in Section V. B. in accordance with the Regulatory Flexibility Act (5 U.S.C. 601-612).
The Coast Guard received two comments regarding Executive Order 13771 (“Reducing Regulation and Controlling Regulatory Costs”) directing a reduction of the promulgation of new regulations. As discussed in the next section, this rule is exempt from this Executive order.
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 discuss First Amendment rights of protestors.
Executive Orders 12866, Regulatory Planning and Review,” and 13563, “Improving Regulation and Regulatory Review,” direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771, “Reducing Regulation and Controlling Regulatory Costs,” directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget (OMB) and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771. See OMB's Memorandum “Guidance Implementing Executive Order 13771, Titled `Reducing Regulation and Controlling Regulatory Costs' ” (April 5, 2017).
This SNPRM proposes to make permanent the existing TFR safety zone for the navigable waters surrounding the entry of lava from Kilauea volcano into the Pacific Ocean. The safety zone would remain to include waters within 300 meters (984 feet) of where lava enters the ocean. Entry of persons or vessels into the safety zone may only occur if granted permission by the COTP Honolulu, or his designated representative.
Lava has been entering the ocean at Kamokuna lava delta on Kilauea volcano's south coast since July of 2016 and will continue to do so in the future. When lava enters the ocean, hazards emerge. The hazards include, but are not limited to, plumes of corrosive seawater, which can irritate the skin, eyes, and lungs; explosions of debris and scalding water, which can injure passengers; and sudden collapses of lava deltas, which can cause large waves potentially capsizing vessels. This SNPRM seeks to establish a minimum safe operating distance to protect individuals and vessel owners and operators from the hazards of the Kilauea lava flow at sea.
Prior to the original TFR, any vessel could enter within 300 meters of the point where lava reaches the ocean. This SNPRM proposes to make permanent the original TFR so that any vessel wishing to enter the safety zone must request permission in writing to enter the safety zone from the COTP Honolulu.
Therefore, this proposed rule affects any vessel that would normally travel within 300 meters of points where lava reaches the ocean. Due to the hazards and relative remoteness of such an area, the Coast Guard is not aware of any vessel operations within 300 meters of a point where lava enters the ocean other than those by lava tour-boat owners and operators. So far, the COTP Honolulu has granted four lava tour-boat owners and operators as well as one photographer authorization to enter the safety zone under certain conditions while the TFR is still in effect. These entities are required to notify the COTP Honolulu by phone before departing for each tour in which they plan on entering the 300-meter safety zone.
When the Coast Guard published the original TFR concurrently with the NPRM on April 3, 2017, vessel owners and operators were required to prepare and submit a written request to the COTP Honolulu to enter the safety zone. Because this SNPRM is consistent with the requirements in the TFR, we are presenting the costs associated with this SNPRM.
The written request requirement was contained in the previous TFR and each lava tour-boat owner and operator seeking authorization to enter the safety zone has complied. Based on discussions with COTP Honolulu personnel, we estimated it takes about 4-hours for a vessel owner or operator to submit a written request to enter the safety zone. This includes the time it would take lava tour-boat owners and operators to respond to questions from the COTP concerning the written request. Lava tour-boat owners and operators would only be required to make a written request once rather than for each voyage. The Coast Guard is not aware that any voyages were terminated due to a lack of authorization to enter the safety zone during the period operators requested to enter.
We obtained the mean hourly wage rate for a captain of a lava tour-boat from the May 2016 Bureau of Labor Statistics (BLS) Occupational Employment Statistics National Occupational Employment and Wage Estimates. Based on BLS' data, the mean hourly wage rate for captains, mates, and pilots of water vessels with the North American Industry Classification System (NAICS) occupational code of 53-5021 in the “Scenic and Sightseeing Transportation, Water” industry is $24.42.
Since all four lava tour-boat owners and operators (and one photographer, who this proposed rule would not affect) were each granted permission to enter the safety zone through an initial written request, the only potential cost to these lava tour-boat owners and operators would be the cost of the initial request. Each owner or operator would also be required to notify the COTP Honolulu by phone during the normal course of their duty before entering the safety zone. These entities shall notify the Coast Guard by phone; however, we did not estimate a cost for the call because the equipment already exists onboard the vessel.
The Federal government would also incur costs of this proposed rule. Government costs to implement this proposed rule include the one-time cost of reviewing the written requests (we did not estimate a cost for the time to receive a call from an owner or operator to when entering a safety zone because the COTP Honolulu conducts this review in the normal course of the COTP duties). To process the written request, we estimated one non-commissioned officer with a rank of E-7, and three officers with ranks of O-4, O-5, and O-6 would take about one hour each to review the written request. Based on the labor rates listed in Table 1,
We estimated the total cost of this proposed rule to lava tour-boat owners and operators and the government to be about $972 ($593.88 for lava tour-boat owners or operators + $378 for the government).
Lava flow that enters the ocean is potentially hazardous and presents a danger to vessels navigating within close proximity of where the flow enters the ocean, particularly when lava deltas collapse.
The primary benefit of this SNPRM is to promote safe navigation, and preserve the safety of life and property. If vessel operators wish to transit through the safety zone they will be required to first contact the COTP Honolulu for permission with an explanation of how their safety and lifesaving equipment is adequate to meet the greater risks present.
In accordance with the Regulatory Flexibility Act (5 U.S.C. 601-612), the Coast Guard prepared this Initial Regulatory Flexibility Analysis (IRFA) that examines the impacts of the rule on small entities (5 U.S.C. 601
A small entity may be: A small independent business, defined as independently owned and operated, is organized for profit, and is not dominant in its field per the Small Business Act (5 U.S.C. 632); a small not-for-profit organization (any not-for-profit enterprise which is independently owned and operated and is not dominant in its field); or a small governmental jurisdiction (locality with fewer than 50,000 people) per the Regulatory Flexibility Act (RFA), 5 U.S.C. 601-612.
An IRFA addresses the following:
(1) A description of the reasons why action by the agency is being considered;
(2) A succinct statement of the objectives of, and legal basis for, the rule;
(3) A description of and, where feasible, an estimate of the number of small entities to which the rule would apply;
(4) A description of the projected reporting, recordkeeping and other compliance requirements of the rule, including an estimate of the classes of small entities that would be subject to the requirement and the type of professional skills necessary for preparation of the report or record;
(5) An identification, to the extent practicable, of all relevant Federal rules that may duplicate, overlap or conflict with the rule; and
(6) A description of any significant alternatives to the rule that accomplish the stated objectives of applicable statutes and that minimize any significant economic impact of the rule on small entities.
We address each of these six elements below:
1. A description of the reasons why action by the agency is being considered.
Lava has been entering the ocean at Kamokuna on Kilauea volcano's south coast since July of 2016 and will continue to do so in the foreseeable future. When lava enters the ocean, potential hazards emerge such as: Plumes of corrosive seawater can irritate the skin, eyes, and lungs; explosions of debris and scalding water can injure passengers; collapses of lava deltas can cause large waves potentially capsizing
2. A succinct statement of the objective of, and legal basis for, the proposed rule.
This safety zone proposes to protect the safety of mariners, lava tour-boat passengers, and the protection of property by establishing a 300 meter safety zone from every direction and all points where lava enters the ocean.
The Coast Guard is issuing this rule under authority 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. The COTP Honolulu has determined that potential hazards exist that are associated with Kilauea's active lava flow entry into the Pacific Ocean on the southeast side of the Island of Hawaii, HI. The Coast Guard considers this area to be a safety concern for anyone who transits within 300 meters (984 feet) in every direction and around all points where the lava flow enters the ocean. The objective of this proposed rule is to protect the public including mariners and passengers aboard lava tour-boat owners and operators traveling in the navigable waters inside the safety zone.
3. A description of and, where feasible, an estimate of the number of small entities to which the proposed rule would apply.
This proposed rule affects any vessel that would normally travel within 300 meters of points where lava reaches the ocean. Due to the hazards and relative remoteness of such an area, the Coast Guard believes only lava tour operators would regularly operate within 300 meters of a point where lava enters the ocean. Based on the Coast Guard's understanding, there are four known lava tour-boat owners and operators (and one photographer) who regularly come within 300 meters of the Kilauea lava flow.
Of the four lava tour-boat owners and operators who would transit within the safety zone, we could not find publically available information such as annual revenues and number of employees for three of the four operators. We assumed these three operators qualified as small entities. We found revenue information on the fourth lava tour-boat owner. Using Manta, a publicly available database for businesses in the United States, we found this lava tour-boat owner to have annual revenues of $220,000 and a NAICS code of 561520, “Tour Operators.”
Based on discussions with COTP Honolulu personnel and using the wage rates and labor hour estimates as established above, we estimated it would take about 4-hours for an owner or operator of a lava tour-boat to prepare a written request to enter the safety zone. This includes the time it would take lava tour-boat owners or operators to respond to questions from the COTP concerning the written request. Lava tour-boat owners and operators would be only required to make this request once rather than for every voyage.
Above we obtained a loaded hourly wage rate of $37.12 for captains, mates, and pilots of water vessels. We estimated the one-time initial cost for an owner or operator to prepare a written request and respond to comments from the Coast Guard to be about $148.47 ($37.12 per hour × 4 hours). We estimated the total cost of the SNPRM to be about $593.88 ($148.47 × 4 lava tour-boat owners or operators).
As mentioned above, we only found revenue data on one of the four operators. Therefore, we estimate the initial revenue impact of this proposed rule on this lava tour-boat owner to be about $148.47, which is 0.07% of the company's revenue. There are no annual revenue impacts because the written request needs to be made once, after which each lava tour-boat operator would notify the COTP Honolulu by phone to obtain permission to enter the safety on a given day.
4. A description of the projected reporting, recordkeeping, and other compliance requirements of the proposed rule, including an estimate of the classes of small entities, which would be subject to the requirements and the type of professional skills necessary for preparation of the report or record.
This proposed rule calls for no new collection of information under the Paperwork Reduction Act of 1995, 44 U.S.C. 3501-3520.
5. An identification, to the extent practicable, of all relevant Federal rules, which may duplicate, overlap, or conflict with the rule.
There are no relevant Federal rules that duplicate, overlap, or conflict with this SNPRM.
6. A description of any significant alternatives to the rule which accomplish the stated objectives of applicable statutes and which minimize any significant economic impact of the rule on small entities.
The Coast Guard considered the alternative of not establishing a safety zone. However, without a safety zone, vessel owners and operators would be unprepared for the greater hazards that are present near the Kilauea lava flow ocean-entry point. These vessel owners and operators and passengers could suffer grave injury or in the extreme case death, in addition to damage to or loss of property, if adequate protection is not provided. Therefore, the Coast Guard decided a safety zone was necessary to promote navigational safety, provide for the safety of life and property, and to accommodate and facilitate the reasonable demands of commerce relating to tourism surrounding the lava entry points. No cost to industry or government would be associated with this alternative; nevertheless, we rejected this alternative because it would not ensure that the boating public would operate within a safe distance of where the lava flow enters the ocean.
Therefore, the Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities. We are interested in the potential impacts from this proposed rule on small businesses and we request public comment on these potential impacts. If you think that this proposed rule would have a significant economic impact on you, your business, or your organization, please submit a comment to the docket at the address under
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
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 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, 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 establishing a safety zone that would prohibit persons and vessels from entry into the 300 meters (984 feet) safety zone extending in all directions around the entry of lava flow into the Pacific Ocean. Normally such actions are categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1, of DHS Instruction Manual 023-01-001-01, Rev. 01. A 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 are 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, and Waterways.
For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 165 as follows:
33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
(a)
(b)
(c)
(1) All persons and vessels are required to comply with the general regulations governing safety zones found this part.
(2) Entry into or remaining in this safety zone is prohibited unless authorized by the COTP Honolulu, or his designated representative.
(3) Persons or vessels desiring to enter the safety zone identified in paragraph (a) should submit a written request to the COTP Honolulu before initial entry into the safety zone. The request must explain how the vessel will operate safely in proximity to lava. A typical request should note the vessel's condition, the operator's familiarity with the surrounding waters, and any specific safety practices for operating near the lava ocean-entry points. Persons authorized initial entry may, thereafter, contact the COTP Honolulu through his designated representatives at the Command Center via telephone:
(4) If permission is granted, all persons and vessels must comply with the instructions of the COTP Honolulu, or his designated representative, and proceed at the minimum speed necessary to maintain a safe course while transiting through or in the safety zone as well as maintain a safe distance from the lava hazards.
(5) The COTP Honolulu will provide notice of enforcement of the safety zone described in this section by verbal radio broadcasts and written notice to mariners. The Coast Guard vessels enforcing this section can be contacted on marine band radio VHF-FM channel 16 (156.8 MHZ). The COTP and his or her designated representatives can be contacted at telephone number listed in (c)(3) of this section.
(6) The Coast Guard may be assisted in the patrol and enforcement of the safety zone by Federal, State, and local agencies.
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve revisions to the San Diego County Air Pollution Control District (SDCAPCD) portion of the California State Implementation Plan (SIP). These revisions concern volatile organic compound (VOC) emissions from polyester resin operations. We are proposing to approve a local rule to regulate these emission sources under the Clean Air Act (CAA or “the Act”), as well as a rule rescission. We are taking comments on this proposal and plan to follow with a final action.
Any comments must arrive by January 19, 2018.
Submit your comments, identified by Docket ID No. EPA-R09-OAR-2017-0140 at
Arnold Lazarus, EPA Region IX, (415) 972-3024,
Throughout this document, “we,” “us” and “our” refer to the EPA.
Table 1 lists the rules addressed by this action with the date that they were adopted and repealed by the local air agency and submitted by the California Air Resources Board (CARB).
There are no previous versions of Rule 67.12.1 in the SIP. We approved Rule 67.12 on March 27, 1997 (62 FR 14639).
VOCs help produce ground-level ozone, smog and particulate matter, which harm human health and the environment. Section 110(a) of the CAA requires states to submit regulations that control VOC emissions. Rule 67.12.1, and the rescinded Rule 67.12, control VOCs emitted from polyester resin
SIP rules must be enforceable (see CAA section 110(a)(2)), must not interfere with applicable requirements concerning attainment and reasonable further progress or other CAA requirements (see CAA section 110(l)), and must not modify certain SIP control requirements in nonattainment areas without ensuring equivalent or greater emissions reductions (see CAA section 193).
Generally, SIP rules must require Reasonably Available Control Technology (RACT) for each category of sources covered by a Control Techniques Guidelines (CTG) document as well as each major source of VOCs in ozone nonattainment areas classified as Moderate or above (see CAA section 182(b)(2)). The SDCAPCD regulates an ozone nonattainment area classified as “Moderate” for the 2008 8-hour ozone National Ambient Air Quality Standard (NAAQS) (40 CFR 81.305). Rule 67.12.1 regulates activities covered by the CTG titled “Control Techniques Guidelines for Fiberglass Boat Manufacturing Materials,” EPA-453/R-08-004, September 2008. However, none of the sources regulated by Rule 67.12.1 meet the applicability threshold for the Fiberglass Boat Manufacturing CTG.
Guidance and policy documents that we use to evaluate enforceability, revision/relaxation and rule stringency requirements for the applicable criteria pollutants include the following:
1. “State Implementation Plans; General Preamble for the Implementation of Title I of the Clean Air Act Amendments of 1990” (57 FR 13498, April 16, 1992 and 57 FR 18070, April 28, 1992).
2. “Issues Relating to VOC Regulation Cutpoints, Deficiencies, and Deviations” (“the Bluebook,” U.S. EPA, May 25, 1988; revised January 11, 1990).
3. “Guidance Document for Correcting Common VOC & Other Rule Deficiencies” (“the Little Bluebook”, EPA Region 9, August 21, 2001).
4. “Control Techniques Guidelines for Fiberglass Boat Manufacturing Materials,” EPA-453/R-08-004, September 2008.
This rule and rule rescission are consistent with the CAA requirements and relevant guidance regarding enforceability, RACT, and SIP relaxations. Based on information provided by the SDCAPCD, the District does not appear to have facilities that are subject to the fiberglass boat manufacturing CTG and therefore the District's RACT analysis for Rule 67.12.1 is not required to address the presumptive RACT limits included in the CTG.
The TSD describes additional rule revisions that we recommend for the next time the local agency modifies the rule.
We recommend the SDCAPCD consider adopting a negative declaration for the fiberglass boat manufacturing operations CTG since the District's data indicate it does not have facilities meeting the CTG's applicability threshold of 15 lb/day or 2.7 tpy.
As authorized in section 110(k)(3) of the Act, the EPA proposes to fully approve the submitted rule and rule rescission because they fulfill all relevant requirements. We will accept comments from the public on this proposal until January 19, 2018. If we take final action to approve the submitted rule and rule rescission, our final action will incorporate the rule and rule rescission into the federally enforceable SIP.
In this rule, the EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by reference the SDCAPCD rule described in Table 1 of this preamble. The EPA has made, and will continue to make, these materials available through
Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this proposed action merely proposes to approve state law as meeting federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this proposed action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866;
• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and
• does not provide the EPA with the discretionary authority to address disproportionate human health or environmental effects with practical, appropriate, and legally permissible methods under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Volatile organic compounds, Particulate matter.
Federal Communications Commission.
Proposed rule.
In this document, we seek further comment on issues related to exceptions to and waivers of the local simulcasting requirement, whether we should let full power broadcasters use channels in the television broadcast band that are vacant to facilitate the transition to 3.0, and finally, we tentatively conclude that local simulcasting should not change the significantly viewed status of a Next Gen TV station.
Comments are due on or before February 20, 2018; reply comments are due on or before March 20, 2018.
You may submit comments, identified by GN Docket No. 16-142, by any of the following methods:
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•
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For additional information, contact Evan Baranoff,
This is a summary of the Commission's
1. In this Further Notice of Proposed Rulemaking, we seek further comment on three topics related to the rules adopted in the companion Report and Order. First, we seek further comment on issues related to exceptions to and waivers of the local simulcasting requirement. Second, we seek comment on whether we should let full power broadcasters use channels in the television broadcast band that are vacant to facilitate the transition to 3.0. Finally, we tentatively conclude that local simulcasting should not change the significantly viewed status of a Next Gen TV station.
2.
3. We seek comment on what further guidance we should provide about the circumstances in which we will grant a waiver of the local simulcasting requirement. How should we determine if a station has a “viable” simulcast partner? Given that we specify in the Report and Order that a Next Gen TV broadcaster's 1.0 simulcast channel must continue to cover its entire community of license, should we consider a station to have no viable partner only if there is no potential simulcasting partner in the same DMA that can cover the station's entire community of license? Alternatively, should we consider adopting a broader definition of viability? For example, should we specify that waiver
4. In addition, we seek comment on what type of “reasonable efforts” we should require a waiver applicant to undertake in order to preserve 1.0 service to existing viewers in its community of license and/or otherwise minimize the impact on viewers in its coverage area. Should it be favorable to our determination if waiver applicants volunteer to provide free or low cost ATSC 3.0 converters to viewers in their coverage area? Should we require such a commitment as a condition for waiver? Are there other efforts to minimize disruption to consumers that we should consider or require? We also invite comment on other circumstances in which we should consider granting waivers of the local simulcasting requirement.
5.
6. In the
7. Given the diversity of comments on this issue, we seek additional comment on the extent to which we should allow full power broadcasters to use vacant channels in the television broadcast band to facilitate the transition to 3.0, and, if so, when they should be able to use these channels, and what procedures we should use to authorize that use. As a threshold matter, how should we define a “vacant” channel for this purpose? We seek specific comment on ONE Media's proposal, and how it potentially would affect the post-incentive auction transition/repacking process and the various other users in the repacked television band.
8. If we were to permit full power licensees priority to use vacant channels as dedicated transition channels, we seek comment on the process for doing so. Specifically, how would broadcasters apply for an authorization to use a vacant channel? Should the request be for Special Temporary Authority (STA)? Should we instead consider a request for a temporary channel to be a minor change of the station's existing license and require a minor change application? If we treat these requests as minor changes, should we process such requests on a first-come, first-served basis? Should we
9. We tentatively conclude that the significantly viewed status of a Next Gen TV station should not change if it moves its 1.0 simulcast channel to a temporary host facility.
10. Stations that vary their signal strength or change their location as a result of moving their 1.0 signal to simulcast raise the question of how this change may affect their status as “significantly viewed” in certain communities or counties under §§ 76.5(i) and 76.54 of our rules. Significantly viewed status allows the significantly viewed station (1) to be carried by a satellite carrier in such community in the other market;
11. We recognize that broadcasters would not soon be able to demonstrate “significant viewing” with their 3.0 signals, but expect they will eventually be able to do so once Next Gen TV service takes hold in the marketplace. In the meantime, we tentatively conclude that maintaining the status quo with respect to eligibility for significantly viewed carriage would avoid some complications and disruptions to cable and satellite television viewers who have come to rely on such signals, while not imposing added mandatory carriage burdens on MVPDs.
12. As required by the Regulatory Flexibility Act of 1980, as amended (RFA), the Federal Communications Commission (Commission) has prepared this present Initial Regulatory Flexibility Analysis (IRFA) concerning the possible significant economic impact on a substantial number of small entities by the policies and rules proposed in the
13. In this Further Notice of Proposed Rulemaking, we seek further comment on three topics related to the rules adopted in the companion Report and Order, which authorizes television broadcasters to use the “Next Generation” broadcast television (Next Gen TV) transmission standard, also called “ATSC 3.0” or “3.0,” on a voluntary, market-driven basis. Next Gen TV broadcasters will continue to deliver current-generation digital television (DTV) service, using the ATSC 1.0 transmission standard, also called “ATSC 1.0” or “1.0,” to their viewers via “local simulcasting.”
14.
15.
16.
17.
18. The proposed action is authorized pursuant to sections 1, 4, 301, 303, 307, 308, 309, 316, 319, 325(b), 336, 338, 399b, 403, 534, and 535 of the Communications Act of 1934, as amended, 47 U.S.C. 151, 154, 301, 303, 307, 308, 309, 316, 319, 325(b), 336, 338, 399b, 403, 534, and 535.
19. The RFA directs agencies to provide a description of, and where feasible, an estimate of the number of small entities that may be affected by the proposed rules, if adopted. The types of small entities that may be affected by the R&O fall within the following categories: (1) Wired Telecommunications Carriers, of which 3,083 are estimated to be small entities; (2) Cable Companies and Systems (Rate Regulation), of which 3,900 are estimated to be small entities; (3) Cable System Operators (Telecom Act Standard), of which 52,403,696 are estimated to be small entities; (4) Direct Broadcast Satellite Service, of which 3,083 are estimated to be small entities, but internally developed FCC data suggest that in general DBS service is only provided by large entities; (5) Satellite Master Antenna Television (SMATV) Systems, also known as Private Cable Operators (PCOs),of which 3,083 are estimated to be small entities; (6) Home Satellite Dish (HSD) Service, of which 3,083 are estimated to be small entities; (7) Open Video Services, of which 3,083 are estimated to be small entities; (8) Wireless Cable Systems—Broadband Radio Service and Educational Broadband Service, of which 440 (BBS) and 2,241 (EBS) are
20. The
21. The RFA requires an agency to describe any significant alternatives that it has considered in reaching its proposed approach, which may include the following four alternatives (among others): “(1) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance and reporting requirements under the rule for such small entities; (3) the use of performance rather than design standards; and (4) an exemption from coverage of the rule, or any part thereof, for small entities.”
22.
23.
24.
25. None.
26. This NPRM may result in new or revised information collection requirements. If the Commission adopts any new or revised information collection requirements, the Commission will publish a notice in the
27.
28. Pursuant to §§ 1.415 and 1.419 of the Commission's rules, 47 CFR 1.415, 1.419, interested parties may file comments and reply comments on or before the dates indicated on the first page of this document. Comments may be filed using the Commission's Electronic Comment Filing System (ECFS). Electronic Filers: Comments may be filed electronically using the internet by accessing the ECFS:
Filings can be sent by hand or messenger delivery, by commercial overnight courier, or by first-class or overnight U.S. Postal Service mail. All filings must be addressed to the Commission's Secretary, Office of the Secretary, Federal Communications Commission.
All hand-delivered or messenger-delivered paper filings for the Commission's Secretary must be delivered to FCC Headquarters at 445 12th St., SW, Room TW-A325, Washington, DC 20554. The filing hours are 8:00 a.m. to 7:00 p.m. All hand deliveries must be held together with rubber bands or fasteners. Any envelopes and boxes must be disposed of
Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9050 Junction Drive, Annapolis Junction, MD 20701.
U.S. Postal Service first-class, Express, and Priority mail must be addressed to 445 12th Street SW, Washington, DC 20554.
29.
Federal Railroad Administration (FRA), Department of Transportation (DOT).
Notice of proposed rulemaking (NPRM).
In response to a petition for reconsideration of a final rule, FRA proposes to amend its regulations (Training, Qualification, and Oversight for Safety-Related Railroad Employees) by delaying certain implementation dates an additional year. FRA previously delayed the regulations' implementation dates for one year in a final rule published May 3, 2017 (May 2017 Final Rule).
Written comments on this proposed rule must be received by January 19, 2018. Comments received after that date will be considered to the extent possible without incurring additional expense or delay.
Comments related to Docket No. FRA-2009-0033 may be submitted by any of the following methods:
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Robert J. Castiglione, Staff Director—Human Performance Division, Federal Railroad Administration, 4100 International Plaza, Suite 450, Fort Worth, TX 76109-4820 (telephone: 817-447-2715); or Alan H. Nagler, Senior Trial Attorney, Federal Railroad Administration, Office of Chief Counsel, 1200 New Jersey Avenue SE, Washington, DC 20590 (telephone: 202-493-6038).
On November 7, 2014, FRA published a final rule (2014 Final Rule) that established minimum training standards for each category and subcategory of safety-related railroad employees and required railroad carriers, contractors, and subcontractors to submit training programs to FRA for approval.
In the preamble to the 2014 Final Rule, FRA noted the importance of establishing implementation dates and providing incentives for the early filing of model programs to improve the efficiency and effectiveness of the review process. FRA recognized it was paramount to give model program developers sufficient time to develop programs and receive FRA approval. FRA also recognized that employers would not use those model programs unless the employers were given reasonable time to consider those programs before the employers' deadline for implementation. Consequently, the 2014 Final Rule provided model program developers with an incentive to file all model programs by May 1, 2017—eight months before the first employers were required to submit model programs and two years before smaller employers (
After publishing the 2014 Final Rule, FRA took significant steps to educate the regulated community on its requirements and assist with the development of model training plans. For example, on March 20, 2017, FRA added information to its website to more broadly disseminate information about the 2014 Final Rule's requirements.
During FRA outreach on the 2014 Final Rule, FRA heard concerns from ASLRRA and the National Railroad Construction and Maintenance Association, Inc. (NRC), which were two of the associations identified in the 2014 Final Rule's Regulatory Impact Analysis (RIA) as likely model program developers. These two associations represent most of the 1,459 employers FRA projected would adopt model training programs rather than develop their own.
Based on ASLRRA and NRC's concerns about their ability to submit their model training programs by the May 1, 2017, deadline, and the significant impact that not meeting the deadline would have on the costs associated with the rule and FRA's approval process, FRA issued the May 2017 Final Rule extending each of the implementation dates in the 2014 Final Rule by one year.
On May 22, 2017, ASLRRA filed a petition for reconsideration of the May 2017 Final Rule. ASLRRA's petition was the only petition FRA received, and FRA did not receive any comments on the May 2017 Final Rule or ASLRRA's petition.
In the petition, ASLRRA stated that the association will need more than a one-year delay on each of the implementation dates in the 2014 Final Rule and requested that the one-year extension be extended further by another year. In the petition, ASLRRA stated that it represents over 500 Class II and III railroads and has assumed the responsibility for preparing model training programs for its member railroads' use. ASLRRA asserts that it still has a significant number of model programs left to develop and submit.
ASLRRA states in its petition that it is utilizing a large group of volunteer safety professionals from the ranks of its Safety and Training Committee to develop the model programs. ASLRRA is using these volunteers because the association asserts it would not otherwise have the resources to complete the task. With the commitments it received from volunteers, ASLRRA has mapped out a schedule to complete the model training programs by fall 2018.
Further, ASLRRA's petition states that extending the one-year delay will allow adequate time to comply with FRA's review and approval process and thereby assure its members that its model programs have been approved by FRA. According to ASLRRA the additional one-year extension will also allow each railroad adequate time to consider how it will implement each of the model programs it will adopt and whether it will need to adapt the programs to address any unique aspects of its operations.
FRA delayed each of the implementation dates in the 2014 Final Rule by one year largely because if both ASLRRA and NRC cannot submit most or all of their model training programs by the model program developer deadline, there would be significant cost impacts associated with the rule and it would complicate the approval process. Indeed, even if the ASLRRA alone were unable to submit its model programs for its more than 500 member railroads, the cost impacts would still be substantial.
The 500 or more railroad employers that rely on ASLRRA to produce model programs would bear significantly higher costs developing personalized training programs, rather than adopting model programs that are generic enough to apply to the gamut of railroads. Further, FRA's resources would be stretched thin reviewing potentially 500 or more individual Class II and Class III railroad employer programs, rather than a relatively small number of model programs. Moreover, by providing ASLRRA additional time to produce model programs, FRA expects the quality of those model programs will be much better than those separately prepared by a large number of individual small or medium-sized railroads. Of course, FRA does not see the value in limiting the extension only to ASLRRA and its member railroads. FRA believes all regulated entities can
Overall, the additional one-year delay of the implementation dates should allow all model training program developers and other regulated entities to meet the rule's deadlines. FRA understands that many regulated entities were on schedule to meet the original deadlines in the 2014 Final Rule, or were preparing to meet the deadlines delayed by the May 2017 Final Rule. For those regulated entities that are prepared to move forward in advance of any deadline, there is certainly no prohibition against doing so and implementing a more robust training program should benefit the overall safety of those employers who are early adopters.
In consideration of the foregoing, FRA proposes to delay each of the implementation dates in the May 2017 Final Rule by an additional year, thereby delaying each of the implementation dates in the 2014 Final Rule by a total of two years.
The implementation dates in this proposed section would be cumulatively delayed by two years from the 2014 Final Rule so all employers have additional time to develop and submit training programs. Specifically, as previously amended by the May 2017 Final Rule, in paragraphs (a)(1) and (b) the January 1, 2019, implementation dates would be changed to January 1, 2020. Likewise, in paragraph (a)(2) the May 1, 2020, implementation date, as previously amended by the May 2017 Final Rule, would be changed to May 1, 2021.
The implementation date in proposed paragraph (a)(3) of this section would be cumulatively delayed by two years from the 2014 Final Rule so that all model program developers have additional time to submit model programs, while also potentially benefiting from an expedited FRA review process. Under the May 2017 Final Rule, each model program submitted to FRA before May 1, 2018, would be considered approved and may be implemented 180 days after the date of the submission, unless FRA otherwise advises that all or part of the program does not conform to the rule's requirements. This NPRM proposes to extend that date until May 1, 2019.
FRA proposes that each training organization or learning institution that has provided training services to employers covered by this part would cumulatively have an additional two years from the 2014 Final Rule to continue to offer such training services without FRA approval. As previously amended by the May 2017 Final Rule, a training organization or learning institution that has provided training services to employers covered by this part before January 1, 2018, may continue to offer such training services without FRA approval until January 1, 2019. FRA proposes to amend paragraph (b) of this section so that both dates are delayed by an additional year. Accordingly, the proposed requirement states that a training organization or learning institution that has provided training services to employers covered by this part before January 1, 2019, may continue to offer such training services without FRA approval until January 1, 2020.
The implementation dates in this section would be cumulatively delayed by two years from the 2014 Final Rule so all employers have additional time to designate each of their existing safety-related railroad employees by occupational category or subcategory, and only permit designated employees to perform safety-related service in such occupational category or subcategory. In paragraph (a)(1), the September 1, 2019, implementation date, as previously amended by the May 2017 Final Rule, would be changed to September 1, 2020. Likewise, in paragraph (a)(2) the January 1, 2021, implementation date, as previously amended by the May 2017 Final Rule, would be changed to January 1, 2022.
In proposed paragraph (b), the January 1, 2019, implementation date, as previously amended by the May 2017 Final Rule, would change to January 1, 2020.
In proposed paragraphs (e)(1) and (2), the implementation dates for refresher training would also be cumulatively delayed by two years from the 2014 Final Rule. Thus, the January 1, 2021, implementation date in paragraph (e)(1), as previously amended by the May 2017 Final Rule, would change to January 1, 2022, and the proposed completion of that refresher training for each employee would be required no later than December 31, 2024, instead of the previously amended date of December 31, 2023. In proposed paragraph (e)(2), each employer with less than 400,000 total employee work hours annually would be required to implement a refresher training program by May 1, 2023, rather than the previously amended date of May 1, 2022, and complete that refresher training for each employee by no later than December 31, 2025, instead of the previously amended date of December 31, 2024.
This proposed rule is a non-significant regulatory action within the meaning of Executive Order 12866 and DOT policies and procedures.
In 2014, FRA published a Final Rule which established minimum training standards for each category and subcategory of safety-related railroad employee, as required by section 401(a) of the RSIA. FRA believes that this proposed rule will reduce the regulatory
The costs arising from part 243 over the 20-year period include: The costs of revising training programs to include “hands-on” training where appropriate, as well as the costs of creating entirely new training programs for any employer that does not have one already; the costs of customizing model training programs for those employers that choose to adopt a model program rather than create a new program; the costs of annual data review and analysis required in order to refine training programs; the costs of revising programs in later years; the costs of additional time new employees may have to spend in initial training; the costs of additional periodic oversight tests and inspections; the costs of additional qualification tests; and the costs of additional time all safety-related railroad employees may have to spend in refresher training.
FRA believes that additional hands-on and refresher training found in the 2014 Final Rule will reduce the frequency and severity of some future accidents and incidents. Expected safety benefits were calculated using full accident costs, which are based on past accident history, the values of preventing future fatalities and injuries sustained, and the cost of property damage. (Full accident costs are determined by the number of fatalities and injuries multiplied by their respective prevention valuations, and the cost of property damage.)
By delaying the implementation dates of the 2014 Final Rule, railroads will realize a cost savings. Railroads will not incur costs during the first two years of this analysis. Also, costs incurred in future years will be discounted an extra two years, which will decrease the present value burden. The present value of costs would be less than if the original implementation dates were adhered to. FRA has estimated this cost savings to be approximately $40.6 million, at a 3% discount rate, and $37.2 million, at a 7% discount rate. The table below shows the costs estimated at the final rule stage as well as the costs with the two-year implementation delay.
FRA has determined and certifies that this proposed rule is not expected to have a significant impact on a substantial number of small entities. The requirements of this proposed rule would apply to employers of safety-related railroad employees, whether the employers are railroads, contractors, or subcontractors. Although a substantial number of small entities would be subject to this proposed rule, it would provide relief by extending all of the implementation dates in the 2014 Final Rule, as amended by the May 2017 Final Rule. Thus, the economic impact of this proposed rule would not be significant because it would only provide additional time for all entities to comply with the 2014 Final Rule.
This proposed rule would have no direct impact on small units of government, businesses, or other organizations. State rail agencies are not required to participate in this program. State owned railroads would receive a positive impact by having additional time to comply.
There are no new collection of information requirements contained in this proposed rule and, in accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3501
This proposed rule would not have a substantial 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. Thus in accordance with Executive Order 13132, “Federalism” (64 FR 43255, Aug. 10, 1999), preparation of a Federalism Assessment is not warranted.
The Trade Agreement Act of 1979 prohibits Federal agencies from engaging in any standards or related activities that create unnecessary obstacles to the foreign commerce of the United States. Legitimate domestic objectives, such as safety, are not considered unnecessary obstacles. The statute also requires consideration of international standards and where appropriate, that they be the basis for U.S. standards.
This proposed rule is purely domestic in nature and is not expected to affect trade opportunities for U.S. firms doing business overseas or for foreign firms doing business in the United States.
FRA has evaluated this proposed rule in accordance with its “Procedures for Considering Environmental Impacts” (FRA's Procedures) (64 FR 28545, May 26, 1999) as required by the National Environmental Policy Act (42 U.S.C. 4321
In accordance with section 4(c) and (e) of FRA's Procedures, the agency has further concluded that no extraordinary circumstances exist with respect to this proposed rule that might trigger the need for a more detailed environmental review. As a result, FRA finds that this proposed rule is not a major Federal action significantly affecting the quality of the human environment.
Pursuant to section 201 of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, 2 U.S.C. 1531), each Federal agency shall, unless otherwise prohibited by law, assess the effects of Federal regulatory actions on State, local, and tribal governments, and the private sector (other than to the extent that such regulations incorporate requirements specifically set forth in law). Section 202 of the Act (2 U.S.C. 1532) further requires that before promulgating any general notice of proposed rulemaking that is likely to result in the promulgation of any rule that includes any Federal mandate that may result in expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of
Executive Order 13211 requires Federal agencies to prepare a Statement of Energy Effects for any “significant energy action.” 66 FR 28355 (May 22, 2001). FRA evaluated this proposed rule in accordance with Executive Order 13211, and determined that this regulatory action is not a “significant energy action” within the meaning of the Executive Order.
Executive Order 13783, “Promoting Energy Independence and Economic Growth,” requires Federal agencies to review regulations to determine whether they potentially burden the development or use of domestically produced energy resources, with particular attention to oil, natural gas, coal, and nuclear energy resources. 82 FR 16093 (March 31, 2017). FRA determined this proposed rule would not burden the development or use of domestically produced energy resources.
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, including any personal information the commenter provides, to
Administrative practice and procedure, Penalties, Railroad employees, Railroad safety, Reporting and recordkeeping requirements.
For the reasons discussed in the preamble, FRA proposes to amend chapter II, subtitle B of title 49 of the Code of Federal Regulations as follows:
49 U.S.C. 20103, 20107, 20131-20155, 20162, 20301-20306, 20701-20702, 21301-21304, 21311; 28 U.S.C. 2461, note; and 49 CFR 1.89.
(a)(1) Effective January 1, 2020, each employer conducting operations subject to this part with 400,000 total employee work hours annually or more shall submit, adopt, and comply with a training program for its safety-related railroad employees.
(2) Effective May 1, 2021, each employer conducting operations subject to this part with less than 400,000 total employee work hours annually shall submit, adopt, and comply with a training program for its safety-related railroad employees.
(b) Except for an employer subject to the requirement in paragraph (a)(2) of this section, an employer commencing operations subject to this part after January 1, 2020, shall submit a training program for its safety-related railroad employees before commencing operations. Upon commencing operations, the employer shall adopt and comply with the training program.
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(3) Each model training program submitted to FRA before May 1, 2019, is considered approved and may be implemented 180 days after the date of submission unless the Associate Administrator advises the organization, business, or association that developed and submitted the program that all or part of the program does not conform.
(b) A training organization or learning institution that has provided training services to employers covered by this part before January 1, 2019, may continue to offer such training services without FRA approval until January 1, 2020. The Associate Administrator may extend this period at any time based on a written request. Such written requests for an extension of time to submit a program should contain any factors the training organization or learning institution wants the Associate Administrator to consider before approving or disapproving the extension.
(a) * * *
(1) By no later than September 1, 2020, each employer with 400,000 total employee work hours annually or more in operation as of January 1, 2020, shall declare the designation of each of its existing safety-related railroad employees by occupational category or subcategory, and only permit designated employees to perform safety-related service in that occupational category or subcategory. The Associate Administrator may extend this period based on a written request.
(2) By no later than January 1, 2022, each employer with less than 400,000 total employee work hours annually in operation as of January 1, 2021, shall declare the designation of each of its existing safety-related railroad employees by occupational category or subcategory, and only permit designated employees to perform safety-related service in that occupational category or subcategory. The Associate Administrator may extend this period based on a written request.
(b) Except for an employer subject to the requirement in paragraph (a)(2) of this section, an employer commencing operations after January 1, 2020, shall declare the designation of each of its existing safety-related railroad employees by occupational category or subcategory before beginning operations, and only permit designated employees to perform safety-related service in that category or subcategory. Any person designated shall have met the requirements for newly hired employees or those assigned new safety-related duties in accordance with paragraph (c) of this section.
(e) * * *
(1) Beginning January 1, 2022, each employer with 400,000 total employee work hours annually or more shall deliver refresher training at an interval not to exceed 3 calendar years from the date of an employee's last training event, except where refresher training is specifically required more frequently in
(2) Beginning May 1, 2023, each employer with less than 400,000 total employee work hours annually shall deliver refresher training at an interval not to exceed 3 calendar years from the date of an employee's last training event, except where refresher training is specifically required more frequently in accordance with this chapter. If the last training event occurs before FRA's approval of the employer's training program, the employer shall provide refresher training either within 3 calendar years from that prior training event or no later than December 31, 2025. Each employer shall ensure that, as part of each employee's refresher training, the employee is trained and qualified on the application of any Federal railroad safety laws, regulations, and orders the person is required to comply with, as well as any relevant railroad rules and procedures promulgated to implement those Federal railroad safety laws, regulations, and orders.
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of proposed regulatory guidance; request for public comment.
FMCSA announces regulatory guidance to clarify the applicability of the “Agricultural commodity” exception to the “Hours of Service of Drivers” regulations, and requests public comments. This regulatory guidance is being proposed to ensure consistent understanding and application of the exception by motor carriers and State officials enforcing hours of service rules identical to or compatible with FMCSA's requirements.
Comments must be received on or before January 19, 2018. This guidance would expire no later than 5 years after it is finalized.
You may insert comments identified by Federal Docket Management System Number FMCSA-2017-0360 by any of the following methods:
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To avoid duplication, please use only one of these four methods. See the “Public Participation and Request for Comments” portion of the
Mr. Thomas Yager, Chief, Driver and Carrier Operations Division, Federal Motor Carrier Safety Administration, U.S. Department of Transportation, 1200 New Jersey Avenue SE, Washington, DC 20590, phone (614) 942-6477, email
If you submit a comment, please include the docket number listed above, indicate the specific section of this document to which your comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online or by fax, mail, or hand delivery. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so that FMCSA can contact you if there are questions regarding your submission.
To submit your comment online, go to
If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 8
FMCSA will consider all comments and material received during the comment period and may change this guidance based on your comments.
To view comments, go to
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its regulatory process. DOT posts these comments, without edit, including any personal information the commenter provides, to
The National Highway System Designation Act of 1995, Public Law 104-59, 345, 109 Stat. 568. 613 (Nov. 28, 1995), provided the initial exception for drivers transporting agricultural commodities or farm supplies for agricultural purposes. This Act limited the exception to a 100 air-mile radius from the source of the commodities or distribution point for the farm supplies
In enacting the Safe, Accountable, Flexible, Efficient Transportation Act: A Legacy for Users (SAFETEA-LU), Congress revised this provision, enacted it to be new section 229 of Title II of the Motor Carrier Safety Improvement Act of 1999, and defined the terms “agricultural commodity” and “farm supplies for agricultural purposes.” Public Law 109-59, §§ 4115 and 4130, 119 Stat. 1144, 1726, 1743 (Aug. 10, 2005). These terms are now defined in 49 CFR 395.2.
Most recently, the statute was amended by section 32101(d) of the Moving Ahead for Progress in the 21st Century Act (MAP-21), Public Law 112-141, 126 Stat. 405, 778 (July 6, 2012). This provision revised the description of the exception's scope and extended the applicable distance from 100 air-miles to 150 air-miles from the source.
The focus of today's guidance is limited to the transportation of agricultural commodities, 49 CFR 395.1(k)(1). It does not address “farm supplies for agricultural purposes” under 49 CFR 395.1(k)(2) or (3) given that the applicable range under these latter two provisions is specifically addressed. While the regulatory provision governing the agricultural commodity exception (49 CFR 395.1(k)(1)) closely tracks the statutory provisions discussed above, the language is susceptible to multiple interpretations, and the Agency acknowledges that various stakeholders and enforcement officials in different States have expressed inconsistent understandings of the exception from time to time.
This proposed regulatory guidance would clarify the exception with regard to: (1) Drivers operating unladen vehicles traveling either to pick up an agricultural commodity, as defined in 49 CFR 395.2, or returning from a delivery point; and (2) drivers engaged in trips beyond 150 air-miles from the source of the agricultural commodity. In addition, the Agency seeks public comment on (1) whether grain elevators and/or livestock sale barns should be considered a “source” of agricultural commodities under section 395.1(k)(1); and (2) how the exception should apply when agricultural commodities are loaded at multiple sources during a trip.
FMCSA's final rule “Electronic Logging Devices and Hours of Service Supporting Documents” (80 FR 78292; December 16, 2015), will require most drivers who use paper logs to document their hours of service to switch to electronic logging devices. That rule did not alter the hours of service rules or the agricultural commodity exception. However, FMCSA has received questions from regulated motor carriers about the agricultural commodity exception and application of the hours of service rules due to the practical ramifications of that rule, and the approaching December 18, 2017 compliance date. Specific scenarios are addressed further below.
Today's proposed regulatory guidance would provide clarity to the agricultural exception in 49 CFR 395.1(k)(1) and specifically addresses two scenarios: (1) Driving an unladen commercial motor vehicle to either pick up an agricultural commodity or on a return trip following the delivery of an agricultural commodity; and (2) application of the agricultural commodity exception to trips involving transportation of the commodity more than 150 air-miles from its source. In addition, the Agency seeks comment on (1) whether grain elevators and/or livestock sale barns should be considered a “source” of agricultural commodities under section 395.1(k)(1); and (2) scenarios where a trip involves the loading of agricultural commodities at multiple sources.
FMCSA proposes Regulatory Guidance, Questions 34 and 35 to 49 CFR 395.1 as follows:
In accordance with section 5203(a)(2)(A) and (a)(3) of the Fixing America's Surface Transportation (FAST) Act, Public Law 114-94, 129 Stat. 1312, 1535 (Dec. 4, 2015), the proposed regulatory guidance will be posted on FMCSA's website,
Refer to the
1. Are there particular segments of the industry that would take advantage of this change more than others?
2. How does the flexibility provided in this guidance impact a carrier's need for an electronic logging device?
3. How many carriers and drivers are there transporting agricultural commodities in various segments (livestock, unprocessed food, others) that are impacted by this guidance?
Fish and Wildlife Service, Interior.
Notification of petition findings and initiation of status reviews.
We, the U.S. Fish and Wildlife Service (Service), announce 90-day findings on several petitions to list or reclassify wildlife or plants under the Endangered Species Act of 1973, as amended (Act). Based on our review, we find that the petitions present substantial scientific or commercial information indicating that the petitioned actions may be warranted with respect to the species mentioned in this notification. Therefore, with the publication of this document, we announce that we plan to initiate a review of the status of each of these species to determine if the petitioned actions are warranted. To ensure that these status reviews are comprehensive, we are requesting scientific and commercial data and other information regarding these species. After completing the status reviews, we will issue 12-month findings on the petitions, which will address whether or not the petitioned action is warranted, in accordance with the Act. In addition, we announce a correction to information contained in the 90-day petition finding for the leopard (
These findings were made on December 20, 2017.
Summaries of the bases for the petition findings contained in this document are available on
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(2)
We request that you send information only by the methods described above. We will post all information we receive on
If you use a telecommunications device for the deaf (TDD), please call the Federal Relay Service (FIRS) at 800-877-8339.
Section 4 of the Act (16 U.S.C. 1533) and its implementing regulations in title 50 of the Code of Federal Regulations (50 CFR part 424) set forth the procedures for adding a species to, or removing a species from, the Federal Lists of Endangered and Threatened Wildlife and Plants. Section 4(b)(3)(A) of the Act requires that we make a finding on whether a petition to list, delist, or reclassify a species presents substantial scientific or commercial information indicating that the petitioned action may be warranted. To the maximum extent practicable, we are to make this finding within 90 days of our receipt of the petition and publish the finding promptly in the
Last year, the Service and the National Marine Fisheries Service of the Department of Commerce revised the regulations that outline the procedures for evaluating petitions (81 FR 66462; September 27, 2016). The new regulations at 50 CFR 424.14 were effective October 27, 2016. We received the petitions referenced in this document prior to that effective date. Therefore, we evaluated these petitions under the 50 CFR 424.14 requirements that were in effect prior to October 27, 2016, as those requirements applied when the petitions were received. The regulations in effect prior to October 27, 2016, establish that the standard for substantial scientific or commercial information with regard to a 90-day petition finding is “that amount of information that would lead a reasonable person to believe that the measure proposed in the petition may be warranted” (former 50 CFR 424.14(b)).
A species may be determined to be an endangered or threatened species because of one or more of the five factors described in section 4(a)(1) of the Act. The five factors are:
(a) The present or threatened destruction, modification, or curtailment of its habitat or range (Factor A);
(b) Overutilization for commercial, recreational, scientific, or educational purposes (Factor B);
(c) Disease or predation (Factor C);
(d) The inadequacy of existing regulatory mechanisms (Factor D); or
(e) Other natural or manmade factors affecting its continued existence (Factor E).These factors represent broad categories of natural or human-caused actions or conditions that could have an effect on a species' continued existence (
If we find that a petition presents such information, our subsequent status review will evaluate all identified threats by considering the individual, population, and species-level effects, and the expected response by the species. We will evaluate individual threats and their expected effects on the species, then analyze the cumulative effect of the threats on the species as a whole. We also consider the cumulative effect of the threats in light of those actions and conditions that will have positive effects on the species—such as any existing regulatory mechanisms or conservation efforts that may ameliorate threats. It is only after conducting this cumulative analysis of threats and the actions that may ameliorate them, and the expected effect on the species now and in the foreseeable future, that we can determine whether the species meets the definition of an “endangered species” or “threatened species.”
If we find that a petition presents substantial scientific or commercial information, the Act requires us to promptly commence a review of the status of the species, and we will subsequently complete a status review in accordance with our prioritization methodology for 12-month findings (81 FR 49248; July 27, 2016).
The petition findings contained in this document are listed in the table below and the bases for the findings, along with supporting information, are available on
Oblong rocksnail (
On June 21, 2016, we received a petition dated the same day from the Center for Biological Diversity and Cahaba Riverkeeper requesting that the oblong rocksnail be listed as endangered or threatened and that critical habitat be designated for this species under the Act. The petition clearly identified itself as such and included the requisite identification information for the petitioners, required at former 50 CFR 424.14(a). This finding addresses the petition.
Based on our review of the petition and sources cited in the petition, we find that the petition presents substantial scientific or commercial information indicating that the petitioned action may be warranted for the oblong rocksnail, based on Factors A and E as set forth in section 4(a)(1) of the Act (for information about these factors, see Background, above). However, during our status review, we will thoroughly evaluate all potential threats to the species, including the extent to which any protections or other conservation efforts have reduced those threats. Thus, for this species, the Service requests any information relevant to whether the species falls within the definition of either “endangered species” under section 3(6) of the Act or “threatened species” under section 3(20) of the Act, including information on the five listing factors under section 4(a)(1) (see Request for Information for Status Reviews, below).
The basis for our finding on this petition, and other information regarding our review of the petition, can be found as an appendix at
Sturgeon chub (
Sicklefin chub (
On August 15, 2016, we received a petition dated August 11, 2016, from WildEarth Guardians requesting that the sturgeon chub and sicklefin chub be listed as endangered or threatened and that critical habitat be designated for these species under the Act. The petition clearly identified itself as such and included the requisite identification information for the petitioner, required at former 50 CFR 424.14(a). This finding addresses the petition.
Based on our review of the petition and sources cited in the petition, we find that the petition presents substantial scientific or commercial information indicating that the petitioned action may be warranted for the sturgeon chub and sicklefin chub, based on Factors A, C, D, and E as set forth in section 4(a)(1) of the Act (for information about these factors, see Background, above). However, during our status review, we will thoroughly evaluate all potential threats to the species, including the extent to which any protections or other conservation efforts have reduced those threats. Thus, for these species, the Service requests any information relevant to whether the species fall within the definition of either “endangered species” under section 3(6) of the Act or “threatened species” under section 3(20) of the Act, including information on the five listing factors under section 4(a)(1) (see Request for Information for Status Reviews, below).
The basis for our finding on this petition, and other information regarding our review of the petition, can be found as an appendix at
Tricolored bat (
On June 14, 2016, we received a petition dated June 14, 2016, from the Center for Biological Diversity and Defenders of Wildlife requesting that the tricolored bat be listed as endangered or threatened and that critical habitat be designated for this species under the Act. The petition clearly identified itself as such and included the requisite identification information for the petitioners, required at former 50 CFR 424.14(a). This finding addresses the petition.
Based on our review of the petition and sources cited in the petition, we find that the petition presents substantial scientific or commercial information indicating that the petitioned action may be warranted for the tricolored bat, based on Factors A, C, and E as set forth in section 4(a)(1) of the Act (for information about these factors, see Background, above). However, during our status review, we will thoroughly evaluate all potential threats to the species, including the extent to which any protections or other conservation efforts have reduced those threats. Thus, for this species, the Service requests any information relevant to whether the species falls within the definition of either “endangered species” under section 3(6) of the Act or “threatened species” under section 3(20) of the Act, including information on the five listing factors under section 4(a)(1) (see Request for Information for Status Reviews, below).
The basis for our finding on this petition, and other information regarding our review of the petition, can be found as an appendix at
Venus flytrap (
On October 21, 2016, we received a petition dated the same day from Donald M. Waller, J.T. Curtis Professor of Botany and Environmental Studies, University of Wisconsin-Madison, and 25 additional supporters requesting that the Venus flytrap be listed as endangered or threatened and that critical habitat be designated for this species under the Act. The petition clearly identified itself as such and included the requisite identification information for the petitioners, required at former 50 CFR 424.14(a). This finding addresses the petition.
Based on our review of the petition and sources cited in the petition, we find that the petition presents substantial scientific or commercial information indicating that the petitioned action may be warranted for the Venus flytrap, based on Factors A, B, and D as set forth in section 4(a)(1) of the Act (see Background, above). However, during our status review, we will thoroughly evaluate all potential threats to the species, including the extent to which any protections or other conservation efforts have reduced those threats. Thus, for this species, the Service requests any information relevant to whether the species falls within the definition of either “endangered species” under section 3(6) of the Act or “threatened species” under section 3(20) of the Act, including information on the five listing factors under section 4(a)(1) (see Request for Information for Status Reviews, below).
The basis for our finding on this petition, and other information regarding our review of the petition, can be found as an appendix at
On November 30, 2016, we published a document in the
The first error we made in the November 30, 2016, 90-day finding is that we mistakenly titled the action “Evaluation of a Petition To Reclassify Leopards Currently Listed as Threatened Species to Endangered Species Under the Act,” inadvertently implying that we will evaluate the status of the species only in the countries in which it is currently listed as threatened. However, the petition requests that we reclassify leopards as endangered throughout the species' current range, and we evaluated the petition based on that request. Our finding on the petition—that the petition contains substantial information that listing the leopard as endangered throughout its range may be warranted—has not changed. Therefore, we clarify that we will evaluate the status of leopards throughout their current range in our assessment of the species' status.
The second error we made in the November 30, 2016, 90-day finding is that we mistakenly described the current range of the leopard as: Democratic Republic of the Congo, Gabon, Kenya, and Uganda. However, the correct current range of the species is as follows:
Leopard (
The corrected information regarding our review of this petition can be found as an appendix at
When we make a finding that a petition presents substantial information indicating that listing, reclassification, or delisting of a species may be warranted, we are required to review the status of the species (a status review). For the status review to be complete and based on the best available scientific and commercial information, we request information on these species from governmental agencies, Native American Tribes, the scientific community, industry, and any other interested parties. We seek information on:
(1) The species' biology, range, and population trends, including:
(a) Habitat requirements;
(b) Genetics and taxonomy;
(c) Historical and current range, including distribution patterns; and
(d) Historical and current population levels and current and projected trends.
(2) The five factors described in section 4(a)(1) of the Act (see Background, above) that are the basis for making a listing, reclassification, or delisting determination for a species under section 4(a) of the Act (16 U.S.C. 1531
(3) The potential effects of climate change on the species and its habitat, and the extent to which it affects the habitat or range of the species.
If, after the status review, we determine that listing is warranted, we will propose critical habitat (see definition at section 3(5)(A) of the Act) for domestic (United States) species under section 4 of the Act, to the maximum extent prudent and determinable at the time we propose to list the species. Therefore, we also request data and information (submitted as provided for in
(1) What may constitute “physical or biological features essential to the conservation of the species,” within the geographical range occupied by the species;
(2) Where these features are currently found;
(3) Whether or not any of these features may require special management considerations or protection;
(4) Specific areas outside the geographical area occupied by the species that are “essential for the conservation of the species”; and
(5) What, if any, critical habitat you think we should propose for designation if the species is proposed for listing, and why such habitat falls within the definition of “critical habitat” at section 3(5) of the Act.
Please include sufficient information with your submission (such as scientific journal articles or other publications) to allow us to verify any scientific or commercial information you include.
Submissions merely stating support for or opposition to the actions under consideration without providing supporting information, although noted, will not be considered in making a determination. Section 4(b)(1)(A) of the Act directs that determinations as to whether any species is an endangered or threatened species must be made “solely on the basis of the best scientific and commercial data available.”
You may submit your information concerning these status reviews by one of the methods listed in
It is important to note that the standard for a 90-day finding differs from the Act's standard that applies to a status review to determine whether a petitioned action is warranted. In making a 90-day finding, we consider information in the petition and sources cited in the petition, as well as information which is readily available, and we evaluate merely whether that information constitutes “substantial information” indicating that the petitioned action “may be warranted.” In a 12-month finding, we must complete a thorough status review of the species and evaluate the “best scientific and commercial data available” to determine whether a petitioned action “is warranted.” Because the Act's standards for 90-day and 12-month findings are different, a substantial 90-day finding does not mean that the 12-month finding will result in a “warranted” finding.
On the basis of our evaluation of the information presented in the petitions under section 4(b)(3)(A) of the Act, we have determined that the petitions referenced above for the oblong rocksnail, sturgeon chub, sicklefin chub, tricolored bat, and Venus flytrap present substantial scientific or commercial information indicating that the requested actions may be warranted. Because we have found that these petitions present substantial information indicating that the petitioned actions may be warranted, we are initiating status reviews to determine whether these actions are warranted under the Act. At the conclusion of each status review, we will issue a finding, in accordance with section 4(b)(3)(B) of the Act, as to whether or not the petitioned action is warranted.
The primary authors of this document are staff members of the Ecological Services Program, U.S. Fish and Wildlife Service.
The authority for these actions is the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce.
Proposed specification; request for comments.
NMFS proposes a 2017 annual catch limit (ACL) of 3,500 lb for Hawaii Kona Crab, and an accountability measure (AM) to correct or mitigate any overages of catch limits. The proposed ACL and AM support the long-term sustainability of fishery resources of the U.S. Pacific Islands.
NMFS must receive comments by January 4, 2018.
You may submit comments on this document, identified by NOAA-NMFS-2017-0120, by either of the following methods:
•
•
NMFS prepared an environmental analysis that describes the potential impacts on the human environment that would result from the proposed ACL and AM. Copies of the environmental analyses and other supporting documents are available at
Sarah Ellgen, NMFS PIR Sustainable Fisheries, 808-725-5173.
The Kona crab fishery in the U.S. Exclusive Economic Zone (generally 3-200 nm from shore) around Hawaii is managed under Fishery Ecosystem Plan for the Hawaiian Archipelago (FEP). The Western Pacific Fishery Management Council (Council) developed the FEP, and NMFS implemented the plan under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act).
The FEP contains a process for the Council and NMFS to specify ACLs and AMs; that process is codified at Title 50, Code of Federal Regulations, Section 665.4 (50 CFR 665.4). The regulations require NMFS to specify, every fishing year, an ACL for each stock and stock complex of management unit species (MUS) in an FEP, as recommended by the Council and considering the best available scientific, commercial, and other information about the fishery. If a fishery exceeds an ACL, the regulations require the Council to take action, which may include reducing the ACL for the subsequent fishing year by the amount of the overage, or other appropriate action.
The Council recommended that NMFS specify an ACL of 3,500 lb of Hawaii Kona crab for fishing year 2017, which began on January 1 and ends on December 31. The Council based its ACL recommendation on a
Hawaii State law prohibits retention of female crabs, but the assessment results included both males and females combined. The assessment acknowledged that the 2010-2030 stock status projections did not account for the effects of the State prohibition after September 2006 and, as a result, the projections are associated with a high degree of uncertainty. At a constant zero-lb annual harvest rate, the assessment predicted that the Kona crab stock would recover from overfished levels after 2015. At a constant 7,000-lb annual commercial harvest rate, the assessment estimated that Kona crab biomass would increase above 50 percent of B
In 2015, NMFS contracted the Center for Independent (CIE) experts to review the stock assessment. Both the CIE reviewers and NMFS Pacific Islands Fisheries Science Center (PIFSC) agreed with the evaluation of the fishery for 2006, and the conclusion that stock projections beyond 2006 probably do not accurately describe current Hawaii Kona crab stock size or structure. PIFSC also agreed with the CIE review that further work is needed to provide advice on the status of the population in more recent years. Therefore, PIFSC is planning to complete a benchmark assessment for Hawaii Kona crab in 2019, which could be available for management use in fishing year 2020.
In developing the proposed ACL recommendation, the Council also considered information indicating a 50:50 male to female landings ratio, and information suggesting that crabs disentangled from Kona crab may have injuries that could result in mortality rates as high as 100 percent if limbs are lost. Therefore, to meet the objective of rebuilding stock biomass to levels above 50 percent of B
As an AM, NMFS proposes to apply a three-year average catch to evaluate fishery performance against the proposed ACLs. Specifically, NMFS proposes to use the average catch of fishing years 2015, 2016, and 2017, to evaluate fishery performance against the 2017 ACL. If, after the end of the fishing year, NMFS and the Council determine that the three-year average catch exceeded the specified ACL, NMFS and the Council will reduce the ACL for that fishery by the amount of the overage in the subsequent year. The Council recommended an AM based on multi-year average catch data to reduce the influence of inter-annual variability in catch estimates in evaluating fishery performance against the ACL.
NMFS will consider public comments on the proposed ACL and AM and will announce the final specification in the
Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Act, the NMFS Assistant Administrator for Fisheries has determined that this proposed specification is consistent with the FEP, other provisions of the Magnuson-Stevens Act, and other applicable laws, subject to further consideration after public comment.
The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration that this proposed specification, if adopted, would not have a significant economic impact on a substantial number of small entities. A description of the proposed action, why it is being considered, and the legal basis for it are contained in the preamble to this proposed specification.
NMFS proposes to specify a 2017 annual catch limit (ACL) of 3,500 lb for Kona crab in Hawaii, as recommended by the Western Pacific Fishery Management Council (Council). The 2017 proposed ACL is based on updated scientific information made available to NMFS. The proposed ACL is much lower than the ACL implemented each year from 2012 and 2015, which had been 27,600 lb. NMFS did not implement an ACL for this stock in 2016.
This rule would affect participants in the commercial and non-commercial fisheries for Hawaii Kona crab. Kona crab landings averaged 2,658 lb from 2014-2016, with an estimated ex-vessel value of $20,965, based on a price of $5.99 per lb. The amount of Kona crab landed each year has generally declined since 2011, when 51 fishermen reported landing 10,883 lb. During the 2016 fishing year, 24 fishermen reported landing 2,577 lb. In 2015, 26 fishermen reported landing 2,332 lb. In 2014, 30 fishermen reported landing 3,067 lb.
Based on available information, NMFS has determined that all vessels in the commercial and non-commercial fisheries for Kona crab are small entities under the Small Business Administration's definition of a small entity. That is, they are engaged in the business of fish harvesting, independently owned or operated, not dominant in their field of operation, and have annual gross receipts not in excess of $11 million, the small business size standard for commercial fishing (NAICS Code: 11411). Therefore, there would be no disproportionate economic impacts between large and small entities. Furthermore, there would be no disproportionate economic impacts among the universe of vessels based on gear, home port, or vessel length.
Even though this proposed action would apply to a substantial number of vessels, this action should not result in significant adverse economic impact to individual vessels. NMFS and the Council are not considering in-season closure in the Kona crab fisheries to which this ACL apply because fishery management agencies are not able to track catch relative to the ACLs during the fishing year. As a result, fishermen would be able to fish throughout the entire year. In addition, the ACLs, as proposed, would not change the gear types, areas fished, effort, or participation of the fishery during the 2017 fishing year. A post-season review of the catch data would be required to determine whether the fishery exceeded its ACL by comparing the ACL to the most recent three-year average catch for which data is available. If an ACL is exceeded, the Council and NMFS would take action in future fishing years to correct the operational issue that caused the ACL overage. NMFS and the Council would evaluate the environmental, social, and economic impacts of future actions, such as changes to future ACLs or AMs, after the required data are available. Specifically, if NMFS and the Council determine that the three-year average catch for a fishery exceeds the
The proposed action does not duplicate, overlap, or conflict with other Federal rules and is not expected to have significant impact on small entities (as discussed above), organizations, or government jurisdictions. The proposed action also will not place a substantial number of small entities, or any segment of small entities, at a significant competitive disadvantage to large entities. For the reasons above, NMFS does not expect the proposed action to have a significant economic impact on a substantial number of small entities. As such, an initial regulatory flexibility analysis is not required and none has been prepared.
This action is exempt from review under E.O. 12866.
16 U.S.C. 1801
U.S. Census Bureau, 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.
To ensure consideration, written comments must be submitted on or before February 20, 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(s) and instructions should be directed to Erica M. Filipek, U.S. Census Bureau, MCD, CENHQ Room 7K057, 4600 Silver Hill Road, Washington, DC 20233, telephone (301) 763-5161 (or via the internet at
The Census Bureau plans to request a three-year extension of a currently approved collection of the Form C-411, Survey of Residential Building or Zoning Permit Systems. The Census Bureau produces statistics used to monitor activity in the large and dynamic construction industry. These statistics help state and local governments and the Federal government, as well as private industry, to analyze this important sector of the economy.
The Census Bureau uses the Form C-411 to obtain information needed to update the universe of permit-issuing places from state and local building and zoning officials. Questions on the form pertain to the legal requirements for issuing building or zoning permits in the local jurisdictions. Information is obtained on such items as geographic coverage and types of construction for which permits are issued.
The universe of permit-issuing places is the sampling frame for the Building Permits Survey (BPS) and the Survey of Construction (SOC). These two sample surveys provide widely used measures of construction activity, including the monthly Principal Federal Economic Indicators Housing Units Authorized by Building Permits and Housing Starts.
One of three variants of the Form C-411 is sent to a jurisdiction when the Census Bureau has reason to believe that a new permit system has been established or an existing one has changed, based on information the Census Bureau obtains from a variety of sources including survey respondents and regional planning councils. Staff in the Census Bureau's Geography Division also monitor changes in corporate status, which indicates if a place is incorporated. Responses rates for the Form C-411 typically approach 85 percent. There are three versions of the form:
• C-411(V) for verification of coverage for jurisdictions with existing permit systems
• C-411(M) for municipalities where a new permit system may have been established
• C-411(C) for counties where new permit systems may have been established.
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.
The Port of Milwaukee, grantee of FTZ 41, submitted a notification of
The applicant has submitted a separate application for subzone designation at AFE, Inc.'s facility under 15 CFR 400.38. The facility would be used to produce whiteboard monitors/interactive displays and televisions with and without tuners. Pursuant to 15 CFR 400.14(b), FTZ activity would be limited to the specific foreign-status materials and components and specific finished products described in the submitted notification (as described below) and subsequently authorized by the FTZ Board.
Production under FTZ procedures could exempt AFE, Inc., from customs duty payments on the foreign-status components used in export production. On its domestic sales, for the foreign-status materials/components noted below, the company would be able to choose the duty rates during customs entry procedures that apply to whiteboard monitors/interactive displays, tuner-free televisions, and televisions with tuners (duty rate ranges from duty-free to 3.9%). The company would be able to avoid duty on foreign-status components which become scrap/waste. Customs duties also could possibly be deferred or reduced on foreign-status production equipment.
The components and materials sourced from abroad include: Printed wire boards (PWBs) for monitors; PWBs for keyboards; infrared light detecting units for remote controllers; open cell liquid crystal displays (LCDs); monitor chassis components and assemblies of plastic and metal; stainless steel screws; reflector sheets; lens sheets; diffusion sheets; light emitting diode (LED) wires; PWBs for LEDs; plastic tapes; bezels; LCD modules; rear cover cable assemblies; power supply and drive units; power cables; LCD control cables; Wi-Fi cables; keyboard cables; speakers; A/C cords; remote controls; flexible flat cable for printed wire boards; AAA batteries; Wi-Fi units; plastic labels; TV stands and stand support brackets; plastic bags; printed setup guides; plastic cable clamps; molded paper packaging; paper packaging; cardboard cartons; plastic packaging; printed instructions; self-tapping screws; wire holders of plastic; plastic spacers; plastic insulator for coolers; keyboard cover assemblies; wooden pallets; PWBs for tuner TV keyboards; infrared light detecting units for tuner TV remote controllers; open cell LCDs for tuner TVs; monitor chassis components and assemblies of plastic and metal for tuner TVs; reflector sheets for tuner TVs; lens sheets for tuner TVs; diffusion sheets for tuner TVs; bezels for tuner TVs; LCD modules for tuner TVs; rear cover cable assemblies for tuner TVs; and, stands for tuner TVs (duty rate ranges from duty-free to 10.7%).
Public comment is invited from interested parties. Submissions shall be addressed to the Board's Executive Secretary at the address below. The closing period for their receipt is January 29, 2018.
A copy of the notification will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 21013, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230-0002, and in the “Reading Room” section of the Board's website, which is accessible via
For further information, contact Christopher Wedderburn at
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (the Department) is conducting an administrative review of the antidumping duty (AD) order on certain crystalline silicon photovoltaic products (solar products) from Taiwan. The period of review (POR) is February 1, 2016, through January 31, 2017. This administrative review covers 11 exporters of the subject merchandise, including one mandatory respondent, Motech Industries, Inc. (Motech). The Department preliminarily determines that Motech made sales of subject merchandise at less than normal value during the POR. Additionally, we are rescinding this administrative review with respect to 23 companies that timely withdrew their requests for administrative review. Interested parties are invited to comment on these preliminary results.
Applicable December 20, 2017.
Ariela Garvett or Thomas Martin, AD/CVD Operations, Office IV, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-3609 or (202) 482-3936, respectively.
On February 8, 2017, the Department notified interested parties of the opportunity to request an administrative review of orders, findings, or suspended investigations with anniversaries in February 2017, including the antidumping duty order on solar products from Taiwan.
In the
On May 24, 2017, the Department selected Motech as a mandatory respondent.
Pursuant to 19 CFR 351.213(d)(1), the Department will rescind an administrative review, in whole or in part, if a party that requested the review withdraws its request within 90 days of the date of publication of the notice of initiation of the requested review. Twenty-three companies
The merchandise covered by this order is crystalline silicon photovoltaic cells, and modules, laminates and/or panels consisting of crystalline silicon photovoltaic cells, whether or not partially or fully assembled into other products, including building integrated materials.
The Department is conducting this review in accordance with section 751(a) of the Tariff Act of 1930, as amended (the Act). Export price and constructed export price are calculated in accordance with section 772 of the Act. Normal value is calculated in accordance with section 773 of the Act.
For a full description of the methodology underlying our conclusions,
As a result of this review, we preliminarily determine the following weighted-average dumping margins for the period February 1, 2016 through January 31, 2017:
The statute and the Department's regulations do not address the establishment of a rate to be applied to respondents not selected for individual examination when the Department limits its examination of companies subject to the administrative review pursuant to section 777A(c)(2)(B) of the Act. Generally, the Department looks to section 735(c)(5) of the Act, which provides instructions for calculating the all-others rate in an investigation, for guidance when calculating the rate for respondents not individually examined in an administrative review. Section 735(c)(5)(A) of the Act articulates a
As noted above, we are rescinding the review with respect to 23 companies that withdrew their requests for an administrative review within 90 days of the date of publication of the
Upon completion of the administrative review, the Department shall determine, and CBP shall assess, antidumping duties on all appropriate entries covered by this review. The Department intends to issue assessment instructions to CBP 15 days after the date of publication of the final results of this review.
For any individually examined respondents whose weighted-average dumping margin is above
The final results of this review shall be the basis for the assessment of antidumping duties on entries of merchandise covered by the final results of this review and for future deposits of estimated duties, where applicable.
The following deposit requirements will be effective upon publication of the notice of final results of administrative review for all shipments of solar products from Taiwan entered, or withdrawn from warehouse, for consumption on or after the date of publication of the final results of this administrative review, as provided for by section 751(a)(2)(C) of the Act: (1) The cash deposit rate for the companies under review will be the rate established in the final results of this review (except, if the rate is zero or
The Department intends to disclose the calculations used in our analysis to interested parties in this review within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b). Interested parties are invited to comment on the preliminary results of this review. Pursuant to 19 CFR 351.309(c)(1)(ii), interested parties may submit case briefs no later than 30 days after the date of publication of this notice. Rebuttal briefs, limited to issues raised in the case briefs, may be filed no later than five days after the time limit for filing case briefs.
Pursuant to 19 CFR 351.310(c), any interested party may request a hearing within 30 days of the publication of this notice in the
We intend to issue the final results of this administrative review, including the results of our analysis of issues raised by the parties in the written comments, within 120 days of publication of these preliminary results in the
This notice also serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Department's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.
These preliminary results of administrative review are issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.213(h)(1).
National Institute of Standards and Technology, Department of Commerce.
Notice; request for information.
The National Institute of Standards and Technology (NIST), an agency of the United States Department of Commerce, is establishing the Accurate Fluorescence Measurements Consortium and invites organizations to participate in this Consortium. The Consortium will develop tools for improving the accuracy of quantitative fluorescence measurements including reference materials, reference data and reference methods for relative spectral correction of spectra, lifetimes and quantum yields and for assessing the associated uncertainties and utilities. Participation in this Consortium is open to all eligible organizations, as described below.
NIST will accept responses for participation in this Consortium on an ongoing basis. The Consortium's activities will commence on January 2, 2018 (“Commencement Date”). Acceptance of participants into the Consortium after the Commencement Date will depend on eligibility and the availability of NIST resources.
Information in response to this notice and request for additional information about the Consortium can be directed via mail to the NIST Consortium Manager, Dr. Paul DeRose, Biosystems and Biomaterials Division of NIST's Material Measurement Laboratory, 100 Bureau Drive, Gaithersburg, Maryland 20899-8312, or via electronic mail to
For further information about partnership opportunities or about the terms and conditions of NIST's Cooperative Research and Development Agreement (CRADA), please contact Jeffrey DiVietro, CRADA and License Officer, National Institute of Standards and Technology's Technology Partnerships Office, by mail to 100 Bureau Drive, Mail Stop 2200, Gaithersburg, Maryland 20899, by electronic mail to
Quantitative fluorescence measurements are used for instrument qualification and method validation in the pharmaceutical and chemical industries. It is also increasingly being used for detection of antibodies in clinical diagnostics and biomedical research. The measurements made on different instrument platforms at different times and locations cannot be compared accurately, which makes diagnostic decisions unreliable and slows down advances in these areas. In response to this limitation, NIST, secondary standards manufacturers and other stakeholders have developed methodologies to implement quantitation fluorescence measurements.
NIST produced SRMs 2940 through 2944 in the past nine years as relative intensity correction standards for fluorescence spectroscopy. These standards are needed by fluorescence instrument manufacturers and regulated communities that use quantitative fluorescence detection. For instance, the pharmaceutical and biotechnology communities use SRMs 2940 through 2944 to calibrate and verify the performance of their fluorescence instruments, which is required to achieve accurate results in secondary screening of drugs and in quantitative analysis of bioassays. Many other communities that use fluorescence detection need similar standards, but cannot afford the price of these SRMs or require different sample formats.
Few secondary standards of this type have been produced by industry because most companies do not have the fluorescence measurement capabilities and expertise to make high accuracy measurements. This Consortium is intended to give secondary standard manufacturers, as well as other stakeholders in the fluorescence measurement community, access to highly accurate fluorescence measurement capabilities available at NIST. In return, these manufacturers provide NIST information about new materials, future material needs, and new customer bases. These manufacturers know the needs of different communities and have developed new materials to meet these needs. Many of the fluorescent materials to be measured have not been used as standards and the suitability of these materials as standards is of great interest to NIST. NIST's understanding of the fluorescent characteristics of such materials through collaborative research and information exchange may lead to new NIST standards in this and other related areas. It is also important for NIST to know about additional standards needed in emerging technologies. Collaborators will supply NIST with this knowledge and work with NIST to design and characterize the best standards for such emerging technologies. Through this process, collaborators will assist NIST to develop better reference materials.
Eligibility will be determined by NIST using the information provided by an organization in response to this notice based on the information requested below.
An organization responding to this notice should provide the following information to NIST's Consortium Manager:
(1) Type of Reference Materials: Format of the sample (
(2) Types of Applications: Fluorescence measurements are used for detection in many areas, but how will the proposed reference materials address the quantitative needs of high impact communities requiring better accuracy and reproducibility?
(3) Experience in production and characterization of reference materials for quantitative fluorescence.
A responding organization should not include any business proprietary information in its response to this request for information. NIST will not treat any information provided in response to this request as proprietary information.
NIST will notify each organization of its eligibility. In order to participate in this Consortium, each eligible organization must sign a Cooperative Research and Development Agreement (CRADA) for this Consortium. All participants to this Consortium will be bound by the same terms and conditions.
15 U.S.C. 3710a.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; issuance of permits.
Notice is hereby given that individuals and institutions have been issued Letters of Confirmation for activities conducted under the General Authorization for Scientific Research on marine mammals. See
The Letters of Confirmation and related documents are available for review upon written request or by appointment in the following office:
Permits and Conservation Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone (301) 427-8401; fax (301) 713-0376.
Office of Protected Resources, Permits and Conservation Division, (301) 427-8401.
The requested Letters of Confirmation have been issued under the authority of the Marine Mammal Protection Act of 1972, as amended (16 U.S.C. 1361
In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Announcement of rescheduled meeting.
The South Atlantic Fishery Management Council (Council) will hold a meeting of its Citizen Science Advisory Panel Finance & Infrastructure Action Team via webinar. The meeting via webinar was originally scheduled for December 13, 2017, but has been rescheduled as a result of schedule changes.
The meeting via webinar has been rescheduled for January 10, 2018, at 1 p.m. The meeting is scheduled to last approximately 90 minutes. Additional Action Team webinar and plenary webinar dates and times will publish in a subsequent issue in the
Amber Von Harten, Citizen Science Program Manager, SAFMC; phone 843/302-8433 or toll free 866/SAFMC-10; FAX 843/769-4520; email:
Due to schedule changes, the Council's Finance & Infrastructure Action Team meeting is rescheduled for Wednesday, January 10, 2018 at 1 p.m.
The South Atlantic Fishery Management Council (Council) created a Citizen Science Advisory Panel Pool in June 2017. The Council appointed members of the Citizen Science Advisory Panel Pool to five Action Teams in the areas of
The Finance & Infrastructure Action Team will meet to continue work on developing recommendations on program policies and operations to be reviewed by the Council's Citizen Science Committee. Public comments will be accepted at the beginning of the meeting.
Items to be addressed during these meetings:
1. Discuss work on tasks in the Terms of Reference.
2. Other Business.
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
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce.
Notice of availability.
In accordance with the Oil Pollution Act of 1990 (OPA), the National Environmental Policy Act (NEPA), and a Consent Decree with BP Exploration & Production Inc. (BP), the
The purpose of this notice is to inform the public of the availability of the Draft SRP/EA and to seek public comments on the document.
The Louisiana TIG will consider public comments received or postmarked on or before Monday, February 5, 2018.
• January 17, 2018, in conjunction with the Coastal Protection and Restoration Authority Board Meeting; 9:30 a.m.; Louisiana State Capitol, House Committee Room 5; 900 North Third Street; Baton Rouge, LA 70802. Additional information regarding logistics for the Public Meeting, including the timing of the public comment opportunity following the Board Agenda, will be posted to the Louisiana (
• January 24, 2018; 5:30 p.m.; University of New Orleans; Homer Hitt Alumni Center; 2000 Lakeshore Drive; New Orleans, LA 70148. The meeting will begin with an open house at 5:30 p.m. and follow with Louisiana TIG presentation and public comment opportunity at 6:00 p.m.
Alternatively, you may request a CD of the Draft SRP/EA (see
• Via the Web:
• Via U.S. Mail: U.S. Fish and Wildlife Service, P.O. Box 49567, Atlanta, GA 30345; or Louisiana Coastal Protection & Restoration Authority, ATTN: Liz Williams, P.O. Box 44027, Baton Rouge, LA 70804.
• In Person: Written and verbal comments may be submitted at the public meetings on January 17 and January 24, 2018.
• National Oceanic and Atmospheric Administration—Mel Landry,
• Louisiana—Liz Williams,
On April 20, 2010, the mobile offshore drilling unit
The
The DWH Trustees are:
• U.S. Department of the Interior, as represented by the National Park Service, U.S. Fish and Wildlife Service, and Bureau of Land Management;
• National Oceanic and Atmospheric Administration, on behalf of the U.S. Department of Commerce;
• U.S. Department of Agriculture;
• U.S. Environmental Protection Agency;
• State of Louisiana Coastal Protection and Restoration Authority, Oil Spill Coordinator's Office, Department of Environmental Quality, Department of Wildlife and Fisheries, and Department of Natural Resources;
• 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
• For the State of Texas, Texas Parks and Wildlife Department, Texas General Land Office, and Texas Commission on Environmental Quality.
On April 4, 2016, the DWH Trustees reached and finalized a settlement of their natural resource damages claims with BP in a Consent Decree approved by the U.S. 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 comprised of the following DWH Trustees:
• 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);
• Department of Natural Resources (LDNR);
• U.S. Department of the Interior, as represented by National Park Service, U.S. Fish and Wildlife Service, and Bureau of Land Management;
• National Oceanic and Atmospheric Administration, on behalf of the U.S. Department of Commerce;
• U.S. Department of Agriculture; and
• U.S. Environmental Protection Agency.
This restoration planning activity is proceeding in accordance with the PDARP/PEIS. Information on the Restoration Type considered in the Draft SRP/EA, as well as the OPA criteria against which alternatives were evaluated, can be viewed in the PDARP/PEIS (
On March 29, 2017, the Louisiana TIG solicited project ideas to sustainably create, restore, and enhance coastal wetlands, and restore or preserve Mississippi River processes (
The Draft SRP/EA is being released in accordance with OPA, the OPA NRDA regulations in the Code of Federal Regulations (CFR) at 15 CFR part 990, and NEPA (42 U.S.C. 4321
The Louisiana TIG focused this SRP/EA on two wetlands, coastal and nearshore habitat restoration approaches described in the PDARP/PEIS: Creating, restoring and enhancing coastal wetlands; and restoring and preserving Mississippi-Atchafalaya River processes. Within the two restoration approaches, the PDARP/PEIS identifies a series of potential restoration techniques. These techniques, spanning both restoration approaches, are as follows (PDARP/PEIS, Appendix 5.D):
• Create or enhance coastal wetlands through placement of dredged material;
• Backfill canals;
• Restore hydrologic connections to enhance coastal habitats;
• Construct breakwaters; and
• Controlled river diversions.
Four project types are carried forward for additional consideration:
• sediment diversion projects;
• large-scale marsh creation projects;
• ridge restoration projects; and
• breakwater construction projects (also referred to as shoreline protection projects).
After reviewing the restoration approaches and techniques, the Louisiana TIG identified 13 example projects from public submissions in response to the Notice of Solicitation and from the 2017 Coastal Master Plan. The Louisiana TIG then combined restoration techniques into four strategic restoration alternatives. With the exception of the natural recovery/no action alternative, each of these alternatives meets the Draft SRP/EA's purpose and need “to restore the ecosystem level injuries in Barataria Basin and to restore, rehabilitate, replace, or acquire the equivalent of the injured wetlands, coastal, and nearshore habitat resources and services and compensate for interim losses of those resources from the
• Alternative 1: Marsh creation, ridge restoration, and large-scale sediment diversion;
• Alternative 2: Marsh creation, ridge restoration, and shoreline protection;
• Alternative 3: Marsh creation and ridge restoration; and
• Alternative 4: Natural recovery/no action.
The Louisiana TIG is proposing two decisions in this draft SRP/EA to restore ecosystem-level injuries in the Gulf of Mexico through restoration of critical wetlands, coastal, and nearshore habitat resources and services in the Barataria Basin. First, the Louisiana TIG proposes a preferred alternative that relies on a suite of restoration techniques in the Barataria Basin, including large-scale sediment diversion, marsh creation, and ridge restoration. Second, the Louisiana TIG proposes to advance specific projects forward for further evaluation and planning: The Mid-Barataria Sediment Diversion and two marsh creation increments within Large Scale Marsh Creation: Component E in northern Barataria Basin. The LA TIG also confirms its 2017 decision to move the Spanish Pass Increment of the Barataria Basin Ridge and Marsh Creation project forward for further evaluation and planning. The trustees are not making a decision to fund these projects for construction at this time. Rather, the trustees will continue to consider the selected projects in future Phase II restoration plans including further OPA and NEPA evaluation.
The Louisiana TIG evaluated strategic restoration alternatives under criteria set forth in the OPA natural resource damage assessment regulations. The strategic restoration alternatives are consistent with the restoration alternatives selected in the Deepwater Horizon Oil Spill: Final Programmatic Damage Assessment and Restoration Plan/Programmatic Environmental Impact Statement (PDARP/PEIS).
NEPA requires federal agencies to consider the potential environmental impacts of planned actions. NEPA provides a mandate and framework for federal agencies to determine if their proposed actions have significant environmental effects and related social and economic effects, consider these effects when choosing between alternative approaches, and inform and involve the public in the environmental analysis and decision-making process. This SRP/EA tiers from the PDARP/PEIS and incorporates by reference the NEPA environmental consequences analysis found in Chapter 6 of the PDARP/PEIS. The Louisiana TIG has found, based on its evaluation in the EA portion of this SRP/EA that: (1) The PDARP/EIS
The public is encouraged to review and comment on the Draft SRP/EA. A public meeting has been 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 SRP/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 SRP/EA can be viewed electronically at
The authority for this action is OPA (33 U.S.C. 2701
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of standard prices and fee percentage.
NMFS publishes the individual fishing quota (IFQ) standard prices and fee percentage for cost recovery for the IFQ Program for the halibut and sablefish fisheries of the North Pacific (IFQ Program). The fee percentage for 2017 is 2.2 percent. This action is intended to provide holders of halibut and sablefish IFQ permits with the 2017 standard prices and fee percentage to calculate the required payment for IFQ cost recovery fees due by January 31, 2018.
Valid on December 20, 2017.
Carl Greene, Fee Coordinator, 907-586-7105.
NMFS Alaska Region administers the IFQ Program in the North Pacific. The IFQ Program is a limited access system authorized by the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) and the Northern Pacific Halibut Act of 1982. Fishing under the IFQ Program began in March 1995. Regulations implementing the IFQ Program are set forth at 50 CFR part 679.
In 1996, the Magnuson-Stevens Act was amended to, among other purposes, require the Secretary of Commerce to “collect a fee to recover the actual costs directly related to the management and enforcement of any . . . individual quota program.” This requirement was further amended in 2006 to include collection of the actual costs of data collection, and to replace the reference to “individual quota program” with a more general reference to “limited access privilege program” at section 304(d)(2)(A). Section 304(d)(2) of the Magnuson-Stevens Act also specifies an upper limit on these fees, when the fees must be collected, and where the fees must be deposited.
On March 20, 2000, NMFS published regulations in § 679.45 implementing cost recovery for the IFQ Program (65 FR 14919). Under the regulations, an IFQ permit holder must pay a cost recovery fee for every pound of IFQ halibut and IFQ sablefish that is landed on his or her IFQ permit(s). The IFQ permit holder is responsible for self-collecting the fee for all IFQ halibut and IFQ sablefish landings on his or her permit(s). The IFQ permit holder is also responsible for submitting IFQ fee payment(s) to NMFS on or before the due date of January 31 of the year following the year in which the IFQ landings were made. The total dollar amount of the fee due is determined by multiplying the NMFS published fee percentage by the ex-vessel value of all IFQ landings made on the permit(s) during the IFQ fishing year. As required by § 679.45(d)(1) and (d)(3)(i), NMFS publishes this notice of the fee percentage for the halibut and sablefish IFQ fisheries in the
The fee is based on the sum of all payments made to fishermen for the sale of the fish during the year. This includes any retro-payments (
For purposes of calculating IFQ cost recovery fees, NMFS distinguishes between two types of ex-vessel value: Actual and standard. Actual ex-vessel value is the amount of all compensation, monetary or non-monetary, that an IFQ permit holder received as payment for his or her IFQ fish sold. Standard ex-vessel value is the default value used to calculate the fee. IFQ permit holders have the option of using actual ex-vessel value if they can satisfactorily document it; otherwise, the standard ex-vessel value is used.
Section 679.45(b)(3)(iii) requires the Regional Administrator to publish IFQ standard prices during the last quarter of each calendar year. These standard prices are used, along with estimates of IFQ halibut and IFQ sablefish landings, to calculate standard ex-vessel values. The standard prices are described in U.S. dollars per IFQ equivalent pound for IFQ halibut and IFQ sablefish landings made during the year. According to § 679.2, IFQ equivalent pound(s) means the weight amount, recorded in pounds, and calculated as round weight for sablefish and headed and gutted weight for halibut, for an IFQ landing. The weight of halibut in pounds landed as guided angler fish is converted to IFQ equivalent pound(s) as
NMFS calculates the fee percentage each year according to the factors and methods described at § 679.45(d)(2). NMFS determines the fee percentage that applies to landings made in the previous year by dividing the total costs directly related to the management, data collection, and enforcement of the IFQ Program (management costs) during the previous year by the total standard ex-vessel value of IFQ halibut and IFQ sablefish landings made during the previous year (fishery value). NMFS captures the actual management costs associated with certain management, data collection, and enforcement functions through an established accounting system that allows staff to track labor, travel, contracts, rent, and procurement. NMFS calculates the fishery value as described under the section, Standard Prices.
Using the fee percentage formula described above, the estimated percentage of management costs to fishery value for the 2017 calendar year is 2.2 percent of the standard ex-vessel value, which is below the 3.0 maximum fee percentage allowed under section 304(d)(2)(B) of the Magnuson-Stevens Act. An IFQ permit holder is to use the fee percentage of 2.2 percent to calculate his or her fee for IFQ equivalent pound(s) landed during the 2017 halibut and sablefish IFQ fishing season. An IFQ permit holder is responsible for submitting the 2017 IFQ fee payment to NMFS on or before January 31, 2018. Payment must be made in accordance with the payment methods set forth in § 679.45(a)(4). NMFS no longer accepts credit card information by phone or in-person for fee payments. NMFS has determined that the practice of accepting credit card information by phone or in-person no longer meets agency standards for protection of personal financial information (81 FR 23645, April 22, 2016).
The 2017 fee percentage of 2.2 percent is lower than the 2016 fee percentage of 3.1 percent, which was capped at 3.0 percent (81 FR 89900, December 13, 2016). The change can be attributed to an estimated 9.8 percent increase in the value of the IFQ Program fisheries from 2016 to 2017, along with a corresponding 21.2% drop in management costs over the same period.
16 U.S.C. 1801
Office of Oceanic and Atmospheric Research (OAR), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC).
Notice of intent to prepare an EA; request for comments.
NOAA announces its intention to prepare an EA, in accordance with the National Environmental Policy Act of 1969, for a new space lease to be occupied by the NOAA/OAR Geophysical Fluid Dynamics Laboratory.
Written comments must be received on or before January 15, 2018.
Written comments on suggested alternatives and potential impacts should be sent to Stephen F. Mayle, Administrative Officer, NOAA/OAR/GFDL, 201 Forrestal Road, Princeton, NJ 08540. Comments may also be submitted via facsimile to 609-452-5395 or by email to
The proposed action would involve a lease for space for the offices, seminar rooms, meeting rooms, etc. and computing facilities used by the Geophysical Fluid Dynamics Laboratory (GFDL). The current facilities, located in the Princeton, New Jersey area, are part of NOAA's Office of Oceanic and Atmospheric Research (OAR). Research conducted at this laboratory includes development and use of mathematical models and computer simulations to improve our understanding and prediction of the behavior of the atmosphere and the oceans. GFDL scientists focus on model-building relevant for society, such as hurricane research, weather and ocean prediction, and forecasting on the continuum of time and space scales. GFDL also collaborates with visiting scientists and students from academic and non-profit institutions with whom NOAA has partnered to further its mission goals. The current physical space for GFDL consists of two buildings that together provide office space, teaching/seminar space, high performance computing space, a command/control center, and mechanical and electrical plants. The current GFDL facilities are approximately 68,675 square feet. Current space can house up to 215 staff, including full-time employees, visiting scientists and students, and contract employees.
The current facilities are in need of repairs and renovations in order to continue to be effectively and safely occupied by GFDL. The existing space is also insufficient to accommodate visiting scientists and students, for example approximately 40 such staff utilize nearby overflow space, and to effectively store and stage necessary equipment for current levels of effort. It also does not allow space to expand to continue to meet NOAA's mission in collaboration with our institutional partners. NOAA is contracting with an architectural and engineering firm to conduct a space programming and planning study, or a Program of Requirements, that will more specifically identify GFDL's space needs. This study is expected to be completed on or about April 1, 2018, and will also inform the alternatives to be considered in an EA.
The purpose of the public scoping process for this EA is to determine relevant issues that will influence the scope of the environmental analysis, including potential alternatives, and the extent to which those issues and impacts will be analyzed in the EA. Federal, state, and local agencies, along with other stakeholders that may be interested in or affected by NOAA's decision on this project are invited to participate in the scoping process and, if eligible, may request or be requested by NOAA to participate as a cooperating agency.
Office of Communications and Outreach, Department of Education.
Request for information.
In accordance with section 5005 of the Every Student Succeeds Act (ESSA), the Secretary seeks information from the public regarding actions the Department of Education (Department) can take to improve how it considers the unique needs of rural schools and local educational agencies (LEAs) as it develops and implements its policies and programs. The Secretary intends to use this information in issuing a final report, required under section 5005, describing the actions it will take to increase the consideration and participation of rural schools and LEAs in the development and execution of the Department's processes, procedures, policies, and regulations.
We must receive your comments no later than February 20, 2018.
Submit your comments through the Federal eRulemaking Portal or via postal mail, commercial delivery, hand delivery, or email. 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.
This is a request for information (RFI) only. This RFI is not a request for proposals (RFP) or a promise to issue an RFP or a notice inviting applications. This RFI does not commit the Department to contract for any supply or service whatsoever. Further, the Department is not seeking proposals and will not accept unsolicited proposals. The Department will not pay for any information or administrative costs that you may incur in responding to this RFI. If you do not respond to this RFI, you may still apply for future contracts and grants. The documents and information submitted in response to this RFI become the property of the U.S. Government and will not be returned.
Michael Chamberlain, U.S. Department of Education, 400 Maryland Avenue SW, Room 5E260, Washington, DC 20202. Telephone: (202) 453-7527 or by email:
If you use a telecommunications device for the deaf or a text telephone, call the Federal Relay Service, toll free, at 1-800-877-8339.
(A) assess the methods and manner through which, and the extent to which, the Department of Education takes into account, considers input from, and addresses the unique needs and characteristics of rural schools and rural local educational agencies; and
(B) determine actions that the Department of Education can take to meaningfully increase the consideration and participation of rural schools and rural local educational agencies in the development and execution of the processes, procedures, policies, and regulations of the Department of Education.”
Section 5005 also requires the Department to publish a preliminary report containing the information described above and provide Congress and the public with 60 days to comment on the proposed actions. Thereafter, the Department must issue a final report to the Department's authorizing committees in the U.S. House of Representatives and Senate and carry out each action described in the final report or explain to the authorizing committees the reason for not carrying out any action described in the final report.
While we invite comment on the entire report, we particularly encourage comment on the proposed actions, as described in the section of the report titled “Additional Actions the Department Can Take to Increase Rural Stakeholder Input.” Specifically, we request feedback on whether:
1. The actions described in the preliminary report will meaningfully increase the consideration and participation of rural schools and LEAs in the development and execution of the Department's processes, procedures, policies, and regulations; and
2. There are other actions the Department can take to achieve this goal.
You may also access documents of the Department published in the
Office of Electricity Delivery and Energy Reliability, DOE.
Notice of filing.
On October 26, 2017, APV Renaissance Opco, LLC, as owner and operator of a new baseload electric generating powerplant, submitted a coal capability self-certification to the Department of Energy (DOE) pursuant to the Powerplant and Industrial Fuel Use Act of 1978 (FUA), as amended, and DOE regulations. The FUA and regulations thereunder require DOE to publish a notice of filing of self-certification in the
Copies of coal capability self-certification filings are available for public inspection, upon request, in the Office of Electricity Delivery and Energy Reliability, Mail Code OE-20, Room 8G-024, Forrestal Building, 1000 Independence Avenue SW, Washington, DC 20585.
Christopher Lawrence at (202) 586-5260.
On October 26, 2017, APV Renaissance Opco, LLC, as owner and operator of a new baseload electric generating powerplant, submitted a coal capability self-certification to the Department of Energy (DOE) pursuant to section 201(d) of the Powerplant and Industrial Fuel Use Act of 1978 (FUA), as amended, and DOE regulations in 10 CFR 501.60, 61. The FUA and regulations thereunder require DOE to publish a notice of filing of self-certification in the
The following owner of a proposed new baseload electric generating powerplant has filed a self-certification of coal-capability with DOE pursuant to FUA section 201(d) and in accordance with DOE regulations in 10 CFR 501.60, 61:
Office of Energy Efficiency and Renewable Energy, U.S. Department of Energy.
Submission for Office of Management and Budget (OMB) review; public comment request.
The Department of Energy (DOE) invites public comment on a revision of a currently approved collection of information that DOE is developing for submission to the Office of Management and Budget (OMB) pursuant to the Paperwork Reduction Act of 1995. The information collection requests a revision and three-year extension of its Energy Efficiency and Conservation Block Grant Program, OMB Control Number 1910-5150.
The proposed action will continue the collection of information on the status of financing program activities, expenditures, and results, to ensure that program funds are being used appropriately, effectively and expeditiously. No changes to the collection instrument are being proposed.
Comments are invited on: (a) Whether the revision of the currently approved 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 pertaining to the approved collection of information, including the validity of the methodology and assumptions used; (c) ways to further enhance the quality, utility, and clarity of the information being collected; and (d) ways to further minimize the burden regarding the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
Comments regarding this revision to an approved information collection must be received on or before January 19, 2018. If you anticipate difficulty in submitting comments within that period, contact the person listed in
Written comments may be sent to Sallie Glaize, EE-5W, U.S. Department of Energy, 1000 Independence Ave. SW, Washington, DC 20585, Email:
Requests for additional information or copies of the information collection instrument and instructions should be directed to: James Carlisle, U.S. Department of Energy, 1000 Independence Ave. SW, Washington, DC 20585, Phone: (202) 287-1724, Fax: (412) 386-5835, Email:
Additional information and reporting guidance concerning the Energy Efficiency and Conservation Block Grant Program (EECBG) is available for review at the following website:
This information collection request contains: (1) OMB No. 1910-5150; (2) Information Collection Request Title: Energy Efficiency and Conservation Block Grant Program Financing Programs; (3) Type of Review: Revision of a Currently Approved Information Collection; (4) Purpose: To collect information on the status of Financing Program activities, expenditures, and results, to ensure that program funds are being used appropriately, effectively and expeditiously; (5) Annual Estimated Number of Respondents: 108; (6) Annual Estimated Number of Total Responses: 175; (7) Annual Estimated Number of Burden Hours: 525; (8) Annual Estimated Reporting and Recordkeeping Cost Burden: $21,000. Respondents, total responses, burden hours and the annual cost burden have all been significantly reduced because of the retirement of grants, fewer programs and a lessened burden on reporting and recordkeeping costs.
U.S. Energy Information Administration (EIA), Department of Energy.
Notice and request for comments.
EIA, pursuant to the Paperwork Reduction Act of 1995, intends to extend with changes for three years with the Office of Management and Budget (OMB), Form EIA-886,
Comments regarding this proposed information collection must be received on or before February 20, 2018. If you anticipate difficulty in submitting comments within that period, contact the person listed in the
Written comments may be sent to Cynthia Sirk, EI-22, U.S. Energy Information Administration, 1000 Independence Avenue SW, Washington, DC 20585, or by fax at (202) 586-9753, or by email at
Requests for additional information or copies of the information collection instrument and instructions should be directed to Cynthia Sirk by phone at (202) 586-1658, or by email at
Comments are invited on: (a) Whether the expanded 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 of the proposed collection of information, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) ways to identify alternate sources of AFV information EIA proposes to collect. EIA will evaluate comments on duplication of data sources based on terms of data coverage, level of aggregation, frequency of collection, data reliability, and statutory requirements to determine whether alternate data sources represent a suitable substitute for EIA data.
This information collection request contains:
(1)
(2)
(3)
(4)
(4a)
(1)
(2)
(5)
(6)
(7)
AFV Suppliers (30 Original Equipment Manufacturers): 3.5 hours per response;
AFV Suppliers (20 Aftermarket Vehicle Converters): 3 hours per response;
AFV Users (100 complex fleets): 4.3 hours per response;
AFV Users (1,900 simple fleets): 4.2 hours per response;
(8)
Section 13(b) of the Federal Energy Administration Act of 1974, Pub. L. 93-275, (FEA Act), and codified at 15 U.S.C. 772 (b), and Section 503(b)(2) of the Energy Policy Act of 1992, Pub. L. 102-486 (EPACT92) codified at 42 U.S.C. 13253.
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j. Mad River Power Associates LP filed its request to use the Traditional Licensing Process on October 17, 2017. Mad River Power Associates LP provided public notice of its request on October 22, 2017. In a letter dated December 13, 2017, the Director of the Division of Hydropower Licensing approved Mad River Power Associates LP's request to use the Traditional Licensing Process.
k. With this notice, we are initiating informal consultation with the U.S. Fish and Wildlife Service and NOAA Fisheries under section 7 of the Endangered Species Act and the joint agency regulations thereunder at 50 CFR, Part 402; and NOAA Fisheries under section 305(b) of the Magnuson-Stevens Fishery Conservation and Management Act and implementing regulations at 50 CFR 600.920. We are also initiating consultation with the New Hampshire State Historic Preservation Officer, as required by section 106 of the National Historic Preservation Act, and the implementing regulations of the Advisory Council on Historic Preservation at 36 CFR 800.2.
l. With this notice, we are designating Mad River Power Associates LP as the Commission's non-federal representative for carrying out informal consultation pursuant to section 7 of the Endangered Species Act and section 305(b) of the Magnuson-Stevens Fishery Conservation and Management Act; and consultation pursuant to section 106 of the National Historic Preservation Act.
m. Mad River Power Associates LP filed a Pre-Application Document (PAD; including a proposed process plan and schedule) with the Commission, pursuant to 18 CFR 5.6 of the Commission's regulations.
n. A copy of the PAD is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's website (
o. The licensee states its unequivocal intent to submit an application for a subsequent license for Project No. 3253. Pursuant to 18 CFR 16.20 each application for a subsequent license and any competing license applications must be filed with the Commission at least 24 months prior to the expiration of the existing license. All applications for license for this project must be filed by October 31, 2020.
p. Register online at
Take notice that on November 9, 2017, Empire Pipeline, Inc., 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 Applicant.
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
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.
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The Commission strongly encourages electronic filing. Please file scoping comments using the Commission's
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 is not ready for environmental analysis at this time.
l. Project Description. The existing Municipal Hydroelectric Project consists of: (1) A 293-foot-long, 58-foot-high reinforced concrete slab and buttress dam that includes: (a) A south non-overflow section; (b) an overflow bulkhead section; (c) an eight-bay spillway section each with a steel tainter gate; (d) a powerhouse intake section; and (e) a north non-overflow section; (2) a 77-acre impoundment with a gross storage capacity of 562 acre-feet at a normal pool elevation of 1,772 feet National Geodetic Vertical Datum of 1929 (NGVD29) and a net storage capacity of 220 acre-feet between elevations 1,768 and 1,772 feet; (3) a 20-foot, 3-inch-wide intake section with angled steel trash racks (3-inch by 5/16th-inch trash rack bars spaced 2.5 inches on center) and a steel roller type head gate; (4) a 27-foot-long steel-lined penstock in concrete that transitions from a 13.5-foot-wide, 11-foot-high entrance to an 8-foot-diameter conveyance to the turbine scroll case; (5) a 30-foot-long, 28-foot-wide, and 62-foot-high powerhouse containing a single 1,185-kilowatt turbine-generator unit; (6) a 2.7-mile-long transmission line connected to the grid; and (7) appurtenant facilities.
The City of Radford proposes to revise its exhibit G to include transmission facilities composed of only three, 560-foot-long, 4.16-kV overhead conductors that transmit power to a switched disconnect/interconnection with the local distribution grid. The City of Radford states that the formerly licensed transmission line now serves to distribute power to other sources along its length and is no longer part of the project.
The City of Radford operates the project in both run-of-river and peaking modes. For the period 1984 through 2013, the project's average annual generation was about 4,550 megawatt-hours.
m. A copy of the application is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's website at
n. You may also register online at
o. Scoping Process. The Commission staff intends to prepare an Environmental Assessment (EA) for the Municipal Hydroelectric Project in accordance with the National Environmental Policy Act. The EA will consider both site-specific and cumulative environmental impacts and reasonable alternatives to the proposed action.
Commission staff issued Scoping Document 1 (SD1) on September 1, 2017 and held scoping meetings on October 2-3, 2017 and an environmental site review on October 2, 2017. Because some entities may not have received proper notice of the issuance of SD1 and the scoping meetings, we are providing an additional 30-day comment period on Scoping Document 2, which will be issued concurrently with this notice, for entities to provide comments, recommendations, and information.
Copies of SD1 and this SD2 outlining the subject areas to be addressed in the EA were distributed to the parties on the Commission's mailing list. Copies of SD1 and SD2 may be viewed on the web at
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection:
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j. Deadline for filing comments, motions to intervene and protests is 30 days from the issuance date of this notice by the Commission. The Commission strongly encourages electronic filing. Please file motions to intervene, protests and comments using the Commission's eFiling system at
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m. Individuals desiring to be included on the Commission's mailing list should do so by writing to the Secretary of the Commission.
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Take notice that on December 1, 2017, pursuant to section 210 of the Public Utility Regulatory Policies Act of 1978 (PURPA), Gregory R. and Beverly F. Swecker (Petitioners) filed a Petition for Enforcement, requesting that the Federal Energy Regulatory Commission (Commission) initiate an enforcement action against Midland Power Cooperative and Central Iowa Power Cooperative to remedy their alleged improper implementation of PURPA, all as more fully explained in their petition.
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. On or before the comment date, it is not necessary to serve motions to intervene or protests on persons other than the Petitioners.
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
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 PURPA 210(m)(3) filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
This constitutes notice, in accordance with 18 CFR 385.2201(b), of the receipt of prohibited and exempt off-the-record communications.
Order No. 607 (64 FR 51222, September 22, 1999) requires Commission decisional employees, who make or receive a prohibited or exempt off-the-record communication relevant to the merits of a contested proceeding, to deliver to the Secretary of the Commission, a copy of the communication, if written, or a summary of the substance of any oral communication.
Prohibited communications are included in a public, non-decisional file associated with, but not a part of, the decisional record of the proceeding. Unless the Commission determines that the prohibited communication and any responses thereto should become a part of the decisional record, the prohibited off-the-record communication will not be considered by the Commission in reaching its decision. Parties to a proceeding may seek the opportunity to respond to any facts or contentions made in a prohibited off-the-record communication, and may request that the Commission place the prohibited communication and responses thereto in the decisional record. The Commission will grant such a request only when it determines that fairness so requires. Any person identified below as having made a prohibited off-the-record communication shall serve the document on all parties listed on the official service list for the applicable proceeding in accordance with Rule 2010, 18 CFR 385.2010.
Exempt off-the-record communications are included in the decisional record of the proceeding, unless the communication was with a cooperating agency as described by 40 CFR 1501.6, made under 18 CFR 385.2201(e)(1)(v).
The following is a list of off-the-record communications recently received by the Secretary of the Commission. The communications listed are grouped by docket numbers in ascending order. These filings are available for electronic review at the Commission in the Public Reference Room or may be viewed on the Commission's website at
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection:
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j. Deadline for filing comments, motions to intervene and protests is 30 days from the issuance date of this notice by the Commission. The Commission strongly encourages electronic filing. Please file motions to intervene, protests and comments using the Commission's eFiling system at
k.
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m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.
n.
o.
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following qualifying facility filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
On July 20, 2017, Gulf South Pipeline Company, LP (Gulf South) filed an application in Docket No. CP17-476-000 requesting a Certificate of Public Convenience and Necessity pursuant to Section 7(c) of the Natural Gas Act to construct and operate facilities in Calcasieu Parish, Louisiana. The proposed project is known as the Westlake Expansion Project (Project) and would provide about 200 million cubic feet of natural gas per day to the proposed 980 megawatt natural gas-fired combined cycle electric generating plant near Westlake, Louisiana.
On July 31, 2017, the Federal Energy Regulatory Commission (Commission or FERC) issued its Notice of Application for the Project. Among other things, that notice alerted agencies issuing federal authorizations of the requirement to complete all necessary reviews and to reach a final decision on a request for a federal authorization within 90 days of the date of issuance of the Commission staff's Environmental Assessment (EA) for the Project. This instant notice identifies the FERC staff's planned schedule for the completion of the EA for the Project.
If a schedule change becomes necessary, additional notice will be provided so that the relevant agencies are kept informed of the Project's progress.
Gulf South proposes to construct and operate the following facilities as part of the Project in Calcasieu Parish, Louisiana:
• One new 10,000 horsepower compressor station (Westlake Compressor Station) and appurtenant facilities;
• approximately 1,600 feet of 16-inch-diamater natural gas pipeline lateral; and
• two new metering and regulating stations (Entergy Lake Charles and Varibus Meter and Regulator Stations).
On August 30, 2017, the Commission issued a
In order to receive notification of the issuance of the EA and to keep track of all formal issuances and submittals in specific dockets, the Commission offers a free service called eSubscription. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. Go to
Additional information about the Project is available from the Commission's Office of External Affairs at (866) 208-FERC or on the FERC website (
Take notice that on December 11, 2017, pursuant to Rule 207(a)(2) of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385.207(a)(2) (2016), Blue Racer NGL Pipelines, LLC (Blue Racer Pipelines), filed a petition for a declaratory order seeking approval of (1) the service structure for the reconfiguration and expansion of the Blue Racer Pipelines system in response to market changes and demand to transport additional natural gas liquids from the Natrium natural gas processing and fractionation facility in Marshall County, West Virginia; and (2) the rate structure and terms agreed upon with the shipper that has made a long-term commitment to utilize, or pay for, significant capacity, as more fully explained in the petition.
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
On December 13, 2017, the Commission issued an order in Docket No. EL18-32-000, pursuant to section 206 of the Federal Power Act (FPA), 16 U.S.C. 824e (2012), instituting an investigation into whether the Reactive Power Revenue Requirements of Carroll County Energy, LLC may be unjust and unreasonable.
The refund effective date in Docket No. EL18-32-000, established pursuant to section 206(b) of the FPA, will be the date of publication of this notice in the
Any interested person desiring to be heard in Docket No. EL18-32-000 must file a notice of intervention or motion to intervene, as appropriate, with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, in accordance with Rule 214 of the Commission's Rules of Practice and Procedure, 18 CFR 385.214, within 21 days of the date of issuance of the order.
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.
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j. Deadline for filing motions to intervene and protests, comments, recommendations, terms and conditions, and prescriptions: 60 days from the issuance date of this notice; reply comments are due 105 days from the issuance date of this notice.
The Commission strongly encourages electronic filing. Please file motions to intervene and protests, comments, recommendations, terms and conditions, and prescriptions using the Commission's eFiling system at
The Commission's Rules of Practice require all intervenors filing documents with the Commission to serve a copy of that document on each person on the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.
k. This application has been accepted for filing and is now ready for environmental analysis.
l. The existing Arpin Dam Project consists of: (1) An approximately 742.5-foot-long, 19-foot-high stone masonry dam (west dam section) that includes two timber stoplog spillway bays and a 318.9-foot-long overflow section; (2) an approximately 452.2-foot-long, 18-foot-high masonry dam (middle dam section) that includes two steel vertical lift gates and a 237.9-foot-long overflow section; (3) an approximately 319.8-foot-long, 16-foot-high masonry dam (east dam section) that includes two tainter gates and a 108-foot-long overflow section; (4) an approximately 294-acre impoundment at a normal full pond water surface elevation of 1,227.32 feet North American Vertical Datum of 1988; (5) a 37-foot-long, 11.5-foot-wide, 14-foot-high concrete, canal headworks structure on the eastern side of the impoundment; (6) an approximately 3,200-foot-long, 56-foot-wide, 6-foot-deep power canal; (7) a 13.5-foot-long, 48-foot-wide, 14.4-foot-high concrete intake structure that includes two 9-foot-wide, 11-foot-high steel stop gates and a 44-foot-wide, 14.4-foot-high trashrack with 1.5- to 1.75-inch clear bar spacing; (8) three 79-foot-long, 8-foot-diameter steel penstocks; (9) a 52-foot-long, 24-foot-wide, 25-foot-high cement block powerhouse containing two 600-kilowatt (kW), and one 250-kW vertical Francis turbine-generator units, for a total capacity of 1,450 kW; (10) a 15-foot-long, 2.4-kilovolt (kV) underground generator lead line that connects the turbine-generator units to a substation containing three step-up transformers; (11) a 3,645-foot-long, 22.9-kV above-ground transmission line; (12) an approximately 100-foot-long, 77-foot-wide tailrace; (13) recreation facilities; and (14) appurtenant facilities.
Flambeau Hydro manually operates the project in a run-of-river mode, with an average annual generation of 7,336 megawatt-hours. Flambeau Hydro is not proposing any changes in project operation. Flambeau Hydro proposes to continue releasing a year-round minimum flow of 40 cubic feet per second to the bypassed reach to protect aquatic resources; limiting fluctuations in the reservoir to one foot below the maximum, except between April 1 and June 1, when fluctuations would be limited to 0.5 foot; and operating and maintaining existing recreation facilities. Flambeau Hydro also proposes to develop an Historic Properties Management Plan to protect historic resources.
m. A copy of the application is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's website at
n. Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of the Commission's Rules of Practice and Procedure, 18 CFR 385.210, .211, and .214. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for the particular application.
All filings must (1) bear in all capital letters the title PROTEST, MOTION TO INTERVENE, COMMENTS, REPLY COMMENTS, RECOMMENDATIONS, TERMS AND CONDITIONS, or PRESCRIPTIONS; (2) set forth in the heading the name of the applicant and the project number of the application to which the filing responds; (3) furnish the name, address, and telephone number of the person protesting or intervening; and (4) otherwise comply with the requirements of 18 CFR 385.2001 through 385.2005. All comments, recommendations, terms and conditions or prescriptions must set forth their evidentiary basis and otherwise comply with the requirements of 18 CFR 4.34(b). Agencies may obtain copies of the application directly from the applicant. A copy of any protest or motion to intervene must be served upon each representative of the applicant specified in the particular application. A copy of all other filings in reference to this application must be accompanied by proof of service on all persons listed in the service list prepared by the Commission in this proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.
You may also register online at
o. Procedural Schedule:
The application will be processed according to the following revised schedule. Revisions to the schedule may be made as appropriate.
Final amendments to the application must be filed with the Commission no
p. A license applicant must file no later than 60 days following the date of issuance of this notice: (1) A copy of the water quality certification; (2) a copy of the request for certification, including proof of the date on which the certifying agency received the request; or (3) evidence of waiver of water quality certification.
Environmental Protection Agency (EPA).
Notice.
In compliance with the Paperwork Reduction Act (PRA), this document announces that EPA is planning to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB). The ICR, entitled: “Residential Lead-Based Paint Hazard Disclosure Requirements” and identified by EPA ICR No. 1710.08 and OMB Control No. 2070-0151, represents the renewal of an existing ICR that is scheduled to expire on October 31, 2018. Before submitting the ICR to OMB for review and approval, EPA is soliciting comments on specific aspects of the proposed information collection that is summarized in this document. The ICR and accompanying material are available in the docket for public review and comment.
Comments must be received on or before February 20, 2018.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2017-0631, by one of the following methods:
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Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
Pursuant to PRA section 3506(c)(2)(A) (44 U.S.C. 3506(c)(2)(A)), EPA specifically solicits comments and information to enable it to:
1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility.
2. Evaluate the accuracy of the Agency's estimates of the burden of the proposed collection of information, including the validity of the methodology and assumptions used.
3. Enhance the quality, utility, and clarity of the information to be collected.
4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology,
1. Sellers of pre-1978 housing must attach certain notification and disclosure language to their sales/leasing contracts. The attachment lists the information disclosed and a statement of compliance by the seller, purchaser and any agents involved in the transaction.
2. Lessors of pre-1978 housing must attach notification and disclosure language to their leasing contracts. The attachment, which lists the information disclosed and a statement of compliance with all elements of the rule, must be signed by the lessor, lessee and any agents acting on their behalf. Agents and lessors must retain the information for
3. Agents acting on behalf of sellers or lessors are specifically required by Section 1018 to comply with the disclosure regulations described above.
Responses to the collection of information are mandatory (see 40 CFR 745, Subpart F, and 24 CFR 35, Subpart H). Respondents may claim all or part of a notice confidential. EPA will disclose information that is covered by a claim of confidentiality only to the extent permitted by, and in accordance with, the procedures in TSCA section 14 and 40 CFR part 2.
The ICR, which is available in the docket along with other related materials, provides a detailed explanation of the collection activities and the burden estimate that is only briefly summarized here:
There is a decrease of 514,832 hours in the total estimated respondent burden compared with that identified in the ICR currently approved by OMB. This decrease reflects revisions to the estimated number of respondents based on updates to data sources, and revisions based on market factors,
EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval pursuant to 5 CFR 1320.12. EPA will issue another
44 U.S.C. 3501
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) have prepared a Draft Restoration Plan and Environmental Assessment #2: Provide and Enhance Recreational Opportunities (RP/EA). The Draft RP/EA describes and proposes restoration project alternatives considered by the Louisiana TIG to compensate for recreational use services lost as a result of the
The Louisiana TIG will consider public comments received on or before January 19, 2018.
Alternatively, you may request a CD of the Draft RP/EA (see
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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 (
• Louisiana—Liz Williams at
• EPA—Tim Landers at
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 November 2016 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 part 990, and NEPA (42 U.S.C. 4321
The Draft RP/EA also evaluates a no action alternative. One or more alternatives may be selected for implementation by the Louisiana TIG to compensate for recreational use services lost as a result of the
The Louisiana TIG has examined the injuries assessed by 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
Federal Accounting Standards Advisory Board.
Notice.
Pursuant to 31 U.S.C. 3511(d), the Federal Advisory Committee Act (Pub. L. 92-463), as amended, and the FASAB Rules Of Procedure, as amended in October 2010, notice is hereby given that the Federal Accounting Standards Advisory Board (FASAB) has issued an exposure draft of a proposed Statement of Federal Financial Accounting Standards (SFFAS) entitled
The exposure draft is available on the FASAB website at
Respondents are encouraged to comment on any part of the exposure draft. Written comments are requested by March 16, 2018, and should be sent to
Ms. Wendy M. Payne, Executive Director, 441 G Street NW, Mailstop 6H19, Washington, DC 20548, or call (202) 512-7350.
Federal Advisory Committee Act, Pub. L. 92-463.
Federal Election Commission.
Notice of filing dates for special elections.
Michigan has scheduled special elections on August 7, 2018, and November 6, 2018, to fill the U.S. House of Representatives seat in the 13th Congressional District vacated by Representative John Conyers, Jr.
Committees required to file reports in connection with the Special Primary Election on August 7, 2018, shall file a 12-day Pre-Primary Report. Committees required to file reports in connection with both the Special Primary and Special General Election on November 6, 2018, shall file a 12-day Pre-Primary, 12-day Pre-General Report and a 30-day Post-General Report.
Ms. Elizabeth S. Kurland, Information Division, 999 E Street NW, Washington, DC 20463; Telephone: (202) 694-1100; Toll Free (800) 424-9530.
All principal campaign committees of candidates who participate in the Michigan Special Primary and Special General Elections shall file a 12-day Pre-Primary Report on July 26, 2018; a 12-day Pre-General Report on October 25, 2018; and a 30-day Post-General Report on December 6, 2018. (See charts below for the closing date for each report.)
All principal campaign committees of candidates participating
Political committees filing on a quarterly basis in 2018 are subject to special election reporting if they make previously undisclosed contributions or expenditures in connection with the Michigan Special Primary or Special General Elections by the close of books for the applicable report(s). (See charts below for the closing date for each report.)
Committees filing monthly that make contributions or expenditures in connection with the Michigan Special Primary or Special General Elections will continue to file according to the monthly reporting schedule.
Additional disclosure information in connection with the Michigan Special Elections may be found on the FEC website at
Principal campaign committees, party committees and Leadership PACs that are otherwise required to file reports in connection with the special elections must simultaneously file FEC Form 3L if they receive two or more bundled contributions from lobbyists/registrants or lobbyist/registrant PACs that aggregate in excess of the lobbyist bundling disclosure threshold during the special election reporting periods (See charts below for closing date of each period.) 11 CFR 104.22(a)(5)(v), (b).
The lobbyist bundling disclosure threshold for calendar year 2017 is $17,900. This threshold amount may increase in 2018 based upon the annual cost of living adjustment (COLA). Once the adjusted threshold amount becomes available, the Commission will publish it in the
On behalf of the Commission,
Federal Election Commission.
Notice of filing dates for special elections.
Arizona has scheduled special elections on February 27, 2018, and April 24, 2018, to fill the U.S. House of Representatives seat in the 8th Congressional District vacated by Representative Trent Franks.
Committees required to file reports in connection with the Special Primary Election on February 27, 2018, shall file a 12-day Pre-Primary Report. Committees required to file reports in connection with both the Special Primary and Special General Election on April 24, 2018, shall file a 12-day Pre-Primary, 12-day Pre-General Report and a 30-day Post-General Report.
Ms. Elizabeth S. Kurland, Information Division, 999 E Street NW, Washington, DC 20463; Telephone: (202) 694-1100; Toll Free (800) 424-9530.
All principal campaign committees of candidates who participate in the Arizona Special Primary and Special General Elections shall file a 12-day Pre-Primary Report on February 15, 2018; a 12-day Pre-General Report on April 12, 2018; and a 30-day Post-General Report on May 24, 2018. (See charts below for the closing date for each report.)
All principal campaign committees of candidates participating
Political committees filing on a quarterly basis in 2018 are subject to special election reporting if they make previously undisclosed contributions or expenditures in connection with the Arizona Special Primary or Special General Elections by the close of books for the applicable report(s). (See charts below for the closing date for each report.)
Committees filing monthly that make contributions or expenditures in connection with the Arizona Special Primary or Special General Elections will continue to file according to the monthly reporting schedule.
Additional disclosure information in connection with the Arizona Special Elections may be found on the FEC website at
Principal campaign committees, party committees and Leadership PACs that are otherwise required to file reports in connection with the special elections must simultaneously file FEC Form 3L if they receive two or more bundled contributions from lobbyists/registrants or lobbyist/registrant PACs that aggregate in excess of the lobbyist bundling disclosure threshold during the special election reporting periods (See charts below for closing date of each period.) 11 CFR 104.22(a)(5)(v), (b).
The lobbyist bundling disclosure threshold for calendar year 2017 is $17,900. This threshold amount may increase in 2018 based upon the annual cost of living adjustment (COLA). Once the adjusted threshold amount becomes available, the Commission will publish it in the
On behalf of the Commission,
The Commission hereby gives notice of the filing of the following agreements under the Shipping Act of 1984. Interested parties may submit comments on any agreements to the Secretary, Federal Maritime Commission, Washington, DC 20573, within twelve days of the date this notice appears in the
By Order of the Federal Maritime Commission.
The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).
The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than January 8, 2018.
1.
1.
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) announces the following meeting.
The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92-463.
Michael Goldcamp, Ph.D., Scientific Review Officer/CDC, 1095 Willowdale Road, Mailstop H1808, Morgantown, West Virginia, 26505, (304) 285-5951;
The Director, Management Analysis and Services Office, has been delegated the authority to sign
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases.” FDA intends to no longer grant orphan drug designation to drugs for pediatric subpopulations of common diseases (
Submit either electronic or written comments on the draft guidance by January 19, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
You may submit comments on any guidance at any time as follows:
Submit electronic comments in the following way:
• Federal eRulemaking Portal:
• 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:
• Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Aaron Friedman, Office of Orphan Products Development, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5295, Silver Spring, MD 20993, 301-796-8660.
FDA is announcing the availability of a draft guidance for industry entitled “Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases.” FDA intends to no longer grant orphan drug designation to drugs for pediatric subpopulations of common diseases (
FDA expects to implement this policy upon publication of the final version of this guidance dependent upon comments received. In the interim, FDA will refrain from issuing final decisions on requests for pediatric-subpopulation designation until the guidance is finalized.
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on orphan designation of drugs and biologics for pediatric subpopulations of common diseases. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.
Persons with access to the internet may obtain the draft guidance at either
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for FDA staff and industry entitled “Drug Products Labeled as Homeopathic.” This draft guidance describes how FDA intends to prioritize enforcement and regulatory action with regard to drug products, including biological products, labeled as homeopathic and marketed in the United States without the required FDA approval.
Submit either electronic or written comments on the draft guidance by March 20, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
You may submit comments on any guidance at any time as follows:
Submit electronic comments in the following way:
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• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
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• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Elaine Lippmann, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6238, Silver Spring, MD 20993, 301-796-3600; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911.
FDA is announcing the availability of a draft guidance for FDA staff and industry entitled “Drug Products Labeled as Homeopathic.” This draft guidance describes how FDA intends to prioritize enforcement and regulatory action with regard to drug products, including biological products, labeled as homeopathic and marketed in the United States without the required FDA approval. Simultaneous with the issuance of the final guidance, FDA will withdraw Compliance Policy Guide (CPG) 400.400, “Conditions Under Which Homeopathic Drugs May be Marketed”, issued on May 31, 1988.
Homeopathy is an alternative medical practice that has an historical basis in theory and practice first systematized in the late 1700s. Homeopathy is generally based on two main principles: (1) A substance that causes symptoms in a healthy person can be used in diluted form to treat symptoms and illnesses (known as “like-cures-like”) and (2) the more diluted the substance, the more potent it is (known as the “law of infinitesimals”).
The definition of “drug” in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 321(g)(1)) includes articles recognized in the Homeopathic Pharmacopoeia of the United States (HPUS) or any supplement to it. As such, homeopathic drugs are subject to the same regulatory requirements as other drugs. Generally, a drug, including a homeopathic drug, is considered a “new drug” if it is not generally recognized by qualified experts as safe and effective (GRAS/E) for its labeled uses (section 201(p) of the FD&C Act). FDA makes GRAS/E determinations for over-the-counter (OTC) drugs marketed under the OTC Drug Review (see 21 CFR part 330). FDA has not reviewed any drug products labeled as homeopathic under the OTC Drug Review because the Agency categorized these products as a separate category and deferred consideration of them (37 FR 9464 at 9466 (May 11, 1972)). Under section 505(a) of the FD&C Act (21 U.S.C. 355(a)), before any “new drug” is marketed, it must be the subject of an approved application submitted pursuant to section 505(b) or section 505(j) of the FD&C Act; however, a biological product with an approved license under section 351(a) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(a)) is not required to have an approved application under section 505 of the FD&C Act. Accordingly, absent a determination that a drug product labeled as homeopathic is not a “new drug” under section 201(p), all drug products labeled as homeopathic are subject to the premarket approval requirements in section 505 of the FD&C Act or section 351 of the PHS Act. There are no drug products labeled as homeopathic that are approved by FDA.
In May 1988, FDA's Center for Drug Evaluation and Research issued CPG 400.400 entitled “Conditions Under Which Homeopathic Drugs May be Marketed.” As stated in the 1988 CPG, it delineates the conditions, including conditions related to ingredients, labeling, prescription status, and current good manufacturing practice, under which homeopathic drug products may ordinarily be marketed.
In light of the growth of the industry and passage of more than 2 decades since the 1988 CPG's issuance, FDA announced on March 27, 2015, that it was evaluating its regulatory framework for these products. In April 2015, FDA held a public hearing to obtain information and comments from stakeholders about the current use of drug products labeled as homeopathic, as well as the Agency's regulatory
As a result of the Agency's evaluation, including consideration of the public input received on this issue, FDA has determined that it is in the best interest of public health to issue a new guidance that applies a risk-based enforcement approach to drug products labeled as homeopathic and marketed in the United States without the required FDA approval, consistent with FDA's risk-based regulatory approaches generally. The Agency generally intends to apply a risk-based enforcement approach to the manufacturing, distribution, and marketing of drug products labeled as homeopathic, as described in the draft guidance, when finalized. However, the Agency has limited enforcement resources and recognizes that many such products likely will fall outside the risk-based categories described in the draft guidance.
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on drug products labeled as homeopathic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.
Persons with access to the internet may obtain the draft guidance at either
U.S. Department of Health and Human Services.
30-Day Day Notice template for Request for Generic Clearance for the Collection of Routine Customer Feedback on (HITRC).
U.S. Department of Health and Human Services (HHS).
Notice and request for comments. Office of the National Coordinator for Health Information Technology is requesting OMB approval for an extension on the Generic Clearance for the Collection of Routine Customer Feedback by OMB.
Department of Health and Human Services, The Office of the Secretary (OS), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public to take this opportunity to comment on the “Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery” for approval under the Paperwork Reduction Act (PRA). This collection was developed as part of a Federal Government-wide effort to streamline the process for seeking feedback from the public on service delivery. This notice announces our intent to submit this collection to OMB for approval and solicits comments on specific aspects for the proposed information collection.
Consideration will be given to all comments received by January 19, 2018.
Submit comments by one of the following methods:
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Comments submitted in response to this notice may be made available to the public through relevant websites. For this reason, please do not include in your comments information of a confidential nature, such as sensitive personal information or proprietary information. If you send an email comment, your email address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the internet. Please note that responses to this public comment request containing any routine notice about the confidentiality of the communication will be treated as public comments that may be made available to the public notwithstanding the inclusion of the routine notice.
Sherrette Funn,
The solicitation of feedback will target areas such as: Timeliness, appropriateness, accuracy of information, courtesy, efficiency of service delivery, and resolution of issues with service delivery. Responses will be assessed to plan and inform efforts to improve or maintain the quality of service offered to the public. If this information is not collected, vital feedback from customers and stakeholders on the Agency's services will be unavailable.
The Agency will only submit a collection for approval under this generic clearance if it meets the following conditions:
• The collections are voluntary;
• The collections are low-burden for respondents (based on considerations of total burden hours, total number of respondents, or burden-hours per respondent) and are low-cost for both the respondents and the Federal Government;
• The collections are non-controversial and do not raise issues of concern to other Federal agencies;
• Any collection is targeted to the solicitation of opinions from respondents who have experience with the program or may have experience with the program in the near future;
• Personally identifiable information (PII) is collected only to the extent necessary and is not retained;
• Information gathered will be used only internally for general service improvement and program management purposes and is not intended for release outside of the agency;
• Information gathered will not be used for the purpose of substantially informing influential policy decisions; and
• Information gathered will yield qualitative information; the collections will not be designed or expected to yield statistically reliable results or used as though the results are generalizable to the population of study.
Feedback collected under this generic clearance provides useful information, but it does not yield data that can be generalized to the overall population. This type of generic clearance for qualitative information will not be used for quantitative information collections that are designed to yield reliably actionable results, such as monitoring trends over time or documenting program performance. Such data uses require more rigorous designs that address: The target population to which generalizations will be made, the sampling frame, the sample design (including stratification and clustering), the precision requirements or power calculations that justify the proposed sample size, the expected response rate, methods for assessing potential non-response bias, the protocols for data collection, and any testing procedures that were or will be undertaken prior to fielding the study. Depending on the degree of influence the results are likely to have, such collections may still be eligible for submission for other generic mechanisms that are designed to yield quantitative results.
As a general matter, information collections will not result in any new system of records containing privacy information and will not ask questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private.
All written comments will be available for public inspection
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 Office of Management and Budget control number.
National Institutes of Health
Notice.
The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the
Only written comments and/or complete applications for a license which are received by the National Cancer Institute's Technology Transfer Center on or before January 4, 2018 will be considered.
Requests for copies of the patent application, inquiries, and comments relating to the contemplated Exclusive Patent License should be directed to: David A. Lambertson, Ph.D., Senior Technology Transfer Manager, NCI Technology Transfer Center, 9609 Medical Center Drive, RM 1E530, MSC 9702, Bethesda, MD 20892-9702 (for business mail), Rockville, MD 20850-9702; Telephone: (240)-276-5530; Facsimile: (240)-276-5504; Email:
United States Provisional Patent Application No. 62/241,896, filed 15 October 2015 and entitled “Anti-CD30 Chimeric Antigen Receptors” [HHS Reference No. E-016-2018/0-US-01]; PCT Patent Application PCT/US2016/056262, filed 10 October 2016 and entitled “Anti-CD30 Chimeric Antigen Receptors” [HHS Reference No. E-016-2018/0-PCT-02]; and U.S. and foreign patent applications claiming priority to the aforementioned applications.
The patent rights in these inventions have been assigned and/or exclusively licensed to the government of the United States of America.
The prospective exclusive license territory may be worldwide and the field of use may be limited to the following:
“The development of a CD30 chimeric antigen receptor (CAR)-based
(1) a single antigen specificity; and
(2) comprising at least:
(a) the complementary determining region (CDR) sequences of the anti-CD30 antibody known as 5F11; and
(b) a T cell signaling domain;
This technology discloses the development of chimeric antigen receptors that recognize the CD30 protein (also known as tumor necrosis factor receptor superfamily member 8 (TNFRSF8)). CD30 is expressed on the cell surface of several rare forms of cancer, including Hodgkin lymphoma (HL), Non-Hodgkin's Lymphoma (NHL), diffuse large B cell lymphoma (DLBCL), peripheral T cell lymphoma not otherwise specified (PTCL-NOS), anaplastic large cell lymphoma (ALCL), and angioimmunoblastic T cell lymphoma (AITL). The development of a new therapeutic targeting CD30 will benefit public health by offering up a treatment for these rare cancers in instances when conventional first line therapies are ineffective.
This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license will be royalty bearing, and the prospective exclusive license may be granted unless within fifteen (15) days from the date of this published notice, the National Cancer Institute receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.
In response to this Notice, the public may file comments or objections. Comments and objections, other than those in the form of a completed license application, will not be treated confidentially, and may be made publicly available.
License applications submitted in response to this Notice will be presumed to contain business confidential information and any release of information in these license applications will be made only as required and upon a request under the Freedom of Information Act, 5 U.S.C. 552.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
National Institutes of Health.
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 Cancer Institute (NCI) will publish periodic summaries of propose 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: Jackie Lavigne, Ph.D., M.P.H., Chief, Office of Education, Division of Cancer Epidemiology and Genetics, 9609 Medical Center Drive, MSC, Bethesda, Maryland 20892 or call non-toll-free number 240.276.7237or Email your request, including your 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 agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize's the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological
OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 218 hours.
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 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Dr. Natalie Greco, 301-761-7898;
Technology description follows.
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.
• Research reagent—can be applied to a variety of biological disciplines.
• Diagnostic medical imaging reagent—characterization of disease state/condition.
• Simple, quick and inexpensive procedure that has been extensively validated.
• Generates excellent tissue transparency, resulting in high quality images.
• Compatible with highly multiplexed staining/labeling techniques, including antibody-based methods, fluorescently tagged reporter proteins, and RNA-FISH.
• Fluorescence is maintained in diverse fluorescent proteins and fluorophores.
• Enables quantitative analysis of tissue composition and cellular distribution in whole organs, and has advantages over flow cytometric techniques.
• Prototype.
Coast Guard, DHS.
Notice.
The Coast Guard announces that it is modifying the conditions of entry for vessels arriving to the United States from Côte d'Ivoire by adding an exception to the conditions of entry for two facilities in the Republic of Côte d'Ivoire.
The policy takes effect January 3, 2018.
For information about this document call or email Juliet Hudson, International Port Security Evaluation Division, United States Coast Guard, telephone 202-372-1173.
The authority for this notice is 5 U.S.C. 552(a), 46 U.S.C. 70110, and Department of Homeland Security Delegation No. 0170.1(II)(97.f). Section 70110(a) provides that the Secretary of Homeland Security may impose conditions of entry into the United States from ports that are not maintaining effective anti-terrorism measures. Section 70110(d) provides that these conditions may be removed upon Secretary's determination that the measures are maintained. The Secretary delegated the authority to carry out the provisions of these sections to the Coast Guard. Section 552(a)(1)(E) requires an agency to provide a
On May 27, 2011, the Coast Guard determined that ports in the Republic of Côte d'Ivoire did not maintain effective anti-terrorism measures and that Côte d'Ivoire's designated authority's oversight, access control and cargo control remained deficient (76 FR 30954). However, since 2014 the Coast Guard has assessed and found that the port facilities listed in Table 1 do have effective anti-terrorism measures. As such, port facilities listed in Table 1 are exempted from the conditions of entry previously imposed.
Accordingly, beginning January 3, 2018, the conditions of entry shown in Table 2 below will apply to any vessel that visited a non-exempted Côte d'Ivoire port facility in its last five port calls.
The list of countries that do not maintain effective anti-terrorist measures is available in a Port Security Advisory notice available at
Office of Strategic Planning and Management, Grants Management and Oversight Division, HUD.
Notice.
HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: Colette Pollard, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street SW, Room 4176, Washington, DC 20410-5000; telephone 202-402-3400 (this is not a toll-free number) or email at
Ann vom Eigen, Grants Management and Oversight Division, Office of Strategic Planning and Management, Department of Housing and Urban Development, 451 Seventh St. SW, Room 3156, Washington, DC 20410 or by email
Copies of the proposed data collection forms may be requested from Ms. Pollard.
This notice informs the public that Department will submit the proposed information collection to OMB for review, as required by the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35, as amended). HUD is seeking approval from OMB for the information collection described in Section A.
HUD is seeking approval from OMB for the information collection described in Section A.
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points.
(1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) The accuracy of the agency's estimate of the burden of the proposed collection of information;
(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) Ways to minimize the burden of the collection of information on those who are to respond; including using appropriate automated collection techniques or other forms of information technology,
The solicitation template provides a framework for program-specific Notices of Funding Availability (NOFAs) soliciting applications for funding. A program solicitation or NOFA outlines the specific program requirements, describes eligibility requirements, details information, data, and forms applicants must submit in the application process; outlines program evaluation and performance measures; explains selection criteria and the review process; and provides registration dates, deadlines, and instructions on how to apply. The burden associated with the information collection subject to the Paperwork Reduction Act is actually reflected in the information collected through the forms enumerated in this collection rather than the templates themselves.
This collection consolidates many previously approved collections with new collections for the two templates for NOFAs and other pending PRAs. This request includes the burden associated with OMB approved forms as well as reporting where a specific form is not required.
HUD-Standard forms are used by all discretionary grant programs. The HUD Common forms are used by multiple discretionary grant programs or competitions. The Program-Specific forms are used by individual programs or competitions. Post-Award forms are used for reporting and oversight.
The information collected and to be collected is used in evaluating applications for HUD financial assistance and oversight of awards. Changes may be made based on actions of the Appropriations Committees and revisions to Departmental policies.
Estimate of the Total Number of Respondents and the Amount of Time Estimated for an Average Respondent To Respond:
The following table shows the estimated burden on applicants to prepare responses for information requests in applications by application.
The following table shows the estimated burden on recipients who submit performance and financial reports.
Federal staff and others review and rate applications. The following table shows the average burden of reviewing applications for HUD's discretionary grant programs.
The following table shows the estimated burden of Federal oversight per financial assistance award.
Section 2 of the Paperwork Reduction Act of 1995, as codified at 44 U.S.C. 3507.
Fish and Wildlife Service, Interior.
Notice of receipt of applications for permit.
We, the U.S. Fish and Wildlife Service, invite the public to comment on the following applications to conduct certain activities with endangered and threatened species. With some exceptions, the Endangered Species Act prohibits activities with listed species unless Federal authorization is acquired that allows such activities.
We must receive comments or requests for documents on or before January 19, 2018.
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When submitting comments, please also indicate the name of the applicant and the PRT# you are commenting on. We will post all comments on
Joyce Russell, Government Information Specialist, Division of Management Authority, U.S. Fish and Wildlife Service Headquarters, MS: IA; 5275 Leesburg Pike, Falls Church, VA 22041-3803; telephone 703-358-2023; facsimile 703-358-2280.
Send your request for copies of applications or comments and materials concerning any of the applications to the contact listed under
Please make your requests or comments as specific as possible. Please confine your comments to issues for which we seek comments in this notice, and explain the basis for your comments. Include sufficient information with your comments to allow us to authenticate any scientific or commercial data you include.
The comments and recommendations that will be most useful and likely to influence agency decisions are: (1) Those supported by quantitative information or studies; and (2) those that include citations to, and analyses of, the applicable laws and regulations. We will not consider or include in our administrative record comments we receive after the close of the comment period (see
Comments, including names and street addresses of respondents, will be available for public review at the street address listed under
To help us carry out our conservation responsibilities for affected species, and in consideration of section 10(a)(1)(A) of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
We invite the public to comment on applications to conduct certain activities with endangered species. With some exceptions, the ESA prohibits activities with listed species unless Federal authorization is acquired that allows such activities.
The applicant requests a permit to import one captive-born male orangutan (
The applicant requests a permit to import any endangered or threatened wildlife and plant species from worldwide sources, for the purpose of scientific research in applied animal ecology using stable isotope analysis. This notification covers activities to be conducted by the applicant over a 5-year period.
The applicant requests a permit authorizing interstate and foreign commerce, export, and cull of excess red lechwe (
The application requests a permit authorizing multiple-use import of American crocodile (
The applicant requests a permit to import howler monkey (
In the
The applicant requests a captive-bred wildlife registration under 50 CFR
African slender-snouted crocodile (
In the
The applicant requests a renewal of their permit authorizing the culling of excess barasingha (also known as “swamp deer”;
The applicant requests authorization to export and reimport nonliving museum specimens of endangered and threatened species previously accessioned into the applicant's collection for scientific research. This notification covers activities to be conducted by the applicant over a 5-year period.
The applicant requests a permit authorizing the culling of excess barasingha (
The following applicants each request a permit to import a sport-hunted trophy of a male bontebok (
If the Service decides to issue permits to any of the applicants listed in this notice, we will publish a notice in the
You may submit your comments and materials concerning this notice by one of the methods listed in
If you submit a comment via
We will post all hardcopy comments on
The authority for this action is the Endangered Species Act of 1973 (16 U.S.C. 1531
Fish and Wildlife Service, Interior.
Notice of receipt of permit applications; request for comments.
We, the U.S. Fish and Wildlife Service, invite the public to comment on applications for permits to conduct activities intended to enhance the propagation or survival of endangered species. With some exceptions, the Endangered Species Act (ESA) prohibits certain activities that constitute take of listed species unless a Federal permit is issued that allows such activity. The ESA also requires that we invite public comment before issuing these permits.
To ensure consideration, we must receive your written comments by January 19, 2018.
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Kathy Konishi, Recovery Permits Coordinator, Ecological Services, 719-628-2670 (phone);
We, the U.S. Fish and Wildlife Service, invite the public to comment on applications for permits to conduct activities intended to promote recovery of species that are listed as endangered under the Endangered Species Act (16 U.S.C. 1531
The ESA prohibits certain activities with endangered and threatened species unless authorized by a Federal permit. The ESA and our implementing regulations in part 17 of title 50 of the Code of Federal Regulations (CFR) provide for the issuance of such permits and require that we invite public comment before issuing permits for activities involving endangered species.
A recovery permit issued under section 10(a)(1)(A) of the ESA authorizes the permittee to conduct activities with endangered species for scientific purposes that promote recovery or for enhancement of propagation or survival of the species. Our regulations implementing section 10(a)(1)(A) for these permits are found at 50 CFR 17.22 for endangered wildlife species, 50 CFR 17.32 for threatened wildlife species, 50 CFR 17.62 for endangered plant species, and 50 CFR 17.72 for threatened plant species.
We invite local, state and Federal agencies, tribes, and the public to comment on the following applications.
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. If you submit a hardcopy comment that includes personal identifying information, you may request at the top of your document that we withhold this information from public review; however, we cannot guarantee that we will be able to do so.
Please make your comments as specific as possible. Please confine your comments to issues for which we seek comments in this notice, and explain the basis for your comments. Include sufficient information with your comments to allow us to authenticate any scientific or commercial data you include.
The comments and recommendations that will be most useful and likely to influence agency decisions are: (1) Those supported by quantitative information or studies; and (2) Those that include citations to, and analyses of, the applicable laws and regulations.
If we decide to issue permits to any of the applicants listed in this notice, we will publish a notice in the
We publish this notice under section 10(c) of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
Fish and Wildlife Service, Interior.
Notice of availability; request for public comment.
We, the U.S. Fish and Wildlife Service, announce the receipt and availability of a draft Habitat Conservation Plan (HCP) and draft environmental assessment (EA), which evaluates the impacts of, and alternatives to, the proposed Hinkley Groundwater Remediation Project. The Hinkley HCP was submitted by Pacific Gas & Electric Company (PG&E) in support of an application under the Endangered Species Act of 1973, as amended, for a permit authorizing the incidental take of covered species resulting from covered activities. PG&E's application is for a 50-year incidental take permit to cover groundwater remediation activities within a plan area of approximately 29,927 acres in and around Hinkley, California. We request review and comment on the Hinkley HCP and the draft EA from local, State, and Federal agencies; Tribes; and the public.
To ensure consideration, please send your written comments by January 19, 2018.
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○ Hinkley IRP Manager Office, 36236 Serra Rd., Hinkley, CA 92347.
○ PG&E Public Outreach Office, 22999 Community Blvd., Hinkley, CA 92347.
○ Barstow Library, 304 E Buena Vista St, Barstow, CA 92311.
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Scott Hoffmann, by mail at the U.S. Fish and Wildlife Service, 777 East Tahquitz Canyon Way, Suite 208, Palm Springs, CA 92262; or by phone at (760) 322-2070.
We, the U.S. Fish and Wildlife Service (Service), announce the receipt and availability of a draft Habitat Conservation Plan (HCP) and draft environmental assessment (EA), which evaluates the impacts of, and alternatives to, the proposed Hinkley Groundwater Remediation Project. The Hinkley HCP was submitted by the Pacific Gas & Electric Company (PG&E) in support of an application under section 10 of the Endangered Species Act of 1973, as amended (ESA), for a permit authorizing the incidental take of covered species resulting from covered activities. The proposed Hinkley HCP area encompasses approximately 29,927 acres in the southeastern portion of San Bernardino County, within the State of California.
Under section 10(c) of the ESA and under the National Environmental Policy Act of 1969 (NEPA), this notice advises the public of the receipt and availability for public review of the draft Hinkley HCP and draft EA, which evaluates the impacts of, and alternatives to, the Hinkley HCP, submitted with an application for a permit to authorize the incidental take of federally listed covered species resulting from covered activities within the plan area. The Service is the Lead Agency pursuant to NEPA. The proposed Federal action is issuance to PG&E of an incidental take permit (ITP) under section 10(a)(1)(B) of the ESA.
Section 9 of the ESA prohibits “take” of fish and wildlife species listed as endangered under section 4 (16 U.S.C. 1538, 1533, respectively). Section 10(a)(1)(B) of the ESA provides for the issuance of a permit for the taking of listed fish and wildlife species that is incidental to, and not the purpose of, the carrying out of an otherwise lawful activity (“incidental take”). The ESA implementing regulations extend, under certain circumstances, the prohibition of take to threatened species (50 CFR 17.31). Regulations governing permits for endangered and threatened species are at 50 CFR 17.22 and 17.32. For more about the HCP program, go to
Under section 10(a) of the ESA, the Service may issue permits to authorize incidental take of listed fish and wildlife species. Section 10(a)(2)(B) of the ESA contains criteria for issuing ITPs to non-Federal entities for the take of endangered and threatened species, provided the following criteria are met:
• The taking will be incidental;
• The applicant will, to the maximum extent practicable, minimize and mitigate the impact of such taking;
• The applicant will develop an HCP and ensure that adequate funding for the plan will be provided;
• The taking will not appreciably reduce the likelihood of the survival and recovery of the species in the wild; and
• The applicant will carry out any other measures that the Secretary may require as being necessary or appropriate for the purposes of the HCP.
The purpose of issuing an ITP to PG&E would be to permit incidental take of the covered species resulting from groundwater remediation activities conducted by PG&E and conditioned on PG&E's minimization and mitigation of the impacts of such take in accordance with an approved Hinkley HCP. Implementation of the Hinkley HCP is intended to maximize the benefits of conservation measures for covered species and eliminate expensive and time-consuming efforts associated with processing individual ITPs for each groundwater remediation project within PG&E's plan area.
The proposed Hinkley HCP includes measures intended to minimize and mitigate the impacts of the taking to the maximum extent practicable from groundwater remediation activities within the plan area.
The proposed action is the issuance of an ITP by the Service to PG&E for the
The plan area is approximately 29,927 acres, and includes all areas within which PG&E is proposing to conduct groundwater remediation activities. The plan area is common to both alternatives analyzed in the EA, and represents the surface area above the projected maximum spatial extent of contaminated groundwater. The plan area also defines the maximum spatial extent of surface areas within which PG&E may implement groundwater remediation activities, and the maximum spatial extent of potential groundwater effects such as drawdown or accumulation of remediation byproducts.
We considered two alternatives in the EA: (1) The Proposed Action as described in the HCP, and (2) the No Action alternative. Two other alternatives, discussed in the HCP as alternatives considered but not utilized, were not carried forward for analysis in the EA. The No Action alternative is based on PG&E's continued implementation of groundwater remediation activities, consistent with current laws and regulations, in areas where take of listed species would be avoided; under this alternative we would not issue an ITP.
Consistent with section 10(c) of the ESA, we invite your submission of written comments, data, or arguments with respect to PG&E's permit application, the Hinkley HCP, and proposed permitting decision.
Written comments we receive become part of the public record associated with this action. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you may request in your comment that we withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so. All submissions from organizations or businesses, and from individuals identifying themselves as representatives or officials of organizations or businesses, will be made available for public disclosure in their entirety.
Issuance of an incidental take permit is a Federal proposed action subject to compliance with NEPA. We will evaluate the application, associated documents, and any public comments we receive to determine whether the application meets the requirements of section 10(a) of the ESA. If we determine that those requirements are met, we will issue a permit to the applicant for the incidental take of the covered species. We will make our final permit decision no sooner than 30 days after the public comment period closes.
We provide this notice under section 10(c) of the ESA (16 U.S.C. 1531
Bureau of Land Management, Interior.
Notice of realty action.
The Bureau of Land Management (BLM) is proposing to sell 5.93 acres of public land to resolve an unauthorized use and occupancy in Santa Barbara County, California, to Arc Vineyards, LLC, under the Federal Land Policy and Management Act of 1976 (FLPMA), as amended, at not less than the fair market value of $19,500.
Submit written comments to the BLM at the address below. Comments must be received by the BLM on or before February 5, 2018.
Bureau of Land Management, Bakersfield Field Office, 4801 Pegasus Dr., Bakersfield, CA 93308. Attn: Gabriel Garcia, Field Manager.
Maria Soto, Realty Specialist, 661-391-6023, at the above address or email to
The following described land located in Santa Barbara County, California, is proposed for direct sale under the authority of Section 203 of FLPMA (43 U.S.C. 1713).
The area described contains 5.93 acres.
The BLM determined the land is no longer required for any other Federal purpose. A direct sale of this parcel is in conformance with the 1997 Caliente Resource Management Plan (RMP), as amended by Environmental Assessment DOI-BLM-CA-C060-2012-0021 Decision Record signed on July 2, 2014. Subsequently, the 2014 Bakersfield RMP replaced the Caliente RMP. The parcel was identified as suitable for disposal and sale under Section 203 of FLPMA and is limited to the smallest acreage necessary to resolve the unauthorized use and occupancy. The BLM found no significant biological or cultural resource values on the lands and expects no impacts to resource values from this action. An Environmental Site Assessment has been performed and is available for review. The sale would dispose of an isolated public land parcel that is difficult to manage because it is completely surrounded by private land and there is no legal access, would
The regulation at 43 CFR 2711.3-3(a)(5) authorizes the BLM to make direct sale of public lands when a competitive sale is not appropriate and the public interest would be best served by a direct sale. The BLM determined a direct sale will serve important public objectives by disposing of a parcel of isolated public land that the public cannot use or legally access and that the BLM cannot properly manage, and to resolve the inadvertent unauthorized use and occupancy of the land. The BLM prepared a mineral potential report dated October 25, 2011, concluding there are known mineral values in the land offered for sale. Therefore, the BLM will reserve the Federal mineral interest to the United States. Such minerals will be subject to the right to explore, prospect for, mine, and remove under applicable law and regulations.
On December 20, 2017, the above described parcel will be segregated from appropriation under the public land laws, including the mining laws, except the sale provisions of the FLPMA. Until completion of the sale or termination of the segregation, the BLM will no longer accept land-use applications affecting the identified public lands, except applications for the amendment of previously filed right-of-way applications or existing authorizations to increase the term of the grants in accordance with 43 CFR 2807.15 and 2886.15. The segregation will terminate upon issuance of a patent, publication in the
Conveyance of the identified public land would be subject to valid existing rights of record and the following terms, conditions, and reservations:
1. A right-of-way thereon for ditches and canals constructed by authority of the United States, Act of August 30, 1890 (43 U.S.C. 945).
2. A reservation of all minerals to the United States, and the right to prospect for, mine, and remove the minerals under applicable law and any regulations that the Secretary of the Interior may prescribe, including all necessary access and exit rights.
3. An appropriate indemnification clause protecting the United States from claims arising out of the patentee's use, occupancy, or occupation on the patented land.
Detailed information, including NEPA documentation and all other documents associated with this sale, are available for review during the 45-day public comment period for this notice at the Bakersfield Field Office at the above address.
For a period until February 5, 2018, interested parties and the general public may submit in writing any comments concerning the land being considered for sale, including notification of any encumbrances or other claims relating to the identified land, to the Field Manager, BLM Bakersfield Field Office, at the above address. Email will also be accepted and should be sent to:
Individual respondents may request confidentiality. Before including your address, telephone number, email address, or other personal identifying information in your comment, the BLM will make your entire comment—including your personal identifying information—publicly available at any time. While you can ask in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so. If you wish to have your name or address withheld from public disclosure under the Freedom of Information Act, you must state this prominently at the beginning of your comments. Any determination by the BLM to release or withhold the names and/or addresses of those who comment will be made on a case-by-case basis. Such requests will be honored to the extent allowed by law. The BLM will make available for public review, in their entirety, all comments submitted by businesses or organizations, including comments by individuals in their capacity as an official or representative of a business or organization.
The BLM California State Director or other authorized official of the Department of the Interior will review comments regarding the sale and may sustain, vacate, or modify this realty action in whole or in part. In the absence of timely filed objections, this realty action will become the final determination of the Department of the Interior.
U.S. International Trade Commission.
Notice.
Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on November 14, 2017, under section 337 of the Tariff Act of 1930, as amended, on behalf of Align Technology, Inc. of San Jose, California. An amended complaint and supplement were filed on December 4, 2017. The amended complaint alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain color intraoral scanners and related hardware and software by reason of infringement of one or more of U.S. Patent No. 8,363,228 (“the '228 patent”); U.S. Patent No. 8,451,456 (“the '456 patent”); U.S. Patent No. 8,675,207 (“the '207 patent”); U.S. Patent No. 9,101,433 (“the '433 patent”); U.S. Patent No. 6,948,931 (“the '931 patent”); and U.S. Patent No. 6,685,470 (“the '470 patent”). The amended complaint further alleges that an industry in the United States exists as required by the applicable Federal Statute.
The complainant requests that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders.
The complaint, except for any confidential information contained therein, is available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW, Room 112, Washington, DC 20436, telephone
The Office of Docket Services, U.S. International Trade Commission, telephone (202) 205-1802.
(1) Pursuant to subsection (b) of section 337 of the Tariff Act of 1930, as amended, an investigation be instituted to determine whether there is a violation of subsection (a)(1)(B) of section 337 in the importation into the United States, the sale for importation, or the sale within the United States after importation of certain color intraoral scanners and related hardware and software by reason of infringement of one or more of claims 1, 2, 4, 5, 7, 18, 20, 21, and 26 of the '228 patent; claims 1-8 and 15-18 of the '456 patent; claims 1, 2, 4, and 15-21 of the '207 patent; claims 1, 4, 7, 10, 12, and 14 of the '433 patent; and claims 1-12 of the '931 patent; and claims 1-12 of the '470 patent, and whether an industry in the United States exists as required by subsection (a)(2) of section 337;
(2) For the purpose of the investigation so instituted, the following are hereby named as parties upon which this notice of investigation shall be served:
(a) The complainant is: Align Technology, Inc., 2820 Orchard Parkway, San Jose, CA 95134.
(b) The respondents are the following entities alleged to be in violation of section 337, and are the parties upon which the complaint is to be served:
3Shape A/S, Holmens Kanal 7, 1060 Copenhagen K, Denmark.
3Shape, Inc., 10 Independence Boulevard, Suite 150, Warren, NJ 07059.
(3) For the investigation so instituted, the Chief Administrative Law Judge, U.S. International Trade Commission, shall designate the presiding Administrative Law Judge, and the Chief Administrative Law Judge is authorized to consider whether to consolidate Inv. No. 337-TA-1091 with Inv. No. 337-TA-1090, and to consolidate them if he deems it appropriate.
The Office of Unfair Import Investigations will not participate as a party in this investigation.
Responses to the complaint and the notice of investigation must be submitted by the named respondents in accordance with section 210.13 of the Commission's Rules of Practice and Procedure, 19 CFR 210.13. Pursuant to 19 CFR 201.16(e) and 210.13(a), such responses will be considered by the Commission if received not later than 20 days after the date of service by the Commission of the complaint and the notice of investigation. Extensions of time for submitting responses to the complaint and the notice of investigation will not be granted unless good cause therefor is shown.
Failure of a respondent to file a timely response to each allegation in the complaint and in this notice may be deemed to constitute a waiver of the right to appear and contest the allegations of the complaint and this notice, and to authorize the administrative law judge and the Commission, without further notice to the respondent, to find the facts to be as alleged in the complaint and this notice and to enter an initial determination and a final determination containing such findings, and may result in the issuance of an exclusion order or a cease and desist order or both directed against the respondent.
By order of the Commission.
On the basis of the record
The Commission, pursuant to section 751(c) of the Act (19 U.S.C. 1675(c)), instituted these reviews on June 1, 2017 (82 FR 25324) and determined on September 5, 2017 that it would conduct expedited reviews (82 FR 46524, October 5, 2017).
The Commission made these determinations pursuant to section 751(c) of the Act (19 U.S.C. 1675(c)). It completed and filed its determinations in these reviews on January 8, 2018. The views of the Commission are contained in USITC Publication 4751 (January 2018), entitled
By order of the Commission.
On December 14, 2017, the Department of Justice lodged a proposed Consent Decree with the United States District Court for the Northern District of New York in the lawsuit entitled
The proposed Consent Decree requires Honeywell to pay $7.3 million in reimbursement of response costs incurred by the United States with respect to the Site. The proposed Consent Decree provides Honeywell with a covenant not to sue for response costs incurred by the United States in connection with the Site through the date of lodging of the Consent Decree. Honeywell previously entered into a settlement with the New York State Department of Environmental Conservation (NYSDEC) that required Honeywell to perform a cleanup of the Lake Bottom portion of the Site.
The proposed Consent Decree also resolves the liability of other potentially responsible parties (“Other Settling Parties”) who have previously settled (or may settle in the future) with Honeywell, and the United States provides the Other Settling Parties with a covenant not to sue for certain of the costs incurred by the United States in connection with the Site. The Other Settling Parties also agree to provide a covenant not to sue the United States for certain costs and natural resource damages in connection with the Site.
The proposed Consent Decree also resolves Honeywell's claim against the United States under Section 113(f) of CERCLA and requires the United States to reimburse Honeywell $6.25 million of Honeywell's costs incurred in cleaning up the Site. Honeywell alleges that certain federal agencies were liable for the disposal of contaminants at the Site during World War II. Under the proposed Consent Decree, Honeywell provides the United States with a covenant not to sue for response costs and natural resource damages incurred or to be incurred by Honeywell in connection with the Site.
The publication of this notice opens a period for public comment on the Consent Decree. Please address comments to the Assistant Attorney General, Environment and Natural Resources Division and refer to
During the public comment period, the Consent Decree may be examined and downloaded at this Justice Department website:
Please enclose a check or money order for $10.75 (25 cents per page reproduction cost) payable to the United States Treasury.
National Science Foundation.
Notice of permits issued.
The National Science Foundation (NSF) is required to publish notice of permits issued under the Antarctic Conservation Act of 1978. This is the required notice.
Nature McGinn, ACA Permit Officer, Office of Polar Programs, National Science Foundation, 2415 Eisenhower Avenue, Alexandria, VA 22314; 703-292-8030; email:
On October 27, 2017, the National Science Foundation published notices in the
Nuclear Regulatory Commission.
Indirect transfer of license; order.
The U.S. Nuclear Regulatory Commission (NRC) is issuing an Order approving the indirect transfer of several licenses. AREVA, Inc., is the holder of materials license no. SNM-1227, which authorizes the possession and use of special nuclear material (SNM) at the AREVA, Inc. site in Richland, Washington. AREVA, Inc. is also the holder of export license nos. XSNM3551, XSNM3697, XSNM3747, XSOU8833, XCOM1202, XW015, XCOM1304, XSNM3780, XSNM3781, XSNM3782, and import license no. IW009 which authorize the import and export of licensed materials/components to and from facilities in the United States. The Order approves the indirect transfer of control of the above licenses resulting from a planned reorganization of AREVA, Inc.'s parent company and the sale of part of the parent company. There will be no direct transfer of control because AREVA, Inc. will continue to be the license holder. The Order became effective upon issuance.
The Order was issued on November 14, 2017, and is applicable until March 31, 2018.
Please refer to Docket ID NRC-2017-0148 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document using any of the following methods:
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Kevin M. Ramsey, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-7506, email:
The text of the Order is attached.
The documents identified in the following table are available to interested persons through one or more of the following methods, as indicated.
For the Nuclear Regulatory Commission.
AREVA, Inc., is the holder of materials license no. SNM-1227, which authorizes the possession and use of special nuclear material (SNM) at the AREVA, Inc. site in Richland, Washington. AREVA, Inc. is also the holder of export license nos. XSNM3551, XSNM3697, XSNM3747, XSOU8833, XCOM1202, XW015, XCOM1304, XSNM3780, XSNM3781, XSNM3782, and import license no. IW009 which authorize the import and export of licensed materials/components to and from facilities in the United States.
By letter dated April 14, 2017, and supplemented by letters dated July 14, August 31, and October 4, 2017 (collectively the Application), AREVA, Inc. requested the U.S. Nuclear Regulatory Commission's (NRC's) approval of the indirect transfer of control of the licenses listed above. The indirect transfer of control would result from a planned reorganization of AREVA SA to create a new, wholly-owned subsidiary and the sale of controlling interest in the new subsidiary to Electricite de France (EDF). AREVA SA, a company organized under the laws of France, is the ultimate parent company of AREVA NP SAS, a company organized under the laws of France and the current intermediate parent of AREVA, Inc. After the reorganization is complete, AREVA NP SAS will have a new, wholly-owned subsidiary called New NP SA. AREVA, Inc. will be a wholly-owned subsidiary of New NP SA, which in turn will be a wholly-owned subsidiary of AREVA NP SAS and indirect subsidiary of AREVA SA. AREVA SA will transfer controlling interest in New NP SA to EDF, a company organized under the laws of France. AREVA, Inc. will be an indirect subsidiary of EDF. The transaction will thus involve the indirect transfer of control over AREVA, Inc.'s NRC-issued licenses.
There will be no direct transfer of control because AREVA, Inc. will continue to be the license holder. There will be no change in the management or technical personnel responsible for licensed activities. The current safety, security, and licensing organizations within AREVA, Inc. will remain unchanged. Additionally, there are no planned changes in the operational organization, location, facilities, equipment, or procedures associated with the NRC licenses, and there will be no changes in AREVA, Inc. operating procedures, emergency procedures, or decommissioning financial assurance. Because the licensee remains the same, there will be no physical transfer of any records. All records concerning the safe and effective decommissioning of the facility, public dose, and waste disposal will remain physically located, maintained, and available at the Richland, Washington, site. EDF will abide by, and be ultimately responsible for meeting, all commitments and representations previously made by AREVA, Inc. with respect to the licenses listed above. These include, but are not limited to, maintaining decommissioning records, implementing decontamination activities, and eventually decommissioning the facilities and site. No physical or operational changes affecting the AREVA site and licensed activities were proposed in the Application.
Approval of the change of control was requested pursuant to Section 184 of the Atomic Energy Act of 1954, as amended (the Act), and Title 10 of the
Pursuant to 10 CFR 70.36, no 10 CFR part 70 license shall be transferred, assigned, or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, unless the NRC, after securing full information, finds that the transfer is in accordance with the provisions of the Act, and gives its consent in writing. Pursuant to 10 CFR 110.50, a specific license under Part 110 may be transferred, disposed of, or assigned to another person only with the approval of the Commission. After review of the information
The findings set forth above are supported by the NRC's Safety Evaluation Report issued with this Order.
Accordingly, pursuant to Sections 161b, 161i, 183, and 184 of the Act; 42 U.S.C. 2201(b), 2201(i), 2233, and 2234; and 10 CFR 70.36 and 110.50, IT IS HEREBY ORDERED that the Application regarding the indirect transfer of control over licenses listed above from AREVA SA to EDF is approved, subject to the following conditions:
1. With respect to the licenses listed above, EDF, as stated in the Application, will abide by all commitments and representations previously made by AREVA, Inc. These include, are not limited to, maintaining decommissioning records and financial assurance, implementing decontamination activities, and eventually decommissioning the site.
2. The commitments/representations made in the Application regarding reporting relationships and authority over safety and security issues and compliance with NRC requirements shall be adhered to and may not be modified without the prior written consent from the Director, Office of Nuclear Material Safety and Safeguards, or his designee.
IT IS FURTHER ORDERED that AREVA, Inc. at least one (1) business day before all actions necessary to accomplish the indirect transfer of control are completed shall so inform the Director of the Office of Nuclear Material Safety and Safeguards, in writing. If the necessary supporting actions have not been completed by March 31, 2018, this Order shall become null and void; provided, however, that, upon timely written application and for good cause shown, such completion date may be extended by further Order.
This Order is effective on issuance.
For further details with respect to this Order, see the initial Application listed in Section II above, and the Safety Evaluation Report supporting this action, which are available for public inspection at the Commission's Public Document Room (PDR), located at One White Flint North, Public File Area 01-F21, 11555 Rockville Pike (first floor), Rockville, Maryland, and accessible, electronically, through the Agencywide Documents Access and Management System (ADAMS) Public Electronic Reading Room, on the internet the NRC website
Dated and issued this 14th day of November, 2017.
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Notice of submission to the Office of Management and Budget; request for comment.
The U.S. Nuclear Regulatory Commission (NRC) has recently submitted a request for renewal of an existing collection of information to the Office of Management and Budget (OMB) for review. The information collection is entitled, NRC Form 483, Registration Certificate—“
Submit comments by January 19, 2018.
Submit comments directly to the OMB reviewer at: Brandon DeBruhl, Desk Officer, Office of Information and Regulatory Affairs (3150-0038), NEOB-10202, Office of Management and Budget, Washington, DC 20503; telephone: 202-395-0710, email:
David Cullison, NRC Clearance Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-2084; email:
Please refer to Docket ID NRC-2017-0166 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:
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The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC posts all comment submissions at
If you are requesting or aggregating comments from other persons for submission to the OMB, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment submissions into ADAMS.
Under the provisions of the Paperwork Reduction Act of 1995 (44
The NRC published a
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For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Notice of submission to the Office of Management and Budget; request for comment.
The U.S. Nuclear Regulatory Commission (NRC) has recently submitted a request for renewal of an existing collection of information to the Office of Management and Budget (OMB) for review. The information collection is entitled, “NRC Form 445, “Request for Approval of Official Foreign Travel.”
Submit comments by January 19, 2018.
Submit comments directly to the OMB reviewer at: Brandon De Bruhl, Desk Officer, Office of Information and Regulatory Affairs (3150-0193), NEOB-10202, Office of Management and Budget, Washington, DC 20503; telephone: 202-395-0710, email:
David Cullison, NRC Clearance Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-2084; email:
Please refer to Docket ID NRC-2016-0274 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:
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The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC posts all comment submissions at
If you are requesting or aggregating comments from other persons for submission to the OMB, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment submissions into ADAMS.
Under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the NRC recently submitted a request for renewal of an existing collection of information to OMB for review entitled, NRC Form 445, “Request for Approval of Official Foreign Travel.” The NRC hereby informs potential respondents that an agency may not conduct or sponsor, and that a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
The NRC published a
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For the Nuclear Regulatory Commission.
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth A. Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 14, 2017, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth A. Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 14, 2017, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth A. Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 14, 2017, it filed with the Postal Regulatory Commission a
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange filed a proposal to amend Rule 19.6, Series of Options Contracts Open for Trading.
The text of the proposed rule change is available at the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in Sections A, B, and C below, of the most significant parts of such statements.
The purpose of this filing is to amend Rule 19.6 to modify the strike setting regime for IVV, SPY, and DIA options. Specifically, for IVV, SPY, and DIA options the Exchange proposes to explicitly allow $1 strike price intervals. The Exchange believes that the proposed rule change would make IVV, SPY, and DIA options easier for investors and traders to use and more tailored to their investment needs, as well as to better align BZX's strike regime with other options exchange. The Exchange notes that this proposal is based on the rules of BOX Options Exchange LLC (“Box”) and the Cboe Exchange, Inc. (f/k/a Chicago Board Options Exchange, Inc.) (Cboe).
Rule 19.6(d)(4) provides that:
The interval between strike prices of series of options on Fund Shares approved for options trading pursuant to Rule 19.3(i) shall be fixed at a price per share which is reasonably close to the price per share at which the underlying security is traded in the primary market at or about the same time such series of options is first open for trading on BZX Options, or at such intervals as may have been established on another options exchange prior to the initiation of trading on BZX Options.
Rule 19.6.02(a) provides:
BZX Options may list $1 Strike Prices on any other option classes if those classes are specifically designated by other national securities exchanges that employ a similar $1 Strike Price Program under their respective rules.
The SPY and IVV exchange-traded funds (“ETFs”) are designed to roughly track the performance of the S&P 500 Index. The DIA ETF is designed to roughly track the performance of the Dow Jones Industrial Average (“DJIA”) with the price of SPY and IVV designed to roughly approximate 1/10th of the price of the S&P 500 Index and the price of DIA designed to roughly approximate 1/100th of the price of the DJIA. Accordingly, SPY and IVV strike prices reflect a value roughly equal to 1/10th of the value of the S&P 500 Index and DIA strike prices reflect a value roughly equal to 1/100th of the value of the DJIA with each having a multiplier of $100. For example, if the S&P 500 Index is at 1972.56, SPY options might have a value of approximately 197.26 with a notional value of $19,726. If the DJIA is at 16,569.98, DIA options may have a value of 165.70 with a notional value of $16,570. In general, SPY, IVV, and DIA options provide retail investors and traders with the benefit of trading the broad market in a manageably sized contract. As options with an ETP underlying, SPY, IVV, and DIA options are listed in the same manner as equity options under the Rules.
Unlike other options exchanges, BZX rules do not specifically identify the strike price interval for IVV, SPY, and DIA options. This proposed rule change seeks to match the strike setting regime for IVV, SPY, and DIA options available on other options exchanges.
Due to the Exchange's current ability to list $1 strikes in IVV, SPY, and DIA options when another options exchange lists such strikes, this proposed rule change is unlikely to augment the potential total number of options series available on the Exchange. However, the Exchange believes it and the Options Price Reporting Authority (“OPRA”) have the necessary systems capacity to handle any potential additional traffic associated with this proposed rule change. The Exchange also believes that Trading Permit Holders will not have a capacity issue due to the proposed rule change. In addition, the Exchange represents that it does not believe that this expansion will cause fragmentation of liquidity.
The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act. Specifically, the Exchange believes the proposed rule change is consistent with the Section 6(b)(5) requirements that the rules of an exchange be designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, to foster cooperation and coordination with persons engaged in regulating, clearing, settling, processing information with respect to, and facilitating transactions in securities, to remove impediments to and perfect the mechanism of a free and open market and a national market system, and, in general, to protect investors and the public interest. Additionally, the Exchange believes the proposed rule change is consistent with the Section 6(b)(5) requirement that the rules of an exchange not be designed to permit unfair discrimination between customers, issuers, brokers, or dealers.
In particular, the proposed rule change will allow investors to more easily use SPY, IVV, DIA options, which protects investors and the public interest. The Exchange also believes the proposed rule change is consistent with Section 6(b)(1) of the Act, which provides that the Exchange be organized and have the capacity to be able to carry out the purposes of the Act and the rules and regulations thereunder, and the rules of the Exchange. The Exchange does not believe that the proposed rule would create additional capacity issues or affect market functionality. The Exchange believes that the proposed rule change, like other strike price programs currently offered by the Exchange, will benefit investors by giving them increased flexibility to more closely tailor their investment and hedging decisions. Moreover, the
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. Rather, the Exchange believes that the proposed rule change will result in additional investment options and opportunities to achieve the investment and trading objectives of market participants seeking efficient trading and hedging vehicles, to the benefit of investors, market participants, and the marketplace in general. Additionally, this proposed rule change seeks to match the strike setting regime for IVV, SPY, and DIA options available on other options exchanges; thus, the proposed rule change may alleviate any potential burden on competition.
Written comments were neither solicited nor received.
Because the foregoing proposed rule change does not: (A) Significantly affect the protection of investors or the public interest; (B) impose any significant burden on competition; and (C) by its terms, become operative for 30 days from the date on which it was filed or such shorter time as the Commission may designate it has become effective pursuant to Section 19(b)(3)(A) of the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is: (1) Necessary or appropriate in the public interest; (2) for the protection of investors; or (3) otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Securities and Exchange Commission (“Commission”).
Notice.
Notice of an application under (a) section 6(c) of the Investment Company Act of 1940 (“Act”) for an exemption from sections 2(a)(32), 2(a)(35), 14(a), 19(b), 22(d) and 26(a)(2)(C) of the Act and rules 19b-1 and rule 22c-1 thereunder and (b) sections 11(a) and 11(c) of the Act for approval of certain exchange and rollover privileges.
Secretary, Securities and Exchange Commission, 100 F Street, NE, Washington, DC 20549-1090; Applicants, 3250 Lacey Road, Suite 130, Downers Grove, IL 60515, and Morrison C. Warren, Walter L. Draney and Suzanne M. Russell, Chapman and Cutler LLP, 111 West Monroe Street, Chicago, IL 60603.
Laura L. Solomon, Senior Counsel, at (202) 551-6915, or David J. Marcinkus, Branch Chief, at (202) 551-6821 (Division of Investment Management, Chief Counsel's Office).
The following is a summary of the application. The complete application may be obtained via the Commission's website by searching for the file number, or an applicant using the Company name box, at
1. Ausdal Unit Investment Trust and any future Trust will be a UIT registered under the Act. Ausdal, an Iowa corporation, is registered under the Securities Exchange Act of 1934 as a broker-dealer and will be the Depositor of Ausdal Unit Investment Trust. Each Series will be created by a trust indenture between the Depositor and a banking institution or trust company as trustee.
2. The Depositor acquires a portfolio of securities, which it deposits with the series trustee (“Trustee”) in exchange for certificates representing units of fractional undivided interest in the Series' portfolio (“Units”). The Units are offered to the public through the Depositor and dealers at a price which, during the initial offering period, is based upon the aggregate market value of the underlying securities, or, the aggregate offering side evaluation of the underlying securities if the underlying securities are not listed on a securities exchange, plus a front-end sales charge, a deferred sales charge or both. The maximum sales charge may be reduced in compliance with rule 22d-1 under the Act in certain circumstances, which are disclosed in the Series' prospectus.
3. The Depositor may, but is not legally obligated to, maintain a secondary market for Units of an outstanding Series. Other broker-dealers may or may not maintain a secondary market for Units of a Series. If a secondary market is maintained, investors will be able to purchase Units on the secondary market at the current public offering price plus a front-end sales charge. If such a market is not maintained at any time for any Series, holders of the Units (“Unitholders”) of that Series may redeem their Units through the Trustee.
1. Applicants request an order to the extent necessary to permit one or more Series to impose a sales charge on a deferred basis (“DSC”). For each Series, the Depositor would set a maximum sales charge per Unit, a portion of which may be collected “up front” (
2. When a Unitholder redeems or sells Units, the Depositor intends to deduct any unpaid DSC from the redemption or sale proceeds. When calculating the amount due, the Depositor will assume that Units on which the DSC has been paid in full are redeemed or sold first. With respect to Units on which the DSC has not been paid in full, the Depositor will assume that the Units held for the longest time are redeemed or sold first. Applicants represent that the DSC collected at the time of redemption or sale, together with the Installment Payments and any amount collected up front, will not exceed the maximum sales charge per Unit. Under certain circumstances, the Depositor may waive the collection of any unpaid DSC in connection with redemptions or sales of Units. These circumstances will be disclosed in the prospectus for the relevant Series and implemented in accordance with rule 22d-1 under the Act.
3. Each Series offering Units subject to a DSC will state the maximum charge per Unit in its prospectus. In addition, the prospectus for such Series will include the table required by Form N-1A (modified as appropriate to reflect the difference between UITs and open-end management investment companies) and a schedule setting forth the number and date of each Installment Payment, along with the duration of the collection period. The prospectus also will disclose that portfolio securities may be sold to pay the DSC if distribution income is insufficient and that securities will be sold pro rata, if practicable, otherwise a specific security will be designated for sale.
1. Applicants request an order to the extent necessary to permit Unitholders of a Series to exchange their Units for Units of another Series (“Exchange Option”) and Unitholders of a Series that is terminating to exchange their Units for Units of a new Series of the same type (“Rollover Option”). The Exchange Option and Rollover Option would apply to all exchanges of Units sold with a front-end sales charge, a DSC or both.
2. A Unitholder who purchases Units under the Exchange Option or Rollover Option would pay a lower sales charge than that which would be paid for the Units by a new investor. The reduced sales charge will be reasonably related to the expenses incurred in connection with the administration of the DSC program, which may include an amount that will fairly and adequately compensate the Depositor and participating underwriters and brokers for their services in providing the DSC program.
1. Section 4(2) of the Act defines a “unit investment trust” as an investment company that issues only redeemable securities. Section 2(a)(32) of the Act defines a “redeemable security” as a security that, upon its presentation to the issuer, entitles the holder to receive approximately his or her proportionate share of the issuer's current net assets or the cash equivalent of those assets. Rule 22c-1 under the Act requires that the price of a redeemable security issued by a registered investment company for purposes of sale, redemption or repurchase be based on the security's current net asset value (“NAV”). Because the collection of any unpaid DSC may cause a redeeming Unitholder to receive an amount less than the NAV of the redeemed Units, applicants request relief from section 2(a)(32) and rule 22c-1.
2. Section 22(d) of the Act and rule 22d-1 under the Act require a registered investment company and its principal underwriter and dealers to sell securities only at the current public offering price described in the investment company's prospectus, with the exception of sales of redeemable securities at prices that reflect scheduled variations in the sales load. Section 2(a)(35) of the Act defines the term “sales load” as the difference between the sales price and the portion of the proceeds invested by the depositor or trustee. Applicants request relief from section 2(a)(35) and section 22(d) to permit waivers, deferrals or other scheduled variations of the sales load.
3. Under section 6(c) of the Act, the Commission may exempt classes of transactions, if and to the extent that such exemption is necessary or appropriate in the public interest and consistent with the protection of investors and the purposes fairly intended by the policy and provisions of the Act. Applicants state that their proposal meets the standards of section 6(c). Applicants state that the provisions of section 22(d) are intended to prevent (a) riskless trading in investment company securities due to backward pricing, (b) disruption of orderly distribution by dealers selling shares at a discount, and (c) discrimination among investors resulting from different prices charged to different investors. Applicants assert that the proposed DSC program will present none of these abuses. Applicants further state that all scheduled variations in the sales load will be disclosed in the prospectus of each Series and applied uniformly to all investors, and that applicants will comply with all the conditions set forth in rule 22d-1.
4. Section 26(a)(2)(C) of the Act, in relevant part, prohibits a trustee or custodian of a UIT from collecting from the trust as an expense any payment to the trust's depositor or principal underwriter. Because the Trustee's payment of the DSC to the Depositor may be deemed to be an expense under section 26(a)(2)(C), applicants request relief under section 6(c) from section 26(a)(2)(C) to the extent necessary to permit the Trustee to collect Installment Payments and disburse them to the Depositor. Applicants submit that the relief is appropriate because the DSC is more properly characterized as a sales load.
1. Sections 11(a) and 11(c) of the Act prohibit any offer of exchange by a UIT for the securities of another investment company unless the terms of the offer have been approved in advance by the Commission. Applicants request an order under sections 11(a) and 11(c) for Commission approval of the Exchange Option and the Rollover Option.
1. Section 14(a) of the Act requires that a registered investment company have $100,000 of net worth prior to making a public offering. Applicants state that each Series will comply with this requirement because the Depositor will deposit more than $100,000 of securities. Applicants assert, however, that the Commission has interpreted section 14(a) as requiring that the initial capital investment in an investment company be made without any intention to dispose of the investment. Applicants state that, under this interpretation, a Series would not satisfy section 14(a) because of the Depositor's intention to sell all the Units of the Series.
2. Rule 14a-3 under the Act exempts UITs from section 14(a) if certain conditions are met, one of which is that the UIT invest only in “eligible trust securities,” as defined in the rule. Applicants state that they may not rely on rule 14a-3 because certain Series (collectively, “Structured Series”) will invest all or a portion of their assets in equity securities, certain debt securities, shares of registered investment companies, Flexible Exchange® Options (“FLEX Options”),
3. Applicants request an exemption under section 6(c) of the Act to the extent necessary to exempt the Structured Series from the net worth requirement in section 14(a). Applicants state that the Series and the Depositor will comply in all respects with the requirements of rule 14a-3, except that the Structured Series will not restrict their portfolio investments to “eligible trust securities.”
1. Section 19(b) of the Act and rule 19b-1 under the Act provide that, except under limited circumstances, no registered investment company may distribute long-term gains more than once every twelve months. Rule 19b-1(c), under certain circumstances, exempts a UIT investing in eligible trust securities (as defined in rule 14a-3) from the requirements of rule 19b-1. Because the Structured Series do not limit their investments to eligible trust securities, however, the Structured Series will not qualify for the exemption in paragraph (c) of rule 19b-1. Applicants therefore request an exemption under section 6(c) from section 19(b) and rule 19b-1 to the extent necessary to permit capital gains earned in connection with the sale of portfolio securities to be distributed to Unitholders along with the Structured Series' regular distributions. In all other respects, applicants will comply with section 19(b) and rule 19b-1.
2. Applicants state that their proposal meets the standards of section 6(c). Applicants assert that any sale of portfolio securities would be triggered by the need to meet Trust expenses, Installment Payments, or by redemption requests, events over which the Depositor and the Structured Series do not have control. Applicants further state that, because principal distributions must be clearly indicated in accompanying reports to Unitholders as a return of principal and will be relatively small in comparison to normal dividend distributions, there is little danger of confusion from failure to differentiate among distributions.
Applicants agree that any order granting the requested relief will be subject to the following conditions:
1. Whenever the Exchange Option or Rollover Option is to be terminated or its terms are to be amended materially, any holder of a security subject to that privilege will be given prominent notice of the impending termination or amendment at least 60 days prior to the date of termination or the effective date of the amendment, provided that: (a) No such notice need be given if the only material effect of an amendment is to reduce or eliminate the sales charge payable at the time of an exchange, to add one or more new Series eligible for the Exchange Option or the Rollover Option, or to delete a Series which has terminated; and (b) no notice need be given if, under extraordinary circumstances, either (i) there is a suspension of the redemption of Units of the Series under section 22(e) of the Act and the rules and regulations promulgated thereunder, or (ii) a Series temporarily delays or ceases the sale of its Units because it is unable to invest amounts effectively in accordance with
2. An investor who purchases Units under the Exchange Option or Rollover Option will pay a lower sales charge than that which would be paid for the Units by a new investor.
3. The prospectus of each Series offering exchanges or rollovers and any sales literature or advertising that mentions the existence of the Exchange Option or Rollover Option will disclose that the Exchange Option and the Rollover Option are subject to modification, termination or suspension without notice, except in certain limited cases.
4. Any DSC imposed on a Series' Units will comply with the requirements of subparagraphs (1), (2) and (3) of rule 6c-10(a) under the Act.
5. Each Series offering Units subject to a DSC will include in its prospectus the disclosure required by Form N-1A relating to deferred sales charges (modified as appropriate to reflect the differences between UITs and open-end management investment companies) and a schedule setting forth the number and date of each Installment Payment.
Applicants will comply in all respects with the requirements of rule 14a-3 under the Act, except that the Structured Series will not restrict their portfolio investments to “eligible trust securities.”
For the Commission, by the Division of Investment Management, under delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend Rule 4120 (Limit Up-Limit Down Plan and Trading Halts)
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The purpose of this proposal is to amend Rule 4120 (Limit Up-Limit Down Plan and Trading Halts) to reduce the length of the Display-Only Period for the initial pricing on Nasdaq of a security that is the subject of an IPO from 15 minutes to 10 minutes. In all other respects, the process for conducting the initial pricing of an IPO security will remain unchanged.
Initial pricing of an IPO security on Nasdaq occurs by means of the IPO Halt Cross provided for in Rule 4753. Prior to the IPO Halt Cross, trading in the security is halted, pursuant to Rule 4120(a)(7), until such time as the conditions in Rule 4120(c)(8) are satisfied and Nasdaq releases the security for trading. Market participants may enter orders in the security for participation in the IPO Halt Cross beginning at 4:00 a.m. As the scheduled time for the IPO Halt Cross approaches, the security enters a Display-Only Period during which indicative information about the potential outcome of the IPO Halt Cross is displayed to market participants and during which market participants may continue to enter orders.
After the conclusion of the Display-Only Period, the security enters a “Pre-Launch Period” of indeterminate duration, during which indicative information continues to be disseminated.
• Nasdaq receives notice from the underwriter of the IPO that the security is ready to trade. The Nasdaq system then calculates the Current Reference Price at that time (the “Expected Price”) and displays it to the underwriter. If the underwriter then approves proceeding, the Nasdaq system will conduct two pricing validation checks.
• First, the Nasdaq system must determine that all market orders will be executed in the IPO Halt Cross; and
• Second, if the actual price calculated by the IPO Halt Cross differs from the Expected Price by an amount in excess of a price band previously selected by the underwriter, the security will not be released for trading and the Pre-Launch Period will continue.
Based on feedback from underwriters participating in the IPO process, Nasdaq is proposing to reduce the time of the Display-Only Period from 15 minutes to 10 minutes. As discussed above, market participants may begin entering orders in an IPO security at 4:00 a.m., while the initial pricing of IPOs occurs no
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. In particular, the Exchange believes that the change will enhance the competitiveness of its process for initial pricing of IPO securities without imposing any burdens on the ability of underwriters or other market participants to participate in that process.
No written comments were either solicited or received.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, the proposed rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is: (i) Necessary or appropriate in the public interest; (ii) for the protection of investors; or (iii) otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule change should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend a subsidy program, the Market Access and Routing Subsidy (“MARS”), for GEMX Members that provide certain order routing functionalities
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to amend the definition of Eligible Contracts to exclude options overlying NDX
By way of background, MARS pays a subsidy to GEMX Members that provide certain order routing functionalities to other GEMX Members and/or use such functionalities themselves. GEMX pays participating GEMX Members to subsidize their costs of providing routing services to route orders to GEMX. The Exchange believes that MARS will attract higher volumes of equity and ETF options volume to the Exchange from non-GEMX market participants as well as GEMX Members.
To qualify for MARS, a GEMX Member's order routing functionality would be required to meet certain criteria. Specifically the Member's routing system (hereinafter “System”) would be required to: (1) Enable the electronic routing of orders to all of the U.S. options exchanges, including GEMX; (2) provide current consolidated market data from the U.S. options exchanges; and (3) be capable of interfacing with GEMX's API to access current GEMX match engine functionality. The Member's System would also need to cause GEMX to be one of the top four default destination exchanges for (a) individually executed marketable orders if GEMX is at the national best bid or offer (“NBBO”), regardless of size or time or (b) orders that establish a new NBBO on GEMX's Order Book, but allow any user to manually override GEMX as the default destination on an order-by-order basis. Any GEMX Member may apply for MARS, provided the above-referenced requirements are met, including a robust and reliable System.
A MARS Payment is paid to GEMX Members that have System Eligibility and have routed the requisite number of Eligible Contracts daily in a month, which were executed on GEMX. For the purpose of qualifying for the MARS Payment, Eligible Contracts include Non-Nasdaq GEMX Market Maker (FARMM),
GEMX Members that have System Eligibility and have executed the requisite number of Eligible Contracts in a month are paid the following per contract rebates:
The specified MARS Payment is paid on all executed Eligible Contracts that add liquidity, which are routed to GEMX through a participating GEMX Member's System and meet the requisite Eligible Contracts ADV. No payment will be made with respect to orders that are routed to GEMX, but not executed.
The Exchange proposes to exclude options overlying NDX from Eligible Contracts for purposes of qualifying for a MARS Payment. Only Eligible Contracts are paid rebates, therefore no MARS Payment would be paid on options overlying NDX.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Exchange's proposal to exclude options overlying NDX from MARS Eligible Contracts is reasonable because the Exchange believes that despite the exclusion of NDX, the MARS program will continue to attract higher volumes of equity and ETF options volume to the Exchange, which will benefit all GEMX Members by offering greater price discovery, increased transparency, and an increased opportunity to trade on the Exchange.
The Exchange's proposal to exclude options overlying NDX from MARS Eligible Contracts is equitable and not unfairly discriminatory because any qualifying GEMX Member that offers market access and connectivity to the Exchange and/or utilizes such functionality themselves may earn the MARS Payment for all Eligible Contracts, excluding NDX. The Exchange would not pay any MARS Payment on options overlying NDX because options overlying NDX will uniformly be excluded from the volume calculation for all qualifying GEMX Members for MARS. Further, MARS Payments are only made on Eligible Contracts so no GEMX Member would be paid a MARS rebate on options overlying NDX.
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. In terms of inter-market competition, the Exchange notes that it operates in a highly competitive market in which market participants can readily favor competing venues if they deem fee levels at a particular venue to be excessive, or rebate opportunities available at other venues to be more favorable. In such an environment, the Exchange must continually adjust its fees to remain competitive with other exchanges and with alternative trading systems that have been exempted from compliance with the statutory standards applicable to exchanges. Because competitors are free to modify their own fees in response, and because market participants may readily adjust their order routing practices, the Exchange believes that the degree to which fee changes in this market may impose any burden on competition is extremely limited.
The Exchange believes that excluding option overlying NDX from the Eligible Contracts does not create an undue burden on intra-market competition because options overlying NDX will uniformly be excluded from the volume calculation for all qualifying GEMX Members for MARS. Further, MARS Payments are only made on Eligible Contracts so no GEMX Member would be paid a MARS rebate on options overlying NDX. The MARS Program should continue to generate increased order flow which should bring increased liquidity to the Exchange for the benefit of all market participants. To the extent the purpose of the proposed MARS program is achieved, all market participants should benefit from the improved market liquidity.
No written comments were either solicited or received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Act.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On August 30, 2017, the Municipal Securities Rulemaking Board (the “MSRB” or “Board”) filed with the Securities and Exchange Commission (the “SEC” or “Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Exchange Act” or “Act”)
The Commission received eleven comment letters on the proposed rule change.
As described more fully in the Notice of Filing and Amendment No.1, the MSRB stated that the purpose of the proposed rule change is to: Clarify the application of the CUSIP number requirements to dealers in private placements; apply the CUSIP number requirements to all municipal advisors advising on a competitive sale of municipal securities; provide an exception from the CUSIP number and depository eligibility requirements in certain circumstances; and make certain technical and non-substantive changes.
The MSRB stated that proposed rule change would amend Rule G-34(a)(i)(A) to delete the definition of “underwriter” from the rule text and would add a new definition of “underwriter” in new section (e), on definitions. New subsection (e)(vii) of Rule G-34 would cross reference the term “underwriter” to the same term as it is defined in Exchange Act Rule 15c2-12(f)(8).
The MSRB stated that paragraph (a)(i)(A) of Rule G-34 would be amended to apply the CUSIP number requirements to all municipal advisors (whether dealers or non-dealers) advising on a competitive sale of a new issue of municipal securities.
The proposed rule change would amend subparagraph (a)(i)(A)(3) of Rule G-34 which clarifies the timeframe within which municipal advisors
The proposed rule change, as modified by Amendment No. 1, would amend Rule G-34(a)(i) to add paragraph (F), to add an exception from the CUSIP number requirement for situations where municipal securities are purchased directly by a bank,
The proposed rule change would clarify that the depository eligibility requirements of Rule G-34(a)(ii)(A) do not apply in the case of an exemption under Rule G-34(d), which exempts securities that are ineligible for CUSIP number assignment and municipal fund securities.
The MSRB stated that the proposed rule change also would make technical and non-substantive amendments as follows:
• The proposed rule change would move definitions that apply generally throughout the rule into a new section (e) on definitions, and, as noted above, would add a new definition of “underwriter” in subsection (e)(vii). The terms moved into the new section (e) would be (i) auction agent; (ii) auction rate security; (iii) notification period; (iv) program dealer; (v) remarketing agent; (vi) SHORT system; (vii) underwriter; and (viii) variable rate demand obligation.
• The proposed rule change would amend the rule to make more specific references to the provision that describes information necessary for CUSIP number assignments. Currently, the rule refers throughout to paragraph (a)(i)(A). The proposed rule change would amend these references to refer to subparagraph (a)(i)(A)(4). Similarly, references in the rule to the enumerated items to be included in a CUSIP number application would be changed from “(1) through (8)” to “(a) through (h).”
• The proposed rule change would change capitalized defined terms to lower case, as appropriate throughout the rule, and would amend references to sections, subsections, paragraphs and subparagraphs, as necessary, to be consistent with other MSRB rule formatting.
The MSRB requested that the proposed rule change be effective six months from the date of Commission approval and is requesting accelerated approval of Amendment No. 1.
As noted previously, the Commission received eleven comment letters in response to the Notice of Filing and two comment letters in response to Amendment No. 1. The MSRB responded to the comment letters on the Notice of Filing in its November Response Letter,
In response to the Notice of Filing, six commenters opposed requiring municipal advisors in competitive sales to apply for CUSIP numbers, and instead suggested dealers, in all instances, should bear the responsibility of obtaining a CUSIP number for new issue municipal securities.
The MSRB stated that the policy reason for initially adopting a requirement for financial advisors to apply for CUSIP numbers in competitive sales of new issue municipal securities was meant to provide for assignment of a CUSIP number prior to the award date of the sale.
The MSRB stated that while it appreciates commenters' views that the dealer, in all instances, should be required to apply for the CUSIP number, it believes this arrangement could have unintended results in the market.
In response to the Notice of Filing, commenters noted their concern about the proposed requirement that a municipal advisor relying on the principles-based exception in a competitive transaction must have a reasonable belief as to the purchaser's present intent. These commenters indicated that when a municipal advisor interacts with investors, for example, to obtain their present intent, the municipal advisor may be viewed as engaging in broker-dealer activity.
The MSRB stated that it appreciates the commenters concerns and understands that determining whether an activity may be deemed broker-dealer in nature is a facts and circumstances analysis that must be closely considered.
In response to the Notice of Filing, several commenters indicated that the principles-based exception in the original proposed rule change did not accurately reflect the fundamental workings of the direct purchase market.
In response to the Notice of Filing, one commenter suggested that more clarity should be provided as to the documentation underwriters and municipal advisors may be required to produce during an examination and that sufficient documentation to reach the “reasonable belief” should include any reasonable indicia of an investor's present intent.
In response to Amendment No. 1 and the November Response Letter, SIFMA reiterated its concerns about the proposed rule change, as modified by Amendment No.1, particularly the scope of the proposed principles-based exception in the proposed rule change as so modified, and urged the SEC to institute disapproval proceedings.
The MSRB stated that it addressed most of SIFMA's concerns about the proposed principles-based exception in the November Response Letter and Amendment No. 1.
In the First SIFMA Letter, SIFMA stated that the proposed language in the principles-based exception was “unduly restrictive” because “[f]or a bond maturing in 20 or 30 years, it is typical to include a call or mandatory tender date at 5 to 10 years to permit a refinancing or other restructuring.”
The MSRB noted that the principles-based exception requires that the dealer or municipal advisor reach a reasonable belief as to the purchaser's present intent regarding holding the municipal securities in question.
In response to the Notice of Filing, several commenters stated that the principles-based exception from the CUSIP number requirements should be expanded to include private placements of municipal securities with other municipal entities, including state revolving funds.
The MSRB stated that, in consideration of comments received from commenters, it amended the proposed rule change, in Amendment No. 1, to expand the principles-based exception to include issuances of municipal securities purchased by a municipal entity with funds that are, at least in part, from the proceeds of, or used to fully or partially secure or pay, the purchasing entity's issue of municipal obligations, such as in the case of a state revolving fund or bond bank.
The MSRB stated that it believes a dealer (or municipal advisor in a competitive sale) should apply for a CUSIP number in sales of municipal securities between municipal entities, other than in the scenarios discussed above.
In response to the Notice of Filing, one commenter suggested that the proposed rule change be amended to permit the use of “appropriate open-standard identifiers.”
In response to the Notice of Filing, one commenter suggested that the SEC should require issuers of municipal securities to be identified by a legal entity identifier (“LEI”) as part of the proposed rule change.
In response to the Notice of Amendment No. 1, the ABA stated that it maintains its support for the exception to the proposed rule requirement to obtain CUSIP numbers for dealers and municipal advisors in private placements of municipal obligations to a single bank, its affiliates (other than a registered broker-dealer), or a consortium of such entities if the intent of the purchasing entity or entities is to hold the municipal obligation until maturity.
The Commission has carefully considered the proposed rule change, the comment letters received, the MSRB Response Letters, and Amendment No. 1. The Commission finds that the proposed rule change, as modified by Amendment No. 1, is consistent with the requirements of the Act and the rules and regulations thereunder applicable to the MSRB.
In particular, the proposed rule change, as modified by Amendment No. 1, is consistent with Section 15B(b)(2)(C) of the Act.
The Commission believes that the proposed rule change, as modified by Amendment No. 1, is consistent with the provisions of Section 15B(b)(2)(C)
In approving the proposed rule change, as modified by Amendment No. 1, the Commission also has considered the impact of the proposed rule change, as modified by Amendment No. 1, on efficiency, competition, and capital formation.
As noted above, the Commission received eleven comment letters on the Notice of Filing and two comment letters on Amendment No. 1. The Commission believes that the MSRB, through its responses and through Amendment No. 1, has addressed commenters' concerns.
For the reasons noted above, the Commission believes that the proposed rule change, as modified by Amendment No. 1, is consistent with the Act.
The Commission finds good cause for approving the proposed rule change, as modified by Amendment No. 1, prior to the 30th day after the date of publication of the Notice of Amendment No. 1 in the
The MSRB stated that the only substantive change made by Amendment No. 1 to the proposed rule change is responsive to commenters and that Amendment No. 1 expands the application of the previously proposed principles-based exception to include sales of new issue municipal securities to municipal entities that are purchasing the underlying municipal securities with funds that are at least in part proceeds of the purchasing entity's issue of municipal obligations, or the municipal securities being purchased are used to fully or partially secure or pay the purchasing entity's issue of municipal obligations.
For the foregoing reasons, the Commission finds good cause for approving the proposed rule change, as modified by Amendment No. 1, on an accelerated basis, pursuant to Section 19(b)(2) of the Act.
For the Commission, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend Rule 701, entitled “Openings,” to specify the obligations of a Primary Market Maker (“PMM”) when entering Valid Width Quotes
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The
The Exchange is proposing to amend Rule 701, Openings, to amend the obligations of a PMM when entering Valid Width Quotes during the Opening Process. In addition, the Exchange proposes to make clear the obligations of a PMM and a Competitive Market Maker (“CMM”) once an options series has opened.
Currently, Rule 701(c)(1) provides, the Opening Process for an option series will be conducted pursuant to paragraphs (f)-(j) of GEMX Rule 701 on or after 9:30 a.m. Eastern Time if: The ABBO, if any, is not crossed; and the system has received, within two minutes (or such shorter time as determined by the Exchange and disseminated to membership on the Exchange's website) of the opening trade or quote on the market for the underlying security in the case of equity options or, in the case of index options, within two minutes of the receipt of the opening price in the underlying index (or such shorter time as determined by the Exchange and disseminated to membership on the Exchange's website), or within two minutes of market opening for the underlying security in the case of U.S. dollar-settled foreign currency options (or such shorter time as determined by the Exchange and disseminated to membership on the Exchange's website) any of the following: (i) The PMM's Valid Width Quote; (ii) the Valid Width Quotes of at least two CMM or (iii) if neither the PMM's Valid Width Quote nor the Valid Width Quotes of two CMMs have been submitted within such timeframe, one CMM has submitted a Valid Width Quote.
Thereafter, Rule 701(c)(3) specifies that the PMM assigned in a particular equity or index option must enter a Valid Width Quote, in 90% of their assigned series, not later than one minute following the dissemination of a quote or trade by the market for the underlying security or, in the case of index options, following the receipt of the opening price in the underlying index. The PMM assigned in a particular U.S. dollar-settled foreign currency option must enter a Valid Width Quote, in 90% of their assigned series, not later than one minute after the announced market opening. PMMs must promptly enter a Valid Width Quote in the remainder of their assigned series, which did not open within one minute following the dissemination of a quote or trade by the market for the underlying security or, in the case of index options, following the receipt of the opening price in the underlying index or, with respect to U.S. dollar-settled foreign currency options, following the announced market opening.
The Exchange proposes to make clear that a PMM has the obligations specified in GEMX Rule 701(c)(3) to promptly enter a Valid Width Quote in the remainder of their assigned series in cases where the PMM's assigned series was not already opened by a CMM as permitted by Rule 701(c)(1)(ii) and (iii) as noted herein. The PMM would continue to have the ultimate obligation to open each assigned series, however this rule change would not require the PMM to enter a Valid Width Quote for the 10% of their assigned series, not later than one minute following the dissemination of a quote or trade by the market for the underlying security or, in the case of index options, following the receipt of the opening price in the underlying index during the Opening Process if an options series has opened pursuant to Rule 701(c)(1)(ii) and (iii) within the timeframe specified for the PMM to enter a Valid Width Quote as noted in Rule 701(c)(3). Also, the PMM assigned in a particular U.S. dollar-settled foreign currency option would not be required to enter a Valid Width Quote for 10% of their assigned series, not later than one minute after the announced market opening during the Opening Process if an options series opened pursuant to Rule 701(c)(1)(ii) and (iii) within the timeframe specified for the PMM to enter a Valid Width Quote as noted in Rule 701(c)(3).
Today GEMX Rule 701 requires a PMM to open the market and provides an alternative mechanism to permit an alternative opening by a CMM.
The Exchange proposes to make clear that a PMM has an obligation to enter Valid Width Quotes during the Opening Process within the timeframes specified in Rule 701(c)(3). In the event that an options series opened pursuant to Rule 701(c)(1)(ii) and (iii), a PMM would be required to submit continuous, two-sided quotes in such options series pursuant to Supplementary Material .01 to Rule 804. Also, in this instance, a CMM would be required to submit continuous, two-sided quotes in such option series pursuant to Rule 804(e)(2)(iii). The Exchange notes that a CMM would not have an obligation to quote in such option series pursuant to Rule 804(e)(2)(iii), unless the CMM submitted a quote pursuant to Rule 701 or otherwise submitted a quote intra-day.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. Once an options series has opened, [sic] a PMM continues to be responsible to enter Valid Width Quotes during the Opening Process and thereafter submit continuous, two-sided quotes in such options series pursuant to Supplementary Material .01 to Rule 804. Also, if an options series opened pursuant to GEMX Rule 701(c)(1)(ii) or (iii), a CMM shall be required to submit continuous, two-sided quotes in such option series, once an option series has opened. pursuant to Rule 804(e)(2)(iii). This proposed rule text makes clear that CMMs are required to submit continuous, two-sided quotes in such option series pursuant to Rule 804(e)(2)(iii), in the event an options series opened pursuant to Rule 701(c)(1)(ii) and (iii). The proposal provides greater clarity to the Opening Process and also to the interplay between quoting obligations during the Opening Process and intra-day quoting obligations noted within Rule 804.
No written comments were either solicited or received.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A)(iii) of the Act
A proposed rule change filed under Rule 19b-4(f)(6) normally does not become operative prior to 30 days after the date of filing. However, Rule 19b-4(f)(6)(iii)
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
On June 13, 2017, the New York Stock Exchange LLC (“NYSE” or the “Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act” or “Exchange Act”)
The proposed rule change was published for comment in the
On August 16, 2017, the Exchange withdrew Amendment No. 1 and filed Amendment No. 2 to the proposed rule change, which superseded and replaced the proposed rule change in its entirety.
Section 19(b)(2) of the Act
The Commission finds that it is appropriate to designate a longer period within which to issue an order approving or disapproving the proposed rule change so that it has sufficient time to consider the proposed rule change, as modified by Amendment No. 3. Accordingly, the Commission, pursuant to Section 19(b)(2) of the Act,
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange filed proposed rule change to list and trade under BZX Rule 14.11(c)(3) the common shares of beneficial interest of the PowerShares Income Builder Portfolio (the “Fund”), a series of PowerShares Exchange-Traded Fund Trust II (the “Trust”). The common shares of beneficial interest of the Fund are referred to herein as the “Shares.”
The text of the proposed rule change is available at the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in Sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes to list and trade the Shares of the Fund under BZX Rule 14.11(c)(5),
Invesco PowerShares Capital Management LLC will be the investment adviser (the “Adviser”) to the Fund. Invesco Advisers, Inc. will be the investment sub-adviser (the “Sub-Adviser”) to the Fund.
As discussed in more detail below, the Fund's investment objective is to seek to track the investment results (before fees and expenses) of the Goldman Sachs Bond Buyers Equity Basket Index (the “Underlying Index”). The Underlying Index is designed to measure the performance of a hypothetical portfolio of common equity stocks with an overlay of fully-collateralized written put options on those stocks.
The Underlying Index was developed by Goldman, Sachs & Co. (“Goldman Sachs”). Solactive AG (the “Calculation Agent”) maintains, calculates, and publishes the value of the Underlying Index on each business day. The Calculation Agent is not registered as an investment adviser or broker-dealer and is not affiliated with any broker-dealers. The Calculation Agent has also implemented and will maintain procedures designed to prevent the use and dissemination of material, non-public information regarding the Underlying Index as required under Rule 14.11(c)(5)(A)(iii). None of the Trust, the Adviser, the Sub-Adviser, the Custodian or the Distributor is affiliated with Goldman Sachs, the Calculation Agent or their respective affiliates.
The Exchange is submitting this proposed rule change because the Underlying Index for the Fund does not meet the listing requirements of Rule 14.11(c)(5) applicable to an index that consists of both equity securities (and with respect to this underlying index, U.S. Component Stocks)
All statements and representations made in this filing regarding the Underlying Index composition, the description of the portfolio or reference assets, limitations on portfolio holdings or reference assets, dissemination and availability of the Underlying Index, reference asset, and intraday indicative values, and the applicability of
As noted above, the Underlying Index will consist of a mixture of (1) 100 U.S. exchange-listed common stocks of large capitalization that have listed options traded on a U.S. exchange (the “Stock Component”), (2) put options
Under normal market conditions,
The Underlying Index is composed of a Stock Component (represented by 100 U.S. exchange-listed common stocks of large capitalization that have listed options traded on a U.S. exchange), the Options Strategy, and Collateral (represented by Treasury bills) intended to fully-collateralize the Options Strategy. The selection of common stocks for the Stock Component, the selection of strike prices of the fully-collateralized put options for the Options Strategy, and the asset allocation between the Stock Component and Collateral are determined pursuant to the Underlying Index's methodology, as described more fully below.
According to the Registration Statement, the Underlying Index is designed to obtain yield from three sources: (1) The dividends and returns on the common stocks in the Stock Component, (2) the premiums received from the put options sold via the Options Strategy,
The constituents in the Stock Component are selected in accordance with Goldman Sachs' rules-based methodology, as described herein. The Underlying Index is designed to identify common stocks of companies with relatively low volatility, issued by companies with relatively strong financial conditions (as measured by a company's “free cash flow” (“FCF”)). Companies with high FCF have a lower probability of entering distress and/or higher probability of paying consistent dividends.
From an investible universe consisting of common stocks (which excludes American depositary receipts and ETFs) that have listed options traded on a U.S. stock exchange, the Underlying Index identifies the 800 largest stocks (based on the issuer's capitalization) and applies two screens: (1) The first screen eliminates the 25%
The Underlying Index calculates the following information for each remaining eligible security: (1) The security's latest available FCF yield
The Underlying Index then adjusts each remaining eligible stock's FCF yield based on its implied volatility by dividing each stock's actual FCF yield in FY0 and estimated FCF yield in FY1 by its implied volatility. The result produces two values for each eligible stock: A “volatility-adjusted” FCF yield for FY0 and a volatility-adjusted FCF yield for FY1. It then averages the two results from FY0 and FY1 to establish each security's “average volatility adjusted FCF yield.” The 100 stocks with the highest average FCF yield, after adjusting for volatility, are included in the Underlying Index, subject to minimum and maximum sector weighting requirements. Stocks with lower implied volatility receive greater weighting in the Underlying Index.
After establishing the Stock Component, the Underlying Index's methodology determines the Options Strategy. The Options Strategy writes or sells put options on the 100 stocks included in the Stock Component. Those put options are standardized options listed and traded on U.S. exchanges and will have terms of at least six but no more than 18 months as of each quarterly rebalance date (described below).
The strike price for each put option will be selected, in accordance with the Underlying Index's methodology, at an amount that will generate a premium that (when annualized) is as close as possible to the expected return of the underlying stock.
According to the Registration Statement, at any given time, depending on market conditions, the Underlying Index's assets are allocated between the Stock Component and the Collateral to generate income.
The Underlying Index is rebalanced quarterly in March, June, September and December, typically on the Friday before the third Saturday of the month (the “rebalance date”). The 100 common stocks to be included in the Stock
After investing at least 90% of its total assets in components of the Underlying Index, the Fund may invest up to 10% of its total assets in the following: (i) Exchange-traded U.S. equity securities not included in the Underlying Index, but which the Adviser or Sub-Adviser believes will help the Fund to track the Underlying Index;
The Fund will concentrate its investments (
The Fund may hold up to an aggregate amount of 15% of its net assets (calculated at the time of investment) in assets deemed illiquid by the Adviser or Sub-Adviser.
The Fund may loan the equity securities in its portfolio; however, the Fund will not loan its securities if, as a result, the aggregate amount of all outstanding securities loans by the Fund exceeds 33
The Fund intends to qualify for, and to elect to be treated as, a regulated investment company (“RIC”) under Subchapter M of the Internal Revenue Code of 1986, as amended.
The Fund's investments will be consistent with the Fund's investment objective. The Fund does not presently intend to engage in any form of borrowing for investment purposes, and will not be operated as a “leveraged ETF” or “inverse leveraged ETF,”
The Fund will issue and sell Shares only in large blocks of Shares (“Creation Units”) in transactions with Authorized Participants, as defined below. The Fund currently anticipates that a Creation Unit will consist of 50,000 Shares, though this number may change from time to time, including prior to the listing of the Fund. The exact number of Shares that will comprise a Creation Unit will be disclosed in the Fund's Registration Statement. The Trust will issue and sell Shares of the Fund in Creation Units on a continuous basis through the Distributor or its agent, without a sales load, at a price based on the Fund's net asset value (“NAV”) per Share next determined after receipt, on any business day.
To initiate an order for a Creation Unit, an Authorized Participant must submit to the Distributor or its agent an irrevocable order to purchase Shares of the Fund, in proper form, generally before 3:30 p.m., Eastern Time, on any business day to receive that day's NAV. On days when the Exchange closes earlier than normal, the Fund may require orders to be placed earlier in the day.
The consideration for a purchase of a Creation Unit of the Fund generally will consist of either (i) the in-kind deposit of a designated portfolio of securities (including any portion of such securities for which cash may be substituted) (“Deposit Securities”) and a corresponding “Cash Component” (defined below), computed as described below, or the cash value of the Deposit Securities (“Deposit Cash”) and the “Cash Component,” computed as described below.
Together, the Deposit Securities or Deposit Cash, as applicable, and the Cash Component constitute the “Fund Deposit,” which will be applicable (subject to possible amendment or correction) to creation requests received in proper form. The Fund Deposit represents the minimum initial and subsequent investment amount for a Creation Unit. The “Cash Component” represents the difference between the NAV of the Shares (per Creation Unit) and the market value of the Deposit Securities or Deposit Cash, as applicable. The Cash Component serves the function of compensating for any difference between the NAV per Creation Unit and the market value of the Deposit Securities or Deposit Cash, as applicable.
A portfolio composition file, to be sent via the NSCC, will be made available on each business day, prior to the opening of business of the Exchange (currently 9:30 a.m., Eastern Time), containing a list of the names and the required number of shares of each Deposit Security to be included in the current Fund Deposit (based on information at the end of the previous business day). In addition, on each business day, the estimated Cash Component, effective through and including the previous business day, will be made available through NSCC. Such Fund Deposit is applicable, subject to any adjustments,
Shares of the Fund may be redeemed only in Creation Units on a business day, and only by Authorized Participants at the NAV next determined after receipt of a redemption request in proper form by the Distributor or its agent. Unless cash redemptions are permitted or required for the Fund, the redemption proceeds for a Creation Unit generally will consist of a designated portfolio of securities (including any portion of such securities for which cash may be substituted) that will be applicable (subject to possible amendment or correction) to redemption requests received in proper form on that day (the “Fund Securities”), plus an amount of cash (the “Cash Amount”) equal to the difference between the NAV of the Shares being redeemed, as next determined after the receipt of a redemption request in proper form, and the value of Fund Securities, less any redemption transaction fees.
The Custodian will make available through the NSCC, prior to the opening of business on the Exchange on each business day, the Fund Securities and corresponding Cash Amount (each being subject to possible amendment or correction) that will be applicable to redemptions requests received in proper form on that day. The Fund reserves the right to honor a redemption request by delivering a basket of securities or cash that differs from the Fund Securities.
Orders to redeem Creation Units of the Fund must be delivered through a DTC Participant that has executed the Participant Agreement with the Distributor. A DTC Participant who wishes to place an order for redemption of Creation Units of the Fund to be effected need not be a Participating Party, but such orders must state that redemption of Creation Units of the Fund will instead be effected through transfer of Creation Units of the Fund directly through DTC. An order to redeem Creation Units of a Fund is deemed received by the Distributor on the transmittal date if (i) such order is received not later than 3:30 p.m. Eastern Time on such transmittal date; (ii) such order is preceded or accompanied by the requisite number of Shares of
After the Distributor has deemed an order for redemption received, the Distributor will initiate procedures to transfer the requisite Fund Securities which are expected to be delivered within two business days and the Cash Amount to the redeeming beneficial owner by the second business day following the transmittal date on which such redemption order is deemed received.
The right of redemption may be suspended or the date of payment postponed with respect to the Fund: (i) For any period during which the Exchange is closed (other than customary weekend and holiday closings); (ii) for any period during which trading on the Exchange is suspended or restricted; (iii) for any period during which an emergency exists as a result of which disposal of the shares of the Fund's portfolio securities or determination of its NAV is not reasonably practicable; or (iv) in such other circumstance as is permitted by the Commission.
The Trust's website (
On each business day, before commencement of trading in Shares during the Regular Trading Hours
In addition, for the Fund, an estimated value, defined in BZX Rule 14.11(c)(6)(A) as the “Intraday Indicative Value,” that reflects an estimated intraday value of the Fund's portfolio, will be disseminated. Moreover, the Intraday Indicative Value will be based upon the current value for the components of the Disclosed Portfolio and will be updated and widely disseminated by one or more major market data vendors and broadly displayed at least every 15 seconds during the Exchange's Regular Trading Hours.
The dissemination of the Intraday Indicative Value, together with the Disclosed Portfolio, will allow investors to determine the value of the underlying portfolio of the Fund on a daily basis and will provide a close estimate of that value throughout Regular Trading Hours.
Intraday, closing, and settlement prices of common stocks and other exchange-listed instruments will be readily available from the exchanges trading such securities as well as automated quotation systems, published or other public sources, or online information services such as Bloomberg or Reuters. In addition, price information for U.S. exchange-traded options will be available from the Options Price Reporting Authority. Quotation information from brokers and dealers or pricing services will be available for U.S. government obligations, high quality securities issued or guaranteed by the U.S. government (in addition to Treasury bills) and non-U.S. governments, and each of their agencies and instrumentalities, money market instruments, convertible securities, structured notes, and OTC options.
Information regarding market price and trading volume of the Shares will be continually available on a real-time basis throughout the day on brokers' computer screens and other electronic services. Information regarding the previous day's closing price and trading volume for the Shares will be published daily in the financial section of newspapers. Quotation and last sale information for the Shares will be on the facilities of the CTA.
The Shares of the Fund will conform to the initial and continued listing criteria under BZX Rule 14.11(c), other than the portion of the Fund that consists of options. The Exchange represents that, for initial and/or continued listing, the Fund and the Trust must be in compliance with Rule 10A-3
With respect to trading halts, the Exchange may consider all relevant factors in exercising its discretion to halt or suspend trading in the Shares of the Fund. The Exchange will halt trading in the Shares under the conditions specified in BZX Rule 11.18. Trading may be halted because of market conditions or for reasons that, in the view of the Exchange, make trading in the Shares inadvisable. These may include: (1) The extent to which trading is not occurring in the securities and/or the financial instruments constituting the Disclosed Portfolio of the Fund; or (2) whether other unusual conditions or circumstances detrimental to the maintenance of a fair and orderly market are present. Trading in the Shares also will be subject to Rule 14.11(c)(1)(B)(iv), which sets forth circumstances under which Shares of the Fund may be halted. Further, trading in the Shares will be halted if an interruption to the dissemination of either of the Intraday Indicative Value or the value of the Underlying Index persists past the trading day in which it occurred.
The Exchange deems the Shares to be equity securities, thus rendering trading in the Shares subject to the Exchange's existing rules governing the trading of equity securities. The Exchange will allow trading in the Shares from 8:00 a.m. until 5:00 p.m. Eastern Time and has appropriate rules to facilitate transactions in the Shares during all trading sessions. As provided in BZX Rule 11.11(a), the minimum price variation for quoting and entry of orders in securities traded on the Exchange is $0.01, with the exception of securities that are priced less than $1.00, for which the minimum price variation for order entry is $0.0001.
The Exchange believes that its surveillance procedures are adequate to properly monitor the trading of the Shares on the Exchange during all trading sessions and to deter and detect violations of Exchange rules and the applicable federal securities laws. Trading of the Shares through the Exchange will be subject to the Exchange's surveillance procedures for derivative products, including Index Fund Shares. The issuer has represented to the Exchange that it will advise the Exchange of any failure by the Fund to comply with the continued listing requirements, and, pursuant to its obligations under Section 19(g)(1) of the Act, the Exchange will surveil for compliance with the continued listing requirements. If the Fund is not in compliance with the applicable listing requirements, the Exchange will commence delisting procedures under BZX Rule 14.12. All exchange-listed options and equities (including certain investment company securities such as ETFs) held by the Fund will be traded on U.S. exchanges, all of which are members of ISG or are exchanges with which the Exchange has in place a comprehensive surveillance sharing agreement. The Exchange may obtain information regarding trading in the Shares and other exchange-traded securities and instruments held by the Fund via the ISG, from other exchanges that are members or affiliates of the ISG, or with which the Exchange has entered into a comprehensive surveillance sharing agreement.
Prior to the commencement of trading, the Exchange will inform its members in an Information Circular of the special characteristics and risks associated with trading the Shares. Specifically, the Information Circular will discuss the following: (1) The procedures for purchases and redemptions of Shares in Creation Units (and that Shares are not individually redeemable); (2) BZX Rule 3.7, which imposes suitability obligations on Exchange members with respect to recommending transactions in the Shares to customers; (3) how information regarding the Intraday Indicative Value and the Underlying Index is disseminated; (4) the risks involved in trading the Shares during the Pre-Opening
In addition, the Information Circular will advise members, prior to the commencement of trading, of the prospectus delivery requirements applicable to the Fund. Members purchasing Shares from the Fund for resale to investors will deliver a prospectus to such investors. The Information Circular will also discuss any exemptive, no-action and interpretive relief granted by the Commission from any rules under the Act.
In addition, the Information Circular will reference that the Fund is subject to various fees and expenses described in the Registration Statement. The Information Circular will also disclose the trading hours of the Shares of the Fund and the applicable NAV calculation time for the Shares. The Information Circular will disclose that information about the Shares of the Fund will be publicly available on the Fund's website. In addition, the Information Circular will reference that the Fund is subject to various fees and expenses described in the Fund's Registration Statement.
The Exchange believes that the proposed rule change is designed to prevent fraudulent and manipulative acts and practices in that the Shares will be listed and traded on the Exchange pursuant to the listing criteria in BZX Rule 14.11(c), except that the Underlying Index will consist in part of written put options, which are based on U.S. Component Stocks, rather than completely on U.S. Component Stocks themselves. The Exchange believes that its surveillances, which generally focus on detecting securities trading outside of their normal patterns which could be indicative of manipulative or other
The Calculation Agent has implemented and will maintain procedures designed to prevent the use and dissemination of material, non-public information regarding the Underlying Index. The Adviser and the Sub-Adviser are affiliated with a broker-dealer and have implemented, and will maintain, a fire wall with respect to its broker-dealer affiliate regarding access to information concerning the composition and/or changes to the Fund's portfolio.
Under normal market conditions, not less than 90% of the Fund's total assets will be comprised of common stocks, put options, and Treasury bills (serving as collateral for written put options), although the Fund may also invest in other U.S. government and money market instruments. The Fund may hold up to an aggregate amount of 15% of its net assets in illiquid assets (calculated at the time of investment), consistent with Commission guidance. The Fund will not use derivative instruments to enhance leverage.
The proposed rule change is designed to promote just and equitable principles of trade and to protect investors and the public interest in that a large amount of information will be publicly available regarding the Fund and the Shares, thereby promoting market transparency. The Fund's portfolio holdings will be disclosed on the Fund's website daily after the close of trading on the Exchange and prior to the opening of trading on the Exchange the following day.
Moreover, the Intraday Indicative Value will be widely disseminated by one or more major market data vendors at least every 15 seconds during Regular Trading Hours. The current value of the Underlying Index will be calculated and disseminated at least once every 15 seconds during regular market session and will be available from major market data vendors, provided however, that with respect to the fixed income components of the index, such value will be calculated and disseminated at least once daily. Information regarding market price and trading volume of the Shares will be continually available on a real-time basis throughout the day on brokers' computer screens and other electronic services, and quotation and last sale information will be available via the CTA high-speed line. Quotation and last sale information for U.S. exchange-listed options contracts cleared by The Options Clearing Corporation will be available via the Options Price Reporting Authority. The intra-day, closing and settlement prices of exchange-traded portfolio assets, including investment companies, will be readily available from the securities exchanges trading such securities, as the case may be, automated quotation systems, published or other public sources, or online information services such as Bloomberg or Reuters. Such price information on other portfolio securities, including money market instruments, and other Fund assets traded in the OTC markets, is available from major broker-dealer firms or market data vendors, as well as from automated quotation systems, published or other public sources, or online information services.
The website for the Fund will include the prospectus for the Fund and additional data relating to NAV and other applicable quantitative information. Moreover, prior to the commencement of trading, the Exchange will inform its Members in an information circular of the special characteristics and risks associated with trading the Shares. If the Exchange becomes aware that the NAV is not being disseminated to all market participants at the same time, it will halt trading in the Shares until such time as the NAV is available to all market participants. With respect to trading halts, the Exchange may consider all relevant factors in exercising its discretion to halt or suspend trading in the Shares of the Fund. Trading also may be halted because of market conditions or for reasons that, in the view of the Exchange, make trading in the Shares inadvisable. These may include: (1) The extent to which trading is not occurring in the securities and/or the financial instruments composing the daily disclosed portfolio of the Fund; or (2) whether other unusual conditions or circumstances detrimental to the maintenance of a fair and orderly market are present. Trading in the Shares also will be subject to Rule 14.11(c)(1)(B)(iv), which sets forth circumstances under which Shares of the Fund may be halted. If the Intraday Indicative Value of the Fund or value of the Underlying Index are not being disseminated as required, the Exchange may halt trading during the day in which the interruption to the dissemination of the Intraday Indicative Value or index value occurs.
The proposed rule change is designed to perfect the mechanism of a free and open market and, in general, to protect investors and the public interest in that it will facilitate the listing and trading of an additional type of exchange-traded product that will enhance competition among market participants, to the benefit of investors and the marketplace. As noted above, the Exchange has in place surveillance procedures relating to trading in the Shares and may obtain information in the Shares and other exchange-traded securities and instruments held by the Fund via ISG, from other exchanges that are members of ISG, or with which the Exchange has entered into a comprehensive surveillance sharing agreement. In addition, investors will have ready access to information regarding the Intraday Indicative Value and quotation and last sale information for the Shares.
For the above reasons, the Exchange believes the proposed rule change is consistent with the requirements of Section 6(b)(5) of the Act.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange notes that the proposed rule change will facilitate the listing and trading of an additional type of exchange-traded product that will enhance competition among market participants, to the benefit of investors and the marketplace.
The Exchange has neither solicited nor received written comments on the proposed rule change.
Within 45 days of the date of publication of this notice in the
A. By order approve or disapprove the proposed rule change, or
B. institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposal is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
The Exchange proposes to amend Rule 300 (Trading Licenses). The proposed rule change is available on the Exchange's website at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
NYSE Rule 300(b) currently provides that, in each annual offering, up to 1,366 trading licenses for the following calendar year will be sold annually at a price per trading license to be established each year by the Exchange pursuant to a rule filing submitted to the Securities and Exchange Commission (“Commission”) and that the price per trading license will be published each year in the Exchange's price list.
The Exchange proposes to delete the phrase “each year” in the first and second sentences of Rule 300(b) and the phrase “established for that year by the Exchange pursuant to section (b) above” in Rule 300(b)(i).
The Exchange establishes its fees for trading licenses pursuant to separate proposed rule changes. The last time the Exchange amended its trading license fee was on July 1, 2016.
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act,
For the foregoing reasons, the Exchange believes that the proposal is consistent with the Exchange Act.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The proposed rule change is not designed to address any competitive issues but rather eliminate the requirement for a rule filing that would not change any fees and that could cause potential confusion that fees may be changing in a year when they are not.
No written comments were solicited or received with respect to the proposed rule change.
The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act
A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the Act
At any time within 60 days of the filing of such proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings under Section 19(b)(2)(B)
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend Rule 701, entitled “Openings,” to specify the obligations of a Primary Market Maker (“PMM”) when entering Valid Width Quotes
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange is proposing to amend Rule 701, Openings, to amend the obligations of a PMM when entering Valid Width Quotes during the Opening Process. In addition, the Exchange proposes to make clear the obligations of a PMM and a Competitive Market Maker (“CMM”) once an options series has opened.
Currently, Rule 701(c)(1) provides, the Opening Process for an option series will be conducted pursuant to paragraphs (f)-(j) of ISE Rule 701 on or after 9:30 a.m. Eastern Time if: The ABBO, if any, is not crossed; and the system has received, within two minutes (or such shorter time as determined by the Exchange and disseminated to membership on the Exchange's website) of the opening trade or quote on the market for the underlying security in the case of equity options or, in the case of index options, within two minutes of the receipt of the opening price in the underlying index (or such shorter time as determined by the Exchange and disseminated to membership on the Exchange's website), or within two minutes of market opening for the underlying security in the case of U.S. dollar-settled foreign currency options (or such shorter time as determined by the Exchange and disseminated to membership on the Exchange's website) any of the following: (i) The PMM's Valid Width Quote; (ii) the Valid Width Quotes of at least two CMM or (iii) if neither the PMM's Valid Width Quote nor the Valid Width Quotes of two CMMs have been submitted within such timeframe, one CMM has submitted a Valid Width Quote.
Thereafter, Rule 701(c)(3) specifies that the PMM assigned in a particular equity or index option must enter a Valid Width Quote, in 90% of their assigned series, not later than one minute following the dissemination of a quote or trade by the market for the underlying security or, in the case of index options, following the receipt of the opening price in the underlying index. The PMM assigned in a particular U.S. dollar-settled foreign currency option must enter a Valid Width Quote, in 90% of their assigned series, not later than one minute after the announced market opening. PMMs must promptly enter a Valid Width Quote in the remainder of their assigned series, which did not open within one minute following the dissemination of a quote or trade by the market for the underlying security or, in the case of index options, following the receipt of the opening price in the underlying index or, with respect to U.S. dollar-settled foreign currency options, following the announced market opening.
The Exchange proposes to make clear that a PMM has the obligations specified in ISE Rule 701(c)(3) to promptly enter a Valid Width Quote in the remainder of their assigned series in cases where the PMM's assigned series was not already opened by a CMM as permitted by Rule 701(c)(1)(ii) and (iii) as noted herein. The PMM would continue to have the ultimate obligation to open each assigned series, however this rule change would not require the PMM to enter a Valid Width Quote for the 10% of their assigned series, not later than one minute following the dissemination of a quote or trade by the market for the underlying security or, in the case of index options, following the receipt of the opening price in the underlying index during the Opening Process if an options series has opened pursuant to Rule 701(c)(1)(ii) and (iii) within the timeframe specified for the PMM to enter a Valid Width Quote as noted in Rule 701(c)(3). Also, the PMM assigned in a particular U.S. dollar-settled foreign currency option would not be required to enter a Valid Width Quote for 10% of their assigned series, not later than one minute after the announced market opening during the Opening Process if an options series opened pursuant to Rule 701(c)(1)(ii) and (iii) within the timeframe specified for the PMM to enter a Valid Width Quote as noted in Rule 701(c)(3).
Today ISE Rule 701 requires a PMM to open the market and provides an alternative mechanism to permit an alternative opening by a CMM.
The Exchange proposes to make clear that a PMM has an obligation to enter Valid Width Quotes during the Opening Process within the timeframes specified in Rule 701(c)(3). In the event that an options series opened pursuant to Rule 701(c)(1)(ii) and (iii), a PMM would be required to submit continuous, two-sided quotes in such options series pursuant to Supplementary Material .01 to Rule 804. Also, in this instance, a CMM would be required to submit continuous, two-sided quotes in such option series pursuant to Rule 804(e)(2)(iii). The Exchange notes that a CMM would not have an obligation to quote in such option series pursuant to Rule 804(e)(2)(iii), unless the CMM submitted a quote pursuant to Rule 701 or otherwise submitted a quote intra-day.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. Once an options series has opened, [sic] a PMM continues to be responsible to enter Valid Width Quotes during the Opening Process and thereafter submit continuous, two-sided quotes in such options series pursuant to Supplementary Material .01 to Rule 804. Also, if an options series opened pursuant to ISE Rule 701(c)(1)(ii) or (iii), a CMM shall be required to submit continuous, two-sided quotes in such option series, once an option series has opened. pursuant to Rule 804(e)(2)(iii). This proposed rule text makes clear that CMMs are required to submit continuous, two-sided quotes in such option series pursuant to Rule 804(e)(2)(iii), in the event an options series opened pursuant to Rule 701(c)(1)(ii) and (iii). The proposal provides greater clarity to the Opening Process and also to the interplay between quoting obligations during the Opening Process and intra-day quoting obligations noted within Rule 804.
No written comments were either solicited or received.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A)(iii) of the Act
A proposed rule change filed under Rule 19b-4(f)(6) normally does not become operative prior to 30 days after the date of filing. However, Rule 19b-4(f)(6)(iii)
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On October 11, 2017, NYSE Arca, Inc. (“Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
Section 19(b)(2) of the Act
The Commission finds that it is appropriate to designate a longer period within which to take action on the proposed rule change so that it has sufficient time to consider the proposed rule change. Accordingly, the Commission, pursuant to Section 19(b)(2) of the Act,
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend its Schedule of Fees to amend the calculation of the Member Order Routing Program.
While these amendments are effective upon filing, the Exchange has designated the proposed amendments to be operative on December 1, 2017.
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange operates the Member Order Routing Program (“MORP”),
Eligible MORP Electronic Access Members (EAMS) that execute a monthly average daily volume (ADV) in unsolicited Crossing Orders of 30,000 originating contract sides or more on their MORP designated sessions are eligible for increased Facilitation and Solicitation break-up rebates in addition to enhanced rebates for Unsolicited Crossing Orders. Break-up rebates, which are shown in the table below, apply instead of rebates described in Sections I, II, and III of the Schedule of Fees, and will be provided for contracts that are submitted to the Facilitation and Solicited Order Mechanisms that do not trade with their contra order except when those contracts trade against pre-existing orders and quotes on the Exchange's order books. The applicable fee for Crossing Orders is applied to any contracts for which a rebate is provided.
Facilitation and Solicitation Break-Up Rebates are as follows:
Currently, an EAM that is MORP eligible receives a rebate for all unsolicited Crossing Orders of $0.05 per originating contract side, provided that the member executes a minimum ADV in unsolicited Crossing Orders of 30,000 to 99,999 originating contract sides though their MORP designated sessions. If the member executed greater than 100,000 originating contract sides, the rebate for all unsolicited Crossing Orders is $0.07 per originating contract side.
With respect to the Facilitation and Solicitation Break-Up Rebate, any EAM that qualifies for the MORP rebate by executing an ADV of 30,000 originating contract sides or more on their MORP designated sessions is also eligible for increased Facilitation and Solicitation break-up rebates
This proposal would exclude options overlying NDX from the monthly ADV when calculating the originating contract side for unsolicited Crossing Orders executed by an eligible EAM on their MORP designated sessions. NDX would not be subject to unsolicited Crossing Orders rebates and Facilitation and Solicitation break-up rebates. NDX will continue to be subject to Section I Index Options pricing for simple orders and Non-Select pricing for complex orders.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Exchange's proposal to exclude options overlying NDX from the monthly ADV when calculating unsolicited Crossing Orders rebates and also from Facilitation and Solicitation break-up rebates is reasonable because the MORP will continue to be attractive to members that participate in the program.
The Exchange's proposal to exclude options overlying NDX from the monthly ADV when calculating unsolicited Crossing Orders rebates and also from Facilitation and Solicitation break-up rebates is equitable and not unfairly discriminatory because no Member would be eligible to include NDX in monthly ADV and receive MORP rebates. The Exchange would uniformly calculate tiers and pay rebates associated with MORP.
Any EAM that participates in the program will be provided the rebates on an equal and non-discriminatory basis based on the order flow executed on the Exchange.
In accordance with Section 6(b)(8) of the Act,
The Exchange operates in a highly competitive market in which market participants can readily direct their order flow to competing venues. In such an environment, the Exchange must continually review, and consider adjusting, its fees and rebates to remain competitive with other exchanges. For the reasons described above, the Exchange believes that the proposed fee changes reflect this competitive environment.
No written comments were either solicited or received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Act.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend Rule 1017, entitled “Openings in Options,” to specify the obligations of a Specialist when entering Valid Width Quotes
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange is proposing to amend Rule 1017, Openings in Options, to amend the obligations of a Specialist when entering Valid Width Quotes during the Opening Process. In addition, the Exchange proposes to make clear the obligations of a Specialist and a Phlx Electronic Market Maker once an options series has opened.
Currently, Rule 1017(d)(i) provides, the Opening Process for an option series will be conducted pursuant to paragraphs (f)-(k) of Phlx Rule 1017 below on or after 9:30 a.m. if: The ABBO, if any, is not crossed; and the system has received, within two minutes (or such shorter time as determined by the Exchange and disseminated to membership on the Exchange's website) of the opening trade or quote on the market for the underlying security in the case of equity options or, in the case of index options, within two minutes of the receipt of the opening price in the underlying index (or such shorter time as determined by the Exchange and disseminated to membership on the Exchange's website), or within two minutes of market opening for the underlying currency in the case of U.S. dollar-settled FCO (or such shorter time as determined by the Exchange and disseminated to membership on the Exchange's website) any of the following: (A) The Specialist's Valid Width Quote; (B) the Valid Width Quotes of at least two Phlx Electronic Market Makers other than the Specialist; or (C) if neither the Specialist's Valid Width Quote nor the Valid Width Quotes of two Phlx Electronic Market Makers have been submitted within such timeframe, one Phlx Electronic Market Maker has submitted a Valid Width Quote.
Thereafter, Rule 1017(d)(iii) specifies that the Specialist assigned in a particular equity or index option must enter a Valid Width Quote, in 90% of their assigned series, not later than one minute following the dissemination of a quote or trade by the market for the underlying security or, in the case of index options, following the receipt of the opening price in the underlying index. The Specialist assigned in a particular U.S. dollar-settled FCO must enter a Valid Width Quote, in 90% of their assigned series, not later than 30 seconds after the announced market opening. The Specialist must promptly enter a Valid Width Quote in the remainder of their assigned series, which did not open within one minute following the dissemination of a quote or trade by the market for the underlying security or, in the case of index options, following the receipt of the opening price in the underlying index or, with respect to a U.S. dollar-settled FCO, following the announced market opening.
The Exchange proposes to make clear that a Specialist has the obligations specified in Phlx Rule 1017(d)(iii) to promptly enter a Valid Width Quote in the remainder of their assigned series in cases where the Specialist's assigned series was not already opened by a Phlx Electronic Market Maker as permitted by Rule 1017(d)(i) as noted herein. The Specialist would continue to have the ultimate obligation to open each assigned series, however this rule change would not require the Specialist to enter a Valid Width Quote for the 10% of their assigned series, not later than one minute following the dissemination of a quote or trade by the market for the underlying security or, in the case of index options, following the receipt of the opening price in the underlying index during the Opening Process if a Phlx Electronic Market Maker entered an order pursuant to Rule 1017(d)(i)(B) and (C) within the timeframe specified for the Specialist to enter a Valid Width Quote as noted in Rule 1017(d)(iii). Also, the Specialist assigned in a particular U.S. dollar-settled FCO must enter a Valid Width Quote for 10% of their assigned series, not later than 3 [sic] seconds after the announced market opening during the Opening Process if a Phlx Electronic Market Makers entered [sic] an order pursuant to Rule 1017(d)(i)(B) and (C)
Today Phlx Rule 1017 requires a Specialist to open the market and provides an alternative mechanism to permit an alternative opening by a Phlx Electronic Market Maker.
Further, the Exchange proposes to add rule text to Rule 1017(d)(iv) to states that “A Phlx Electronic Market Maker other than a Specialist that submits a quote pursuant to Rule 1017 in any option series when the Specialist's quote has not been submitted shall be required, once an options series has opened, to submit continuous, two-sided quotes in such option series pursuant to Rule 1014(b)(ii)(D)(1).”
The Exchange proposes to make clear that a Specialist has an obligation to enter Valid Width Quotes during the Opening Process within the timeframes specified in Rule 1017(d)(iii). In the event that an options series opened pursuant to 1017(d)(i)(B) and (C), a Specialist would be required to submit continuous, two-sided quotes in such options series pursuant to Rule 1014(b)(ii)(D)(2). Also, in this instance, a Phlx Electronic Market would be required to submit continuous, two-sided quotes in such option series pursuant to Rule 1014(b)(ii)(D)(1). The purpose of this new rule text is to make clear the quoting obligations for both Specialists and Phlx Electronic Markets during the opening and the manner in which Rule 1701, relating to the Opening Process, and Rule 1014, relating to market maker quoting obligations, interact with each other.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. Once an options series has opened, [sic] a Specialist continues to be responsible to enter Valid Width Quotes during the Opening Process and thereafter submit continuous, two-sided quotes in such options series pursuant to 1014(b)(ii)(D)(2). Also, if an options series opened pursuant to Rule 1017(d)(i)(B) or (C), a Phlx Electronic Market Maker shall be required to submit continuous, two-sided quotes in such option series, once an option series has opened pursuant to 1014(b)(ii)(D)(1). This proposed rule text makes clear that Phlx Electronic Market Makers are required to submit continuous, two-sided quotes in such option series pursuant to 1014(b)(ii)(D)(1), in the event an options series opened pursuant to Rule 1017(d)(i)(B) or (C). The proposal provides greater clarity to the Opening Process and also to the interplay between quoting obligations during the Opening Process and intra-day quoting obligations noted within Rule 1014.
No written comments were either solicited or received.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A)(iii) of the Act
A proposed rule change filed under Rule 19b-4(f)(6) normally does not become operative prior to 30 days after the date of filing. However, Rule 19b-4(f)(6)(iii)
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend Rule 701, entitled “Openings,” to specify the obligations of a Primary Market Maker (“PMM”) when entering Valid Width Quotes
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange is proposing to amend Rule 701, Openings, to amend the obligations of a PMM when entering Valid Width Quotes during the Opening Process. In addition, the Exchange proposes to make clear the obligations of a PMM and a Competitive Market Maker (“CMM”) once an options series has opened.
Currently, Rule 701(c)(1) provides, the Opening Process for an option series will be conducted pursuant to paragraphs (f)-(j) of MRX Rule 701 on or after 9:30 a.m. Eastern Time if: the ABBO, if any, is not crossed; and the system has received, within two minutes (or such shorter time as determined by the Exchange and disseminated to membership on the Exchange's website) of the opening trade or quote on the market for the underlying security in the case of equity options or, in the case of index options,
Thereafter, Rule 701(c)(3) specifies that the PMM assigned in a particular equity or index option must enter a Valid Width Quote, in 90% of their assigned series, not later than one minute following the dissemination of a quote or trade by the market for the underlying security or, in the case of index options, following the receipt of the opening price in the underlying index. The PMM assigned in a particular U.S. dollar-settled foreign currency option must enter a Valid Width Quote, in 90% of their assigned series, not later than one minute after the announced market opening. PMMs must promptly enter a Valid Width Quote in the remainder of their assigned series, which did not open within one minute following the dissemination of a quote or trade by the market for the underlying security or, in the case of index options, following the receipt of the opening price in the underlying index or, with respect to U.S. dollar-settled foreign currency options, following the announced market opening.
The Exchange proposes to make clear that a PMM has the obligations specified in MRX Rule 701(c)(3) to promptly enter a Valid Width Quote in the remainder of their assigned series in cases where the PMM's assigned series was not already opened by a CMM as permitted by Rule 701(c)(1)(ii) and (iii) as noted herein. The PMM would continue to have the ultimate obligation to open each assigned series, however this rule change would not require the PMM to enter a Valid Width Quote for the 10% of their assigned series, not later than one minute following the dissemination of a quote or trade by the market for the underlying security or, in the case of index options, following the receipt of the opening price in the underlying index during the Opening Process if an options series has opened pursuant to Rule 701(c)(1)(ii) and (iii) within the timeframe specified for the PMM to enter a Valid Width Quote as noted in Rule 701(c)(3). Also, the PMM assigned in a particular U.S. dollar-settled foreign currency option would not be required to enter a Valid Width Quote for 10% of their assigned series, not later than one minute after the announced market opening during the Opening Process if an options series opened pursuant to Rule 701(c)(1)(ii) and (iii) within the timeframe specified for the PMM to enter a Valid Width Quote as noted in Rule 701(c)(3).
Today MRX Rule 701 requires a PMM to open the market and provides an alternative mechanism to permit an alternative opening by a CMM.
The Exchange proposes to make clear that a PMM has an obligation to enter Valid Width Quotes during the Opening Process within the timeframes specified in Rule 701(c)(3). In the event that an options series opened pursuant to Rule 701(c)(1)(ii) and (iii), a PMM would be required to submit continuous, two-sided quotes in such options series pursuant to Supplementary Material .01 to Rule 804. Also, in this instance, a CMM would be required to submit continuous, two-sided quotes in such option series pursuant to Rule 804(e)(2)(iii). The Exchange notes that a CMM would not have an obligation to quote in such option series pursuant to Rule 804(e)(2)(iii), unless the CMM submitted a quote pursuant to Rule 701 or otherwise submitted a quote intra-day.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. Once an options series has opened, [sic] a PMM continues to be responsible to enter Valid Width Quotes during the Opening Process and thereafter submit continuous, two-sided quotes in such options series pursuant to Supplementary Material .01 to Rule 804. Also, if an options series opened pursuant to MRX Rule 701(c)(1)(ii) or (iii), a CMM shall be required to submit continuous, two-sided quotes in such option series, once an option series has opened pursuant to Rule 804(e)(2)(iii). This proposed rule text makes clear that CMMs are required to submit continuous, two-sided quotes in such option series pursuant to Rule 804(e)(2)(iii), in the event an options series opened pursuant to Rule 701(c)(1)(ii) and (iii). The proposal provides greater clarity to the Opening Process and also to the interplay between quoting obligations during the Opening Process and intra-day quoting obligations noted within Rule 804.
No written comments were either solicited or received.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A)(iii) of the Act
A proposed rule change filed under Rule 19b-4(f)(6) normally does not become operative prior to 30 days after the date of filing. However, Rule 19b-4(f)(6)(iii)
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
Securities and Exchange Commission (“Commission”).
Notice.
Notice of an application for an order under section 12(d)(1)(J) of the Investment Company Act of 1940 (the “Act”) for an exemption from sections 12(d)(1)(A), (B), and (C) of the Act and under sections 6(c) and 17(b) of the Act for an exemption from sections 17(a)(1) and (2) of the Act. The requested order would permit certain registered open-end investment companies to acquire shares of certain registered open-end investment companies, registered closed-end investment companies, and business development companies, as defined in section 2(a)(48) of the Act (“BDCs”), and registered unit investment trusts (collectively, “Underlying Funds”) that are within and outside the same group of investment companies as the acquiring investment companies, in excess of the limits in section 12(d)(1) of the Act.
Consulting Group Capital Markets Funds, a Massachusetts business trust that is registered under the Act as an open-end management investment company with multiple series (the “Trust”) and Consulting Group Advisory Services LLC (the “Initial Adviser”), a Delaware limited liability company, registered as an investment adviser under the Investment Advisers Act of 1940.
The application was filed on June 1, 2017 and amended on September 22, 2017.
An order granting the requested relief will be issued unless the Commission orders a hearing. Interested persons may request a hearing by writing to the Commission's Secretary and serving applicants with a copy of the request, personally or by mail. Hearing requests should be received by the Commission by 5:30 p.m. on January 8, 2018, and should be accompanied by proof of service on the applicants, in the form of an affidavit, or, for lawyers, a certificate of service. Pursuant to Rule 0-5 under the Act, hearing requests should state the nature of the writer's interest, any facts bearing upon the desirability of a hearing on the matter, the reason for the request, and the issues contested. Persons who wish to be notified of a hearing may request notification by writing to the Commission's Secretary.
Secretary, U.S. Securities and Exchange Commission, 100 F Street, NE, Washington, DC 20549-1090. Applicants: c/o John J. O'Brien, Esq., Morgan, Lewis & Bockius LLP, 1701 Market Street, Philadelphia, PA 19103.
Laura J. Riegel, Senior Counsel, at (202) 551-3038, or Robert H. Shapiro, Branch Chief, at (202) 551-6821 (Division of Investment Management, Chief Counsel's Office).
The following is a summary of the application. The complete application may be obtained via the Commission's website by searching for the file number, or for an applicant using the Company name box, at
1. Applicants request an order to permit (a) a Fund
2. Certain Underlying Funds may invest up to 25% of their assets in a wholly-owned and controlled subsidiary of the Underlying Fund organized under the laws of the Cayman Islands as an exempted company or under the laws of another non-U.S. jurisdiction (each, a “Cayman Sub”), in order to invest in commodity-related instruments and certain other instruments. Applicants state that these Cayman Subs are created for tax purposes in order to ensure that the Underlying Fund would remain qualified as a regulated investment company for U.S. federal income tax purposes.
3. Applicants agree that any order granting the requested relief will be subject to the terms and conditions stated in the application. Such terms and conditions are designed to, among other things, help prevent any potential (i) undue influence over an Underlying Fund that is not in the same “group of investment companies” as the Fund of Funds through control or voting power, or in connection with certain services, transactions, and underwritings, (ii) excessive layering of fees, and (iii) overly complex fund structures, which are the concerns underlying the limits in sections 12(d)(1)(A), (B), and (C) of the Act.
4. Section 12(d)(1)(J) of the Act provides that the Commission may exempt any person, security, or transaction, or any class or classes of persons, securities, or transactions, from any provision of section 12(d)(1) if the exemption is consistent with the public interest and the protection of investors. Section 17(b) of the Act authorizes the Commission to grant an order permitting a transaction otherwise prohibited by section 17(a) if it finds that (a) the terms of the proposed transaction are fair and reasonable and do not involve overreaching on the part of any person concerned; (b) the proposed transaction is consistent with the policies of each registered investment company involved; and (c) the proposed transaction is consistent with the general purposes of the Act. Section 6(c) of the Act permits the Commission to exempt any persons or transactions from any provision of the Act if such exemption is necessary or appropriate in the public interest and consistent with the protection of investors and the purposes fairly intended by the policy and provisions of the Act.
For the Commission, by the Division of Investment Management, pursuant to delegated authority.
U.S. Small Business Administration.
Notice.
This is a notice of an Economic Injury Disaster Loan (EIDL) declaration for the State of Montana, dated 12/11/2017.
Issued on 12/11/2017.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
Notice is hereby given that as a result of the Administrator's EIDL declaration, applications for economic injury disaster loans may be filed at the address listed above or other locally announced locations. The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
Businesses and Small Agricultural Cooperatives without Credit Available Elsewhere.
Non-Profit Organizations without Credit Available Elsewhere.
The number assigned to this disaster for economic injury is 154060.
The States which received an EIDL Declaration # are Montana, Idaho.
Department of State.
Notice.
The Acting Assistant Secretary of State for Oceans and International Environmental and Scientific Affairs, acting pursuant to delegated authorities, issued a Presidential permit to the State of North Dakota on October 24, 2017, authorizing the State of North Dakota to construct, connect, operate, and maintain the existing POE border-crossing facilities at the U.S.-Canada border in Pembina County, North Dakota. In accordance with Executive Order 11432 (August 16, 1968) as amended, the Acting Assistant Secretary of State for Oceans and International Environmental and Scientific Affairs determined that issuance of this permit would serve the national interest.
Bryan Koontz, 202-647-3030,
Additional information concerning the Pembina-Emerson POE border crossing facilities and documents related to the Department of State's review of the application for a Presidential permit can be found at
By virtue of the authority vested in me as Acting Assistant Secretary of State for the Bureau of Oceans and International Environmental and Scientific Affairs, including those authorities under Executive Order 11423, 33 Fed. Reg. 11741 (1968); as amended by Executive Order 12847 of May 17, 1993, 58 Fed. Reg. 29511 (1993), Executive Order 13284 of January 23, 2003, 68 Fed. Reg. 4075 (2003), and Executive Order 13337 of April 30, 2004, 69 Fed. Reg. 25299 (2004); 25299 (2004); and Department of State Delegation of Authority 118-2 of January 26, 2006 and Delegation 415 of January 18, 2017; having considered the environmental effects of the proposed action consistent with the National Environmental Policy Act of 1969, as amended (83 Stat. 852, 42 U.S.C. 4321 et seq.), and other statutes relating to environmental concerns; having considered the proposed action consistent with the National Historic Preservation Act of 1966, as amended (80 Stat. 917, 16 U.S.C. 470f et seq.); and having requested and received the views of various of the federal departments and other interested persons; I hereby grant permission, subject to the conditions herein set forth, to the State of North Dakota (hereinafter referred to as “permittee”), to construct, connect, operate, and maintain the Pembina-Emerson Port of Entry (hereinafter referred to as the “POE”).
The term “facilities” as used in this permit means the port of entry, its approaches and any land, structures, or installations appurtenant thereto, including all structures as described in the May 2, 2016 for a Presidential permit (the “Application”) submitted by the permitee to the Department of State.
The term “U.S. facilities” as used in this permit means those parts of the facilities in the United States, as described in the Application.
This permit is subject to the following conditions:
(2) The construction, connection, operation, and maintenance of the facilities shall be in all material respects as described in the Application.
(2) The permittee shall hold harmless and indemnify the United States from any claimed or adjudged liability arising out of the construction, connection, operation or maintenance of the facilities.
(3) The permittee shall maintain the U.S. facilities and every part thereof in a condition of good repair for their safe operation, and in compliance with prevailing environmental standards and regulations.
IN WITNESS WHEREOF, I, Judith G. Garber, Acting Assistant Secretary for the Bureau of Oceans and International Environmental and Scientific Affairs, have hereunto set my hand this 24th day of October, 2017 in the City of Washington, District of Columbia.
Notice of request for public comment and submission to OMB of proposed collection of information.
The Department of State has submitted the information collection described below to the Office of Management and Budget (OMB) for approval. In accordance with the Paperwork Reduction Act of 1995 we are requesting comments on this collection from all interested individuals and organizations. The purpose of this Notice is to allow 30 days for public comment.
Submit comments directly to the Office of Management and Budget (OMB) up to January 19, 2018.
Direct comments to the Department of State Desk Officer in the Office of Information and Regulatory Affairs at the Office of Management and Budget (OMB). You may submit comments by the following methods:
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Direct requests for additional information regarding the collection listed in this notice, including requests for copies of the proposed collection instrument and supporting documents, to G. Kevin Saba, Director, Office of Policy and Program Support, Office of Private Sector Exchange, ECA/EC, SA-5, Floor 5, Department of State, 2200 C Street NW, Washington, DC 20522-0505, who may be reached on 202-632-3206 or at
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We are soliciting public comments to permit the Department to:
• Evaluate whether the proposed information collection is necessary for the proper functions of the Department.
• Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used.
• Enhance the quality, utility, and clarity of the information to be collected.
• Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.
Please note that comments submitted in response to this Notice are public record. Before including any detailed personal information, you should be aware that your comments as submitted, including your personal information, will be available for public review.
CSX Transportation, Inc. (CSXT) has filed a verified notice of exemption under 49 CFR pt. 1152 subpart F—
CSXT has certified that: (1) No local freight traffic has moved over the Line for at least two years; (2) because the Line is not a through line, no overhead traffic has operated, and, thus, none needs to be rerouted over other lines; (3) no formal complaint filed by a user of a rail service on the Line (or by a state or local government entity acting on behalf of such user) regarding cessation of service over the Line is either pending with the Surface Transportation Board (Board) or with any U.S. District Court or has been decided in favor of a complainant within the two-year period; and (4) the requirements at 49 CFR 1105.11 (transmittal letter), 49 CFR 1105.12 (newspaper publication), and 49 CFR
As a condition to this exemption, any employee adversely affected by the abandonment shall be protected under
Provided no formal expression of intent to file an offer of financial assistance (OFA) has been received, this exemption will be effective on January 19, 2018, unless stayed pending reconsideration. Petitions to stay that do not involve environmental issues,
A copy of any petition filed with the Board should be sent to Louis E. Gitomer, Law Offices of Louis E. Gitomer, LLC, 600 Baltimore Avenue, Suite 301, Towson, MD 21204.
If the verified notice contains false or misleading information, the exemption is void ab initio.
CSXT has filed a combined environmental and historic report that addresses the effects, if any, of the abandonment on the environment and historic resources. OEA will issue an environmental assessment (EA) by December 26, 2017. Interested persons may obtain a copy of the EA by writing to OEA (Room 1100, Surface Transportation Board, Washington, DC 20423-0001) or by calling OEA at (202) 245-0305. Assistance for the hearing impaired is available through the Federal Information Relay Service at (800) 877-8339. Comments on environmental and historic preservation matters must be filed within 15 days after the EA becomes available to the public.
Environmental, historic preservation, public use, or trail use/rail banking conditions will be imposed, where appropriate, in a subsequent decision.
Pursuant to the provisions of 49 CFR 1152.29(e)(2), CSXT shall file a notice of consummation with the Board to signify that it has exercised the authority granted and fully abandoned the Line.
If consummation has not been effected by CSXT's filing of a notice of consummation by December 20, 2018, and there are no legal or regulatory barriers to consummation, the authority to abandon will automatically expire.
Board decisions and notices are available on our website at
By the Board, Scott M. Zimmerman, Acting Director, Office of Proceedings.
Federal Aviation Administration (FAA), DOT.
Notice of Request to Release Deed Restrictions.
The FAA is considering a request from the State of Montana to release certain deed restrictions at the Yellowstone Airport, MT.
Comments must be received on or before January 19, 2018.
Comments on this application may be mailed or delivered to the FAA at the following address: Mr. William C. Garrison, Manager, Federal Aviation Administration, Northwest Mountain Region, Airports Division, Helena Airports District Office, 2725 Skyway Drive, Suite 2, Helena, Montana 59602.
In addition, one copy of any comments submitted to the FAA must be mailed or delivered to Ms. Debbie Alke, Administrator, Montana Department of Transportation Aeronautics Division, at the following address: Ms. Debbie Alke, Administrator, Aeronautics Division, Montana Department of Transportation, P.O. Box 200507, Helena, MT 59620-0507.
Mr. Steve Engebrecht, Civil Engineer/Compliance Specialist, Federal Aviation Administration, Northwest Mountain Region, Helena Airports District Office, 2725 Skyway Drive, Suite 2, Helena, Montana 59602.
The request to release deed restrictions may be reviewed, by appointment, in person at this same location.
The FAA invites public comment on the request to release deed restrictions at the Yellowstone Airport under the provisions of the Title 49, U.S.C. Section 47125.
The FAA Modernization and Reform Act of 2012, HR 658, Section 817, gave the Secretary of Transportation the authorization to grant an airport, city, or county release from any of the terms, conditions, reservations, or restrictions contained in a deed under which the United States conveyed to the airport, city, or county an interest in real property for airport purposes pursuant to Section 16 of the Federal Airport Act (60 Stat. 179) or Section 23 of the Airport and Airway Development Act of 1970 (84 Stat. 232).
Release of the deed restrictions at the Yellowstone Airport will allow the State of Montana the opportunity to consider additional revenue sources for maintaining and operating the airport.
On October 25, 2017, the FAA determined that the request to release deed restrictions at the Yellowstone Airport submitted by the Montana Department of Transportation meets the procedural requirements of the Federal Aviation Administration. The FAA may approve the request, in whole or in part, after January 19, 2018.
The following is a brief overview of the request:
The Montana Department of Transportation is proposing the release of deed restrictions at the Yellowstone Airport from a Correction Deed issued on August 12, 1968. On October 7, 1963, a deed containing restrictions transferred the airport property from the United States to the State of Montana. The airport was built in 1963 as a cooperative effort between the United States Departments of the Interior and Agriculture, the Federal Aviation Administration (FAA), and the State of Montana. A subsequent Correction Deed (correcting the legal description) issued
• Deed Restriction 1. “The State of Montana will use the lands herein conveyed for airport development.”: Requesting release of approximately 175 acres from this deed restriction in order to maintain financial viability by permitting possible development of these areas for non-airport development related purposes to generate new sources of income to operate and maintain the airport.
• Deed Restriction 6. “That all facilities of the airport developed with Federal aid and all those useable for landing and take-off of aircraft will be available at all times without charge for use by the Department of Agriculture and Interior in the conduct of its official business in common with other aircraft.”: Requesting release of all airport property from this deed restriction in order to maintain financial viability by being permitted to charge for substantial use by the Department of Agriculture and Department of Interior aircraft, in compliance with Grant Assurance 27.
• Deed Restriction 7. “That no commercial overnight facilities, such a motels, hotels, or private residences will be constructed on the property herein conveyed.”: Requesting release of approximately 65 acres from this deed restriction in order to maintain financial viability by permitting possible development of commercial overnight facilities and generate new sources of income to operate and maintain the airport. MDT understands that residential development is non-compliant with its federal grant assurances and has no intention of allowing private residences to be constructed on airport property.
• Deed Restriction 8. “That commercial advertising signs will be prohibited within the airport access road area.”: Requesting release of approximately 65 acres from this deed restriction in order to maintain financial viability by permitting possible development of commercial advertising signs within the airport access road area and generate new sources of income to operate and maintain the airport.
If the deed restrictions are released, prior to moving forward with any associated non-aeronautical development, MDT understands it will still be required to: Obtain a release from federal obligation to change the designated use of the property from aeronautical to non-aeronautical use, comply with National Environmental Policy Act (NEPA), and undergo an aeronautical study through the 7460-1 process.
Any person may inspect, by appointment, the request in person at the FAA office listed above under
In addition, any person may, upon appointment and request, inspect the request to release deed restrictions and other documents germane to the request in person at the Yellowstone Airport.
Office of the Comptroller of the Currency (OCC), Treasury.
Notice and request for comment.
The OCC, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other federal agencies to take this opportunity to comment on a continuing information collection as required by the Paperwork Reduction Act of 1995 (PRA).
In accordance with the requirements of the PRA, the OCC may not conduct or sponsor, and the respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number.
Currently, the OCC is soliciting comment concerning the renewal of an information collection titled “Debt Cancellation Contracts and Debt Suspension Agreements.” The OCC also is giving notice that it has sent the collection to OMB for review.
You should submit written comments by: January 19, 2018.
Because paper mail in the Washington, DC area and at the OCC is subject to delay, commenters are encouraged to submit comments by email, if possible. Comments may be sent to: Legislative and Regulatory Activities Division, Office of the Comptroller of the Currency, Attention: 1557-0224, 400 7th Street SW, Suite 3E-218, Washington, DC 20219. In addition, comments may be sent by fax to (571) 465-4326 or by electronic mail to
All comments received, including attachments and other supporting materials, are part of the public record and subject to public disclosure. Do not include any information in your comment or supporting materials that you consider confidential or inappropriate for public disclosure.
Additionally, please send a copy of your comments by mail to: OCC Desk Officer, 1557-0224, U.S. Office of Management and Budget, 725 17th Street NW, #10235, Washington, DC 20503 or by email to:
Shaquita Merritt, OCC Clearance Officer, (202) 649-5490 or, for persons who are deaf hearing impaired, TTY, (202) 649-5597, Legislative and Regulatory Activities Division, Office of the Comptroller of the Currency, 400 7th Street SW, Washington, DC 20219.
Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from OMB for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) to include agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. The OCC is requesting that OMB extend its approval of the following collection.
Section 37.6 requires the form of the disclosures to be readily understandable and meaningful. The content of the short and long form may vary, depending on whether a bank elects to provide a summary of the conditions and exclusions in the long form disclosures or refer the customer to the pertinent paragraphs in the contract. For example, the short form disclosure requires a bank to instruct the customer to read carefully both the long form disclosures and the contract for a full explanation of the contract terms, while the long form gives a bank the option of either: (i) Summarizing the limitations; or (ii) advising the customer that a complete explanation of the eligibility requirements, conditions, and exclusions is available in the contract and identifying the paragraphs where the customer may find that information.
Section 37.6 and appendices A and B to part 37 require a bank to provide the following disclosures (summarized below), as appropriate:
• Anti-tying (short and long form)—A bank must inform the customer that purchase of the product is optional and that neither the bank's decision whether to approve the loan nor the terms and conditions of the loan are conditioned on the purchase of a DCC or DSA.
• Explanation of debt suspension agreement (long form)—A bank must disclose that if a customer activates the agreement, the customer's duty to pay the loan principal and interest is only suspended and the customer must fully repay the loan after the period of suspension has expired.
• Amount of the fee (long form)—A bank must make disclosures regarding the amount of the fee. The content of the disclosure depends on whether the credit is open-end or closed-end. In the case of closed-end credit, the bank must disclose the total fee. In the case of open-end credit, the bank must either: (i) Disclose that the periodic fee is based on the account balance multiplied by a unit cost and provide the unit cost; or (ii) disclose the formula used to compute the fee.
• Lump sum payment of fee (short and long form)—A bank must disclose, where appropriate, that a customer has the option to pay the fee in a single payment or in periodic payments and adding the fee to the amount borrowed will increase the cost of the contract. This disclosure is not appropriate in the case of a DCC or DSA provided in connection with a home mortgage loan because the option to pay the fee in a single payment is not available in that case.
• Lump sum payment of fee with no refund (short and long form)—A bank must disclose that the customer has the option to choose a contract with or without a refund provision. This disclosure must also state that the prices of refund and no-refund products are likely to differ.
• Refund of fee paid in lump sum (short and long form)—If a bank permits a customer to pay the fee in a single payment and add the fee to the amount borrowed, the bank must disclose its cancellation policy. The disclosure informs the customer of the bank's refund policy, as applicable,
• Whether use of a credit line is restricted (long form)—A bank must inform a customer if the customer's activation of the contract would prohibit the customer from incurring additional charges or using the credit line.
• Termination of a DCC or DSA (long form)—If termination is permitted during the life of the loan, a bank must include an explanation of the circumstances under which a customer or the bank may terminate the contract.
• Additional disclosures (short form)—A bank must inform consumers that it will provide additional information before the customer is required to pay for the product.
• Eligibility requirements, conditions, and exclusions (short and long form)—A bank must describe any material limitations relating to the DCC or DSA.
Section 37.7 requires a bank to obtain a customer's written affirmative election to purchase a contract and written acknowledgment of receipt of the disclosures required by § 37.6. The section further provides that the election and acknowledgment must be conspicuous, simple, direct, readily understandable, and designed to call attention to their significance. Pursuant to § 37.7(b), if the sale of the contract occurs by telephone, the customer's affirmative election to purchase and acknowledgment of receipt of the required short form may be made orally, provided the bank: (i) Maintains sufficient documentation to show that the customer received the short form disclosures and then affirmatively elected to purchase the contract; (ii) mails the affirmative written election and written acknowledgment, together with the long form disclosures required by § 37.6, to the customer within 3 business days after the telephone solicitation and maintains sufficient documentation to show it made reasonable efforts to obtain the documents from the customer; and (iii) permits the customer to cancel the purchase of the contract without penalty within 30 days after the bank has mailed the long form disclosures to the customer.
Pursuant to § 37.7(c), if the DCC or DSA is solicited through written materials such as mail inserts or “take one” applications and the bank provides only the short form disclosures in the written materials, then the bank shall mail the acknowledgment, together with the long form disclosures, to the customer. The bank may not obligate the customer to pay for the contract until after the bank has received the customer's written acknowledgment of receipt of disclosures, unless the bank takes certain steps, maintains certain documentation, and permits the customer to cancel the purchase within 30 days after mailing the long form disclosures to the customer. Section 37.6(d) permits the customer's affirmative election and acknowledgment to be made electronically.
The OCC issued a notice for 60 days of comment regarding this collection, 82 FR 44875. No comments were received. Comments continue to be invited on:
(a) Whether the collection of information is necessary for the proper performance of the functions of the OCC, including whether the information shall have practical utility;
(b) The accuracy of the OCC's estimate of the burden of the collection of information;
(c) Ways to enhance the quality, utility, and clarity of the information to be collected;
(d) Ways to minimize the burden of the collection on respondents, including through the use of automated collection techniques or other forms of information technology; and
(e) Estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information.
The Department of Veterans Affairs (VA) gives notice under the Federal Advisory Committee Act that a meeting of the Advisory Committee on the Readjustment of Veterans will be held February 6, 7, and 8, 2018. All meeting sessions will be conducted at the Department of Veterans Affairs National Headquarters, located at 810 Vermont Avenue NW, Conference Room 530, Washington, DC, 20420. The meetings will begin at 8:00 a.m. and adjourn at 4:30 p.m. The meetings are open to the public.
The purpose of the Committee is to review the post-war readjustment needs of combat-theater Veterans and to evaluate the availability, effectiveness and coordination of VA programs available to meet Veterans' readjustment service needs.
The agenda for Tuesday February 6 will feature meetings with VA and the Veterans Health Administration (VHA) senior leadership to review the general values, strategic priorities and current perspectives on Veterans' physical health and psychosocial welfare. The day's agenda will also include briefings from the Readjustment Counseling Service (RCS) Chief Officer regarding the current activities of the RCS Vet Centers to include the full scope of outreach and readjustment counseling being provided to combat-theater Veterans, Service members and their families. The briefing will also provide a status report regarding the RCS organizational transition to a single point of service within the general organizational transformation of VHA.
On Wednesday February 7, the Committee will focus on VA mental health services and best practices for coordinating VA mental health services with RCS readjustment counseling services to better serve the combat-theater Veteran population. To this end Committee members will receive briefings from VA's mental health leadership on the types and distribution of psychiatric disorders currently being presented by Operation Iraqi Freedom/Operation Enduring Freedoms Veterans and the various treatment regimens provided for their care inclusive of psychotherapy and psychopharmacology. VA Mental Health and RCS leadership will additionally present on the collaborative activities currently underway between RCS and the Office of Mental Health and Suicide Prevention to achieve life-saving outcomes for at risk combat-theater Veterans and Service members.
On Thursday February 8, the Committee will engage in strategic round table discussions with various other VHA program officials to review the objectives and anticipated outcomes for developing a “Veterans Engagement Subcommittee”. This project is being initiated through collaborative partnership between RCS and the National Center for Post-Traumatic Stress Disorder (NC/PTSD) to strengthen the collaborative ties between the RCS and the NC/PTSD, to improve VA services and products through Veteran consumer feedback and to provide greater public awareness of VA and its achievements through quality services to Veterans and families.
In addition, the agenda will include time for Committee strategic planning focused on its annual operations priorities for 2018 and the strategic perspectives for developing its 19th annual report to Congress.
No time will be allocated at this meeting for receiving oral presentations from the public. However, members of the public may direct written questions or submit prepared statements for review by the Committee before the meeting to Mr. Charles M. Flora, M.S.W., Designated Federal Officer, Readjustment Counseling Service, Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420. Because the meeting will be in a Government building, please provide valid photo identification for check-in. Please allow 15 minutes before the meeting for the check-in process. If you plan to attend or have questions concerning the meeting, contact Mr. Flora at (202) 461-6525 or via email at
Department of Veterans Affairs.
Notice.
The Veterans Access, Choice, and Accountability Act of 2014, Public Law 113-146, as amended, directs the Department of Veterans Affairs (VA) to publish in the
Joseph Duran, Director, Policy and Planning (10D1A1), Veterans Health Administration, Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420, (303) 372-4629. This is not a toll free number.
The Veterans Access, Choice, and Accountability Act of 2014, Public Law 113-146, as amended, (the Act), section 802, established the Veterans Choice Fund to be used by the Secretary of Veterans Affairs to carry out the Veterans Choice Program established by section 101 of the Act. Pursuant to sections 101(p)(1) and (2) of the Act, the Secretary may not furnish care and services under the Veterans Choice Program after the date on which the Secretary has exhausted all amounts deposited in the Veterans Choice Fund. Section 101(p)(3) of the Act directs, not later than 30 days prior, VA to publish this date in the
The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Gina S. Farrisee, Deputy Chief of Staff, Department of Veterans Affairs, approved this document on December 14, 2017, for publication.
Food and Drug Administration, HHS.
Final rule.
The Food and Drug Administration (FDA, the Agency, or we) is issuing this final rule establishing that certain active ingredients used in nonprescription (also known as over-the-counter or OTC) antiseptic products intended for use by health care professionals in a hospital setting or other health care situations outside the hospital are not generally recognized as safe and effective (GRAS/GRAE). FDA is issuing this final rule after considering the recommendations of the Nonprescription Drugs Advisory Committee (NDAC); public comments on the Agency's notices of proposed rulemaking; and all data and information on OTC health care antiseptic products that have come to the Agency's attention. This final rule finalizes the 1994 tentative final monograph (TFM) for OTC health care antiseptic drug products that published in the
This rule is effective December 20, 2018.
For access to the docket to read background documents or the electronic and written/paper comments received, go to
Michelle M. Jackson, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5420, Silver Spring, MD 20993-0002, 301-796-0923.
This final rule finalizes the 2015 Health Care Antiseptic PR. This final rule applies to health care antiseptic products that are intended for use by health care professionals in a hospital setting or other health care situations outside the hospital. Health care antiseptic products include health care personnel hand washes, health care personnel hand rubs, surgical hand scrubs, surgical hand rubs, and patient antiseptic skin preparations (
In response to several requests submitted to the 2015 Health Care Antiseptic PR, FDA has deferred further rulemaking on six active ingredients used in OTC health care antiseptic products to allow for the development and submission to the record of new safety and effectiveness data for these ingredients. The deferred active ingredients are benzalkonium chloride, benzethonium chloride, chloroxylenol, alcohol (also referred to as ethanol or ethyl alcohol), isopropyl alcohol, and povidone-iodine. Accordingly, FDA does not make a GRAS/GRAE determination in this final rule for these six active ingredients for use as OTC health care antiseptics. The monograph or nonmonograph status of these six ingredients will be addressed, either after completion and analysis of ongoing studies to address the safety and effectiveness data gaps of these ingredients or at a later date, if these studies are not completed.
This rulemaking finalizes the nonmonograph status of the remaining 24 active ingredients intended for use in health care antiseptics identified in the 2015 Health Care Antiseptic PR. No additional data were submitted to support monograph conditions for these 24 health care antiseptic active ingredients. Therefore, this rule finalizes the 2015 Health Care Antiseptic PR and finds that 24 health care antiseptic active ingredients are not GRAS/GRAE for use as OTC health care antiseptics. Accordingly, OTC health care antiseptic drugs containing any of these 24 active ingredients are new drugs under section 201(p) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321(p)) for which approved applications under section 505 of the FD&C Act (21 U.S.C. 355) and part 314 (21 CFR 314) of the regulations are required for marketing and may be misbranded under section 502 of the FD&C Act (21 U.S.C. 352).
This final rule covers only OTC health care antiseptics that are intended for use by health care professionals in a hospital setting or other health care situations outside the hospital. This final rule does not cover consumer antiseptic washes (78 FR 76444, 81 FR 61106); consumer antiseptic rubs (81 FR 42912); antiseptics identified as “first aid antiseptics” in the 1991 First Aid tentative final monograph (TFM) (56 FR 33644); or antiseptics used by the food industry.
Several important scientific developments that affect the safety evaluation of OTC health care antiseptic active ingredients have occurred since FDA's 1994 safety evaluation. Improved analytical methods now exist that can detect and more accurately measure these active ingredients at lower levels in the bloodstream and tissue. Consequently, new data suggest that the
The minimum data needed to demonstrate safety for all health care antiseptic active ingredients fall into four broad categories: (1) Human safety studies described in current FDA guidance (
We have considered the recommendations from the public meetings held by the Agency on antiseptics (see section IV.B, table 2) and evaluated the available literature, as well as the data, the comments, and other information that were submitted to the rulemaking on the safety of the 24 non-deferred health care antiseptic active ingredients addressed in this final rule. The available information and published data for these 24 active ingredients considered in this final rule are insufficient to establish the safety of these active ingredients for use in health care antiseptic products. No additional data were provided for these 24 ingredients. Consequently, the available data do not support a GRAS determination for the OTC non-deferred health care antiseptic active ingredients addressed in this final rule.
A determination that an active ingredient is GRAS/GRAE for a particular intended use requires a benefit-to-risk assessment for the drug for that use. New information on potential risks posed by the increased use of certain health care antiseptics in clinical practice, as well as input from the 2005 NDAC, prompted us to reevaluate the data needed to determine whether health care antiseptic active ingredients are generally recognized as effective (GRAE). We continued to propose the use of surrogate endpoints (bacterial log reductions) as a demonstration of effectiveness for health care antiseptics combined with in vitro testing to characterize the antimicrobial activity of the active ingredient (80 FR 25166).
We have considered the recommendations from the public meetings held by the Agency on antiseptics (see section IV.B, table 2) and evaluated the available literature, as well as the data, the comments, and other information that were submitted to the rulemaking on the effectiveness of the 24 non-deferred health care antiseptic active ingredients addressed in this final rule. Since the publication of the 2015 Health Care Antiseptic PR, no new data or information was submitted on the effectiveness of these 24 non-deferred health care antiseptic active ingredients. Consequently, there is insufficient data to support a GRAE determination for these ingredients.
This rule establishes that 24 eligible active ingredients are not generally recognized as safe and effective for use in nonprescription (also referred to as over-the-counter or OTC) health care antiseptics. However, data from the FDA drug product registration database suggest that only one of these 24 ingredients is found in OTC health care antiseptic products currently marketed pursuant to the TFM: Triclosan. Regulatory action is being deferred on six active ingredients that were included in the health care antiseptic proposed rule: Benzalkonium chloride, benzethonium chloride, chloroxylenol, ethyl alcohol, isopropyl alcohol, and povidone-iodine. This final rule also addresses comments on the eligibility of three active ingredients—alcohol (ethyl alcohol), benzethonium chloride, and chlorhexidine gluconate—and finds that these three active ingredients are ineligible for evaluation under the OTC Drug Review for certain health care antiseptic uses because these active ingredients were not included in health care antiseptic products marketed for the specified indications prior to May 1972. To our knowledge, there is only one ineligible product currently on the market, an alcohol-containing surgical hand scrub, which is affected by this rule.
Benefits are quantified as the volume reduction in exposure to triclosan found in health care antiseptic products affected by the rule, but these benefits are not monetized. Annual benefits are estimated to be a reduction in exposure of 88,000 kilograms (kg) of triclosan per year.
Costs are calculated as the one-time costs associated with reformulating health care antiseptic products containing the active ingredient triclosan and relabeling reformulated products. We believe that the alcohol-containing surgical hand scrub that is affected by this rule is likely to be removed from the market. We categorize the associated loss of sales revenue as a transfer from one manufacturer to another and not a cost, because we assume that the supply of other, highly substitutable, products is highly elastic.
Annualizing the one-time costs over a 10-year period, we estimate total annualized costs to range from $1.1 to $4.1 million at a 3 percent discount rate, and from $1.2 to $4.7 million at a 7 percent discount rate. The present value of total costs ranges from $9.0 to $34.6 million at a 3 percent discount rate, and from $8.7 to $29.6 million at a 7 percent discount rate.
In this final rule, small entities will bear costs to the extent that they must reformulate and re-label any health care antiseptic containing triclosan that they produce. The average cost to small firms of implementing the requirements of this final rule is estimated to be $213,176 per firm. The costs of the changes, along with the small number of firms affected, implies that this burden would not be significant, so we certify that this final rule will not have a significant economic impact on a substantial number of small entities. This analysis, together with other relevant sections of this document, serves as the Regulatory Flexibility Analysis, as required under the Regulatory Flexibility Act.
The full discussion of economic impacts is available in docket FDA-2015-N-0101 and at
In the following sections, we provide a brief description of terminology used in the OTC Drug Review regulations, an overview of OTC topical antiseptic drug products, and a more detailed description of the OTC health care antiseptic active ingredients that are the subject of this final rule.
To conform to terminology used in the OTC Drug Review regulations (§ 330.10 (21 CFR 330.10)), the advance notice of proposed rulemaking (ANPR) that was published in the
The OTC drug regulations in § 330.10 use the terms “Category I” (generally recognized as safe and effective and not misbranded), “Category II” (not generally recognized as safe and effective or misbranded), and “Category III” (available data are insufficient to classify as safe and effective, and further testing is required). Section 330.10 provides that any testing necessary to resolve the safety or effectiveness issues that resulted in an initial Category III classification, and submission to FDA of the results of that testing or any other data, must be done during the OTC drug rulemaking process before the establishment of a final monograph (
At this final monograph stage, FDA does not use the terms “Category I,” “Category II,” and “Category III.” Instead, the term “monograph conditions” is used in place of Category I, and “nonmonograph conditions” is used in place of Categories II and III.
The OTC topical antimicrobial rulemaking has had a broad scope, encompassing drug products that may contain the same active ingredients, but that are labeled and marketed for different intended uses. The 1974 ANPR for topical antimicrobial products encompassed products for both health care and consumer use (39 FR 33103). The 1974 ANPR covered seven different intended uses for these products: (1) Antimicrobial soap; (2) health care personnel hand wash; (3) patient preoperative skin preparation; (4) skin antiseptic; (5) skin wound cleanser; (6) skin wound protectant; and (7) surgical hand scrub (39 FR 33103 at 33140). FDA subsequently identified skin antiseptics, skin wound cleansers, and skin wound protectants as antiseptics used primarily by consumers for first aid use and referred to them collectively as “first aid antiseptics.” We published a separate TFM covering first aid antiseptics in the
The four remaining categories of topical antimicrobials were addressed in the 1994 TFM (59 FR 31402). The 1994 TFM covered: (1) Antiseptic hand wash (
The 1994 TFM did not distinguish between consumer antiseptic washes and rubs and health care antiseptic washes and rubs. In the 2013 Consumer Wash PR, we proposed that our evaluation of OTC antiseptic drug products be further subdivided into health care antiseptics and consumer antiseptics (78 FR 76444 at 76446). These categories are distinct based on the proposed use setting, target population, and the fact that each
We refer to the group of products covered by this final rule as “health care antiseptics.” Health care antiseptics are drug products that are generally intended for use by health care professionals in a hospital setting or other health care situations outside the hospital. Patient antiseptic skin preparations, which are products that are used for preparation of the skin prior to surgery (
In this final rule, we use the term “health care antiseptics” to include the following products:
This final rule covers health care antiseptic products that are rubs and others that are washes. The 1994 TFM did not distinguish between products that we are now calling health care “antiseptic washes” and products we are now calling health care “antiseptic rubs.” Washes are rinsed off with water, and include health care personnel hand washes and surgical hand scrubs. Rubs are sometimes referred to as “leave-on products” and are not rinsed off after use. Rubs include health care personnel hand rubs, surgical hand rubs, and patient antiseptic skin preparations.
Completion of the monograph for health care antiseptic products and certain other monographs for the active ingredient triclosan is subject to a Consent Decree entered by the U.S. District Court for the Southern District of New York on November 21, 2013, in
In this section, we describe the significant rulemakings and public meetings relevant to this rulemaking and discuss our response to comments received on the 2015 Health Care Antiseptic PR.
A summary of the significant
In addition to the
This rulemaking finalizes the nonmonograph status of the 24 listed health care antiseptic active ingredients (see section IV.D.1). Requests were made that benzalkonium chloride, benzethonium chloride, chloroxylenol, alcohol, isopropyl alcohol, and povidone-iodine be deferred from consideration in this health care antiseptic final rule to allow more time for interested parties to complete the studies necessary to fill the safety and effectiveness data gaps identified in the 2015 Health Care Antiseptic PR for these ingredients. In January 2017, we agreed to defer rulemaking on these six ingredients (see Docket No. 2015-N-0101 at
For the 24 active ingredients included in this final rule, no additional data were submitted to the record to fill the safety and effectiveness data gaps identified in the 2015 Health Care Antiseptic PR for these 24 active ingredients. Therefore, we find that these 24 active ingredients are not GRAS/GRAE for use in health care antiseptic drug products and these ingredients are not included in the OTC topical antiseptic monograph at this time. Products containing these ingredients are new drugs for which approved new drug applications (NDAs) or abbreviated new drug applications (ANDAs) are required prior to marketing. Accordingly, FDA is amending part 310 (21 CFR part 310) to add the active ingredients covered by this final rule to the list of active ingredients in § 310.545 (21 CFR 310.545) that are not GRAS/GRAE for use in the specified OTC drug products.
An OTC drug is covered by the OTC Drug Review if its conditions of use existed in the OTC drug marketplace on or before May 11, 1972 (37 FR 9464) (Ref. 5).
Table 3 lists the health care antiseptic active ingredients that have been considered under this rulemaking and shows whether each ingredient is eligible or ineligible for evaluation under the OTC Drug Review for use in health care antiseptics for each of the five specified uses: Patient antiseptic skin preparation, health care personnel hand wash, health care personnel hand rub, surgical hand scrub, and surgical hand rub.
In the 2015 Health Care Antiseptic PR (and as outlined in table 3), we identified certain active ingredients that were considered ineligible for evaluation under the OTC Drug Review as a health care antiseptic for specific indications. We noted, however, that if the requested documentation for eligibility was submitted, these active ingredients could be determined to be eligible for evaluation (80 FR 25166 at 25171).
We received a comment requesting that benzethonium chloride be deemed eligible for evaluation under the OTC Drug Review for use as a health care personnel hand rub and surgical hand rub. For the reasons explained in section V.C.1, we find that benzethonium chloride continues to be ineligible for evaluation under the OTC Drug Review for use as a health care personnel hand rub and surgical hand rub. Consequently, drug products containing benzethonium chloride for use in health care personnel hand rubs and surgical hand rubs will require approval under an NDA or ANDA prior to marketing.
We also received comments arguing that chlorhexidine gluconate is eligible for evaluation under the OTC Drug Review for use as a health care antiseptic. For the reasons explained in section V.C.2, we find that chlorhexidine gluconate continues to be ineligible for evaluation under the OTC Drug Review for use as a health care antiseptic. Consequently, drug products containing chlorhexidine gluconate for use in health care antiseptics will require approval under an NDA or ANDA prior to marketing.
In addition, we received a comment requesting that alcohol be deemed eligible for evaluation under the OTC Drug Review for use as a surgical hand scrub. For the reasons explained in section V.C.3, we find that alcohol continues to be ineligible for evaluation under the OTC Drug Review for use as a surgical hand scrub. Consequently, drug products containing alcohol for use in surgical hand scrubs will require approval under an NDA or ANDA prior to marketing.
Moreover, for the remaining health care antiseptic active ingredients that we proposed were ineligible for evaluation under the OTC Drug Review, we have not received any new information since the publication of the 2015 Health Care Antiseptic PR demonstrating that these ineligible active ingredients are eligible for
FDA may determine that an active ingredient is not GRAS/GRAE for a given OTC use (
In response to the 2015 Health Care Antiseptic PR, we received approximately 29 comments from drug manufacturers, trade associations, academia, testing laboratories, health professionals, and individuals. We also received additional data and information for certain deferred health care antiseptic active ingredients.
We describe and respond to the comments in section V.B through V.F. We have numbered each comment to help distinguish among the different comments. We have grouped similar comments together under the same number, and in some cases, we have separated different issues discussed in the same comment and designated them as distinct comments for purposes of our responses. The number assigned to each comment or comment topic is purely for organizational purposes and does not signify the comment's value, importance, or the order in which comments were received.
(Comment 1) Several comments requested that FDA extend its timeline under the 2015 Health Care Antiseptic PR to allow more time for the submission of new data and information. They asserted that the one year compliance date was too short and that it could take several years to design, execute, analyze, and report on the necessary safety and effectiveness studies.
(Response 1) In the 2015 Health Care Antiseptic PR, we provided a process for seeking an extension of time to submit the required safety and effectiveness data if such an extension is necessary (80 FR 25166 at 25169). As explained in the proposed rule, we stated that we would consider all the data and information submitted to the record in conjunction with all timely and completed requests to extend the timeline to finalize the monograph status for a given ingredient. We received requests to defer six health care antiseptic active ingredients from this rulemaking. Consideration for deferral for an ingredient was given to requests with clear statements of intent to conduct the necessary studies required to fill all the data gaps identified in the proposed rule for that ingredient. After analyzing the data and information submitted related to the requests for extensions, we determined that a deferral is warranted for the six health care antiseptic active ingredients—benzalkonium chloride, benzethonium chloride, chloroxylenol, alcohol, isopropyl alcohol, and povidone-iodine—to allow more time for interested parties to complete the studies necessary to fill the safety and effectiveness data gaps identified for these ingredients in the 2015 Health Care Antiseptic PR. The monograph status of these six ingredients will be addressed either after completion and analysis of ongoing studies to address the safety and effectiveness data gaps of these ingredients or at a later date if these studies are not completed. We did not receive any deferral requests for the 24 remaining health care antiseptic active ingredients, and so we decline to defer final action on the proposed rule for these ingredients.
(Comment 2) One comment requested that FDA “better clarify and define the scope” of this rulemaking on the use of health care antiseptics in health care settings outside of the hospital “in order that the proper antiseptic products are provided for patients in the spectrum of health care settings while also being covered by health care insurers.” The comment stated that patients and health care workers in these other settings deserve the same level of safety and efficacy standards as those in the hospital setting. The comment expressed concern that certain entities may determine that they need to supply products intended for “consumer use,” which, the comment stated, may have different and lesser standards.
(Response 2) We agree that health care antiseptic products are used in a variety of health care settings, not just hospitals. Over the past several decades, there has been a significant shift in health care delivery from the acute, inpatient hospital setting to a variety of outpatient and community-based settings. There are many examples of health care settings outside the hospital that involve the use of antiseptic products. These settings include, but are not limited to, the care of patients in outpatient medical and surgical facilities, dental clinics, skilled nursing facilities or nursing homes, adult medical day care centers, public health clinics, imaging centers, oncology clinics, infusion centers, dialysis centers, behavioral health clinics, physical therapy and rehabilitation centers, and in private homes. The term “health care” as used in this rulemaking includes all these settings.
We note, however, that this rule does not address the use of a specific health care antiseptic drug product in a particular health care situation. In addition, the coverage of antiseptic drug products by health care insurers is outside FDA's purview.
(Comment 3) Several comments requested that FDA reconsider its proposal in the 2015 Health Care Antiseptic PR to classify alcohol, isopropyl alcohol, and povidone-iodine as Category III active ingredients. In the 1994 TFM, alcohol, isopropyl alcohol,
(Response 3) As we explained in the 2015 Heath Care Antiseptic PR, the OTC drug procedural regulations in § 330.10 use the terms “Category I” (generally recognized as safe and effective and not misbranded), “Category II” (not generally recognized as safe and effective or misbranded), and “Category III” (available data are insufficient to classify as safe and effective, and further testing is required) (80 FR 25166 at 25168). We classify ingredients as Category I, II, or III until the final monograph stage, at which point we use the term “monograph conditions” in place of Category I, and the term “nonmonograph conditions” in place of Categories II and III. In the 1994 TFM, alcohol and povidone-iodine were both proposed to be classified as Category I topical antiseptic ingredients for use in surgical hand scrubs, patient antiseptic skin preparations, and antiseptic hand washes or health care personnel hand wash products (59 FR 31402 at 31420 and 31433). Isopropyl alcohol was proposed to be classified as Category I for patient antiseptic skin preparation “for the preparation of the skin prior to an injection” (59 FR 31402 at 31433).
In the 2015 Health Care Antiseptic PR, we changed the proposed classification of alcohol, isopropyl alcohol, and povidone-iodine from Category I to III for these indications, because we found that there was not enough data on these three ingredients to meet our proposed safety and effectiveness data requirements. We explained that we were proposing changes to the safety and effectiveness data requirements identified in the 1994 TFM in light of comments we received, input from subsequent public meetings, and our independent evaluation of other relevant scientific information (80 FR 25166 at 25166).
Among other things, our proposed revisions to the data requirements identified in the 1994 TFM were based on several important scientific developments that affected the safety evaluation of health care antiseptic active ingredients, including improved analytical methods that can detect and more accurately measure these ingredients at lower levels in the bloodstream and tissue (80 FR 25166 at 25166 to 25167). As a result of these improved methods, we have learned that some systemic exposures can be detected, where previously they were undetected, and that some systemic exposures are higher than previously thought. We also have new information about the potential risks from systemic absorption and long-term exposure (80 FR 25166 at 25167). In addition, the standard battery of tests that were used to determine the safety of drugs had changed over time to incorporate improvements in safety testing. As we explained in the 2015 Health Care Antiseptic PR, it is critical that the safety and effectiveness of these ingredients be supported by data that meet the most current standards, considering the prevalent use of health care antiseptic products (80 FR 25166 at 25167).
Our decision to propose revising the safety and effectiveness data requirements identified in the 1994 TFM was also based in part on meetings of the NDAC that were held in March 2005 and September 2014. As we noted in the preamble to the 2015 Health Care Antiseptic PR, input from participants at the March 2005 NDAC meeting prompted us to reevaluate the data needed for classifying health care antiseptic active ingredients as GRAE (80 FR 25166 at 25166). Moreover, at the meeting held in September 2014, the NDAC discussed FDA's proposed revisions to the safety data requirements and unanimously voted that the revised safety data requirements were appropriate to demonstrate that a health care antiseptic active ingredient is GRAS.
As one comment noted, at the September 2014 meeting, several NDAC members expressed concerns about changing the proposed classification of alcohol, isopropyl alcohol, and povidone-iodine from Category I to Category III, indicating that this change in the proposed classification could lead health care personnel to stop using products with these active ingredients. At the same meeting, FDA emphasized both that health care antiseptics are a critically important part of the infection control paradigm in place in every hospital across the country and that our goal is not to remove such products from the market (Ref. 4). That remains our goal, and we note that these ingredients have each been deferred, so they are not addressed in this final rule.
(Comment 4) One comment asked FDA to clarify the term “patient preoperative skin preparation,” noting that, in the 2015 Health Care Antiseptic PR, the term “patient preoperative skin preparation” includes skin preparation prior to an injection (preinjection) and that this may cause confusion because it could be misinterpreted to mean that all products listed can be used for either patient preoperative skin preparation or preinjection.
Several comments also asserted that the effectiveness testing for preinjection should have different clinically relevant time points because preinjection use serves a different purpose and has a different use pattern than patient preoperative skin preparations. They argued that surgical incision demands persistent activity due to the invasive nature of cutting through the skin's natural barrier over a larger area, the procedure duration (which can be hours), and the time the incision point will be open and will subsequently need to heal. As such, the comments argued, persistence may be an important attribute of patient preoperative skin preparations. They explained that in contrast, an injection is a procedure lasting only seconds and poses a relatively low risk of infection. They also explained that the injection site heals quickly, so there is no need for persistent antimicrobial activity. They stated that if patient preinjection skin preparation products are required to meet the same effectiveness requirements as patient preoperative skin preparation products, this would effectively clear the market of available cost effective solutions for those who need these products. Therefore, the comments asserted that the effectiveness requirements for patient preoperative skin preparation should be different from the effectiveness requirements for patient preinjection skin preparations.
(Response 4) We agree that the circumstances under which health care
Examples of procedures that are covered by a preinjection claim include the following:
Examples of procedures that are not covered by the preinjection claim include the following:
As stated in the 2015 Health Care Antiseptic PR (80 FR 25166 at 25176), the effectiveness criteria for health care antiseptics are based on the premise that bacterial reductions achieved using tests that simulate conditions of actual use for each OTC health care antiseptic product reflect the bacterial reductions that would be achieved under conditions of such use. Thus, the effectiveness requirements for determining whether an active ingredient is GRAE for use in patient preinjection skin preparations should be consistent with the actual use of that product. We agree that patient antiseptic skin preparations used for preinjection involve a process lasting a much shorter period of time, sometime seconds, compared to surgery, which can last several hours, and that such preinjection use has a lower risk of infection. For these reasons, we also agree that the effectiveness requirements for preinjection should be different than the effectiveness requirements for patient preoperative skin preparations. We discuss these effectiveness requirements in more detail in section V.D.2.
We also note that, although we do not address labeling in this final rule because at this time we have not found any active ingredients to be GRAS/GRAE for use in patient antiseptic skin preparations, we anticipate that labeling for these products will include directions for use that will help providers determine the proper use of preoperative and preinjection antiseptic products.
(Comment 5) Several comments requested that FDA formally recognize antiseptic hand washes and rubs used in the food industry as a distinct food handler category subject to its own monograph. The comments also requested that FDA confirm that food handler antiseptics can continue to be marketed until FDA issues a food handler monograph.
(Response 5) As stated in the 2016 Consumer Wash Final Rule (81 FR 61106 at 61109) and the 2015 Health Care Antiseptic PR (80 FR 25166 at 25168), we continue to classify the food handler antiseptic washes as a separate and distinct monograph category. As explained in those rulemakings, food handler antiseptic products are not part of these rulemakings on the health care and consumer antiseptic monographs. We continue to believe a separate category is warranted because of additional issues raised by the public health consequences of foodborne illness, differences in frequency and type of use, and contamination of the hands by grease and other oils.
(Comment 6) In response to the 2015 Health Care Antiseptic PR, we received a comment asserting that benzethonium chloride is eligible for review under the monograph for use in health care personnel hand rubs and surgical hand rubs and that benzethonium chloride be categorized as a Category I ingredient for both indications. Information submitted in the comment showed that methylbenzethonium chloride was present in Bactine, a topical antiseptic for first aid and wound care before May 1972. The comment also asserted that:
• Methylbenzethonium chloride was the active ingredient in the antiseptic, Bactine.
• Bactine with methylbenzethonium chloride was in use before 1972 as a leave-on antiseptic (not rinsed off).
• Methylbenzethonium chloride and benzethonium chloride are equivalent.
• The conditions of use for benzethonium chloride in the 2015 Health Care Antiseptic PR are the same as for Bactine.
(Response 6) In the 2015 Health Care Antiseptic PR (80 FR 25166 at 25171), we explained that an OTC drug is covered by the OTC Drug Review if its conditions of use existed in the OTC drug marketplace on or before May 11, 1972. Conditions of use include active ingredient, dosage form and dosage strength, route of administration, and the specific OTC use or indication of the product. If the eligibility of a product for OTC Drug Review is in question, FDA must have actual product labeling or a facsimile of labeling that documents the conditions of marketing the product before May 1972 (see § 330.10(a)(2)). If benzethonium chloride was the active ingredient in a drug before May 1972 for use as a health care personnel hand rub and/or surgical hand rub, then it would be eligible for the OTC Drug Review for those indications.
We disagree with the comment's statement asserting that methylbenzethonium chloride (the active ingredient in Bactine) is essentially equivalent to benzethonium chloride based on their similar structure and chemical function (both are quaternary ammonium chloride antiseptic ingredients). Although these two ingredients are chemically similar such that they could be grouped as quaternary ammonium compounds, they are not equivalent molecules. Furthermore, although not suggested by the comment, there is no evidence that methylbenzethonium is a prodrug for benzethonium chloride, or requires
Moreover, although the comment provided data to demonstrate that methylbenzethonium chloride was used in Bactine before May 1972, the submitted label for Bactine contained indications that are not equivalent to the indications for health care personnel hand rubs or surgical hand rubs. The indications and directions on the Bactine label (
We also performed a literature search to investigate whether benzethonium chloride was used as an active ingredient in an OTC health care antiseptic leave-on product for the indication of a health care personnel hand rub or surgical hand rub before May 1972. Our search did not find evidence for the use of benzethonium chloride as a health care personnel hand rub or surgical hand rub.
In sum, we find that the data submitted in support of the eligibility of benzethonium chloride as a monograph active ingredient for use as a health care personnel hand rub and/or a surgical hand rub do not demonstrate that benzethonium chloride is eligible for use for these health care antiseptic indications. For these reasons, we find that benzethonium chloride continues to be ineligible for evaluation under the OTC Drug Review for use as a health care personnel hand rub and surgical hand rub. Consequently, drug products containing benzethonium chloride for use in health care personnel hand rubs and surgical hand rubs will require approval under an NDA or ANDA prior to marketing.
(Comment 7) FDA received two comments asserting that chlorhexidine gluconate should be eligible for inclusion in the OTC health care antiseptic monograph. The comments also stated that more data are needed to find chlorhexidine gluconate GRAS/GRAE for use as an OTC health care antiseptic.
(Response 7) Chlorhexidine gluconate was not included in the 1994 TFM because we had previously found chlorhexidine gluconate to be ineligible for inclusion in the monograph for any health care antiseptic use (80 FR 25166 at 25172, citing 59 FR 31402 at 31413). In the 2015 Health Care Antiseptic PR, we explained that we had not received any new information since the 1994 TFM that supported the eligibility of chlorhexidine gluconate for inclusion in the monograph. Consequently, we proposed not to change the categorization of chlorhexidine gluconate based on the lack of documentation demonstrating its eligibility under the OTC Drug Review for use as a health care antiseptic (80 FR 25166 at 25172).
The comments on chlorhexidine gluconate submitted in response to the 2015 Health Care Antiseptic PR did not include any data or any new information to support chlorhexidine gluconate's eligibility for inclusion in the health care antiseptic monograph. Specifically, no evidence was submitted for chlorhexidine gluconate to demonstrate that chlorhexidine gluconate was an active ingredient in OTC health care antiseptics in the United States before May 1972. Consequently, we find that chlorhexidine gluconate continues to be ineligible for evaluation under the OTC Drug Review for use as a health care antiseptic. Drug products containing chlorhexidine gluconate for use in health care antiseptics will require approval under an NDA or ANDA prior to marketing. Because chlorhexidine gluconate continues to be ineligible for consideration under the health care antiseptic monograph, it is unnecessary to address the comments' statement that more safety and effectiveness data are needed to find chlorhexidine gluconate GRAS/GRAE for OTC health care antiseptic use.
(Comment 8) In response to the 2015 Health Care Antiseptic PR, we also received a comment expressing concerns regarding the bacterial resistance of chlorhexidine gluconate. In addition, we received a comment that suggested that chlorhexidine gluconate is superior to povidone-iodine as a patient preoperative skin preparation.
(Response 8) Because we find that chlorhexidine gluconate is ineligible for consideration under the health care antiseptic monograph and these comments do not have an impact on this finding, we do not address these comments in this final rule.
(Comment 9) In response to the 2015 Health Care Antiseptic PR, a comment was submitted that argued that alcohol should be deemed eligible for evaluation under the OTC Drug Review for use as a surgical hand scrub. The comment asserted that FDA first made its distinction between “rubs” and “scrubs” in the 2015 Health Care Antiseptic PR, in which FDA proposed that alcohol was ineligible for inclusion in the health care antiseptic monograph as a surgical hand scrub. The comment stated that FDA based this conclusion on the fact that information for rinse-off products was not submitted to the OTC Drug Review. But, the comment claimed, manufacturers had no reason to submit such information because FDA had found alcohol to be GRAS/GRAE for use in surgical hand scrub products in the 1994 TFM, and manufacturers had no notice that FDA was expecting such submissions. The comment argued that the Agency's exclusion of alcohol from the 2015 Health Care Antiseptic PR for use as a surgical hand scrub was arbitrary and capricious and in violation of the Administrative Procedure Act (APA), 5 U.S.C.A. sections 501
(Response 9) In the 2015 Health Care Antiseptic PR, we explained that the 1994 TFM did not distinguish between products that we are now calling “antiseptic washes” and products we are now calling “antiseptic rubs.” However, based on comments submitted in response to the 1994 TFM, we tentatively determined that there should be a distinction between antiseptic washes and antiseptic rubs, as well as a distinction between consumer antiseptic and health care antiseptic products. As evidenced by the comments received in response to the 1994 TFM, formulation practices and marketing intent of these products has changed over time and products may not be eligible for conditions under which they are currently marketed. We explained that washes are rinsed off with water, and include health care personnel hand washes and surgical hand scrubs, while rubs are sometimes referred to as “leave-on products” and are not rinsed off after use, and include health care personnel hand rubs,
We disagree with the comment's assertions that manufacturers did not have notice or an opportunity to submit information to the OTC Drug Review on alcohol's eligibility for use as a surgical hand scrub. First, we note that the 1994 TFM was a proposed rule, not a final rule; we proposed, but had not yet found, alcohol to be GRAS/GRAE for use in surgical hand scrub products. Moreover, in the 2015 Health Care Antiseptic PR, our proposal that alcohol was ineligible for use as a surgical hand scrub also was a preliminary determination based on the lack of adequate evidence of eligibility for evaluation under the OTC Drug Review. In the proposed rule, we invited parties to submit such evidence of eligibility. We explained that if the documentation demonstrated that an active ingredient met the OTC Drug Review requirements, the active ingredient could be determined to be eligible for evaluation for the specified use. Parties had 180 days to submit comments on the proposed rule and 12 months to submit any new data or information on the proposed rule, including evidence and documentation on eligibility (80 FR 25166 at 25169). The comment submitted in response to the 2015 Health Care Antiseptic PR on this issue did not include any documentation or evidence to demonstrate that alcohol is eligible for use as a surgical hand scrub under the OTC antiseptic monograph, despite the opportunity to include such information. Also, there was no additional data or information submitted to the record thereafter to demonstrate alcohol's eligibility for evaluation under the OTC Drug Review for use as a surgical hand scrub.
For these reasons, we find that alcohol continues to be ineligible for evaluation under the OTC Drug Review for use as a surgical hand scrub. Consequently, drug products containing alcohol for use in surgical hand scrubs will require approval under an NDA or ANDA prior to marketing.
We also note that where these active ingredients are ineligible for evaluation under the OTC Drug Review, interested parties may have the option to submit a time and extent application under § 330.14 (21 CFR 330.14) of FDA's regulations to request that the Agency amend the health care antiseptic monograph to include these active ingredients for use in health care antiseptics for the specified indications.
(Comment 10) One comment stated that FDA should require the same clinical studies that were required to show a benefit of OTC consumer antiseptic washes over and above washing with non-antibacterial soap for OTC antiseptics used in the health care setting. The comment asserted that there are numerous safety concerns with the use of these active ingredients and given these concerns and health care workers' extensive exposure to these ingredients in their workplaces on a daily basis, the Agency should find that there is a benefit over and above washing with plain soap and water in order to make a GRAE determination for these active ingredients. The comment stated that if FDA relies on bacterial reduction as a proxy for effectiveness in the health care setting, it must require that that reduction be compared against plain soap and water, especially given that workers in the health care setting likely wash their hands more frequently than the general public, and thus, are exposed to higher levels of these ingredients.
(Response 10) As we explained in the 2015 Health Care Antiseptic PR (80 FR 25166 at 25175 to 25176), study design limitations and ethical concerns prevent the use of clinical outcome studies to demonstrate the effectiveness of active ingredients used in health care antiseptic products. Participants at the March 2005 NDAC meeting acknowledged the difficulty in designing clinical trials to demonstrate the impact of health care antiseptics on rates of infection where numerous factors contribute to hospital-acquired infections, and therefore, would need to be controlled for in the design of these types of studies. Participants at the March 2005 NDAC meeting recommended that manufacturers perform an array of trials to look simultaneously at the effect on the surrogate endpoint and the clinical endpoint to try to establish a link between the surrogate and clinical endpoints, but provided no guidance on possible study designs. At the time, participants at the March 2005 NDAC meeting agreed that there were currently no clinical trials presented that showed a definitive clinical benefit for a health care antiseptic. However, recently, using an active comparator, Tuuli et al. demonstrated fewer infections following caesarean section with use of an approved patient preoperative health care antiseptic (Ref. 6). Otherwise, we have seen very few examples of well-controlled studies of this type to date.
Participants at the March 2005 NDAC meeting also believed it would be unethical to perform a hospital trial using a vehicle control instead of an antiseptic given the concerns with performing placebo-controlled studies on patients (Ref. 3). The inclusion of such control arms in a clinical outcome study conducted in a hospital setting could pose an unacceptable health risk to study subjects (hospitalized patients and health care providers). In such studies, a vehicle or negative control would be a product with no antimicrobial activity. The use of vehicle or saline (a negative control) in a hospital setting (a setting with an already elevated risk of infections) could increase the risk of infection for both health care providers and their patients. For these reasons, we continue to find that the use of clinical simulation studies relying on surrogate endpoints to evaluate the effectiveness of health care antiseptics is the best means available of assessing the effectiveness of health care antiseptic products.
(Comment 11) Given the ethical concerns with performing clinical trials in a health care setting, one comment urged FDA to evaluate natural experiments that have already occurred (
(Response 11) We believe that applying health care-associated high risk microbial pathogens (
In addition, the standard infection control guidance broadly implemented by CDC (Refs. 7 and 8), which involves measures such as gloving, hand hygiene, patient-to-patient contact, and waste disposal, makes it difficult to design an adequate clinical study (Ref. 9).
Moreover, the in vitro testing required for proof of effectiveness against microorganisms (80 FR 25166 at 25177 to 25178), is already intended to characterize the activity (broad spectrum) of the antimicrobial ingredient. The American Type Culture Collection (ATCC) strains we reference in the 2015 Health Care Antiseptic PR for the in vitro testing are chosen to represent a broad spectrum of bacteria that present a challenge to antisepsis and are the principal bacterial pathogens encountered in hospital settings. The clinical simulation studies described in the 2015 Health Care Antiseptic PR are based on the premise that bacterial reductions achieved using tests that simulate conditions of actual use for each OTC health care antiseptic product category reflect the bacterial reductions that would be achieved under such conditions of use.
(Comment 12) Multiple comments were submitted to the 2015 Health Care Antiseptic docket on the in vivo testing criteria that use bacterial log reductions for determining the effectiveness of active ingredients used in health care antiseptic products. One comment stated that single application testing and increased log reduction for health care personnel hand rubs is not supported by scientific evidence and that current gaps exist within the peer-reviewed literature. The comment recommended that the Agency not change the testing requirements for the health care personnel hand rub products because alcohol-based hand rubs are used millions of times a day across the United States in all health care facilities. The comment also asserted that the recommended changes to the testing requirements by FDA could result in the unavailability of hand hygiene products to the clinicians who utilize them daily to prevent the transmission of health care associated infections to patients. One comment also asserted that FDA should retain the effectiveness criteria proposed for surgical hand scrubs identified in the 1994 TFM for single applications only.
Several comments also asserted that FDA should retain the effectiveness criteria proposed in the 1994 TFM for health care personnel hand wash and rub products as 2 log
Several comments also asserted that it is inappropriate to propose a 30-second contact time for patient preoperative skin preparations. The comments argued that most active ingredients for use in patient preoperative skin preparations would be unable to make the log reduction effectiveness criteria at 30 seconds. The comments asserted that, although it may be possible for some patient preoperative skin preparation products to make the log reduction effectiveness criterion and that it may be possible for some patient preoperative skin preparation products to make the 70 percent success rate for abdomen, no products can make the 70 percent success rate for the groin area at 30 seconds. One comment agreed with the 30-second time point, but argued that sampling should include a time point after the drying time is completed according to the directions. The comment stated that, in the proposed amendment to the 1994 TFM, it is unclear whether the antiseptic would be tested 30 seconds after application and while still wet, potentially resulting in efficacy compromise. The comment asserted that FDA should allow the product to fully dry before collecting 30-second time point efficacy testing, especially with topical skin antiseptics, because it is important that the skin be fully dry to achieve maximum efficacy and also to minimize potential skin irritation associated with use. Similarly, another comment asserted that, when referring to time points after product application for patient preoperative skin preparation, it should be explicitly stated that “after product application” means “product application plus required dry time.” Several comments also stated that the proposed 10-minute application period identified in the 1994 TFM is more representative of current clinical application practices.
(Response 12) As described in the 2015 Health Care Antiseptic PR, we proposed revisions to the log reduction criteria for health care personnel hand washes and rubs, and for surgical hand scrubs and rubs based on the recommendations of the March 2005 NDAC meeting and comments to the 1994 TFM that argued that the demonstration of a cumulative antiseptic effect for these products is unnecessary (80 FR 25166 at 25178). We agreed that the critical element of effectiveness is that a product must be effective after the first application because that represents the way in which health care personnel hand washes and rubs and surgical hand scrubs and rubs are used. Given that we were no longer requiring a cumulative antiseptic effect, the log reduction criteria were revised to reflect this single product application and fall between the log reductions previously proposed for the first and last application. Accordingly, we continue to find that the log reduction criteria for these products should be applied to a single application of the product rather than to multiple applications of the product.
Moreover, in the 2015 Health Care Antiseptic PR, we also proposed that patient antiseptic skin preparations (
Based on comments submitted on the 2015 Health Care Antiseptic PR and the Agency's further evaluation of additional data, we have updated the underlying statistical analysis related to the log reduction criteria for classifying health care antiseptic active ingredients as GRAE (Refs. 10, 11, 12, 13, 14, and 15).
In the 1994 TFM, FDA recommended that the general effectiveness of antiseptics be assessed in a number of ways, including conducting clinical simulation studies with the surrogate endpoint of the number of bacteria removed from the skin. In the 2015 Health Care Antiseptic PR, FDA made revisions to the effectiveness criteria set forth in the 1994 TFM, while continuing to recommend that bacterial log reduction studies be used to demonstrate that an active ingredient is GRAE for use in a health care antiseptic product. FDA recommended that these bacterial log reduction studies: (1) Include both a negative control (test product vehicle or saline solution) and an active control; (2) have an adequate sample size to show that the test product is superior to its negative control; (3) incorporate the use of an appropriate neutralizer and a demonstration of neutralizer validation; and (4) include an analysis of the proportion of subjects who meet the recommended log reduction criteria based on a two-sided statistical test for superiority to negative control and a 95 percent confidence interval approach (80 FR 25166 at 25178 to 25179). FDA also recommended that the success rate or responder rate of the test product be significantly higher than 70 percent. This meant that the lower bound of the 95 percent confidence interval for the proportion of subjects who met the log reduction criteria was expected to be at least 70 percent.
Consistent with the 1994 TFM and 2015 Health Care Antiseptic PR, we find that bacterial log reduction studies should continue to be used to demonstrate that an active ingredient is effective for use in a health care antiseptic product. Also consistent with the 2015 Health Care Antiseptic PR, subjects should be randomized to a three-arm study: Test, active control, and negative control. However, based on comments submitted on the 2015 Health Care Antiseptic PR and the Agency's further evaluation of additional data, we are updating the statistical analysis related to the log reduction criteria for classifying health care antiseptic active ingredients as GRAE. Also, as we explain in section V.B.4, we include separate effectiveness criteria for patient preinjection skin preparations to more accurately reflect the actual use of these products. We also clarify, for patient preoperative skin preparations and patient preinjection skin preparations, that the sampling time point commences after the applied product dries.
The updated analysis is designed to assess whether the average treatment effects (ATE) across subjects meet indication-specific conditions of superiority and non-inferiority, rather than whether the percentage of subjects who meet an indication-specific threshold significantly exceeds 70 percent. More specifically, the updated analysis estimates the ATE from a linear regression of post-treatment bacterial count (log
Superiority to negative control by a specific margin is needed because our evaluation suggests that application of a negative control, whether test product's vehicle or saline, may exhibit some minimal antimicrobial properties. Thus, using superiority to negative control by those margins will help ensure that we can appropriately assess the effectiveness of the deferred antimicrobial products. The margins we identify in this section were derived from review and analysis of existing data, and may be revised as data gaps on deferred antimicrobial products are filled. Because of existing data gaps, we also require the deferred ingredient to show non-inferiority to active controls by a 0.5 margin (log
Accordingly, based on the updated analysis, the bacterial log reduction studies used to assess whether an active ingredient is effective for use in health care antiseptics should include the following:
• The test product should be non-inferior to an FDA-approved active control with a 0.5 margin (log
○ Patient preoperative skin preparation:
• The test product should be superior to the vehicle control by an indication-specific margin. That is, we expect the lower bound of the 95 percent confidence interval of the ATE of the test product compared to the vehicle control to be greater than the indication-specific margin. In cases where the vehicle cannot be used as a negative
As discussed in more detail in section V.D.4, we believe that persistence of antimicrobial effect is an important attribute for health care antiseptic products, and in particular for patient preoperative skin preparations, surgical hand scrubs, and surgical hand rubs. To show persistence of effect for these health care antiseptic indications, the 6 hours post-treatment measurement should be lower than or equal to the baseline measurement for 100 percent of the subjects in each indication and body area tested.
Moreover, for the deferred ingredients, a minimum sample size of 100 subjects per treatment arm should be included for each indication. This sample size will ensure that ATE will be estimated precisely for the deferred ingredients and can be used for future reference in final product monographs. Exact sample size can be based on the margins for non-inferiority and superiority as well as an assessment of variability. In addition, two adequate and well-controlled clinical simulation pivotal studies should be conducted for each indication at two separate independent laboratory facilities by independent principal investigators.
(Comment 13) Several comments asserted that the Agency does not specify a minimum baseline bacterial count for subject eligibility in the clinical simulation studies and that the 1994 TFM is vague with regard to baseline values. The 1994 TFM states only that sites are to possess bacterial populations large enough to allow demonstrations of bacterial reduction of up to 2 log
(Response 13) We do not specify a minimum baseline bacterial count for subject eligibility in the clinical simulation studies; however, the test sites should possess bacterial populations large enough to meet the updated statistical criteria as explained in section III.D.2. We do not specify a minimum baseline bacterial count because, as explained in section III.D.2, the ATE is used to demonstrate effectiveness. Rather than using only a change from baseline, each criterion (groin site and abdomen site) uses the ATE, an estimated difference of the effect of two treatments correcting for baseline count. Manufacturers are encouraged to select subjects with baseline counts significantly higher than the expected log reductions achieved during the testing (
Moreover, if manufacturers find it challenging to recruit subjects who have resident bacterial counts high enough to be eligible for these studies, we recommend the use of the back as an alternate dry test site, rather than using the arm. We do not recommend the use of an occlusive dressing (sterile gauze). Covering the test sites has the potential to change the make-up of the microbial population. Therefore, the use of occlusion may not provide an accurate assessment of how effective the product will be under actual use conditions.
(Comment 14) One comment stated that current infection control procedures make persistence of antimicrobial activity for surgical hand scrub and patient preoperative skin preparations irrelevant. The comment asserted that persistence of effect may, in fact, be a negative attribute for these products because it may cause irritation. The comment suggested that the Agency place more emphasis on the mildness of these products rather than the persistence of these products. Another comment agreed with the Agency's requirement that patient preoperative skin preparations and surgical scrubs have a persistent antimicrobial effect. Another comment contended that the Agency's statement about the need for persistence of effect for patient preoperative hand scrubs lacks substantiating data. Another comment stated that the concept of persistence of antimicrobial activity is not consistent for surgical scrub and patient preoperative skin preparations, nor is it consistent with clinical practice. The comment asserted that the testing requirements for a patient preoperative skin preparation limit the definition of
(Response 14) In the 1994 TFM, we described the importance of persistence as a characteristic of antiseptic drug
FDA continues to believe that persistence of antimicrobial effect is an important attribute because it can suppress the growth of residual skin flora, as well as transient microorganisms not removed by preoperative prepping or hand scrubbing. FDA is also aware that the donning of surgical gloves may produce a rapid increase in microbial count on the hands (Refs. 16, 17, and 18), even after use of a surgical hand antiseptic product, which is another reason why persistence of effect is a critical characteristic for antiseptic products. Accordingly, we find that persistence is a requirement for surgical hand scrubs, surgical hand rubs, and patient preoperative skin preparations. We find that these antimicrobial products must be fast-acting and consist of broad spectrum, persistent antiseptic-containing preparations that significantly reduce the number of microorganisms on intact skin. As discussed in section V.D.2 of this final rule, to show the persistence of effect for these health care antiseptic indications, the 6 hours post-treatment measurement should be lower than or equal to the baseline measurement for 100 percent of subjects for each indication and body area tested.
(Comment 15) Several comments objected to the use of controls because we do not specify what positive control material to use in the effectiveness studies. One comment contended that, because the Agency does not specify the control product, the test results will differ depending on the effectiveness of the positive control. Another comment recommended that we convene an expert panel to develop standard positive controls. They cite the trend, on a worldwide basis, to identify and adopt standardized testing procedures. They believe it would be far better for the international harmonization effort if a standard chemical, rather than a specific product or commercial formulation, was used as the control. For these reasons, the comment recommended that the positive control should be a standard chemical that can be produced on a global basis and will perform consistently and reproducibly.
Other comments requested that we clarify how to interpret the results of the positive control. One comment asked if our standard is meeting the required log reduction, superiority to the positive control, or both. Another comment pointed out that the Agency does not define the criterion for an acceptable outcome for the positive control. For instance, the comment states that it is unclear if an 80 percent success rate in the positive control for a surgical hand scrub would be acceptable and if so, whether the new treatment could be 20 percent less successful than the positive control and still be equivalent. For health care personnel hand washes, they assert that it is not clear if the control must meet the requirements of 2 and 3 log
Several comments agreed that the Agency's proposed changes to the in vivo efficacy testing will reflect more accurately the real world use of topical antiseptic drug products. The comments requested that the Agency provide a validated “gold standard” for use as an active control. One comment stated that it is appropriate that GRAS/GRAE active ingredients would serve as the active control for any effectiveness studies required for final formulations. For example, the comment explained that alcohol at the concentration and application instructions evaluated in the pivotal studies to help establish GRAS/GRAE status would become the active control for effectiveness studies involving alcohol-based final formulations. This would be more appropriate than using an FDA-approved product for the active control, particularly for alcohol-based hand sanitizer products where the only FDA-approved drug is a dual-active product.
(Response 15) We do not define a specific positive control material to use in the effectiveness studies in this final rule, but we do recommend the use of an appropriate FDA-approved NDA antiseptic as the positive control (
• We do not have sufficient data to choose a specific universal active control product that will be appropriate for all test formulations or active ingredients.
• Changes to the formulation or manufacturing of the chosen active control product might affect its activity in future studies. Consequently, products tested against the modified active control might not be held to the same standards as products tested previously.
Although we do not identify a specific control product, we do identify test criteria for the active control. As described in section V.D.2, we recommend the use of non-inferiority of the test product to an FDA-approved active control by a margin of 0.5 (log
In addition, we recommend the use of an active control product of the same type as the test product. For example, if the test product is a leave-on surgical hand antiseptic, then an FDA-approved leave-on surgical hand antiseptic should be used as the active control rather than a rinse-off surgical hand antiseptic. We believe it is more appropriate to compare similar types of products.
(Comment 16) One comment stated that a vehicle typically refers to the product formulated without the active ingredient. The comment recommended that the term “vehicle” be replaced with the term “negative control.” Another comment requested that FDA clarify whether testing of the vehicle is required.
(Response 16) We recognize that the term “negative control” may be broader than the term “vehicle,” and we agree that the term “vehicle” should be replaced with the term “negative control” where applicable. As discussed in section V.D.2, we recommend that the effectiveness testing study design for health care antiseptic active ingredients include a negative control arm, which is used as a comparator for the test product. The appropriate negative control to be used in the studies is the test product's vehicle, which we interpret to be the same product being tested, without the active ingredient included, and therefore, best represents the independent contribution of the antiseptic active ingredient. Because the same directions for use will apply to the negative control and the test product, this should account for any potential mechanical removal of microorganisms, which occurs during the rubbing, scrubbing, wiping, or rinsing process, independent of the active ingredient effect. If there is a scientific reason why testing a product using its vehicle as a negative control is not feasible, discussions can be had with FDA to determine whether the use of an alternative negative control, such as a saline solution or nonantimicrobial soap (for health care personnel and surgical hand antiseptics), may be acceptable.
We note that the testing described in this document pertains to single active ingredients. Manufacturers should contact us if, in the future, they would like to develop a fixed-combination health care antiseptic drug product.
(Comment 17) One comment outlined the Agency's proposed requirements listed in the 2015 Health Care Antiseptic PR (80 FR 25166 at 25177 to 25178) for an evaluation of the spectrum and kinetics of antimicrobial activity of a health care antiseptic as including the following:
• A determination of the in vitro spectrum of antimicrobial activity against recently isolated normal flora and cutaneous pathogens;
• Minimum inhibitory concentration (MIC) or minimum bactericidal concentration (MBC) testing of 25 representative clinical isolates and 25 reference strains of each of the microorganisms listed in the 1994 TFM; and
• Time-kill testing of each of the microorganisms listed in the 1994 TFM to assess how rapidly the antiseptic active ingredient produces its effect. The dilutions and time points tested should be relevant to the actual use pattern of the final product.
Another comment stated that the Agency has proposed in vitro testing of 1,150 microorganisms (25 clinical isolates and 25 reference isolates for 23 microorganisms). The comment argued that the Agency's suggestion that previous tests of the same or similar strains are no longer valid is arbitrary and that the requirement for new repeated tests is unduly burdensome. The comment asserted that the proposed number of clinical and reference isolates far exceeds the number required for FDA-approved hand hygiene products, which have successfully completed the review process. The comment recommended that organisms of current clinical value as well as recent clinical isolates be utilized to better assess the in vitro efficacy of these active ingredients. Another comment similarly asserted that the microorganisms identified by FDA for antimicrobial activity testing do not include pathogens that are relevant to current health care settings; the comment argued that the list should include Methicillin-resistant
(Response 17) We agree that the determination of the in vitro spectrum of antimicrobial activity against recently isolated normal flora and cutaneous pathogens is meant to describe what will be learned from the MIC and/or MBC and time-kill studies and is not intended to be a separate study. With regards to testing for the emergence of resistance, we are requiring resistance testing for three of the six deferred active ingredients—benzalkonium chloride, benzethonium chloride, and chloroxylenol (Refs. 10, 11, 12, 13, 14, and 15). However, we are not requiring resistance testing for the other three deferred active ingredients—ethyl alcohol, isopropyl alcohol, and povidone-iodine (see section V.D.2).
In addition, we disagree that we are suggesting that previous tests of the same or similar strains are no longer valid. In the 2015 Health Care Antiseptic PR, we proposed the option of assessing the MBC as an alternative to testing the MIC. We also reiterated our proposal that the evaluation of the spectrum and kinetics of antimicrobial activity of health care antiseptic active ingredients should include MIC (or MBC) testing of 25 representative clinical isolates and 25 reference (
As we explained in the 2015 Health Care Antiseptic PR, we agree that the in vitro testing proposed in the 1994 TFM is not necessary for testing every final formulation of an antiseptic product that contains a GRAE ingredient (80 FR 25166 at 25177). However, we continue to believe that a GRAE determination for health care antiseptic active ingredients should be supported by adequate in vitro characterization of the antimicrobial activity of the ingredient. We note that, for the six deferred active ingredients, the Agency is reviewing proposed protocols for the safety and effectiveness studies, including the list of organisms for the time-kill testing and MIC/MBC testing, which may include additional resistant organisms that are relevant to current health care settings.
(Comment 18) Several comments proposed that the Agency recognize specific ASTM protocols as standardized test methods for demonstrating that an active ingredient is GRAE for use in health care antiseptics and demonstrating effectiveness for final product formulations. These ASTM test methods include the ASTM E1174 “Standard Test Method for the Evaluation of the Effectiveness of Health Care Personnel Handwash Formulations”; the ASTM E2755-10 “Standard Test Method for Determining the Bacteria-Eliminating Effectiveness of Hand Sanitizer Formulations Using Hands of Adults”; the ASTM E1115-11 “Standard Test Method for Evaluation of Surgical Hand Scrub Formulations”; the ASTM E1173-15 “Standard Test Method for Evaluation of Preoperative, Precatheterization, or Preinjection Skin Preparations”; the ASTM E1054 “Standard Test Methods for Evaluation of Inactivators of Antimicrobial Agents”; the ASTM E2783 “Standard Test Method for Assessment of Antimicrobial Activity for Water Miscible Compounds Using a Time-Kill Procedure”; and the Clinical and Laboratory Standards Institute M07-A10 “Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically.”
(Response 18) For purposes of the six deferred active ingredients, we have reviewed these test methods and believe they may be useful to help establish GRAE status for the health care antiseptic products for their respective indications. We are currently discussing with manufacturers and trade organizations that requested the deferrals how these test methods may be used to meet the current effectiveness criteria.
Testing requirements for final formulation, however, are not addressed in this final rule because none of the active ingredients subject to this final rule have been found to be GRAE for use in health care antiseptic products. The testing requirements for final formulation of these products containing the six deferred active ingredients will be addressed after a decision is made regarding the monograph status of those ingredients.
(Comment 19) One comment supported FDA's proposal to require additional safety data for the health care antiseptic active ingredients. The comment agreed that more testing is needed to support a GRAS determination for these active ingredients. Other comments, however, asserted that the safety testing proposed in the 2015 Health Care Antiseptic PR for active ingredients used in health care antiseptics is unnecessary and burdensome. The comments asserted that FDA has not provided data to justify that additional safety data are needed for these ingredients to make a GRAS determination and stated that the extensive historical use of these products should serve as proof of the products' safety and effectiveness.
Another comment stated that FDA must document how the systemic absorption levels of active ingredients from the use of health care antiseptics differ from FDA's previous assessment of the safety of these ingredients. The comment asserted that, given the lack of information on FDA's current position on the specific details regarding risk assessment, FDA should consider in vitro data and dose-extrapolation data.
Another comment suggested that long-term systemic exposure to active ingredients used in health care antiseptics could be reduced if the efficacy standards for these products were decreased because lower dose products could be formulated.
(Response 19) We continue to believe that the additional safety data outlined in the 2015 Health Care Antiseptic PR are necessary to support a GRAS classification for the health care antiseptic active ingredients. As was explained in the 2015 Health Care Antiseptic PR, several important scientific developments that affect the safety evaluation of the health care antiseptic active ingredients have occurred since FDA's 1994 evaluation. New data and information on the health care antiseptic active ingredients raise concerns regarding potential risks from systemic absorption and long-term exposure, as well as development of bacterial resistance related to widespread antiseptic use (80 FR 25166 at 25167). Data that meet current safety standards are needed for FDA to conduct an adequate safety evaluation to ensure that health care antiseptic active ingredients are GRAS. Moreover, as previously explained in this document, the September 2014 NDAC meeting participants discussed FDA's proposed revisions to the safety data requirements and agreed that these requirements were appropriate to demonstrate that a health care antiseptic active ingredient is GRAS. Participants at the September 2014 NDAC meeting further concluded that these safety standards are reasonable and considered them to be minimal safety standards for currently available, as well as future healthcare antiseptic products (Ref. 19).
Moreover, the long history of use of a drug product is not sufficient to demonstrate the safety of the product. In the case of antiseptic products, the Agency has requested safety data in both the 1994 TFM and the 2015 Health Care Antiseptic PR in order to finalize the antiseptic rules. Relying solely on adverse event reporting cannot fill data gaps regarding risks such as reproductive toxicity or carcinogenicity. As an example, phenolphthalein was an OTC product with a long history of use as a laxative, but when animal studies were conducted, evidence of carcinogenicity was detected. The April 30, 1997, FDA Center for Drug Evaluation and Research (CDER) Carcinogenicity Assessment Committee (CAC) meeting concluded that there was supportive evidence indicating that phenolphthalein may be carcinogenic through a genotoxic mechanism. FDA concluded “phenolphthalein caused chromosome aberrations, cell transformation, and mutagenicity in mammalian cells. Because benign and malignant tumor formation occurs at multiple tissue sites in multiple species of experimental animals, phenolphthalein is reasonably anticipated to have human carcinogenic potential.” This conclusion led to the removal of phenolphthalein from the market (64 FR 4535, 4538) (Ref. 20).
Finally, in this context, the safety data required to make a final GRAS determination on active ingredients used in health care antiseptic products would remain the same even if FDA determined that the data requirements necessary to make a GRAE determination should be changed.
(Comment 20) Several comments also stated that the additional testing requirements could cause disruptions of the availability of health care antiseptics for clinical use. One comment urged the Agency to fully consider the consequences of the additional testing requirements, especially at a time when hand hygiene is considered to be the cornerstone for preventing the spread of pathogenic organisms in health care settings.
(Response 20) We agree that health care antiseptic products are an important component of infection control strategies in health care settings and remain the standard of care to prevent illness and the spread of infections (Refs. 7 and 8). As we emphasized in the 2015 Health Care Antiseptic PR, our proposal for more safety and effectiveness data for health
We do not believe that these additional testing requirements will disrupt the availability of health care antiseptics for clinical use. As explained in the 2015 Health Care Antiseptic PR, we provided a process for seeking an extension of time to submit the required safety and/or effectiveness data if needed (80 FR 25166 at 25169). As discussed in this document, we have deferred further rulemaking on six active ingredients used in OTC health care antiseptic products to allow for the development and submission of new safety and efficacy data. Although in this final rule we find that the 24 non-deferred active ingredients are not GRAS/GRAE for use in OTC health care antiseptic products, health care antiseptic drug products that have been approved under an NDA or that contain one or more of the six deferred active ingredients still continue to be available.
Accordingly, we do not believe that the additional testing requirements will cause a disruption in the availability of OTC health care antiseptic products.
(Comment 21) Another comment asserted that FDA's reasons for requesting additional safety data are flawed. The comment stated that FDA should analyze all existing hazard data and consider the extent of human or environmental exposure as part of the process for deciding the nature and extent of hazard data required to understand potential safety concerns. The comment asserted that data generation based on an understanding of human exposure prevents the irresponsible use of laboratory animals and waste of resources necessary to generate toxicology data that will not further inform potential safety decisions.
The comment also contended that the safety data gaps cited by FDA for the ingredients in the 2015 Health Care Antiseptic PR (human pharmacokinetics, animal pharmacokinetics, carcinogenicity, reproductive toxicity, potential hormonal effects, and potential antimicrobial resistance) do not all have to be filled in order for FDA to make a GRAS determination. In support of its position, the comment cited FDA's presentation to the September 2014 NDAC meeting, and listed FDA's stated criteria associated with the GRAS standard, including: (1) A low incidence of adverse events when used as directed and in the context of warnings; (2) low potential for harm if abused under conditions of widespread availability; (3) significant human marketing experience; (4) and, adequate tests to show proof of safety, among other criteria. The comment stated that FDA is not taking into account the low incidence of adverse events associated with the use of antiseptic active ingredients and the overall acceptance of these products globally. The comment also mentioned that numerous scientific and regulatory bodies have performed exposure-driven risk assessments and have not required the types of human or animal data mentioned in the 2015 Health Care Antiseptic PR.
(Response 21) FDA presented the safety paradigm for OTC health care antiseptics at the September 2014 NDAC meeting (Ref. 21) where the Agency sought NDAC's advice about the type and scope of safety data needed for OTC health care antiseptic products. In FDA's presentation to NDAC, we explained that when evaluating a proposed monograph active ingredient, FDA applies the following regulatory standards, which are cited in 21 CFR 330.10(a)(4)(i):
• Safety means a low incidence of adverse reactions or significant side effects under adequate directions for use and warnings against unsafe use, as well as low potential for harm which may result from abuse under conditions of widespread availability.
• Proof of safety shall consist of adequate tests by methods reasonably applicable to show the drug is safe under the prescribed, recommended, or suggested conditions of use. This proof shall include, but not be limited to, results of significant human experience during marketing.
• General recognition of safety shall ordinarily be based upon published studies, which may be corroborated by unpublished studies and other data.
As FDA explained in its presentation, the proposed safety studies are necessary to provide data that are needed to support a GRAS determination for the health care antiseptic active ingredients. The NDAC unanimously agreed that the safety standards proposed by FDA are appropriate to support a GRAS determination for a health care antiseptic active ingredient. The NDAC also noted that the safety standards presented by FDA are reasonable minimal safety standards for the currently available antiseptics, as well as for products to be formulated in the future (Ref. 19) and are required to support a GRAS determination for these ingredients.
In terms of animal testing, the September 2014 NDAC meeting addressed the issue of the appropriateness of conducting animal studies to obtain safety data for health care antiseptic products (Ref. 4). We understand that animal use in tests for the efficacy and safety of human and animal products has been and continues to be a concern, and FDA continues to support efforts to reduce animal testing, particularly where new alternative methods for safety evaluation have been validated and accepted by International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) regulatory authorities. To address this issue, we encourage manufacturers to consult with the Agency on the use of non-animal testing methods that may be suitable, adequate, validated, and feasible to fill important data gaps that cannot be filled with marketing experience alone. However, there are still many areas where non-animal testing has not been sufficiently developed as an alternative option and animal studies are still considered necessary to fill important safety gaps (Refs. 4 and 19).
(Comment 22) One comment asserted that FDA should reconsider the need to conduct MUsTs to assess systemic exposures associated with extreme use applications. The comment stated that the clinical utility of this testing has not been firmly established and the methodology necessary to conduct this type of testing has yet to be clearly validated to establish its utility. The comment argued that these types of studies need significant further development and validation before considering them a reliable method for systemic absorption studies and further guidance from FDA is needed. The comment said that FDA should also consider the use of existing modeling methods as a means to assess potential systemic exposure to avoid unnecessary clinical testing of active ingredients where modeling is available in conjunction with animal data.
(Response 22) The MUsT paradigm has been used in the evaluation of topical dermatological agents approved in the United States since the early 1990s. It represents over 20 years of interactions with multi-national drug companies, during which time the study design has been refined into its current state. Moreover, the MUsT is a published methodology that has been
FDA also understands and recognizes the potential of pharmacokinetic (PK) and physiologically-based pharmacokinetic (PBPK) modeling. FDA has considered these options and concluded that the currently proposed alternatives, including in silico, in vitro, and PBPK modeling, are not adequately validated to be a substitute for the MUsT described in the 2015 Health Care Antiseptic PR. We also note that, going forward, in order to validate the PBPK or any other alternative modeling-based approach, one would need, as part of their validation, a direct performance comparison to a series of in vivo MUsTs as part of the process to demonstrate the comparability and reproducibility of the results between the tests. For these reasons, we find that results from a human PK MUsT are needed to support a GRAS determination for active ingredients used in health care antiseptic products.
(Comment 23) Another comment disagreed with FDA's position that the lack of pharmacokinetic data prevents FDA from calculating a margin of exposure for the risk assessment. The comment asserted that, although the safety evaluation of drugs may rely on correlating findings from animal toxicity studies to humans based on kinetic information in both species, safety evaluations for antiseptic ingredients in health care products are not based on kinetic information under standard international practice. Instead, the comment argued, safety evaluations are based on conservative assumptions of exposure and potential differences between species, and kinetic information is only required when use of these conservative assumptions fails to provide a sufficient margin of exposure. The comment stated that using these conservative and internationally accepted approaches, other scientific bodies and regulatory authorities have been able to complete the risk assessment for these types of ingredients in formulations with much greater levels of human exposure than these health care antiseptic uses. The European Commission Scientific Committee on Consumer Safety Guidance for the Testing of Cosmetic Substances and Their Safety Evaluation (8th Revision) was cited as a justification for this concept. Based on this reasoning, the comment asserted that FDA should not require additional animal testing unless the following conditions are met:
• Use of conservative approaches to calculate the margin of exposure is inadequate.
• The margin of exposure justifies the need for more data, but it is not possible to generate the data by non-animal approaches, such as using physiologically-based pharmacokinetic modeling, or through animal alternative test methods.
• There is perceived need for all active ingredients to have the same type of information.
(Response 23) Calculating the margin of exposure was one of the topics discussed at the September 2014 NDAC meeting (Refs. 4 and 19). At that time, the consensus reached was that these types of calculations are more informed when taking the results of the MUsT-acquired data and using that information along with the pharmacology/toxicology results in the calculation of the safety margin. We also note that the references the comments provided for the risk assessment strategies that are followed by other international agencies are for cosmetic ingredients rather than for drug products. Accordingly, the referenced guidance may be designed to address different concerns than those at issue here.
(Comment 24) Another comment stated that FDA should reconsider the concept of the MUsT and its value in determining the safety of health care antiseptic products. The comment said that the 2015 Health Care Antiseptic PR would require a MUsT to characterize maximum systemic exposure following health care antiseptic product use during the course of a work day or shift in health care settings. The comment stated that measured levels determined by the MUsT would establish the maximum systemic dose for the active ingredient in the particular antimicrobial product type, and the representativeness of the measured systemic active concentration would be dependent upon a number of variables associated with this trial, including the number of applications made per day or shift, the appropriate usage of the product, the concentration of active ingredient in the tested product, the sensitivity of the analytical method applied, and the extent to which the experimental protocol matches or approximates the actual usage of the product in the health care setting. The comment asserted that the use of the same product in different health care settings (
The comment also argued that limitations exist in the practical conduct of a MUsT that influence and dictate what may be achieved by a specific protocol. The comment stated that practical requirements, for instance, the time needed to collect biological samples, or even to perform washing or application of the product, will dictate how many washes or applications are possible in a given time period regardless of what may be deemed desirable or required to evaluate perceived or empirical usage. As a result, the comment argued, the MUsT conditions described in the 2015 Health Care Antiseptic PR will result in assays that are very large and complex, and there is very little precedent to consult in the published literature. The comment also argued that the practical aspects of conducting a MUsT dictate what can reasonably be performed in terms of number of product applications, number of subjects, study arms, and timing. The comment asserted that if the defined, or desired, maximal use is not achievable in a MUsT and the resulting data do not meet the needs of the safety and risk assessment process, it is reasonable to question the utility, and expense, of conducting the study at all.
(Response 24) The MUsT intends to reflect the upper end of use expected in the real-world. Because the MUsT is designed to represent, as closely as possible, the maximal use of the health care antiseptic product under actual use conditions in the health care setting, the conduct of the trial itself should be feasible. The goal of the MUsT is to evaluate absorption under conditions of maximum use, so lower rates of application, different sites, and different frequency of application will be covered. As we also mentioned, with respect to the six deferred active ingredients, FDA is reviewing protocol designs for the respective deferred active ingredients.
(Comment 25) Another comment stated that, while data on the level of active ingredient in systemic circulation is arguably important for risk and safety assessment, it is not clear what any observed levels from MUsT may mean in this context in regards to risk and safety assessment. The comment argued that FDA has provided little guidance on how the MUsT data are used and that FDA has provided no data to indicate that there are any safety issues associated with any of the six active ingredients identified in the comment (alcohol, isopropyl alcohol, benzalkonium chloride, benzethonium
(Response 25) We disagree with the comment's assertion that the Agency has not provided any data to indicate that there are safety issues associated with the six active ingredients identified in the comment, which are the six active ingredients we have deferred from this rulemaking. Based on known available data, including data submitted by the interested parties, FDA identified and summarized safety concerns and safety data gaps for the health care active ingredients at the September 2014 NDAC meeting (Refs. 4 and 21) and in the 2015 Health Care antiseptic PR (80 FR 25166 at 25179 to 25195).
Moreover, the MUsT approach was specifically discussed at the September 2014 NDAC meeting (Refs. 4, 19, and 21). Information on systemic exposure derived from the MUsTs is necessary to determine a safety margin for the active ingredients. A margin of safety is a calculation that takes the no observed adverse effect level (NOAEL) derived from animal data and estimates a maximum safe level of exposure for humans, the data for which would be derived from data generated in the MUsT. In its objection to the proposed MUsT requirements, the comment did not provide an alternative or other validated and accepted approach available to assess human systemic exposure to the active ingredients (Refs. 4 and 21).
(Comment 26) Another comment stated that if MUsTs are to be executed, field studies of health care facility application frequency would be necessary to determine maximum rates as adequate data do not currently exist. The comment asserted that while these studies could take the form of a direct observational study, other avenues may also be considered, such as the use of automated hand hygiene monitoring data. The comment also stated that this data acquisition approach is not subject to behavioral modification interferences by the observer, or hospital department access restrictions, such as the intensive care and surgery units. The comment asserted that this technology has recently progressed substantially in its sophistication and data reliability.
(Response 26) As was mentioned earlier, FDA is discussing the design and conduct of their MUsT program of studies for the six deferred active ingredients.
(Comment 27) One comment submitted in response to the 2015 Health Care Antiseptic PR stated its support for an industry comment submitted to the September 2014 NDAC meeting, which stated that the FDA proposed a safety testing program for OTC products similar to those required for new molecular entity or new chemical entity (NCE) review. The submission asserted that the active ingredients under the 1994 TFM are not NCEs and should not be subjected to requirements that surpass the requirements of a conventional NDA. The submission stated that, in FDA's proposal for the consumer antiseptic wash TFM, the unsubstantiated justification for additional safety data is stated as “new information regarding the potential risks from systemic absorption and long-term exposure to antiseptic active ingredients” and the fact that exposure may be “higher than previously thought,” which, the submission argued, is not supported by information in the 2013 Consumer Antiseptic Wash PR or in the docket.
(Response 27) The assertion that the standards being proposed “surpass the requirements of a conventional NDA” is incorrect. As an example, the MUsT has been required of topical NDA products approved since the early 1990s. Also, a MUsT is often necessary to assess absorption when a topical NDA product is reformulated. Whereas, for the health care antiseptic products under consideration in this rulemaking, once an active ingredient is determined to be GRASE for a particular indication, although in vitro testing would be required under the current framework, no further in vivo studies, including a MUsT, would be required unless in vitro testing suggests that substantially greater absorption may occur with a particular formulation.
(Comment 28) Several comments asked FDA to reconsider the requirements for carcinogenicity studies, asserting that a good quality systemic carcinogenicity data set exists, along with in vitro genetic toxicology studies, for the majority of the active ingredients. The comments stated that it is unclear why FDA is requesting additional carcinogenicity studies for these ingredients. The comments also asserted that FDA should justify the requirement for additional carcinogenicity studies by the dermal route of exposure when a carcinogenicity study by the oral route exists because it is highly unlikely that systemic exposure would be higher from the dermal route of exposure than that resulting from the oral route of exposure. One comment requested that FDA focus on the “health effects to be addressed in the safety assessment” rather than establishing “studies to be performed.” Another comment stated that if inhalation carcinogenicity data are available, that such data may be used for worst-case exposure scenarios.
(Response 28) The FDA is requesting dermal carcinogenicity assessment for these topically applied ingredients because the dose that the skin is exposed to following topical exposure can be much higher than the skin dose resulting from systemic exposure (81 FR 61106 at 61123). FDA does not consider in vitro genetic toxicology studies to be a substitute for in vivo carcinogenicity studies. In addition, systemic exposure to the parent drug and metabolites can differ significantly in topically applied products, compared to orally administered products because the skin has its own metabolic capability (81 FR 61106 at 61123). Furthermore, the first-pass metabolism, which is available following oral exposure, is bypassed in the topical route of administration (81 FR 61106 at 61123) (Ref. 22). Dermal carcinogenicity studies, therefore, are not used solely to assess the effect of a drug on the skin tissue, but rather to evaluate the effect of topical exposure to all tissues of the treated animals.
(Comment 29) One comment agreed with the Agency that any toxicological risk assessment should consider whether, under conditions of use, an ingredient could cause adverse effects as a result of its ability to interfere with endocrine homeostasis. The comment also agreed with the Agency's statement that general and reproductive toxicology studies are generally adequate to identify potential hormonal effects. The comment urged FDA to take a flexible approach to measuring hormonal effects, and stated that any potential for hormonal effects can be addressed by the interpretation of repeat-dose or developmental and reproductive toxicity testing (DART) data. Specifically, the comment stated that FDA should emphasize that a repeat-dose DART study will provide the point of departure (
(Response 29) We agree that data for hormonal effects can be gleaned from
(Comment 30) Numerous comments on the issue of bacterial resistance were submitted in response to the 2015 Health Care Antiseptic PR. In general, the comments disagreed on whether antiseptics pose a public health risk from bacterial resistance. Some comments argued that the pervasive use of health care antiseptics poses an unacceptable risk for the development of resistance and that such products should be banned. Other comments argued that antiseptics do not pose such risks and criticized the data on which they believe FDA based its concerns.
Specifically, several comments dismissed the in vitro data cited by FDA in the 2015 Health Care Antiseptic PR as not reflecting real-life conditions. The comments recommended that the most useful assessment of the risk of biocide resistance and cross-resistance to antibiotics are in situ studies, studies of clinical and environmental strains, or biomonitoring studies. Some comments asserted that studies of this type have reinforced the evidence that resistance and cross-resistance associated with antiseptics is a laboratory phenomenon observed only when tests are conducted under unrealistic conditions. One comment stated that there is little credible evidence that antiseptic products play any role in antibiotic resistance in human disease. The comment stated that, while some in vitro lab studies have been successful in forcing expression of resistance in some bacteria to antiseptic active ingredients, real world data from community studies using actual product formulations show no correlation between the use of such products and antibiotic resistance. The comment stated that further evidence of real world data showing no antimicrobial resistance development after the continued use of consumer products containing antimicrobial active compounds can be extracted from oral care clinical studies, which provide in vivo data, under well-controlled conditions, on exposure to antimicrobial-containing formulations over prolonged periods of time (
(Response 30) As stated in the 2015 Health Care Antiseptic PR, we continue to believe that the development of bacteria that are resistant to antibiotics is an important public health issue, and additional data may tell us whether use of antiseptics in health care settings may contribute to the selection of bacteria that are less susceptible to both antiseptics and antibiotics (80 FR 25166 at 25183). Thus, we have conducted ingredient-specific reviews of the literature pertaining to antiseptic resistance and antibiotic cross-resistance, and determined that additional studies to assess the development of cross-resistance to antibiotics are needed for three of the deferred active ingredients—benzalkonium chloride, benzethonium chloride, and chloroxylenol. In the case of ethyl alcohol and isopropyl alcohol, sufficient data has been provided to assess the risk of antiseptic resistance and antibiotic cross-resistance.
Laboratory studies have identified and characterized bacterial resistance mechanisms that confer a reduced susceptibility to antiseptics and, in some cases, antibiotics. Specifically, these data suggest that resistance development in the laboratory is very common for some active ingredients, such as benzethonium and benzalkonium chloride (Refs. 28, 29, 30, 31, and 32), and chloroxylenol (Refs. 33, 34, 35, 36, 37, and 38). In contrast, resistance to other active ingredients, such as povidone-iodine (Refs. 39, 40, and 41) occurs infrequently in the laboratory setting. We acknowledge that observations made in the laboratory setting are not necessarily replicated in the real world setting. Therefore, we assessed additional studies performed in the clinical setting.
Studies performed using clinical isolates found strong evidence of antiseptic resistance to benzethonium and benzalkonium chloride (Refs. 42, 43, 44, 45, 46, 47, 48, 49, and 50). Antiseptic resistance genes
Only one clinical study could be found assessing resistance to chloroxylenol. Khor et al. (Ref. 53) collected samples from disinfectant solutions in hospitals. Of the chloroxylenol solutions tested, 42 percent had bacterial contamination. Isolation of these bacteria demonstrated that 81 percent were resistant to chloroxylenol, suggesting that these organisms have adapted to survival at concentrations which are usually bactericidal. Clinical studies assessing bacterial resistance to povidone-iodine were primarily negative (Refs. 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, and 64). Only one study, by Mycock et al. (Ref. 65), demonstrated resistance to povidone-iodine using clinical isolates, yet this study could not be repeated (Ref. 66). We believe that there is sufficient information to determine that exposure to povidone-iodine does not lead to the development of bacterial resistance, but additional data is necessary to assess this issue with regards to chloroxylenol.
Other studies examined a possible correlation between antiseptic and antibiotic resistance (Refs. 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 52, 53, 54, 55, 67, 68, 69, 70, 71, and 72). Comparisons suggest that alterations in the mean susceptibility of
In general, studies have not clearly demonstrated an impact of antiseptic bacterial resistance mechanisms in the clinical setting. However, the available studies have limitations. As we noted in the 2015 Health Care Antiseptic PR, studies in a clinical setting that we evaluated were limited by the small numbers and types of organisms, the brief time periods, and the locations examined. Bacteria expressing resistance mechanisms with a decreased susceptibility to antiseptics and some antibiotics have been isolated from a variety of natural settings (Refs. 73 and 74). Although the prevalence of antiseptic tolerant subpopulations in natural microbial populations is currently low, overuse of antiseptic active ingredients has the potential to select for resistant microorganisms.
In sum, adequate data do not exist currently to determine whether the development of bacterial antiseptic resistance could also select for antibiotic resistant bacteria or how significant this selective pressure would be relative to the overuse of antibiotics, an important driver for antibiotic resistance. Moreover, the possible correlation between antiseptic and antibiotic resistance is not the only concern. Reduced antiseptic susceptibility may allow the persistence of organisms in the presence of low-level residues and contribute to the survival of antibiotic resistant organisms. Data are not currently available to assess the magnitude of this risk.
(Comment 31) The comments also disagreed on the data needed to assess the risk of the development of resistance. One comment disagreed with the proposed testing described in the 2015 Health Care Antiseptic PR, arguing that there are no standard laboratory methods for evaluating the development of antimicrobial resistance. With regard to the recommendation for mechanism studies, they believed that it is unlikely that this kind of information can be developed for all active ingredients, particularly given that the mechanism(s) of action may be concentration dependent and combination/formulation effects may be highly relevant. The comments also believed that data characterizing the potential for transferring a resistance determinant to other bacteria is also an unrealistic requirement for a GRAS determination.
Conversely, one comment recommended that antimicrobial resistance be addressed first through in vitro MIC determinations. The comment stated that, if an organism is shown to develop resistance rapidly, FDA should consider this information in its evaluation. The commenter believed that this test of the potential for the development of resistance is important because health care compliance with recommended use of health care antiseptic wash products is variable and products that result in the rapid development of antimicrobial resistance would pose a public health risk. The comment also asserted that GRAS/GRAE ingredients should pose little in the way of a resistance risk.
(Response 31) In the 2015 Health Care Antiseptic PR, we described the data needed to help establish a better understanding of the interactions between antiseptic active ingredients in health care antiseptic products and bacterial resistance mechanisms and the data needed to provide the information necessary to perform an adequate risk assessment for these health care product uses. We suggested a tiered approach as an efficient means of developing data to address this resistance issue—beginning with laboratory studies aimed at evaluating the impact of exposure to nonlethal amounts of antiseptic active ingredients on antiseptic and antibiotic bacterial susceptibilities, along with additional data, if necessary, to help assess the likelihood that changes in susceptibility observed in the preliminary studies would occur in the health care setting (80 FR 25166 at 25183 to 25184).
As we explained in the 2015 Health Care Antiseptic PR, we recognize that the science of evaluating the potential of compounds to cause bacterial resistance is evolving and acknowledged the possibility that alternative data may be identified as an appropriate substitute for evaluating resistance (80 FR 25166 at 25180). We also explained that we are aware that there are no standard protocols for these studies, but there are numerous publications in the literature of studies of this type that could provide guidance on the study design (Refs. 75, 76, and 77).
As explained in this document, we have deferred from this rulemaking six of the active ingredients used in health care antiseptic products, and we are discussing proposed protocols for the safety and effectiveness studies (Refs. 10, 11, 12, 13, 14, and 15). For those active ingredients for which resistance testing is required—chloroxylenol, benzethonium chloride, and benzalkonium chloride—we have advised manufacturers, as an initial step, to conduct an active ingredient-specific literature review related to antiseptic resistance and antibiotic cross-resistance to assess the active ingredient's effect on development of cross-resistance to antiseptics and antibiotics in the health care setting, and to submit as much information and data as can be provided. If the literature review results show evidence of antiseptic or antibiotic resistance, additional studies may be necessary, consistent with the recommendations outlined in the 2015 Health Care Antiseptic PR (80 FR 25166 at 25183 to 25184), to help assess the impact of the active ingredient on antiseptic and antibiotic susceptibilities. If, however, the literature review provides no evidence that the active ingredient affects antiseptic or antibiotic susceptibility, then it is likely that no further studies to address development of resistance will be needed to support a GRAS determination.
(Comment 32) One comment also stated that FDA's evaluation of risks associated with the extensive use of health care antiseptic soaps by health care workers should include the data from the Nurses' Health Studies (NHS), which are a series of long-term studies of health outcomes in several large cohorts of nurses. The comment asserted that these studies did not show any evidence that the use of topical health care antiseptics leads to adverse health outcomes in nurses. The comment concedes that the studies were not designed to evaluate risks associated with the use of antiseptic soaps, but still believes these studies are adequate to detect clinically-relevant health outcomes, including those associated with endocrine effects, that might arise from the use of antiseptic soaps.
The comment also noted that the FDA's Safety Information and Adverse Event Reporting Program, MedWatch, did not have any safety-related reports on the health care antiseptic products identified in the 2015 Health Care Antiseptic PR. In addition, the comment stated that FDA has not issued any safety alerts related to antiseptic skin products.
(Response 32) FDA searched the NHS website cited in the comment,
We also note that the safety signals FDA uses in making a GRAS determination, such as developmental and reproductive toxicity, carcinogenicity, or hormonal effects, would not likely be reported by consumers or health care professionals to MedWatch. Thus, the lack of MedWatch safety-related reports does not eliminate the need for the safety data outlined in the 2015 Health Care Antiseptic PR.
(Comment 33) One comment stated that, for FDA to fully assess the safety of the health care topical antiseptic active ingredients, it must consider the impact of exposure on groups that may be particularly sensitive to exposure, including pregnant women, children, and the elderly, particularly with regards to chronic or highly sensitive (
The comment also proposed that in classifying an ingredient as GRAS/GRAE, FDA should expand the health impacts (
The comment also asserted that data used in the safety evaluation of these ingredients should include metabolic parameters of disease states of individuals who would be chronically exposed to health care antiseptics in animal pharmacokinetic absorption, distribution, metabolism, and excretion (ADME) models.
(Response 33) We agree that the impact of exposure to sensitive populations should be considered. Our paradigm of safety evaluation, which includes a battery of safety studies (ADME, MUsT, carcinogenicity, DART, and hormonal effects), can be used to establish a safety margin for potential safety signals in all populations, including sensitive ones.
Currently, the effect of health care antiseptic active ingredients on the microbiome have not been included as a safety signal in classifying an active ingredient as GRAS or non-GRAS. FDA will continue to monitor emerging technologies that can help address safety signals for all of the products that it regulates, including products under the OTC topical antiseptic monograph.
In addition, because there are many disease states which health care professionals or patients could have, it is not feasible to develop metabolic parameters for individual disease states in conducting the GRAS determinations of the active ingredients used in health care antiseptic products. Nor could one prospectively identify which specific metabolic parameters should be tracked, or if there were defined levels of changes in each parameter that would be of concern.
(Comment 34) Another comment stated that FDA needs to address the impact of inactive ingredients and final formulations on the safety assessments of health care antiseptic products.
(Response 34) Testing requirements for the final product formulations, which would require exposure to both active and inactive ingredients, are not addressed in this final rule because none of the active ingredients that are the subject of this final rule are considered GRAS/GRAE for use in health care antiseptic products, given the lack of sufficient effectiveness and safety data submitted for these ingredients. The testing requirements for final formulations of products containing the six deferred active ingredients will be addressed, if applicable, after a decision is made regarding the monograph status of those ingredients.
(Comment 35) One comment indicated that the cost of conducting safety studies is expensive and asserted that the testing requirements run counter to the spirit of the OTC monograph. The comment proposed that the safety studies, should therefore, be conducted by academic and National Institutes of Health (NIH) investigators.
(Response 35) The monograph process is public in nature and studies may be conducted by any interested parties, including academics and NIH investigators. FDA is willing to review all relevant available data in order to reach a final determination of safety and effectiveness. Ultimately, manufacturers are responsible for the safety and effectiveness of the drug products they market.
(Comment 36) One comment contended that NDA products, such as Avagard (1 percent chlorhexidine gluconate, 62 percent ethyl alcohol) should be subject to the safety standards proposed in the 2015 Health Care Antiseptic PR.
(Response 36) FDA regulates NDA products under a different regulatory pathway than the OTC drug monograph products, such as the OTC health care antiseptics that are the subject of this rulemaking. We consider safety criteria for both monograph and NDA products. The review of an individual product under an NDA may warrant a different assessment than a group of active ingredients used in a range of products.
(Comment 37) Several comments raised issues concerning the preliminary regulatory impact analysis and the Agency's assessment of the net benefit of the rulemaking.
(Response 37) Our response is provided in the full discussion of economic impacts, available in the docket for this rulemaking (Docket No. FDA-2015-N-0101, (Ref. 78),
No additional safety or effectiveness data have been submitted to support a GRAS/GRAE determination for the non-deferred health care antiseptic active ingredients described in this rule. Thus, the following active ingredients are not GRAS/GRAE for use as a health care antiseptic:
Accordingly, OTC health care antiseptic drug products containing these active ingredients will require approval under an NDA or ANDA prior to marketing.
In the 2015 Health Care Antiseptic PR, we recognized, based on the scope of products subject to this final rule, that manufacturers would need time to comply with this final rule. Thus, as proposed in the 2015 Health Care Antiseptic PR (80 FR 25166 at 25195), this final rule will be effective 1 year after the date of the final rule's publication in the
The summary analysis of benefits and costs included in this final rule is drawn from the detailed Regulatory Impact Analysis that is available at
We have examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, Executive Order 13771, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). Executive Order 13771 requires that the costs associated with significant new regulations “shall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least two prior regulations.” We believe that this final rule is a significant regulatory action as defined by Executive Order 12866. This final rule is considered an Executive Order 13771 regulatory action.
The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because we estimate that only four small businesses will be adversely affected by the final rule, we certify that the final rule will not have a significant economic impact on a substantial number of small entities.
The Unfunded Mandates Reform Act of 1995 (Section 202(a)) requires us to 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. This final rule would not result in an expenditure in any year that meets or exceeds this amount
As discussed in the preamble of this final rule, this rule establishes that 24 eligible active ingredients are not generally recognized as safe and effective for use in OTC health care antiseptics. However, data from the FDA drug product registration database suggest that only one of these 24 ingredients is found in OTC health care antiseptic products currently marketed pursuant to the TFM: Triclosan. Regulatory action is being deferred on six active ingredients that were addressed in the health care antiseptic proposed rule: Benzalkonium chloride, benzethonium chloride, chloroxylenol, ethyl alcohol, isopropyl alcohol, and povidone-iodine. This final rule also addresses the eligibility of three active ingredients—alcohol (ethyl alcohol, see section V.C.3), benzethonium chloride, and chlorhexidine gluconate—and finds that these three active ingredients are ineligible for evaluation under the OTC Drug Review for certain health care antiseptic uses (see section IV.D.1, table 3). To our knowledge, there is only one ineligible product currently on the market, an alcohol-containing surgical hand scrub, which is affected by this rule.
Benefits are quantified as the volume reduction in exposure to triclosan found in health care antiseptic products affected by the rule, but these benefits are not monetized. Annual benefits are estimated to be a reduction in exposure of 88,000 kg of triclosan per year.
Costs are calculated as the one-time costs associated with reformulating health care antiseptic products containing the active ingredient triclosan and relabeling reformulated products, plus the lost producer surplus (measured as lost revenues) due to removing one alcohol surgical hand scrub from the market. We believe that the alcohol-containing surgical hand scrub that is affected by this rule is likely to be removed from the market. We categorize the associated loss of sales revenue as a transfer from one manufacturer to another and not a cost, because we assume that the supply of other, highly substitutable, products is highly elastic.
Annualizing the one-time costs over a 10-year period, we estimate total annualized costs to range from $1.1 to $4.1 million at a 3 percent discount rate, and from $1.2 to $4.7 million at a 7 percent discount rate. The present value of total costs ranges from $9.0 to $34.6 million at a 3 percent discount rate, and from $8.7 to $29.6 million at a 7 percent discount rate.
In this final rule, small entities will bear costs to the extent that they must reformulate and re-label any health care antiseptic containing triclosan that they produce. The average cost to small firms of implementing the requirements of this final rule is estimated to be $213,176 per firm. The costs of the changes, along with the small number of firms affected, implies that this burden would not be significant, so we certify that this final rule will not have a significant economic impact on a substantial number of small entities. This analysis, together with other relevant sections of this document, serves as the Regulatory Flexibility Analysis, as required under the Regulatory Flexibility Act.
We have developed a comprehensive Economic Analysis of Impacts that assesses the impacts of the final rule. The full analysis of economic impacts is available in docket FDA-2015-N-0101 (Ref. 78) and at
This final rule contains no collection of information. Therefore, clearance by OMB under the Paperwork Reduction Act of 1995 is not required.
We have determined under 21 CFR 25.31(a) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
We have analyzed this final rule in accordance with the principles set forth in Executive Order 13132. Section 4(a) of the Executive order requires agencies to “construe . . . a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State authority conflicts with the exercise of Federal authority under the Federal statute.” The sole statutory provision giving preemptive effect to the final rule is section 751 of the FD&C Act (21 U.S.C. 379r). We have complied with all of the applicable requirements under the Executive order and have determined that the preemptive effects
The following references are on display at the office of the Dockets Management Staff (see
Administrative practice and procedure, Drugs, Labeling, Medical devices, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 310 is amended as follows:
21 U.S.C. 321, 331, 351, 352, 353, 355, 360b-360f, 360j, 360hh-360ss, 361(a), 371, 374, 375, 379e, 379k-l; 42 U.S.C. 216, 241, 242(a), 262.
The additions read as follows:
(a) * * *
(27) * * *
(v) [Reserved]
(vi)
(vii) [Reserved]
(viii)
(ix) [Reserved]
(x)
(d) * * *
(42) December 20, 2018, for products subject to paragraphs (a)(27)(vi) through (x) of this section.
| 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 |