83_FR_142
Page Range | 34933-35103 | |
FR Document |
Page and Subject | |
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83 FR 35000 - Announcement of the Per- and Polyfluoroalkyl Substances (PFAS) Pennsylvania Community Engagement | |
83 FR 35099 - Establishing the President's National Council for the American Worker | |
83 FR 35022 - Government in the Sunshine Act Meeting Notice | |
83 FR 35041 - Sunshine Act Meetings | |
83 FR 34987 - Applications for New Awards; Training and Information for Parents of Children With Disabilities-Technical Assistance for Parent Centers | |
83 FR 35052 - Notice of Opportunity for Public Comment on a Land Use Change From Aeronautical to Non-Aeronautical Use for Revenue Generation of 8.5 Acres of Airport Land at Southbridge Municipal Airport in Southbridge, MA | |
83 FR 35052 - Corrections to Previous Notice Regarding Supplemental Guidance on the Airport Improvement Program (AIP) for Fiscal Years 2018-2020 | |
83 FR 35056 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Multiple IRS Information Collection Requests | |
83 FR 35000 - Information Collections Being Submitted for Review and Approval to the Office of Management and Budget | |
83 FR 34983 - Submission for OMB Review; Comment Request | |
83 FR 35018 - Agency Information Collection Activities: Entry/Immediate Delivery Application and ACE Cargo Release | |
83 FR 34951 - Fisheries of the Exclusive Economic Zone Off Alaska; Reapportionment of the 2018 Gulf of Alaska Pacific Halibut Prohibited Species Catch Limits for the Trawl Deep-Water and Shallow-Water Fishery Categories | |
83 FR 35001 - Notice of Agreements Filed | |
83 FR 34983 - Export Trade Certificate of Review | |
83 FR 35031 - Proposed Submission of Information Collections for OMB Review; Comment Request; Reportable Events; Notice of Failure To Make Required Contributions | |
83 FR 34998 - Agency Information Collection Extension | |
83 FR 35017 - Submission for OMB Review; 30-Day Comment Request; DERT Extramural Grantee Data Collection (NIEHS) | |
83 FR 34986 - Agency Information Collection Activities: Notice of Intent To Extend Collection 3038-0069, Information Management Requirements for Derivatives Clearing Organizations | |
83 FR 34981 - Submission for OMB Review; Comment Request | |
83 FR 35028 - Agency Information Collection Activities: Proposed Collection; Comment Request | |
83 FR 35052 - Petition for Waiver of Compliance | |
83 FR 35054 - Notice of Submission of Proposed Information Collections to OMB; Agency Request for Renewal of Previously Approved Information Collections: Nondiscrimination on the Basis of Disability in Air Travel | |
83 FR 34953 - Sweet Onions Grown in the Walla Walla Valley of Southeast Washington and Northeast Oregon; Proposed Amendments to the Marketing Order (No. 956) | |
83 FR 34951 - Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; 2018 Commercial Accountability Measure and Closure for South Atlantic Snowy Grouper | |
83 FR 35002 - Formations of, Acquisitions by, and Mergers of Bank Holding Companies | |
83 FR 35001 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company | |
83 FR 34935 - Marketing Order Regulating the Handling of Spearmint Oil Produced in the Far West; Salable Quantities and Allotment Percentages for the 2018-2019 Marketing Year | |
83 FR 34987 - Intent To Grant an Exclusive License of U.S. Government-Owned Patents | |
83 FR 34999 - Combined Notice of Filings #1 | |
83 FR 34999 - Wildcat Ranch Wind Project, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
83 FR 35029 - Southern Nuclear Operating Company, Inc.; Vogtle Electric Generating Plant, Units 3 and 4; Consistency and Clarification Changes to Annex Building, Auxiliary Building, and Basemat ITAAC | |
83 FR 35007 - Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments | |
83 FR 35004 - Board of Scientific Counselors, Office of Public Health Preparedness and Response, (BSC, OPHPR) | |
83 FR 35005 - Regulatory Perspectives on Otic and Vestibular Toxicity: Challenges in Translating Animal Studies to Human Risk Assessment; Public Workshop | |
83 FR 35009 - International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies To Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Marker Residue Depletion Studies To Establish Product Withdrawal Periods in Aquatic Species; Draft Guidance for Industry; Availability | |
83 FR 35006 - Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development; Draft Guidance for Industry; Availability | |
83 FR 35053 - Notice of Receipt of Petition for Decision That Nonconforming Model Year 2013 Porsche Panamera Passenger Cars Are Eligible for Importation | |
83 FR 34944 - Safety Zones; Pipeline Construction, Tennessee River Miles 465 to 466, Chattanooga, TN | |
83 FR 35023 - Proposed Modification to the List of Appropriate NRTL Program Test Standards and the Scopes of Recognition of Several NRTLs | |
83 FR 35026 - MET Laboratories, Inc.: Application for Expansion of Recognition and Proposed Modification to the NRTL Program's List of Appropriate Test Standards | |
83 FR 35022 - TUV SUD America, Inc.: Application for Expansion of Recognition | |
83 FR 35033 - Self-Regulatory Organizations; ICE Clear Credit LLC; Notice of Filing of Proposed Rule Change Relating to ICC's Risk Management Model Description Document and ICC's Risk Management Framework | |
83 FR 35048 - Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing of Proposed Rule Change Relating to Amendments to the ICE Clear Europe CDS End-of-Day Price Discovery Policy (“Price Discovery Policy”) | |
83 FR 35044 - Self-Regulatory Organizations; The Depository Trust Company; Notice of Filing of Proposed Rule Change To Amend Rule 35 To Provide for Designated Accounts for Use With Designated Collateral Management Service Providers | |
83 FR 35040 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Designation of a Longer Period for Commission Action on Proceedings To Determine Whether To Approve or Disapprove a Proposed Rule Change Relating to Listing and Trading of the Direxion Daily Bitcoin Bear 1X Shares, Direxion Daily Bitcoin 1.25X Bull Shares, Direxion Daily Bitcoin 1.5X Bull Shares, Direxion Daily Bitcoin 2X Bull Shares and Direxion Daily Bitcoin 2X Bear Shares Under NYSE Arca Rule 8.200-E | |
83 FR 35038 - Self-Regulatory Organizations; Nasdaq ISE, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the Exchange's Schedule of Fees To Waive Fees and Rebates for Trades in NQX Options | |
83 FR 35041 - Self-Regulatory Organizations; National Securities Clearing Corporation; Notice of Filing of a Proposed Rule Change To Terminate the Commission Billing Service and the Commission Billing Limited Membership | |
83 FR 35040 - Self-Regulatory Organizations; NYSE American LLC; Notice of Designation of a Longer Period for Commission Action on a Proposed Rule Change To Amend Exchange Rule 7.35E Relating to the Auction Reference Price for a Trading Halt Auction Following a Regulatory Halt | |
83 FR 34933 - Program Fraud Civil Remedies: Civil Monetary Penalty Inflation Adjustment | |
83 FR 35058 - Findings of Research Misconduct | |
83 FR 34982 - Proposed Information Collection; Comment Request; Report of Building or Zoning Permits Issued for New Privately-Owned Housing Units (Building Permits Survey) | |
83 FR 35051 - Surrender of License of Small Business Investment Company | |
83 FR 34948 - Security Zone; Seattle's Seafair Fleet Week Moving Vessels, 2018, Puget Sound, WA | |
83 FR 35020 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Indian Highway Safety Grants | |
83 FR 34948 - Safety Zone; Fleet Week Maritime Festival, Pier 66, Elliot Bay, Seattle, Washington | |
83 FR 35051 - Administrative Declaration of a Disaster for the State of Louisiana | |
83 FR 35032 - Proposed Collection; Comment Request | |
83 FR 35028 - National Space-Based Positioning, Navigation, and Timing Advisory Board; Meeting | |
83 FR 34946 - Safety Zone; Fleet Week Maritime Festival, Pier 66, Elliot Bay, Seattle, Washington | |
83 FR 35002 - Agency Information Collection Activities: Proposed Collection; Comment Request | |
83 FR 35017 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting | |
83 FR 34981 - Notice of Public Meeting of the Montana Advisory Committee | |
83 FR 35018 - National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting | |
83 FR 35020 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; National Ground-Water Monitoring Network Cooperative Funding Application | |
83 FR 35058 - Veterans' Advisory Committee on Rehabilitation; Notice of Meeting | |
83 FR 35004 - Final National Occupational Research Agenda for Construction | |
83 FR 35012 - Draft Indian Health Service Strategic Plan Fiscal Year 2018-2022 | |
83 FR 35011 - National Vaccine Injury Compensation Program; List of Petitions Received | |
83 FR 34956 - Proposed Amendment of Class D and Class E Airspace, and Establishment of Class E Airspace; Honolulu, HI | |
83 FR 35021 - Request for Nominations for the Cold War Advisory Committee | |
83 FR 34958 - Concept Release on Compensatory Securities Offerings and Sales | |
83 FR 34940 - Exempt Offerings Pursuant to Compensatory Arrangements | |
83 FR 34949 - Approval of California Plan Revisions; Northern Sonoma County Air Pollution Control District; Stationary Source Permits | |
83 FR 34968 - Receipt of Several Pesticide Petitions Filed for Residues of Pesticide Chemicals in or on Various Commodities | |
83 FR 34967 - Accidental Release Prevention Requirements: Risk Management Programs Under the Clean Air Act; Notification of Data Availability and Extension of Comment Period | |
83 FR 35016 - National Cancer Institute; Notice of Closed Meetings | |
83 FR 35062 - Endangered and Threatened Wildlife and Plants: Final Rulemaking To Designate Critical Habitat for the Main Hawaiian Islands Insular False Killer Whale Distinct Population Segment | |
83 FR 34974 - Text-Enabled Toll Free Numbers; Toll Free Service Access Codes |
Agricultural Marketing Service
Census Bureau
International Trade Administration
National Oceanic and Atmospheric Administration
Army Department
Federal Energy Regulatory Commission
Agency for Healthcare Research and Quality
Centers for Disease Control and Prevention
Food and Drug Administration
Health Resources and Services Administration
Indian Health Service
National Institutes of Health
Coast Guard
U.S. Customs and Border Protection
Geological Survey
Indian Affairs Bureau
National Park Service
Occupational Safety and Health Administration
Federal Aviation Administration
Federal Railroad Administration
National Highway Traffic Safety Administration
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Office of Personnel Management (OPM).
Final rule.
This rule adjusts the level of civil monetary penalties contained in U.S. Office of Personnel Management regulations implementing the Program Fraud Civil Remedies Act of 1986, with an initial “catch-up” adjustment under the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 and Office of Management and Budget guidance. It also makes subsequent annual catch up adjustments.
Effective August 23, 2018.
Austin Fulk, Office of the General Counsel, Office of Personnel Management, 1900 E St, NW, Washington, DC 20415,
On November 2, 2015, the President signed into law the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Sec. 701 of Pub. L. 114-74) (“the Act”). The Act required agencies to: (1) Adjust the level of civil monetary penalties with an initial “catch-up” adjustment through an interim final rulemaking, and (2) make subsequent annual adjustments for inflation. The purpose of these adjustments is to maintain the deterrent effect of civil penalties.
On July 19, 2016, OPM made an initial adjustment to the following civil monetary penalties to carry out the requirements of the 2015 Act, based on instructions found in Office of Management and Budget Memorandum M-16-06:
That rule took effect on August 1, 2016.
This rule takes into account adjustments for the year 2016 based on inflation for that year. These calculations were made based on guidance contained in Office of Management and Budget Memorandum M-17-11:
This rule makes additional adjustments for the year 2017 based on inflation for that year. These calculations were made based on guidance contained in Office of Management and Budget Memorandum M-18-03:
This final rule is being issued without prior public notice or opportunity for public comments. The 2015 Act's amendments to the Inflation Adjustment Act required the agency to adjust penalties initially through an interim final rulemaking, which did not require the agency to complete a notice and comment process prior to promulgating the interim final rule. The amendments also explicitly required the agency to make subsequent annual adjustments notwithstanding 5 U.S.C. 553 (the section of the Administrative Procedure Act that normally requires agencies to engage in notice and comment). The formula used for adjusting the amount of civil penalties is given by statute, with no discretion provided to OPM regarding the computation of the adjustments. OPM is charged only with performing ministerial computations to determine the amount of adjustment to the civil penalties due to increases in
The Office of Management and Budget (OMB) issued guidance on calculating the initial catch-up adjustment.
The Office of Management and Budget published guidance on adjusting penalties based on the increase in the CPI-U between October of 2015 and October of 2016, as well as between October of 2016 and 2017.
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 designated a not significant regulatory action, under Executive Order 12866. E.O. 13771.
This final rule is not an E.O. 13771 regulatory action because this rule is not significant under E.O. 12866.
I certify that this regulation will not have a significant economic impact on a substantial number of small entities.
The Regulatory Flexibility Act (RFA) requires an agency to prepare a regulatory flexibility analysis for rules unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. The RFA applies only to rules for which an agency is required to first publish a proposed rule. See 5 U.S.C. 603(a) and 604(a). The Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015
This rule is not a major rule under the Small Business Regulatory Enforcement Fairness Act. This rule:
(a) Does not have an annual effect on the economy of $100 million or more.
(b) Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions.
(c) Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of United States-based enterprises to compete with foreign-based enterprises.
This rule does not involve a Federal mandate that may result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $100 million or more and that such rulemaking will not significantly or uniquely affect small governments.
This rule does not have takings implications.
We have examined this rule in accordance with Executive Order 13132, Federalism, and have determined that this rule will not have any negative impact on the rights, roles, and responsibilities of State, local, or Tribal governments.
This rule complies with the requirements of E.O. 12988. Specifically, this rule:
(a) Does not unduly burden the judicial system;
(b) Meets the criteria of section 3(a) requiring that all regulations be reviewed to eliminate errors and ambiguity and be written to minimize litigation; and
(c) Meets the criteria of section 3(b)(2) requiring that all regulations be written in clear language and contain clear legal standards.
In accordance with Executive Order 13175, OPM has evaluated this rule and determined that it has no tribal implications.
This rule does not involve any collections of information subject to the Paperwork Reduction Act of 1995, Public Law 104-13.
Program fraud civil remedies, Claims, Penalties, Basis for civil penalties and assessments.
For the reasons set forth in the preamble, OPM amends part 185 of title 5 of the Code of Federal Regulations as follows:
28 U.S.C. 2461 note.
Agricultural Marketing Service, USDA.
Final rule.
This rule implements a recommendation from the Far West Spearmint Oil Administrative Committee (Committee) to establish salable quantities and allotment percentages of Class 1 (Scotch) and Class 3 (Native) spearmint oil for the 2018-2019 marketing year. This rule also removes references to past volume regulation no longer in effect.
Effective August 23, 2018.
Barry Broadbent, Marketing Specialist, or Gary Olson, Regional Director, Northwest Marketing Field Office, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA; Telephone: (503) 326-2724, Fax: (503) 326-7440, or Email:
Small businesses may request information on complying with this regulation by contacting Richard Lower, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, STOP 0237, Washington, DC 20250-0237; Telephone: (202) 720-2491, Fax: (202) 720-8938, or Email:
This action, pursuant to 5 U.S.C. 553, amends regulations issued to carry out a marketing order as defined in 7 CFR 900.2(j). This rule is issued under Marketing Order No. 985, as amended (7 CFR part 985), regulating the handling of spearmint oil produced in the Far West. Part 985 (referred to as the “Order”) is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.” The Committee locally administers the Order and is comprised of spearmint oil producers operating within the area of production, and a public member.
The Department of Agriculture (USDA) is issuing this rule in conformance with Executive Orders 13563 and 13175. This rule falls within a category of regulatory actions that the Office of Management and Budget (OMB) exempted from Executive Order 12866 review. Additionally, because this rule does not meet the definition of a significant regulatory action, it does not trigger the requirements contained in Executive Order 13771. See OMB's Memorandum titled “Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017, titled `Reducing Regulation and Controlling Regulatory Costs' ” (February 2, 2017).
This rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under the Order now in effect, salable quantities and allotment percentages may be established for classes of spearmint oil produced in the Far West. This rule establishes quantities and percentages for Class 1 (Scotch) and Class 3 (Native) spearmint oil for the 2018-2019 marketing year, which began on June 1, 2018.
The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. A handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.
Pursuant to §§ 985.50, 985.51, and 985.52, the Order requires the Committee to meet each year to consider supply and demand of spearmint oil and a marketing policy for the ensuing marketing year. When such considerations indicate a need to establish or maintain stable market conditions through volume regulation, the Committee recommends salable quantity limitations and producer allotments to regulate the quantity of Far West spearmint oil available to the market.
According to § 985.12, “salable quantity” is the total quantity of each class of oil that handlers may purchase from, or handle on behalf of, producers during a given marketing year. The total industry allotment base is the aggregate of all allotment bases held individually by producers as prescribed under § 985.53(d)(1). The total allotment base is generally revised each year on June 1 due to producer base being lost because of the bona fide effort production provision of § 985.53(e). The allotment percentage for each class of spearmint oil is derived by dividing the salable quantity by the total industry allotment base for that same class of oil. The allotment percentage is the percentage used to calculate each producer's prorated share of the salable quantity or their “annual allotment,” as defined in § 985.13.
The Committee met on October 25, 2017, to consider its marketing policy for the 2018-2019 marketing year. At that meeting, the Committee determined that, based on overall market and supply conditions, volume regulation for Classes 1 and 3 (Scotch and Native, respectively) spearmint oil is necessary. With a unanimous vote, the Committee recommended the establishment of a salable quantity and allotment percentage for Class 1 (Scotch) and Class 3 (Native) spearmint oil of 760,660 pounds and 35 percent, and 1,307,947 pounds and 53 percent, respectively. The Committee also unanimously set its 2018-2019 marketing year trade demand estimate for Far West Scotch spearmint oil at 850,000 pounds, and for Far West Native spearmint oil at 1,306,605 pounds. Salable quantities and allotment percentages have been placed into effect each season since the Order's inception in 1980.
The Committee's recommended 2018-2019 marketing year salable quantity and allotment percentage for Far West Scotch spearmint oil represent a decrease from the previous year's volume restrictions. The 2018-2019 marketing year salable quantity of 760,660 pounds is 13,985 pounds less than the 2017-2018 salable quantity of
The Committee considered several factors in making its recommendation, including the current and projected supply, estimated future demand, production costs, and producer prices. The Committee's recommendations also account for declining acreage of Far West Scotch spearmint oil, decreasing consumer demand, existing carry-in and reserve pool volume, and increasing production in competing markets.
According to the Committee, as costs of production have increased, many producers have forgone new plantings. This has resulted in a significant decline in production of Far West Scotch spearmint oil over past years. Production has decreased from 1,229,258 pounds produced in 2015, to 1,113,346 pounds produced in 2016 and, finally, to an estimated 817,857 pounds for 2017.
Industry reports also indicate that the relatively low trade demand for Far West spearmint oil is the result of decreased consumer demand for spearmint-flavored products, especially chewing gum in China and India. Far West Scotch spearmint oil sales have averaged 941,140 pounds per year over the last three years and 966,875 pounds over the last five years. For the 2017-2018 crop, the Committee estimated trade demand at 800,000 pounds.
In addition, increasing production of spearmint oil in competing markets, most notably Canada and the U.S. Midwest, has also put downward pressure on the Far West Scotch market.
Given the general decline in demand and anticipated market conditions for the coming year, the Committee decided it was prudent to anticipate 2018-2019 trade demand at 850,000 pounds. Should the established volume regulation levels prove insufficient to adequately supply the market, the Committee has the authority to recommend intra-seasonal increases, as has been implemented in previous marketing years.
The Committee calculated the minimum salable quantity of Far West Scotch spearmint oil that will be required during the 2018-2019 marketing year by subtracting the estimated salable carry-in on June 1, 2018, (215,757) from the estimated trade demand (850,000), resulting in 634,243 pounds. This salable quantity represents the minimum amount of Scotch spearmint oil that the Committee expects to be needed to satisfy estimated demand for the coming year. The Committee then factored in a projected 2019-2020 carry-in of 126,417 pounds to arrive at a recommended 2018-2019 salable quantity of 760,660 pounds.
The salable quantity of 760,660 pounds, combined with an estimated 215,757 pounds of salable quantity (salable carry-in) from the previous year, yields a total available supply of 976,417 pounds Far West Scotch spearmint oil for the 2018-2019 marketing year. This amount will adequately supply the Committee's estimated market demand of 850,000 pounds for the 2018-2019 marketing year and is expected to result in a desired 2019-2020 carry-in of 126,417 pounds.
Salable carry-in is the primary measure of excess spearmint oil supply under the Order, as it represents overproduction in prior years that is currently available to the market without restriction. Under volume regulation, spearmint oil that is designated as salable continues to be available to the market until it is sold and may be marketed at any time at the discretion of the owner. Salable quantities established under volume regulation over the last three seasons have exceeded sales, leading to a gradual build of Far West Scotch spearmint oil salable carry-in.
The Committee estimates that there will be 215,757 pounds of salable carry-in of Scotch spearmint oil on June 1, 2018. If current market conditions are maintained and the Committee's projections are correct, salable carry-in will decrease to 126,417 pounds at the beginning of the 2019-2020 marketing year. This level is slightly below the quantity that the Committee considers favorable (generally 150,000 pounds). However, the Committee believes that this lower salable carry-in will be manageable given the expected production level of Far West Scotch spearmint oil in the current marketing year and the quantity of oil held in the reserve pool.
Spearmint oil held in reserve is oil that has been produced in excess of a producer's marketing year allotment. Oil held in the reserve pool is a less reliable indicator of excess supply as it is not available to the market in the current marketing year without an increase in the salable quantity and allotment percentage.
Far West Scotch spearmint oil held in the reserve pool, which was completely depleted at the beginning of the 2014-2015 marketing year, has also been gradually increasing over the past four years. The Committee reported that there were 71,088 pounds of Far West Scotch spearmint oil held in the reserve pool as of May 31, 2017. The Committee estimates the reserve pool will increase to 114,274 pounds by May 31, 2018. This quantity of reserve pool oil should be an adequate buffer to supply the market, if necessary, if the industry experiences an unexpected increase in demand.
The Committee recommended an allotment percentage of 35 percent for the 2018-2019 marketing year. During its October 25, 2017, meeting, the Committee calculated an initial allotment percentage by dividing the minimum required salable quantity (634,243 pounds) by the total estimated allotment base (2,173,315 pounds), resulting in 29.2 percent. However, producers and handlers at the meeting indicated that the computed percentage (29.2 percent) might not adequately supply the potential 2018-2019 Scotch spearmint oil market demand or may result in inadequate carry-in for the subsequent marketing year. After deliberation, the Committee increased the targeted allotment percentage to 35 percent. The total estimated allotment base (2,173,315 pounds) for the 2018-2019 marketing year multiplied by the recommended salable allotment percentage (35 percent) yields 760,660 pounds, which is also the recommended salable quantity for the 2018-2019 marketing year.
The 2018-2019 marketing year computational data for the Committee's recommendations is further outlined below.
(A)
(B)
(C)
(D)
(E)
(F)
(G)
(H)
For the reasons stated above, the Committee believes that the recommended salable quantity and allotment percentage for Scotch spearmint oil will adequately meet demand, will result in a reasonable carry-in for the following year, and will contribute to orderly marketing conditions as intended under the Order.
The Committee recommended a Native spearmint oil salable quantity of 1,307,947 pounds and an allotment percentage of 53 percent for the 2018-2019 marketing year. These figures are, respectively, 206,955 pounds and 9 percentage points less than the final levels established for the 2017-2018 marketing year after an intra-seasonal increase.
The Committee utilized handlers' anticipated sales estimates of Far West Native spearmint oil for the coming year, historical and current Native spearmint oil production, inventory statistics, and international market data obtained from consultants for the spearmint oil industry to arrive at these recommendations.
The Committee anticipates that 2017 production will total 1,462,976 pounds, down from 1,694,684 pounds in 2016. Committee figures show that declining production is the result of a 1,107-acre year-over-year reduction in total Native spearmint acres, and an average yield per acre drop from 166.2 pounds per acre in 2016 to 160.9 pounds per acre in 2017. Conversely, sales of Native spearmint oil have been increasing at about a 4 percent rate from the 2015-2016 season through the 2017-2018 marketing year.
The Committee expects that 57,968 pounds of salable Native spearmint oil from prior years will be carried into the 2018-2019 marketing year. This amount is down from the estimated 143,011 pounds of salable Native spearmint oil carried into the 2017-2018 marketing year, and 142,657 pounds carried into the 2016-2017 marketing year.
Further, the Committee estimates that there will be 1,237,237 pounds of Native spearmint oil in the reserve pool at the beginning of the 2018-2019 marketing year. This figure is 142,578 pounds higher than the quantity of reserve pool oil held by producers the previous year and is in line with the gradual increase in reserves over the past three marketing years.
Exports of Far West Native spearmint oil, as of July 2017, are above their five-year average. Canada, India, and China are the largest destination markets for Far West Native spearmint oil exports. As a common practice, large end users often buy spearmint oil to build reserve stocks when prices are low as a hedge against future price increases. End users of Native spearmint oil are expected to continue to rely on Far West production as their main source of high quality Native spearmint oil, but demand may be at lower quantities moving forward in response to long-term market factors. A sharp spike in demand for Far West Native spearmint oil was experienced by handlers late in the 2017-2018 marketing year, spurred by the popularity of a new product in the market. This sharp spike in demand caused the remaining available 2017-2018 salable quantity of Native oil to be depleted.
The Committee estimates the 2018-2019 marketing year Native spearmint oil trade demand to be 1,306,605 pounds. This figure is based on input provided by producers at six Native spearmint oil production area meetings held in mid-October 2017, as well as estimates provided by handlers and other meeting participants at the October 25, 2017, meeting. This figure represents an increase of 56,605 pounds from the previous year's initial estimate. The average estimated trade demand for Native spearmint oil from the six production area grower's meetings was 1,349,379 pounds, whereas the handlers' estimates ranged from 1,350,000 to 1,500,000 pounds. The average of Far West Native spearmint oil sales over the last three years is also 1,305,605 pounds. However, the quantity marketed over the most recent full marketing year, 2016-2017, was 1,287,691 pounds. The Committee chose to be slightly conservative in the establishment of its trade demand estimate for the 2018-2019 marketing year to avoid oversupplying the market.
The estimated 2018-2019 carry-in of 57,968 pounds of Native spearmint oil plus the recommended salable quantity of 1,307,947 pounds results in an estimated total available supply of 1,365,915 pounds of Native spearmint oil during the 2018-2019 marketing year. With the corresponding estimated trade demand of 1,306,605 pounds, the Committee projects that 59,310 pounds of Native spearmint oil will be carried into the 2019-2020 marketing year, resulting in a slight increase of 1,342 pounds year-over-year. The Committee estimates that there will be 1,237,237 pounds of Native spearmint oil held in the reserve pool at the beginning of the 2018-2019 marketing year. Should the industry experience an unexpected increase in trade demand, Native spearmint oil in the reserve pool could be released to satisfy that demand.
The Committee recommended an allotment percentage of 53 percent for the 2018-2019 marketing year. During its October 25, 2017, meeting, the Committee calculated an initial allotment percentage by dividing the minimum required salable quantity (1,248,637 pounds) by the total estimated allotment base (2,467,825 pounds), resulting in 50.6 percent. However, producers and handlers at the meeting expressed that the computed percentage (50.6 percent) may not adequately supply the potential 2018-2019 Native spearmint oil market demand or result in adequate carry-in for the subsequent marketing year. After deliberation, the Committee increased the recommended allotment percentage
The 2018-2019 marketing year computational data for the Committee's recommendations is further outlined below.
(A)
(B)
(C)
(D)
(E)
(F)
(G)
(H)
The Committee's recommended Scotch and Native spearmint oil salable quantities and allotment percentages of 760,660 pounds and 35 percent, and 1,307,947 pounds and 53 percent, respectively, match the available supply of each class of spearmint oil to the estimated demand of each, thus avoiding extreme fluctuations in inventories and prices. This volume regulation final rule is similar to regulations issued in prior seasons.
The salable quantities established herein are not expected to cause a shortage of spearmint oil supplies. Any unanticipated or additional market demand for spearmint oil which may develop during the marketing year could be satisfied by an intra-seasonal increase in the salable quantity. The Order contains a provision in § 985.51 for intra-seasonal increases to allow the Committee the flexibility to respond quickly to changing market conditions.
Under volume regulation, producers who produce more than their annual allotments during the marketing year may transfer such excess spearmint oil to producers who have produced less than their annual allotment. In addition, on December 1 of each year, producers who have not transferred their excess spearmint oil to other producers must place their excess spearmint oil production into the reserve pool to be released in the future in accordance with market needs and under the Committee's direction.
In conjunction with the issuance of this rule, USDA has reviewed the Committee's marketing policy statement for the 2018-2019 marketing year. The Committee's marketing policy statement, a requirement whenever the Committee recommends volume regulation, meets the requirements of §§ 985.50 and 985.51.
The establishment of the salable quantities and allotment percentages will allow for adequate supply to meet anticipated market needs. In determining anticipated market needs, the Committee considered historical sales, as well as changes and trends in production and demand. This rule also provides producers with information on the amount of spearmint oil that should be produced during the 2018-2019 growing season to meet anticipated market demand.
Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), the Agricultural Marketing Service (AMS) has considered the economic impact of this rule on small entities. Accordingly, AMS has prepared this final regulatory flexibility analysis.
The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and the rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.
There are approximately 43 producers and 94 producers of Scotch and Native spearmint oil, respectively, in the regulated production area and approximately seven spearmint oil handlers subject to regulation under the Order. Small agricultural service firms are defined by the Small Business Administration (SBA) as those having annual receipts of less than $7,500,000, and small agricultural producers are defined as those having annual receipts of less than $750,000 (13 CFR 121.201).
The Committee reported that recent producer prices for spearmint oil range from $15.50 to $18.00 per pound. The National Agricultural Statistics Service (NASS) reported that the 2016 U.S. season average spearmint oil grower price per pound was $17.40. Multiplying $17.40 per pound by 2016-17 spearmint oil utilization of 2,168,257 million pounds yields a crop value estimate of about $37.7 million. Total 2016-17 spearmint oil utilization, reported by the Committee, is 958,711 pounds and 1,209,546 pounds for Scotch and Native spearmint oil, respectively.
Given the accounting requirements for the volume regulation provisions of the Order, the Committee maintains accurate records of each producer's production and sales. Using the $17.40 average spearmint oil price, and Committee production data for each producer, the Committee estimates that 38 of the 43 Scotch spearmint oil producers and 88 of the 94 Native spearmint oil producers could be classified as small entities under the SBA definition.
There is no third party or governmental entity that collects and reports spearmint oil prices received by spearmint oil handlers. However, the Committee estimates an average spearmint oil handling markup at approximately 20 percent of the price received by producers. Multiplying 1.20 by the 2016 producer price of $17.40 yields a handler f.o.b. price per pound estimate of $20.88.
Multiplying this handler f.o.b price by spearmint oil utilization of 2,168,257 pounds results in an estimated handler-level spearmint oil value of $45.3 million. Dividing this figure by the number of handlers (7) yields estimated average annual handler receipts of about $6.5 million, which is below the SBA threshold for small agricultural service firms.
Using confidential data on pounds handled by each handler, and the abovementioned handler price per pound, the Committee reported that it is likely that at least two of the seven handlers had 2016-2017 marketing year spearmint oil sales value that exceeded the SBA threshold.
Therefore, in view of the foregoing, the majority of producers and handlers of spearmint oil may be classified as small entities.
This final rule establishes the quantity of spearmint oil produced in the Far West, by class, which handlers may purchase from, or handle on behalf of, producers during the 2018-2019 marketing year. The Committee recommended this action to help maintain stability in the spearmint oil market by matching supply to estimated demand, thereby avoiding extreme fluctuations in supplies and prices. Establishing quantities that may be purchased or handled during the marketing year through volume regulations allows producers to coordinate their spearmint oil production with the expected market demand. Authority for this action is provided in §§ 985.50, 985.51, and 985.52.
The Committee estimated trade demand for the 2018-2019 marketing year for both classes of oil at 2,156,605 pounds and expects that the combined salable carry-in will be 273,725 pounds. The combined required salable quantity is 1,882,880 pounds. Under volume regulation, total sales of spearmint oil by producers for the 2018-2019 marketing year will be held to 2,342,332 pounds (the recommended salable quantity for both classes of spearmint oil of 2,068,607 pounds plus 273,725 pounds of carry-in). This total available supply of 2,342,332 pounds should be more than adequate to supply the 2,156,605 pounds of anticipated total trade demand for spearmint oil. In addition, as of May 31, 2017, the total reserve pool for both classes of spearmint oil stood at 1,067,138 pounds. Furthermore, that quantity is expected to rise over the course of the 2017-2018 marketing year. Should trade demand increase unexpectedly during the 2018-2019 marketing year, reserve pool spearmint oil could be released into the market to supply that increase in demand.
The recommended allotment percentages, upon which 2018-2019 marketing year producer allotments are based, are 35 percent for Scotch spearmint oil and 53 percent for Native spearmint oil. Without volume regulation, producers would not be held to these allotment levels, and could produce and sell unrestricted quantities of spearmint oil. The USDA econometric model estimated that the season average producer price per pound (from both classes of spearmint oil) would decline about $1.90 per pound because of the higher quantities of spearmint oil that would be produced and marketed without volume regulation. The surplus situation for the spearmint oil market that would exist without volume regulation in 2018-2019 also would likely dampen prospects for improved producer prices in future years because of the buildup in stocks.
The use of volume regulation allows the industry to fully supply spearmint oil markets while avoiding the negative consequences of over-supplying these markets. The use of volume regulation is believed to have little or no effect on consumer prices of products containing spearmint oil and will not result in fewer retail sales of such products.
The Committee discussed alternatives to the recommendations established by this rule for both classes of spearmint oil. The Committee discussed and rejected the idea of not regulating any volume for either class of spearmint oil because of the severe, price-depressing effects that would likely occur without volume regulation. The Committee also discussed and considered salable quantities and allotment percentages that were above and below the levels that were ultimately recommended for both classes of spearmint oil. Ultimately, the action taken by the Committee was to decrease the salable quantity and allotment percentage for Class 1 (Scotch) spearmint oil, and to increase the salable quantity and allotment percentage Class 3 (Native) spearmint oil from the 2017-2018 marketing year levels.
As noted earlier, the Committee's recommendation to establish salable quantities and allotment percentages for both classes of spearmint oil was made after careful consideration of all available information including: (1) The estimated quantity of salable oil of each class held by producers and handlers; (2) the estimated demand for each class of oil; (3) the prospective production of each class of oil; (4) the total of allotment bases of each class of oil for the current marketing year and the estimated total of allotment bases of each class for the ensuing marketing year; (5) the quantity of reserve oil, by class, in storage; (6) producer prices of oil, including prices for each class of oil; and (7) general market conditions for each class of oil, including whether the estimated season average price to producers is likely to exceed parity.
Based on its review, the Committee believes that the salable quantities and allotment percentages established herein will achieve the objectives sought. The Committee also believes that, should there be no volume regulation in effect for the upcoming marketing year, the Far West spearmint oil industry would return to the pronounced cyclical price patterns that occurred prior to the promulgation of the Order. As previously stated, annual salable quantities and allotment percentages have been issued for both classes of spearmint oil since the Order's inception. The salable quantities and allotment percentages established by this final rule are expected to facilitate the goal of maintaining orderly marketing conditions for Far West spearmint oil for the 2018-2019 and future marketing years.
Costs to producers and handlers, large and small, resulting from this final rule are expected to be offset by the benefits derived from a more stable market and increased returns. The benefits of this rule are expected to be equally available to all producers and handlers regardless of their size. In addition, the Committee's meeting was widely publicized throughout the Far West spearmint oil industry, and all interested persons were invited to attend the meeting and participate in
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), the Order's information collection requirements have been previously approved by OMB and assigned OMB No. 0581-0178, Specialty Crops Program. No changes are necessary in those requirements as a result of this action. Should any changes become necessary, they would be submitted to OMB for approval.
This rule establishes salable quantities and allotment percentages for Class 1 (Scotch) spearmint oil and Class 3 (Native) spearmint oil produced in the Far West during the 2018-2019 marketing year. Accordingly, this rule imposes no additional reporting or recordkeeping requirements on either small or large Far West spearmint oil producers or handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public-sector agencies. As mentioned in the initial regulatory flexibility analysis, USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this final rule.
AMS is committed to complying with the E-Government Act, to promote the use of the internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.
A proposed rule concerning this action was published in the
A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at:
After consideration of all relevant material presented, including the information and recommendation submitted by the Committee and other available information, it is hereby found that this rule, will tend to effectuate the declared policy of the Act.
Marketing agreements, Oils and fats, Reporting and recordkeeping requirements, Spearmint oil.
For the reasons set forth in the preamble, 7 CFR part 985 is amended as follows:
7 U.S.C. 601-674.
The salable quantity and allotment percentage for each class of spearmint oil during the marketing year beginning on June 1, 2018, shall be as follows:
(a) Class 1 (Scotch) oil—a salable quantity of 760,660 pounds and an allotment percentage of 35 percent.
(b) Class 3 (Native) oil—a salable quantity of 1,307,947 pounds and an allotment percentage of 53 percent.
Securities and Exchange Commission.
Final rule.
The Securities and Exchange Commission is adopting an amendment to its regulations under the Securities Act of 1933 (the “Securities Act”), which provide an exemption from registration for securities issued by non-reporting companies pursuant to compensatory arrangements. As mandated by the Economic Growth, Regulatory Relief, and Consumer Protection Act (the “Act”), the amendment revises a rule to increase from $5 million to $10 million the aggregate sales price or amount of securities sold during any consecutive 12-month period in excess of which the issuer is required to deliver additional disclosures to investors.
Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Use the Federal eRulemaking Portal (
• Send paper comments in triplicate to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
Anne M. Krauskopf, Senior Special Counsel, and Adam F. Turk, Special Counsel, Office of Chief Counsel, Division of Corporation Finance, at (202) 551-3500.
We are adopting an amendment to 17 CFR
Rule 701 provides an exemption from the registration requirements of the Securities Act for offers and sales of securities under certain compensatory benefit plans or written agreements relating to compensation. The exemption covers securities offered or sold under a plan or agreement between a non-reporting company
As mandated by Section 507 of the Act,
• A copy of the summary plan description required by the Employee Retirement Income Security Act of 1974 (“ERISA”) [29 U.S.C. 1104-1107] or, if the plan is not subject to ERISA, a summary of the plan's material terms;
• risk factors associated with investment in the securities under the plan or agreement; and
• the financial statements required in an offering statement on Form 1-A [17 CFR 239.90] under Regulation A [17 CFR 230.251 through 230.263].
The Administrative Procedure Act (“APA”) generally requires an agency to publish notice of a proposed rulemaking in the
We are mindful of the costs imposed by and the benefits obtained from our rules and amendments.
The baseline for our economic analysis is the disclosure requirement of Item 701(e) prior to the amendment being adopted, which required an issuer to deliver additional disclosures to investors if the aggregate sales price or amount of securities sold during any consecutive 12-month period exceeded $5 million. The amendment will affect non-reporting companies that rely on Rule 701 to offer securities to plan
Plan participants who make use of issuer disclosures will also be affected by the amendment mandated by the Act. To the extent a company issues more than $5 million but less than $10 million in aggregate sales price of securities under the rule in a 12-month period, the company will not be required to deliver the Rule 701(e) disclosures to plan participants.
The statutory mandate requires the Commission to raise the threshold for requiring issuers to deliver additional disclosure to plan participants in Rule 701 offerings from $5 million to $10 million in any consecutive 12-month period. This will lower the regulatory burden in terms of required disclosures and thereby reduce the cost of securities offerings in this range pursuant to compensatory benefit plans by affected non-reporting companies. In addition, if the regulatory burden under the baseline currently deters some non-reporting companies from using this form of compensation arrangement to an extent that otherwise would be desired, such companies may be able to improve the efficiency of their employee compensation plans or contracts under the amendment and thereby improve company performance (
The amendment may reduce the amount of information available to plan participants, as issuers conducting offerings in the $5 million to $10 million range will not be required to provide Rule 701(e) disclosures to investors a reasonable period of time before the date of sale. Less information to plan participants may in turn make it harder for them to accurately value the offerings, and may partially offset the efficiency gains noted above. To the extent non-reporting issuers have issued securities in reliance on Regulation A and made available the information required by Rule 701(e) or have issued securities in excess of $5 million in reliance on Rule 701 in the current 12-month period, and, at their option, continue to provide the disclosures required by Rule 701(e), there may be no loss of information to participants.
We expect the amendment to make compliance burdens the same between companies seeking to use Rule 701 to offer amounts up to $5 million and companies seeking to use Rule 701 to offer amounts between $5 million and $10 million. By doubling the amount of securities that can be offered to employees without requiring the additional disclosure under Rule 701(e) from $5 million to $10 million, the amendment to Rule 701 may have competitive effects for non-reporting companies that offer or sell securities as compensation. Although the Commission does not anticipate that the amendment will have substantial competitive effects among firms that currently rely on Rule 701, the amendment may permit some smaller companies to compete with larger companies to recruit and retain employees by increasing the offering amount threshold for additional disclosure from $5 million to $10 million.
Relatedly, companies seeking to offer amounts between $5 million and $10 million will experience a reduction in regulatory burden compared to companies wishing to offer amounts over $10 million. As discussed below in Section V.A, for the purposes of the Paperwork Reduction Act, the Commission estimates that approximately 10% of the 16,149 non-reporting companies, or 1,600 issuers, provide information under Rule 701, and that approximately one-half of those issuers (800) will sell securities in compensatory benefit plans between $5 million to $10 million over a 12-month period. Using these estimates, we further estimate that the amendment will reduce the regulatory burden associated with Rule 701 by 400 hours of company personnel time and $480,000 in professional costs per year.
Finally, to the extent compensatory benefit plans are used by non-reporting companies to attract and retain persons that are in demand internationally, a reduction in regulatory burden due to the amendment of Rule 701(e) may also increase the international competiveness of the companies affected by the amendment.
Certain provisions of Rule 701 that will be affected by the amendment contain “collection of information” requirements within the meaning of the Paperwork Reduction Act of 1995 (“PRA”).
Rule 701 (OMB Control No. 3235-0522).
Rule 701 provides an exemption from registration for offers and sales of securities pursuant to certain compensatory benefit plans and contracts relating to compensation. Issuers conducting employee benefit plan offerings in excess of $5 million in reliance on Rule 701 are required to provide plan participants with certain disclosures, including financial statement disclosures. This disclosure constitutes a collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information requirement unless it displays a currently valid OMB control number. Compliance with the information collection is mandatory. Responses to the information collection are not kept confidential and there is no mandatory retention period for the information disclosed.
We estimate that currently approximately 1,600 issuers
We therefore estimate the total annual decrease in the paperwork burden for all affected companies to comply with the collection of information requirements of Rule 701, as amended, will be approximately 1,600 hours, allocated as a decrease of 400 hours (800 issuers × 0.5 burden hour) of company personnel time and a decrease of $480,000 of professional costs (800 issuers × 1.5 hours × $400 per hour).
We request comments in order to evaluate: (1) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information would have practical utility; (2) the accuracy of our estimate of the burden of the collection of information; (3) whether there are ways to enhance the quality, utility and clarity of the information to be collected; and (4) whether there are ways to minimize the burden of the collection of information on those who are to respond, including through the use of automated collection techniques or other forms of information technology.
Any member of the public may direct to us any comments concerning the accuracy of these burden estimates and any suggestions for reducing the burdens. Persons who desire to submit comments on the collection of information requirements should direct their comments to the Office of Management and Budget, Attention: Desk Officer for the Securities and Exchange Commission, Office of Information and Regulatory Affairs, Washington, DC 20503, and send a copy of the comments to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090, with reference to File No. S7-17-18. Requests for materials submitted to the OMB by us with regard to these collections of information should be in writing, refer to File No. S7-17-18 and be submitted to the Securities and Exchange Commission, Office of FOIA Services, 100 F Street NE, Washington, DC 20549-0213. Interested persons are encouraged to send comments to the OMB by August 23, 2018.
The amendment contained in this release is adopted under the authority set forth in sections 3(b), 19(a), and 28 of the Securities Act and section 507 of the Economic Growth, Regulatory Relief, and Consumer Protection Act.
Reporting and recordkeeping requirements, Securities.
For the reasons set out in the preamble, title 17 chapter II of the Code of Federal Regulations is amended as follows:
15 U.S.C. 77b, 77b note, 77c, 77d, 77f, 77g, 77h, 77j, 77r, 77s, 77z-3, 77sss, 78c, 78d, 78j, 78
(e)
By the Commission.
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone for all navigable waters of the Tennessee River from mile marker 465 to mile marker 466. This safety zone is necessary to protect persons, property, and the marine environment from potential hazards associated with the construction of an underground pipeline. Entry of vessels or persons into this zone is prohibited unless authorized by the Captain of the Port Sector Ohio Valley or a designated representative.
This rule is effective from 7:30 a.m. on July 24, 2018, through 7 p.m. on August 24, 2018. This rule will be enforced from 7:30 a.m. through 7 p.m. each day during the effective period, excluding Saturdays and Sundays.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, call or email Petty Officer Nicholas Jones, Marine Safety Detachment Nashville, U.S. Coast Guard; telephone 615-736-5421, email
On July 10, 2018, Reynolds Construction, L.L.C notified Marine Safety Detachment Nashville that their underwater pipeline construction operations at mile marker 465.2 of the Tennessee River would be ready to commence on July 24, 2018. Reynolds Construction estimates that the work will take 20 days, excluding weekends and holidays, and will conclude no later than August 24, 2018.
The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(3)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable. We must establish this safety zone by July 24, 2018, and lack sufficient time to provide a reasonable comment period and then consider those comments before issuing the rule.
Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making it effective less than 30 days after publication in the
The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port Sector Ohio Valley (COTP) has determined that potential hazards associated with the underwater blasting and pipeline construction will be a safety concern for anyone on a one-mile stretch of the Tennessee River. This rule is necessary to protect persons, vessels, and the marine environment during the construction operations.
This rule establishes a temporary safety zone from 7:30 a.m. on July 24, 2018 through 7 p.m. on August 24, 2018 from mile marker 465 to mile marker 466 on the Tennessee River in Chattanooga, TN. The safety zone will be enforced from 7:30 a.m. through 7 p.m. each day, excluding Saturdays and Sundays. A safety vessel will coordinate all vessel traffic during the enforcement periods. The COTP may terminate enforcement of this rule if the work is finished earlier. The duration of the safety zone is intended to protect persons, vessels, and the marine environment during the construction operations.
No vessel or person is permitted to enter the safety zone without obtaining permission from the COTP or a designated representative. A designated representative is a commissioned, warrant, or petty officer of the U.S. Coast Guard assigned to units under the operational control of Sector Ohio Valley, U.S. Coast Guard. They may be contacted on VHF Channel 13 or 16, or at 1-800-253-7465. All persons and vessels permitted to enter this safety zone must transit at their slowest safe speed and comply with all directions issued by the COTP or the designated representative. The COTP or a designated representative will inform the public of the enforcement times and dates for this safety zone through Broadcast Notices to Mariners (BNMs), Local Notices to Mariners (LNMs), and/or Marine Safety Information Bulletins (MSIBs), as appropriate.
We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses
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, and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.
This regulatory action determination is based on the size, location, duration, and time-of-day of the safety zone. This safety zone prohibits transit on a one-mile stretch of the Tennessee River for about 12 hours on weekdays only during a one-month period. The rule also allows vessels to seek permission to enter the zone.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the temporary safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Directive 023-01 and Commandant Instruction M16475.1D, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule prohibits transit on a one-mile stretch of the Tennessee River for about 12 hours on weekdays only during a one-month period. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the U.S. Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.2.
(a)
(b)
(c)
(d)
(2) Persons or vessels requiring entry into or passage through the area must request permission from the COTP or a designated representative. U.S. Coast Guard Sector Ohio Valley may be contacted on VHF Channel 13 or 16, or at 1-800-253-7465.
(3) A safety vessel will coordinate all vessel traffic during the enforcement of this safety zone. All persons and vessels permitted to enter this safety zone must transit at their slowest safe speed and comply with all directions issued by the COTP or the designated representative.
(e)
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is temporarily amending the Fleet Week Maritime Festival safety zone. This year's Parade of Ships will commence with the aerial demonstration followed by the pass and review of ships. The safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards associated with the Parade of Ships. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port Puget Sound.
This temporary rule is effective from 8 a.m. until 8 p.m. on July 31, 2018.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, call or email Petty Officer Zachary Spence, Sector Puget Sound Waterways Management Division, Coast Guard; telephone (206) 217-6051, email
The Coast Guard is issuing this temporary rule, without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(3)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule due to unanticipated modifications to this year's Fleet Week Maritime Festival's sequence of events imposed by event organizers on the Coast Guard. It is impracticable to publish an NPRM for this temporary rule because the safety zone must be established by July 31, 2018, to protect the public.
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
On June 28, 2018, the Fleet Week planning Committee notified the Coast Guard of a change to the sequence of events for this year's Parade of Ships to conduct aerial demonstrations prior to instead of immediately following the pass and review of ships. This temporary amendment to our safety zone regulation for the Fleet Week Maritime Festival, Pier 66, Elliott Bay, Seattle, Washington, 33 CFR 165.1330, will reflect the actual order of events for this year's Parade of Ships, and is needed to notify the public of the change in the sequence of events this year and avoid uncertainty as to the effective period of the rule, which remains unchanged.
The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone associated with the Parade of Ships.
This rule temporarily amends § 165.1330 to reflect this year's sequence of events. During this year's Parade of Ships, the aerial demonstration will occur before the pass and review of ships near Pier 66. The duration of the zone is intended to protect personnel, vessels, and the marine environment in these navigable waters immediately before and after the aerial demonstration and the parade of the ships near Pier 66. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.
The regulation will be enforced for the same area as in past years and for same hours—from 8 a.m. until 8 p.m. The only change to the regulation is how it describes the sequence of events.
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
This regulatory action determination is based on the size, location, duration, and time-of-day of the safety zone. Vessel traffic will be able to safely transit around this safety zone which will impact a small designated area of Elliott Bay for 12 hours. Moreover, the Coast Guard will issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone, and the rule will allow vessel operators to seek permission to enter the zone.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Directive 023-01 and Commandant Instruction M16475.1D, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves amending a safety zone to specify the sequence of events during this year's Fleet Week Maritime Festival. It is categorically excluded from further review under paragraph L60a of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
(e)
Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce Seattle's Seafair Fleet Week Moving Vessels security zones from 10 a.m. on July 31, 2018, through 6 p.m. on August 6, 2018. These security zones are necessary to help ensure the security of the vessels from sabotage or other subversive acts during Seafair Fleet Week Parade of Ships. The designated participating vessels are: HMCS YELLOWKNIFE (MM 706), HMCS WHITEHORSE (MM 705), and USCGC MELLON (WHEC 717). During the enforcement period, no person or vessel may enter or remain in the security zones without the permission of the Captain of the Port (COTP), Puget Sound or her designated representative. The COTP has granted general permission for vessels to enter the outer 400 yards of the security zones as long as those vessels within the outer 400 yards of the security zones operate at the minimum speed necessary to maintain course unless required to maintain speed by the navigation rules.
The regulations in 33 CFR 165.1333 will be enforced from 10 a.m. July 31, 2018, through 6 p.m. on August 6, 2018, unless cancelled sooner by the Captain of the Port Puget Sound or her designated representative.
If you have questions about this notice of enforcement, call or email Petty Officer Zachary Spence, Sector Puget Sound Waterways Management Division, Coast Guard; telephone 206-217-6051, email
The Coast Guard will enforce the security zones for Seattle's Seafair Fleet Week Moving Vessels in 33 CFR 165.1333 from 10 a.m. on July 31, 2018, through 6 p.m. on August 6, 2018.
In accordance with the general regulations in 33 CFR part 165, subpart D, no person or vessel may enter or remain in the security zones without the permission of the Captain of the Port, Puget Sound or her designated representative. For 2018, the following areas are § 165.1333 security zones: All navigable waters within 500 yards of HMCS YELLOWKNIFE (MM 706), HMCS WHITEHORSE (MM 705), and USCGC MELLON (WHEC 717) while each such vessel is in the Sector Puget Sound COTP Zone.
The COTP has granted general permission for vessels to enter the outer 400 yards of the security zones as long as those vessels within the outer 400 yards of the security zones operate at the minimum speed necessary to maintain course unless required to maintain speed by the navigation rules. The COTP may be assisted by other federal, state or local agencies with the enforcement of the security zones.
All vessel operators who desire to enter the inner 100 yards of the security zones or transit the outer 400 yards at greater than minimum speed necessary to maintain course must obtain permission from the COTP or her designated representative by contacting the on-scene patrol craft on VHF Ch 13 or Ch 16. Requests must include the reason why movement within this area is necessary. Vessel operators granted permission to enter the security zones will be escorted by the on-scene patrol craft until they are outside of the security zones.
This notice of enforcement is issued under authority of 33 CFR 165.1333 and 5 U.S.C. 552(a). In addition to this notice of enforcement, the Coast Guard will provide the maritime community with advanced notification of the security zones via the Local Notice to Mariners and marine information broadcasts on the day of the event. In the event that there are changes to the participating vessels, due to operational requirements, the Coast Guard will provide actual notice for any additional designated participating vessels not covered in this notice. In addition, members of the public may contact Sector Puget Sound COTP at 206-217-6002 for an up-to-date list of designated participating vessels. For a pending amendment to § 165.1333(a) related to possible changes in participating vessels after the notice of enforcement is published, see final rule published June 28, 2018 (83 FR 30345). That rule will become effective July 30, 2018. If the COTP determines that the security zones need not be enforced for the full duration stated in this notice of enforcement, a Broadcast Notice to Mariners may be used to grant general permission to enter all portions of the regulated areas.
Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce the Fleet Week Maritime Festival's Pier 66 Safety Zone in Elliott Bay, WA on July 31, 2018. This action is necessary to promote the safety of personnel, vessels and the marine environment on navigable waters. During the enforcement period, entry into, transit through, mooring, or anchoring within this safety zone is prohibited unless authorized by the Captain of the Port, Puget Sound, or her designated representative.
The regulations in 33 CFR 165.1330 will be enforced from 8 a.m. until 8 p.m. on July 31, 2018.
If you have questions about this notice of enforcement, call or email Petty Officer Zachary Spence, Sector Puget Sound Waterways Management Division, U.S. Coast Guard; telephone (206) 217-6051, email
The Coast Guard will enforce the safety zone for the Fleet Week Maritime Festival in 33 CFR 165.1330, as amended by Temporary Final Rule (Docket Number USCG-2018-0656), from 8 a.m. until 8 p.m. on July 31, 2018 to ensure the safe completion of the Parade of Ships and associated aerial demonstrations. For the purpose of this notice of enforcement, the Parade of Ships includes both the pass and review of the ships near Pier 66 and the aerial demonstrations immediately before the pass and review. The Captain of the Port may be assisted by other federal, state, or local agencies as needed.
In accordance with the general regulations in 33 CFR part 165, subpart C, no vessel operator may enter, transit, moor, or anchor within this safety zone, except for vessels authorized by the Captain of the Port, Puget Sound or her designated representative. All vessel operators desiring entry into this safety zone shall gain prior authorization by contacting either the on-scene patrol craft on VHF Ch. 13 or Ch. 16, or Coast Guard Sector Puget Sound Joint Harbor Operations Center (JHOC) via telephone at (206) 217-6002. Vessel operators granted individual permission to enter this safety zone will be escorted by the on-scene patrol until no longer within the safety zone.
In addition to this notice of enforcement in the
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is taking final action to approve revisions to the Northern Sonoma County Air Pollution Control District (NSCAPCD or District) portion of the California State Implementation Plan (SIP). These revisions concern the District's prevention of significant deterioration (PSD) permitting program for new and modified sources of air pollution. We are approving local rules under the Clean Air Act (CAA or the Act).
This rule is effective on August 23, 2018.
The EPA has established a docket for this action under Docket ID No. EPA-R09-OAR-2018-0171. All documents in the docket are listed on the
T. Khoi Nguyen, EPA Region IX, (415) 947-4120,
Throughout this document, “we,” “us” and “our” refer to the EPA.
On April 4, 2018, the EPA proposed an approval of Rules 130—Definitions, 220—New Source Review, and 230—Action on Applications, as noted in Table 1, submitted by the California Air Resources Board (CARB) for incorporation into the NSCAPCD portion of the California SIP. 81 FR 69390. Table 1 also lists the dates the rules were adopted by the NSCAPCD and submitted by CARB, which is the governor's designee for California SIP submittals.
Rules 130, 220, and 230 contain the requirements for review and permitting of individual stationary sources in the NSCAPCD. We proposed to approve these rules because we determined that they comply with the relevant CAA requirements. The changes the District made to the rules listed above resolve the limited disapproval issues identified in a previous action. 81 FR 69390 (October 6, 2016). The EPA listed four items that need addressing for the three rules with limited approval to become fully approved—listing lead as a pollutant and indicating a significant emission rate, requiring provisions for air quality modeling based on applicable models, databases, and other requirements as specified in Part 51 Appendix W, correcting a typographic error, and including specific language regarding source obligations. The revisions to the three submitted rules address these four deficiencies.
We are now finalizing approval of Rules 130, 220, and 230 because we have determined these rules satisfy all of the statutory and regulatory requirements for an NSR permit program (including the PSD program) as set forth in the applicable provisions of part C of title I of the Act and in 40 CFR 51.165 and 40 CFR 51.307.
Our proposed action contains more information on the rule and our evaluation.
The EPA's proposed action provided a 30-day public comment period. During this period, we received six comments. Only one comment pertained to the action. This comment was submitted by the NSCAPCD expressing support for the EPA's proposed action. The NSCAPCD states that this action will help the District maintain its portion of the California SIP in good standing. The EPA thanks the NSCAPCD for its support of our proposed action.
The comments have been added to the docket for this action and are accessible at
No comments were submitted that change our assessment of the rule as described in our proposed action. Therefore, as authorized in section 110(k)(3) of the Act, the EPA is fully approving this rule into the California SIP.
In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of the NSCAPCD rules described in the amendments to 40 CFR part 52 set forth below. The EPA has made, and will continue to make, these documents available through
Under the CAA, the EPA 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 Act. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Is not an Executive Order 13771 (82 FR 9339, February 3, 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, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, these rules do not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by September 24, 2018. Filing a petition for reconsideration by the Administrator of these final rules does not affect the finality of these rules for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rules or action. This action may not be challenged later in proceedings to enforce its requirements. (See CAA section 307(b)(2).)
Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
Part 52, chapter I, title 40 of the Code of Federal Regulations is amended as follows:
42 U.S.C. 7401
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(480) * * *
(i) * * *
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(
(
(
(504) * * *
(i) * * *
(B) Northern Sonoma County Air Pollution Control District.
(
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(
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; closure.
NMFS implements accountability measures (AMs) for commercial snowy grouper in the exclusive economic zone (EEZ) of the South Atlantic. NMFS projects commercial landings for snowy grouper will reach the commercial annual catch limit (ACL) by July 24, 2018. Therefore, NMFS closes the commercial sector for snowy grouper in the South Atlantic EEZ on July 24, 2018, and it will remain closed until the start of the next commercial fishing season on January 1, 2019. This closure is necessary to protect the snowy grouper resource.
This rule is effective 12:01 a.m., local time, July 24, 2018, until 12:01 a.m., local time, January 1, 2019.
Mary Vara, NMFS Southeast Regional Office, telephone: 727-824-5305, email:
The snapper-grouper fishery of the South Atlantic includes snowy grouper and is managed under the Fishery Management Plan for the Snapper-Grouper Fishery of the South Atlantic Region (FMP). The FMP was prepared by the South Atlantic Fishery Management Council and is implemented by NMFS under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622.
The commercial ACL (commercial quota) for snowy grouper in the South Atlantic is 144,315 lb (65,460 kg), gutted weight, 170,291 lb (77,243 kg), round weight, for the current fishing year, January 1 through December 31, 2018, as specified in 50 CFR 622.190(a)(1)(iv).
Under 50 CFR 622.193(b)(1), NMFS is required to close the commercial sector for snowy grouper when the commercial quota is reached or projected to be reached, by filing a notification to that effect with the Office of the Federal Register. NMFS projects that commercial landings of South Atlantic snowy grouper, as estimated by the Science and Research Director, will reach the commercial quota by July 24, 2018. Accordingly, the commercial sector for South Atlantic snowy grouper is closed effective 12:01 a.m., local time, July 24, 2018, until 12:01 a.m., local time, January 1, 2019.
The operator of a vessel with a valid commercial vessel permit for South Atlantic snapper-grouper having snowy grouper on board must have landed and bartered, traded, or sold such snowy grouper prior to 12:01 a.m., local time, July 24, 2018. During the commercial closure, harvest and possession of snowy grouper in or from the South Atlantic EEZ is limited to the bag and possession limits, as specified in § 622.187(b)(2)(ii) and (c)(1). Also during the commercial closure, the sale or purchase of snowy grouper taken from the EEZ is prohibited. The prohibition on sale or purchase does not apply to the sale or purchase of snowy grouper that were harvested, landed ashore, and sold prior to 12:01 a.m., local time, July 24, 2018, and were held in cold storage by a dealer or processor.
For a person on board a vessel for which a Federal commercial or charter vessel/headboat permit for the South Atlantic snapper-grouper fishery has been issued, the bag and possession limits and the sale and purchase provisions of the commercial closure for snowy grouper would apply regardless of whether the fish are harvested in state or Federal waters, as specified in 50 CFR 622.190(c)(1)(ii).
The Regional Administrator, Southeast Region, NMFS, has determined this temporary rule is necessary for the conservation and management of snowy grouper and the South Atlantic snapper-grouper fishery and is consistent with the Magnuson-Stevens Act and other applicable laws.
This action is taken under 50 CFR 622.193(b)(1) and is exempt from review under Executive Order 12866.
These measures are exempt from the procedures of the Regulatory Flexibility Act, because the temporary rule is issued without opportunity for prior notice and comment.
This action responds to the best scientific information available. The Assistant Administrator for NOAA Fisheries (AA), finds that the need to immediately implement this action to close the commercial sector for snowy grouper constitutes good cause to waive the requirements to provide prior notice and opportunity for public comment pursuant to the authority set forth in 5 U.S.C. 553(b)(B), as such procedures would be unnecessary and contrary to the public interest. Such procedures are unnecessary because the implementing final rule for these AMs has already been subject to notice and comment, and all that remains is to notify the public of the closure. Such procedures are contrary to the public interest because of the need to immediately implement this action to protect snowy grouper since the capacity of the fishing fleet allows for rapid harvest of the commercial quota. Prior notice and opportunity for public comment would require time and would potentially result in a harvest well in excess of the established commercial quota.
For the aforementioned reasons, the AA also finds good cause to waive the 30-day delay in the effectiveness of this action under 5 U.S.C. 553(d)(3).
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; reapportionment.
NMFS is reapportioning the seasonal apportionments of the 2018
Effective 1200 hours, Alaska local time (A.l.t.), July 19, 2018 through 2400 hours, A.l.t., December 31, 2018.
Obren Davis, 907-586-7228.
NMFS manages the groundfish fishery in the Gulf of Alaska (GOA) exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.
The final 2018 and 2019 harvest specifications for groundfish in the GOA (83 FR 8768, March 1, 2018) apportions the 2018 Pacific halibut PSC limit for trawl gear in the GOA to two trawl fishery categories: A deep-water species fishery and a shallow-water species fishery. The halibut PSC limit for these two trawl fishery categories is further apportioned by season, including four seasonal apportionments to the shallow-water species fishery and three seasonal apportionments to the deep-water species fishery. The two fishery categories also are apportioned a combined, fifth seasonal halibut PSC limit. Unused seasonal apportionments are added to the next season apportionment during a fishing year.
Regulations at § 679.21(d)(4)(iii)(D) require NMFS to combine management of the available trawl halibut PSC limits in the second season (April 1 through July 1) deep-water and shallow-water species fishery categories for use in either fishery from May 15 through June 30 of each year. Furthermore, NMFS is required to reapportion the halibut PSC limit between the deep-water and shallow-water species fisheries after June 30 to account for actual halibut PSC use by each fishery category during May 15 through June 30. As of July 18, 2018, NMFS has determined that the trawl deep-water and shallow-water fisheries used 133 metric tons (mt) and 4 mt of halibut PSC, respectively, from May 15 through June 30. Accordingly, pursuant to § 679.21(d)(4)(iii)(D), the Regional Administrator is reapportioning the combined first and second seasonal apportionments (810 mt) of halibut PSC limit between the trawl deep-water and shallow-water fishery categories to account for the actual PSC use (533 mt) in each fishery from January 1, 2018 through June 30, 2018. Therefore, Table 15 of the final 2018 and 2019 harvest specifications for groundfish in the GOA (83 FR 8768, March 1, 2018) is revised 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 originally specified apportionment of the halibut PSC limits to the deep-water and shallow-water fishery categories. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of July 18, 2018.
The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.
This action is required by § 679.20 and is exempt from review under Executive Order 12866.
16 U.S.C. 1801
Agricultural Marketing Service, USDA.
Proposed rule.
This proposed rule invites comments on proposed amendments to Marketing Order No. 956, which regulates the handling of sweet onions grown in the Walla Walla Valley of Southeast Washington and Northeast Oregon. The proposed amendments would change the Walla Walla Sweet Onion Marketing Committee's (Committee) size, quorum, and voting requirements. It would also change the staggered term limits so that one-half of the producer and handler member terms expire every two fiscal periods instead of one-third every three fiscal periods.
Comments must be received by September 24, 2018.
Interested persons are invited to submit written comments concerning this proposed rule. Comments must be sent to the Docket Clerk, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, STOP 0237, Washington, DC 20250-0237; Fax: (202) 720-8938; or internet:
Geronimo Quinones, Marketing Specialist, or Julie Santoboni, Rulemaking Branch Chief, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, Stop 0237, Washington, DC 20250-0237; Telephone: (202) 720-2491, Fax: (202) 720-8938, or Email:
Small businesses may request information on complying with this regulation by contacting Richard Lower, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, STOP 0237, Washington, DC 20250-0237; Telephone: (202) 720-2491, Fax: (202) 720-8938, or Email:
This action, pursuant to 5 U.S.C. 553, proposes an amendment to regulations issued to carry out a marketing order as defined in 7 CFR 900.2(j). This proposal is issued under Marketing Order No. 956, as amended (7 CFR part 956), regulating the handling of sweet onions grown in the Walla Walla Valley of Southeast Washington and Northeast Oregon. Part 956 (referred to as the “Order”) is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.” The Committee locally administers the Order and is comprised of sweet onion producers and handlers operating within the area of production and a public member.
Section 608c(17) of the Act and the applicable rules of practice and procedure governing the formulation of marketing agreements and orders (7 CFR part 900) authorizes amendment of the Order through this informal rulemaking action. The Agricultural Marketing Service (AMS) will consider comments received in response to this proposed rule, and based on all the information available, will determine if the Order amendment is warranted. If AMS determines amendment of the Order is warranted, a subsequent proposed rule and notice of referendum would be issued and producers would be allowed to vote for or against the proposed Order amendments. AMS would then issue a final rule effectuating any amendments approved by producers in the referendum.
The Department of Agriculture (USDA) is issuing this proposed rule in conformance with Executive Orders 13563 and 13175. This action falls within a category of regulatory actions that the Office of Management and Budget (OMB) exempted from Executive Order 12866 review. Additionally, because this proposed rule does not meet the definition of a significant regulatory action it does not trigger the requirements contained in Executive Order 13771. See OMB's Memorandum titled “Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017, titled `Reducing Regulation and Controlling Regulatory Costs' ” (February 2, 2017).
This proposal has been reviewed under Executive Order 12988, Civil Justice Reform. This rule is not intended to have retroactive effect. This rule shall not be deemed to preclude, preempt, or supersede any State program covering sweet onions grown in the Walla Walla Valley of Southeast Washington and Northeast Oregon.
The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. A handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed no later than 20 days after the date of entry of the ruling.
Section 1504 of the Food, Conservation, and Energy Act of 2008 (2008 Farm Bill)(Pub. L. 110-246) amended section 8c(17) of the Act, which in turn required the addition of supplemental rules of practice to 7 CFR
AMS has considered these factors and has determined that the amendments proposed are not unduly complex and the nature of the proposed amendments is appropriate for utilizing the informal rulemaking process to amend the Order. A discussion of the potential regulatory and economic impacts on affected entities is discussed later in the “Initial Regulatory Flexibility Analysis” section of this proposed rule.
The proposed amendments were unanimously recommended by the Committee following deliberations at two public meetings held on November 14, 2017 and March 3, 2018. The proposals would amend the Order by changing the Committee's size, quorum, and voting requirements. This action would also change the staggered term limits so that one-half of the producer and handler member terms expire every two fiscal periods instead of one-third every three fiscal periods.
Section 956.20 provides that the Committee consists of ten members, six of whom shall be producers, three of whom shall be handlers, and one public member. This proposal would amend § 956.20 by reducing the size of the Committee from ten to seven members, four of whom shall be producers, two of whom shall be handlers, and one public member. The requirement that each member have an alternate with the same qualifications as the member would remain unchanged.
Since promulgation of the Order in 1995, the number of Walla Walla sweet onion producers and handlers operating in the industry has decreased, which makes it difficult to find enough members and alternates to fill all the positions on the Committee. Decreasing the Committee's size from ten members to seven members would make it more reflective of today's industry. Having a smaller size committee would enable it to fulfill membership and quorum requirements. These changes should help the Committee streamline its operations and increase its effectiveness.
Section 956.21 requires Committee members and their alternates to serve for three years in staggered terms with one-third of the terms expiring each year.
This proposal would change § 956.21 by revising the terms of office for the producer and handler members from three years to two years beginning on June 1 so that one-half of the Committee changes every year. The staggered terms would also change so that one-half of the producer and handler member terms expire every two fiscal periods instead of one-third of the producer and handler members forms expiring every three fiscal periods. The proposed term limit changes would only apply to producer and handler members, and the public member term would remain three years.
Currently, Section 956.28(a) states that six members of the Committee shall constitute a quorum, and six concurring votes shall be required to pass any motion or approve any Committee action, except that recommendations made pursuant to § 956.61 shall require seven concurring votes.
The proposed changes would modify § 956.28 to state that four rather than six members would constitute a quorum and four rather than six concurring votes would be required to pass any motion to approve any Committee action, except for recommendations made pursuant to § 956.61, which would require five rather than seven concurring votes. These changes would help to streamline the Committee's operations and increase its effectiveness.
Pursuant to the requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), AMS has considered the economic impact of this action on small entities. Accordingly, AMS has prepared this initial regulatory flexibility analysis.
The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.
There are eight handlers of Walla Walla sweet onions subject to regulation under the Order and approximately 15 producers in the regulated production area. Small agricultural service firms are defined by the Small Business Administration as those having annual receipts of less than $7,500,000, and small agricultural producers are defined as those having annual receipts of less than $750,000 (13 CFR 121.201).
The Committee reported that approximately 390,000 50-pound bags or equivalents of Walla Walla sweet onions were shipped into the fresh market in 2017. Based on information reported by USDA's Market News Service, the average 2017 marketing year f.o.b. shipping point price for the Walla Walla sweet onions was $14.90 per 50-pound equivalent. Multiplying the $14.90 average price by the shipment quantity of 390,000 50-pound equivalents yields an annual crop revenue estimate of $5,811,000. The average annual revenue for each of the eight handlers is therefore calculated to be $726,375 ($5,811,000 divided by eight), which is considerably less than the Small Business Administration threshold of $7,500,000. Consequently, all the Walla Walla sweet onion handlers could be classified as small entities.
In addition, based on information provided by the National Agricultural Statistics Service (NASS), the average producer price for Walla Walla sweet onions for the 2012 through 2016 marketing years is $15.27 per 50-pound equivalent. NASS has not released data regarding the 2017 marketing year at this time. Multiplying the 2012-2016 marketing year average price of $15.27 by the 2017 marketing year shipments of 390,000, 50-pound equivalents yields an annual crop revenue estimate of $5,955,300. The estimated average annual revenue for each of the 15 producers is therefore calculated to be approximately $397,020 ($5,955,300 divided by 15), which is less than the Small Business Administration threshold of $750,000. In view of the foregoing, the majority of Walla Walla sweet onion producers, and all of the Walla Walla sweet onion handlers, may be classified as small entities.
The proposed amendments would change the Committee's size, quorum, and voting requirements. They would also change the staggered term limits so that one-half of the producer and handler member terms expire every two fiscal periods instead of one-third every three fiscal periods.
The Committee's proposed amendments were unanimously recommended at two public meetings on November 14, 2017 and March 3, 2018. If these proposals are approved in
The Committee believes these changes will serve the needs of the Committee and the industry. No economic impact is expected if the proposed amendments are approved because they would not establish any new regulatory requirements on handlers, nor would they have any assessment or funding implications. There would be no change in financial costs, reporting, or recordkeeping requirements if this proposal is approved.
Alternatives to this proposal, including making no changes at this time, were considered by the Committee. Due to changes in the industry, AMS believes the proposals are justified and necessary to ensure the Committee's ability to locally administer the program. Reducing the size of the Committee would enable it to fulfill membership and quorum requirements fully, thereby ensuring a more efficient and orderly flow of business.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), the Order's information collection requirements have been previously approved by OMB and assigned OMB No. 0581-0178 (Vegetable and Specialty Crops). No changes in those requirements are necessary because of this action. Should any changes become necessary, they would be submitted to OMB for approval.
This proposed rule would impose no additional reporting or recordkeeping requirements on either small or large Walla Walla Valley sweet onion handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public-sector agencies.
AMS is committed to complying with the E-Government Act, to promote the use of the internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.
USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this action.
The Committee's meetings were widely publicized throughout the Walla Walla Valley sweet onion production area. All interested persons were invited to attend the meetings and encouraged to participate in Committee deliberations on all issues. Like all Committee meetings, the November 14, 2017 and March 3, 2018, meetings were public, and all entities, both large and small, were encouraged to express their views on the proposals.
Finally, interested persons are invited to submit comments on the proposed amendments to the Order, including comments on the regulatory and information collection impacts of this action on small businesses.
Following analysis of any comments received on the amendments proposed in this proposed rule, AMS will evaluate all available information and determine whether to proceed. If appropriate, a proposed rule and notice of referendum would be issued, and producers would be provided the opportunity to vote for or against the proposed amendments. Information about the referendum, including dates and voter eligibility requirements, would be published in a future issue of the
A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at:
The findings hereinafter set forth are supplementary to the findings and determinations which were previously made in connection with the issuance of Marketing Order 956; and all said previous findings and determinations are hereby ratified and affirmed, except insofar as such findings and determinations may be in conflict with the findings and determinations set forth herein.
1. Marketing Order 956 as hereby proposed to be amended and all the terms and conditions thereof, would tend to effectuate the declared policy of the Act;
2. Marketing Order 956 as hereby proposed to be amended regulates the handling of sweet onions grown in the Walla Walla Valley of Southeast Washington and Northeast Oregon and is applicable only to persons in the respective classes of commercial and industrial activity specified in the Order;
3. Marketing Order 956 as hereby proposed to be amended is limited in application to the smallest regional production area which is practicable, consistent with carrying out the declared policy of the Act, and the issuance of several marketing orders applicable to subdivisions of the production area would not effectively carry out the declared policy of the Act;
4. Marketing Order 956 as hereby proposed to be amended prescribes, insofar as practicable, such different terms applicable to different parts of the production area as are necessary to give due recognition to the differences in the production and marketing of onions produced or packed in the production area; and
5. All handling of onions produced or packed in the production area as defined in Marketing Order 956 is in the current of interstate or foreign commerce or directly burdens, obstructs, or affects such commerce.
A 60-day comment period is provided to allow interested persons to respond to these proposals. Any comments received on the amendments proposed in this proposed rule will be analyzed, and if AMS determines to proceed based on all the information presented, a producer referendum would be conducted to determine producer support for the proposed amendments. If appropriate, a final rule would then be issued to effectuate the amendments favored by producers participating in the referendum.
Onions, Marketing agreements, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, 7 CFR part 956 is proposed to be amended as follows:
7 U.S.C. 601-674.
(a) The Walla Walla Sweet Onion Marketing Committee, consisting of seven members, is hereby established. The Committee shall consist of four producer members, two handler members, and one public member. Each
(a) Except as otherwise provided in paragraph (b) of this section, the term of office of grower and handler Committee members and their respective alternates shall be two years beginning on June 1. The terms shall be determined so that one-half of the grower membership and one-half of the handler membership shall terminate every year. Members and alternates shall serve during the term of office for which they are selected and have been qualified, or during that portion thereof beginning on the date on which they qualify during such term of office and continuing until the end thereof, or until their successors are selected and have qualified.
(b) The term of office of the initial members and alternates shall begin as soon as possible after the effective date of this subpart. One-half of the initial industry grower and handler members and alternates shall serve for a one year term and one-half shall serve for a two year term. The initial, as well as all successive terms of office of the public member and alternate member shall be for three years.
(c) The consecutive terms of office for all members shall be limited to two two-year terms. There shall be no such limitation for alternate members.
(a) Four members of the Committee shall constitute a quorum, and four concurring votes shall be required to pass any motion or approve any Committee action, except that recommendations made pursuant to § 956.61 shall require five concurring votes.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to modify Class D airspace, and Class E airspace extending upward from 700 feet above the surface, and establish Class E surface area airspace at Wheeler Army Airfield (AAF), Honolulu, HI. This action also would update the airport name and geographic coordinates in the associated Class D and E airspace areas to match the FAA's aeronautical database, and would replace outdated language in the airspace description. An editorial change to the airspace designations also would be made.
Comments must be received on or before September 7, 2018.
Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE, West Building Ground Floor, Room W12-140, Washington, DC 20590; telephone: 1-800-647-5527, or (202) 366-9826. You must identify FAA Docket No. FAA-2014-0878; Airspace Docket No. 14-AWP-10, at the beginning of your comments. You may also submit comments through the internet at
FAA Order 7400.11B, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
Steve Haga, Federal Aviation Administration, Operations Support Group, Western Service Center, 2200 S 216th St., Des Moines, WA 98198-6547; telephone (206) 231-2252.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority, as it would amend Class D and Class E airspace at Wheeler Army Airfield (AAF), Honolulu, HI, to support standard instrument approach procedures for IFR operations at the airport.
Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Persons wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to FAA-2014-0878; Airspace Docket No. 14-AWP-10”. The postcard will be date/time stamped and returned to the commenter.
All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. A report summarizing each substantive
An electronic copy of this document may be downloaded through the internet at
You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the
This document proposes to amend FAA Order 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, and effective September 15, 2017. FAA Order 7400.11B is publicly available as listed in the
The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) part 71 by modifying Class D airspace, Class E airspace extending upward from 700 feet above the surface, and establishing Class E surface area airspace at Wheeler AAF, Honolulu, HI.
Class D airspace extending upward from the surface to and including 3,300 feet MSL would be modified to within a 2.6-mile radius of Wheeler AAF, (formerly Wheeler AFB), then extend to a 3.7-mile radius from the southeast to the southwest, adjoining the boundary of Restricted Area R-3109 to the west, excluding that airspace below 1,800 feet MSL beyond 3.3 miles from the airport from the 89° bearing clockwise to the 218° bearing from the airport.
Additionally, an editorial change would be made to the Class D airspace legal description removing the words “Airport/Facility Directory”. An editorial change also would be made removing the city associated with the airport name in the airspace designation to comply with a recent change to FAA Order 7400.2L, Procedures for Handling Airspace Matters.
Class E surface area airspace would be established to be coincident with the lateral dimensions of the Class D airspace, and would be effective continuously to provide protection to instrument procedures.
Class E airspace extending upward from 700 feet would be modified to that airspace within a 4.2-mile radius of Wheeler AAF. The Koko Head VORTAC navigation aid would be removed, as it is no longer needed to describe the boundary.
Additionally, this action proposes to update the airport name from Wheeler AFB to Wheeler AAF, and the geographic coordinates for the associated Class D and Class E airspace areas to match the FAA's aeronautical database.
Class D and Class E airspace designations are published in paragraph 5000, 6002, and 6005, respectively, of FAA Order 7400.11B, dated August 3, 2017, and effective September 15, 2017, which is incorporated by reference in 14 CFR 71.1. The Class D and E airspace designations listed in this document will be published subsequently in the Order.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.
Airspace, Incorporation by reference, Navigation (air).
Accordingly, pursuant to the authority delegated to me, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from the surface to and including 3,300 feet MSL bounded by a line from lat. 21°31′03″ N, long. 158°04′30″ W; to lat. 21°31′25″ N, long. 158°03′00″ W, thence clockwise along a 2.6-mile radius of Wheeler AAF to lat. 21°30′33″ N, long. 158°00′07″ W; to lat. 21°28′41″ N, long. 157°58′19″ W, thence clockwise along a 3.7-mile radius of the airport to lat. 21°25′46″ N, long. 158°04′24″ W; to lat. 21°26′52″ N, long. 158°04′31″ W; to lat. 21°27′17″ N, long. 158°05′45″ W; to lat. 21°29′14″ N, long. 158°04′50″ W; to lat. 21°30′18″ N, long. 158°03′59″ W; thence to the point of beginning, excluding that airspace below 1,800 feet MSL beyond 3.3 miles from the airport from the 89° bearing clockwise to the 218° bearing from the airport. This Class D airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Pacific Chart Supplement.
That airspace extending upward from the surface bounded by a line from lat. 21°31′03″ N, long. 158°04′30″ W; to lat. 21°31′25″ N, long. 158°03′00″ W, thence clockwise along a 2.6-mile radius of Wheeler AAF to lat. 21°30′33″ N, long. 158°00′07″ W; to lat.
That airspace extending upward from 700 feet above the surface within a 4.2-mile radius of Wheeler AAF, excluding that portion within Restricted Area R-3109, when active.
Securities and Exchange Commission
Concept release; request for comment.
The Securities and Exchange Commission (“Commission”) is publishing this release to solicit comment on the exemption from registration under the Securities Act of 1933 (the “Securities Act”) for securities issued by non-reporting companies pursuant to compensatory arrangements, and Form S-8, the registration statement for compensatory offerings by reporting companies. Significant evolution has taken place both in the types of compensatory offerings issuers make and the composition of the workforce since the Commission last substantively amended these regulations. Therefore, as we amend the exemption as mandated by the Economic Growth, Regulatory Relief, and Consumer Protection Act (the “Act”), we seek comment on possible ways to modernize the exemption and the relationship between it and Form S-8, consistent with investor protection.
Comments should be received on or before September 24, 2018.
Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
Anne M. Krauskopf, Senior Special Counsel, and Adam F. Turk, Special Counsel, Office of Chief Counsel, Division of Corporation Finance, at (202) 551-3500.
Under the Securities Act, every offer and sale of securities must be registered or subject to an exemption from registration. The Commission has long recognized that offers and sales of securities as compensation present different issues than offers and sales that raise capital for the issuer of the securities.
Equity compensation can be an important component of the employment relationship. Using equity for compensation can align the incentives of employees with the success of the enterprise, facilitate
Since Rule 701 and Form S-8
In 1988, the Commission adopted Rule 701 under the Securities Act
(i) More than 50 percent of the outstanding voting securities of which are directly or indirectly owned of record by residents of the United States; and
(ii) Any of the following:
(A) The majority of the executive officers or directors are United States citizens or residents;
(B) More than 50 percent of the assets of the issuer are located in the United States; or
(C) The business of the issuer is administered principally in the United States.
The rule provides an exemption from registration only for securities issued in compensatory circumstances and is not available for plans or schemes inconsistent with this purpose, such as to raise capital.
Since 1999,
• $1 million;
• 15% of the total assets of the issuer,
• 15% of the outstanding amount of the class of securities being offered and sold in reliance on the rule, measured at the issuer's most recent balance sheet date.
These measures apply on an aggregate basis, not plan-by-plan. For securities underlying options, the aggregate sales price is determined when the option grant is made, without regard to when it becomes exercisable.
In all cases, the issuer must deliver to investors a copy of the compensatory benefit plan or contract. Further, Rule 701 transactions are subject to the antifraud provisions of the federal securities laws.
In addition, if the aggregate sales price or amount of securities sold during the 12-month period exceeds $5 million,
• A copy of the summary plan description required by ERISA,
• Information about the risks associated with investment in the securities sold under the plan or contract; and
• Financial statements required to be furnished by Part F/S of Form 1-A
This disclosure should be provided to all investors before sale. For options and other derivative securities, the issuer must deliver disclosure a reasonable period of time before the date of exercise or conversion.
The exemption covers securities offered or sold under a plan or agreement between a non-reporting company (or its parents, majority-owned subsidiaries or majority-owned subsidiaries of its parent) and the company's employees, officers, directors, partners, trustees, consultants and advisors.
Consultants and advisors may participate in Rule 701 offerings only if:
• They are natural persons;
• They provide
• The services are not in connection with the offer or sale of securities in a capital-raising transaction, and do not directly or indirectly promote or maintain a market for the issuer's securities.
In adopting these restrictions on the range of eligible consultants and advisors, the Commission also provided that a person in a
Offers and sales under Rule 701 are deemed part of a single discrete offering and are not subject to integration with any other offers or sales, whether registered under the Securities Act or exempt from registration.
Section 502 of the Jumpstart Our Business Startups Act
Questions have arisen about whether the current requirements of Rule 701 would benefit from updates in light of developments since the Commission last substantively revised the rule. Forms of equity compensation that were not typically used at that time, particularly restricted stock units (“RSUs”), have become common, and new types of contractual relationships between companies and individuals involving alternative work arrangements have emerged in the so-called “gig economy.”
Due in large part to the internet, new types of contractual relationships are arising between companies and individuals in the labor markets and the workplace economy. These can involve short-term, part-time or freelance arrangements, where the individual—rather than the company—may set the work schedule. Typically, this involves the individual's use of the company's internet “platform” for a fee to find business, whether that involves the individual providing services to end users, or using the platform to sell goods or lease property. Platforms are available that offer end users such services as ride-sharing, food delivery, household repairs, dog-sitting, and tech support. Other platforms offer hand-made craft objects, lodging, or car rentals. An individual who provides services or goods through these platforms may have similar relationships with multiple companies, through which the individual may engage in the same or different business activities.
Individuals participating in these arrangements do not enter into traditional employment relationships, and thus may not be “employees” eligible to receive securities in compensatory arrangements under Rule 701.
Our comment requests focus on what activities an individual should need to engage in to be eligible to participate in exempt compensatory offerings:
1. To what extent should definitions of “employee” under other regulatory regimes guide our thinking on eligible participants in compensatory securities offerings? Which regulatory regimes should we consider for this purpose? Should any new test apply equally to all companies, or would there be a reason to apply different tests based on the nature of the working relationship?
2. Would the application of Rule 701 to consultants and advisors in any circumstances cover the alternative work arrangements described above?
3. What, if any, services should an individual participating in the “gig economy” need to provide to the issuer to be eligible under Rule 701? Do these individuals in fact provide services to the issuer, or instead to the issuer's customers or end users? Should this fact make any difference for purposes of Rule 701 eligibility?
4. Should we consider a test that identifies Rule 701 eligible participants as individuals who use the issuer's platform to secure work providing lawful services to end users?
a. Are any other factors necessary to establish any level of control by the issuer, such as requiring the work to be assigned by the issuer? Or is it necessary that the issuer control what the individual charges end users for services, such as by setting hourly rates or ride fares? Should a written contractual relationship between the issuer and individual be necessary? Why or why not?
b. Does it matter whether the individual goes through a vetting or screening process by the issuer to use the platform?
c. Does it matter whether the issuer controls when and how the individual receives monetary compensation for the services provided?
5. Would it be sufficient for an individual to use the issuer's platform to sell goods, to earn money from leasing real estate or personal property, or to conduct a business activity? Would the individual be considered to be providing a service to either or both the company and its end-users or customers? Does it matter whether that business activity provides a service typically provided by an employee or is of a more entrepreneurial nature? How do the answers to these questions affect whether there is a sufficient nexus between the individual and the issuer to justify application of the exemption for compensatory transactions?
6. Should it make a difference whether the end user pays the issuer for the goods or leased property, and the issuer then provides a monetary payment to the individual, or the end user pays the individual directly, who then pays a fee to the issuer?
Our comment requests also focus on whether a potential eligibility test should consider the individual's level of dependence on the issuer, or, conversely, the issuer's degree of dependence on the individuals:
7. For example, should it matter what percentage of the individual's earned income is derived from using the issuer's platform? If so, should this be based on earned income during the last year, a series of consecutive years, or current expectations? Should there be a minimum percentage? How should this be verified? How should such a test be applied where the individual provides services to multiple companies? How would the issuer be able to determine how much of an individual's income is derived from using the issuer's platform?
8. Alternatively, where the individual provides services, should eligibility be based on information objectively verifiable by the issuer, such as amount of income earned, or percentage of time or number of hours worked?
9. Where use of the platform relates to leasing a property, should the test focus on how frequently the property is available, how often it actually is leased, the revenues generated by the property, or other factors?
10. Should the test focus on the extent to which the individual uses the issuer's platform to obtain business on a regular basis? Should it consider the duration of time over which the individual has so used the issuer's platform?
11. Should the test instead focus on the extent to which the issuer's business is dependent on individuals' use of the issuer's platform? If so, why, and how should that dependence be measured?
12. What test or tests would leave an issuer best positioned to determine whether it could rely on Rule 701?
We are mindful that extending eligibility to individuals participating in the “gig economy” could increase the volume of Rule 701 issuances. In this regard:
13. Would revising the rule have an effect on a company's decision to become a reporting company? Would such revisions encourage companies to stay private longer?
14. Would investors be harmed if the exemption is expanded to individuals participating in the “gig economy,” potentially resulting in higher levels of equity ownership in the hands of persons who would not be shareholders of record for purposes of triggering
15. Should the amount of securities issuable pursuant to Rule 701 to individuals participating in the “gig economy” in a 12-month period be subject to a separate ceiling rather than the current Rule 701(d) ceilings? If so, how should that ceiling be designed and measured?
16. Should additional disclosures be provided? If so, what and when?
Employers have many reasons for compensating employees with securities. These can include aligning the company's interests with those of employees', retaining staff, and offering higher compensation than the company may be able to pay in cash or other benefits.
17. Do companies utilizing “gig economy” workers issue securities as compensation to those individuals? If so, how prevalent is this practice?
18. How might companies benefit from the ability to offer securities to a broader range of individuals by expanding Rule 701 eligibility to individuals participating in the “gig economy”?
19. What effect would the use of Rule 701 for “gig economy” companies have on competition among those companies and newer companies and more established companies vying for the same talent?
The “gig economy” has enabled even very small companies to conduct cross-border operations.
20. Do existing regulations affect the ability of employers to use Rule 701 to compensate overseas employees through securities?
21. To the extent that U.S. companies would seek to use Rule 701 to compensate non-U.S. based workers in a “gig economy” model, would there be any competitive effects?
When Rule 701 was originally adopted in 1988,
The 1999 adoption of the $5 million disclosure threshold reflected concern that eliminating the overall $5 million ceiling on the annual amount of securities sold during a 12-month period “could result in some very large offerings of securities without the protections of registration, even though made pursuant to compensatory arrangements.”
Inflation since 1999
As noted above, in a separate release, the Commission is amending Rule 701(e) to implement the Act's mandate to increase from $5 million to $10 million the aggregate sales price or amount of securities sold during any consecutive 12-month period in excess of which the issuer is required to deliver additional disclosures to investors.
While the adopted amendment may provide non-reporting issuers flexibility in further utilizing the exemption, it does not address some of the concerns we have heard regarding Rule 701(e). In particular, although the threshold is higher, the need to anticipate the consequences of crossing it remains.
In light of these concerns, we request comment:
22. Should Rule 701(e) continue to require more disclosure for a period that precedes the threshold amount being exceeded? If so, should the consequence for failure to deliver continue to be loss of the exemption for the entire offering?
23. To what extent are non-reporting companies that issue securities in an amount that would exceed the new threshold already preparing forms of financial disclosure, such as in connection with 17 CFR 230.500 through 230.508 (Regulation D) or Regulation A?
24. Alternatively, should the consequence for failing to provide the disclosure be loss of the exemption only for transactions in offerings that occur after the threshold is crossed and for which disclosure was not provided?
a. If disclosure is required only for transactions that occur after the $10 million threshold is crossed, should disclosure be required for all transactions immediately following that event, or should an interval of time be provided to permit the disclosure to be prepared before it must be delivered? If
b. Should the disclosure subsequently also be made available to investors in transactions that occurred before the $10 million threshold is crossed?
25. Alternatively, should there instead be a grace period, such that if the threshold is crossed, the issuer has an opportunity to provide the required disclosure before losing the exemption for the entire offering?
26. Should we provide a regulatory option whereby all Rule 701(e) information would be disclosed to all investors, so that all would receive equal information and there would be no risk of losing the exemption in the manner there is today? Should we provide a different regulatory alternative that would provide all investors all Rule 701(e) information other than the financial statement disclosure?
Part F/S of Form 1-A prescribes that financial statements are required for Regulation A Tier 1 and Tier 2 offerings. In Regulation A offerings, companies include two years of consolidated balance sheets, statements of income, cash flows, and changes in stockholders' equity.
27. Should the type of information provided depend on who is the recipient of the securities? For example, should more disclosure be provided to the types of recipients described in Section II.B. above? Why or why not? If so, what, specifically, should be added to the disclosures and why?
28. Should this disclosure be updated less frequently than currently required? For example, should we require updates once a year unless an event results in a material change to the company's enterprise value or value of the securities issued?
29. Should we consider other alternatives to the Regulation A financial statements, such as the issuer's most recent balance sheet and income statement as of a date no more than 180 days before the sale of securities?
30. Should we provide a regulatory option that would provide valuation information regarding the securities in lieu of, or in addition to, financial statements? If so, what valuation method should be used? Would ASC Topic 718
Under existing Rule 701, foreign private issuers are required to provide financial information on the same schedule as domestic issuers.
31. Because foreign private issuers that are subject to the Exchange Act reporting requirements generally are not required to submit quarterly financial statements, should non-reporting foreign private issuers that rely on Rule 701 be subject to the condition to provide quarterly financial statements if they are continuing to sell securities throughout the year? Why or why not?
32. Should we amend any other aspect of the Rule 701 financial statement requirements that apply to foreign private issuers? If so, what should we amend and why?
Rule 701(e) requires the prescribed disclosure to be delivered “a reasonable period of time before the date of sale.” However, the rule does not prescribe the manner or medium in which disclosure should be delivered. We are aware that non-reporting companies are sensitive to maintaining the confidentiality of financial information so that it does not fall into the hands of competitors.
To determine if the rule needs further clarification, we request comment:
33. Do we need to clarify what it means to deliver disclosure “a reasonable period of time before the date of sale”? Should that mean any time before sale such that the recipient has an opportunity to review the disclosure? Should any new standard further clarify that the disclosure provided to the recipient must remain current during that time?
34. Should we specify a different time for providing disclosure? If so, when should that be and why?
35. Should we also specify the manner or medium in which disclosure should be delivered? Should we specify how to deliver information electronically? Should we require a method for confirming receipt of the information? If so, what vehicles would best give effect to the purpose of disclosure without undermining issuers' confidentiality concerns?
36. Should the rule specify that confidentiality safeguards should not be so burdensome that intended recipients cannot effectively access the required disclosures?
For options and other derivative securities, whether the issuer is obligated to deliver Rule 701(e) disclosure is based on whether the option or other derivative security was granted during a 12-month period during which the disclosure threshold is exceeded.
This approach simplifies the operation of Rule 701 for options and other derivative securities for which the recipient must make an investment decision to exercise or convert. However, because instruments such as RSUs settle by their terms without the recipient taking such an action, the relevant investment decision for the RSU, if there is one, likely takes place
In light of this concern, we request comment:
37. Should Rule 701 be amended to specifically address when disclosure is required for RSUs? If so, when should Rule 701(e) disclosure be required for an RSU? Should we revisit the concept of “convert or exercise” as providing the relevant date for disclosure? For new hires who receive RSUs, should we require that disclosure be provided within 30 days after commencing employment? If not, when should Rule 701(e) disclosure be required for RSUs issued to new hires?
38. Should we clarify that RSUs should be valued for Rule 701 purposes based on the value of the underlying securities on the date of grant? If not, how should they be valued?
39. Are there any other instruments that should be specifically addressed in the rule?
Questions have arisen whether the current 12-month sales cap of the greater of 15% of the total assets of the issuer or 15% of the total outstanding amount of the class of securities being offered and sold in reliance on the rule, subject to the annual availability of a $1 million cap if greater than either of these tests, is unduly restrictive, particularly for smaller and start-up companies that may be more dependent on equity compensation to attract and retain necessary talent.
Recently, however, concern has been expressed that because there is no longer any statutorily imposed ceiling on the exemption,
In light of these factors, we request comment:
40. Is there a continuing need for any annual regulatory ceiling for Rule 701 transactions? Why or why not? Would investors be harmed if the ceiling is eliminated or raised significantly? Does an annual ceiling provide benefits in curbing potential abuse of the rule for non-compensatory sales? If so, how?
41. If a ceiling is retained, should it be raised? If so, what threshold would be appropriate, and why? Would compliance be easier if issuers are permitted to measure the 15% alternatives as of last fiscal year-end, rather than at the issuer's most recent balance sheet date?
Form S-8 was originally adopted in 1953, as a simplified form for the registration of securities to be issued pursuant to employee stock purchase plans.
Form S-8 is available for the registration of securities to be offered under any employee benefit plan
Form S-8 does not require that a form of prospectus be filed with the registration statement for employee benefit plan offerings. Instead, 17 CFR 230.428 (Rule 428) specifies the documents that, together, constitute a prospectus that meets the requirements of Securities Act Section 10(a):
• Certain documents containing the employee benefit plan information required by Item 1 of the Form;
• the statement of availability of company information, employee benefit plan annual reports and other information required by Item 2 of the Form; and
• the documents containing registrant information and employee benefit plan annual reports that are incorporated by reference in the registration statement pursuant to Item 3 of the Form.
Companies are also permitted to file a resale prospectus covering only control securities or restricted securities acquired pursuant to an employee benefit plan.
To prevent abuse of Form S-8 to register securities issued in capital-raising transactions, in 1999 the Commission revised the eligibility standards for “consultants and advisors” for the purposes of Form S-8.
42. To the extent we change the application of Rule 701 by changing the scope of individuals eligible for compensatory offerings, such as to include individuals participating in the “gig economy,”
43. Would differences between the eligibility standards of Rule 701 and Form S-8 cause problems for issuers or recipients?
Issuers register a specified number of company shares on Form S-8. For registration fee purposes, if the offering price is not known, the fee is computed based on the price of securities of the same class, in the same manner as for other offerings at fluctuating market prices.
The Commission has sought to reduce the costs and burdens incident to registration of securities issued through such plans, where consistent with investor protection,
• Allowing Form S-8 to go effective automatically without review by the staff or other action by the Commission;
• allowing the incorporation by reference of certain past and future reports required to be filed by the issuer under Section 13 or 15(d) under the Exchange Act;
• adopting an abbreviated disclosure format that eliminated the need to file a separate prospectus and permitting the delivery of regularly prepared materials to advise employees about benefit plans to satisfy prospectus delivery requirements;
• providing for registration of an indeterminate amount of plan interests and providing that there is no separate fee calculation for registration of plan interests;
• providing a procedure for the filing of a simplified registration statement covering additional securities of the same class to be issued pursuant to the same employee benefit plan.
We remain interested in simplifying the requirements of Form S-8 and reducing the complexity and cost of compliance to issuers for securities issuances to employees and other eligible employee benefit plan participants while retaining appropriate investor protections. We therefore seek comment on ways we could further reduce the burdens associated with registration on Form S-8:
44. What effects would stem from revising the form in this way? Would such revisions encourage more companies to become reporting companies?
45. Should we further simplify the registration requirements of Form S-8? For example, does registering a specific number of shares result in Section 5 compliance problems when plan sales exceed the number of shares registered, such as for Section 401(k) plans and similar defined contribution retirement savings plans? If so, how should we address this issue?
46. Should Form S-8 allow an issuer to register on a single form the offers and sales pursuant to all employee benefit plans that it sponsors?
47. If we facilitate a single registration statement for all employee benefit plan securities, should the number of shares to be registered continue to be specified in the initial registration statement? Alternatively, should issuers be able to add securities to the existing Form S-8 by an automatically effective post-effective amendment?
48. With respect to either alternative above, would the ability to have a single Form S-8 reduce administrative burdens given that many issuers currently monitor and track multiple registration statements on Form S-8?
49. Well-known seasoned issuers are permitted, at their option, to pay filing fees on a “pay-as-you-go” basis at the time of each takedown off the shelf registration statement in an amount calculated for that takedown.
a. For well-known seasoned issuers using the pay-as-you-go fee structure, a cure is available that allows such issuers to pay required filing fees after the original payment due date if the issuer makes a good faith effort to pay the fee timely and then pays the fee within four business days of the original fee due date.
50. Alternatively, should we require the payment of registration fees on a periodic basis with respect to the securities, the offer and sale of which were registered on Form S-8, during the prior period? How would such a system best be implemented? How could we structure such a system consistent with the requirements of Securities Act Section 6(c)?
51. Are there any other ways to reduce the administrative burdens associated with filing and updating Form S-8? If so, please explain.
We also are soliciting comment more broadly on Form S-8 itself:
52. Does the current operation of Form S-8 present significant challenges to the use of employee benefit plans? If so, please explain how.
53. It has been suggested that Form S-8 registration would no longer be necessary if the Commission were to extend the Rule 701 exemption to Exchange Act reporting companies.
54. Form S-8 requires issuers to remain current in their Exchange Act reports in order to be eligible to use the form,
55. Since Exchange Act reports are automatically incorporated by reference into Form S-8, would the lack of a filed registration statement for employee benefit plans result in reduced scrutiny of Exchange Act filings by issuers and their representatives?
56. If Form S-8 were rescinded, how would issuers be likely to register the resale of restricted securities issued pursuant to employee benefit plans? Would Form S-8 remain necessary as a method of registering resales of control securities or restricted securities acquired pursuant to an employee benefit plan? Alternatively, should the provisions of General Instruction C to Form S-8 be moved to Securities Act Form S-3?
We are interested in the public's opinions regarding the matters discussed in this concept release. We encourage all interested parties to submit comments on these topics. In addition, we solicit comment on any other aspect of Rule 701 and Form S-8 that commenters believe may be improved upon.
By the Commission.
Environmental Protection Agency (EPA).
Proposed rule; notification of data availability and extension of comment period.
EPA is providing notice that it is supplementing the record for the proposed Risk Management Program (RMP) Reconsideration rule published on May 30, 2018. We have placed into the rulemaking docket the November 2017 version of the RMP database containing risk management plans submitted to EPA. EPA used this version to support analysis of changes in the RMP reporting facility universe discussed in the Regulatory Impact Analysis of the proposed Reconsideration rule. To afford the public an opportunity to comment on the updated RMP database and its impacts on the proposed Reconsideration rule, EPA is extending the comment period for the proposed rule.
The comment period for the proposed rule published on May 30, 2018 at 83 FR 24850, is extended. Comments and additional material must be received on or before August 23, 2018.
Submit comments and additional materials, identified by docket EPA-HQ-OEM-2015-0725 to the Federal eRulemaking Portal:
James Belke, United States Environmental Protection Agency, Office of Land and Emergency Management, 1200 Pennsylvania Ave. NW (Mail Code 5104A), Washington, DC 20460; telephone number: (202) 564-8023; email address:
Detailed background information describing the proposed RMP Reconsideration rulemaking may be found in a previously published document: Accidental Release Prevention Requirements: Risk Management Programs Under the Clean Air Act; Proposed Rule (83 FR 24850, May 30, 2018).
During the week of July 9, 2018 several stakeholders notified EPA that we had failed to provide in the rulemaking docket for the proposed RMP Reconsideration rule (referred to herein as the Reconsideration Proposal) the risk management plan data we used to compare the number of facilities reporting in the February 2015 version of the RMP database to those reporting in the November 2017 version. This analysis of the change in the number of facilities was presented in the Regulatory Impact Analysis (RIA) for the Reconsideration Proposal. Stakeholders requested that EPA supply the risk management plan data used in the RIA that supported the comparison analysis. They also requested that EPA extend the comment period for the Reconsideration Proposal for 60 days to allow the public to access and review the data so that they may have enough time to assess the impacts of the updated data on the proposal and provide comments.
As a result, in this supplemental action, EPA is providing additional information in the docket for the proposed action. On July 11, 2018, EPA placed into the docket the November 2017 version of the database containing risk management plans submitted by RMP facilities. This database does not contain the restricted offsite consequence analysis (OCA) data. This database (Docket ID: EPA-HQ-OEM-2015-0725-0989) consists of a digital versatile disc (DVD) containing the RMP database as a 1.4 gigabyte size file in .mdb format. The database file is too large to be provided online through
On May 30, 2018, EPA proposed a rule (Reconsideration Proposal) that seeks comment on various proposed changes to the final RMP Amendments rule (Amendments rule) issued on
The RIA for the Amendments rule utilized a February 2015 version of the RMP database to compile the universe of RMP facilities. The database reflected that approximately 12,500 facilities had filed current risk management plans with EPA and could have been potentially affected by the Amendments final rule. EPA had provided in the rulemaking docket, the non-OCA version of the risk management plan data submitted by facilities as of February 2015. (Docket ID: EPA-HQ-OEM-2015-0725-0311). For the RIA for the Reconsideration Proposal (Docket ID: EPA-HQ-OEM-2015-0725-0907), EPA compared the February 2015 version of the risk management plan database to the most recent version of the database from November 2017 for the purposes of understanding and comparing how the universe of RMP facilities had changed in the intervening period between developing the Amendments rule RIA and the Reconsideration Proposal RIA. EPA also developed a comparison of the number of RMP facilities by industry sector, by employee size, by RMP program level, by process complexity and by responding/nonresponding status. These counts of RMP facilities are presented in various data tables in Chapter 3 of the Reconsideration Proposal RIA and were extracted from the two versions of the RMP database. The comparison revealed that the number of RMP facilities and processes had experienced minor changes in the more than two years between rulemakings. In total, the number of RMP facilities decreased by 1.8% over the time-period and included small changes in the number of facilities in most industry codes and process levels. As discussed in Chapter 3 of the Reconsideration Proposal RIA, EPA determined that the differences between the databases were minor, with the exception of the number of accidents. As a result, EPA utilized the costs estimated for the 2017 Amendments rule RIA as the baseline set of costs to be impacted by the Reconsideration Proposal.
For the Amendments rule, EPA had also provided in the docket as a separate dataset data on accidents occurring at RMP facilities from 2004-2013, as reported in the risk management plan database as of February 2015. This accident data was provided in an Excel spreadsheet file (Docket ID: EPA-HQ-OEM-2015-0725-0002). This ten-year set of accident data was used as the basis of some of the cost estimates discussed in the Amendments rule RIA. EPA provided similar accident data in an Excel spreadsheet in the docket for RMP accidents occurring in 2014-2016 (Docket ID: EPA-HQ-OEM-2015-0725-0909), as a supporting document for the Reconsideration Proposal. EPA developed the latter spreadsheet from the November 2017 version of the database.
While the various parties requesting an extension of the comment period asked that EPA extend the period 60 days, we are extending the comment period through August 23, 2018. EPA notes that the November 2017 database was used for limited purposes in the preparation of the Reconsideration Proposal. Primarily, it was used to corroborate that the information from the prior RIA regarding the universe of stationary sources subject to the RMP rule did not change significantly by the time we prepared the RIA for the Reconsideration Proposal. Tables in the Reconsideration Proposal RIA presented the information extracted from the database, so the public could always comment on the information. The major impact was the inability to verify the information from its source. The updated database also was used to confirm that the 2004-2013 trend of declining accident rates over time continued. EPA included in the Reconsideration Proposal docket an Excel spreadsheet on accident data for RMP accidents occurring from 2014-2016 that we derived from the November 2017 database.
Because the November 2017 database was used mostly for corroboration, we do not believe there were fundamental data about sources subject to the RMP Rule that could not have been observed in the 2015 database that was already in the docket. We also note that we have docketed the November 2017 RMP database (non-OCA version) as of July 11, 2018 and on July 10, 2018, provided it to the first party to draw our attention to it not being in the docket. In the interest of expeditiously completing the reconsideration process and putting into effect provisions of the Amendments that we intend to retain or modify, we believe closing comments on August 23, 2018 strikes an appropriate balance.
Environmental Protection Agency (EPA).
Notice of filing of petitions and request for comment.
This document announces the Agency's receipt of several initial filings of pesticide petitions requesting the establishment or modification of regulations for residues of pesticide chemicals in or on various commodities.
Comments must be received on or before August 23, 2018.
Submit your comments, identified by docket identification (ID) number and the pesticide petition number (PP) of interest as shown in the body of this document, by one of the following methods:
•
•
•
Robert McNally, Biopesticides and Pollution Prevention Division (BPPD) (7511P), main telephone number: (703) 305-7090; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under
1.
2.
3.
EPA is announcing its receipt of several pesticide petitions filed under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, requesting the establishment or modification of regulations in 40 CFR part 180 for residues of pesticide chemicals in or on various food commodities. The Agency is taking public comment on the requests before responding to the petitioners. EPA is not proposing any particular action at this time. EPA has determined that the pesticide petitions described in this document contain the data or information prescribed in FFDCA section 408(d)(2), 21 U.S.C. 346a(d)(2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the pesticide petitions. After considering the public comments, EPA intends to evaluate whether and what action may be warranted. Additional data may be needed before EPA can make a final determination on these pesticide petitions.
Pursuant to 40 CFR 180.7(f), a summary of each of the petitions that are the subject of this document, prepared by the petitioner, is included in a docket EPA has created for each rulemaking. The docket for each of the petitions is available at
As specified in FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), EPA is publishing notice of the petitions so that the public has an opportunity to comment on these requests for the establishment or modification of regulations for residues of pesticides in or on food commodities. Further information on the petitions may be obtained through the petition summaries referenced in this unit.
1. PP 7E8616. (EPA-HQ-OPP-2017-0674). Interregional Research Project No. 4 (IR-4), Rutgers, The State University of New Jersey, 500 College Road East, Suite 201W, Princeton, NJ 08540, proposes upon establishment of tolerances referenced in this document under “New Tolerances” for PP 7E8616, to remove existing tolerances in 40 CFR 180.658 for residues of the fungicide, penthiopyrad, (N-[2-(1,3-dimethylbutyl)-3-thienyl]-1-methyl-3-(trifluoromethyl)-1H-pyrazole-4-carboxamide) in or on the following raw agricultural commodities: Brassica, head and stem, subgroup 5A at 5.0 ppm; Brassica, leafy greens, subgroup 5B at 50 ppm; Canola at 1.5 ppm; Cotton, seed at 1.5 ppm; Fruit, stone, group 12 at 4.0 ppm; Nut, tree, group 14 at 0.06 ppm; Pistachio at 0.06 ppm; Sunflower, seed at 1.5 ppm and Vegetable, leafy, except brassica, group 4 at 30 ppm.
2. PP 7E8629. (EPA-HQ-OPP-2017-0671). Interregional Research Project No. 4 (IR-4), IR-4 Project Headquarters, Rutgers, The State University of NJ, 500 College Road East, Suite 201W, Princeton, NJ 08540, requests to amend 40 CFR 180.637 by removing the tolerances for residues of mandipropamid: 4-chloro-N-[2-(3-methoxy-4-(2-propynyloxy)phenyl]ethyl]-alpha-(2-propynyloxy)-benzeneacetamide in or on the raw agricultural commodities Bean, snap at 0.90 ppm; Brassica, head and stem, subgroup 5A at 3 ppm; Brassica, leafy greens, subgroup 5B at 25 ppm; Vegetable, leafy except Brassica, group 4 at 20 ppm. Analytical method RAM 415-01 was developed for determination of mandipropamid residues in crops.
3. PP 7E8644. (EPA-HQ-OPP-2018-0088). Interregional Research Project No. 4 (IR-4), IR-4 Project Headquarters, Rutgers, The State University of NJ, 500 College Road East, Suite 201W, Princeton, NJ 08540, requests to amend 40 CFR 180.505 by removing the tolerances for residues of emamectin benzoate, including its metabolites and degradates, determined by measuring only the sum of emamectin (a mixture of a minimum of 90% 4′-epi-methylamino-4′-deoxyavermectin B1a and maximum of 10% 4′-epi-methylamino-4′-deoxyavermectin B1b) and its metabolites 8,9-isomer of the B1a and B1b component of the parent (8,9-ZMA), or 4′-deoxy-4′-epi-amino-avermectin B1a and 4′-deoxy-4′-epi-amino-avermectin B1b; 4′-deoxy-4′-epi-amino avermectin B1a (AB1a); 4′-deoxy-4′-epi-(N-formyl-N-methyl)amino-avermectin (MFB1a); and 4′-deoxy-4′-epi-(N-formyl)amino-avermectin B1a (FAB1a), calculated as the stoichiometric equivalent of emamectin in or on the raw agricultural commodities Fruit, pome, group 11 at 0.025 parts per million, ppm, Nut, tree, group 14 at 0.02 ppm, Pistachio at 0.02 ppm, Turnip, greens at 0.050 ppm, Vegetable, leafy, except brassica, group 4 at 0.100 ppm, Vegetable, brassica, leafy, group 5 at 0.050 ppm, and Vegetable fruiting, group 8 at 0.020 ppm. Adequate analytical methods (HPLC-fluorescence methods) are
4. PP 7E8648. (EPA-HQ-OPP-2018-0094). Interregional Research Project No.4 (IR-4), Rutgers, The State University of New Jersey, 500 College Road East, Suite 201W, Princeton, NJ 08540, requests to amend the tolerances in 40 CFR part 180.474 upon establishment of tolerances referenced in this document under “New Tolerances” for PP 7E8648, by removing established tolerances for residues of the fungicide tebuconazole [α-[2-(4-chlorophenyl) ethyl]-α-(1,1-dimethylethyl)-1H-1,2,4-triazole-1-ethanol], in or on the raw agricultural commodities: Brassica, leafy greens, subgroup 5B at 2.5 parts per million, ppm; Cotton, undelinted seed at 2.0 ppm; Fruit, pome, group 11 at 0.05 ppm; Fruit, stone, group 12, except cherry at 1.0 ppm; Grape at 5.0 ppm; Lychee at 1.6 ppm; Nut, tree, group 14 at 0.05 ppm; Peach at 1.0 ppm; Pistachio at 0.05 ppm; Plum, pre- and post-harvest at 1.0 ppm; Sunflower, seed at 0.05 ppm.
5. PP 7E8652. (EPA-HQ-OPP-2018-0128). The Interregional Research Project Number 4 (IR-4), Rutgers, The State University of New Jersey, 500 College Road East, Suite 201W, Princeton, NJ 08540, proposes upon establishment of tolerances referenced in this document under “New Tolerances” for PP 8E8652, to remove existing tolerances in 40 CFR 180.317 for residues of the herbicide pronamide (propyzamide), 3,5-dichloro-
6. PP 7E8654. (EPA-HQ-OPP-2018-0161). Interregional Research Project No. 4 (IR-4), IR-4 Project Headquarters, Rutgers, The State University of NJ, 500 College Road East, Suite 201W, Princeton, NJ 08540, requests to amend 40 CFR 180.511 by removing the established tolerances for residues of buprofezin, 2-(1,1-dimethylethyl)iminotetrahydro-3(1-methylethyl)-5-phenyl-4H-1,3,5-thiadiazin-4-one in or on the raw agricultural commodities: Acerola at 0.30 parts per million (ppm); Brassica, head and stem, subgroup 5A at 12.0 ppm, Brassica, leafy greens, subgroup 5B at 60 ppm, Cotton, undelinted seed at 0.35 ppm; Fruit, citrus, group 10 at 2.5 ppm; Fruit, stone, group 12, except apricot and peach at 1.9 ppm; Grape at 2.5 ppm; Longan at 0.30 ppm; Lychee at 0.30 ppm; Nut, tree group 14 at 0.05 ppm; Olive at 3.5 ppm; Olive, oil at 4.8 ppm; Pistachio at 0.05 ppm; Spanish lime at 0.30 ppm; Turnip, greens at 60 ppm; Vegetable, leafy, except Brassica, group 4, except head lettuce and radicchio at 35 ppm; and Wax jambu at 0.30 ppm. The enforcement analytical methods are available in PAM I and PAM II for the enforcement of buprofezin tolerances, which include gas chromatography methods with nitrogen phosphorus detection (GC/NPD), and a gas chromatography/mass spectrometry (GC/MS) method for confirmation of buprofezin residues in plant commodities.
7. PP 8E8658. (EPA-HQ-OPP-2018-0127). Interregional Research Project No. 4 (IR-4), Rutgers, The State University of New Jersey, 500 College Road East, Suite 201W, Princeton, NJ 08540, proposes, upon establishment of tolerances referenced in this document under “New Tolerances” for PP 8E8758, the following: (i). To remove existing tolerances in 40 CFR 180.613(a) for the residues of propiconazole, including its metabolites and degradates, in or on the raw agricultural commodities: Beet, garden, roots at 0.30 parts per million (ppm); Brassica leafy greens, subgroup 5B at 20 ppm; Carrot, roots at 0.25 ppm; Leaf petioles subgroup 4B at 5.0 ppm; Pistachio at 0.1 ppm; Radish, roots at 0.04 ppm; and Tomato at 3.0 ppm, and (ii). To amend 40 CFR 180.434(b)
8. PP 8E8664. (EPA-HQ-OPP-2018-0143). Interregional Research Project No. 4 (IR-4), IR-4 Project Headquarters, Rutgers, The State University of NJ, 500 College Road East, Suite 201W, Princeton, NJ 08540, requests to amend 40 CFR 180.449 by removing the established tolerances for residues of abamectin, including its metabolites and degradates, in or on the following commodities: Lychee at 0.01 parts per million (ppm) and Vegetable, leafy, except brassica, group 4 at 0.10 ppm. The analytical methods involve homogenization, filtration, partition, and cleanup with analysis by high performance liquid chromatography (HPLC)-fluorescence detection. The methods are sufficiently sensitive to detect residues at or above the tolerances proposed. All methods have undergone independent laboratory validation.
9. PP 8E86669. (EPA-HQ-OPP-2018-0179). Interregional Research Project No. 4 (IR-4), IR-4 Project Headquarters, Rutgers, The State University of NJ, 500 College Road East, Suite 201W, Princeton, NJ 08540, requests to amend 40 CFR 180.668 by removing the established tolerances for residues of Sulfoxaflor ((N-methyloxido1-6-(trifluoromethyl)-3-pyridinyl]ethyl]-γ4-sulfanylidene]cyanamide) in or on the raw agricultural commodities: Fruit, stone, group 12 at 3.0 ppm, Leafy greens, subgroup 4A at 6.0 ppm, Leafy petiole, subgroup 4B at 2.0 ppm, Nuts, tree, group 14 at 0.015 ppm, Pistachio at 0.015 ppm and Vegetable, brassica, leafy, group 5, except cauliflower at 2.0 ppm. Analytical method 091116, “Enforcement Method for the Determination of Sulfoxaflor (XDE-208) and its Main Metabolites in Agricultural Commodities using Offline Solid-Phase Extraction and Liquid Chromatography with Tandem Mass Spectrometry Detection” was validated on a variety of plant matrices.
10. PP 8E8673. (EPA-HQ-OPP-2018-0286). Interregional Research Project Number 4 (IR-4), Rutgers, The State University of New Jersey, 500 College Road East, Suite 201W, Princeton, NJ 08540, proposes upon establishment of tolerances referenced in this document under “New Tolerances” for PP 8E8673, to remove existing tolerances in 40 CFR 180.414 for residues of the insecticide cyromazine, (N-cyclopropyl-1,3,5-triazine-2,4,6-triamine) in or on cabbage, abbyssinian at 10.0 parts per million (ppm); cabbage, seakale at 10.0 ppm, garlic at 0.2 ppm; garlic, great-headed, bulb at 0.2 ppm; hanover salad, leaves at 10.0 ppm; leek at 3.0 ppm; onion, bulb at 0.2 ppm; onion, green at 3.0 ppm; onion, potato at 3.0 ppm; onion, tree at 3.0 ppm; onion, welsh at 3.0 ppm; pepper at 1.0 ppm; potato at 0.8 ppm; rakkyo, bulb at 0.2 ppm; shallot, bulb at 0.2 ppm; shallot, fresh leaves at 3.0 ppm; tomato at 0.5 ppm; turnip, greens at 10.0 ppm; vegetable, brassica, leafy, group 5, except broccoli at 10.0; vegetable, leafy, except brassica, group 4 at 7.0 ppm. The analytical methods AG-408 and AG-417 are used to measure and evaluate the chemical cyromazine. Contact: RD
PP IN-11080. (EPA-HQ-OPP-2018-0202). OMC Ag Consulting, Inc., 828 Tanglewood Ln., East Lansing, MI 48823, on behalf of Nutri Ag Inc., 4740 N Interstate 35 E., Waxahachie, TX 75165, requests to establish an exemption from the requirement of a tolerance for residues of protein hydrolyzates, animal (CAS Reg. No. 100085-61-8) when used as an inert ingredient (carrier) in pesticide formulations applied to growing crops and raw agricultural commodities under
PP 8F8670. (EPA-HQ-OPP-2018-0244). Monsanto Company, 800 N Lindbergh Blvd., St. Louis, MO 63167, requests to establish an exemption from the requirement of a tolerance in 40 CFR part 180 for residues of the plant regulator LCO MOR116 (chemical name: D-glucose, O-6-deoxy-2-O-methyl-α-L-galactopyranosyl-(1→6)-O-[O-2-deoxy-2-[[(11Z)-1-oxo-11-octadecen-1-yl]amino]-β-D-glucopyranosyl-(1→4)-O-2-(acetylamino)-2-deoxy-β-D-glucopyranosyl-(1→4)-O-2-(acetylamino)-2-deoxy-β-D-glucopyranosyl-(1→4)-2-(acetylamino)-2-deoxy-β-D-glucopyranosyl-(1→4)]-2-(acetylamino)-2-deoxy-; and D-glucose, O-2-deoxy-2-[[(11Z)-1-oxo-11-octadecen-1-yl]amino]-β-D-glucopyranosyl-(1→4)-O-2-(acetylamino)-2-deoxy-β-D-glucopyranosyl-(1→4)-O-2-(acetylamino)-2-deoxy-β-D-glucopyranosyl-(1→4)-O-2-(acetylamino)-2-deoxy-β-D-glucopyranosyl-(1→4)-O-[6-deoxy-α-L-galactopyranosyl-(1→6)]-2-(acetylamino)-2-deoxy-) in or on all food commodities. The petitioner believes no analytical method is needed because, even in the unlikely event that dietary exposure does occur associated with the requested uses, the demonstrated favorable toxicological profile for LCO MOR116 does not present a potential for hazard to humans or the environment.
1. PP 7E8616. (EPA-HQ-OPP-2017-0674). Interregional Research Project No. 4 (IR-4), Rutgers, The State University of New Jersey, 500 College Road East, Suite 201W, Princeton, NJ 08540, is proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 by establishing a tolerance for residues of the fungicide penthiopyrad, (N-[2-(1,3-dimethylbutyl)-3-thienyl]-1-methyl-3-(trifluoromethyl)-1H-pyrazole-4-carboxamide) in or on the raw agricultural commodities: Brassica, leafy greens, subgroup 4-16B at 50 parts per million (ppm); Bushberry subgroup 13-07B at 6 ppm; Fruit, stone, group 12-12 at 4.0 ppm; Caneberry subgroup 13-07A at 10 ppm; Celtuce at 30 ppm; Fennel, Florence at 30 ppm; Kohlrabi at 5.0 ppm; Leaf petiole vegetable subgroup 22B at 30 ppm; Leafy greens subgroup 4-16A at 30 ppm; Nut, tree, group 14-12 at 0.06 ppm; Oilseed group 20 at 1.5 ppm; and Vegetable, brassica, head and stem, group 5-16 at 5.0 ppm. An analytical enforcement method, liquid chromatograph (LC) equipped with a reverse phase column and a triple quadruple mass spectrometer (MS/MS) detection is available for determining penthiopyrad residues in plants. The limit of quantification (LOQ) is 0.01 ppm for most matrices except for very dry matrices,
2. PP 7E8629. (EPA-HQ-OPP-2017-0671). Interregional Research Project No. 4 (IR-4), IR-4 Project Headquarters, Rutgers, The State University of NJ, 500 College Road East, Suite 201W, Princeton, NJ 08540, requests to establish a tolerance in 40 CFR part 180 for residues of mandipropamid: 4-chloro-N-[2-(3-methoxy-4-(2-propynyloxy)phenyl]ethyl]-alpha-(2-propynyloxy)-benzeneacetamide] in or on the raw agricultural commodities Asparagus bean, edible podded at 0.90 ppm; Bean (Phaseolus spp.), edible podded at 0.90 ppm; Bean (Vigna spp.), edible podded at 0.90 ppm; Brassica, leafy greens, subgroup 4-16B at 25 ppm; Catjang bean, edible podded at 0.90 ppm; Celtuce at 20 ppm; Chinese longbean, edible podded at 0.90 ppm; Citrus, dried pulp at 0.14 ppm; Citrus, oil at 2.2 ppm; Cowpea, edible podded at 0.90 ppm; Florence fennel at 20 ppm; French bean, edible podded 0.90 ppm; Fruit, citrus, group 10-10 at 0.5 ppm; Garden bean, edible podded at 0.90 ppm; Goa bean, edible podded at 0.90 ppm; Green bean, edible podded at 0.90 ppm; Guar bean, edible podded at 0.90 ppm; Jackbean, edible podded at 0.90 ppm; Kidney bean, edible podded at 0.90 ppm; Kohlrabi at 3 ppm; Lablab bean, edible podded at 0.90 ppm; Leaf petiole vegetable subgroup 22B at 20 ppm; Leafy greens subgroup 4-16A at 25 ppm; Moth bean, edible podded at 0.90 ppm; Mung bean, edible podded at 0.90 ppm; Navy bean, edible podded at 0.90 ppm; Rice bean, edible podded at 0.90 ppm; Scarlet runner bean, edible podded at 0.90 ppm; Snap bean, edible podded at 0.90 ppm; Sword bean, edible podded at 0.90 ppm; Urd bean, edible podded at 0.90 ppm; Vegetable soybean, edible podded at 0.90 ppm; Vegetable, brassica, head and stem, group 5-16 at 3 ppm; Velvet bean, edible podded at 0.90 ppm; Wax bean, edible podded at 0.90 ppm; Winged pea, edible podded at 0.90 ppm; Yardlong bean, edible podded at 0.90 ppm. Analytical method RAM 415-01 was developed for determination of mandipropamid residues in crops.
3. PP 7F8642. EPA-HQ-OPP-2018-0143. Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, NC 27419-8300, requests to establish a tolerance in 40 CFR part 180 for residues of the insecticide, abamectin, in or on edible-podded legume vegetables subgroup 6a at 0.03 parts per million (ppm), succulent shelled pea and bean subgroup 6B at 0.005 ppm, and dried shelled pea and bean (except soybean) subgroup 6C at 0.005 ppm. The high performance liquid chromatography (HPLC) analytical method is used to measure and evaluate the chemical abamectin.
4. PP 7E8644. (EPA-HQ-OPP-2018-0088). Interregional Research Project No. 4 (IR-4), IR-4 Project Headquarters, Rutgers, The State University of NJ, 500 College Road East, Suite 201W, Princeton, NJ 08540, requests to establish a tolerance in 40 CFR part 180 for residues of emamectin, including its metabolites and degradates, determined by measuring only the sum of emamectin (a mixture of a minimum of 90% 4′-epi-methylamino-4′-deoxyavermectin B1a and maximum of 10% 4′-epi-methylamino-4′-deoxyavermectin B1b) and its metabolites 8,9-isomer of the B1a and B1b component of the parent (8,9-ZMA), or 4′-deoxy-4′-epi-amino-avermectin B1a and 4′-deoxy-4′-epi-amino-avermectin B1b; 4′-deoxy-4′-epi-amino avermectin B1a (AB1a); 4′-deoxy-4′-epi-(N-formyl-N-methyl)amino-avermectin (MFB1a); and 4′-deoxy-4′-epi-(N-formyl)amino-avermectin B1a (FAB1a), calculated as the stoichiometric equivalent of emamectin in or on the raw agricultural commodities Artichoke, globe at 0.06 parts per million (ppm), Brassica, leafy greens, subgroup 4-16B at 0.050 ppm, Celtuce at 0.100 ppm, Cherry subgroup 12-12A at 0.10 ppm, Fennel, Florence at 0.100 ppm, Fruit, pome, group 11-10 at 0.025 ppm, Herb subgroup 19A at 0.50 ppm, Kohlrabi at 0.050 ppm, Leafy greens subgroup 4-16A at 0.100 ppm, Leaf petiole vegetable subgroup 22B at 0.100 ppm, Nut, tree, group 14-12 at 0.02 ppm, Vegetable, brassica, head and stem, group 5-16 at 0.050 ppm, and Vegetable, fruiting, group 8-10 at 0.020 ppm. Adequate analytical methods (HPLC-fluorescence methods) are available for enforcement purposes.
5. PP 7E8645. (EPA-HQ-OPP-2018-0095). Interregional Research Project No. 4 (IR-4), Rutgers, The State University of New Jersey, 500 College Road East, Suite 201W, Princeton, NJ 08540, requests to establish a tolerance
6. PP 7F8646. (EPA-HQ-OPP-2018-0053). BASF Corporation, 26 Davis Dr., P.O. Box 13528, Research Triangle Park, NC 27709, requests to establish a tolerance in 40 CFR part 180 for residues of the insecticide, broflanilide, including its metabolites and degradates, in or on grain, cereal, except rice, group 15; amaranth grain; quinoa, grain; spelt, grain; canihua, grain; chia, grain; cram-cram, grain; huauzontle, grain; teff, grain; corn, sweet, kernel plus cob with husks removed at 0.01 parts per million (ppm) and commodity vegetables, tuberous and corm, subgroup 1C at 0.04 ppm. Tolerances are also requested for cattle, meat; goat, meat; horse, meat; sheep, meat at 0.01 ppm, and commodity milk, fat; poultry, fat at 0.02 ppm, and commodity cattle, fat; sheep, fat; goat, fat at 0.05 ppm. Additionally, tolerances are requested for grain, cereal, forage, fodder and straw, group 16, except rice; quinoa, hay; teff, hay; corn, sweet, stover; corn, sweet, forage at 0.01 ppm, and commodity corn, field, milled products at 0.015 ppm and potato, wet peel at 0.1 ppm for processed commodities. In addition, BASF is proposing to establish a tolerance of 0.01 ppm for residues of Broflanilide in or on all food items in food handling establishments where food and food products are held, processed, prepared and/or served. The independently validated analytical method is used to measure and evaluate the chemical Broflanilide and its metabolites S(PFP-OH)-8007 and DM-8007. An independently validated analytical method has been submitted for analyzing residues of parent Broflanilide plus metabolites DM-8007 and DC-DM-8007 in animal matrices by Liquid chromatography with tandem mass spectrometry (LC-MS/MS). Food handling matrices samples were analyzed for Broflanilide residues using a combination of the plant and animal methods with minor modifications.
7. PP 7E8648. (EPA-HQ-OPP-2018-0094). Interregional Research Project No.4 (IR-4), Rutgers, The State University of New Jersey, 500 College Road East, Suite 201W, Princeton, NJ 08540, requests to establish a tolerance in 40 CFR part 180 for residues of the fungicide tebuconazole, including its metabolites and degradates. Compliance with the tolerance levels specified is to be determined by measuring only tebuconazole [α-[2-(4-chlorophenyl) ethyl]-α-(1,1-dimethylethyl)-1H-1,2,4-triazole-1-ethanol], in or on the raw agricultural commodities: Brassica, leafy greens, subgroup 4-16B, except watercress at 2.5 parts per million (ppm); Cottonseed subgroup 20C at 2.0 ppm; Fruit, pome, group 11-10 at 1.0 ppm; Fruit, stone, group 12-12, except cherry at 1.0 ppm; Fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 6.0 ppm; Nut, tree, group 14-12 at 0.05 ppm; Sunflower subgroup 20B at 0.1 ppm, Tropical and subtropical, small fruit, inedible peel, subgroup 24A at 1.6 ppm; and Watercress at 9.0 ppm. Practical analytical methods for enforcement purposes in detecting and measuring levels of tebuconazole and the triazole metabolites: 1,2,4-triazole (T), traizole alanine (TA) and the traizole acetic acid (TAA) have been developed and validated in/on all appropriate agricultural commodities and respective processing fractions.
8. PP 7F8651. (EPA-HQ-OPP-2018-0194). ISK Biosciences Corporation, 7470 Auburn Rd, Suite A, Concord, OH 44077, requests to establish a tolerance in 40 CFR part 180 for residues of the insecticide cylaniliprole on citrus fruit (crop group 10-10) at 0.5 ppm; tuberous & corm vegetables (crop group 1C) at 0.01 ppm; and berry & small fruit (crop subgroup 13-07A, 13-07B, 13-07E except grape, and 13-07G) at 1.5 ppm. Liquid chromatography-MS/MS is used to measure and evaluate the chemical cyclaniliprole residues.
9. PP 7E8652. (EPA-HQ-OPP-2018-0128). The Interregional Research Project Number 4 (IR-4), Rutgers, The State University of New Jersey, 500 College Road East, Suite 201W, Princeton, NJ 08540, requests to establish tolerances in 40 CFR part 180. 317 for residues of the herbicide pronamide (propyzamide), 3,5-dichloro-N-(1,1-dimethyl-2-propynyl)benzamide in or on berry, low growing, except strawberry, subgroup 13-07H at 1 parts per million (ppm), bushberry subgroup 13-07B at 0.05 ppm; caneberry subgroup 13-07A at 0.05 ppm; fruit, pome, group 11-10 at 0.1 ppm; fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 0.1 ppm; and fruit, stone, group 12-12 at 0.1 ppm. The GLC/ECD method listed in the Pesticide Analytical Manual (PAM) Volume II is used to measure and evaluate the chemical.
10. PP 7E8654. (EPA-HQ-OPP-2018-0161). Interregional Research Project No. 4 (IR-4), IR-4 Project Headquarters, Rutgers, The State University of NJ, 500 College Road East, Suite 201W, Princeton, NJ 08540, requests to establish tolerances for residues of buprofezin, 2-(1,1-dimethylethyl)iminotetrahydro-3(1-methylethyl)-5-phenyl-4H-1,3,5-thiadiazin-4-one in or on the raw agricultural commodities Fig at 0.70 parts per million (ppm), Leafy greens subgroup 4-16A, except head lettuce and radicchio at 35 ppm; Brassica, leafy greens, subgroup 4-16B at 60 parts per million (ppm); Vegetable, brassica, head and stem, group 5-16 at 12.0 ppm; Leaf petiole vegetable subgroup 22B at 35 ppm; Celtuce at 35 ppm; Fennel, Florence at 35 ppm; Kohlrabi at 12.0 ppm; Tropical and subtropical, small fruit, edible peel, subgroup 23A at 5.0 ppm; Tropical and subtropical, small fruit, inedible peel, subgroup 24A at 0.30 ppm; Cottonseed subgroup 20C at 0.35 ppm; Fruit, citrus, group 10-10 at 2.5 ppm; Fruit, stone, group 12-12, except apricot and peach at 2.0 ppm; Fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 2.5 ppm and Nut, tree, group 14-12 at 0.05 ppm. The enforcement analytical methods are available in PAM I and PAM II for the enforcement of buprofezin tolerances, which include gas chromatography methods with nitrogen phosphorus detection (GC/NPD), and a gas chromatography/mass spectrometry (GC/MS) method for confirmation of buprofezin residues in plant commodities.
11. PP 8E8658. (EPA-HQ-OPP-2018-0127). Interregional Research Project No. 4, (IR-4), Rutgers, The State University of New Jersey, 500 College Road East, Suite 201W, Princeton, NJ 08540 requests, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.434 (a) General by establishing a tolerance for residues of propiconazole, including
12. PP 8E8660. (EPA-HQ-OPP-2018-0275). The Interregional Research Project Number 4 (IR-4), Rutgers, The State University of New Jersey, 500 College Road East, Suite 201W, Princeton, NJ 08540, requests to establish a tolerance in 40 CFR part 180. 446 for residues of the insecticide clofentezine, 3,6-bis(2-chlorophenyl)-1,2,4,5-tetrazine in or on guava at 1 part per million (ppm). The analytical method for residues of clofentezine in fruit (Western Red Delicious Apples) by high-performance liquid chromatography (HPLC) and ultra violet (UV) Detection” is used to measure and evaluate the chemical.
13. PP 8E8664. (EPA-HQ-OPP-2018-0143). Interregional Research Project No. 4 (IR-4), IR-4 Project Headquarters, Rutgers, The State University of NJ, 500 College Road East, Suite 201 W, Princeton, NJ 08540, requests to establish tolerances for residues of abamectin, including its metabolites and degradates, in or on the following commodities. Compliance with the tolerance levels is to be determined by measuring only avermectin B1 a mixture of avermectins containing greater than or equal to 80% avermectin B1 a (5-O-demethyl avermectin A1) and less than or equal to 20% avermectin B1b (5-O-demethyl-25-de(1-methylpropyl)-25-(1-methylethyl) avermectin A1) and its delta-8,9-isomer in or on the raw agricultural commodities: Arugula at 0.10 parts per million (ppm), Carrot, roots at 0.03 ppm, Celtuce at 0.10 ppm, Fennel, Florence at 0.10 ppm, Garden cress at 0.10 ppm, Leaf petiole vegetable subgroup 22B at 0.10 ppm, Leafy greens subgroup 4-16A at 0.10 ppm, Tropical and subtropical, small fruit, inedible peel, subgroup 24A at 0.01 ppm, and Upland cress at 0.10 ppm. The analytical methods involve homogenization, filtration, partition, and cleanup with analysis by high performance liquid chromatography (HPLC)-fluorescence detection. The methods are sufficiently sensitive to detect residues at or above the tolerances proposed. All methods have undergone independent laboratory validation.
14. PP 8E8666. (EPA-HQ-OPP-2018-0179). Interregional Research Project No. 4 (IR-4), IR-4 Project Headquarters, Rutgers, The State University of NJ, 500 College Road East, Suite 201 W, Princeton, NJ 08540, requests to establish tolerances for residues of sulfoxaflor ((N-methyloxido1-6-(trifluoromethyl)-3-pyridinyl]ethyl]-γ4-sulfanylidene]cyanamide) in or on the raw agricultural commodities: Artichoke, globe at 0.70 parts per million (ppm), Asparagus at 0.015 ppm, Brassica, leafy greens, subgroup 4-16B, except watercress at 2.0 ppm, Bushberry subgroup 13-07B at 2.0 ppm, Caneberry subgroup 13-07A at 1.5 ppm, Celtuce at 2.0 ppm, Florence fennel at 2.0 ppm, Fruit, stone, group 12-12 at 3.0 ppm, Kohlrabi at 2.0 ppm, Leafy greens subgroup 4-16A at 6.0 ppm, Leaf petiole vegetable subgroup 22B at 2.0 ppm, Nut, tree, group 14-12 at 0.015 ppm, Sunflower subgroup 20B at 0.30 ppm, and Vegetable, brassica, head and stem, group 5-16, except cauliflower at 2.0 ppm. Analytical method 091116, “Enforcement Method for the Determination of Sulfoxaflor (XDE-208) and its Main Metabolites in Agricultural Commodities using Offline Solid-Phase Extraction and Liquid Chromatography with Tandem Mass Spectrometry Detection” was validated on a variety of plant matrices.
15. PP 8E8667. (EPA-HQ-OPP-2018-0273). Interregional Research Project No.4 (IR-4), Rutgers, The State University of New Jersey, 500 College Road East, Suite 201W, Princeton, NJ 08540, requests to establish a tolerance in 40 CFR part 180 for residues of the insecticide flonicamid, including its metabolites and degradates, determined by measuring only the sum of flonicamid, N-(cyanomethyl)-4-(trifluoromethyl)-3-pyridinecarboxamide, and its metabolites, TFNA (4-trifluoromethylnicotinic acid), TFNA-AM (4-trifluoromethylnicotinamide), and TFNG, N-(4-trifluoromethylnicotinoyl)glycine, calculated as the stoichiometric equivalent of flonicamid, in or on raw agricultural commodities as follows: Sunflower subgroup 20B at 0.70 parts per million (ppm). Analytical methodology to determine above designated residues of flonicamid for the majority of crops includes an initial extraction with acetonitrile (ACN)/deionized (DI) water, followed by a liquid-liquid partition with ethyl acetate. The final sample solution is quantitated using a liquid chromatograph (LC) equipped with a reverse phase column and a triple quadruple mass spectrometer (MS/MS).
16. PP 8E8673. (EPA-HQ-OPP-2018-0286). Interregional Research Project Number 4 (IR-4), Rutgers, The State University of New Jersey, 500 College Road East, Suite 201W, Princeton, NJ 08540, requests to establish a tolerance in 40 CFR part 180. 414 for residues of the insecticide cyromazine, (N-cyclopropyl-1,3,5-triazine-2,4,6-triamine) in or on Brassica, leafy greens, subgroup 4-16B at 10.0 parts per million (ppm); Celtuce at 7.0 ppm; Chickpea, edible podded at 0.4 ppm; Chickpea, succulent shelled at 0.3 ppm; Dwarf pea, edible podded at 0.4 ppm; Edible podded pea, edible podded at 0.4 ppm; English pea, succulent shelled at 0.3 ppm; Florence fennel at 7.0 ppm; Garden pea, succulent shelled at 0.3 ppm; Grass-pea, edible podded at 0.4 ppm; Green pea, edible podded at 0.4 ppm; Green pea, succulent shelled at 0.3 ppm; Kohlrabi at 10.0 ppm; Leaf petiole subgroup 22B at 7.0 ppm; Leafy green subgroup 4-16A at 7.0 ppm; Lentil, edible podded at 0.4 ppm; Lentil, succulent shelled at 0.3 ppm; Onion, bulb, subgroup 3-07A at 0.2 ppm; Onion, green, subgroup 3-07B at 3.0 ppm; Pepper/eggplant 8-10B at 1.0 ppm; Pigeon pea, edible podded at 0.4 ppm; Pigeon pea, succulent shelled at 0.3 ppm; Snap pea, edible podded at 0.4 ppm; Snow pea, edible podded at 0.4 ppm; Sugar snap pea, edible podded at 0.4 ppm; Tomato subgroup 8-10A at 1.0 ppm; Vegetable, brassica, head and stem, group 5-16, except broccoli at 10.0 ppm; and Vegetable, tuberous and corm, subgroup 1C at 0.8 ppm. The analytical methods AG-408 and AG-417 are used to measure and evaluate the chemical cyromazine.
17. PP 8E8678. EPA-HQ-OPP-2018-0300. Dow AgroSciences, 9330 Zionsville Road, Indianapolis, IN 46268, requests to establish import tolerance in 40 CFR part 180 for residues of the fungicide fenbuconazole (alpha-(2-(4-chlorophenyl)ethyl]-alpha-phenyl-3-(1H-1,2,4-triazole)-1-propanenitrile) and its metabolites cis and trans-5-(4-chlorophenyl)-dihydro-3-phenyl-3-(1H-
18. PP 8F8661. EPA-HQ-OPP-2018-0297. Cheminova A/S, P.O. Box 9, DK-7620, Lemvig, Denmark and on behalf of FMC Corporation, 2929 Walnut Street, Philadelphia, PA 19104, requests to establish tolerance in 40 CFR part 180 for residues of the fungicide flutriafol [chemical name (±)‐α‐(2‐fluorophenyl‐α‐(4‐fluorophenyl)‐1H‐1,2,4‐triazole‐1‐ethanol] in or on the raw agricultural commodities alfalfa, forage at 15 parts per million (ppm); alfalfa, hay at 50 ppm; barley, grain at 1.5 ppm; barley, hay at 7.0 ppm; barley, straw at 8.0 ppm; corn, sweet, forage at 9.0 ppm; corn, sweet, kernels plus cobs with husks removed at 0.03 ppm; corn, sweet, stover at 8 ppm; rice, bran at 0.4 ppm; rice, grain at 0.5 ppm; rice, hulls at 1.5 ppm; and rice, straw at 0.9 ppm. The analytical methodology gas chromatography (GC) employing mass selective (MSD) detection and or HPLC/UPLC employing tandem mass spectrometric (MS/MS) detection is used to measure and evaluate the chemical flutriafol.
21 U.S.C. 346a.
Federal Communications Commission.
Proposed rule.
In this document, the Federal Communications Commission adopts a Notice of Proposed Rulemaking (
Comments are due on or before August 23, 2018, and reply comments are due on or before September 7, 2018. Written comments on the Paperwork Reduction Act proposed information collection requirements must be submitted by the public, Office of Management and Budget (OMB), and other interested parties on or before September 24, 2018.
You may submit comments, identified by both WC Docket No. 18-28, and CC Docket No. 95-155 by any of the following methods:
For detailed instructions for submitting comments and additional information on the rulemaking process, see the
Wireline Competition Bureau, Competition Policy Division, E. Alex Espinoza, at (202) 418-0849, or
This is a summary of the Commission's Notice of Proposed Rulemaking (NPRM) in WC Docket No. 18-28, and CC Docket No. 95-155, adopted June 7, 2018, and released June 12, 2018. The full text of this document is available for public inspection during regular business hours in the FCC Reference Information Center, Portals II, 445 12th Street SW, Room CY-A257, Washington, DC 20554. It is available on the Commission's website
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4. We believe that requiring RespOrgs to update the SMS Database when a toll free number is text-enabled will help alleviate concerns that unassigned toll free numbers could be text-enabled because the RespOrg, in attempting to update the database, would realize if the toll free number to be text-enabled is reserved by a RespOrg or not. If not, the toll free number may not be text-enabled as clarified in our Declaratory Ruling. Are there other approaches we should consider, such as the approach recommended by CTIA to allow the industry to decide how to implement a toll free subscriber's authorization to text-enable a toll free number? What impact would such an approach have on the existing toll free system? Are there pros and cons to this approach and, if so, what are they? What other issues should we consider with respect to documenting a subscriber's authorization to text-enable a toll free number?
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7. Alternatively, if parties believe a separate registry is needed, who should have access to such a registry? Should it be limited to RespOrgs, or open to messaging providers or others (and, if so, whom)? Also, should we consider multiple registries or would having a single registry be more efficient for the toll free subscriber to address any issues or concerns raised by text-enabling and thereby more effectively prevent abuse or fraud? Would being able to access a single registry rather than multiple registries be less burdensome to RespOrgs and messaging providers? Would multiple registries cause confusion for entities that text-enable toll free numbers as to which registry to use? Would these entities need to know all the registries and be required to make sure a text-enabled toll free number is registered with each one? How would the Commission, state commissions, or law enforcement agencies manage a process that could require accessing multiple registries for information on a particular text-enabled toll free number? Would the sum of the costs of multiple registry administrators be higher than the costs incurred by a single registry administrator?
8. Alternatively, are there benefits to a multi-registry system we should consider? CTIA argues that the Commission, “should not assume that the approach to selecting a single vendor of toll free registry services in the context of voice telecommunications services should be extended to messaging.” What are the benefits of a multi-registry system? Do they outweigh the efficiencies of a single registry? We invite interested stakeholders to address these questions.
9. If we determine that a single toll free texting registry is appropriate, should we make, as recommended by some commenters, the TFNA the registrar as part of its overall toll free number administration responsibilities? The TFNA has developed a toll free texting registry—the “TSS Registry”—which is being used by some industry members. Some commenters support its use as the single registry of text-enabled toll free numbers, and maintain that the TFNA is the proper entity to operate the toll free texting registry; it has already been deemed “impartial” by the Commission and is required to make toll free numbers available “on an equitable basis” pursuant to section 251(e)(1) of the Act. Would Somos, the current TFNA, be neutral in its role as operator of the toll free texting registry?
10. On the other hand, some commenters oppose designating the current SMS Database or TSS Registry as the single authorized text-enabled toll
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15. In this NPRM, we propose, pursuant to that same authority, that a toll free subscriber must inform its RespOrg of its authorization to text-enable a toll free number and that the RespOrg must update the appropriate records in the SMS Database. We believe these additional steps will help safeguard the toll free number assignment process in general and the toll free text-enabling process in particular by alleviating confusion about the status of a toll free number, and will also prevent any potential abuse, such as spoofing or fraud. For this reason and those previously discussed in this NPRM, the proposals herein further our statutory mandate to set policy on numbering administration in the United States. We also seek comment herein on a number of additional measures to promote these same goals and that, if adopted, would also rely upon our numbering authority under section 251(e)(1) of the Act. We invite comment on the sources of authority discussed above.
16. As required by the Regulatory Flexibility Act of 1980, as amended (RFA), the Commission has prepared this Initial Regulatory Flexibility Analysis (IRFA) of the possible significant economic impact on a substantial number of small entities by the policies and rules proposed in this
17. In this NPRM, we propose that a toll free subscriber must inform its RespOrg of its authorization to text-enable a toll free number and that the RespOrg must update the appropriate records in the SMS Database. We believe this proposal will further safeguard the toll free text-enabling process, and fulfill our statutory mandate that numbers be made available on an equitable basis. We also believe this additional step are necessary to avoid any confusion about the status of a toll free number and to prevent any potential abuse, such as spoofing or fraud. We seek comment by interested stakeholders on this proposed rule.
18. The legal basis for any action that may be taken pursuant to this NPRM is contained in sections 1, 4(i), 201(b), and 251(e)(1) of the Communications Act of 1934, as amended, 47 U.S.C. 151, 154(i), 201(b), and 251(e)(1).
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 rule revisions, if adopted. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small-business concern” under the Small Business Act. A “small-business concern” is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any
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25. We have included small incumbent LECs in this present RFA analysis. As noted above, a “small business” under the RFA is one that,
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32. The Commission's own data—available in its Universal Licensing System—indicate that, as of October 25, 2016, there are 280 Cellular licensees that will be affected by our actions today. The Commission does not know how many of these licensees are small, as the Commission does not collect that information for these types of entities. Similarly, according to internally developed Commission data, 413 carriers reported that they were engaged in the provision of wireless telephony, including cellular service, Personal Communications Service, and Specialized Mobile Radio Telephony services. Of this total, an estimated 261 have 1,500 or fewer employees, and 152 have more than 1,500 employees. Thus, using available data, we estimate that the majority of wireless firms can be considered small.
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39. The NPRM proposes and seeks comment on a rule change that will affect toll free text-enablement. In particular, we propose a revised definition for the Service Management System Database § 52.101(d). The NPRM seeks comment on this proposal.
40. The RFA requires an agency to describe any significant, specifically small business, 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 rules 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 such small entities.
41. In this NPRM, we propose that a toll free subscriber must inform its RespOrg of its authorization to text-enable a toll free number and that the RespOrg must update the appropriate records in the SMS Database. We believe this proposal will further safeguard the toll free text-enabling process, and fulfill our statutory mandate that numbers be made available on an equitable basis. The NPRM also seeks comment on administrative issues to implement the proposed registry that would not be overly burdensome on RespOrgs and messaging providers. For example, we seek comment on whether toll free texting information should be included in the SMS Database or if there should be a single toll free texting registry, as opposed to multiple registries, to limit burden on RespOrgs and messaging providers some of which may be small entities.
42. None.
43. 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 in the
•
•
Filings can be sent by hand or messenger delivery, by commercial
• 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.
•
44. This proceeding shall be treated as a “permit-but-disclose” proceeding in accordance with the Commission's
45. Pursuant to the Regulatory Flexibility Act (RFA), the Commission has prepared an Initial Regulatory Flexibility Analysis (IRFA) of the possible significant economic impact on small entities of the policies and actions considered in this Notice of Proposed Rulemaking. The text of the IRFA is set forth above. Written public comments are requested on this IRFA. Comments must be identified as responses to the IRFA and must be filed by the deadlines for comment on the Notice of Proposed Rulemaking. The Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, will send a copy of this Notice of Proposed Rulemaking, including the IRFA, to the Chief Counsel for Advocacy of the Small Business Administration (SBA).
46. This document may contain proposed new or modified information collection requirements. The Commission, as part of its continuing effort to reduce paperwork burdens, invites the general public and the Office of Management and Budget (OMB) to comment on the information collection requirements contained in this document, as required by the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, we seek specific comment on how we might further reduce the information collection burden for small business concerns with fewer than 25 employees.
47. For further information about this proceeding, please contact E. Alex Espinoza, FCC Wireline Competition Bureau, Competition Policy Division, Room 5-C211, 445 12th Street SW, Washington, DC 20554, at (202) 418-0849 or
1. Accordingly,
2.
Numbering.
For the reasons set forth in the preamble, the Federal Communications Commission proposes to amend part 52 of title 47 of the Code of Federal Regulations as follows:
Authority: 47 U.S.C. 151-55, 201-05, 207-09, 218, 225-27, 251-52, 271, 332 unless otherwise noted.
(d)
The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are required regarding (1) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Comments regarding this information collection received by August 23, 2018 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725 17th Street NW, Washington, DC 20502. Commenters are encouraged to submit their comments to OMB via email to:
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
U.S. Commission on Civil Rights.
Announcement of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act (FACA) that a meeting of the Montana Advisory Committee (Committee) to the Commission will be held at 3:00 p.m. (Mountain Time) Thursday, July 26, 2018. The purpose of the meeting is for the Committee to discuss the draft of the Bordertown Discrimination Report.
The meeting will be held on Thursday, July 26, 2018 at 3:00 p.m. MT.
David Barreras at
This meeting is available to the public through the following toll-free call-in number: 800-231-9012, conference ID number: 7840110. Any interested member of the public may call this number and listen to the meeting. Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-877-8339 and providing the Service with the conference call number and conference ID number.
Members of the public are entitled to make comments during the open period at the end of the meeting. Members of the public may also submit written comments; the comments must be received in the Regional Programs Unit within 30 days following the meeting. Written comments may be mailed to the Western Regional Office, U.S. Commission on Civil Rights, 300 North Los Angeles Street, Suite 2010, Los Angeles, CA 90012. They may be faxed
Records and documents discussed during the meeting will be available for public viewing prior to and after the meeting at
Please click on the “Meeting Details” and “Documents” links. Records generated from this meeting may also be inspected and reproduced at the Regional Programs Unit, as they become available, both before and after the meeting. Persons interested in the work of this Committee are directed to the Commission's website,
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 September 24, 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 Erica Filipek, U.S. Census Bureau, Economic Indicators Division, 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 Form C-404, “Report of Building or Zoning Permits Issued for New Privately-Owned Housing Units”, otherwise known as the Building Permits Survey. The Census Bureau uses this survey to produce statistics to monitor activity in the large and dynamic construction industry. For New Residential Construction (which includes Housing Units Authorized by Building Permits, Housing Starts, and Housing Completions), form C-404 is used to collect the estimate for Housing Units Authorized by Building Permits. For New Residential Construction and Sales, the number of housing units authorized by building permits is a key component utilized in the estimation of housing units started, completed, and sold.
These statistics help state and local governments, the Federal Government, and private industry, analyze the housing and construction industry sector of the economy. Building permits for new private housing units also are a component of The Conference Board's Leading Economic Index.
The Census Bureau uses Form C-404 to collect information on changes to the geographic coverage of permit-issuing places, the number and valuation of new residential housing units authorized by building permits, and additional information on residential permits valued at $1 million or more, including, but not limited to, site address and type of building. The Census Bureau uses these data to estimate the number of housing units started, the number of housing units completed, the number of single-family houses sold, and to select samples for the Census Bureau's demographic surveys. The Building Permits Survey is the only source of statistics on residential construction for states and smaller geographic areas. The Census Bureau uses the detailed geographic data collected from state and local officials on new residential construction authorized by building permits in the development of annual population estimates that are used by government agencies to allocate funding and other resources to local areas. Policymakers, planners, businesses, and others also use the detailed geographic data to monitor growth, plan for local services, and to develop production and marketing plans.
Respondents may submit their data via internet or a mailed or faxed form. Some respondents choose to email proprietary electronic files or mail proprietary printouts of permit information in lieu of returning the form.
The survey universe is comprised of approximately 20,325 local governments that issue building permits. Due to resource availability and the time required to complete the data review and analysis, the Census Bureau collects data from a sample of permit-issuing jurisdictions monthly, and the remainder of the jurisdictions annually. We collect this information monthly for about 7,850 permit-issuing jurisdictions who respond via internet or who mail or fax the provided form. Another 325 jurisdictions have established reporting arrangements that allow them to submit their responses monthly via proprietary electronic files or mailed printouts using their own file format. We collect this information annually for about 11,700 permit-issuing jurisdictions who respond via internet or who mail or fax the provided form. Another 450 jurisdictions have established reporting arrangements that allow them to submit their responses annually via proprietary electronic files or mailed printouts using their own file format.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.
The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.
The associated monthly M3 Survey estimates are based on a panel of approximately 5,000 reporting units that represent approximately 3,100 companies and provide an indication of month-to-month change for the Manufacturing Sector. These reporting units may be divisions of diversified large companies, large homogenous companies, or single-unit manufacturers. The M3 estimates are periodically benchmarked to comprehensive data on the manufacturing sector from the Annual Survey of Manufactures (ASM), the Economic Census (shipments and inventories) and the M3UFO Survey, which is the subject of this notice. Unfilled orders data are not collected in the ASM or the Economic Census. To obtain more accurate M3 estimates of unfilled orders, which are also used in deriving M3 estimates of new orders, we conduct the M3UFO Survey annually to be used as the source for benchmarking M3 unfilled orders data. Industries that maintain unfilled orders cannot fulfill the order in the same month in which the order is received. This is not true for each industry, and occurs mainly in industries where production takes longer than one month. In order to reduce burden from our respondents, the M3UFO data are used to determine which North American Industry Classification System (NAICS) industries continue to maintain unfilled orders. We then utilize that information to only request unfilled orders on the monthly M3 survey from the NAICS industries that actually have unfilled orders which cannot be completed within the same month that the order was placed.
There are no changes to the MA-3000 form, which is used to conduct the M3UFO survey.
The Census Bureau will use mail out or mail back survey forms to collect the data with online reporting encouraged. Online response for the survey is typically 70 percent. Companies are asked to respond to the survey within 30 days of receipt. The Census Bureau mails letters encouraging participation to companies that have not responded within 30 days and later uses telephone follow-up to seek response from delinquent companies.
This information collection request may be viewed at
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Notice of issuance of an amended Export Trade Certificate of Review to Aerospace Industries Association of America, Inc., Application no. 92-14A001.
The U.S. Department of Commerce issued an amended Export Trade Certificate of Review to Aerospace Industries Association of America, Inc. (“AIA”) on July 9, 2018.
Joseph Flynn, Director, Office of Trade and Economic Analysis, International Trade Administration, by telephone at (202) 482-5131 (this is not a toll-free number) or email at
Title III of the Export Trading Company Act of 1982 (15 U.S.C. 4001-21) authorizes the Secretary of Commerce to issue Export Trade Certificates of Review. The regulations implementing Title III are found at 15 CFR part 325 (2014). The U.S. Department of Commerce, International Trade Administration, Office of Trade and Economic Analysis (“OTEA”) is issuing this notice
AIA's Export Trade Certificate of Review has been amended to:
1. Add the following companies as new Members of the Certificate within the meaning of section 325.2(l) of the Regulations (15 CFR 325.2(l)):
2. Delete the following companies as Members of AIA's Certificate:
3. Change in name or address for the following Members:
The effective date of the amendment is April 4, 2018, the date on which
Commodity Futures Trading Commission.
Notice.
The Commodity Futures Trading Commission (“CFTC or Commission”) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (“PRA”), Federal agencies are required to publish notice in the
Comments must be submitted on or before September 24, 2018.
You may submit comments, identified by OMB Control No. 3038-0069, by any of the following methods:
• The Agency's website, at
•
•
Please submit your comments using only one method. All comments must be submitted in English, or if not, accompanied by an English translation. Comments will be posted as received to
Eileen Chotiner, Division of Clearing and Risk, Commodity Futures Trading Commission, (202) 418-5467; email:
Under the PRA, 44 U.S.C. 3501
With respect to the collection of information, the CFTC invites comments on:
• Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information will have a practical use;
• The accuracy of the Commission's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Ways to enhance the quality, usefulness, and clarity of the information to be collected; and
• Ways to minimize the burden of 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;
You should submit only information that you wish to make available publicly. If you wish the Commission to consider information that you believe is exempt from disclosure under the Freedom of Information Act, a petition for confidential treatment of the exempt information may be submitted according to the procedures established in § 145.9 of the Commission's regulations.
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
There are no capital costs or operating and maintenance costs associated with this collection.
Department of the Army, DoD.
Notice.
In accordance with applicable laws and regulations, announcement is made of the intent to grant an exclusive, non-royalty-bearing, revocable license.
Commander, U.S. Army Medical Research and Materiel Command, ATTN: Command Judge Advocate, MCMR-JA, 504 Scott Street, Fort Detrick, MD 21702-5012.
For licensing issues, Mr. Paul G. Michaels, Office of Research & Technology Applications, (301) 619-4145. For patent issues, Ms. Elizabeth Arwine, Patent Attorney, (301) 619-7808, both at telefax (301) 619-5034.
In accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i), announcement is made of the intent to grant an exclusive, non-royalty-bearing, revocable license to United States Patent Application US 15/723,448, filed October 3, 2017, entitled, “Aerosol Concentrating Apparatus for Use with Aerosol Aging Drum,” and Patent Cooperation Treaty Patent Application PCT/US2017/016845, filed February 7, 2017, entitled, “Oro-Nasal Inhalation Plethysmography Mask Exposure System,” and Patent Cooperation Treaty Patent Application PCT/US2017/016811, filed February 7, 2017, entitled, “Head-Only and/or Whole Body Inhalation Exposure Chamber” to PneumoDose, LLC, having its principal place of business at 112 Lynhaven Drive, Alexandria, VA 22305.
Anyone wishing to object to grant of this license can file written objections along with supporting evidence, if any, within 15 days from the date of this publication. Written objections are to be filed with the Command Judge Advocate (see
Office of Special Education and Rehabilitative Services, Department of Education.
Notice.
The Department of Education (Department) is issuing a notice inviting
For the addresses for obtaining and submitting an application, please refer to our Common Instructions for Applicants to Department of Education Discretionary Grant Programs, published in the
Carmen Sanchez, U.S. Department of Education, 400 Maryland Avenue SW, Room 5175, Potomac Center Plaza, Washington, DC 20202-5076. Telephone: (202) 245-6595.
If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.
This priority is:
The 93 parent centers (
PTACs provide support to parent centers to carry out these statutorily required activities and thereby help parents participate in the education of their children to improve their children's outcomes. In addition, section 673(b) of IDEA lists areas in which parent centers may also need TA from PTACs: (1) Coordinating parent training efforts; (2) disseminating scientifically based research and information; (3) promoting the use of technology, including assistive technology devices and services; (4) reaching underserved populations, including parents of low-income and limited English proficient children with disabilities; (5) including children with disabilities in general education programs; (6) facilitating all transitions from early intervention through postsecondary environments; and (7) promoting alternative methods of dispute resolution, including mediation.
PTACs provide needed support to parent centers on other topics as well, including current information on laws and policies; evidence-based (as defined in this notice) practices (EBPs) that impact children with disabilities and their families; how to help parents learn about and access high-quality education options that meet their children's unique needs; and ways to effectively engage in school reform activities, including Federal, State, and local initiatives. Ongoing TA, responsive to the individual needs of parent centers, can increase parent center staff knowledge and expertise on these topics. In addition, since many parent centers are grassroots organizations with small budgets, they often benefit from TA on managing a Federal grant, maximizing efficiencies, meeting complex statutory and regulatory requirements for nonprofits, and providing professional development to staff.
Parent centers also need support to increase their capacity to reach and provide services to youth with disabilities and to all parents of children with disabilities, particularly parents of infants, toddlers, preschool children and transition-age youth; and underserved parents with additional needs or unique circumstances, including low income-parents, parents with limited English proficiency, parents with low literacy levels, parents who themselves experience disability, parents of youth involved in the
In order to ensure that parent centers receive the TA they need to increase their knowledge and capacity to provide services to parents and youth effectively and efficiently, the Department plans to fund five technical assistance centers for parent centers. The Department will fund a CPIR that will, in coordination with the regional PTACs, develop and disseminate resources for all parent centers to use when working with parents of children with disabilities and youth with disabilities. CPIR will also develop and disseminate materials that all parent centers can use to train staff to effectively reach and serve all parents and youth. The Department will also fund four regional PTACs that will provide TA to parent centers to effectively manage their centers and reach and serve all parents and youth within their region. The CPIR and regional PTACs will coordinate their efforts in order to maximize resources and avoid duplication. The following website provides more information on the current parent centers, including links to each grantee's website:
(a) Increased parent centers' knowledge, through the development and dissemination of high-quality, accurate, and impartial information and products, of:
(1) Early intervention and educational EBPs, and current Federal and State laws and policies, that impact children with disabilities and their families;
(2) The range of educational options that may be available in States to families of children with disabilities;
(3) Effective practices in carrying out parent center activities including outreach, family-centered services, and self-advocacy skill building;
(4) Effective and appropriate practices in outreach and service provision to underserved parents, including parents with limited English proficiency, parents with low literacy levels, parents who themselves experience disability, parents of youth involved in the juvenile justice system, foster parents, military-connected parents, and Native American parents; and
(5) Effective nonprofit management practices;
(b) Increased parent centers' use of, high-quality, accurate, and impartial materials and approaches to train:
(1) Staff in reaching all parents and youth, including underserved parents of children with disabilities, which includes parents with limited English proficiency, parents with low literacy levels, parents who themselves experience disability, parents of youth involved in the juvenile justice system, foster parents, military-connected parents, and Native American parents; and
(2) Multilingual staff in their native languages and assure the accuracy of the information the staff provide in languages other than English.
In addition to these programmatic requirements, to be considered for funding under Focus Area 1 of this priority, applicants must meet the application and administrative requirements in this priority, which are:
(a) Demonstrate, in the narrative section of the application under “Significance,” how the proposed project will—
(1) Address parent centers' needs both for resources to effectively reach and serve all parents of children with disabilities and youth with disabilities, including underserved parents, which includes parents with limited English proficiency, parents with low literacy levels, parents who themselves experience disability, parents of youth involved in the juvenile justice system, foster parents, military-connected parents, and Native American parents, and for materials to train staff to effectively reach and serve all parents and youth. To meet this requirement, the applicant must—
(i) Present applicable information on the needs of parent centers nationally; and
(ii) Demonstrate knowledge of—
(A) Current educational issues and policy initiatives relating to early childhood (ages birth through five), general and special education, secondary transition services, and postsecondary options; and
(B) Best practices in:
(
(
(
(2) Increase the knowledge of parent centers on how to reach and provide services to all parents and youth, train staff using high-quality, accurate, and impartial training materials, and manage their projects; and indicate the likely magnitude or importance of the improvements.
(b) Demonstrate, in the narrative section of the application under “Quality of project services,” how the proposed project will—
(1) Ensure equal access and treatment for members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age, or disability. To meet this requirement, the applicant must describe how it will—
(i) Identify the informational and TA needs of the parent centers.
(ii) Ensure that services and products meet the needs of the parent centers;
(2) Achieve its goals, objectives, and intended outcomes. To meet this requirement, the applicant must provide—
(i) Measurable intended project outcomes; and
(ii) In Appendix A, the logic model (as defined in this notice) by which the proposed project will achieve its intended outcomes that depicts, at a minimum, the goals, activities, outputs, and intended outcomes of the proposed project;
(3) Use a conceptual framework (and provide a copy in Appendix A) to develop project plans and activities, describing any underlying concepts, assumptions, expectations, beliefs, or theories, as well as the presumed relationships or linkages among these variables, and any empirical support for this framework;
(4) Be based on current research and make use of EBPs. To meet this requirement, the applicant must describe—
(i) The current research on outreach, family-centered services, and self-advocacy skill building, including effective and appropriate outreach and service provision to underserved parents of children with disabilities, including parents with limited English proficiency, parents with low literacy levels, parents who themselves experience disability, parents of youth involved in the juvenile justice system, foster parents, military-connected parents, and Native American parents; staff training, including multilingual staff; and nonprofit management;
(ii) The current research about adult learning principles and implementation science that will inform the proposed TA; and
(iii) How the proposed project will incorporate current research and EBPs in the development and delivery of its products and services;
(5) Develop products and provide services that are of high quality and sufficient intensity and duration to achieve the intended outcomes of the proposed project. To address this requirement, the applicant must describe—
(i) How it proposes to identify how knowledgeable the parent centers are of: Outreach, family-centered services, and self-advocacy skill building, including effective and appropriate outreach and service provision to underserved parents of children with disabilities, including parents with limited English proficiency, parents with low literacy levels, parents who themselves experience disability, parents of youth involved in the juvenile justice system, foster parents, military-connected parents, and Native American parents; staff training, including multilingual staff; and nonprofit management;
(ii) Its proposed approach to universal, general TA,
(A) Create, update, and maintain an online, annotated repository of high-quality, accurate, and impartial resources,
(B) Develop up-to-date, family-centered resources as needed that parent centers can use with parents in a variety of languages, formats, and reading levels; disseminate and modify, as needed, family-centered resources developed by OSEP and other federally funded centers to provide families with strategies to enhance their children's literacy, numeracy, and scientific reasoning at home; and revise materials developed by the previously funded Military PTAC and the Native American PTAC as necessary;
(C) Compile and create materials to train staff, including multilingual staff, to provide effective, appropriate, and impartial outreach and service provision to underserved parents of children with disabilities, including parents with limited English proficiency, parents with low literacy levels, parents who themselves experience disability, parents of youth involved in the juvenile justice system, foster parents, military-connected parents, and Native American parents;
(D) Compile and create materials on nonprofit management, as necessary, and develop a process for an annual orientation of new parent center directors and other key personnel and members of the boards of directors that provides the new personnel with the information and resources they need to carry out their responsibilities; and
(6) Develop products and implement services that maximize efficiency. To address this requirement, the applicant must describe—
(i) How the proposed project will use technology to achieve the intended project outcomes;
(ii) With whom the proposed project will collaborate and the intended outcomes of this collaboration;
(iii) How the proposed project will use existing knowledge and expertise within parent centers to achieve intended project outcomes; and
(v) How the proposed project will use non-project resources to achieve the intended project outcomes; and
(7) Assist parent centers in the collection of annual performance data required under section 671(b)(12) of IDEA, in consultation with the OSEP project officer.
(c) In the narrative section of the application under “Quality of the project evaluation,” include an evaluation plan for the project as described in the following paragraphs. The evaluation plan must describe: Measures for evaluating the quality, accuracy, and impartiality of project services and products; measures of progress in implementation, including the criteria for determining the extent to which the project's products and services have met the goals for reaching its target population; measures of intended outcomes or results of the project's activities in order to evaluate those activities; and how well the goals or objectives of the proposed project, as described in its logic model, have been met.
The applicant must provide an assurance that, in designing the evaluation plan, it will—
(1) Designate, with the approval of the OSEP project officer, a project liaison staff person with sufficient dedicated time, experience in evaluation, and knowledge of the project to work in collaboration with the TA Center to Improve Program and Project Performance (CIP3),
(i) Revise, as needed, the logic model submitted in the grant application to provide for a more comprehensive measurement of implementation and outcomes and to reflect any changes or clarifications to the model discussed at the kick-off meeting;
(ii) Refine the evaluation design and instrumentation proposed in the grant application consistent with the logic model (
(iii) Revise, as needed, the evaluation plan submitted in the grant application such that it clearly—
(A) Specifies the measures and associated instruments or sources for data appropriate to the evaluation questions, suggests analytic strategies for those data, provides a timeline for conducting the evaluation, and includes staff assignments for completion of the plan;
(B) Delineates the data expected to be available by the end of the second project year for use during the project's evaluation (3+2 review) for continued funding described under the heading
(C) Can be used to assist the project director and the OSEP project officer, with the assistance of CIP3, as needed, to specify the performance measures to be addressed in the project's Annual Performance Report;
(2) Cooperate with CIP3 staff in order to accomplish the tasks described in paragraph (1) of this section; and
(3) Dedicate sufficient funds in each budget year to cover the costs of carrying out the tasks described in paragraphs (1) and (2) of this section and implementing the evaluation plan.
(d) Demonstrate, in the narrative section of the application under “Adequacy of resources,” how—
(1) The proposed project will encourage applications for employment from persons who are members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age, or disability, as appropriate;
(2) The proposed key project personnel, consultants, and subcontractors have the qualifications and experience to carry out the proposed activities and achieve the project's intended outcomes;
(3) The applicant and any key partners have adequate resources to carry out the proposed activities; and
(4) The proposed costs are reasonable in relation to the anticipated results and benefits.
(e) Demonstrate, in the narrative section of the application under “Quality of the management plan,” how—
(1) The proposed management plan will ensure that the project's intended outcomes will be achieved on time and within budget. To address this requirement, the applicant must describe—
(i) Clearly defined responsibilities for key project personnel, consultants, and subcontractors, as applicable; and
(ii) Timelines and milestones for accomplishing the project tasks;
(2) Key project personnel and any consultants and subcontractors will be allocated and how these allocations are appropriate and adequate to achieve the project's intended outcomes;
(3) The proposed management plan will ensure that the products and services provided are of high quality, impartial, relevant, and useful to recipients; and
(4) The proposed project will benefit from a diversity of perspectives, including those of families using a variety of education options, youth, educators, TA providers, researchers, and policy makers, among others, in its development and operation.
(f) Address the following application requirements. The applicant must—
(1) Include, in Appendix A, personnel-loading charts and timelines, as applicable, to illustrate the management plan described in the narrative;
(2) Include, in the budget, attendance at the following:
(i) A one and one-half day kick-off meeting in Washington, DC, after receipt of the award, and an annual planning meeting in Washington, DC, with the OSEP project officer and other relevant staff during each subsequent year of the project period;
(ii) A two and one-half day project directors' conference in Washington, DC, during each year of the project period;
(iii) Two annual two-day trips to attend Department briefings, Department-sponsored conferences, and other meetings, as requested by OSEP; and
(iv) A one-day intensive 3+2 review meeting in Washington, DC, during the last half of the second year of the project period;
(3) Include, in the budget, a line item for an annual set-aside of five percent of the grant amount to support emerging needs that are consistent with the proposed project's intended outcomes, as those needs are identified in consultation with, and approved by, the OSEP project officer. With approval from the OSEP project officer, the project must reallocate any remaining funds from this annual set-aside no later than the end of the third quarter of each budget period;
(4) Ensure that the budget allocates at least $200,000 annually to carry out the project services described in paragraphs (b)(5)(ii)(A) through (C) of this focus area;
(5) Maintain a high-quality website, with an easy-to-navigate design, including the repository described in paragraph (b)(5)(ii)(A) of this focus area, that meets government or industry-recognized standards for accessibility; and
(6) Include, in Appendix A, an assurance to assist OSEP with the transfer of pertinent resources and products and to maintain the continuity of services to parent centers during the transition to this new award period, as appropriate.
(a) The recommendation of a 3+2 review team consisting of experts selected by the Secretary. This review will be conducted during a one-day intensive meeting that will be held during the last half of the second year of the project period;
(b) The timeliness with which, and how well, the requirements of the negotiated cooperative agreement have been or are being met by the project; and
(c) The quality, relevance, and usefulness of the project's products and services and the extent to which the project's products and services are aligned with the project's objectives and likely to result in the project achieving its intended outcomes.
(a) Increased parent center capacity to accurately and impartially train parents on, and inform them about:
(1) Early intervention and educational EBPs;
(2) Their rights and responsibilities under Federal, State, and local laws and policies that impact children with disabilities and their families; and
(3) The range of education options that may be available to families of children with disabilities in the area served by the parent center.
(b) Increased parent center capacity to reach more parents and youth; and effectively provide parent center services to help more parents improve outcomes for their children, and youth build their self-advocacy skills;
(c) Increased parent center capacity to provide effective and appropriate outreach and service provision to underserved parents of children with disabilities including parents with limited English proficiency, parents with low literacy levels, parents who themselves experience disability, parents of youth involved in the juvenile justice system, foster parents, military-connected parents, and Native American parents; and
(d) Increased parent center capacity to effectively manage their projects and provide high-quality training to staff, including multilingual staff, to reach and serve all parents and youth in their region.
The geographic regions served by the four regional PTACs are generally aligned with the States served by the Equity Assistance Centers funded under Title IV of the 1964 Civil Rights Act, while also balancing the number of centers each regional PTAC will have in their region. This alignment will help the regional PTACs meet the requirement in section 673(c) of IDEA that the regional PTACs develop collaborative agreements with the geographically appropriate centers. The four regional PTACs will be awarded to represent the following geographic regions:
In addition to these programmatic requirements, to be considered for funding under Focus Area 2 of this priority, applicants must meet the application and administrative requirements in this priority, which are:
(a) Demonstrate, in the narrative section of the application under “Significance,” how the proposed project will—
(1) Address the needs of parent centers in its region for TA to increase their capacity to reach and provide services to parents and youth in their areas, including underserved parents of children with disabilities, which includes parents with limited English proficiency, parents with low literacy levels, parents who themselves experience disability, parents of youth involved in the juvenile justice system, foster parents, military-connected parents, and Native American parents; build youth's self-advocacy skills; train staff; and effectively manage their centers. To meet this requirement the applicant must—
(i) Present applicable information on the needs of parent centers in the region; and
(ii) Demonstrate knowledge of—
(A) Current early intervention and educational issues and policy initiatives relating to early childhood, general and special education, secondary transition services, and postsecondary options; and
(B) Best practices in:
(
(
(
(2) Increase the capacity of parent centers to reach and provide services to all parents and youth, train staff, and manage their projects; and indicate the likely magnitude or importance of the improvements.
(b) Demonstrate, in the narrative section of the application under “Quality of project services,” how the proposed project will—
(1) Ensure equal access and treatment for members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age, or disability. To meet this requirement, the applicant must describe how it will—
(i) Identify the needs of the parent centers in the proposed region for TA and information.
(ii) Ensure that services and products meet the needs of the parent centers;
(2) Achieve its goals, objectives, and intended outcomes. To meet this requirement, the applicant must provide—
(i) Measurable intended project outcomes; and
(ii) In Appendix A, the logic model (as defined in this notice) by which the proposed project will achieve its intended outcomes that depicts, at a minimum, the goals, activities, outputs, and intended outcomes of the proposed project;
(3) Use a conceptual framework (and provide a copy in Appendix A) to develop project plans and activities, describing any underlying concepts, assumptions, expectations, beliefs, or theories, as well as the presumed relationships or linkages among these variables, and any empirical support for this framework;
(4) Be based on current research and make use of EBPs. To meet this requirement, the applicant must describe—
(i) The current research on: Outreach, family-centered services, and self-advocacy skill building, including effective and appropriate outreach and service provision to underserved parents of children with disabilities, including parents with limited English proficiency, parents with low literacy levels, parents who themselves experience disability, parents of youth involved in the juvenile justice system, foster parents, military-connected parents, and Native American parents; staff training, including multilingual staff; and nonprofit management;
(ii) The current research about adult learning principles and implementation science that will inform the proposed TA; and
(iii) How the proposed project will incorporate current research and EBPs in the development and delivery of its products and services;
(5) Develop products and provide services that are of high quality and sufficient intensity and duration to achieve the intended outcomes of the proposed project. To address this requirement, the applicant must describe—
(i) How it proposes to work with the CPIR to identify the knowledge base for parent centers': Outreach, family-centered services, and self-advocacy skill building, including effective and appropriate outreach and service provision to underserved families of children with disabilities, including parents with limited English proficiency, parents with low literacy levels, parents who themselves experience disability, parents of youth involved in the juvenile justice system, foster parents, military-connected parents, and Native American parents;
(ii) Its proposed approach to targeted, specialized TA,
(A) Conduct at least one in-person, on-site visit to each parent center in the region during the course of the five-year project period;
(B) Increase parent centers' capacity to reach and provide services to all parents with children with disabilities and youth, including underserved parents, which includes parents with limited English proficiency, parents with low literacy levels, parents who themselves experience disability, parents of youth involved in the juvenile justice system, foster parents, military-connected parents, and Native American parents;
(C) Increase parent centers' capacity to train staff, including multilingual staff, to provide effective and appropriate outreach and service provision to underserved families of children with disabilities, including parents with limited English proficiency, parents with low literacy levels, parents who themselves experience disability, parents of youth involved in the juvenile justice system, foster parents, military-connected parents, and Native American parents; and
(D) Increase parent centers' capacity to effectively manage nonprofit organizations, including developing the board of directors so that parent centers have the organizational policies, procedures, and a structure in place to manage their grants effectively;
(iii) Its proposed approach to intensive, sustained TA,
(A) The intended recipients, including the type and number of recipients, that will receive the products and services under this approach;
(B) Its proposed approach to measure the readiness of the parent centers to work with the project, including their commitment to the initiative, current infrastructure, and available resources;
(C) Its proposed plan for assisting parent centers to build or enhance their staff training and professional development based on adult learning principles and coaching; and
(D) Its proposed approach to providing intensive TA when requested by OSEP project officers; and
(6) Develop products and implement services that maximize efficiency. To address this requirement, the applicant must describe—
(i) How the proposed project will use technology to achieve the intended project outcomes;
(ii) With whom the proposed project will collaborate and the intended outcomes of this collaboration;
(iii) How the proposed project will use existing knowledge and expertise within parent centers to achieve intended project outcomes;
(iv) How the proposed project will use the resources housed in and developed by the CPIR—including family-centered resources that provide families with strategies to enhance their children's literacy, numeracy, and scientific reasoning at home—and build on the CPIR's universal TA; and
(v) How the proposed project will use non-project resources to achieve the intended project outcomes.
(c) In the narrative section of the application under “Quality of the project evaluation,” include an evaluation plan for the project. The evaluation plan must describe: Measures for evaluating the quality, accuracy, and impartiality of project services and products; measures of progress in implementation, including the criteria for determining the extent to which the project's products and services have met the goals for reaching its target population; measures of intended outcomes or results of the project's activities in order to evaluate those activities; and how well the goals or objectives of the proposed project, as described in its logic model, have been met.
(d) Demonstrate, in the narrative section of the application under “Adequacy of resources,” how—
(1) The proposed project will encourage applications for employment from persons who are members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age, or disability, as appropriate;
(2) The proposed key project personnel, consultants, and subcontractors have the qualifications and experience to carry out the proposed activities and achieve the project's intended outcomes;
(3) The applicant and any key partners have adequate resources to carry out the proposed activities; and
(4) The proposed costs are reasonable in relation to the anticipated results and benefits.
(e) Demonstrate, in the narrative section of the application under “Quality of the management plan,” how—
(1) The proposed management plan will ensure that the project's intended outcomes will be achieved on time and within budget. To address this requirement, the applicant must describe—
(i) Clearly defined responsibilities for key project personnel, consultants, and subcontractors, as applicable; and
(ii) Timelines and milestones for accomplishing the project tasks;
(2) Key project personnel and any consultants and subcontractors will be allocated and how these allocations are appropriate and adequate to achieve the project's intended outcomes;
(3) The proposed management plan will ensure that the products and services provided are of high quality, impartial, relevant, and useful to recipients; and
(4) The proposed project will benefit from a diversity of perspectives, including those of families using a variety of education options, youth, educators, TA providers, researchers, and policy makers, among others, in its development and operation.
(f) Address the following application requirements. The applicant must—
(1) Include, in Appendix A, personnel-loading charts and timelines, as applicable, to illustrate the management plan described in the narrative;
(2) Include, in the budget, attendance at the following:
(i) A one and one-half day kick-off meeting in Washington, DC, after receipt of the award, and an annual planning meeting in Washington, DC, with the OSEP project officer and other relevant staff during each subsequent year of the project period.
(ii) A two and one-half day project directors' conference in Washington, DC, during each year of the project period; and
(iii) Two annual two-day trips to attend Department briefings, Department-sponsored conferences, and other meetings, as requested by OSEP;
(5) Ensure that the budget allocates $75,000 annually to carry out the project services described in paragraphs (b)(5)(ii)(B) and (C) (military connected and native American parents and youth) of this focus area.
(6) Include, in the budget, a line item for an annual set-aside of five percent of the grant amount to support emerging needs that are consistent with the proposed project's intended outcomes, as those needs are identified in consultation with, and approved by, the OSEP project officer. With approval from the OSEP project officer, the project must reallocate any remaining funds from this annual set-aside no later than the end of the third quarter of each budget period; and
(7) Maintain a presence on a high-quality website, with an easy-to-navigate design, that meets government or industry-recognized standards for accessibility.
These priorities are:
Section 671(a)(2) of IDEA defines a “parent organization” as a private nonprofit organization (other than an institution of higher education) that—
(A) Has a board of directors—
(i) The majority of whom are parents of children with disabilities ages birth through 26;
(ii) That includes—
(I) Individuals working in the fields of special education, related services, and early intervention;
(II) Individuals with disabilities; and
(iii) The parent and professional members of which are broadly representative of the population to be served, including low-income parents and parents of limited English proficient children; and
(B) Has as its mission serving families of children with disabilities who—
(i) Are ages birth through 26; and
(ii) Have the full range of disabilities described in section 602(3) of IDEA.
Applicants under Focus Area 2 that are located in the region they propose to serve.
(i) A randomized controlled trial employs random assignment of, for example, students, teachers, classrooms, or schools to receive the project component being evaluated (the treatment group) or not to receive the project component (the control group).
(ii) A regression discontinuity design study assigns the project component being evaluated using a measured variable (
(iii) A single-case design study uses observations of a single case (
(i) A practice guide prepared by the WWC using version 2.1 or 3.0 of the WWC Handbook reporting a “strong evidence base” or “moderate evidence base” for the corresponding practice guide recommendation;
(ii) An intervention report prepared by the WWC using version 2.1 or 3.0 of the WWC Handbook reporting a “positive effect” or “potentially positive effect” on a relevant outcome based on a “medium to large” extent of evidence, with no reporting of a “negative effect” or “potentially negative effect” on a relevant outcome; or
(iii) A single experimental study or quasi-experimental design study reviewed and reported by the WWC using version 2.1 or 3.0 of the WWC Handbook, or otherwise assessed by the Department using version 3.0 of the WWC Handbook, as appropriate, and that—
(A) Meets WWC standards with or without reservations;
(B) Includes at least one statistically significant and positive (
(C) Includes no overriding statistically significant and negative effects on relevant outcomes reported in the study or in a corresponding WWC intervention report prepared under version 2.1 or 3.0 of the WWC Handbook; and
(D) Is based on a sample from more than one site (
(i) A practice guide prepared by WWC reporting a “strong evidence base” or “moderate evidence base” for the corresponding practice guide recommendation;
(ii) An intervention report prepared by the WWC reporting a “positive effect” or “potentially positive effect” on a relevant outcome with no reporting of a “negative effect” or “potentially negative effect” on a relevant outcome; or
(iii) A single study assessed by the Department, as appropriate, that—
(A) Is an experimental study, a quasi-experimental design study, or a well-designed and well-implemented correlational study with statistical controls for selection bias (
(B) Includes at least one statistically significant and positive (
(i) A practice guide prepared by the WWC using version 2.1 or 3.0 of the WWC Handbook reporting a “strong evidence base” for the corresponding practice guide recommendation;
(ii) An intervention report prepared by the WWC using version 2.1 or 3.0 of the WWC Handbook reporting a “positive effect” on a relevant outcome based on a “medium to large” extent of evidence, with no reporting of a “negative effect” or “potentially negative effect” on a relevant outcome; or
(iii) A single experimental study reviewed and reported by the WWC using version 2.1 or 3.0 of the WWC Handbook, or otherwise assessed by the Department using version 3.0 of the WWC Handbook, as appropriate, and that—
(A) Meets WWC standards without reservations;
(B) Includes at least one statistically significant and positive (
(C) Includes no overriding statistically significant and negative effects on relevant outcomes reported in the study or in a corresponding WWC intervention report prepared under version 2.1 or 3.0 of the WWC Handbook; and
(D) Is based on a sample from more than one site (
Contingent upon the availability of funds and the quality of applications, we may make additional awards in FY 2019 from the list of unfunded applications from this competition.
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(b) Applicants for, and recipients of, funding must, with respect to the aspects of their proposed project relating to the absolute priority, involve individuals with disabilities, or parents of individuals with disabilities ages birth through 26, in planning, implementing, and evaluating the project (see section 682(a)(1)(A) of IDEA).
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• A “page” is 8.5″ x 11″, on one side only, with 1″ margins at the top, bottom, and both sides.
• Double-space (no more than three lines per vertical inch) all text in the application narrative, including titles, headings, footnotes, quotations, reference citations, and captions, as well as all text in charts, tables, figures, graphs, and screen shots.
• Use a font that is 12 point or larger.
• Use one of the following fonts: Times New Roman, Courier, Courier New, or Arial.
The recommended page limit does not apply to Part I, the cover sheet; Part II, the budget section, including the narrative budget justification; Part IV, the assurances and certifications; or the abstract (follow the guidance provided in the application package for completing the abstract), the table of contents, the list of priority requirements, the resumes, the reference list, the letters of support, or the appendices. However, the recommended page limit does apply to all of the application narrative, including all text in charts, tables, figures, graphs, and screen shots.
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(a)
(1) The Secretary considers the significance of the proposed project.
(2) In determining the significance of the proposed project, the Secretary considers the following factors:
(i) The extent to which the proposed project will focus on serving or otherwise addressing the needs of disadvantaged individuals;
(ii) The extent to which specific gaps or weaknesses in services, infrastructure, or opportunities have been identified and will be addressed by the proposed project, including the nature and magnitude of those gaps or weaknesses; and
(iii) The importance or magnitude of the results or outcomes likely to be attained by the proposed project.
(b)
(1) The Secretary considers the quality of the services to be provided by the proposed project.
(2) In determining the quality of the services to be provided by the proposed project, the Secretary considers the quality and sufficiency of strategies for ensuring equal access and treatment for eligible project participants who are members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age, or disability.
(3) In addition, the Secretary considers the following factors:
(i) The extent to which the goals, objectives, and outcomes to be achieved by the proposed project are clearly specified and measurable;
(ii) The extent to which there is a conceptual framework underlying the proposed research or demonstration activities and the quality of that framework;
(iii) The extent to which the services to be provided by the proposed project reflect up-to-date knowledge from research and effective practice;
(iv) The extent to which the services to be provided by the proposed project are appropriate to the needs of the intended recipients or beneficiaries of those services;
(v) The extent to which the services to be provided by the proposed project involve the collaboration of appropriate partners for maximizing the effectiveness of project services; and
(vi) The extent to which the technical assistance services to be provided by the proposed project involve the use of efficient strategies, including the use of technology, as appropriate, and the leveraging of non-project resources.
(c)
(1) The Secretary considers the quality of the evaluation to be conducted of the proposed project.
(2) In determining the quality of the evaluation, the Secretary considers the following factors:
(i) The extent to which the methods of evaluation are thorough, feasible, and appropriate to the goals, objectives, and outcomes of the proposed project;
(ii) The extent to which the methods of evaluation are appropriate to the context within which the project operates;
(iii) The extent to which the methods of evaluation will provide performance feedback and permit periodic assessment of progress toward achieving intended outcomes; and
(iv) The extent to which the methods of evaluation include the use of objective performance measures that are clearly related to the intended outcomes of the project and will produce quantitative and qualitative data to the extent possible.
(d)
(1) The Secretary considers the adequacy of resources and quality of project personnel for the proposed project.
(2) In determining the quality of project personnel, the Secretary considers the extent to which the applicant encourages applications for employment from persons who are members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age, or disability.
(3) In determining the adequacy of resources and quality of project personnel for the proposed project, the Secretary considers the following factors:
(i) The qualifications, including relevant training and experience, of the project director or principal investigator;
(ii) The qualifications, including relevant training and experience, of key project personnel;
(iii) The qualifications, including relevant training and experience, of project consultants or subcontractors;
(iv) The adequacy of support, including facilities, equipment, supplies, and other resources, from the applicant organization or the lead applicant organization;
(v) The relevance and demonstrated commitment of each partner in the proposed project to the implementation and success of the project; and
(vi) The extent to which the costs are reasonable in relation to the objectives, design, and potential significance of the proposed project.
(e)
(1) The Secretary considers the quality of the management plan for the proposed project.
(2) In determining the quality of the management plan for the proposed project, the Secretary considers the following factors:
(i) The adequacy of the management plan to achieve the objectives of the proposed project on time and within budget, including clearly defined responsibilities, timelines, and milestones for accomplishing project tasks;
(ii) The extent to which the time commitments of the project director and principal investigator and other key project personnel are appropriate and adequate to meet the objectives of the proposed project;
(iii) The adequacy of mechanisms for ensuring high-quality products and services from the proposed project; and
(iv) How the applicant will ensure that a diversity of perspectives are brought to bear in the operation of the proposed project, including those of parents, teachers, the business community, a variety of disciplinary and professional fields, recipients or beneficiaries of services, or others, as appropriate.
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In addition, in making a competitive grant award, the Secretary requires various assurances, including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department of Education (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).
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Please note that, if the total value of your currently active grants, cooperative agreements, and procurement contracts from the Federal Government exceeds $10,000,000, the reporting requirements in 2 CFR part 200, Appendix XII, require you to report certain integrity information to FAPIIS semiannually. Please review the requirements in 2 CFR part 200, Appendix XII, if this grant plus all the other Federal funds you receive exceed $10,000,000.
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If your application is not evaluated or not selected for funding, we notify you.
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We reference the regulations outlining the terms and conditions of an award in the
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(b) At the end of your project period, you must submit a final performance report, including financial information, as directed by the Secretary. If you receive a multiyear award, you must submit an annual performance report that provides the most current performance and financial expenditure
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Grantees will be required to report information on their project's performance in annual reports to the Department (34 CFR 75.590).
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In making a continuation award, the Secretary also considers whether the grantee is operating in compliance with the assurances in its approved application, including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).
You may also access documents of the Department published in the
U.S. Department of Energy.
Notice and request for OMB review and comment.
The Department of Energy (DOE) has submitted an information collection request to OMB for extension under the provisions of the Paperwork Reduction Act of 1995. The information collection requests a three-year extension of its Labor Relations Report collection. The collection requests information from the Department of Energy Management and Operation (M&O) and Facilities Management Contractors for contract administration, management oversight, and cost control. The information collection will assist the Department in evaluating the implementation of the contractors' work force collective bargaining agreements, and apprise the Department of significant labor-management developments at DOE contractor sites. This information is used to ensure that Department contractors maintain good labor relations and retain a workforce in accordance with the terms of their contract and in compliance with statutory and regulatory requirements as identified by contract.
Comments regarding this collection must be received on or before August 23, 2018. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, please advise the OMB Desk Officer of your intention to make a submission as soon as possible. The Desk Officer may be telephoned at (202) 395-4650.
Written comments should be sent to the: DOE Desk Officer, Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10102, 735 17th Street NW, Washington, DC 20503.
And to: John M. Sullivan, GC-63, U.S. Department of Energy, 1000 Independence Avenue SW, Washington, DC 20585, Or by fax at (202) 586-0971; or by email to
Requests for additional information or copies of the information collection instrument and instructions should be directed to: John M. Sullivan, Attorney-Advisor (Labor), GC-63, U.S. Department of Energy, 1000 Independence Avenue SW, Washington, DC 20585, or by fax at (202) 586-0971 or by email to
This information collection request contains: (1)
42 U.S.C. 7254, 7256.
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:
This is a supplemental notice in the above-referenced proceeding of Wildcat Ranch Wind Project, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is August 7, 2018.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the website that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC
In notice document 2018-14738 appearing on pages 31968-31969 in the issue of July 10, 2018, make the following correction:
On page 31968, in the second column, under the
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
The Commission may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written comments should be submitted on or before August 23, 2018. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contacts listed below as soon as possible.
Direct all PRA comments to Nicholas A. Fraser, OMB, via email
For additional information or copies of the information collection, contact Nicole Ongele at (202) 418-2991. To view a copy of this information collection request (ICR) submitted to OMB: (1) Go to the web page
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
Section 54.703 states that industry and non-industry groups may submit to the Commission for approval nominations for individuals to be appointed to the USAC Board of Directors.
Sections 54.719 through 54.725 describes the procedures for Commission review of USAC decisions including the general filing
The Order the Commission adopted on May 19, 2005, sets forth rules requiring providers of VoIP services that interconnect with the nation's existing public switched telephone network (interconnected VoIP services) to supply E911 capabilities to their customers.
To ensure E911 functionality for customers of VoIP service providers the Commission requires the following information collections:
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The Commission hereby gives notice of the filing of the following agreement under the Shipping Act of 1984. Interested parties may submit comments on the agreements to the Secretary by email at
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 August 8, 2018.
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The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.
Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than August 20, 2018.
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Agency for Healthcare Research and Quality, HHS.
Notice.
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project “Medical Office Survey on Patient Safety Culture Database.”
This proposed information collection was previously published in the
Comments on this notice must be received by August 23, 2018.
Written comments should be submitted to: AHRQ's OMB Desk Officer by fax at (202) 395-6974 (attention: AHRQ's desk officer) or by email at
Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at
In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. In 1999, the Institute of Medicine called for health care organizations to develop a “culture of safety” such that their workforce and processes focus on improving the reliability and safety of care for patients (IOM, 1999;
The survey is designed to enable medical offices to assess provider and staff perspectives about patient safety issues, medical error, and error reporting. The survey includes 38 items that measure 10 composites of patient safety culture. In addition to the composite items, 14 items measure staff perceptions of how often medical offices have problems exchanging information with other settings as well as other patient safety and quality issues. AHRQ made the survey publicly available along with a Survey User's Guide and other toolkit materials in December, 2008 on the AHRQ website (located at
The AHRQ Medical Office SOPS Database consists of data from the AHRQ Medical Office Survey on Patient Safety Culture and may include reportable, non-required supplemental items. Medical offices in the U.S. can voluntarily submit data from the survey to AHRQ, through its contractor, Westat. The Medical Office SOPS Database (OMB No. 0935-0196, last approved on August 25, 2015) was developed by AHRQ in 2011 in response to requests from medical offices interested in tracking their own survey results. Those organizations submitting data receive a feedback report, as well as a report of the aggregated, de-identified findings of the other medical offices submitting data. These reports are used to assist medical office staff in their efforts to improve patient safety culture in their organizations.
This database will:
(1) Present results from medical offices that voluntarily submit their data,
(2) Provide data to medical offices to facilitate internal assessment and learning in the patient safety improvement process, and
(3) Provide supplemental information to help medical offices identify their strengths and areas with potential for improvement in patient safety culture.
This study is being conducted by AHRQ through its contractor, Westat, pursuant to AHRQ's statutory authority to conduct and support research on health care and on systems for the delivery of such care, including activities with respect to: The quality, effectiveness, efficiency, appropriateness and value of health care services; quality measurement and improvement; and database development. 42 U.S.C. 299a(a)(1), (2), and (8).
To achieve the goal of this project the following activities and data collections will be implemented:
(1)
(2)
(3)
(4)
Survey data from the AHRQ Medical Office Survey on Patient Safety Culture are used to produce three types of products:
(1) A Medical Office SOPS Database Report that is made publicly available on the AHRQ website (see Medical Office User Database Report);
(2) Individual Medical Office Survey Feedback Reports that are customized for each medical office that submits data to the database; and
(3) Research data sets of individual-level and medical office-level de-identified data to enable researchers to conduct analyses. All data released in a data set are de-identified at the individual-level and the medical office-level.
Medical offices will be invited to voluntarily submit their Medical Office SOPS survey data to the database. AHRQ's contractor, Westat, then cleans and aggregates the data to produce a PDF-formatted Database Report displaying averages, standard deviations, and percentile scores on the survey's 38 items and 10 patient safety culture composites of patient safety culture, and 14 items measuring how often medical offices have problems exchanging information with other settings and other patient safety and quality issues. The report also displays these results by medical office characteristics (size of office, specialty, geographic region, etc.) and respondent characteristics (staff position).
The Database Report includes a section on data limitations, emphasizing that the report does not reflect a representative sampling of the U.S. medical office population. Because participating medical offices will choose to voluntarily submit their data into the database and therefore are not a random or national sample of medical offices, estimates based on this self-selected group might be biased estimates. We recommend that users review the database results with these caveats in mind.
Each medical office that submits its data receives a customized survey feedback report that presents their results alongside the aggregated results from other participating medical offices.
Medical offices use the Medical Office SOPS, Database Reports, and Individual Medical Office Survey Feedback Reports for a number of purposes, to:
• Raise staff awareness about patient safety;
• Elucidate and assess the current status of patient safety culture in their medical office;
• Identify strengths and areas for patient safety culture improvement;
• Evaluate trends in patient safety culture change over time; and
• Evaluate the cultural impact of patient safety initiatives and interventions.
Exhibit 1 shows the estimated annualized burden hours for the respondents' time to participate in the database. An estimated 70 POCs, each representing an average of 35 individual medical offices each, will complete the database submission steps and forms. Each POC will submit the following:
• Eligibility and registration form (completion is estimated to take about 3 minutes).
• Data Use Agreement (completion is estimated to take about 3 minutes).
• Medical Office Information Form (completion is estimated to take about 5 minutes).
• Survey data submission will take an average of one hour.
The total burden is estimated to be 283 hours.
Exhibit 2 shows the estimated annualized cost burden based on the respondents' time to submit their data. The cost burden is estimated to be $14,880 annually.
In accordance with the Paperwork Reduction Act, comments on AHRQ's information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ's health care research and health care information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ's estimate of burden (including hours and costs) of the proposed collection(s) 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 upon the respondents, including the use of automated collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized and included in the Agency's subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record.
National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice of availability.
NIOSH announces the availability of the final
The final document was published on July 17, 2018.
The document may be obtained at the following link:
Emily Novicki, M.A., M.P.H, (
On September 27, 2017, NIOSH published a request for public review in the
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice of meeting.
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, Office of Public Health Preparedness and Response, (BSC, OPHPR). This meeting is open to the public, limited only by 1,500 web conference lines. Public participants should pre-register for the meeting as described below.
The public is welcome to view/listen to the meeting via Adobe Connect. Pre-
The meeting will be held on August 30, 2018, 2:00 p.m. to 5:00 p.m., EDT.
Web Conference.
Dometa Ouisley, Office of Science and Public Health Practice, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Mailstop D-44, Atlanta, Georgia 30333, Telephone: (404) 639-7450; Fax: (404) 471-8772; Email:
The Director, Management Analysis and Services Office, has been delegated the authority to sign
Food and Drug Administration, HHS.
Notice of public workshop.
The Food and Drug Administration (FDA) is announcing the following public workshop entitled “Regulatory Perspectives on Otic and Vestibular Toxicity: Challenges in Translating Animal Studies to Human Risk Assessment.” The purpose of the public workshop is to identify the challenges involved in the translation of toxicities from animal studies to clinical trials, to highlight potential endpoints that can be used in both nonclinical and clinical phases of drug development, and to provide a platform for engaging discussions to improve safety assessments for drugs impacting auditory and vestibular functions. This public workshop will bring together regulatory medical and toxicologist reviewers, veterinary and clinical neurologists, and experts in evaluating auditory and vestibular endpoints.
The public workshop will be held on August 21, 2018, from 9 a.m. until 12 p.m. See the
FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993. Entrance for the public workshop participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to
Deepa B. Rao, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4235, Silver Spring, MD 20993, 240-402-6544,
Although multiple drugs are known to cause hearing loss, otic and vestibular toxicities remain a neglected component in routine drug development. In drug safety evaluations, comparative clinical assessments for auditory and vestibular systems between animals and humans remain largely unexplored. The objective of this public workshop is to identify the challenges involved in the translation of toxicities from animal toxicology studies to clinical trials, to highlight potential endpoints that can be used in nonclinical and clinical phases of drug development, and to provide a platform for engaging discussions to improve safety assessments for ototoxic drugs. This public workshop will bring together regulatory medical and toxicologist reviewers, veterinary and clinical neurologists, and experts in evaluating auditory and vestibular endpoints.
A regulatory perspective of drug development and the occurrence of otic and vestibular toxicity will be presented, with a focus on the current regulatory recommendations on assessment of the auditory and vestibular systems in clinical and nonclinical studies. Relevant endpoints of vestibular and auditory function (clinical evaluation, non-invasive electrophysiological measurements, and histopathology) will be discussed from a clinical and nonclinical perspective. The public workshop will end with an open platform discussion between the audience and panelists regarding the adequacy of the current evaluation and potential future approaches towards improving safety assessments for agents impacting auditory and vestibular functions. We support the principles of the “3Rs,” to reduce, refine, and replace animal use in testing when feasible. We encourage sponsors to consult with us if it they wish to use a non-animal testing method they believe is suitable, adequate, validated, and feasible. We will consider if such an alternative method could be assessed for equivalency to an animal test method.
Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public workshop must register by August 20, 2018, midnight Eastern Time. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization.
For any participant in need of sign language interpretation, please send an email request to
If you have never attended a Connect Pro event before, test your connection at
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development.” This draft guidance describes FDA's current recommendations regarding how to optimize and standardize dietary management in clinical trials for the development of drugs treating inborn errors of metabolism (IEM) for which dietary management is a key component of patients' metabolic control. Optimizing dietary management in these patients before entry into and during the clinical trial(s) is essential to providing an accurate evaluation of the efficacy of new drug products.
Submit either electronic or written comments on the draft guidance by September 24, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
You may submit comments on any guidance at any time as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Dina Zand, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5239, Silver Spring, MD 20993, 240-402-2538; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-002, 240-402-7911.
FDA is announcing the availability of a draft guidance for industry entitled “Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development.” This draft guidance describes FDA's current recommendations regarding how to optimize and standardize dietary management in clinical trials for the development of drugs treating IEM for which dietary management is a key component of patients' metabolic control. Optimizing dietary management in these patients before entry into and during the clinical trial(s) is essential to providing an accurate evaluation of the efficacy of new drug products.
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 how sponsors can optimize and standardize dietary management for clinical trials in the development of drugs for inborn errors of metabolism that use dietary management. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.
This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 312 have been approved under OMB control number 0910-0014.
Persons with access to the internet may obtain the draft guidance at either
Food and Drug Administration, HHS.
Notice; establishment of a public docket; request for comments.
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pharmacy Compounding Advisory Committee (PCAC). The general function of the committee is to provide advice on scientific, technical, and medical issues concerning drug compounding under the Federal Food, Drug, and Cosmetic Act (FD&C Act), and, as required, any other product for which FDA has regulatory responsibility, and to make appropriate recommendations to the Agency. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
The meeting will be held on September 12, 2018, from 8 a.m. to 4:30 p.m.
FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at:
FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2018-N-2733. The docket will close on September 11, 2018. Submit either electronic or written comments on this public meeting by September 11, 2018. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before September 11, 2018. The
Comments received on or before August 28, 2018, will be provided to the committee. Comments received after that date will be taken into consideration by FDA.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• 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.” FDA 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
Jay Fajiculay, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, Fax: 301-847-8533,
One of the conditions that must be satisfied to qualify for the exemptions under section 503A of the FD&C Act is that a bulk drug substance (active pharmaceutical ingredient) used in a compounded drug product must meet one of the following criteria: (1) Complies with the standards of an applicable United States Pharmacopoeia (USP) or National Formulary monograph, if a monograph exists, and the USP chapter on pharmacy compounding; (2) if an applicable monograph does not exist, is a component of a drug approved by the Secretary of Health and Human Services (the Secretary); or (3) if such a monograph does not exist and the drug substance is not a component of a drug approved by the Secretary, appears on a list developed by the Secretary through regulations issued by the Secretary (the “503A Bulks List”) (see section 503A(b)(1)(A)(i) of the FD&C Act).
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's website after the meeting. Background material is available at
Persons attending FDA's advisory committee meetings are advised that FDA is not responsible for providing access to electrical outlets.
For press inquiries, please contact the Office of Media Affairs at
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Jay Fajiculay (see
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #257 entitled “Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Marker Residue Depletion Studies to Establish Product Withdrawal Periods in Aquatic Species” (VICH GL57). This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH draft guidance document is intended to provide study design recommendations that will facilitate the universal acceptance of the generated residue depletion data to fulfill the national/regional requirements. This draft guidance document provides recommendations on what should be included in a marker residue depletion study design for aquatic food-producing species.
Submit either electronic or written comments on the draft guidance by September 24, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
You may submit comments on any guidance at any time as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
Submit written requests for single copies of the guidance to the Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Julia Oriani, Center for Veterinary Medicine (HFV-151), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0788,
FDA is announcing the availability of a draft GFI #257 entitled “Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Marker Residue Depletion Studies to Establish Product Withdrawal Periods in Aquatic Species” (VICH GL57). In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote the international harmonization of regulatory requirements. FDA has participated in efforts to enhance harmonization and has expressed its commitment to seek scientifically based, harmonized technical procedures for the development of pharmaceutical products. One of the goals of harmonization is to identify, and then reduce, differences in technical requirements for drug development among regulatory agencies in different countries. FDA has actively participated in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use to develop harmonized technical requirements for the approval of human pharmaceutical and biological products among the European Union, Japan, and the United States. The VICH is a parallel initiative for veterinary medicinal products. The VICH is concerned with developing harmonized technical requirements for the approval of veterinary medicinal products in the European Union, Japan, and the United States, and includes input from both regulatory and industry representatives.
The VICH Steering Committee is composed of member representatives from the European Commission and European Medicines Agency, International Federation for Animal Health—Europe; FDA; the U.S. Department of Agriculture; the U.S. Animal Health Institute; the Japanese Ministry of Agriculture, Forestry, and Fisheries; and the Japanese Veterinary Products Association. Six observers are eligible to participate in the VICH Steering Committee: One representative from the government of Australia/New Zealand, one representative from the industry in Australia/New Zealand, one representative from the government of Canada, one representative from the industry in Canada, one representative from the government of South Africa, and one representative from the industry in South Africa. The VICH Secretariat, which coordinates the preparation of documentation, is provided by the International Federation for Animal Health.
The VICH Steering Committee held a meeting in November 2017 and agreed that the draft guidance document entitled “Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Marker Residue Depletion Studies to Establish Product Withdrawal Periods in Aquatic Species” (VICH GL 57) should be made available for public comment. This draft guidance document is intended to provide study design recommendations that will facilitate the universal acceptance of the generated residue depletion data to fulfill the national/regional requirements. This draft guidance document provides recommendations on what should be included in a marker residue depletion study design for aquatic food-producing species.
FDA and the VICH Expert Working Group will consider comments about the draft guidance document.
This level 1 draft guidance, developed under the VICH process, is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). For example, the document has been designated “guidance” rather than “guideline.” In addition, guidance documents do not include mandatory language such as “shall,” “must,” “require,” or “requirement,” unless FDA is using these words to describe a statutory or regulatory requirement.
The draft guidance, when finalized, will represent the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.
This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 514 have been approved under OMB control number 0910-0032.
Persons with access to the internet may obtain the draft guidance at either
Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS).
Notice.
HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
For information about requirements for filing petitions, and the Program in general, contact Lisa L. Reyes, Clerk of Court, United States Court of Federal Claims, 717 Madison Place NW, Washington, DC 20005, (202) 357-6400. For information on HRSA's role in the Program, contact the Director, National Vaccine Injury Compensation Program, 5600 Fishers Lane, Room 08N146B, Rockville, MD 20857; (301) 443-6593, or visit our website at:
The Program provides a system of no-fault compensation for certain individuals who have been injured by specified childhood vaccines. Subtitle 2 of Title XXI of the PHS Act, 42 U.S.C. 300aa-10
A petition may be filed with respect to injuries, disabilities, illnesses, conditions, and deaths resulting from vaccines described in the Vaccine Injury Table (the Table) set forth at 42 CFR 100.3. This Table lists for each covered childhood vaccine the conditions that may lead to compensation and, for each condition, the time period for occurrence of the first symptom or manifestation of onset or of significant aggravation after vaccine administration. Compensation may also be awarded for conditions not listed in the Table and for conditions that are manifested outside the time periods specified in the Table, but only if the petitioner shows that the condition was caused by one of the listed vaccines.
Section 2112(b)(2) of the PHS Act, 42 U.S.C. 300aa-12(b)(2), requires that “[w]ithin 30 days after the Secretary receives service of any petition filed under section 2111 the Secretary shall publish notice of such petition in the
Section 2112(b)(2) also provides that the special master “shall afford all interested persons an opportunity to submit relevant, written information” relating to the following:
1. The existence of evidence “that there is not a preponderance of the evidence that the illness, disability, injury, condition, or death described in the petition is due to factors unrelated to the administration of the vaccine described in the petition,” and
2. Any allegation in a petition that the petitioner either:
a. “[S]ustained, or had significantly aggravated, any illness, disability, injury, or condition not set forth in the Vaccine Injury Table but which was caused by” one of the vaccines referred to in the Table, or
b. “[S]ustained, or had significantly aggravated, any illness, disability, injury, or condition set forth in the Vaccine Injury Table the first symptom or manifestation of the onset or significant aggravation of which did not occur within the time period set forth in the Table but which was caused by a vaccine” referred to in the Table.
In accordance with Section 2112(b)(2), all interested persons may submit written information relevant to the issues described above in the case of the petitions listed below. Any person choosing to do so should file an original and three (3) copies of the information with the Clerk of the U.S. Court of Federal Claims at the address listed above (under the heading
Indian Health Service, IHS.
Request for comments; notice of Tribal Consultation and Urban Indian Confer.
The Indian Health Service (IHS) is developing an Agency-wide Strategic Plan to guide the work and strengthen partnerships with Tribes and Urban Indian Organizations. The IHS is
Comments due by August 23, 2018.
The IHS virtual town hall sessions:
1. Urban Indian Confer on August 3 2018, from 2:00 p.m.-3:30 p.m. (Eastern Time).
2. Tribal Consultation on August 6, 2018, from 2:00 p.m.-3:30 p.m. (Eastern Time).
Written comments on the Draft IHS Strategic Plan FY 2018-2022 may be provided by email, or by United States (U.S.) postal mail.
Please use “DRAFT IHS STRATEGIC PLAN FY 2018-2022” as the subject line.
CAPT Francis Frazier, Director, Office of Public Health Support, IHS, 5600 Fishers Lane, Mail Stop: 09E10D, Rockville, Maryland 20857. Telephone (301) 443-0222 (This is not a toll-free number).
The IHS participated in a strategic planning process informed by feedback received from Tribes, Urban Indian Organizations, and staff, as described in more detail below, to develop the Draft IHS Strategic Plan FY 2018-2022 for consideration. The IHS is committed to improving health care delivery services and enhancing critical public health services to strengthen the health status of American Indian and Alaska Native people throughout the health system.
The Draft IHS Strategic Plan FY 2018-2022 includes a revised IHS Mission statement, a new IHS Vision statement, and articulates how the IHS will achieve its mission through three strategic goals. The three strategic goals are: (1) To ensure that comprehensive, culturally acceptable personal and public health services are available and accessible to American Indian and Alaska Native people; (2) To promote excellence and quality through innovation of the Indian health system into an optimally performing organization; and (3) To strengthen IHS program management and operations. Each goal is supported by objectives and strategies. To review the current IHS Mission statement and priorities, please visit:
The strategic planning Consultation and Confer process is an opportunity for the IHS to further refine and strengthen the Draft IHS Strategic Plan FY 2018-2022. The IHS appreciates the invaluable feedback received to date on the Draft IHS Strategic Plan FY 2018-2022 and seeks to ensure all Agency stakeholders have the opportunity to comment. As we build on the current Draft IHS Strategic Plan FY 2018-2022, we look forward to receiving your comments by August 23, 2018.
The Urban Indian Confer on August 3, 2018, and the Tribal Consultation on August 6, 2018, will be held telephonically and by webinar. A letter will be sent to Urban Indian Organization Leaders and Tribal Leaders to notify them about details associated with conference call and webinar schedules and call-in information.
To develop the Draft IHS Strategic Plan FY 2018-2022, the IHS used a process similar to the U.S. Department of Health and Human Services (HHS) Strategic Plan FY 2018-2022, including use of goals; objectives and strategies; environmental scans; Strengths, Weaknesses, Opportunities, and Threats (SWOT) analysis; and workgroup participation. The environmental scan reviewed several IHS Areas, Headquarters Offices, and other available documents, and the SWOT exercise was conducted with IHS staff. Informed by these documents and analysis, the IHS developed an initial framework for review and comment by Tribes, Urban Indian Organizations, and IHS staff. The IHS first initiated Tribal Consultation and Urban Indian Confer on the IHS Strategic Plan initial framework on September 15, 2017, and formed an IHS Federal-Tribal Strategic Planning Workgroup (workgroup) to review all comments and recommend a list of final goals and objectives for IHS leadership review and approval.
During the initial framework comment period (September 15, 2017-October 31, 2017), the IHS held listening sessions, presented at Tribal meetings, and held conference calls with Tribal and Urban Indian Organization leaders. The workgroup membership included IHS staff at the Area, Service Unit, and Headquarters levels (including a representative from the IHS Office of Urban Indian Health Programs); Tribal leaders or their designees. The workgroup reviewed the comments received from 150 Tribes, Tribal Organizations, Urban Indian Organizations and IHS staff on the initial framework and suggested strategies during six meetings over a 3-month period, resulting in final recommendations on the IHS Mission, Vision, Goals, Objectives, and Strategies. These recommendations are the basis of the Draft IHS Strategic Plan FY 2018-2022.
Since initiating Tribal Consultation and Urban Indian Confer on the IHS Strategic Plan initial framework, the IHS has issued four letters to Tribal Leaders and Urban Indian Organization Leaders to update Tribes and Urban Indian Organizations on progress. Additionally, the IHS issued several communications stating that comments on the Draft IHS Strategic Plan FY 2018-2022 will be accepted throughout the strategic planning process. The IHS strategic planning Web site includes more information about the IHS strategic plan timeline, as well as links to the Tribal Leader letters, Urban Indian Organization Leader letters, and workgroup activities.
The IHS values all feedback and input regarding the Draft IHS Strategic Plan FY 2018-2022 and invites Tribes, Tribal Leaders, and/or their designees to Consult and Urban Indian Organization Leaders to Confer on the Draft IHS Strategic Plan FY 2018-2022. Tribal Consultation will be conducted with elected or appointed leaders of Tribal Governments and their designated representatives. Those wishing to participate in the Tribal Consultation as a designee must have a copy of a letter signed by an elected or appointed Tribal official or their designee that authorizes them to serve as the representative of the Tribe. Urban Indian Confer will be conducted with recognized representatives from Urban Indian Organizations, as defined by 25 U.S.C. 1603(29). Representatives from other Tribal Organizations and Native non-profit organizations are welcome as observers. Those wishing to be recognized representatives from Urban Indian Organizations should provide documentation that their organization meets the definition at 25 U.S.C. 1603(29) and that the selected participant has the official capacity to
The text of the Draft IHS Strategic Plan FY 2018-2022 is available at the IHS Web site at:
The Indian Health Service (IHS) provides a wide range of clinical, public health, community and facilities infrastructure services to approximately 2.2 million American Indians and Alaska Natives (AI/AN) from 573 federally recognized Tribes in 37 States. Comprehensive primary health care and disease prevention services are provided through a network of hospitals, clinics, and health stations on or near Indian reservations. These facilities are predominately located in rural and primary care settings and are managed by IHS, Tribes, and Tribal Organizations. In addition, IHS contracts with Urban Indian Organizations for health care services provided in urban centers. The Draft IHS Strategic Plan FY 2018-2022 includes the Mission statement, a new Vision statement and articulates how the IHS will achieve its mission through three strategic goals. Each goal is supported by objectives and strategies.
Mission: To raise the physical, mental, social, and spiritual health of American Indians and Alaska Natives to the highest level.
Vision: Healthy communities and quality health care systems through strong partnerships and culturally relevant practices.
Goal 1: To ensure that comprehensive, culturally acceptable personal and public health services are available and accessible to American Indian and Alaska Native people.
Goal Explanation: The Indian Health Service (IHS) provides comprehensive primary health care and public health services, which are critical to improving the health of AI/AN people. The Indian health system delivers care through health care services provided in IHS, Tribal, and Urban (I/T/U) health facilities (e.g., hospitals, clinics) and by supporting the purchase of essential health care services not available in IHS and Tribal health care facilities, known as the Purchased/Referred Care (PRC) program. Additional services include environmental health improvements as well as traditional healing to complement the medical, dental, pharmacy, laboratory, behavioral health and other primary care medical programs. Expanding access to these services in AI/AN communities is essential to improving the health status of the AI/AN population. This goal includes securing the needed workforce, strengthening collaboration with a range of public and private, Tribal, and Urban Indian providers and expanding access to quality health care services to promote the health needs of AI/AN communities.
Objective 1.1: Recruit, develop, and retain a dedicated, competent, and caring workforce.
Objective Explanation: Consistent, skilled, and well-trained leadership is essential to recruiting and retaining well-qualified health care professionals and administrative professionals. Attracting, developing, and retaining the needed staff will require streamlining hiring practices and other resources that optimize health care outcomes. Within the Indian health system, staff development through orientation, job experience, mentoring, and short and long-term training and education opportunities are essential for maintaining and expanding quality services and maintaining accreditation of facilities. Also, continuing education and training opportunities are necessary to increase employees' skill sets and knowledge to keep pace in rapidly evolving areas of medical science, prevention science, improvement science, and information technology, as well as to increase opportunities for employee career advancement and/or to maintain necessary professional credentialing and accreditation.
Strategies—The following strategies support this objective:
Health Care Recruitment and Retention:
1. Improve and innovate a process that increases recruitment and retention of talented, motivated, desirable, and competent workers, including through partnerships with Tribal communities and others.
2. Continue and expand the utilization of the IHS and Health Resources and Services Administration's National Health Service Corps scholarship and loan repayment programs, as authorized by the law, to increase health care providers at I/T/U facilities.
3. Support IHS sponsorship of fellowship slots in certain specialized leadership programs for recruitment of future physician leaders.
4. Evaluate new organizational structure options and reporting relationships to improve oversight of the Indian Health Professions program.
5. Expand the use of paraprofessionals and mid-level practitioners to increase the workforce and provide needed services.
6. Develop training programs in partnership with health professional schools and training hospitals and expand opportunities to educate and mentor Native youth interested in obtaining health science degrees.
7. Enhance and streamline IHS Human Resources infrastructure to hire well-qualified personnel.
Staff Capacity Building:
8. Strengthen the workforce to improve access to, and quality of, services.
9. Improve leadership skills, adopt a consistent leadership model, and develop mentoring programs.
10. Improve continuity processes and knowledge sharing of critical employee, administrative, and operational functions through written communications and documentation within IHS.
11. Improve workplace organizational climate with staff development addressing teamwork, communication, and equity.
12. Strengthen employee performance and responsiveness to the Agency, Tribes, and patients by improving employee orientation and opportunities for training and education, including, customer service skills.
Objective 1.2: Build, strengthen, and sustain collaborative relationships.
Objective Explanation: Collaboration fostered through an environment that values partnership is vital to expanding the types of services to improve population health outcomes that can be achieved within the health care delivery system. These relationships include those between Tribes, Urban Indian programs, communities, other government agencies, not-for-profits, universities/schools, foundations, private industry, as well as internal cooperation within the Agency and collaborative project management.
Strategies—The following strategies support this objective:
Enhancing Collaboration:
1. Collaborate with Tribes in the development of community-based health programs, including health promotion and disease prevention programs and interventions that will increase access to quality health programs.
2. Develop a community feedback system/program where community members can provide suggestions regarding services required and received.
3. Support cross collaboration and partnerships among I/T/U stakeholders.
Service Expansion:
4. Promote collaborations between IHS, other Federal agencies, Tribes, and Tribal Organizations to expand services, streamline functions and funding, and advance health care goals and initiatives.
5. Work with community partners to develop new programs responsive to local needs.
Objective 1.3: Increase access to quality health care services.
Objective Explanation: Expanded access to health care services, including individual and community health services, requires using many approaches and is critical to improving the health of AI/AN people and reducing the leading causes of death risk factors. Among the needs identified are increased prevention, specialty care, innovative use of health care providers, traditional medicine, long-term and aftercare services (which may require advancing holistic and culturally centered population health models), and expanded facilities and locations. To assess the success of these efforts, measures are needed to evaluate provider productivity, patient satisfaction, and align improvements in support operations (e.g., human resources, contracting, technology) to optimize access to quality health care services.
Strategies—The following strategies support this objective:
Health Care Service Access Expansion:
1. Develop and support a system to increase access to preventive care services and quality health care in Indian Country.
2. Develop and expand programs in locations where AI/AN people have no access to quality health care services.
3. Overcome or mitigate challenges and enhance partnerships across programs and
4. Increase access to quality community, direct/specialty, long-term care and support services, and referred health care services and identify barriers to care for Tribal communities.
5. Leverage technologies such as telemedicine and asynchronous electronic consultation systems to include a more diverse array of specialties and to expand, standardize, and increase access to health care through telemedicine.
6. Improve team effectiveness in the care setting to optimize patient flow and efficiency of care delivery.
7. Reduce health disparities in the AI/AN population.
8. Provide evidence-based specialty and preventive care that reduces the incidence of the leading causes of death for the AI/AN population.
9. Incorporate Traditional cultural practices in existing health and wellness programs, as appropriate.
10. Improve the ability to account for complexity of care for each patient to gauge provider productivity more accurately.
11. Hold staff and management accountable to outcomes and customer service through satisfaction surveys.
Facilities and Locations:
12. In consultation with Tribes, modernize health care facilities to expand access to quality health care services.
13. In consultation with Tribes, review and incorporate a resource allocation structure to ensure equity among Tribes.
14. Develop and execute a coordinated plan (including health care, environmental engineering, environmental health, and health facilities engineering services) to effectively and efficiently execute response, recovery, and mitigation to disasters and public health emergencies.
Goal 2: To promote excellence and quality through innovation of the Indian health system into an optimally performing organization.
Goal Explanation: In pursuit of high reliability health care services
Objective 2.1: Create quality improvement capability at all levels of the organization.
Objective Explanation: Ensure quality improvement is operational in all direct care, public health, administrative, and management services throughout the system. Quality improvement will be achieved at all levels of the organization including Headquarters, Area Offices, and Service Units and will be made available to Tribes, Tribal Organizations, and Urban Indian Organizations, as requested. Creating quality improvement capability at all levels will require training, resources, commitment, and consistency to assure that every employee shares a role in continuous quality improvement in all IHS operations and services. This objective will build upon current efforts of the 2016-2017 IHS Quality Framework
Strategies—The following strategies support this objective:
Quality Data:
1. Improve the quality of data collected regarding health care services and program outcomes.
2. Develop and integrate quality standards and metrics into governance, management, and operations.
3. Standardize quality metrics across the IHS and use results to share information on best practices, performance trends, and identification of emerging needs.
Continuous Quality Improvement:
4. Provide training, coaching, and mentoring to ensure continuous quality improvement and accountability of staff at all levels of the organization.
5. Evaluate training efforts and staff implementation of improvements, as appropriate.
Standards of Care:
6. Develop and provide standards of care to improve quality and efficiency of health services across IHS.
7. Adopt the Model of Improvement in all clinical, public health, and administrative activities in the Indian health system.
8. Adopt patient-centered models of care, including patient centered medical home recognition and care integration.
Objective 2.2: Provide care to better meet the health care needs of Indian communities.
Objective Explanation: Key to improving health outcomes and sustaining population health is culturally responsive health care that is patient-centered and community supported. IHS will implement culturally appropriate and effective clinical and public health tools, as appropriate, to improve and better meet the health care needs of AI/AN communities. This objective reinforces current efforts addressing culturally appropriate care and support dissemination of best practices.
Strategies—The following strategies support this objective:
Culturally Appropriate Care:
1. Strengthen culturally competent organizational efforts and reinforce implementation of culturally appropriate and effective care models and programs.
2. Promote and evaluate excellence and quality of care through innovative, culturally appropriate programs.
3. Promote the total health integration within a continuum of care that integrates acute, primary, behavioral, and preventive health care.
4. Explore environmental and social determinants of health and trauma-informed care in health care delivery. Expand best practices across the IHS.
5. Continue to develop and implement trauma-informed care models and programs.
Sharing Best Practices:
6. Work collaboratively within IHS, and among other Federal, State, Tribal programs, and Urban Indian programs to improve health care by sharing best practices.
Goal 3: To Strengthen IHS program management and operations.
Goal Explanation: This goal addresses issues of management, accountability, communication, and modernized information systems. IHS is committed to the principles of improved internal and external communication, and sound management. Assuring the availability and ongoing development of a comprehensive information technology (IT) system is essential to improving access to integrated clinical, administrative, and financial data to support individual patient care, and decision-making.
Objective 3.1: Improve communication within the organization with Tribes and other stakeholders, and with the general public.
Objective Explanation: This objective addresses the critical need to improve communication throughout the IHS, with employees and patients, with Tribes, with Urban Indian Organizations, with the many organizations working with IHS and with the general public. Most important is to assist Tribes, Urban programs, and IHS in better understanding Tribal and Urban Indian needs and IHS program needs, to encourage full participation in information exchange, and to engage Tribes and Urban programs in partnership and coalition building. This includes defining and characterizing community needs and health program needs, modifying health programs as needed, and monitoring the effectiveness of programs and program modifications.
Strategies—The following strategies support this objective:
Communication Improvements:
1. Improve communication and transparency among all employees, managers, and senior leadership.
2. Develop and define proactive communications plans for internal and external stakeholders.
3. Enhance health-related outreach and education activities to patients and families.
4. Design social media platforms that will ensure wide dissemination of information to interested and affected individuals and organizations.
Strengthened Partnership:
5. Assure quality reporting relationships between service units, Area offices, and
6. Effectively collaborate with other IHS offices (e.g., the Loan Repayment Program) and HHS Staff and Operating Divisions where missions, goals, and authorities overlap.
Objective 3.2: Secure and effectively manage the assets and resources.
Objective Explanation: This objective supports the delivery of health care through improved management of all types of assets and non-workforce resources. To elevate the health status of the AI/AN population and increase access to medical care, IHS must continue to help ensure patients understand their health care options and improve business process and efficiencies to the health care system. IHS will also increase the effectiveness of operations and reporting, while providing more assistance and infrastructure support to Areas and facilities.
Strategies—The following strategies support this objective:
Infrastructure, Capacity, and Sustainability:
1. Enhance transparency of the IHS management and accountability infrastructure to properly manage and secure assets.
2. Ensure that Federal, State, Tribal, territorial, and local Tribal health programs have the necessary infrastructure to effectively provide essential public health services.
3. Provide technical assistance to strengthen the capacity of service units and Area Offices to enhance effective management and oversight.
4. Apply economic principles and methods to assure ongoing security and sustainability of Federal, Tribal and Urban Indian facilities.
Improved Business Process:
5. Routinely review management operations to effectively improve key business management practices.
6. Optimize business functions to ensure IHS is engaged in discussions on value-based purchasing.
7. Develop policies, use tools, and apply models that ensure efficient use of assets and resources.
8. Strengthen management and operations through effective oversight.
9. Develop standardized management strategies for grants, contracts, and other funding opportunities to promote innovation and excellence in operations and outcomes.
Patient Education and Resources:
10. Strengthen patients' awareness of their health care options, including Medicaid and Medicare enrollment, which may increase access to health care and optimize third party reimbursements.
Objective 3.3: Modernize information technology and information systems to support data driven decisions.
Objective Explanation: This objective is to assure the availability and ongoing improvement of a comprehensive information technology (IT) system that meets the needs of providers, patients, and I/T/Us, including using technology to provide improved, timely access to care and to reduce the need for transit. This objective recognizes that qualified and capable IT staff and leadership are fundamental in achieving the strategies listed below and further reinforces the workforce objectives outlined elsewhere in the plan. An improved Indian health IT network increases access to integrated clinical, administrative, and financial data to support individual patient care, decision-making, and advocacy. The need for data will require the development of a system integrated with Tribal and Urban Indian programs that will address the current and projected clinical, administrative, and fiscal data needs. Timely fiscal data dissemination to all Federal partners when developing budgets is necessary to accurately address health care needs of Indian communities. Data quality (i.e., accuracy, reliability, and validity) and quality patient care will continue to play a highly visible role both within and outside the IHS. Data quality is only partially dependent upon technology. Improved data quality also reflects other sustained initiatives, such as accuracy of data entry, legibility of handwriting, appropriate and timely data exports, and accuracy of coding.
Strategies—The following strategies support this objective:
Health Information Technology (HIT):
1. Evaluate electronic health record needs of the IHS and the ability for the health information systems to meet those needs, create seamless data linkages, and meet data access needs for Tribes and Tribal program health information systems.
2. Develop a consistent, robust, stable, secure, state-of-the-art HIT system to support clinicians workflow, improve data collection, and provide regular and ongoing data analysis.
3. Modernize the HIT system for IHS Resource and Patient Management System (RPMS) or commercial off-the-shelf packages.
4. Align with universal patient record systems to link off-reservation care systems that serve AI/AN.
5. Enhance and expand technology such as the IHS telecom to provide access for consultative care, stabilization of care, decreased transportation, and timeliness of care at any IHS-funded health program.
Data Process:
6. Provide available data to inform decision making for internal and external stakeholders.
7. Act upon performance data and standardize data and reporting requirements.
8. Assure system of data sharing to solidify partnerships with Tribal Epidemiology Centers and other Tribal programs.
9. Establish capability for data federation
This draft plan is developed for public consideration, it is intended to improve the management and administration of the IHS and strategic direction of the Agency over the next 5 years, and it is not intended to create any right, benefit, or legal responsibility, substantive or procedural, enforceable at law by a party against the United States, its agencies, or any person.
The IHS will publish an additional
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 grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The 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, HHS.
Notice.
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.
Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs,
To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Dr. Kristianna Pettibone, Evaluator, Program Analysis Branch, NIEHS, NIH, 530 Davis Dr., Room 3064, Morrisville, NC 20560, or call non-toll-free number 984-287-3303 or Email your request, including your address to:
This proposed information collection was previously published in the
The National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
Information gained from this primary data collection will be used in conjunction with data from grantee progress reports and presentations at grantee meetings to inform internal programs and new funding initiatives. Outcome information to be collected includes measures of agency-funded research resulting in dissemination of findings, investigator career development, grant-funded knowledge and products, commercial products and drugs, laws, regulations and standards, guidelines and recommendations, information on patents and new drug applications and community outreach and public awareness relevant to extramural research funding and emerging areas of research. Satisfaction information to be collected includes measures of satisfaction with the type of funding or program management mechanism used, challenges and benefits with the program support received, and gaps in the research.
•
• National Institute on Deafness and Other Communication Disorders (NIDCD);
• National Institute of Mental Health (NIMH);
• National Institute of Neurological Disorders and Stroke (NINDS);
• National Institute of Environmental Health Sciences (NIEHS);
• National Cancer Institute (NCI); and
• Environmental Protection Agency (EPA).
OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 800.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
U.S. Customs and Border Protection (CBP), Department of Homeland Security.
30-Day notice and request for comments; extension of an existing collection of information.
The Department of Homeland Security, U.S. Customs and Border Protection will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). The
Interested persons are invited to submit written comments on this proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget. Comments should be addressed to the OMB Desk Officer for Customs and Border Protection, Department of Homeland Security, and sent via electronic mail to
Requests for additional PRA information should be directed to Seth Renkema, Chief, Economic Impact Analysis Branch, U.S. Customs and Border Protection, Office of Trade, Regulations and Rulings, 90 K Street NE, 10th Floor, Washington, DC 20229-1177, Telephone number (202) 325-0056 or via email
CBP invites the general public and other Federal agencies to comment on the proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
CBP Forms 3461 and 3461 ALT are provided for by 19 CFR 141 and 142. These forms and instructions for Form 3461 are accessible at:
ACE Cargo Release is a program for ACE entry summary filers in which importers or brokers may file Simplified Entry data in lieu of filing the CBP Form 3461. This data consists of 12 required elements: Importer of record; buyer name and address; buyer employer identification number (consignee number), seller name and address; manufacturer/supplier name and address; Harmonized Tariff Schedule 10-digit number; country of origin; bill of lading; house air waybill number; bill of lading issuer code; entry number; entry type; and estimated shipment value. Three optional data elements are the container stuffing location; consolidator name and address, and ship to party name and address. The data collected under the ACE Cargo Release program is intended to reduce transaction costs, expedite cargo release, and enhance cargo security. ACE Cargo Release filing minimizes the redundancy of data submitted by the filer to CBP through receiving carrier data from the carrier. This design allows the participants to file earlier in the transportation flow. Guidance on using ACE Cargo Release may be found at
ACE Cargo Release to include electronic submission for 3461/3461ALT:
U.S. Geological Survey, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, we, the U.S. Geological Survey (USGS) are proposing to renew an information collection.
Interested persons are invited to submit comments on or before August 23, 2018.
Send written comments on this information collection request (ICR) to the Office of Management and Budget's Desk Officer for the Department of the Interior by email at
To request additional information about this ICR, contact Daryll Pope by email at
We, the USGS, in accordance with the Paperwork Reduction Act of 1995, provide the general public and other Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.
A
We are again soliciting comments on the proposed ICR that is described below. We are especially interested in public comment addressing the following issues: (1) Is the collection necessary to the proper functions of the USGS; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the USGS enhance the quality, utility, and clarity of the information to be collected; and (5) how might the USGS minimize the burden of this collection on the respondents, including through the use of information technology.
Comments that you submit in response to this notice are a matter of public record. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you may ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501,
Bureau of Indian Affairs (BIA), Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, we, the BIA Indian Highway Safety Program (IHSP) are proposing a new information collection.
Interested persons are invited to submit comments on or before August 23, 2018.
Send written comments on this information collection request (ICR) to the Office of Management and Budget's Desk Officer for the Department of the Interior by email at
To request additional information about this ICR, contact Indian Highway Program Director L.G. Robertson, 1001 Indian School Road NW, Albuquerque NM, 87104 by email at
In accordance with the Paperwork Reduction Act of 1995, we provide the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.
A
We are again soliciting comments on the proposed ICR that is described below. We are especially interested in public comment addressing the following issues: (1) Is the collection necessary to the proper functions of the BIA IHSP; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the BIA IHSP enhance the quality, utility, and clarity of the information to be collected; and (5) how might the BIA IHSP minimize the burden of this collection on the respondents, including through the use of information technology.
Comments that you submit in response to this notice are a matter of public record. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
National Park Service, Interior.
Request for nominations.
The National Park Service (NPS), U.S. Department of the Interior is requesting nominations for qualified persons to serve as members on the Committee.
Nominations should be received by August 23, 2018.
Nominations should be sent to Robie Lange, U.S. Department of the Interior, National Park Service, National Historic Landmarks Program, 1849 C Street NW, MS 2280, Washington, DC 20240-0001, or email
Robie Lange, U.S. Department of the Interior, National Park Service, National Historic Landmarks Program, 1849 C Street NW, MS 2280, Washington, DC 20240-0001, or via email at
The Cold War Advisory Committee was established by Title VII, Subtitle C, Section 7210(c) of Public Law 111-11, the Omnibus Public Land Management Act of 2009, March 30, 2009 (16 U.S.C. 1a-5 note). The purpose of the Committee is to assist the Secretary of the Interior in the preparation of a national historic landmark theme study to identify sites and resources significant to the Cold War.
The Committee will be composed of nine members, to be appointed by the Secretary, of whom: (1) Three shall have expertise in Cold War history; (2) two shall have expertise in historic preservation; (3) one shall have expertise in the history of the United States; and (4) three shall represent the general public.
We are currently seeking members to represent all categories.
Nominations should be typed and should include a resume providing an adequate description of the nominee's qualifications, including information that would enable the Department of the Interior to make an informed decision regarding meeting the membership requirements of the Committee and permit the Department to contact a potential member. All documentation, including letters of recommendation,
Members of the Committee may serve as special Government employees and be required on an annual basis to complete ethics training and file a Confidential Financial Disclosure Report. Members of the Committee serve without compensation. However, while away from their homes or regular places of business in the performance of services for the Committee as approved by the NPS, members may be allowed travel expenses, including per diem in lieu of subsistence, in the same manner as persons employed intermittently in Government service are allowed such expenses under section 5703 of title 5 of the United States Code.
16 U.S.C. 1a-5 note.
United States International Trade Commission.
July 31, 2018 at 9:30 a.m.
Room 101, 500 E Street SW, Washington, DC 20436, Telephone: (202) 205-2000.
Open to the public.
1. Agendas for future meetings: None.
2. Minutes.
3. Ratification List.
4. Vote on Inv. Nos. 701-TA-489 and 731-TA-1201 (Review) (Drawn Stainless Steel Sinks from China). The Commission is currently scheduled to complete and file its determinations and views of the Commission by August 13, 2018.
5. Outstanding action jackets: None.
In accordance with Commission policy, subject matter listed above, not disposed of at the scheduled meeting, may be carried over to the agenda of the following meeting.
By order of the Commission.
Occupational Safety and Health Administration (OSHA), Labor.
Notice.
In this notice, OSHA announces the application of TUV SUD America, Inc., for expansion of its recognition as a Nationally Recognized Testing Laboratory (NRTL) and presents the agency's preliminary finding to grant the application.
Submit comments, information, and documents in response to this notice, or requests for an extension of time to make a submission, on or before August 8, 2018.
Submit comments by any of the following methods:
Information regarding this notice is available from the following sources:
The Occupational Safety and Health Administration is providing notice that TUV SUD America, Inc. (TUVAM), is applying for expansion of its current recognition as a NRTL. TUVAM requests the addition of two test standards to its NRTL scope of recognition.
OSHA recognition of a NRTL signifies that the organization meets the requirements specified in 29 CFR 1910.7. Recognition is an acknowledgment that the organization can perform independent safety testing and certification of the specific products covered within its scope of recognition. Each NRTL's scope of recognition includes (1) the type of products the NRTL may test, with each type specified by its applicable test standard; and (2) the recognized site(s) that has/have the technical capability to perform the product-testing and product-certification activities for test standards within the NRTL's scope. Recognition is not a delegation or grant of government authority; however, recognition enables employers to use products approved by the NRTL to meet OSHA standards that require product testing and certification.
The Agency processes applications by a NRTL for initial recognition and for an expansion or renewal of this recognition, following requirements in Appendix A of 29 CFR 1910.7. This appendix requires that the Agency publish two notices in the
TUVAM currently has six facilities (sites) recognized by OSHA for product testing and certification, with its headquarters located at: TUV SUD America, Inc., 10 Technology Drive, Peabody, MA 01960. A complete list of TUVAM's scope of recognition (including sites) recognized by OSHA is available at
TUVAM submitted an application, dated June 12, 2017 (OSHA-2007-0043-0023), to expand its recognition to include two additional test standards. OSHA staff performed a detailed analysis of the application packet and reviewed other pertinent information. OSHA did not perform any on-site reviews in relation to this application.
Table 1 below lists the appropriate test standards found in TUVAM's application for expansion for testing and certification of products under the NRTL Program.
TUVAM submitted an acceptable application for expansion of its scope of recognition. OSHA's review of the application file, and pertinent documentation, indicates that TUVAM can meet the requirements prescribed by 29 CFR 1910.7 for expanding its recognition to include the addition of these two test standards for NRTL testing and certification listed above. This preliminary finding does not constitute an interim or temporary approval of TUVAM's application.
OSHA welcomes public comment as to whether TUVAM meets the requirements of 29 CFR 1910.7 for expansion of its recognition as a NRTL. Comments should consist of pertinent written documents and exhibits. Commenters needing more time to comment must submit a request in writing, stating the reasons for the request. Commenters must submit the written request for an extension by the due date for comments. OSHA will limit any extension to 10 days unless the requester justifies a longer period. OSHA may deny a request for an extension if the request is not adequately justified. To obtain or review copies of the exhibits identified in this notice, as well as comments submitted to the docket, contact the Docket Office, at the above address. These materials also are available online at
OSHA staff will review all comments to the docket submitted in a timely manner and, after addressing the issues raised by these comments, will make a recommendation to the Assistant Secretary for Occupational Safety and Health whether to grant TUVAM's application for expansion of its scope of recognition. The Assistant Secretary will make the final decision on granting the application. In making this decision, the Assistant Secretary may undertake other proceedings prescribed in Appendix A to 29 CFR 1910.7.
OSHA will publish a public notice of its final decision in the
Loren Sweatt, Deputy Assistant Secretary of Labor for Occupational Safety and Health, authorized the preparation of this notice. Accordingly, the Agency is issuing this notice pursuant to 29 U.S.C. 657(g)(2), Secretary of Labor's Order No. 1-2012 (77 FR 3912, Jan. 25, 2012), and 29 CFR 1910.7.
Occupational Safety and Health Administration (OSHA), Labor.
Notice.
In this notice, OSHA proposes to delete three test standards from the NRTL Program's list of appropriate test standards; and update the scopes of recognition of several NRTLs.
Submit comments, information, and documents in response to this notice, or requests for an extension of time to make a submission, on or before August 23, 2018. All submissions must bear a postmark or provide other evidence of the submission date.
Information regarding this notice is available from the following sources:
The NRTL Program recognizes organizations that provide product safety testing and certification services to manufacturers. These organizations perform testing and certification, for purposes of the Program, to U.S. consensus-based product safety test standards. The products covered by the NRTL Program consist of those items for which OSHA safety standards require “certification” by a NRTL. The requirements affect electrical products and 38 other types of products. OSHA does not develop or issue these test standards, but generally relies on standards development organizations (SDOs) which develop and maintain the standards using a method that provides input and consideration of views of industry groups, experts, users, consumers, governmental authorities and others having broad experience in the safety field involved.
OSHA may propose to remove a test standard from the NRTL list of appropriate test standards based on an internal review in which NRTL Program staff review the NRTL list of appropriate test standards to determine if the test standard conforms to the definition of appropriate test standard defined in NRTL Program regulations and policy. There are several reasons for removing a test standard based on the internal review by NRTL Program staff. First, a document that provides the methodology for a single test is a test method rather than an appropriate test standard. A test standard must specify the safety requirements for a specific type of product(s) (29 CFR 1910.7(c)). A test method, however, is a “specified technical procedure for performing a test” (CPL 1-0.3, App. B). As such, a test method is not an appropriate test standard. While a NRTL may use a test method to determine if certain safety requirements are met, a test method is not itself a safety requirement for a specific product category.
Second, a document that focuses primarily on usage, installation, or maintenance requirements would also not be considered an appropriate test standard (CPL 1-0.3, App. D.IV.B). In some cases, however, a document may also provide safety test specifications in addition to usage, installation, and maintenance requirements. In such cases, the document would be retained as an appropriate test standard based on the safety test specifications.
Finally, a document may not be considered an appropriate test standard if the document covers products for which OSHA does not require testing and certification (CPL 1-0.3, App. D.IV.A).
Similarly, a document that covers electrical product components would not be considered an appropriate test standard. These documents apply to types of components that have limitation(s) or condition(s) on their use, in that they are not appropriate for use as end-use products. These documents also specify that these types of components are for use only as part of an end-use product. NRTLs, however, evaluate such components only in the context of evaluating whether end-use products requiring NRTL approval are safe for use in the workplace. Testing such components alone would not indicate that the end-use products containing the components are safe for use. Accordingly, as a matter of policy, OSHA considers that documents covering such components are not appropriate test standards under the NRTL Program. OSHA notes, however, that it is not proposing to delete from NRTLs' scopes of recognition any test standards covering end-use products that contain such components.
OSHA may additionally propose to remove a test standard from the NRTL list of appropriate test standards if it has been withdrawn by a SDO. However, OSHA will recognize a NRTL for an appropriate replacement test standard if the NRTL has the requisite testing and evaluation capability for implementing the replacement test standard, and the replacement standard does not require an additional or different technical capability than an existing test standard. OSHA can add the replacement test standard to affected NRTLs' scopes of recognition.
In this notice, OSHA proposes to delete three test standards from the
Table 1 lists the test standards that OSHA proposes to delete from the NRTL Program's list of appropriate test standards, as well as an abbreviated rationale for OSHA's proposed actions. For a full discussion of the rationale, see, above, Section I of this notice.
In this notice, OSHA proposes to update the scopes of recognition of several NRTLs. The tables in this section (Table 2 thru Table 5) list, for each affected NRTL, the test standard(s) that OSHA proposes to delete from the scope of recognition of the NRTL and the proposed appropriate replacement test standard. OSHA's analysis shows that the proposed replacement standards do not require additional or different technical capability than the proposed deleted standards so that the proposed replacement standards are comparable to the proposed deleted standards. These proposed replacement standards are already on the NRTL List of Appropriate Test Standards.
OSHA seeks comment on whether its proposed deletions are appropriate, and whether individual tables omit any appropriate replacement test standard that is comparable to a withdrawn test standard. If OSHA determines any appropriate replacement test standard that is comparable to a withdrawn test standard was omitted, then the final determination will incorporate that replacement test standard into the scope of recognition of each affected NRTL.
Comments should consist of pertinent written documents and exhibits. Commenters needing more time to comment must submit a request in writing, stating the reasons for the request, by the due date for comments. OSHA will limit any extension to 10 days unless the requester justifies a longer time period. OSHA may deny a request for an extension if it is not adequately justified.
To obtain or review copies of comments submitted to the docket, contact the Docket Office, Occupational Safety and Health Administration, U.S. Department of Labor, at the above address. These materials will also be available online at
OSHA staff will review all comments to the docket submitted in a timely manner and, after addressing the issues raised by these comments, will make a recommendation to the Assistant Secretary for Occupational Safety and Health regarding the removal of three test standards from the NRTL Program's List of Appropriate Test Standards and to update the scopes of recognition of several NRTLs. The Assistant Secretary will make the final decision. In making this decision, the Assistant Secretary may undertake other proceedings prescribed in Appendix A to 29 CFR 1910.7. OSHA will publish a public notice of this final decision in the
Loren Sweatt, Deputy Assistant Secretary of Labor for Occupational Safety and Health, authorized the preparation of this notice. Accordingly, the Agency is issuing this notice pursuant to 29 U.S.C. 657(g)(2)), Secretary of Labor's Order No. 1-2012 (77 FR 3912, Jan. 25, 2012), and 29 CFR 1910.7.
Occupational Safety and Health Administration (OSHA), Labor.
Notice.
In this notice, OSHA announces the application of MET Laboratories, Inc., for expansion of its recognition as a Nationally Recognized Testing Laboratory (NRTL) and presents the Agency's preliminary finding to grant the application. Additionally, OSHA proposes to add one new test standard to the NRTL Program's List of Appropriate Test Standards.
Submit comments, information, and documents in response to this notice, or requests for an extension of time to make a submission, on or before August 8, 2018.
Submit comments by any of the following methods:
Information regarding this notice is available from the following sources:
The Occupational Safety and Health Administration is providing notice that MET Laboratories, Inc. (MET), is applying for expansion of its current recognition as a NRTL. MET requests the addition of one test standard to its NRTL scope of recognition.
OSHA recognition of a NRTL signifies that the organization meets the requirements specified in 29 CFR 1910.7. Recognition is an acknowledgment that the organization can perform independent safety testing and certification of the specific products covered within its scope of recognition. Each NRTL's scope of recognition includes (1) the type of products the NRTL may test, with each type specified by its applicable test standard; and (2) the recognized site(s) that has/have the technical capability to perform the product-testing and product-certification activities for test standards within the NRTL's scope. Recognition is not a delegation or grant of government authority; however, recognition enables employers to use products approved by the NRTL to meet OSHA standards that require product testing and certification.
The Agency processes applications by a NRTL for initial recognition and for an expansion or renewal of this recognition, following requirements in Appendix A to 29 CFR 1910.7. This appendix requires that the Agency publish two notices in the
MET currently has one facility (site) recognized by OSHA for product testing and certification, with its headquarters located at: MET Laboratories, Inc., 914 West Patapsco Avenue, Baltimore, Maryland 21230. A complete list of MET's scope of recognition is available at
MET submitted an application, dated January 29, 2016 (OSHA-2006-0028-0046), to expand its recognition to include one additional test standard. OSHA staff performed a detailed analysis of the application packet and reviewed other pertinent information. OSHA did not perform any on-site reviews in relation to this application.
Table 1, below, lists the appropriate test standard found in MET's application for expansion for testing and certification of products under the NRTL Program.
Periodically, OSHA will propose to add new test standards to the NRTL list of appropriate test standards following an evaluation of the test standard document. To qualify as an appropriate test standard, the Agency evaluates the document to (1) verify it represents a product category for which OSHA requires certification by a NRTL, (2) verify the document represents an end product and not a component, and (3) verify the document defines safety test specifications (not installation or operational performance specifications). OSHA becomes aware of new test standards through various avenues. For example, OSHA may become aware of new test standards by: (1) Monitoring notifications issued by certain Standards Development Organizations; (2) reviewing applications by NRTLs or applicants seeking recognition to include new test standards in their scopes of recognition; and (3) obtaining notification from manufacturers, manufacturing organizations, government agencies, or other parties. OSHA may determine to include a new test standard in the list, for example, if the test standard is for a particular type of product that another test standard also covers or it covers a type of product that no standard previously covered.
In this notice, OSHA proposes to add one new test standard to the NRTL Program's List of Appropriate Test Standards. Table 2, below, lists the test standard that is new to the NRTL Program. OSHA preliminarily determined that this test standard is an appropriate test standard and proposes to include it in the NRTL Program's List of Appropriate Test Standards. OSHA seeks public comment on this preliminary determination.
MET submitted an acceptable application for expansion of its scope of recognition. OSHA's review of the application file, and pertinent documentation, indicate that MET can meet the requirements prescribed by 29 CFR 1910.7 for expanding its recognition to include the addition of this one test standard for NRTL testing and certification listed in Table 2. This preliminary finding does not constitute an interim or temporary approval of MET's application.
OSHA welcomes public comment as to whether MET meets the requirements of 29 CFR 1910.7 for expansion of its recognition as a NRTL. Comments should consist of pertinent written documents and exhibits. Commenters needing more time to comment must submit a request in writing, stating the reasons for the request. Commenters must submit the written request for an extension by the due date for comments. OSHA will limit any extension to 10 days unless the requester justifies a longer period. OSHA may deny a request for an extension if the request is not adequately justified. To obtain or review copies of the exhibits identified in this notice, as well as comments submitted to the docket, contact the Docket Office, at the above address. These materials also are available online at
OSHA staff will review all comments to the docket submitted in a timely manner and, after addressing the issues
OSHA will publish a public notice of its final decision in the
Loren Sweatt, Deputy Assistant Secretary of Labor for Occupational Safety and Health, authorized the preparation of this notice. Accordingly, the Agency is issuing this notice pursuant to 29 U.S.C. 657(g)(2), Secretary of Labor's Order No. 1-2012 (77 FR 3912, Jan. 25, 2012), and 29 CFR 1910.7.
National Aeronautics and Space Administration (NASA).
Notice of meeting.
In accordance with the Federal Advisory Committee Act, as amended, and the President's 2004 U.S. Space-Based Positioning, Navigation, and Timing (PNT) Policy, the National Aeronautics and Space Administration (NASA) announces an intersession meeting of the National Space-Based Positioning, Navigation and Timing (PNT) Advisory Board. The meeting will be held via teleconference and WebEx.
Monday, August 6, 2018, 12:00 p.m. to 4:00 p.m., Eastern Time.
Mr. James J. Miller, Designated Federal Officer, Human Exploration and Operations Mission Directorate, NASA Headquarters, Washington, DC 20546, (202) 358-4417, fax (202) 358-4297, or
This meeting will be open to the public telephonically and by WebEx. Any interested person may call the USA toll free conference call number at 1-844-467-4685 or the USA local toll number at 1-720-259-7012 passcode: 106724 to participate in this meeting by telephone. The WebEx link is
National Credit Union Administration (NCUA).
Notice and request for comment.
The National Credit Union Administration (NCUA), as part of a continuing effort to reduce paperwork and respondent burden, invites the general public and other federal agencies to take this opportunity to comment on the following extensions of a currently approved information collections, as required by the Paperwork Reduction Act of 1995.
Written comments should be received on or before September 24, 2018 to be assured consideration.
Send comments regarding the burden estimates, or any other aspect of the information collection, including suggestions for reducing the burden to Dawn Wolfgang, National Credit Union Administration, 1775 Duke Street, Suite 5080, Alexandria, Virginia 22314; Fax No. 703-519-8572; or Email at
Requests for additional information should be directed to the address above or telephone 703-548-2279.
By Gerard Poliquin, Secretary of the Board, the National Credit Union Administration, on July 19, 2018.
Nuclear Regulatory Commission.
Exemption and combined license amendment; issuance.
The U.S. Nuclear Regulatory Commission (NRC) is granting an exemption to allow a departure from the certification information of Tier 1 of the generic design control document (DCD) and is issuing License Amendment Nos. 128 and 127 to Combined License (COL) Nos. NPF-91 and NPF-92, respectively. The COLs were issued to Southern Nuclear Operating Company, Inc., and Georgia Power Company, Oglethorpe Power Corporation, MEAG Power SPVM, LLC, MEAG Power SPVJ, LLC, MEAG Power SPVP, LLC, and the City of Dalton, Georgia (the licensee); for construction and operation of the Vogtle Electric Generating Plant (VEGP) Units 3 and 4, located in Burke County, Georgia.
The granting of the exemption allows the changes to Tier 1 information asked for in the amendment. Because the acceptability of the exemption was determined in part by the acceptability of the amendment, the exemption and amendment are being issued concurrently.
The exemption and amendment were issued on June 27, 2018.
Please refer to Docket ID NRC-2008-0252 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document using any of the following methods:
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Chandu Patel, Office of New Reactors, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-3025; email:
The NRC is granting an exemption from paragraph B of section III, “Scope and Contents,” of appendix D, “Design Certification Rule for the AP1000,” to part 52 of title 10 of the
Part of the justification for granting the exemption was provided by the review of the amendment. Because the exemption is necessary in order to issue the requested license amendment, the NRC granted the exemption and issued the amendment concurrently, rather than in sequence. This included issuing a combined safety evaluation containing the NRC staff's review of both the exemption request and the license amendment. The exemption met all applicable regulatory criteria set forth in sections 50.12, 52.7, and section VIII.A.4 of appendix D to 10 CFR part 52. The license amendment was found to be acceptable as well. The combined safety evaluation is available in ADAMS under Accession No. ML18138A252.
Identical exemption documents (except for referenced unit numbers and license numbers) were issued to the licensee for VEGP Units 3 and 4 (COL Nos. NPF-91 and NPF-92). The exemption documents for VEGP Units 3 and 4 can be found in ADAMS under Accession Nos. ML18138A246 and ML18138A247, respectively. The exemption is reproduced (with the exception of abbreviated titles and additional citations) in Section II of this document. The amendment documents for COL Nos. NPF-91 and NPF-92 are available in ADAMS under Accession Nos. ML18138A248 and ML18138A250, respectively. A summary of the amendment documents is provided in Section III of this document.
Reproduced below is the exemption document issued to VEGP Units 3 and Unit 4. It makes reference to the combined safety evaluation that provides the reasoning for the findings made by the NRC (and listed under Item 1) in order to grant the exemption:
1. In a letter dated December 15, 2017, as supplemented by letter dated April 6, 2018, the Southern Nuclear Operating Company (SNC) requested from the Commission an exemption to allow departures from Tier 1 information in the certified DCD incorporated by reference in 10 CFR part 52, Appendix D, as part of license amendment request 17-040, “Consistency and Clarification Changes to Annex Building, Auxiliary Building and Basemat ITAAC.”
For the reasons set forth in Section 3.2 of the NRC staff's Safety Evaluation, which can be found in ADAMS under Accession No. ML18138A252, the Commission finds that:
A. The exemption is authorized by law;
B. the exemption presents no undue risk to public health and safety;
C. the exemption is consistent with the common defense and security;
D. special circumstances are present in that the application of the rule in this circumstance is not necessary to serve the underlying purpose of the rule;
E. the special circumstances outweigh any decrease in safety that may result from the reduction in standardization caused by the exemption; and
F. the exemption will not result in a significant decrease in the level of safety otherwise provided by the design.
2. Accordingly, SNC is granted an exemption from the certified DCD Tier 1 information, with corresponding changes to Appendix C of the Facility Combined License, as described in the licensee's request dated December 15, 2017, as supplemented by letter dated April 6, 2018. This exemption is related to, and necessary for the granting of License Amendment No. 128 (Unit 3) and No. 127 (Unit 4), which is being issued concurrently with this exemption.
3. As explained in Section 5.0 of the NRC staff's Safety Evaluation (ADAMS Accession No. ML18138A252), this exemption meets the eligibility criteria for categorical exclusion set forth in 10 CFR 51.22(c)(9). Therefore, pursuant to 10 CFR 51.22(b), no environmental impact statement or environmental assessment needs to be prepared in connection with the issuance of the exemption.
4. This exemption is effective as of the date of its issuance.
By letter dated December 15, 2017 (ADAMS Accession No. ML17349A924), as supplemented by letter dated April 6, 2018 (ADAMS Accession No. ML18096A718), the licensee requested that the NRC amend the COLs for VEGP, Units 3 and 4, COL Nos. NPF-91 and NPF-92. The proposed amendment is described in Section I of this
The Commission has determined for these amendments that the application complies with the standards and requirements of the Atomic Energy Act of 1954, as amended (the Act), and the Commission's rules and regulations. The Commission has made appropriate findings as required by the Act and the Commission's rules and regulations in 10 CFR chapter I, which are set forth in the license amendment.
A notice of consideration of issuance of amendment to facility operating license or COL, as applicable, proposed no significant hazards consideration determination, and opportunity for a hearing in connection with these actions, was published in the
The Commission has determined that these amendments satisfy the criteria for categorical exclusion in accordance with 10 CFR 51.22. Therefore, pursuant to 10 CFR 51.22(b), no environmental impact statement or environmental assessment need be prepared for these amendments.
Using the reasons set forth in the combined safety evaluation, the staff granted the exemptions and issued the amendments that the licensee requested on December 15, 2017, as supplemented by letter dated April 6, 2018.
The exemptions and amendments were issued on June 27, 2018, as part of a combined package to the licensee (ADAMS Accession No. ML18138A244).
For the Nuclear Regulatory Commission.
Pension Benefit Guaranty Corporation.
Notice of intention to request extension of OMB approval.
The Pension Benefit Guaranty Corporation (PBGC) intends to request that the Office of Management and Budget (OMB) extend approval, under the Paperwork Reduction Act, of collections of information under PBGC's regulation on Reportable Events and Certain Other Notification Requirements (OMB control numbers 1212-0013 and 1212-0041, expiring November 30, 2018) with modifications. This notice solicits public comment.
Comments must be submitted by September 24, 2018 to be assured of consideration.
Comments may be submitted by any of the following methods:
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All submissions received must include the agency's name (Pension Benefit Guaranty Corporation, or PBGC) and refer to the OMB control number(s) they relate to. All comments received will be posted without change to PBGC's website,
Copies of the collections of information and comments may be obtained without charge by writing to Disclosure Division, Office of the General Counsel, Pension Benefit Guaranty Corporation, 1200 K Street NW, Washington, DC 20005-4026; faxing a request to 202-326-4042; or calling 202-326-4040 during normal business hours. (TTY users may call the Federal relay service toll-free at 1-800-877-8339 and ask to be connected to 202-326-4040.) The reportable events regulation, forms, and instructions are available at
Stephanie Cibinic, Deputy Assistant General Counsel for Regulatory Affairs (
Section 4043 of the Employee Retirement Income Security Act of 1974 (ERISA) requires plan administrators and plan sponsors to report certain plan and employer events to PBGC. The reporting requirements give PBGC notice of events that indicate plan or employer financial problems. PBGC uses the information provided in determining what, if any, action it needs to take. For example, PBGC might need to institute proceedings to terminate a plan (placing it in trusteeship) under section 4042 of ERISA to ensure the continued payment of benefits to plan participants and their beneficiaries or to prevent unreasonable increases in PBGC's losses.
The provisions of section 4043 of ERISA have been implemented in PBGC's regulation on Reportable Events and Certain Other Notification Requirements (29 CFR part 4043). Subparts B and C of the regulation deal with reportable events.
PBGC has issued Forms 10 and 10-Advance and related instructions under subparts B and C (approved under OMB control number 1212-0013). OMB approval of this collection of information expires November 30, 2018. PBGC intends to request that OMB extend its approval for three years, with modifications. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
PBGC estimates that it will receive 590 reportable event notices per year under subparts B and C of the reportable events regulation using Forms 10 and 10-Advance and that the average annual burden of this collection of information is 1,770 hours and $439,500.
Section 303(k) of the Employee Retirement Income Security Act of 1974 (ERISA) and section 430(k) of the Internal Revenue Code of 1986 (Code) impose a lien in favor of an underfunded single-employer plan that is covered by PBGC's termination insurance program if (1) any person fails to make a required payment when due, and (2) the unpaid balance of that payment (including interest), when added to the aggregate unpaid balance of all preceding payments for which payment was not made when due (including interest), exceeds $1 million. (For this purpose, a plan is underfunded if its funding target attainment percentage is less than 100 percent.) The lien is upon all property and rights to property belonging to the person or persons that are liable for required contributions (
Only PBGC (or, at its direction, the plan's contributing sponsor or a member of the same controlled group) may perfect and enforce this lien. ERISA and the Code require persons that fail to make payments to notify PBGC within 10 days of the due date whenever there is a failure to make a required payment and the total of the unpaid balances (including interest) exceeds $1 million.
PBGC Form 200, Notice of Failure to Make Required Contributions, and related instructions implement the statutory notification requirement. Submission of Form 200 is required by 29 CFR 4043.81 (Subpart D of PBGC's regulation on Reportable Events and Other Notification Requirements, 29 CFR part 4043).
OMB has approved this collection of information under OMB control number 1212-0041, which expires November 30, 2018. PBGC intends to request that OMB extend its approval for three years, with modifications. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
PBGC estimates that it will receive 100 Form 200 filings per year and that the average annual burden of this collection of information is 100 hours and $72,500.
PBGC is soliciting public comments to—
• evaluate whether the proposed collections of information are necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• evaluate the accuracy of the agency's estimate of the burden of the proposed collections of information, including the validity of the methodologies and assumptions used;
• enhance the quality, utility, and clarity of the information to be collected; and
• minimize the burden of the collections of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
In accordance with the requirement of Section 3506 (c)(2)(A) of the Paperwork Reduction Act of 1995 which provides opportunity for public comment on new or revised data collections, the Railroad Retirement Board (RRB) will publish periodic summaries of proposed data collections.
1.
Section 2 of the Railroad Retirement Act (RRA), provides for the payment of an annuity to the spouse or divorced spouse of a retired railroad employee. For the spouse or divorced spouse to qualify for an annuity, the RRB must determine if any of the employee's current marriage to the applicant is valid.
The requirements for obtaining documentary evidence to determine valid marital relationships are prescribed in 20 CFR 219.30 through 219.35. Section 2(e) of the RRA requires that an employee must relinquish all rights to any railroad employer service before a spouse annuity can be paid.
The RRB uses Form G-346, Employee's Certification, to obtain the information needed to determine whether the employee's current marriage is valid. Form G-346 is completed by the retired employee who is the husband or wife of the applicant for a spouse annuity. Completion is required to obtain a benefit. One response is requested of each respondent. The RRB proposes no changes to Form G-346.
Form G-346sum, Employee Certification Summary, which mirrors the information collected on Form G-346, is used when an employee, after being interviewed by an RRB field office representative, “signs” the form using an alternative signature method known as “attestation.” Attestation refers to the action taken by the RRB field office representative to confirm and annotate the RRB's records of the applicant's affirmation under penalty of perjury that the information provided is correct and the applicant's agreement to sign the form by proxy. The RRB proposes no changes to Form G-346sum.
2.
Section 6 of the Railroad Retirement Act provides for a lump-sum payment to an employee or the employee's survivors equal to the Tier II taxes paid by the employee on a separation allowance or severance payment for which the employee did not receive credits toward retirement. The lump-sum is not payable until retirement benefits begin to accrue or the employee dies. Also, Section 4(a-1) (iii) of the Railroad Unemployment Insurance Act provides that a railroad employee who is paid a separation allowance is disqualified for unemployment and sickness benefits for the period of time the employee would have to work to earn the amount of the allowance. The reporting requirements are specified in 20 CFR 209.14.
In order to calculate and provide payments, the Railroad Retirement Board (RRB) must collect and maintain records of separation allowances and severance payments which were subject to Tier II taxation from railroad employers. The RRB uses Form BA-9, Report of Separation Allowance or Severance Pay, to obtain information from railroad employers concerning the separation allowances and severance payments made to railroad employees and/or the survivors of railroad employees. Employers currently have the option of submitting their reports on paper Form BA-9, (or in like format) on a CD-ROM, or by File Transfer Protocol (FTP), or Secure Email. Completion is mandatory. One response is requested of each respondent. The RRB proposes no changes to Form BA-9.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934, 15 U.S.C. 78s(b)(1) and Rule 19b-4, 17 CFR 240.19b-4, notice is hereby given that on July 5, 2018, ICE Clear Credit LLC (“ICC”) filed with the Securities and Exchange Commission the proposed rule change as described in Items I, II and III below, which Items have been prepared by ICC. The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons.
The principal purpose of the proposed rule change is to make revisions to the ICC Risk Management Model Description Document and the ICC Risk Management Framework related to the transition from a stress-based approach to a Monte Carlo-based methodology for the spread response and recovery rate (“RR”) sensitivity response components of the Initial Margin model. These revisions do not require any changes to the ICC Clearing Rules.
In its filing with the Commission, ICC included statements concerning the purpose of and basis for the proposed rule change, security-based swap submission, or advance notice and discussed any comments it received on the proposed rule change, security-based swap submission, or advance notice. The text of these statements may be examined at the places specified in Item IV below. ICC has prepared summaries, set forth in sections (A), (B), and (C) below, of the most significant aspects of these statements.
ICC proposes revising its Risk Management Model Description Document and its Risk Management Framework. ICC believes such revisions will facilitate the prompt and accurate clearance and settlement of securities transactions and derivative agreements, contracts, and transactions for which it is responsible. The proposed revisions are described in detail as follows.
The purpose of the proposed changes is to transition from a stress-based approach to a Monte Carlo-based methodology for the spread response and recovery rate (“RR”) sensitivity response components of the Initial Margin model. ICC notes certain limitations of its stress-based approach, namely, that it generates a limited number of stress scenarios that may not capture the risk of portfolios with more complex non-linear instruments and that it does not provide for a consistent estimation of the portfolio level spread response based on a defined risk measure (
To derive the spread response component, the current stress-based approach considers a set of hypothetical “tightening” and “widening” credit spread scenarios, from which it computes instrument Profit/Loss (“P/L”) responses for every Risk Factor (“RF”) scenario. All instrument P/L responses for a scenario are aggregated to obtain the portfolio P/L response for that scenario. Since the set of scenarios does not reflect the joint distribution of the considered RFs, offsets between P/Ls are applied to provide some portfolio benefits. To derive the RR sensitivity response component, all instruments belonging to a RF or Risk Sub-Factor (“RSF”) are subjected to RR stress scenarios to obtain the resulting P/L responses, and the worst scenario response is chosen for the estimation of the RF/RSF RR sensitivity response component.
Under the proposed Monte Carlo-based methodology, the “integrated spread response” component replaces the spread response and RR sensitivity response components. This component will be computed by creating P/L distributions from a set of jointly-simulated hypothetical (forward looking) spread and RR scenarios. The proposed Monte Carlo-based methodology utilizes standard tools in modeling dependence, which can be seen as a means for constructing multivariate distributions with different univariate distributions and with desired dependence structures, to generate the spread and RR scenarios. The proposed Monte Carlo-based methodology provides flexibility in modeling tail dependence, an important concept in risk management as it provides information about how frequently extreme values are expected to occur, and thus ICC considers them particularly suitable for implementing its Monte Carlo framework.
The univariate RF distribution assumptions do not change under the proposed Monte Carlo-based
ICC proposes revisions to the `Initial Margin Methodology' section of the Risk Management Model Description Document to reflect the described transition from a stress-based approach to a Monte Carlo-based methodology for the spread response and RR sensitivity response components. ICC proposes to clarify its risk management approach to note that it features stress loss considerations and a P/L distribution analysis at selected quantile levels that are 99% or higher. The proposed changes also include a description of each of the Initial Margin model components, which are separated into statistically calibrated components and stress-based add-on components. The statistically calibrated components (
ICC proposes to reorganize the ‘Initial Margin Methodology’ section to begin with the ‘LGD Risk Analysis’ section. The proposed changes to the ‘LGD Risk Analysis’ section include minor updates to terminology. The proposed revisions clarify that the LGD calculation considers RSF-specific RR level scenarios and that the Jump-To-Default (“JTD”) RR stress levels are updated if needed. ICC proposes to update the Profit/Loss-Given-Default (“P/LGD”) calculation at the RSF level to indicate the association between JTD and the RR level scenarios. ICC proposes to remove a reference to the stress levels noted in the current ‘RR Sensitivity Risk Analysis’ section. ICC proposes to move the RF level P/LGD calculation ahead of the Risk Factor Group (“RFG”) LGD calculations to avoid disrupting the grouping of RFG LGD calculations.
ICC proposes amendments to the ‘JTD Risk Analysis’ section. The proposed revisions to the Uncollateralized LGD (“ULGD”) calculation incorporate the integrated spread response component described above and remove reference to the current RR sensitivity response component. ICC also proposes, for clarity, to shorten a description in the WWR JTD calculation and to move details regarding the Kendall tau rank-order correlation to follow the WWR JTD calculation since such details are associated with the WWR JTD calculation. The details regarding the Kendall tau rank-order correlation remain unchanged, except for the addition of clarifying language referencing regulatory guidance with respect to RFs deemed highly correlated. ICC proposes to include this information, which is currently located in a source in a footnote, within the text to provide further description of the source in the footnote. ICC also proposes minor structural updates to its description of specific WWR (“SWWR”) to enhance readability.
ICC proposes to add clarifying language to the ‘Interest Rate Sensitivity Risk Analysis’ section to note that the interest rate sensitivity component is a statistically calibrated Initial Margin component. ICC also proposes to correct a notation to reflect an inverse distribution function.
ICC proposes amendments to the ‘Basis Risk Analysis’ section, which consist of combining into this section the current index decomposition process, followed by SN position offsets, and then generating basis risk requirements. Currently, the index decomposition process and SN position offsets are discussed under the ‘Spread Risk Analysis’ section. However, given the proposed changes to the ‘Spread Risk Analysis’ section along with the interrelation of these concepts, ICC proposes to combine these concepts by discussing each of them as a different subsection under the ‘Basis Risk Analysis’ section. Since the index decomposition process, followed by SN position offsets, generates basis risk requirements, these concepts are particularly well suited for discussion within the same section. Specifically, ICC proposes moving the description under the current ‘Long-Short Benefits among RFs with Common Basis’ subsection to the proposed ‘Index Decomposition and Long-Short Offsets’ subsection. ICC proposes minor changes to such description, including removing references to the spread response component that ICC proposes to replace.
Similarly, ICC proposes moving the description under the current ‘Portfolio Benefits Hierarchy Summary’ subsection to the proposed ‘Long/Short Offset Hierarchy’ subsection. The description includes the hierarchy to be followed in the allocation of each SN position to the index derived opposite positions and remains largely the same. ICC proposes minor changes to remove references to the current spread response component and to update the index series in an example.
ICC proposes moving the analysis under the current ‘Basis Risk Analysis’ section to the proposed ‘Index-Basis Risk Estimation’ subsection. The analysis discusses the calculation of the basis risk component and remains largely the same. The proposed edits state that the basis risk component is statistically calibrated to provide additional clarity, update a description to specify that index instruments may react to changing market conditions differently than SN instruments to more accurately reflect trading characteristics, and remove an example considered to be unnecessary and overly specific given its applicability to one index.
ICC proposes to combine the current ‘Spread Risk Analysis’ and ‘RR Sensitivity Risk Analysis’ sections into the proposed ‘Spread and RR Risk Analysis’ section to reflect ICC’s transition from a stress-based approach to a Monte Carlo-based methodology for the spread response and RR sensitivity response components. As discussed above, ICC currently utilizes different methodologies to separately derive the spread response and the RR sensitivity response components, which are discussed in the ‘Spread Risk Analysis’ and ‘RR Sensitivity Risk Analysis’ sections, respectively. Under the proposed approach, ICC will utilize credit spreads and RR distributions to jointly simulate scenarios to estimate portfolio risk measures. Accordingly, ICC proposes to combine the ‘Spread Risk Analysis’ and ‘RR Sensitivity Risk Analysis’ sections into the ‘Spread and RR Risk Analysis’ section given their interrelation under the proposed approach, in which the integrated spread response will be computed by creating P/L distributions from a set of jointly-simulated hypothetical (forward looking) spread and RR scenarios.
ICC proposes to remove details regarding the current stress-based approach from the ‘Initial Margin
The univariate RF distribution assumptions do not change under the Monte Carlo-based methodology and thus the ‘Distribution of the Credit Spreads’ subsection remains largely the same with some clarifying changes to language included.
ICC proposes to describe the implementation of the Monte Carlo-based methodology in the new ‘Multivariate Statistical Approach via Copulas’ subsection. ICC proposes to include a discussion on the construction and application of the standard tools in modeling dependence, including the review of their theoretical background, in the new ‘Copulas’ subsection.
ICC proposes the ‘Tail Dependence’ subsection to provide a description of the concept of tail dependence, given its relevancy as it indicates the probability of extreme values occurring jointly. The proposed subsection provides additional support behind ICC’s conclusion that the tools for modeling dependence are particularly suitable for connecting the various univariate distributions in a multivariate setting as they provide flexibility in modeling tail dependence.
Under the proposed ‘Copula Simulation’ subsection, ICC describes its Monte Carlo-based simulation approach. The proposed approach is based on first generating for all SN RF/RSF and On The Run indices Most Actively Traded Tenor (“MATT”) scenarios using the stochastic representation of the selected multivariate distribution under consideration. The conditional simulation approach is then utilized to generate individual RF/tenor-specific scenarios. ICC also proposes to describe the block simulation approach that it utilizes in generating scenarios, which departs from an approach where all tenors for all SNs are simulated together. Instead, specific blocks of the correlation matrix are considered through the stepwise block simulation approach.
Under the proposed ‘Copula Parameter Estimation’ subsection, ICC discusses the estimation of a new parameter. The proposed subsection includes a description of two methods that can be used for parameter estimation, namely the “quasi Maximum Likelihood” approach and the “Canonical Maximum Likelihood” method. ICC proposes to include the value at which this parameter is set conservatively and to explain that such a value reflects strong tail dependence within the simulation framework, which is important because ICC estimates that tail dependence will increase in stressed market conditions.
Next, ICC proposes to remove details regarding the current stress-based approach for the RR sensitivity response component and to describe how ICC jointly simulates credit spread and RR scenarios using Monte Carlo techniques in the amended ‘RR Risk Analysis’ section. As discussed above, under the current stress-based approach, the RR sensitivity response component is computed in terms of RR stress scenarios and incorporates potential losses associated with changes in the market implied RR. The proposed Monte Carlo-based methodology considers the risk arising from fluctuations in the market implied RRs of each SN RF and/or RSF jointly with the fluctuations in the curves of credit spreads.
The univariate RR distribution assumptions do not change under the Monte Carlo-based methodology and thus the proposed ‘Distribution of RRs’ subsection contains much of the relevant analysis under the current ‘RR Sensitivity Risk Analysis’ section with some additional clarifying language to further specify that the RR stress-based sensitivity requirement transitioned to a Monte Carlo simulation-based methodology. ICC proposes to note the assumption regarding the analysis of each SN RF/RSF that includes the description located under the current ‘Beta Distribution’ subsection since the integrated spread response also assumes a Beta distribution describing the behavior of the RRs.
The amended ‘Parameter Estimation’ subsection discusses the parameter calibration necessary to simulate RR scenarios and is largely the same. The proposed revisions remove or replace terminology associated with the stress-based approach with terminology associated with the Monte Carlo-based approach.
The proposed ‘Spread-Recovery-Rate Bivariate Model’ subsection describes the use of credit spread and RR distributions to jointly simulate scenarios to estimate portfolio risk measures under the Monte Carlo-based methodology. Namely, ICC proposes to discuss the use of the conditional simulation approach to jointly simulate SN RF/RSF-specific RR scenarios with SN RF/RSF MATT spread log-return scenarios. ICC proposes to note several assumptions under this model, along with an explanation of how it generates the individual SN RF/RSF-specific RR scenarios and the tenor-specific spread scenarios using copulas.
ICC proposes moving the ‘Arbitrage-Free Modeling’ subsection, which is currently located under the ‘Spread Risk Analysis’ section, under the ‘Spread and RR Risk Analysis’ section. The analysis remains largely the same with some language clarifications, including references to simulated spread levels in conjunction with simulated RR levels within the text and within formulas to ensure consistency with the proposed ‘Spread and RR Risk Analysis’ section. ICC proposes further revisions to terminology, such as removing terminology associated with the stress-based approach and incorporating the Monte Carlo simulation based methodology described above to ensure consistency with the proposed ‘Spread and RR Risk Analysis’ section. ICC also proposes replacing specific references to the current most actively traded tenor with references to the more general concept of “most actively traded tenor” to account for a situation in which the referenced most actively traded tenor is different.
Under the proposed ‘Risk Estimations’ subsection, ICC describes the computation of the integrated spread response component. Once the Monte Carlo scenarios are simulated, all instruments will be repriced, and the respective instrument P/L responses will be computed. Upon consideration of the instrument positions in each portfolio along with the instrument P/L responses, portfolio risk estimations will be performed and the integrated spread response component will be established.
ICC proposes to discuss its calculation of P/Ls for instruments, RFs, common currency sub-portfolios, and multi-currency sub-portfolios under the new ‘RF and Sub-Portfolio Level Integrated Spread Response’ subsection. ICC proposes to retain the use of sub-portfolios as is currently done today. However, the portfolio benefits across sub-portfolios will be limited. This enhancement allows ICC to decompose portfolio level P/L at the sub-portfolio level and to estimate sub-portfolio level risk measures.
Under the proposed ‘Instrument P/L Estimations’ subsection, ICC describes the calculation of instrument P/Ls. Namely, ICC will reprice all instruments
Under the proposed ‘RF P/L Estimations’ subsection, ICC describes the calculation of RF P/Ls. ICC will utilize the simulated P/L scenarios, combined with the post-index-decomposition positions related to a given RF, to generate a currency-specific RF P/L distribution. ICC will utilize this RF-related P/L distribution to estimate the RF-specific integrated spread response as the 99.5% VaR measure in the currency of the considered RF.
Under the proposed ‘Common Currency Sub-Portfolio P/L Estimations’ subsection, ICC describes the calculation of common currency sub-portfolio P/Ls. For a currency specific sub-portfolio, ICC extracts the relevant risk measures from sub-portfolio level P/L distributions, which are obtained from the aggregation of common currency RF P/L distributions.
Under the proposed ‘Multi-Currency Sub-Portfolio P/L Estimations’ subsection, ICC adds clarifying language describing the calculation of multi-currency sub-portfolio P/Ls. ICC proposes to extend multi-currency portfolio benefits to RFs with similar market characteristics, where the RFs and their respective instruments are denominated in different currencies. Under the proposed approach, long-short integrated spread response benefits are provided between Corporate RFs that are denominated in different currencies. ICC proposes to retain the multi-currency risk aggregation approach, which involves obtaining U.S. Dollar (“USD”) and Euro (“EUR”) denominated sub-portfolio P/L distributions, to RFs within the North American Corporate and European Corporate sub-portfolios denominated in USD and EUR currencies, respectively.
ICC proposes to include its calculation for the portfolio level integrated spread response component in the ‘Portfolio level Integrated Spread Response’ subsection. The calculation will include the sub-portfolio-specific integrated spread response after any potential multicurrency benefits and the RF-specific integrated spread response. ICC proposes the new ‘RF Attributed Integrated Spread Response Requirements’ subsection to describe the calculation of the RF attributed integrated spread response component for each RF in the considered portfolio.
ICC proposes minor revisions to the ‘Anti-Procyclicality Measures’ subsection to replace terminology associated with the stress-based approach with terminology associated with the Monte Carlo-based approach. ICC also proposes to update calculation descriptions relating to portfolio responses to note that certain amounts are converted to or represented in USD using the EOD established foreign exchange (“FX”) rate.
ICC proposes updates to the ‘Multi-Currency Portfolio Treatment’ section to incorporate the proposed integrated spread response component. ICC proposes to clarify that it implements a multi-currency portfolio treatment methodology for portfolios with instruments that are denominated in different currencies. The proposed changes also remove references to the current spread response component.
ICC propose minor edits to the ‘Portfolio Loss Boundary Condition’ section to remove or replace references to the current spread response and RR sensitivity response components with references to the proposed integrated spread response component within the text and within formulas to ensure consistency with the proposed ‘Spread and RR Risk Analysis’ section, specifically the ‘Portfolio Level Integrated SR’ subsection. Moreover, ICC proposes to reference, for clarity, the total number of RFs within the considered sub-portfolio in its calculations of the maximum portfolio loss and the maximum portfolio integrated spread response to ensure consistency with the proposed ‘Spread and RR Risk Analysis’ section, specifically the ‘Portfolio Level Integrated SR’ subsection.
ICC proposes minor changes to the ‘Guaranty Fund (“GF”) Methodology’ section. The proposed changes move the descriptions associated with the credit spread curve shape scenarios (
ICC proposes other non-material changes to the Risk Management Model Description Document, including minor grammatical, typographical, and structural changes to enhance readability and minor updates to calculations to update symbol notations.
ICC proposes conforming revisions to its Risk Management Framework to reflect the transition from a stress-based approach to a Monte Carlo-based methodology for the spread response and RR sensitivity response components of the Initial Margin model. The proposed revisions are described in detail as follows.
ICC proposes changes to the ‘Waterfall Level 2: Initial Margin’ section to combine the spread response and the RR sensitivity components into the proposed integrated spread response component. The proposed revisions introduce the integrated spread response component under the amended ‘Integrated Spread Response Requirements’ section and replace all references to the spread response with references to the integrated spread response. ICC proposes conforming changes throughout the framework. Currently, the spread response component is obtained by estimating scenario P/L for a set of hypothetical “tightening” and “widening” credit spread scenarios and by considering the largest loss. Under the proposed revisions, the integrated spread response will be computed by creating P/L distributions from a set of jointly-simulated hypothetical (forward looking) credit spread and RR scenarios. The proposed changes provide an updated calculation of the instrument scenario P/L, note the mappings between spread and RR levels and prices are performed by means of the International Swap and Derivatives Association (“ISDA”) standard conversion convention, and specify that the hypothetical prices are forward looking. ICC also proposes to state that the integrated spread response approach assumes a distribution that describes the behavior of the RRs.
ICC proposes the new ‘Index Decomposition Approach’ subsection, which contains the analysis under the current ‘Index Decomposition Benefits between Index RFs and SN RSFs’
Section 17A(b)(3)(F) of the Act
The proposed rule change will also satisfy the requirements of Rule 17Ad-22.
Rule 17Ad-22(b)(3)
Rule 17Ad-22(d)(8)
ICC does not believe the proposed rule changes would have any impact, or impose any burden, on competition. The proposed changes to ICC's Risk Management Model Description Document and ICC's Risk Management Framework will apply uniformly across
Written comments relating to the proposed rule change have not been solicited or received. ICC will notify the Commission of any written comments received by ICC.
Within 45 days of the date of publication of this notice in the
(A) By order approve or disapprove such proposed rule change, or
(B) institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change, security-based swap submission, or advance notice is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
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 the Exchange's Schedule of Fees, as further described below.
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 recently received approval to list index options on the Nasdaq 100 Reduced Value Index (“NQX”) on a pilot basis.
The Exchange now proposes to amend its Schedule of Fees to provide that there will be no fees or rebates for trades in NQX options executed from June 26-29, 2018. Volume executed in NQX options during this period will continue to be counted toward a member's tier for June activity. As such, NQX executions from June 26-29, 2018 will be included in the applicable volume tier calculations for a member's June activity, including those volume calculations specific to Non-Select Symbols (
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Exchange believes that it is reasonable and equitable to assess no fees or rebates for executions in NQX from June 26-29, 2018 because it will simplify the Exchange's billing and promote members to trade in NQX during the first week of listing, as further discussed above. For the same foregoing reasons, the Exchange also believes that it is reasonable and equitable to provide that volume executed in NQX during this time period will continue to be counted toward a member's tier for June activity. The Exchange also believes that it is reasonable to include NQX volume in this manner because it would be more burdensome to make changes to the Exchange's billing system in the middle of the month rather than the start to exclude a new symbol from the applicable volume tier calculations, as described above. The Exchange further believes that its proposal is not unfairly discriminatory as it will apply to trades in NQX that are executed by all market participants.
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. As discussed above, the proposed change to not assess any fees or rebates for executions of NQX orders from June 26-29, 2018 is merely intended to simplify the Exchange's billing, and promote members to trade in NQX during the first week of listing. Furthermore, the proposal will apply uniformly to all similarly situated market participants, as discussed above. For the foregoing reasons, the Exchange does not believe that its proposal will impose an undue burden on 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.
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 May 15, 2018, NYSE American LLC (“Exchange” or “NYSE American”) 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
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.
On January 4, 2018, NYSE Arca, Inc. (“NYSE Arca”) 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 it 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 this proposed rule change. 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.
2:00 p.m. on Thursday, July 26, 2018.
Closed Commission Hearing Room 10800.
This meeting will be closed to the public.
Commissioners, Counsel to the Commissioners, the Secretary to the Commission, and recording secretaries will attend the closed meeting. Certain staff members who have an interest in the matters also may be present.
The General Counsel of the Commission, or his designee, has certified that, in his opinion, one or more of the exemptions set forth in 5 U.S.C. 552b(c)(3), (5), (6), (7), (8), 9(B) and (10) and 17 CFR 200.402(a)(3), (a)(5), (a)(6), (a)(7), (a)(8), (a)(9)(ii) and (a)(10), permit consideration of the scheduled matters at the closed meeting.
Commissioner Jackson, as duty officer, voted to consider the items listed for the closed meeting in closed session.
The subject matters of the closed meeting will be:
Institution and settlement of injunctive actions;
Institution and settlement of administrative proceedings; and
Other matters relating to enforcement proceedings.
At times, changes in Commission priorities require alterations in the scheduling of meeting items.
For further information and to ascertain what, if any, matters have been added, deleted or postponed; please contact Brent J. Fields from the Office of the Secretary at (202) 551-5400.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The proposed rule change consists of amendments to Rules and Procedures of NSCC (“Rules”) in order to in order to terminate the Commission Billing service and the Commission Billing type of limited membership, as described in greater detail below.
In its filing with the Commission, the clearing agency 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 clearing agency has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
NSCC is proposing to revise its Rules in order to discontinue its Commission Billing service and the Commission Billing type of limited membership, for the reasons described below.
As currently described in Rule 16, NSCC provides a service through which it facilitates the payment of commissions on monthly basis between its Members and Commission Billing Members.
Currently, Commission Billing Members are floor broker firms that are members of the New York Stock Exchange (“NYSE”) and NYSE American (formerly the American Stock Exchange), although historically the service was available to floor broker firms on any U.S. exchange. As provided for in Rule 2 of the Rules, Commission Billing Members participate solely in the collection and payment of commissions as provided for under Rule 16 of the Rules.
Floor broker firms execute trades on behalf of their clients for a commission. In order to process commission charges applied to clients who are Members, floor broker firms that are Commission Billing Members may submit these charges to NSCC. Commission charges are submitted to NSCC in one of two ways. In most cases, where the Commission Billing Member is a member of NYSE, NYSE may act as a payment-data aggregator and creates and submits payment files to NSCC. Alternatively, Commission Billing Members may submit payments directly to NSCC through a web-based system. NSCC tabulates all payment records received on a monthly basis, and either sends amounts to The Depository Trust Company (“DTC”) for payment (for billed Members that are also Participants of DTC) or processes
For many years, the Commission Billing service provided these brokers and Members with an efficient way to submit and receive commission payments when few alternative payment options existed in the industry that would handle the large volume of transactions.
NSCC is proposing to terminate the Commission Billing service for a number of reasons, as described below. Because the Commission Billing type of limited membership exists only for the purposes of the use of this service, NSCC would terminate the existing Commission Billing memberships simultaneously with the termination of the service.
Over the years, the volumes of trades handled by floor brokers firms have decreased, leading to a significant decrease in commission bill transactions and the use of this service. Between January 2017 and June 2018, the Commission Billing service processed an average of approximately 87 commission payments per month (averaging a total of approximately $370,000 each month), compared to an average of approximately 10,000 commission payments per month in the early 2000's. The number of Commission Billing Members has also declined, with only seven new firms joining over the last eight years. Commission Billing Members have alternative methods to process commission payments. For example, firms may process the charges and payments through their own accounts payable systems, charging and collecting payments from their clients directly. Due to the lower volumes of commission payments, this is a more reasonable alternative to the Commission Billing Service than it may have been when volumes of payments were higher. Therefore, the industry's reliance on this service, which was built to provide an efficient way to process large volumes of payments, has been diminishing.
Since the introduction of the service, NSCC has provided the Commission Billing service as a utility service to the industry and its Members; the service provided its Members and the industry with value, but it was not designed to generate profit for NSCC. Over time, the reduced volumes of transactions has caused this service to be provided at a financial loss to NSCC. Costs of providing the service include engaging an ACH settling bank and ongoing system operating costs.
Additionally, due to the use of legacy systems that lack automation and support features, the service continues to rely on manual processes and requires personnel involvement. While errors in the operation of the service are infrequent, the reliance on manual processes creates a risk of such errors. Remediation of such errors, if they occur, could distract support resources from higher priority tasks. NSCC would be required to invest in enhancements to the systems that support the Commission Billing service if it continued to offer the service.
Therefore, due to the reduced reliance on this service by the industry, the cost of providing this service, and the availability of other methods for Members and brokers to process these payments, NSCC is proposing to terminate the Commission Billing service.
In order to terminate the Commission Billing service, NSCC would amend the Rules to remove Rule 16 (Settlement of Commissions) and to remove references to the Commission Billing type of limited membership from Rule 1 (Definitions and Descriptions), Rule 2 (Members and Limited Members), Rule 2A (Initial Membership Requirements), Rule 2B (Ongoing Membership Requirements and Monitoring), Rule 18 (Procedures for When the Corporation Declines or Ceases to Act), Rule 22 (Suspension of Rules), Rule 24 (Charges for Services Rendered), Rule 26 (Bills Rendered), Rule 34 (Insurance), Rule 37 (Hearing Procedures), Rule 46 (Restrictions on Access to Services), Rule 58 (Limitations on Liability), Rule 64 (DTCC Shareholders Agreement), Addendum A (Fee Structure), Addendum B (Qualifications and Standards of Financial Responsibility, Operational Capability and Business History), Addendum D (Statement of Policy Envelope Settlement Service, Mutual Fund Services, Insurance and Retirement Processing Services, and Other Services Offered by the Corporation), and Addendum P (Fine Schedule). NSCC would also make necessary conforming changes to Addendum B (Qualifications and Standards of Financial Responsibility, Operational Capability and Business History) and Rule 1 (Definitions and Descriptions). Finally, NSCC would add a legend to each of the above listed Rules and Addenda that identifies the implementation date of the proposed changes.
Given that all current Commission Billing Members are floor broker members of NYSE and NYSE American, NSCC will work closely with these exchanges to provide these firms with notice of the proposed termination of this service and their related limited memberships with NSCC. NSCC also would provide these firms with time to transition to alternative methods for the submission of charges and receipt of commission payments. Subject to the approval of this proposed rule change filing, NSCC would implement this proposed rule change and terminate the Commission Billing service by no later than November 30, 2018.
NSCC believes that the proposed changes are consistent with the Section 17A(b)(3)(F) of the Act, which requires, in part, that the rules of a registered clearing agency be designed to promote the prompt and accurate clearance and settlement of securities transactions, for the reasons described below.
Rule 17Ad-22(e)(21)(iv) under the Act requires, in part, that NSCC be efficient and effective in meeting the requirements of its participants and the markets it serves, and have the covered clearing agency's management regularly review the efficiency and effectiveness of its use of technology and communication procedures.
The proposed rule change could have an impact on competition because Commission Billing Members that currently use the service to process their commission bills, and firms that may apply to use the service in the future, would no longer be able to do so. However, NSCC does not believe that the impact of this proposed rule change on competition would be significant. First, the proposal is unlikely to have a significant impact because the use of the service has diminished over time, as described above. NSCC has not onboarded a new Commission Billing Member in over two years, and the number of active Commission Billing Members has declined over time. Therefore, elimination of the service is unlikely to impact many firms that may wish to join as Commission Billing Members in the future. Second, while current Commission Billing Members would need to use other methods to process commission payments, alternatives currently exist, including using their own accounts payable system. Given that volumes of commission bills have trended lower over the past few years, these firms should not incur a significant cost in processing commission bills and collecting commission payments through their own internal billing systems. Therefore, NSCC does not believe that the proposed rule change would have a significant impact on competition.
NSCC also believes that any impact the proposed rule change may have on competition would be both necessary and appropriate in furtherance of the purposes of the Act.
The proposed rule change would afford NSCC the option to utilize its resources for matters that better support and promote the prompt and accurate clearance and settlement of securities transactions, consistent with Section 17A(b)(3)(F) of the Act.
Additionally, NSCC believes that the proposed rule change is a reasonable method of advancing NSCC's ability to meet these requirements. As noted above, Members' use of this service has reduced over time, and the cost to NSCC of providing the service has outweighed the benefit it provides to the industry. NSCC would provide Members and Commission Billing Members with notice and time to transition to other viable methods for processing these payments. Therefore, NSCC believes the proposed rule change is a reasonable method of advancing NSCC's ability to meet the requirements of both Section 17A(b)(3)(F) of the Act
Therefore, NSCC does not believe that the proposed rule change would have a significant impact on competition, and further believes that any such impact would be both necessary and appropriate in furtherance of the purposes of the Act.
NSCC has not solicited or received any written comments relating to this proposal. NSCC will notify the Commission of any written comments that it receives.
Within 45 days of the date of publication of this notice in the
(A) By order approve or disapprove such proposed rule change, or
(B) institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549.
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 proposed rule change of DTC would amend Rule 35
In its filing with the Commission, the clearing agency 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 clearing agency has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The proposed rule change of DTC would amend Rule 35 to permit a Participant or Pledgee to designate one or more collateral management service providers, acting on behalf of the Participant or Pledgee, to receive reports and information from, and provide certain instructions to, DTC with respect to specified Accounts of the Participant or Pledgee. In addition, the proposed rule change would make ministerial changes to Rule 35, as discussed below.
On May 4, 2017, the Commission approved a DTC rule change that added Rule 35.
As DEGCL sought to expand its activities under Rule 35, which would have required one or more amendments to the rule, DTC considered whether a more comprehensive approach to Rule 35 might better serve the collateral management needs of its Participants and Pledgees.
The proposed rule change to amend Rule 35 would apply to any collateral management service provider that satisfies the requirements of the rule, and to any Account designated by a Participant or Pledgee. The amended rule would authorize DTC to provide information to the collateral management service provider (as it does for DEGCL currently) but, further, to act on instructions of the collateral management service provider.
More specifically, the proposed rule change would:
(1) Introduce the concept of a “CMSP,” a collateral management service provider designated to DTC by a Participant or Pledgee to act on behalf of the Participant or Pledgee under the proposed rule. The concept of a CMSP would replace the singular designation of DEGCL to act under this rule;
(2) Introduce the concept of a “CMSP Account,” an Account of a Participant or Pledgee that the Participant or Pledgee, respectively, has designated as subject to the proposed rule. The scope of a CMSP Account would replace the narrower concept of the existing CMS Sub-Account;
(3) Add the concept of a “CMSP Instruction,” an instruction of a CMSP to DTC for the Delivery, Pledge, or Release of Securities to or from a CMSP Account for which the CMSP is designated under the proposed rule; and
(4) Introduce the defined terms “CMSP Position Report” and “CMSP Information” (collectively, “CMSP
Proposed Section 2 of Rule 35 would set forth the requirements to be a CMSP.
Proposed Section 2 of Rule 35 would also provide that DTC may decline to accept an entity as a CMSP if it would present material risk to DTC, its Participants and Pledgees, or impose material costs to DTC. For illustrative purposes only, some examples of circumstances in which DTC might reject a collateral management service provider as a CMSP may include, without limitation, circumstances in which DTC reasonably believes that acceptance of the collateral management service provider as a CMSP would (i) subject DTC to additional legal or regulatory regimes, to which it is not otherwise subject; (ii) expose DTC to additional technology risk; or (iii) cause DTC to be in violation of applicable law or regulation.
The proposed rule change would amend Rule 35 to allow either a Participant or a Pledgee to designate any Account as a CMSP Account. The key feature of a CMSP Account is that it allows the designated CMSP access and authority to provide instruction to DTC (as further described below) for the Delivery, Pledge, or Release of Securities on behalf of a Participant or Pledgee, as applicable. The proposed rule change would specify that, with respect to a CMSP Account, a Participant or Pledgee would retain the right to instruct DTC as otherwise provided in the Rules and Procedures.
Pursuant to proposed Section 3 of Rule 35, a Participant or Pledgee would be able to designate one or more CMSP Accounts and, concurrently, designate one or more CMSPs with respect to each CMSP Account. The designation of a CMSP with respect to a CMSP Account by a Participant or Pledgee would constitute:
(1) The appointment of the CMSP by the Participant or Pledgee of the CMSP to act on its behalf under Rule 35;
(2) the authorization of the appointed CMSP by the Participant or Pledgee to receive CMSP Reports and to provide CMSP Instructions;
(3) the authorization of DTC by the Participant or Pledgee to act in accordance with any CMSP Instruction of such CMSP; and
(4) the representation and warranty of the Participant or Pledgee that it is duly authorized to instruct DTC to provide CMSP Reports to the CMSP and to act in accordance with any CMSP Instruction.
With the exception of references to Pledgees and to the new concept of CMSP Instruction, these authorizations, representations, and warranties would substantially track Rule 35, as previously adopted.
In addition, the proposed rule change would not substantially alter the liability and indemnification provisions in Rule 35. The proposed rule change would provide that each Participant and Pledgee that designates a CMSP with respect to a CMSP Account would indemnify DTC, and any nominee of DTC, against any loss, liability or expense as a result of any claim arising from the compliance of DTC with CMSP Instructions, except to the extent such loss, liability, or expense is caused directly by the DTC's gross negligence or willful misconduct.
As discussed above, Rule 35 currently provides a mechanism for a Participant to authorize DEGCL to receive position and transaction information from DTC, in the form of CMS Reports and CMS Delivery Information.
Existing Rule 35 defines “CMS Delivery Information” to mean, “with respect to CMS Securities and any Delivery or Pledge thereof from, or Delivery or Release thereof to, a CMS Sub-Account, a copy of any Delivery, Pledge, or Release message sent to the CMS Participant by DTC, including the following information: (x) the CUSIP, ISIN, or other identification number of such CMS Securities, and (y) the number of shares or other units or principal amount of such CMS Securities.” This definition was drafted to align with DEGCL specifications. Pursuant to the proposed rule change, the definition would be drafted in more general terms to provide flexibility for the different collateral management service offerings of CMSPs (in addition to DEGCL). Pursuant to the proposed rule change, “CMSP Information” would mean, “with respect to a CMSP Account of a Participant or Pledgee, a copy of any message sent to the Participant or Pledgee by the Corporation.” These messages would include, but would not be limited to, the Delivery, Pledge, and Release messages referenced in the definition of CMS Delivery Information in existing Rule 35.
Similarly, existing Rule 35 defines “CMS Report” to mean, “with respect to a CMS Participant and its CMS Sub-Account, the following information identifying the CMS Securities that are, at the time of such report, credited to such CMS Sub-Account: (i) The CUSIP, ISIN, or other identification number of the CMS Securities, and (ii) the number of shares or other units or principal amount of the CMS Securities.” This definition was drafted to align with DEGCL specifications. Pursuant to the proposed rule change, “(i) the CUSIP, ISIN, or other identification number of the CMS Securities, and (ii) the number of shares or other units or principal amount of the CMS Securities” would be deleted from the definition.
Finally, similar to existing Rule 35, proposed Rule 35 would provide that DTC would have no liability to any Participant or Pledgee as a result of providing one or more CMSP Reports to any CMSP pursuant to proposed Section 5 of Rule 35.
The proposed rule change would further amend Rule 35 to provide that a CMSP designated by a Participant or Pledgee with respect to a CMSP Account would be authorized to instruct DTC, on behalf of the Participant or Pledgee, for the Delivery, Pledge, or Release of Securities credited to such CMSP Account, as applicable.
Pursuant to the proposed rule change, the right of any CMSP to instruct DTC with respect to a CMSP Account would not preclude instructions by the Participant or Pledgee itself, or CMSP Instructions by another CMSP, with respect to the same CMSP Account. Furthermore, Rule 35 would provide that DTC has no liability (i) to a Participant or Pledgee for acting in accordance with, or relying upon, CMSP Instructions, or (ii) to any CMSP as a result of DTC acting in accordance with, or relying upon, instructions of any other Person, including, but not limited to, the Participant or Pledgee or any other designated CMSP.
In connection with the foregoing, DTC proposes to make the following changes (including ministerial changes) to Rule 35.
For additional clarity, DTC is also proposing to make ministerial changes to (i) update articles, pronouns, and determiners, and (ii) modify language for stylistic conformity within the proposed rule.
DTC will implement the proposed rule change two Business Days after approval of this filing by the Commission. Participants would be advised of the implementation date of this proposed rule change through the issuance of a DTC Important Notice.
DTC believes that the proposed rule change is consistent with the requirements of the Act, and the rules and regulations thereunder applicable to DTC, in particular Section 17A(b)(3)(F) of the Act.
Section 17A(b)(3)(F) of the Act
Rule 17Ad-22(e)(21) promulgated under the Act requires,
DTC believes that the proposed rule change to amend Rule 35 to (i) expand its application to CMSPs generally, (ii) provide that Pledgees, in addition to Participants, may designate an Account under Rule 35, and (iii) provide for CMSP Instructions to DTC with respect to a CMSP Account, would have an impact on competition by potentially promoting competition, and would not
DTC does not believe that the proposed ministerial changes to Rule 35 would have any impact on competition because these clarifications would merely make changes for accuracy and consistency and therefore would not affect the rights and obligations of any Participant or Pledgee or other interested party.
Written comments relating to the proposed rule change have not been solicited or received. DTC will notify the Commission of any written comments received by DTC.
Within 45 days of the date of publication of this notice in the
(A) By order approve or disapprove such proposed rule change, or
(B) institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
ICE Clear Europe proposes to modify certain provisions of its Price Discovery Policy related to the bid-offer width (“BOW”) methodology for pricing single name credit default swap (“CDS”) contracts. These revisions do not require any changes to the ICE Clear Europe Clearing Rules or Procedures.
In its filing with the Commission, ICE Clear Europe included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. ICE Clear Europe has prepared summaries,
ICE Clear Europe proposes revising its Price Discovery Policy to enhance the methodology used to determine BOWs for single name CDS contracts and to make corresponding changes to related governance processes.
Each business day, ICE Clear Europe determines end-of-day (“EOD”) levels for CDS Contracts through in accordance with the Price Discovery Policy, based on EOD submissions from its CDS Clearing Members. ICE Clear Europe uses these EOD levels for mark-to-market and risk management purposes. As part of this price discovery process, ICE Clear Europe determines BOWs for each CDS Contract. The BOW is intended to estimate the bid-offer width for the two-way market available for each clearing-eligible instrument at the specified determination time on each business day. The BOWs are then used in ICE Clear Europe's price discovery process as inputs in the determination of EOD levels, and other risk management matters.
The current methodology for determining BOWs for single-name CDS Contracts is based on a consensus BOW derived from observed intraday spread-quotes for the most actively traded instrument (“MATI”) across the term structure and cleared coupons. The spread-based consensus BOW is multiplied by a “scrape factor” to reflect any differences between the BOWs provided in intraday quotes and BOWs achieved in the market. ICE Clear Europe applies various factors to the consensus BOW to reflect differences in instrument liquidity at longer and shorter maturities, and at higher and lower coupons.
ICE Clear Europe is proposing to enhance the methodology for determining EOD BOWs for single name instruments. The enhancement eliminates the use of the ISDA CDS Standard Model from the computation of single name BOWs. ICE Clear Europe established its current BOW methodology at a time when it accepted submissions to its end-of-day price discovery process in both spread and price terms, at the discretion of its Clearing Members. Since that time, ICE Clear Europe has enhanced its end-of-day price discovery process to accept Single Name submissions only in price terms, eliminating the need for spread-based BOWs.
Under the proposed enhancement ICE Clear Europe will compute a consensus BOW for each benchmark instrument, not only for the most actively traded instrument. Rather than consensus BOWs being derived only from intraday quotes, they will be computed as a price-based floor plus a fraction of the instrument's currently observed level, based on the average of price-space mid-market levels submitted by CDS Clearing Members as part of the EOD price discovery process. ICE Clear Europe will continue to apply various factors to the consensus BOW to reflect differences in liquidity at longer and shorter maturities and at higher and lower coupons. Under the proposed enhancement, the Clearing House will determine systematic BOWs for each benchmark instrument at the most actively traded coupon (“MATC”) by applying tenor scaling factors to the corresponding consensus BOWs. These tenor scaling factors reflect the BOW of each tenor relative to the BOW of the most actively traded tenor. ICE Clear Europe will determine systematic BOWs for each benchmark instrument at other coupons by applying a combination of tenor scaling factors and coupon scaling factors to the corresponding consensus BOWs. Coupon scaling factors are an adjustment to the BOW to reflect decreased market activity at coupons larger or smaller than the MATC, and accordingly result in a wider BOW for such coupons as compared to the MATC. ICE Clear Europe will apply the appropriate Single Name variability factor resulting in the final systematic EOD BOWs based on the applicable variability band (a similar variability factor can be applied in the current approach, but on a discretionary basis). The variability factor is an additional scaling factor that widens the BOW to account for volatile or fast-moving market conditions, on the basis of a market proxy variability band that is designed to reflect observed variability levels in intraday quotes.
ICE Clear Europe will determine the final EOD BOW as the greater of an instrument's systematic BOW, and a dynamic BOW established for the instrument based on the dispersion of price-based mid-market EOD submissions by CDS Clearing Members for the given instrument. The amendments remove the requirement for ICE Clear Europe to provide the spread space equivalents for BOWs.
ICE Clear Europe also proposes revisions to the governance provisions of the Price Discovery Policy. Under the revisions, and consistent with the amendments to the methodology described above, the parameters used in the EOD price discovery process are established by ICE Clear Europe's clearing risk department in consultation with ICE Clear Europe's trading advisory committee, which provides additional insight into current market dynamics and conditions. The responsibilities of ICE Clear Europe's clearing risk department in this regard will include determining the price-based floors and scaling factors used to establish BOWs. (References to determination of scrape factors, which are no longer used, have been removed.)
The revised Price Discovery Policy removes a duplicative table relating to the assignment of index risk factors to market proxy groups, and updates cross-references accordingly. ICE Clear Europe also proposes a revision that trading desks at each self-clearing member are requested (but not required), to copy ICE Clear Europe on the intraday quotes they provide market participants via email.
ICE Clear Europe believes that the proposed amendments are consistent with the requirements of Section 17A of the Act
(6) Cover, if the covered clearing agency provides central counterparty services, its credit exposures to its participants by establishing a risk-based margin system that, at a minimum:
(i) Considers, and produces margin levels commensurate with, the risks and particular attributes of each relevant product, portfolio, and market;
(ii) Marks participant positions to market and collects margin, including variation margin or equivalent charges if relevant, at least daily and includes the authority and operational capacity to make intraday margin calls in defined circumstances;
(iii) Calculates margin sufficient to cover its potential future exposure to participants in the interval between the last margin collection and the close out of positions following a participant default;
(iv) Uses reliable sources of timely price data and uses procedures and sound valuation models for addressing circumstances in which pricing data are not readily available or reliable;
(v) Uses an appropriate method for measuring credit exposure that accounts for relevant product risk factors and portfolio effects across products;
(vi) Is monitored by management on an ongoing basis and is regularly reviewed, tested, and verified by:
(A) Conducting backtests of its margin model at least once each day using standard predetermined parameters and assumptions;
(B) Conducting a sensitivity analysis of its margin model and a review of its parameters and assumptions for backtesting on at least a monthly basis, and considering modifications to ensure the backtesting practices are appropriate for determining the adequacy of the covered clearing agency's margin resources;
(C) Conducting a sensitivity analysis of its margin model and a review of its parameters and assumptions for backtesting more frequently than monthly during periods of time when the products cleared or markets served display high volatility or become less liquid, or when the size or concentration of positions held by the covered clearing agency's participants increases or decreases significantly; and
(D) Reporting the results of its analyses under paragraphs (e)(6)(vi)(B) and (C) of this section to appropriate decision makers at the covered clearing agency, including but not limited to, its risk management committee or board of directors, and using these results to evaluate the adequacy of and adjust its margin methodology, model parameters, and any other relevant aspects of its credit risk management framework; and
(vii) Requires a model validation for the covered clearing agency's margin system and related models to be performed not less than annually, or more frequently as may be contemplated by the covered clearing agency's risk management framework established pursuant to paragraph (e)(3) of this section.”
(2) Provide for governance arrangements that:
(i) Are clear and transparent;
(ii) Clearly prioritize the safety and efficiency of the covered clearing agency;
(iii) Support the public interest requirements in Section 17A of the Act (15 U.S.C. 78q-1) applicable to clearing agencies, and the objectives of owners and participants;
(iv) Establish that the board of directors and senior management have appropriate experience and skills to discharge their duties and responsibilities;
(v) Specify clear and direct lines of responsibility; and
(vi) Consider the interests of participants' customers, securities issuers and holders, and other relevant stakeholders of the covered clearing agency.”
ICE Clear Europe does not believe the proposed rule changes would have any impact, or impose any burden, on competition not necessary or appropriate in furtherance of the purpose of the Act. The proposed changes to the Price Discovery Policy, and in particular the revised BOW methodology for Single Name instruments, will apply uniformly across all CDS Clearing Members and market participants. ICE Clear Europe does not believe the amendments will adversely affect competition among CDS Clearing Members, the cost of clearing, or the ability of market participants to clear CDS contracts generally. Similarly, the Clearing House does not believe the amendments will reduce access to clearing of CDS contracts or limit market participants' choices for clearing CDS contracts. Therefore, ICE Clear Europe does not believe the proposed rule changes impose any burden on competition that is inappropriate in furtherance of the purposes of the Act.
Written comments relating to the proposed amendments have not been solicited or received by ICE Clear Europe. ICE Clear Europe will notify the Commission of any comments received with respect to the proposed rule change.
Within 45 days of the date of publication of this notice in the
(A) By order approve or disapprove the proposed rule change or
(B) institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change, security-based swap submission or advance notice is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
All comments received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-ICEEU-2018-009 and should be submitted on or before August 14, 2018.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to the authority granted to the United States Small Business Administration under the Small Business Investment Act of 1958, as amended, under Section 309 of the Act and Section 107.1900 of the Small Business Administration Rules and Regulations (13 CFR 107.1900) to function as a small business investment company under the Small Business Investment Company License No. 02/02-0621 issued to Brookside Pecks Capital Partners, L.P., said license is hereby declared null and void.
U.S. Small Business Administration.
Notice.
This is a notice of an Administrative declaration of a disaster for the State of Louisiana dated 07/17/2018.
Issued on 07/17/2018.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
Notice is hereby given that as a result of the Administrator's disaster declaration, applications for disaster loans may be filed at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The number assigned to this disaster for physical damage is 15588 C and for economic injury is 15589 0.
The States which received an EIDL Declaration # are Louisiana, Arkansas, Texas.
Federal Aviation Administration (FAA), U.S. Department of Transportation.
Notice.
On July 9, 2018, the FAA published a
Elliott Black, Director, Office of Airport Planning and Programming, APP-1, at (202) 267-8775.
The July 9, 2018 notice required airport sponsors to submit specific information via electronic mail (email) in order to request supplemental funding. In addition to the original requirements, for each request, the submission must also identify the total capital cost of the proposed project and the amount of funding being requested.
In addition, the FAA is developing an optional form that may make it easier for airports to ensure they provide all required information. The FAA will post the form online at
Finally, in the July 9 notice, footnotes #6, 7 and 9 incorrectly referred to footnote #4.
They should have referred instead to footnote #5.
All other information, including submission requirements, evaluation criteria and deadlines remain unchanged from the original July 9 notice.
Federal Aviation Administration (FAA), DOT.
Request for public comments.
Notice is being given that the FAA is considering a request from the Town of Southbridge, MA, to change the land use from aeronautical to non-aeronautical use for 8.5 acres of land for revenue generation. The parcel is located southwest of the runway and terminal building and will be used for a solar farm. The land lease rate is based on an appraisal and the annual lease will be placed in the airport's operations and maintenance account.
Comments must be received on or before August 23, 2018.
You may send comments using any of the following methods:
•
•
•
•
Interested persons may inspect the request and supporting documents by contacting the FAA at the address listed under
Mr. Jorge E. Panteli, Compliance and Land Use Specialist, Federal Aviation Administration New England Region Airports Division, 1200 District Avenue, Burlington, Massachusetts 01803. Telephone: 781-238-7618.
Under part 211 of Title 49 Code of Federal Regulations (CFR), this provides the public notice that by a letter dated May 31, 2018, Kansas City Southern Railway Company (KCSR) petitioned the Federal Railroad Administration (FRA) for a modification of its waiver of compliance from certain provisions of the Federal railroad safety regulations contained at 49 CFR part 232. FRA assigned the petition Docket Number FRA-2007-28700.
By letter dated December 11, 2017, KCSR received an extension of its conditional relief (originally granted by FRA on January 18, 2008) from 49 CFR 232.205,
A copy of the petition, as well as any written communications concerning the petition, is available for review online at
Interested parties are invited to participate in these proceedings by submitting written views, data, or comments. FRA does not anticipate scheduling a public hearing in connection with these proceedings since the facts do not appear to warrant a hearing. If any interested parties desire an opportunity for oral comment and a public hearing, they should notify FRA, in writing, before the end of the comment period and specify the basis for their request.
All communications concerning these proceedings should identify the appropriate docket number and may be submitted by any of the following methods:
•
•
•
•
Communications received by August 23, 2018 will be considered by FRA before final action is taken. Comments received after that date will be considered if practicable.
Anyone can search the electronic form of any written communications and comments received into any of our dockets by the name of the individual submitting the comment (or signing the document, if submitted on behalf of an association, business, labor union, etc.). In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its processes. DOT posts these comments, without edit, including any personal information the commenter provides, to
Issued in Washington, DC.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Receipt of petition.
This document announces receipt by the National Highway Traffic Safety Administration (NHTSA) of a petition for a decision that certain model year (MY) 2013 Porsche Panamera passenger cars (PCs) that were not originally manufactured to comply with all applicable Federal motor vehicle safety standards (FMVSS) are eligible for importation into the United States because they are substantially similar to vehicles that were originally manufactured for sale in the United States and that were certified by their manufacturer as complying with the safety standards (the U.S.-certified version of the MY 2013 Porsche Panamera PCs) and are capable of being readily altered to conform to the standards.
The closing date for comments on the petition is August 23, 2018.
Interested persons are invited to submit written data, views, and arguments on this petition. Comments must refer to the docket and notice number cited in the title of this notice and may be submitted by any of the following methods:
•
•
•
• Comments may also be faxed to (202) 493-2251.
Comments must be written in the English language, and be no greater than 15 pages in length, although there is no limit to the length of necessary attachments to the comments. If comments are submitted in hard copy form, please ensure that two copies are provided. If you wish to receive confirmation that comments you have submitted by mail were received, please enclose a stamped, self-addressed postcard with the comments. Note that all comments received will be posted without change to
All comments, background documentation, and supporting materials submitted to the docket may be viewed by anyone at the address and times given above. The documents may also be viewed on the internet at
DOT's complete Privacy Act Statement is available for review in a
George Stevens, Office of Vehicle Safety Compliance, NHTSA, telephone (202) 366-5308.
Petitions for eligibility decisions may be submitted by either manufacturers or importers who have registered with NHTSA pursuant to 49 CFR part 592. As specified in 49 CFR 593.7
The petitioner submitted information with its petition intended to demonstrate that the subject non-U.S.-certified vehicles as originally manufactured, conform to many applicable FMVSS in the same manner as their U.S.-certified counterparts, or are capable of being readily altered to conform to those standards.
Specifically, the petitioner claims that the non-U.S.-certified MY 2013 Porsche Panamera PCs, as originally manufactured, conform to: Standard Nos. 102
The petitioner also contends that the subject non-U.S.-certified vehicles are capable of being readily altered to meet the following standards in the manners indicated:
Standard No. 101
Standard No. 108
Standard No. 110
Standard No. 111
Standard No. 208
Standard No. 209
Standard No. 301
The petitioner additionally states that a vehicle identification plate must be affixed to the vehicle near the left windshield pillar to meet the requirements of 49 CFR part 565.
Once the petition is granted or denied, notice of the decision will be published in the
This notice of receipt of the subject petition does not represent any agency decision or other exercise of judgment concerning the merits of the petition. Notice of final action on the petition will be published in the
49 U.S.C. 30141(a)(1)(A), (a)(1)(B), and (b)(1); 49 CFR 593.7; delegation of authority at 49 CFR 1.95 and 501.8.
Office of the Secretary, Department of Transportation.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, this notice announces that the Department of Transportation's (Department or DOT) Office of the Secretary (OST) is submitting a request to the Office of Management and Budget (OMB) for renewal of the OMB control number 2105-0571, titled Nondiscrimination on the Basis of Disability in Air Travel, for the information collections described below. On April 18, 2018, the Department published a
Written comments should be submitted by August 23, 2018.
Send comments regarding the burden estimate, including suggestions for reducing the burden, to the Office of Management and Budget, Attention: Desk Officer for the Office of the Secretary of Transportation, 725 17th Street NW, Washington, DC 20503. Comments may also be sent via email to OMB at the following address:
John C. Wood, Office of the General Counsel, Office of the Secretary, U.S. Department of Transportation, 1200 New Jersey Avenue SE, Washington, DC 20590, 202-366-9342 (Voice), 202-366-7152 (Fax), or
The Paperwork Reduction Act of 1995 (PRA) and its implementing regulations, 5 CFR part 1320, require Federal agencies to issue two notices seeking public comment on information collection activities before OMB may approve paperwork packages. 44 U.S.C. 3506, 3507; 5 CFR 1320.5, 1320.8(d)(1), 1320.12. On April 18, 2018, OST published a
The commenter, Paralyzed Veterans of America (PVA), supported both information collections and emphasized that carriers should provide an opportunity for passengers with disabilities to request disability accommodation in advance of arriving at the gate at an easy to locate place on an airline's website. PVA also stated that carriers should then use the information to make sure that passengers receive any needed assistance in a timely manner. PVA added that collecting service request information has the potential to benefit all stakeholders, including carriers, as it helps carriers understand the types and frequency of requests received across routes and travel periods. The PVA comment made no reference to the estimated number of respondents or burden hours for the information collections. The Department also received another comment, but that comment was outside the scope of the Paperwork Reduction Act. It did not address any issue related to the information collections that are the subject of this renewal.
Accordingly, this notice announces that the information collection activities set forth in Part 382 have been re-evaluated and certified under 5 CFR 1320.5(a) and are being forwarded to OMB for review and approval pursuant to 5 CFR 1320.12(c). Before OMB decides whether to approve these proposed collections of information, it must provide 30 days for public comment. 44 U.S.C. 3507(b); 5 CFR 1320.12(d). Federal law requires OMB to approve or disapprove paperwork packages between 30 and 60 days after the 30-day notice is published. 44 U.S.C. 3507(b)-(c); 5 CFR 1230.12(d);
The renewed OMB control number will be applicable to all the provisions set forth in this notice. The title, a description of the information collection, its need and proposed use, respondents, and the periodic reporting burden are set forth below for each of the information collections:
While the content and design of the online service request form is up to the carriers, the Department anticipates that each covered U.S. and foreign carrier that markets scheduled air transportation to the general public in the United States would incur initial costs associated with developing and reviewing a design and implementation plan for the request form, developing, coding, and integrating the form into the website, as well as testing, debugging, and connecting the form with a backend database to store the information. The final regulatory analysis (FRA) for the final rule entitled Nondiscrimination on the Basis of Disability in Air Travel: Accessibility of websites and Automated Kiosks at U.S. Airports estimated that it will take an average of 32 labor hours per carrier to develop, implement, integrate, connect, and test the online request form. Initial costs are reduced for carriers that rely on a request form developed by another entity. There are no recordkeeping or
The incremental labor hours associated with providing the required disclaimer may vary depending on the number of links on the website to which this requirement applies. The FRA estimated that it will take an average of 6 labor hours per carrier to identify the links and then develop, test, and deploy the disclaimer notice on the website. We also estimate that it will take less than 30 minutes per year for a carrier to associate the notice with any new links to external websites or third-party software added to their websites.
There are no recordkeeping or reporting requirements associated with this information collection.
The Paperwork Reduction Act of 1995; 44 U.S.C. chapter 35, as amended; and 49 CFR 1.48.
Departmental Offices, U.S. Department of the Treasury.
Notice.
The Department of the Treasury will submit the following information collection requests to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. The public is invited to submit comments on these requests.
Comments should be received on or before August 23, 2018 to be assured of consideration.
Send comments regarding the burden estimate, or any other aspect of the information collection, including suggestions for reducing the burden, to (1) Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for Treasury, New Executive Office Building, Room 10235, Washington, DC 20503, or email at
Copies of the submissions may be obtained from Jennifer Leonard by emailing
44 U.S.C. 3501
Department of Veterans Affairs.
Notice.
The Veterans Health Administration (VHA), Department of Veterans Affairs (VA), gives notice that the Department has made findings of research misconduct against Alba Chavez-Dozal, Ph.D., a former employee of the New Mexico VA Health Care System in Albuquerque, New Mexico.
Research Misconduct Officer, Office of Research Oversight, 10R, Veterans Health Administration, Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420, (202) 632-7620. This is not a toll free number.
The Veterans Health Administration (VHA), Department of Veterans Affairs (VA), gives notice under VHA Handbook 1058.02 “Research Misconduct” § 6k, that the Department has made findings of research misconduct against Alba Chavez-Dozal, Ph.D., a former employee of the New Mexico VA Health Care System in Albuquerque, New Mexico.
Specifically, the Department found that the Respondent, a post-doctoral research fellow who formerly held a VA without compensation appointment, engaged in research misconduct by intentionally and/or knowingly:
(1) Recording fabricated data that described the generation and characterization of an END3 mutant yeast strain and presenting that data at two lab meetings;
(2) Fabricating the image of a Southern blot reported in Figure 1A of a journal article titled “Functional Analysis of the Exocyst Subunit Sec15 in
(3) Falsifying research results by using the same protein gel to represent two different experiments: A degradation assay utilizing the SEC15 mutant in Figure 6A of the publication
(4) Falsifying research results reported in Figures 4A (vacuole characterization), 6 (cell growth) and 9B (lipase secretion) of the publication
(5) Falsifying protein localization results reported in Figures 7, 8 and 9 of the publication
(6) Republishing falsified data from
In response to these findings, the Department has imposed the following corrective actions:
(1) Prohibition from conducting VA research for four years.
(2) Publication of VA's finding of research misconduct.
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. Jacquelyn Hayes-Byrd, Acting Chief of Staff, Department of Veterans Affairs, approved this document on June 27, 2018, for publication.
The Department of Veterans Affairs (VA) gives notice under the Federal Advisory Committee Act that a meeting of the Veterans' Advisory Committee on Rehabilitation (VACOR) will be held on Tuesday and Wednesday, August 28-29, 2018, in Room 542, 1800 G Street NW, Washington, DC 20006. The meeting will begin at 8:30 a.m. EST and adjourn at 4:00 p.m. EST each day. The meeting is open to the public.
The purpose of the Committee is to provide advice to the Secretary on the rehabilitation needs of Veterans with disabilities and on the administration of VA's rehabilitation programs.
On August 27, 2018, Committee members will be provided with updated briefings on various VA programs designed to enhance the rehabilitative potential of disabled Veterans.
On August 28, 2018, the Committee will begin consideration of potential recommendations to be included in the Committee's next annual report.
Although no time will be allocated for receiving oral presentations from the public, members of the public may submit written statements for review by the Committee to Sabrina McNeil, Designated Federal Officer, Veterans Benefits Administration (28), 810 Vermont Avenue NW, Washington, DC 20420, or via email at
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Final rule.
We, NMFS, issue a final rule to designate critical habitat for the Main Hawaiian Islands (MHI) insular false killer whale (IFKW) (
This rule becomes effective August 23, 2018.
The final rule, maps, and other supporting documents (Economic Report, ESA Section 4(b)(2) Report, and Biological Report) can be found on the NMFS Pacific Island Region's website at
Susan Pultz, NMFS, Pacific Islands Region, Chief, Conservation Planning and Rulemaking Branch, (808) 725-5150; or Lisa Manning, NMFS, Office of Protected Resources (301) 427-8466.
On December 28, 2012, the listing of the MHI IFKW (
Based on the recommendations provided in the Draft Biological Report, the initial Regulatory Flexibility Analysis (RFA) and ESA section 4(b)(2) analysis (which considers exclusions to critical habitat based on economic, national security and other relevant impacts), we published a proposed rule on November 3, 2017 (82 FR 51186) to designate waters from the 45-m depth contour to the 3,200-m depth contour around the main Hawaiian Islands from Niihau east to Hawaii, with some exceptions, as MHI IFKW critical habitat. In accordance with the definition of critical habitat under the ESA, this area contained physical or biological features essential to conservation of the species and which may require special management considerations or protections. The proposed rule included background information on MHI IFKW biology and habitat use, which is not included here but the reader may access by referring to the proposed rule (82 FR 51186; November 3, 2017).
In the proposed rule, we described the physical or biological features essential to the conservation of MHI IFKWs as (1) island-associated marine habitat for MHI IFKWs; (2) prey species of sufficient quantity, quality, and availability to support individual growth, reproduction, and development, as well as overall population growth; (3) waters free of pollutants of a type and amount harmful to MHI IFKWs, and (4) habitat free of anthropogenic noise that would significantly impair the value of the habitat for false killer whale use or occupancy. We requested public comments through January 2, 2018. For a complete description of our proposed action, including the natural history of the MHI IKFW, we refer the reader to the proposed rule (82 FR 51186; November 3, 2017).
The ESA defines critical habitat under section 3(5)(A) as (i) the specific areas within the geographical area occupied by the species, at the time it is listed, on which are found those physical or biological features (1) essential to the conservation of the species and (2) which may require special management considerations or protection; and (ii) specific areas outside the geographical area occupied by the species at the time it is listed upon a determination by the Secretary that such areas are essential for the conservation of the species. (16 U.S.C. 1532(5)(A)). Conservation is defined in section 3(3) of the ESA as: To use, and the use of, all methods and procedures which are necessary to bring any endangered species or threatened species to the point at which the measures provided pursuant to this Act are no longer necessary (16 U.S.C. 1532(3)). Section 3(5)(C) of the ESA provides that except in those circumstances determined by the Secretary, critical habitat shall not include the entire geographical area which can be occupied by the threatened or endangered species.
Section 4(a)(3)(B) prohibits designating as critical habitat any lands or other geographical areas owned or controlled by the Department of Defense (DOD) or designated for its use, that are subject to an Integrated Natural Resources Management Plan (INRMP) prepared under section 101 of the Sikes Act (16 U.S.C. 670a), if the Secretary determines in writing that such plan provides a benefit to the species, and its habitat, for which critical habitat is proposed for designation.
Section 4(b)(2) of the ESA requires us to designate critical habitat for threatened and endangered species on the basis of the best scientific data available and after taking into consideration the economic impact, the impact on national security, and any other relevant impact, of specifying any particular area as critical habitat. This section also grants the Secretary of Commerce (Secretary) discretion to exclude any area from critical habitat upon determining that the benefits of such exclusion outweigh the benefits of specifying such area as part of the critical habitat. However, the Secretary may not exclude areas if this will result in the extinction of the species. Our regulations provide that critical habitat shall not be designated within foreign countries or in other areas outside U.S. jurisdiction (50 CFR 424.12(g)). Once critical habitat is designated, section 7(a)(2) of the ESA requires Federal agencies to ensure that actions they fund, authorize, or carry out are not likely to destroy or adversely modify that habitat (16 U.S.C. 1536(a)(2)). This requirement is in addition to the section 7(a)(2) requirement that Federal agencies ensure their actions are not likely to jeopardize the continued existence of ESA-listed species. Specifying the geographic location of critical habitat also facilitates implementation of section 7(a)(1) of the ESA by identifying areas where Federal agencies can focus their conservation programs and use their authorities to further the purposes of the ESA. Critical habitat requirements do not apply to citizens engaged in actions on private land that do not involve a Federal agency. However, designating critical habitat can help focus the efforts of other conservation partners (
After considering public comments received and the best scientific information available, we have made the following changes: (1) We have combined the four proposed features into a single essential feature with four characteristics that describe how island-associated marine habitat is essential to MHI IFKWs; and (2) we have excluded under section 4(b)(2) the Kaulakahi Channel portion of Warning area 186, the area north of Molokai, the reduced Alenuihaha Channel, the Hawaii Area Tracking System, and the Kahoolawe Training Minefield due to national security impacts.
In the proposed rule we identified four features that are essential to MHI IFKWs: Island-associated habitat, prey, water quality, and sound. We received public comments that questioned the clarity of some of these features, and whether certain features were sufficiently described to meet the definition of critical habitat. For example, one comment criticized the feature, island-associated marine habitat for MHI IFKWs, because it lacks objective parameters that warrant special management considerations or protections. The commenter requested more clarity on or removal of this feature.
After review of this comment and other comments, we recognize the interdependence of movement and space, prey, sound, and water quality characteristics in identifying island-associated habitat that is essential to the conservation of the species because these habitat characteristics collectively support important life history functions, such as foraging and reproduction, which are essential for this population's conservation. Indeed, MHI IFKWs are an island-associated population of false killer whales with their range restricted to the shelf and slope habitat around the MHI, unlike pelagic false killer whales found more in open oceans. Because these habitat characteristics are important components to the ecology of these whales, we have reorganized the essential features in the proposed rule into a single feature, island-associated marine habitat for MHI IFKWs, with four characteristics that support this feature. The four characteristics include (1) adequate space for movement and use within shelf and slope habitat; (2) prey species of sufficient quantity, quality, and availability to support individual growth, reproduction, and development, as well as overall population growth; (3) waters free of pollutants of a type and amount harmful to MHI IFKWs; and (4) sound levels that will not significantly impair false killer whales' use or occupancy (see the
The first characteristic, adequate space for movement and use within shelf and slope habitat, is used to describe, in part, the “island-associated marine habitat” feature in the proposed rule. We have highlighted this as a characteristic of the island-associated habitat for this final rule in response to comments that requested clarity on the special management considerations for this feature. Under the description of this feature, we note the importance of supporting these whales' ability to move to, from, and around areas of concentrated (high) use and provide details about how activities, such as large-scale construction or noise, may act as barriers to movement for these whales within their restricted range.
Characteristics 2 and 3, prey and water quality, have not materially changed from the proposed rule; however, we do provide more information in our description in the
In the proposed rule we solicited comments on the feature “habitat free of anthropogenic noise that would significantly impair the value of the habitat for MHI IFKW use or occupancy.” We received multiple comments that suggested removing this feature for the following reasons: The effects of noise on IFKWs are already considered under the jeopardy standard analysis; the absence of noise is not a feature of the habitat, there is not sufficient scientific justification for the feature, and the management of this feature is not clearly described.
As odontocetes, these whales rely on their ability to receive and interpret sound within their environment in order to forage, travel, and communicate with one another. Accordingly, island-associated habitat must be capable of supporting MHI IFKWs' ability to do so. While noise has the potential to affect individual whales in a manner that may have biological significance (
To clarify how sound as a characteristic of habitat supports these whales and should be managed for this designation, we have revised the language of this characteristic to “sound levels that would not significantly impair MHI IFKW's use or occupancy.” For this characteristic we describe the importance of sound in this populations' ecology and describe how noise sources may alter the value of their habitat. After considering public comments, we recognize that the mere presence of noise in the environment—even noise that might result in harassment—does not necessarily result in adverse modification of critical habitat. Rather, chronic exposure to noise as well as persistent noise may impede the population's ability to use the habitat for foraging, navigating, and communicating, and may deter MHI IFKWs from using the habitat entirely (see also our response to Comment 6 and the
In the proposed rule we noted that we would be considering six additional requests submitted by the Navy, which were subsets of a larger area that the Navy initially requested for exclusion, but which NMFS determined should not be excluded under 4(b)(2). We reviewed these six areas along with four additional areas requested by the Navy consistent with the criteria reviewed for all other areas considered for national security exclusion for this rule.
For the Kaulakahi Channel Portion of W-186, the area north of Molokai, a reduced portion of the Alenuihaha Channel, the Hawaii Area Tracking System, and the Kahoolawe Training Minefield (NMFS 2018b), we find that the benefits of exclusion for national security outweigh the benefit of designating MHI IFKW critical habitat. On June 22, 2017, the Navy requested exclusion of each of these areas as a subset of a larger “Entire Area.” The Navy also identified the area north of Molokai for exclusion as a subset of the “four islands region,” and the Alenuihaha Channel as a portion of the “waters surrounding the Island of Hawaii” exclusion request. NMFS initially proposed not to exclude these areas as included in the larger units (DON 2017a, as referenced in NMFS 2017b). We have now reevaluated these geographically limited portions of the initial request in response to information submitted by the Navy on October 10, 2017, along with the Navy's supplemental information limiting the geographic scope of their request to exclude Alenuihaha Channel. Although the June 22, 2017 request provided a full description of the defense activities in all of these areas, the Navy's supplemental submissions helped improve our understanding of the geographic scope of the particular impacts to national security. For example, the Navy clarified that the Channel Portion of the W-186 area is used to support military activities occurring on the Pacific Missile Range Facility (PMRF) Offshore Areas and that the area north of Molokai provides unique bathymetry that supports the Submarine Command Course (DON 2017b, DON 2018). Supplemental information also identified the unique training capabilities provided by the bathymetry of the Hawaii Area Tracking System and the instrumentation found within the Kahoolawe Training Minefield, which support military readiness. Additionally, with respect to the Alenuihaha Channel, our exclusion decision is limited to the deeper areas of the Channel that support Undersea Warfare training exercises; these waters include approximately 2,609 square kilometers (km
For the other three areas identified in the Navy's October 10, 2017 request, as well as two additional areas identified by the Navy on February 8, 2018, we find that the benefits of designating critical habitat for MHI IFKWs outweigh the benefits of excluding these areas. The
Thus, given these changes, in total we have excluded 14 areas (one area, with two sites, for BOEM and 13 areas requested by the Navy from the critical habitat designation because we have determined that the benefits of exclusion outweigh the benefits of inclusion, and exclusion will not result in extinction of the species. The excluded areas are: (1) The BOEM Call Area offshore of the Island of Oahu (which includes two sites, one off Kaena point and one off the south shore); (2) the Navy Pacific Missile Range Facility's Offshore ranges (including the Shallow Water Training Range (SWTR), the Barking Sands Tactical Underwater Range (BARSTUR), and the Barking Sands Underwater Range Extension (BSURE; west of Kauai)); (3) the Navy Kingfisher Range (northeast of Niihau); (4) Warning Area 188 (west of Kauai); (5) Kaula Island and Warning Area 187 (surrounding Kaula Island); (6) the Navy Fleet Operational Readiness Accuracy Check Site (FORACS) (west of Oahu); (7) the Navy Shipboard Electronic Systems Evaluation Facility (SESEF) (west of Oahu); (8) Warning Areas 196 and 191 (south of Oahu); (9) Warning Areas 193 and 194 (south of Oahu); (10) the Kaulakahi Channel portion of Warning area 186 (the channel between Niihau and Kauai and extending east); (11) the area north of Molokai; (12) the Alenuihaha Channel, (13) the Hawaii Area Tracking System, and (14) the Kahoolawe Training Minefield. In addition, the Ewa Training Minefield and the Naval Defensive Sea Area are precluded from designation under section 4(a)(3) of the ESA because they are managed under the Joint Base Pearl Harbor-Hickam Integrated Natural Resource Management Plan that we find provides a benefit to the MHI IFKW.
We requested comments on the proposed rule to designate critical habitat for the MHI IFKW and associated supporting reports as described above. We received 26 individual submissions in response to that request. We have considered all public comments, and provide responses to all significant issues raised by commenters that are relevant to the proposed designation of MHI IFKW critical habitat. We have not responded to comments or concerns outside the scope of this rulemaking, including comments disagreeing with the listing of this DPS as endangered, or recommendations regarding broad ESA policy issues.
We note that federally managed longline fisheries (including the deep-set and shallow-set fisheries) are currently not considered a “major” threat to this DPS or their habitat. As noted in the MHI IFKW Recovery Outline (NMFS 2016a), which categorizes the significance of threats to this DPS from low to high, the threat of incidental take (
We note that reductions in prey are described as a medium threat, with several fisheries potentially contributing to this risk. In the Draft Biological Report we reviewed the sustainability of stocks that are targeted by the federally managed longline fisheries and that are known IFKW prey species. Current information, although incomplete, suggests that these stocks are sustainably managed and that additional management is not necessary to conserve prey species (NMFS 2018). However, we also note in the Draft and Final Biological Report that, as new information becomes available regarding MHI IFKW dietary needs or the sustainability of overlapping fish stocks, additional management measures may be taken in the future to ensure that MHI IFKW critical habitat is not adversely modified.
With regard to water pollution, we have included water quality as a characteristic of MHI IFKW critical habitat because pollutants in marine waters of the island-associated habitat affect the quality of prey for this DPS and can create environments in which these whales are at higher risk of disease. The Draft and Final Biological Reports discuss water quality threats to MHI IFKW habitat under the Activities that Contribute to Water Pollution section, and discuss activities that may reduce water or prey quality by increasing persistent organic pollutants (POP) or other chemicals of emerging concern, heavy metals, pathogens, or naturally occurring toxins in Hawaii's surrounding waters (NMFS 2017a, 2018a). Although we have not identified additional management measures beyond the existing protections already granted from other regulations (
With regard to military activities, the Draft Biological Report indicated that a wide variety of activities were covered by this category including training, construction, and research activities undertaken by the Department of Defense. We have revised the Final Biological Report to clarify that RIMPAC exercises are included among the military training exercises considered under this category. The report notes that many of the military exercises in the Hawaii Range Complex are subject to a five-year MMPA authorization for the incidental take of marine mammals, which is subject to the consultation requirements of the ESA. These five-year reviews include the consideration of exercises that are undertaken during biannual RIMPAC events.
With regard to the comment that we should not allow RIMPAC to occur in critical habitat, we note that a critical habitat designation does not restrict activities from occurring in critical habitat; it is only during the section 7 consultation process that effects on critical habitat are determined and additional conservation and management measures are considered, as appropriate.
As acknowledged in the Draft Biological Report (NMFS 2017a), current information suggests that risks associated with certain threats may be minimal (
As noted by the Department of Energy, project location can play a large role in minimizing the environmental impacts of any particular project (DOE 2009). While we do find that impacts to critical habitat from offshore energy activities may occur, we do not expect that these project siting considerations will be raised as late as the formal section 7 consultation process. Based on BOEM's objective to work with regulatory agencies early in the planning process and to choose locations that will minimize environmental impacts (Gilman
With regard to the perceived inconsistency between modifications for fishery and energy development activities, we note that our anticipated modifications to minimize effects to MHI IFKW critical habitat vary among activities based on the available information. We recognize that fisheries have the potential to adversely affect MHI IFKW prey stocks and have included this activity in the list of activities that may affect MHI IFKW critical habitat. However, as noted in the Draft and Final Biological Reports, commercial fisheries are already regulated under catch limits and area restrictions that help ensure sustainability of fish stocks, and there is no current information suggesting that fishery catch rates are adversely affecting the availability of prey for IFKWs (NMFS 2017a and 2018a). Nevertheless, we anticipate that through the consultation process, NMFS will recommend project-specific modifications that will help reduce impacts to critical habitat, whether that activity involves commercial fisheries, energy development, or some other Federal action.
The ESA defines critical habitat, in relevant part, as the specific areas within the geographical area occupied by the species at the time it is listed on which are found those physical and biological features (I) essential to the conservation of the species and (II) which may require special management considerations or protection, 16 U.S.C. 1532(5)(A)(i).
Merriam-Webster defines a limiting factor as the environmental factor that is of predominant importance in restricting the size of a population. The ESA does not require that a feature be limiting, but only that it be essential to conservation and that it may require special management. It is rare that a single factor limits a species' conservation; instead, most listed species face multiple threats of varying magnitudes, and the combination of these threats can hinder recovery. As noted in the species' status review and recovery outline (Oleson
The phrase “may require” indicates that critical habitat includes features that may now, or at some point in the future, be in need of special management or protection. Similar to our analyses in the proposed rule, we determined that this characteristic of the essential feature may require special management considerations or protections due to competition from fisheries that catch MHI IFKW prey. Certain laws and regulatory regimes already directly or indirectly protect, to differing degrees and for various purposes, the prey characteristic of the essential feature. However, in determining whether essential features may require special management considerations or protection, we do not base our decision on whether management is currently in place, or whether that management is adequate, but simply that it may require management. That is, we cannot read the statute to require that additional special management be required before we designate critical habitat (See
We recognize that there is uncertainty associated with the relative importance of particular prey items in the diet; however, the diet of these whales and their energetic requirements are sufficiently described in the Draft and Final Biological Reports (NMFS 2017a and 2018a). Specifically, MHI IFKWs are known to primarily forage on large pelagic fish, including yellowfin tuna, albacore tuna, skipjack tuna, broadbill swordfish, mahi-mahi, wahoo, and lustrous pomfret (for the full list of dietary items see Table 2 of the Final Biological Report; NMFS 2018a), and the energetic requirements for the population is estimated to be approximately 2.6 to 3.5 million pounds of fish annually (see the Diet section of the Final Biological Report, NMFS 2017a). As noted in the Fisheries section of the Final Biological Report several fisheries target or catch MHI IFKW prey species. At least nine MHI IFKW prey species (from Table 2) are taken by the Federally managed longline fisheries (see Table 3 of the Final Biological Report) and several other species are incidentally caught by the state and Federal bottomfish fisheries. This overlap in targeted species of fish indicates there may be competition between fisheries and MHI IFKWs. Our designation and associated economic analysis are based upon the best available scientific information available at the time of designation. At this time, the prey characteristic of the essential feature meets the definition of critical habitat, in that it is essential to the conservation of the species and may require special management considerations or protection.
As odontocetes, these whales rely on their ability to receive and interpret sound within their environment in order to forage, travel, and communicate with one another. Accordingly, island-associated habitat must be capable of supporting MHI IFKWs' ability to do so. While it is clear that noise introduced into the environment has the potential to affect individual whales in a manner that may have biological significance (
With regard to the comment that this characteristic has not been expressed as a feature of the habitat, we considered rephrasing this characteristic to describe how ambient sound levels support MHI IFKW's capacity to forage, navigate, and communicate. However, we find that this articulation would not provide sufficient guidance to the regulated community about human activities that may degrade listening conditions for MHI IFKWs within island-associated marine habitat. To clarify how sound as a characteristic of habitat supports these whales and how human activities may adversely affect this characteristic we have revised the language describing this characteristic from “Habitat free of anthropogenic noise that would significantly impair the value of the habitat for false killer whales' use or occupancy” to “sound levels that would not significantly impair MHI IFKW's use or occupancy.” We believe that this formulation appropriately identifies that these whales rely on sound levels within their environment, and that noise that alters sound levels such that it interferes with these whales' use or occupancy may result in adverse effects to MHI IFKW critical habitat.
In this rule (see the
Our designation must be based on the best available scientific information at the time of designation and this includes considerable information on the species' reliance on sound in the environment and the effects of sound on their ability to communicate, forage and travel. Although we may not be able to predict exactly what noise-related activities may result in adverse modification of critical habitat or the management measures that will be taken in the future, we conclude that sound is an important characteristic of this species' habitat that may need special management considerations.
While previous critical habitat designations may not always have directly identified sound levels as a characteristic of critical habitat, we have considered how anthropogenic noise affects habitat use for species that are susceptible to the adverse effects associated with in-water sound for example, by creating barriers to passage or movement of Southern Resident killer whales (71 FR 69054; November 29, 2006) and Atlantic sturgeon (82 FR 39160, August 17, 2017). Although we ultimately did not include sound as an essential feature for the Southern Resident killer whale, our designation of critical habitat for Cook Inlet beluga whales does include the essential feature of the absence of in-water noise at levels resulting in the abandonment of habitat by Cook Inlet whales” (76 FR 20180; April 11, 2011).
As discussed in the Final Biological Report, how human activities that introduce noise in the environment might change the animals' use of habitat and determining the biological significance of that change can be complex and involve consideration of site specific variables, including: The characteristics of the introduced sound (frequency content, duration, and intensity); the physical characteristics of
DAR referred to the large area of the proposed designation at 19,184 mi
Comments received from the Marine Mammal Commission (MMC) also noted the large size of this designation and the potential difficulty in managing acute threats to IFKWs over a broad designation. However, the MMC also noted that, for the time being, the size of this designation was appropriate because information necessary to refine this designation is not yet available for this DPS. The MMC noted that the proposal meets the statutory requirements and went on to recommend that NMFS continue to undertake and support research needed to refine the designation in the future to further support recovery needs for this DPS.
Rather, current information suggests that these whales travel great distances throughout the MHI (Baird
We have not identified the high-use areas of the range as an independent feature of MHI IFKW critical habitat, but rather as a strong indicator of the presence of characteristics of the essential feature. We also use the information about known concentrated habitat use to evaluate the conservation value of areas, as noted in the ESA Section 4(b)(2) Report (NMFS 2018b). Because of the concentrated use of this habitat, we infer the conservation value for high-use areas to be higher than low-use areas of the range. In other words, we considered that these high-use areas of the designation may offer more benefits to IFKWs and that the loss or degradation of these areas may result in a greater impact to the DPS as a whole. In our response to Comment 5, we note that we revised our Biological Report to clarify that we expect siting decisions for renewable energy projects to occur early in the planning stage rather than at the consultation stage. Nonetheless, we do expect planners to take into consideration IFKW use of a particular area and to minimize any potential impacts to these whales and their habitat. Thus, while the effects of certain technologies are largely uncertain, planning groups may choose to avoid placing projects in high conservation value areas if alternative locations exist in low-use areas.
The Council requested that NMFS provide further clarification on the basis for selecting the outer boundary of 3,200 m in depth. The Council noted that the depth appears to have been selected to allow the designation to be drawn in a continuous range around the MHI and that the designation may include areas that may not be essential to the conservation of the MHI IFKWs. The Council recommended that an alternative delineation be made based on different depth ranges around each island and the channels to account separately for habitat characteristics around each island and areas used among islands for movement.
Review of this information revealed that 2.5-3.8 percent of satellite-tag locations were shallower than 45 m across the islands (the higher percent includes points located on land, which likely fall into shallow locations due to the associated error with these satellite-tag locations). When we mapped shallow satellite-tag locations across the islands, we did not observe clear spatial patterns around each island, but saw that shallower use varied somewhat between islands. Similar to the proposed rule, we then reviewed depth frequency histograms of satellite-tag locations, but considered these locations specific to each island as requested by the above comments. These histograms varied slightly from island to island, but we noted that when high-use areas are located near islands, the depth frequency histogram for that island is skewed toward deeper depths, indicating these data may be limited in describing meaningful patterns around the entire island. In addition to considering depth around each island, we reviewed distance from shore and found similarly disparate patterns ranging from 500 m offshore to over 1,200 m. Looking across the islands as a whole, less than four percent of the satellite-tag locations are found at depths shallower than 45 m, and this remains a depth at which the frequency of satellite-tag locations increases and remains more consistent.
Throughout this review we considered whether prescribing a different depth or distance from shore for each island would provide more clarity about MHI IFKW habitat use or management of their habitat around each island; however, prescribing island-specific boundaries would not better match how these animals use Hawaiian waters. Given the DPS's non-uniform treatment of habitat around each island, splitting these data by island may not partition the habitat in manner that is ecologically meaningful.
With regard to the outer boundary, we selected the outer depth boundary to incorporate those areas of island-associated habitat where MHI false killer whales are known to spend a larger proportion of their time (see high-use discussion in Movement and Habitat Use in the Biological Report), and to include island-associated habitat that allows for movement between islands and around each island. As noted above, these whales move great distances throughout the MHI, moving back and forth between areas off multiple islands. The 3,200 m depth boundary best aligns with the span of habitat used on the leeward and windward sides of the islands, allowing for ample space for these whales to move among areas of concentrated or high-use, including habitat across the core portions of the range.
We have not revised the boundaries at this time because the commenters requested revisions are not supported by the data, although some aspects of our analysis indicate that further consideration may be warranted as additional information becomes available. The current delineation of 45-3,200 m is appropriate because it includes a depth just offshore where MHI IFKWs are more likely to be found and an outer boundary that aligns with habitat use on the leeward and windward sides of the islands, while allowing for travel around and between the islands.
The JBPHH INRMP overlaps with the areas under consideration for critical habitat in two areas, the Naval Defensive Sea Area and the Ewa Training Minefield, which include approximately 27 km
During development of the proposed rule the Navy highlighted a number of JBPHH management efforts that benefit MHI IFKW habitat. After reevaluation, we still find that the JBPHH INRMP provides a number of conservation measures that benefit MHI IFKWs and their habitat, including those that address water quality and fishery prey base (see the
We find that some of these protections (
As part of an adaptive management approach for this INRMP, NMFS staff participates in JBPHH INRMP annual reviews to provide recommendations about plan implementation and effectiveness and to receive information about upcoming plan amendments. These reviews help ensure that the plan provides an effective mechanism for addressing MHI IFKW conservation within areas managed under the JBPHH INRMP. Specifically, the reviews provide a reliable method for feedback, regular assurances that the above-described conservation measures are being implemented, and a procedure for assessing and modifying measures to ensure conservation effectiveness.
Although not essential to our determination that the JBPHH INRMP provides a benefit to the MHI IFKW, we also take into consideration additional future measures that the Navy plans to include in updates to the INRMP by December 2018. These expected additional measures include (1) specific information about MHI IFKWs, (2) where MHI IFKWs may be found in areas managed by the installation, (3)
After careful review, we are satisfied that the Navy's 2011 JBPHH INRMP provides a benefit to the MHI IFKW in this relatively small (0.5 percent of habitat that overlaps with areas that meet the definition of MHI IFKW critical habitat) area having low-moderate conservation value to MHI IFKWs. We are satisfied that the Navy's documented history of consistent plan implementation and their commitment to adaptive management through the implementation of mandatory mitigation measures will ensure that MHI IFKWs receive benefits under the JBPHH INRMP, particularly with respect to improving watershed health in the Pearl Harbor area, which will benefit prey and water quality characteristics. Further, we expect that the Navy will continue to strengthen its INRMP through scheduled updates to be completed by December 2018.
We note that the consultation process for critical habitat under the ESA and EFH under the Magnuson-Stevens Act have different requirements and work under different timeframes. We have no basis to conclude that the costs associated with conserving existing EFH are related to costs associated with this critical habitat designation.
With regard to the “Waters Enroute to PMRF,” Kingfisher Range, and Kaula and Warning Area 187 examples, we disagree that our weighing process was inconsistent in the proposed rule, and we note that key differences in our analyses outlined in the ESA Section 4(b)(2) Report turned on differences associated with the size of the requests, the control that DOD has over each area, and the likelihood that other Federal activities may require consultation and may occur in each area. For example, both the Kingfisher and Kaula areas are relatively small in size, and DOD control and use of these areas are likely to preclude other Federal activities that would otherwise undergo consultation, thus presenting a lower benefit of designating critical habitat in these areas. In contrast, “Waters Enroute to PMRF” includes a larger area in which the Air Force's activities and use are not likely to preclude other Federal activities that would otherwise undergo consultation. However, based on this comment, and the question raised about inconsistencies in our decision making process, we have revised tables in our ESA Section 4(b)(2) Report to articulate more clearly the differences in our determinations for this weighing process.
As noted above, we have reassessed our evaluation of the waters south and east of PMRF (the Kaulakahi Channel portion of Warning area 186) after considering supplemental information furnished by the Navy in October of 2017, and for the reasons discussed above, we concluded that the benefits of excluding this area outweigh the benefits of designation. While the Kaulakahi Channel portion of Warning area 186 overlaps in part with the “Waters Enroute to PMRF,” these two areas were assessed independently based on differences in the geographic scopes of the requests made by the Air Force and Navy, as well as differences in the activities occurring in these areas (DOAF 2017, DON 2017b, DON 2018). Although our independent weighing of the Air Force's request for the “Waters Enroute to PMRF” area did not change, we note that a portion of this area is now excluded from critical habitat because it overlaps with the Kaulakahi Channel portion of Warning area 186, where the benefits of exclusion (for Navy activities) were found to outweigh the benefits of designation.
With regard to the six additional areas under consideration for exclusion, Baird noted that only one area, the Kaulakahi Channel Portion of W-186, represents an area that is likely not particularly important to the population. The other five areas, however, represent areas where MHI IFKWs spend a disproportionate amount of time. NRDC and the CBD also commented that the NMFS should not exclude the area south of Oahu, the Kaiwi Channel, or the Alenuihaha Channel due to the importance of areas to MHI IFKWs.
To consider the conservation value of a particular area relative to other areas of the potential designation, we overlaid tracking information from Cascadia
Looking at the maps of MHI IFKW high-density and travel information, FORACS includes areas that fall within low-use areas and moderate to low transit areas, and SESEF and Kingfisher generally fall within low-use areas and low transit areas. After taking into consideration DOD's use of the area (including the types of activities that occur here and the uniqueness of that activity), the likelihood of changes to the consultation, the level of protection already provided by management and the likelihood of non-DOD actions occurring in these areas, we confirm our initial finding that the benefits of excluding these areas for national security still outweigh the benefits of designation. While we recognize that travel to, from, and around habitat areas is important for these whales, we find that existing management protections provide adequate levels of protections for these sites and that Navy control and use of these areas is likely to deter other non-DOD actions that may otherwise require consultation in these particular areas. As such we have excluded these areas from the final designation.
With regard to the six additional areas under consideration for exclusion, we reviewed each area consistent with the review of all other areas considered for national security exclusions for this rule. We agree with commenters that three of these areas (the area north and east of Oahu, the Kaiwi Channel, and the area south of Oahu) represent high-use or high to moderate travel areas for MHI IFKWs. However, the Kaulakahi Channel Portion of W-186, and the area north of Molokai fall within mostly low-use and low travel areas of the designation. Additionally, as noted in the
For the Kaulakahi Channel Portion of W-186, the area north of Molokai, and the reduced Alenuihaha Channel area (NMFS 2018b), we found that the benefits of exclusion for national security outweigh the benefits of designating MHI IFKW critical habitat. We note that on June 22, 2017, the Navy requested exclusion of these areas as a subset of the larger “Entire Area” and, in the case of the area north of Molokai, as a subset of the “four islands region.” NMFS initially proposed not to exclude these two larger units. Although the June 22, 2017, request provided a full description of the defense activities in these areas (DON 2017a as referenced in NMFS 2017b), the Navy's supplemental submission in October 2017 helped improve our understanding of the geographic scope of the particular impacts to national security in the Kaulakahi Channel Portion of W-186 and the area north of Molokai (see Figure 2 of the proposed rule (82 FR 51186; November 03, 2017) and NMFS 2018b). Additionally, the Navy provided supplemental information regarding training activities in the Alenuihaha Channel, and clarified that its request for exclusion included only the deeper areas of the Channel that support Undersea Warfare training exercises. We also note that all three of these areas represent largely low-use and low-transit habitat and were identified as significant for Navy use and activities. Given our improved understanding of the defense activities conducted and the reduced size of the exclusions, we conclude that the benefits of exclusion outweigh the benefits of designating critical habitat, and that exclusions will not result in extinction of the species.
With respect to the remaining three sites (the area north and east of Oahu, the Kaiwi Channel, and the area south of Oahu), we found that the benefits of designation outweighed the benefits of exclusion, largely because these areas represent high-use or high to moderate transit areas for MHI IFKWs and other non-DOD activities that may require consultation may occur in these areas.
With regard to the comment on the Naval Defensive Sea Area and the Ewa Training Minefield, we refer to our response to Comment 12 regarding our decision to find that the JBPHH INRMP provides a benefit to MHI IFKWs.
The Navy submitted comments noting that, while the Navy supports the exclusion of areas suitable for renewable energy development, portions of the currently identified areas (BOEM Call Areas) are not suitable for renewable energy development, due to national security concerns. The Navy asserted that it is committed to bringing renewable energy to Oahu and has identified alternative locations which the Navy deems suitable. In support of identifying areas for renewable energy development, the Navy completed an assessment of areas (see
In recommending that NMFS not exclude this area, the MMC noted that NMFS should only consider exclusion in instances in which the exclusion would not result in the extinction of the DPS and noted that, due to the precarious status of IFKWs, the apparent importance of its entire range to its continued existence, and NMFS' inability to identify which factor or factors caused the population to decline in the past and may continue to threaten its persistence, the exclusion of any of the areas proposed as critical habitat from the final designation could contribute to the population's eventual extirpation.
Given the significance of this offshore area in supporting renewable energy goals for the State of Hawaii and the goals of Executive Order 13795, the low administrative costs of this designation, the existing baseline protections, and the low-use by MHI IKFWs, we find that the benefits of exclusion of this area outweigh the benefits of designation. Based on our best scientific judgment and acknowledging the relatively small size of the area (approximately 0.2 percent of the overall designation), and other safeguards that are in place (
Furthermore, we conclude that none of the exclusions will result in extirpation of the species. As previously noted, this population and its habitat benefit throughout its range from other protections under the ESA as well as other statutes and their regulations. In addition, the exclusions outlined in this rule are limited in scope and include habitat that is of lower conservation value for this population. Thus, this designation provides protections throughout the core portions of the MHI IFKWs' range and in areas of high conservation value.
With regard to the comments about requiring permission and minimizing the impacts of sound, we also refer back to our response to Comment 1, which explains that military activities already undergo consultation to minimize the impacts of their activities and ensure they are not likely to jeopardize the species. Specifically, military readiness activities in the Hawaii Range Complex are subject to a 5-year MMPA incidental take authorization for marine mammals, which is subject to ESA consultation. These review and consultation efforts under the ESA and MMPA help to identify management or mitigation that may be necessary to minimize adverse impacts to MHI IFKWs, and such analyses include reviews of the best scientific information available, including works such as Nachtigall and Supin (2013), to help identify mitigation measures. MHI IFKW critical habitat will establish an additional consideration to the existing ESA section 7 consultation process in designated areas.
In the following sections, we describe the relevant definitions and requirements in the ESA and our implementing regulations, and the key information and criteria used to prepare this critical habitat designation. In accordance with section 4(b)(2) of the ESA and our implementing regulations at 50 CFR part 424, this final rule is based on the best scientific data available.
To assist with identifying potential MHI IFKW critical habitat areas, we convened a critical habitat review team (CHRT) consisting of five agency staff with experience working on issues related to MHI IFKWs and Hawaii's pelagic ecosystem. The CHRT used the best available scientific data and its best professional judgment to (1) determine the geographical area occupied by the DPS at the time of listing, (2) identify the physical and biological features essential to the conservation of the species, and (3) identify specific areas within the occupied area containing those essential physical and biological features. The CHRT's evaluation and recommendations are described in detail in the Biological Report (NMFS 2018a). Beyond the description of the areas, the critical habitat designation process includes two additional steps (although these are not conducted by the CHRT): (1) Identify whether any area may be precluded from designation because the area is subject to an INRMP that we have determined provides a benefit to the DPS, and (2) consider the economic, national security, or any other impacts of designating critical habitat and determine whether to exercise our discretion to exclude any particular areas. These considerations are described further in the Final ESA Section 4(b)(2) Report (NMFS 2018b), and economic impacts of this designation are described in detail in the Final Economic Report (Cardno 2018).
The ESA does not specifically define physical or biological features; however, court decisions and joint NMFS-USFWS regulations at 50 CFR 424.02 (81 FR 7413; February 11, 2016) provide guidance on how physical or biological features are expressed.
Physical and biological features support the life-history needs of the species including, but not limited to, water characteristics, soil type, geological features, sites, prey, vegetation, symbiotic species, or other features. A feature may be a single habitat characteristic, or a more complex combination of habitat characteristics that support ephemeral or dynamic habitat conditions. Features may also be expressed in terms relating to principles of conservation biology, such as patch size, distribution distances, and connectivity. Features may constitute combinations of habitat characteristics, and may encompass the relationship between characteristics or the necessary amount of a characteristic needed to support the life history of the species.
Based on the best available scientific information and in response to public comments, the CHRT identified the specific biological and physical feature essential for the conservation of the Hawaiian IFKW DPS, as the following: Island-associated marine habitat for MHI insular false killer whales.
MHI IFKWs are island-associated whales that rely entirely on the productive submerged habitat of the main Hawaiian Islands to support all of their life-history stages. The following characteristics of this habitat support insular false killer whales' ability to travel, forage, communicate, and move freely around and among between the main Hawaiian Islands:
(1)
Human activities can interfere with movement of the whales and adversely affect their ability to travel to and move throughout areas of high-use. In particular, large marine structures or long-term acoustic disturbance may present obstacles to whale movement. These obstacles could cause the whales to swim further to reach high-use areas, expending additional energy and displacing these whales into waters farther from shore. In severe cases, such obstacles may cause the whales to abandon areas of concentrated use.
(2)
MHI IFKWs are top predators that feed on a variety of large pelagic fish and squid. Prey preference and relative importance is still difficult to determine for this population; however, commonly described prey species from observations include large game fish such as mahi mahi, wahoo, yellowfin tuna, albacore tuna, skipjack tuna, broadbill swordfish and threadfin jack. In addition, analyses from recent strandings of insular false killer whales suggest that some species of squid may play a role in the IFKW diet.
Sustained decreases in prey quantity and availability in island-associated waters can decrease foraging success of these whales and eventually lead to reduced individual growth, reproduction, and development. Additionally, factors that reduce prey size and introduce or increase contaminant or toxin levels reduce the quality of prey for these whales. Decreased prey size reduces the energetic value gained, while
(3)
Pollutants that reach Hawaii's marine waters through point source and nonpoint source pollution have the potential to degrade the water quality or prey quality and increase the health risks to MHI IFKWs. As a long-lived, top marine predator, water quality plays an important role in supporting the MHI IFKWs' ability to forage and reproduce free from disease and impairment. Environmental contaminants, such as organochlorines, heavy metals, and other chemicals that persist and accrue in waters surrounding the MHI, accumulate in prey species and subsequently in MHI IFKWs. Biomagnification of some pollutants can adversely affect health in these top marine predators, causing immune suppression, decreased reproduction, or other impairments. Water pollution and changes in water temperatures may also increase pathogens, naturally occurring toxins, or parasites in surrounding waters. MHI insular false killer whales' may be exposed to these infectious or harmful agents (such as bacteria, viruses, toxins, or parasites) either through their prey or directly through ingestion of contaminated waters. Exposure to water pollutants are known to adversely affect the health and reproduction of cetaceans, including false killer whales.
(4)
For the purposes of this final rule, noises that would significantly impair use or occupancy are those that inhibit MHI IFKW's ability to receive and interpret sound for the purposes of navigation, communication, and detection of predators and prey. Such noises are likely to be long-lasting, continuous, and/or persistent in the marine environment and, either alone or added to other ambient noises, significantly raise local sound levels over a significant portion of an area.
False killer whales rely on their ability to produce and receive sound within their environment to navigate, communicate, and detect predators and prey. With a foraging strategy that is adapted to the shelf and slope habitat of the MHI, these large marine predators travel in subgroups that are dispersed from each other but converge when prey resources are found. Accordingly, these animals rely on their ability to receive and interpret acoustic cues to find prey at a distance and convey information about available prey resources to other dispersed subgroups of IFKWs. Habitats that contribute to the conservation of MHI IFKWs allow these whales to employ underwater sound in ways that support important life history functions, such as foraging and communicating.
A large body of scientific information on the effects of anthropogenic noise on the behavior and distribution of toothed whales, including false killer whales, demonstrates that the presence of anthropogenic noise can adversely affect the value of marine habitat to MHI IFKWs (Shannon
How human activities that introduce noise in the environment might change the animals' use of habitat and the determination of the biological significance of that change can be complex and involve consideration of site specific variables, including: The characteristics of the introduced sound (frequency content, duration, and intensity); the physical characteristics of the habitat; the baseline soundscape; and the animal's use of that habitat. NMFS will continue to use the best scientific information available to analyze chronic or persistent noise sources and determine whether they degrade listening conditions within habitat for the IFKW, including but not limited to, the Technical Guidance for Assessing the Effects of Anthropogenic Sound on Marine Mammal Hearing, (81 FR 51693; August 04, 2016; NMFS 2016b, or replacement publications).
The first steps in the critical habitat revision process is to define the geographical area occupied by the species at the time of listing, and to identify specific areas within this geographical area that contain at least one of the essential features that may require special management considerations or protection. As noted earlier, the best available information indicates that the range of this DPS is smaller than the range identified at the time of listing (77 FR 70915, November 28, 2012; Bradford
To be eligible for designation as critical habitat under the ESA's definition of occupied areas, each specific area must contain at least one essential feature that may require special management considerations or protection. To meet this standard, the CHRT concluded that false killer whale tracking data would provide the best available information to identify habitat use patterns by these whales and to recognize where the physical and biological features essential to their conservation exist. Cascadia Research Collective provided access to MHI IFKW tracking data for the purposes of identifying critical habitat for this DPS. Due to the unique ecology of this island-associated population, habitat use is largely driven by depth. Thus, the features essential to the species' conservation are found in those depths that allow the whales to travel throughout a majority of their range seeking food and opportunities to socialize and reproduce.
One area has been identified as including the essential feature for the MHI IFKW DPS. This area ranges from the 45-m depth contour to the 3,200-m depth contour in waters that surround the MHIs from Niihau east to the Island of Hawaii (see the Biological Report for additional detail; NMFS 2018a). MHI IFKWs are generally found in deeper areas just offshore (Baird
In response to some public comments that suggested we choose different boundaries for this designation (see Comment 9 and response), we re-analyzed the data used to select the boundaries for this designation, and also analyzed new satellite information received from Cascadia Research Collective.
Review of this information revealed that 2.5-3.8 percent of satellite-tag location data were shallower than 45 m across the islands (the higher percentage includes points located on land, which likely fall into shallow locations due to the error associated with these points). When shallow points were mapped across the islands (using GIS), clear spatial patterns were not evident across all islands; for some islands shallower use was seen around a good portion of the island (
Throughout this review we considered whether prescribing a different depth or distance from shore for each island would provide more clarity about MHI IFKW habitat use or for management of their habitat around each island; however, it was not clear that prescribing island-specific boundaries would better match how these animals use Hawaiian waters. Given the population's non-uniform treatment of habitat around each island, splitting these points by island may not partition the habitat in manner that is ecologically meaningful.
As noted above, these whales move great distances throughout the MHI, moving back and forth between areas off multiple islands. NMFS found that the 3,200 m depth boundary best aligns with the span of habitat used on the leeward and windward sides of the islands, allowed for ample space for these whales to move among areas of concentrated or high-use, and included habitat across the core portions of the range.
At this time we find that the current delineation of 45-3,200 m allows for travel around and among the islands and incorporates our objectives of selecting an inner boundary and outer boundary where MHI IFKWs are most likely to be found. The full range of depths—from the 45-m to the 3,200-m depth contours—incorporates approximately 90 percent of the tracking locations of MHI IFKW and includes the feature and characteristics essential to the conservation of the MHI IFKWS DPS. The area that was under consideration for critical habitat included 56,821 km
Joint NMFS and USFWS regulations at 50 CFR 424.02 define special management considerations or protection to mean methods or procedures useful in protecting physical and biological features essential to the conservation of listed species.
Several activities were identified that may threaten the physical and biological feature essential to conservation such that special management considerations or protection may be required. This is based on information from the MHI IFKW Recovery Outline, Status Review for this DPS, and discussions from the Main Hawaiian Islands Insular False Killer Whale Recovery Planning Workshop (NMFS 2016a, Oleson
Section 3(5)(A)(ii) of the ESA authorizes the designation of specific areas outside the geographical area occupied at the time the species is listed, if the Secretary determines “that such areas are essential for the conservation of the species.” There is insufficient evidence at this time to indicate that areas outside the present range are essential for the conservation of this DPS; therefore, no unoccupied areas were identified for designation.
Section 4(a)(3)(B) of the ESA prohibits designating as critical habitat any lands or other geographical areas owned or controlled by DOD, or designated for its use, that are subject to an INRMP prepared under section 101 of the Sikes Act (16 U.S.C. 670a), if the Secretary determines in writing that such a plan provides a benefit to the species for which critical habitat is proposed for designation.
Regulations at 50 CFR 424.12(h) provide that in determining whether an applicable benefit is provided by a “compliant or operational” plan, we will consider the following:
(1) The extent of the area and features present;
(2) the type and frequency of use of the area by the species;
(3) the relevant elements of the INRMP in terms of management objectives, activities covered, and best management practices, and the certainty that the relevant elements will be implemented; and
(4) the degree to which the relevant elements of the INRMP will protect the habitat from the types of effects that would be addressed through a destruction-or-adverse-modification analysis.
NMFS can find that an INRMP provides a benefit to a species where, as here, the species is not directly addressed in the INRMP. In these cases, we consider adaptive conservation management for the features essential to the conservation of the species (
The JBPHH INRMP overlaps with the areas under consideration for critical habitat in two areas, the Naval Defensive Sea Area and the Ewa Training Minefield, which include approximately 27 km
In May 2017, we requested information from the DOD to assist in our analysis. Specifically, we asked for a list of facilities that occur within potential critical habitat areas and available INRMPs for those facilities. The U.S. Navy stated that areas subject to the JBPHH INRMP overlap with the areas under consideration for MHI IFKW critical habitat; no other INRMPs were identified as overlapping with the potential designation. This INRMP was drafted prior to the ESA listing of the MHI IFKW and did not incorporate conservation measures that are specific to MHI IFKWs. The plan was compliant through the end of 2017; and although its five-year review as to operation and effect is late, the INRMP remains funded and effective. The Navy continues to implement and report on conservation measures outlined in the JBPHH INRMP and is currently reviewing and updating the INRMP with a goal of finishing in December 2018.
In the response to NMFS' request for information about this INRMP, the Navy outlined several elements of the 2011 INRMP's implemented and ongoing conservation measures that may benefit the MHI IFKW and their habitat (with the characteristic of the essential element that is addressed): Fishing restrictions adjacent to and within areas that overlap the potential designation (prey), creel surveys that provide information about fisheries in unrestricted areas of Pearl Harbor (prey), restrictions on free roaming cats and dogs in residential areas (water free of pollutants), feral animal removal (water free of pollutants), participation in the Toxoplasmosis and At-large Cat Technical Working Group (which focuses on providing technical information to support policy decisions to address the effects of toxoplasmosis on protected wildlife and provides education and outreach materials on the impacts that free-roaming cats have on Hawaii's environment; waters free of pollutants), efforts taken to prevent and reduce the spread of biotoxins and contaminants from Navy lands (including best management practices, monitoring for contamination, restoration of sediments, and spill prevention; waters free of pollutants), a Stormwater Management Plan and a Stormwater Pollution Control Plan associated with their National Pollutant Discharge Elimination System (waters free of pollutants), and coastal wetland habitat restoration projects (waters free of pollutants) (DON 2017a). Although the 2011 JBPHH INRMP does not specifically address the MHI IFKW, several of the above measures support the protection of the IFKW and the physical and biological feature identified for this designation. Specifically, the Navy's efforts that focused on preventing the spread of toxoplasmosis, biotoxins, and other contaminants to the marine environment provide protections for MHI IFKW water quality and address threats to this feature characteristic; these threats are identified in our Draft Biological Report (NMFS 2017a). Further, efforts to support coastal wetland habitat restoration provide protections for MHI IFKW water quality and provide ancillary benefits to MHI IFKW prey, which also rely on these marine ecosystems. Additionally, fishery restrictions in the NDSA and Ewa Training Minefield provide protections to MHI IFKW prey within the limited overlap areas. Some of the protections associated with the management of stormwater and pollution address effects that would otherwise be addressed through an adverse modification analysis. Other protections associated with the spread of toxoplasmosis to the marine environment or that enhance prey, address effects to MHI IFKW habitat that otherwise may not be subject to a section 7 consultation. In these instances, the Navy's INRMP provides protections aligned with 7(a)(1) of the ESA, which instructs Federal agencies to aid in the conservation of listed species.
As part of an adaptive management approach for this INRMP, NMFS staff participates in JBPHH INRMP annual reviews to provide recommendations about plan implementation and effectiveness and to receive information about upcoming plan amendments. These reviews help ensure that the plan provides an effective mechanism for addressing MHI IFKW conservation within areas managed under the JBPHH INRMP. Specifically, the reviews provide a reliable method for feedback, regular assurances that the above-described conservation measures are being implemented, and a procedure for assessing and modifying measures to ensure conservation effectiveness.
Although not essential to our determination that the JBPHH INRMP provides a benefit to the MHI IFKW, we also take into consideration additional future measures that the Navy plans to include in updates to the INRMP by December 2018. These expected additional measures include (1) specific information about MHI IFKWs, (2) where MHI IFKWs may be found in areas managed by the installation, (3) new projects associated with watershed enhancement, and (4) mandatory mitigation measures already used by the Pacific Fleet to minimize impacts to MHI IFKWs as they use these areas. Procedural mitigation measures are mandatory activity-specific measures taken to avoid or reduce the potential impacts on biological resources from stressors, including those that may cause acoustic or physical disturbance to marine mammals during Navy training and testing. These procedural measures are required in the Navy's Protective Measures Assessment Protocol consistent with letters of authorization for training activities issued under the MMPA and supporting ESA analyses. Procedural mitigation measures are adaptively managed as new information becomes available about effective mitigation techniques, and are identified in the current Hawaii-Southern California Training and Testing Final Environmental Impact Statement. Examples of measures include training personnel to spot and identify marine mammals (lookouts), reporting requirements for trained lookouts, and halt or maneuvering requirements when marine mammals are spotted within identified mitigation zones of Navy activities (DON 2017c). Although not restricted to the JBPHH areas, these mandatory mitigation measures help ensure that the Navy will avoid or reduce the impacts from acoustic stressors on MHI IKFWs. These measures will be reflected in the INRMP by December 2018. Additionally, the Navy's continued efforts towards understanding the baseline conditions of Pearl Harbor (and associated watersheds) and improving water quality in this area will also support the prey and water free of pollutants characteristics of MHI IFKW habitat.
After consideration of the above factors, we determined that the Navy's
Section 4(b)(2) of the ESA requires the Secretary to consider the economic, national security, and any other relevant impacts of designating any particular area as critical habitat. Any particular area may be excluded from critical habitat if the Secretary determines that the benefits of excluding the area outweigh the benefits of designating the area. The Secretary may not exclude a particular area from designation if exclusion will result in the extinction of the species. Because the authority to exclude is discretionary, exclusion is not required for any areas. In this designation, the Secretary has applied statutory discretion to exclude 14 (1 area, with two sites, for economic exclusion and 13 areas for national security exclusion) occupied areas from critical habitat where the benefits of exclusion outweigh the benefits of designation for the reasons set forth below.
In preparation for the ESA section 4(b)(2) analysis, we identified the “particular areas” to be analyzed. The “particular areas” considered for exclusion are defined based on the impacts that were identified. We considered economic impacts and weighed the economic benefits of exclusion against the conservation benefits of designation for two particular areas where economic impacts were identified as being potentially higher than the costs of administrative efforts and where impacts were geographically concentrated. We also considered exclusions based on impacts on national security. Delineating particular areas with respect to consideration of national security impacts was based on land ownership or control (
The primary impact of a critical habitat designation stems from the requirement under section 7(a)(2) of the ESA that Federal agencies ensure that their actions are not likely to result in the destruction or adverse modification of critical habitat. Determining this impact is complicated by the fact that section 7(a)(2) contains the overlapping requirement that Federal agencies must also ensure their actions are not likely to jeopardize the species' continued existence. One incremental impact of the designation is the extent to which Federal agencies modify their actions to ensure their actions are not likely to destroy or adversely modify the critical habitat of the species, beyond any modifications they would make because of the listing and the subsequent requirement to avoid jeopardy. When the same modification would be required due to impacts to both the species and critical habitat, the impact of the designation is considered co-extensive with the ESA listing of the species (
In determining the impacts of designation, we focused on the incremental change in Federal agency actions as a result of critical habitat designation and the adverse modification provision, beyond the changes predicted to occur as a result of listing and the jeopardy provision. Following a line of recent court decisions (including
Once we determined the impacts of the designation, we then determined the benefits of designation. The benefits of designation include the conservation impacts for MHI IFKWs and their habitat that result from the critical habitat designation and the application of ESA section 7(a)(2). The benefits of exclusion include avoidance of the economic, national security, and other relevant impacts (
The primary benefit of designation is the protection afforded under section 7(a)(2) of the ESA, requiring all Federal agencies to ensure their actions are not likely to destroy or adversely modify designated critical habitat. This is in addition to the requirement that all Federal agencies ensure their actions are
In addition to the protections described above, Chapter 12 of the Final Economic Report (Cardno 2018) discusses other forms of indirect benefits that may be attributed to the designation including, but not limited to, use benefits and non-use or passive use benefits (Cardno 2018). Use benefits include positive changes that protections associated with the designation may provide for resource users, such as increased fishery resources, sustained or enhanced aesthetic appeal in ocean areas, or sustained wildlife-viewing opportunities. Non-use or passive benefits include those independent of resource use, where conservation of MHI IFKW habitat aligns with beliefs or values held by particular entities (
Most of these benefits are not directly comparable to the costs of designation for purposes of conducting the section 4(b)(2) analysis described below. Ideally, benefits and costs should be compared on equal terms; however, there is insufficient information regarding the extent of the benefits and the associated values to monetize all of these benefits. We have not identified any available data to monetize the benefits of designation (
Generally, we relied on density analysis of satellite-tracking data as well as an analysis of travel throughout the areas to provide information about MHI IFKW habitat use (Figure 4 of the Final ESA Section 4(b)(2) Report; NMFS 2018b). The descriptions of MHI IFKW habitat use provided in the sections below describe habitat in terms of high and low-use areas using the density analysis described in Baird
High-use areas denote areas where satellite-tracking information indicates more frequent use by MHI IFKWs. High to moderate travel areas provide further understanding about how these whales travel through specific areas. The conservation value for high-use and high-traveled areas is inferred to be higher than low-use and low-traveled areas of the range; however, all areas contain the essential feature and meet the definition of critical habitat for this DPS. As noted in the Biological Report (NMFS 2018a), there is limited representation among social clusters in the tracking data and information. Accordingly, the available satellite-tracking information may not be fully representative of MHI IFKW habitat use. While describing MHI IFKW use for the exclusion of some particular areas, we provide additional information (
Generally, we describe high-use areas as indicating areas of higher conservation value where greater foraging and/or reproductive opportunities are believed to exist. Additionally, high to moderate travel areas indicate areas of concentrated travel. However, particularly within a restricted range, low-use and low-traveled areas continue to offer the essential feature and may provide unique opportunities for foraging as oceanic conditions vary seasonally or temporally.
Economic costs of the designation accrue primarily through implementation of section 7 of the ESA in consultations with Federal agencies to ensure their proposed actions are not likely to destroy or adversely modify critical habitat. The Economic Report (Cardno 2018) considered the Federal activities that may be subject to a section 7 consultation and the range of potential changes that may be required for each of these activities under the adverse modification provision. To the extent possible, the analysis focused on changes beyond those impacts that may result from the listing of the species or that are established within the environmental baseline. However, the report acknowledges that some existing protections to prevent jeopardy to MHI IFKWs are likely to overlap with those protections that may be put in place to prevent adverse modification (Cardno 2018). The project modification impacts represent the benefits of excluding each particular area (that is, the impacts that would be avoided if an area were excluded from the designation).
The Final Economic Report (Cardno 2018) estimates the impacts based on activities that are considered reasonably foreseeable, which include activities that are currently authorized, permitted, or funded by a Federal agency, or for which proposed plans are currently available to the public. These activities align with those identified under the
The Final Economic Report (Cardno 2018) identifies the total estimated present value of the quantified incremental impacts of this designation to be between approximately 196,000 to 213,000 dollars over the next 10 years; on an annualized undiscounted basis, the impacts are equivalent to 19,600 to 21,300 dollars per year. Applying discounted rates recommended in the Office of Management and Budget Circular A-4, the Final Economic Report estimates these incremental impacts of designation to be between 170,000 to 185,000 using a 3 percent discount rate and 143,000 to 156,000 using a 7 percent discount rate (Cardno 2018). These impacts include only incremental administrative efforts to consider critical habitat in section 7 consultations for the section 7 activities identified under the
Both the Final Biological Report and the Final Economic Report recognize that some of the future impacts of the designation are difficult to predict (NMFS 2018a, Cardno 2018). Although considered unlikely, NMFS cannot rule out future modifications for federally managed fisheries and activities that contribute to water quality (NMFS 2018a). For federally managed fisheries, modifications were not predicted as a result of the critical habitat designation based on current management of the fisheries. However, we noted that future revised management measures could result as more information is gained about MHI IFKW foraging ecology, or as we gain a better understanding of the relative importance of certain prey species to the health and recovery of a larger MHI IFKW population. Similarly, modifications to water quality standards were not predicted as a result of this designation; however, future modifications were not ruled out because future management measures may be necessary as more information is gained about how pollutants affect MHI IFKW critical habitat. The Final Economic Report discusses this qualitatively, but does not provide quantified costs associated with any uncertain future modifications (Cardno 2018).
Economic impacts from the designation are largely attributed to the administrative costs of consultations. Generally, the quantified economic impacts for this designation are relatively low because in Hawaii most projects that would require section 7 consultation occur onshore or nearshore and would not overlap with the designation. Projects with a Federal nexus (
BOEM provided comments on our proposed rule indicating their appreciation for the BOEM Call Area exclusion. In addition, the Navy submitted comments on the proposed rule noting that, while they support the exclusion of areas suitable for renewable energy development, portions of the currently identified BOEM Call Areas are not suitable for renewable energy development due to national security concerns. In support of identifying areas for renewable energy development, the Navy completed an assessment of areas (see
In determining the economic costs of this designation, we rely on the best available information to identify where economic costs are likely to occur. The two sites noticed as the BOEM Call Area remain significant in meeting Hawaii's renewable energy goals as these sites have been identified as areas where wind resources, water depth, and proximity to shore are favorable for wind-energy development (81 FR 41335; June 24, 2016). Given that the boundaries of these two sites have not been revised and that the sites are noted as significant for energy development, our exclusion analysis is based on the areas of the current BOEM Call Area (as published in 81 FR 41335; June 24, 2016).
The estimated economic impacts in the BOEM Call Area are expected to occur as a result of three potential commercial wind-energy projects offshore of the island of Oahu (to be located off Kaena point and off the south shore) (81 FR 41335; June 24, 2016).
The BOEM Call Area sites identified for exclusion overlapped with approximately 1,961 km
Although economic costs of this designation in the BOEM Call Area are considered low, NMFS also considers the potential intangible costs of designation in light of Executive Order 13795,
Given the significance of this offshore area in supporting renewable energy goals for the State of Hawaii and the goals of Executive Order 13795, the low administrative costs of this designation, the small size of these areas, and the low-use of this area by MHI IKFWs, we find that the benefits of exclusion of this identified area outweigh the benefits of designation. Although large in-water construction projects are an activity of concern for this DPS, we anticipate that consultations required to ensure that activities are not likely to jeopardize the MHI IFKWs will achieve substantially similar conservation benefits for this DPS. Specifically, we anticipate that conservation measures implemented as a result of consultation to address impacts to the species will also provide incidental protections to the habitat feature. Additionally, wind energy projects in these areas are not expected to result in destruction or adverse modification of critical habitat. Based on our best scientific judgment, and acknowledging the small size of this area (approximately 0.2 percent of the overall designation) and that other safeguards that are in place (
The national security benefits of exclusion are the national security impacts that would be avoided by excluding particular areas from the designation. In preparation for the proposed rule, we contacted representatives of DOD and the Department of Homeland Security to request information on potential national security impacts that may result from the designation of particular areas as critical habitat for the MHI IFKW DPS. In response to the request, the Navy and U.S. Coast Guard each submitted a request that all areas be excluded from critical habitat out of concerns associated with activities that introduce noise to the marine environment (NMFS 2017b). Although we considered the request for exclusion of all areas proposed for critical habitat, we also separately considered particular areas identified by the Navy because these areas support specific military activities. The Coast Guard did not provide specific explanations with regard to particular areas. The Air Force provided a request for exclusion that included the waters leading to and the offshore ranges of the PMRF (NMFS 2017b). As the PMRF offshore ranges were also highlighted as important to Navy activities, we included the information provided by the Air Force regarding their request for exclusion for the PMRF ranges with the Navy's information, due to the similarities between the activities and impacts identified for these areas (
We considered a total of 13 sites for exclusion, and we proposed 8 of those sites for exclusion in the proposed rule. Additionally, we notified the public in the proposed rule that we would be considering six additional requests submitted by the Navy (82 FR 51186; November 03, 2017), which were subsets of a larger area that the Navy initially requested for exclusion, but which NMFS determined should not be excluded under 4(b)(2). In addition to these six areas, the Navy requested the exclusion of two additional areas—north and south of Maui as well as the Hawaii Area Tracking System and the Kahoolawe Training Minefield (see the ESA Section 4(b)(2) Report, NMFS 2018b); these four areas were also subsets of the Four Island Region request for exclusion that was not proposed for exclusion at the proposed rule stage.
For the final designation, we reanalyzed the 13 areas already considered for exclusion using the updated satellite tracking information from the Cascadia Research Collective. Additionally, we separately reviewed each of the 10 areas requested by the Navy that were subsets of the larger areas requested for exclusion, consistent with the review criteria for the 13 previous areas considered for national security exclusion.
Our determinations for these 23 requests are summarized in Table 1 below.
As in the analysis of economic impacts, we weighed the benefits of exclusion (
The primary benefit of exclusion is that the DOD's activities would continue under current regulatory regimes and the DOD would not be required to consult with NMFS under section 7 of the ESA regarding its actions that may affect critical habitat, and thus potential delays or costs associated with conservation measures for critical habitat would be avoided. For each particular area, national security impacts were weighed considering the intensity of use of the area by DOD and how activities in that area may affect the features essential to the conservation of MHI IFKWs. Where additional consultation requirements are likely due to critical habitat at a site, we considered how the consultation may change the DOD activities, and how unique the DOD activities are at the site.
Benefits to the conservation of MHI IFKWs depend on whether designation of critical habitat at a site leads to additional conservation of the DPS above what is already provided by being listed as endangered under the ESA in the first place. We weighed the potential for additional conservation by considering several factors that provide an understanding of the importance of protecting the habitat for the overall conservation of the DPS: MHI IFKW use of the habitat (high vs. low use or travel by MHI IFKWs and/or observational data), the existing baseline protections that may protect that habitat regardless of designation, and the likelihood of other Federal (non-DOD) actions being proposed within the site that would be subject to section 7 consultation associated with critical habitat. Throughout the weighing process the overall size of the area considered for exclusion was considered, along with our overall understanding of importance of protecting that area for conservation purposes.
As discussed in the
Finally, under ESA section 4(b)(2) we consider any other relevant impacts of critical habitat designation to inform our decision as to whether to exclude any areas. For example, we may consider potential adverse effects on existing management plans or conservation plans that benefit listed species, and we may consider potential adverse effects on tribal lands or trust resources. In preparing this designation, we have not identified any such management or conservation plans, tribal lands or resources, or anything else that would be adversely affected by the critical habitat designation. Accordingly, we do not exercise our discretionary authority to exclude any areas based on other relevant impacts.
This rule designates approximately 45,504 km
Section 7(a)(2) of the ESA requires Federal agencies, including NMFS, to ensure that any action authorized, funded, or carried out by the agency (agency action) is not likely to jeopardize the continued existence of any threatened or endangered species or destroy or adversely modify designated critical habitat. When a species is listed or critical habitat is designated, Federal agencies must consult with NMFS on any agency action to be conducted in an area where the species is present and that may affect the species or its critical habitat. During the consultation, NMFS evaluates the agency action to determine whether the action may adversely affect listed species or critical habitat and issues its finding in a biological opinion. If NMFS concludes in the biological opinion that the agency action would likely result in the destruction or adverse modification of critical habitat, NMFS would also recommend any reasonable and prudent alternatives to the action. Reasonable and prudent alternatives are defined in 50 CFR 402.02 as alternative actions identified during formal consultation that can be implemented in a manner consistent with the intended purpose of the action, that are consistent with the scope of the Federal agency's legal authority and jurisdiction, that are economically and technologically feasible, and that would avoid the destruction or adverse modification of critical habitat.
Regulations at 50 CFR 402.16 require Federal agencies that have retained discretionary involvement or control over an action, or where such discretionary involvement or control is authorized by law, to reinitiate consultation on previously reviewed actions in instances in which (1) critical habitat is subsequently designated; or (2) new information or changes to the action may result in effects to critical habitat not previously considered in the biological opinion. Consequently, some Federal agencies may request re-initiation of consultation or conference with NMFS on actions for which formal consultation has been completed, if those actions may affect designated critical habitat. Activities subject to the ESA section 7 consultation process include activities on Federal lands, as well as activities requiring a permit or other authorization from a Federal agency (
ESA section 4(b)(8) requires, to the maximum extent practicable, in any regulation to designate critical habitat, an evaluation and brief description of those activities (whether public or private) that may adversely modify such habitat or that may be affected by such designation. A wide variety of activities may affect MHI IFKW critical habitat and may be subject to the ESA section 7 consultation processes when carried out, funded, or authorized by a Federal agency. The activities most likely to be affected by this critical habitat designation once finalized are the following: (1) In-water construction (including dredging); (2) energy development (including renewable energy projects); (3) activities that affect water quality; (4) aquaculture/mariculture; (5) fisheries; (6) environmental restoration and response activities (including responses to oil spills and vessel groundings, and marine debris clean-up activities); and (7) some military readiness activities. Private entities may also be affected by this critical habitat designation if a Federal permit is required, Federal funding is received, or the entity is indirectly affected by delays or changes in a Federal project. These activities would need to be evaluated with respect to their potential to destroy or adversely modify critical habitat. Changes to the actions to minimize or avoid destruction or adverse modification of designated critical habitat may result in changes to some activities. Please see the Economic Analysis Report (Cardno 2018) for more details and examples of changes that may need to occur in order for activities to minimize or avoid destruction or adverse modification of designated critical habitat. Questions regarding whether specific activities would constitute destruction or adverse modification of critical habitat should be directed to NMFS (see
A complete list of all references cited in this rule can be found on our website at:
Under E.O. 12630, Federal agencies must consider the effects of their actions on constitutionally protected private property rights and avoid unnecessary takings of property. A taking of property includes actions that result in physical invasion or occupancy of private property that substantially affect its value or use. In accordance with E.O. 12630, this rule does not have significant takings implications. The designation of critical habitat for the MHI IFKW DPS is fully described within the offshore marine environment and is not expected to affect the use or value of private property interests. Therefore, a takings implication assessment is not required.
OMB has determined that this rule is significant for purposes of Executive Order 12866 review. Economic and Regulatory Impact Review Analyses and 4(b)(2) analyses as set forth and referenced herein have been prepared to support the exclusion process under section 4(b)(2) of the ESA. To review these documents see
We have estimated the costs for this rule. Economic impacts associated with
The Economic Report (Cardno 2018) identifies the total estimated present value of the quantified impacts above current consultation effort to be between approximately 192,000 to 208,000 dollars over the next 10 years; on an annualized undiscounted basis, the impacts are equivalent to 19,200 to 20,800 dollars per year. Applying discounted rates recommended in the Office of Management and Budget Circular A-4, the Final Economic Report estimates these incremental impacts of designation to be between 170,000 to 185,000 using a 3 percent discount rate and 143,000 to 156,000 using a 7 percent discount rate (Cardno 2018). These total impacts include the additional administrative efforts necessary to consider critical habitat in section 7 consultations. Across the MHI, economic impacts are expected to be small and largely associated with the administrative costs borne by Federal agencies. However, private energy developers may also bear the administrative costs of consultation for large energy projects. The Final Economic Report estimates these costs to be between 0 and 3,000 dollars over the next 10 years. While there are expected beneficial economic impacts of designating critical habitat, there are insufficient data available to monetize those impacts (see
This rule is not expected to be subject to the requirements of E.O. 13771 because this rule is expected to result in no more than
The Executive Order on Federalism, Executive Order 13132, requires agencies to take into account any federalism impacts of regulations under development. It includes specific consultation directives for situations in which a regulation may preempt state law or impose substantial direct compliance costs on state and local governments (unless required by statute). Pursuant to E.O. 13132, we determined that this rule does not have significant federalism effects and that a federalism assessment is not required. We requested information from and coordinated development of this final critical habitat designation with appropriate Hawaii State resources agencies. The designation may have some benefit to state and local resource agencies in that the rule more clearly defines the physical and biological features essential to the conservation of the species and the areas on which those features are found. While this designation would not alter where and what non-Federally sponsored activities may occur, it may assist local governments in long-range planning.
Where state and local governments require approval or authorization from a Federal agency for actions that may affect critical habitat, consultation under section 7(a)(2) would be required. While non-Federal entities that receive Federal funding, assistance, or permits, or that otherwise require approval or authorization from a Federal agency for an action, may be indirectly impacted by the designation of critical habitat, the legally binding duty to avoid destruction or adverse modification of critical habitat rests only on the Federal agency.
Executive Order 13211 requires agencies to prepare a Statement of Energy Effects when undertaking a “significant energy action.” According to Executive Order 13211, “significant energy action” means any action by an agency that is expected to lead to the promulgation of a final rule or regulation that is a significant regulatory action under Executive Order 12866 and is likely to have a significant adverse effect on the supply, distribution, or use of energy. We have considered the potential impacts of this action on the supply, distribution, or use of energy (see section 13.2 of the Economic Report; Cardno 2018). It is unlikely for the oil and gas industry to experience a “significant adverse effect” due to this designation, as Hawaii does not produce petroleum or natural gas, and refineries are not expected to be affected by this designation. Offshore energy projects may affect the essential features of critical habitat for the MHI IFKW DPS. However, foreseeable impacts are limited to two areas off Oahu where prospective wind energy projects are under consideration (see
Under the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
A statement of need for and objectives of this rule is provided earlier in the preamble and is not repeated here. This rule will not impose any recordkeeping or reporting requirements. NMFS received comments on the proposed rule and supplementary reports during the 60-day comment period; no comments were received on the initial regulatory flexibility analysis for this action.
We identified the impacts to small businesses by considering the seven activities most likely impacted by the designation: (1) In-water construction (including dredging); (2) energy development (including renewable energy projects); (3) activities that affect
In accordance with the requirements of the RFA, this analysis considered alternatives to the critical habitat designation for the MHI IFKW that would achieve the goals of designating critical habitat without unduly burdening small entities. The alternative of not designating critical habitat for the MHI IFKW was considered and rejected because such an approach does not meet our statutory requirements under the ESA. We also considered and rejected the alternative of designating as critical habitat all areas that contain at least one identified essential feature (
In summary, the primary benefit of this designation is to ensure that Federal agencies consult with NMFS whenever they carry out, fund, or authorize any action that may adversely affect MHI IFKW critical habitat. Costs associated with critical habitat are primarily administrative costs borne by the Federal agency taking the action. Our analysis did not identify any economic impacts to small businesses based on this designation and current information does not suggest that small businesses will be disproportionately affected by this designation (Cardno 2018). Although the analysis shows that we could have certified that there would not be significant economic impact on a substantial number of small entities, we are instead presenting this FRFA.
During a formal section 7 consultation under the ESA, NMFS, the action agency, and the third party applying for Federal funding or permitting (if applicable) communicate in an effort to minimize potential adverse effects to the species and to the proposed critical habitat. Communication among these parties may occur via written letters, phone calls, in-person meetings, or any combination of these. The duration and complexity of these communications depend on a number of variables, including the type of consultation, the species, the activity of concern, and the potential effects to the species and designated critical habitat associated with the activity that has been proposed. The third-party costs associated with these consultations include the administrative costs, such as the costs of time spent in meetings, preparing letters, and the development of research, including biological studies and engineering reports. There are no small businesses directly regulated by this action and there are no additional costs to small businesses as a result of section 7 consultations to consider.
Under section 307(c)(1)(A) of the Coastal Zone Management Act (CZMA) (16 U.S.C. 1456(c)(1)(A)) and its implementing regulations, each Federal activity within or outside the coastal zone that has reasonably foreseeable effects on any land or water use or natural resource of the coastal zone shall be carried out in a manner which is consistent to the maximum extent practicable with the enforceable policies of approved state coastal management programs. We have determined that the designation of critical habitat for the MHI IFKW DPS is consistent to the maximum extent practicable with the enforceable policies of the approved Coastal Zone Management (CZM) Program of Hawaii. This determination was submitted to the Hawaii CZM Program for review. While the Hawaii CZM Program noted comments from Hawaii's Department of Land and Natural Resources DAR expressing concerns about the expansiveness of the proposed designation, the Hawaii CZM Program concurred with our consistency determination in a letter they issued to NMFS on December 15, 2017. These concerns about the expansiveness of the designation were submitted by DAR and are addressed under our responses to Comments 8 and 10 above.
The purpose of the Paperwork Reduction Act is to minimize the paperwork burden for individuals, small businesses, educational and nonprofit institutions, and other persons resulting from the collection of information by or for the Federal government. This final rule does not contain any new or revised collection of information. This rule, does not impose recordkeeping or reporting requirements on state or local governments, individuals, businesses, or organizations.
In accordance with the Unfunded Mandates Reform Act, we make the following findings:
(A) This proposed rule will not produce a Federal mandate. In general, a Federal mandate is a provision in legislation, statute, or regulation that would impose an enforceable duty upon state, local, tribal governments, or the private sector and includes both “Federal intergovernmental mandates” and “Federal private sector mandates.” The designation of critical habitat does not impose an enforceable duty on non-Federal government entities or private parties. The only regulatory effect of a
(B) This rule will not significantly or uniquely affect small governments. As such, a Small Government Agency Plan is not required.
The longstanding and distinctive relationship between the Federal and tribal governments is defined by treaties, statutes, executive orders, judicial decisions, and agreements, which differentiate tribal governments from the other entities that deal with, or are affected by, the Federal government. This relationship has given rise to a special Federal trust responsibility involving the legal responsibilities and obligations of the United States towards Indian tribes and the application of fiduciary standards of due care with respect to Indian lands, tribal trust resources, and the exercise of tribal rights. Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments,” outlines the responsibilities of the Federal government in matters affecting tribal interests. “Federally recognized tribe” means an Indian or Alaska Native tribe or community that is acknowledged as an Indian tribe under the federally Recognized Indian Tribe List Act of 1994 (25 U.S.C. 479a).
In the list published annually by the Secretary, there are no federally recognized tribes in the State of Hawaii (74 FR 40218; August 11, 2009). Although Native Hawaiian lands are not tribal lands for purposes of the requirements of the President's Memorandum or the Department Manual, recent Department of Interior regulations (43 CFR 50) set forth a process for establishing formal government-to-government relationship with the Native Hawaiian Community. Moreover, we recognize that Native Hawaiian organizations have the potential to be affected by Federal regulations and as such, consideration of these impacts may be evaluated as other relevant impacts from the designation.
We solicited comments regarding areas of overlap with the designation that may warrant exclusion from critical habitat for the MHI IFKW due to such impacts mentioned above, and/or information from affected Native Hawaiian organizations concerning other Native Hawaiian activities that may be affected in areas other than those specifically owned by the organization. We received no additional information regarding any potential impacts.
In conclusion we find that this critical habitat designation does not have tribal implications, because the final critical habitat designation does not include any tribal lands and does not affect tribal trust resources or the exercise of tribal rights.
Pursuant to the Information Quality Act (section 515 of Pub. L. 106-554), this information product has undergone a pre-dissemination review by NMFS. The signed Pre-dissemination Review and Documentation Form is on file with the NMFS Pacific Islands Regional Office (see
Endangered and threatened species, Exports, Imports, Transportation.
Endangered and threatened species.
For the reasons set out in the preamble, 50 CFR part 224 and 226 are amended as follows:
16 U.S.C. 1531-1543 and 16 U.S.C. 1361
(h) * * *
16 U.S.C. 1533.
Critical habitat is designated for main Hawaiian Islands insular false killer whale as described in this section. The maps, clarified by the textual descriptions in this section, are the definitive source for determining the critical habitat boundaries.
(a)
(b)
(1) Adequate space for movement and use within shelf and slope habitat;
(2) Prey species of sufficient quantity, quality, and availability to support individual growth, reproduction, and development, as well as overall population growth;
(3) Waters free of pollutants of a type and amount harmful to main Hawaiian Islands insular false killer whales; and
(4) Sound levels that would not significantly impair false killer whales' use or occupancy.
(c)
(1) Pursuant to Endangered Species Act (ESA) section 4(b)(2), the following areas have been excluded from the designation: The Bureau of Ocean Energy Management Call Area offshore of the Island of Oahu (which includes two sites, one off Kaena point and one off the south shore), the Navy Pacific Missile Range Facility's Offshore ranges (including the Shallow Water Training Range (SWTR), the Barking Sands Tactical Underwater Range (BARSTUR), and the Barking Sands Underwater Range Extension (BSURE; west of Kauai), the Navy Kingfisher Range (northeast of Niihau), Warning Area 188 (west of Kauai), Kaula Island and Warning Area 187 (surrounding Kaula Island), the Navy Fleet Operational Readiness Accuracy Check Site (FORACS) (west of Oahu), the Navy Shipboard Electronic Systems Evaluation Facility (SESEF) (west of Oahu), Warning Areas 196 and 191 (south of Oahu), Warning Areas 193 and 194 (south of Oahu), the Kaulakahi Channel portion of Warning area 186 (the channel between Niihau and Kauai and extending east), the area north of Molokai (found offshore at the outer edge of the designation), the Alenuihaha Channel, the Hawaii Area Tracking System, and the Kahoolawe Training Minefield.
(2) Pursuant to ESA section 4(a)(3)(B), all areas subject to the Joint Base Pearl Harbor-Hickam Integrated Natural Resource Management Pl69.
(d)
(b) In addition to the Co-Chairs, the Council shall include the following officials, or their designees:
(b) The Council shall develop recommendations for:
(a) develop a national campaign to raise awareness of matters considered by the Council, such as the urgency of the skills crisis; the importance of science, technology, engineering, and mathematics education; the creation of new industries and job opportunities spurred by emerging technologies, such as artificial intelligence; the nature of many careers in the trades and manufacturing; and the need for companies to invest in the training and re-training of their workers and more clearly define the skills and competencies that jobs require;
(b) develop a plan for recognizing companies that demonstrate excellence in workplace education, training, and re-training policies and investments, in order to galvanize industries to identify and adopt best practices, innovate their workplace policies, and invest in their workforces;
(c) examine how the Congress and the executive branch can work with private employers, educational institutions, labor unions, other non-profit organizations, and State, territorial, tribal, and local governments to support the implementation of recommendations from the Task Force on Apprenticeship Expansion established in Executive Order 13801 of June 15, 2017 (Expanding Apprenticeships in America), including recommendations related to:
(d) consider the recommendations of the American Workforce Policy Advisory Board (Board) established in section 8 of this order and, as appropriate, adopt recommendations that would significantly advance the objectives of the Council. The Council shall continue to consider and, as appropriate, adopt the Board's recommendations beyond the initial 180-day period provided by this section;
(e) recommend a specific course of action for increasing transparency related to education and job-training program options, including those offered at 4-year institutions and community colleges. The Council shall also propose ways to increase access to available job data, including data on industries and geographic locations with the greatest numbers of open jobs and projected future opportunities, as well as the underlying skills required to fill open jobs, so that American students and workers can make the most informed decisions possible regarding their education, job selection, and career paths. The Council shall also propose strategies for how best to use existing data tools to support informed decision making for American students and workers;
(f) develop recommendations on how the public sector should engage with the private sector in worker re-training, including through the use of online learning resources. In developing these recommendations, the Council shall examine existing private sector efforts to re-train workers or develop them professionally, and consider how investments in worker training and re-training programs compare to investments in other human-resource related areas, such as recruitment, health benefits, and retirement benefits; and
(g) examine public and private-sector expenditures, including tax expenditures, related to providing Americans with knowledge and skills that will enable them to succeed in the workplace at various stages of life (such as during primary and secondary education, postsecondary education, continuing professional development, and re-training), consider the effectiveness of those expenditures, and make suggestions for reforms in order to serve American workers and students better.
(b) The Board shall be composed and function as follows:
(b) The Secretary of Commerce, in consultation with the Co-Chairs of the Council, shall designate an official to serve as Executive Director, to coordinate the day-to-day functions of the Council.
(c) To the extent permitted by law, including the Economy Act (31 U.S.C. 1535), and subject to the availability of appropriations, other agencies may detail staff to the Council, or otherwise provide administrative support, in order to advance the Council's functions.
(d) Agencies shall cooperate with the Council and provide such information regarding its current and planned activities related to policies that affect the American workforce as the Co-Chairs shall reasonably request, to the extent permitted by law.
(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.
(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.
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 |