Federal Register Vol. 83, No.126,
Federal Register Volume 83, Issue 126 (June 29, 2018)
Federal Register Volume 83, Issue 126 (June 29, 2018)
| Page Range | 30525-30829 | |
| FR Document |
Document Created: 2017-12-29 23:38:37
Document Modified: 2017-12-29 23:38:37
| Page and Subject | |
|---|---|
| 83 FR 30778 - Sunshine Act Meeting | |
| 83 FR 30573 - Control of Emissions From New and In-Use Highway Vehicles and Engines | |
| 83 FR 30539 - Occupational Safety and Health Standards | |
| 83 FR 30732 - Agency Information Collection Activities: Submission for OMB Review; Comment Request | |
| 83 FR 30609 - Air Plan Approval; Tennessee; Attainment Plan for Sullivan County SO2 | |
| 83 FR 30626 - Air Plan Approval; ID, Incorporations by Reference Updates and Rule Revisions | |
| 83 FR 30783 - Division of Coal Mine Workers' Compensation; Proposed Collection; Comment Request | |
| 83 FR 30534 - Antimicrobial Animal Drug Sales and Distribution Reporting; Small Entity Compliance Guide; Availability | |
| 83 FR 30539 - Removal of the Sudanese Sanctions Regulations and Amendment of the Terrorism List Government Sanctions Regulations | |
| 83 FR 30708 - Applications for New Awards; Educational Technology, Media, and Materials for Individuals With Disabilities-Center on Early Science, Technology, Engineering, and Math Learning for Young Children With Disabilities | |
| 83 FR 30761 - Notice of Regulatory Waiver Requests Granted for the First Quarter of Calendar Year 2018 | |
| 83 FR 30769 - Proposed Information Collection: Comprehensive Listing of Transactional Documents for Mortgagors, Mortgagees and Contractors Federal Housing Administration (FHA) Healthcare Facility Documents; Re-Opening of Comment Period | |
| 83 FR 30759 - Agency Information Collection Activities: Proposed Collection; Comment Request; Application for Community Disaster Loan (CDL) Program | |
| 83 FR 30733 - Agency Information Collection Activities: Submission for OMB Review; Comment Request | |
| 83 FR 30704 - Proposed Collection; Comment Request | |
| 83 FR 30683 - Adoption of Recommendations | |
| 83 FR 30573 - Promoting Telehealth in Rural America | |
| 83 FR 30772 - ``Made in America'' Outdoor Recreation Advisory Committee Notice of Public Meeting | |
| 83 FR 30528 - Fisheries of the Exclusive Economic Zone Off Alaska; Nontrawl Lead Level 2 Observers | |
| 83 FR 30705 - Intent To Prepare a Draft NEPA Document for the Upper St. Anthony Falls Lock and Dam, Lower St. Anthony Falls Lock and Dam, and Lock and Dam 1 Disposition Study, Hennepin and Ramsey Counties, Minnesota | |
| 83 FR 30666 - Defense Federal Acquisition Regulation Supplement: Submission of Summary Subcontract Reports (DFARS Case 2017-D005) | |
| 83 FR 30598 - Air Plan Approval; Vermont; Infrastructure State Implementation Plan Requirements for the 2012 PM2.5 | |
| 83 FR 30622 - Approval and Promulgation of Implementation Plans; Arkansas; Interstate Transport Requirements for the 2012 PM2.5 | |
| 83 FR 30817 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel PRELUDE; Invitation for Public Comments | |
| 83 FR 30818 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel MELISSA; Invitation for Public Comments | |
| 83 FR 30816 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel BELLA LUNA; Invitation for Public Comments | |
| 83 FR 30661 - Defense Federal Acquisition Regulation Supplement: Electronic Submission and Processing of Payment Requests and Receiving Reports (DFARS Case 2016-D032) | |
| 83 FR 30656 - Defense Federal Acquisition Regulation Supplement: Only One Offer (DFARS Case 2017-D009) | |
| 83 FR 30777 - Folding Gift Boxes From China | |
| 83 FR 30541 - Global Magnitsky Sanctions Regulations | |
| 83 FR 30741 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Food Labeling; Declaration of Certifiable Color Additives | |
| 83 FR 30736 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Practices and Procedures; Formal Evidentiary Public Hearing | |
| 83 FR 30746 - Agency Information Collection Activities; Proposed Collection; Comment Request; Biosimilars User Fee Program | |
| 83 FR 30738 - Agency Information Collection Activities; Proposed Collection; Comment Request; Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration | |
| 83 FR 30752 - Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations; Draft Guidance for Industry; Availability | |
| 83 FR 30811 - Projects Approved for Minor Modifications | |
| 83 FR 30595 - The Food and Drug Administration Predictive Toxicology Roadmap and Its Implementation; Public Hearing; Request for Comments | |
| 83 FR 30740 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; National Agriculture and Food Defense Strategy Survey | |
| 83 FR 30753 - Sun Pharmaceutical Industries, Ltd., and Sun Pharma Global FZE; Withdrawal of Approval of Four Abbreviated New Drug Applications; Correction | |
| 83 FR 30744 - Assessing User Fees Under the Biosimilar User Fee Amendments of 2017; Guidance for Industry; Availability | |
| 83 FR 30742 - Development of Non-Traditional Therapies for Bacterial Infections; Public Workshop; Request for Comments | |
| 83 FR 30700 - Proposed Information Collection; Comment Request; Analysis of Exoskeleton-Use for Enhancing Human Performance Data Collection | |
| 83 FR 30773 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; 30 CFR 580, Prospecting for Minerals Other Than Oil, Gas, and Sulphur on the Outer Continental Shelf and Authorizations of Noncommercial Geological and Geophysical Activities | |
| 83 FR 30825 - Defense Federal Acquisition Regulation Supplement: Offset Costs (DFARS Case 2015-D028) | |
| 83 FR 30824 - Defense Federal Acquisition Regulation Supplement: Repeal of DFARS Clause “Pricing Adjustments” (DFARS Case 2018-D032) | |
| 83 FR 30646 - Defense Federal Acquisition Regulation Supplement: Inapplicability of Certain Laws and Regulations to Commercial Items (DFARS Case 2017-D010) | |
| 83 FR 30584 - Defense Federal Acquisition Regulation Supplement: Undefinitized Contract Action Definitization (DFARS Case 2015-D024) | |
| 83 FR 30587 - Defense Federal Acquisition Regulation Supplement: Repeal of DFARS Clause “Requirements” (DFARS Case 2018-D030) | |
| 83 FR 30659 - Defense Federal Acquisition Regulation Supplement: Modification of DFARS Clause “Surge Option” (DFARS Case 2018-D025) | |
| 83 FR 30644 - Defense Federal Acquisition Regulation Supplement: Use of Commercial or Non-Government Standards (DFARS Case 2017-D014) | |
| 83 FR 30592 - Licensing Private Remote Sensing Space Systems | |
| 83 FR 30735 - Proposed Information Collection Activity | |
| 83 FR 30781 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Bloodborne Pathogens Standard | |
| 83 FR 30535 - Establishment of the Dahlonega Plateau Viticultural Area | |
| 83 FR 30702 - Procurement List; Proposed Additions and Deletions | |
| 83 FR 30589 - Federal Employees' Group Life Insurance Program: Clarifying Annual Rates of Pay and Amending the Employment Status of Judges of the United States Court of Appeals for Veterans Claims | |
| 83 FR 30756 - Request for Information on the HEALing Communities Study: Developing and Testing an Integrated Approach To Address the Opioid Crisis | |
| 83 FR 30717 - Notice of Petition for Waiver of LG Electronics USA, Inc. From the Department of Energy Room Air Conditioner Test Procedure and Notice of Grant of Interim Waiver | |
| 83 FR 30815 - Motor Carrier Safety Advisory Committee (MCSAC); Public Meeting | |
| 83 FR 30690 - Approval of Subzone Status; Amcor Flexibles LLC; Shelbyville, Kentucky | |
| 83 FR 30690 - Approval of Subzone Expansion; Brake Parts Inc.; Hazleton, Pennsylvania | |
| 83 FR 30716 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Federal Student Loan Program Deferment Request Forms | |
| 83 FR 30548 - Special Local Regulation; Corpus Christi Bay, Corpus Christi, TX | |
| 83 FR 30551 - Safety Zone; Tennessee River, Gilbertsville, KY | |
| 83 FR 30688 - Notice of Intent To Prepare an Environmental Impact Statement; Movement and Outdoor Use of Certain Genetically Engineered Organisms | |
| 83 FR 30687 - Determination of Total Amounts of Fiscal Year 2019 WTO Tariff-Rate Quotas for Raw Cane Sugar and Certain Sugars, Syrups and Molasses | |
| 83 FR 30591 - United States Standards for Corn | |
| 83 FR 30590 - United States Standards for Canola | |
| 83 FR 30592 - United States Standards for Soybeans | |
| 83 FR 30639 - Leased Commercial Access; Modernization of Media Regulation Initiative | |
| 83 FR 30551 - Safety Zones; Recurring Events in Captain of the Port Duluth Zone-LaPointe Fireworks | |
| 83 FR 30779 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Occupational Requirements Survey | |
| 83 FR 30778 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Job Openings and Labor Turnover Survey | |
| 83 FR 30781 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; National Longitudinal Survey of Youth 1979 | |
| 83 FR 30701 - Marine Mammals; File No. 21006 | |
| 83 FR 30751 - Quality Metrics Site Visit Program for Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research Staff; Information Available to Industry | |
| 83 FR 30748 - Modernizing Pharmaceutical Quality Systems; Studying Quality Metrics and Quality Culture; Quality Metrics Feedback Program | |
| 83 FR 30783 - Zion Solutions, LLC; Zion Nuclear Power Station, Units 1 and 2 | |
| 83 FR 30730 - Environmental Impact Statements; Notice of Availability | |
| 83 FR 30821 - VA National Academic Affiliations Council, Notice of Meeting | |
| 83 FR 30525 - Special Conditions: Bombardier Model BD-500-1A10 and BD-500-1A11 Airplanes, Installation of Inflatable Lap Belts on Seats | |
| 83 FR 30734 - Submission for OMB Review; Comment Request | |
| 83 FR 30701 - Marine Mammals; File No. 21485 | |
| 83 FR 30731 - Solicitation of Nominations for Appointment to the Healthcare Infection Control Practices Advisory Committee (HICPAC) | |
| 83 FR 30731 - Healthcare Infection Control Practices Advisory Committee (HICPAC); Notice of Charter Amendment | |
| 83 FR 30731 - National Institute for Occupational Safety and Health (NIOSH), Safety and Occupational Health Study Section (SOHSS); Notice of Charter Renewal | |
| 83 FR 30730 - Board of Scientific Counselors, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry (BSC, NCEH/ATSDR); Notice of Charter Renewal | |
| 83 FR 30760 - Agency Information Collection Activities: Submission for OMB Review; Comment Request; Elevation Certificate/Floodproofing Certificate | |
| 83 FR 30758 - Agency Information Collection Activities: Proposed Collection; Comment Request; Standard Flood Hazard Determination Form | |
| 83 FR 30813 - Petition for Exemption; Summary of Petition Received; Avitas Systems, Inc. | |
| 83 FR 30814 - Petition for Exemption; Summary of Petition Received; John E. Green | |
| 83 FR 30804 - Self-Regulatory Organizations; Nasdaq GEMX, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Relocate the Exchange's Rules Pertaining to Co-Location and Direct Connectivity | |
| 83 FR 30802 - Self-Regulatory Organizations; ICE Clear Credit LLC; Notice of Filing of Proposed Rule Change Relating to Amending the ICC Clearing Rules Regarding Mark-to-Market Margin | |
| 83 FR 30793 - Self-Regulatory Organizations; NYSE Arca Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Commentary .02 to Rule 6.72-O in Order To Extend the Penny Pilot in Options Classes in Certain Issues Through December 31, 2018 | |
| 83 FR 30792 - Self-Regulatory Organizations; MIAX PEARL, LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend Exchange Rule 510 To Extend the Penny Pilot Program | |
| 83 FR 30801 - Self-Regulatory Organizations; Nasdaq MRX, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Relocate the Exchange's Rules Pertaining to Co-Location and Direct Connectivity | |
| 83 FR 30786 - Self-Regulatory Organizations; Miami International Securities Exchange LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend MIAX Options Rule 510 To Extend the Penny Pilot Program | |
| 83 FR 30806 - Self-Regulatory Organizations; The Depository Trust Company; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the DTC Operational Arrangements To Add Clarifying Text Relating to the Processing of Unit Investment Trust Securities Through the DTC Investor's Voluntary Redemptions and Sales Service | |
| 83 FR 30808 - Self-Regulatory Organizations; NYSE American LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Commentary .02 to Rule 960NY in Order To Extend the Penny Pilot in Options Classes in Certain Issues Through December 31, 2018 | |
| 83 FR 30787 - Self-Regulatory Organizations; Cboe Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Relating to Exchange Rule 6.2., Hybrid Opening (and Sometimes Closing) System (“HOSS”) | |
| 83 FR 30795 - Self-Regulatory Organizations; Cboe Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Relating to Exchange Rule 6.2., Hybrid Opening (and Sometimes Closing) System (“HOSS”) | |
| 83 FR 30704 - Submission for OMB Review; Comment Request | |
| 83 FR 30791 - Self-Regulatory Organizations; The Depository Trust Company; Fixed Income Clearing Corporation; National Securities Clearing Corporation; Notice of Designation of Longer Period for Commission Action on Proceedings To Determine Whether To Approve or Disapprove Proposed Rule Changes To Amend the Loss Allocation Rules and Make Other Changes | |
| 83 FR 30785 - Self-Regulatory Organizations; The Depository Trust Company; Fixed Income Clearing Corporation; National Securities Clearing Corporation; Notice of Designation of Longer Period for Commission Action on Proceedings To Determine Whether To Approve or Disapprove Proposed Rule Changes To Adopt a Recovery & Wind-Down Plan and Related Rules | |
| 83 FR 30814 - Petition for Exemption; Summary of Petition Received; FlightScan Corporation | |
| 83 FR 30812 - Petition for Exemption; Summary of Petition Received; Victor Lee & Associates Inc. | |
| 83 FR 30813 - Petition for Exemption; Summary of Petition Received; Pan Am International Flight Academy | |
| 83 FR 30690 - Notice of Public Meeting of the Michigan Advisory Committee | |
| 83 FR 30779 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Definition and Requirements for a Nationally Recognized Testing Laboratory | |
| 83 FR 30703 - Submission for OMB Review; Comment Request | |
| 83 FR 30757 - National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings | |
| 83 FR 30758 - National Center for Advancing Translational Sciences; Notice of Closed Meeting | |
| 83 FR 30754 - Center for Scientific Review; Notice of Closed Meetings | |
| 83 FR 30776 - Certain Earpiece Devices and Components Thereof; Institution of Investigation | |
| 83 FR 30689 - Notice of Public Meeting of the Tennessee Advisory Committee | |
| 83 FR 30726 - Vigue, Peter A.; Notice of Supplemental Filing | |
| 83 FR 30729 - ANR Pipeline Company; Notice of Request Under Blanket Authorization | |
| 83 FR 30728 - Notice of Availability of the Draft Environmental Impact Statement for the Proposed Calcasieu Pass Project; Venture Global Calcasieu Pass, LLC, TransCameron Pipeline, LLC | |
| 83 FR 30726 - Combined Notice of Filings #1 | |
| 83 FR 30810 - Data Collection Available for Public Comments | |
| 83 FR 30754 - Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Faculty Loan Repayment Program, OMB No. 0915-0150-Extension | |
| 83 FR 30812 - Petition for Exemption; Summary of Petition Received; Gulfstream Aerospace Corporation | |
| 83 FR 30571 - Air Plan Approval; Michigan; Revisions to Volatile Organic Compound Rules | |
| 83 FR 30818 - Notice of Request for Information Regarding Health Care Access Standards | |
| 83 FR 30819 - Announcement for Public Meeting Regarding Health Care Access Standards | |
| 83 FR 30553 - Approval and Promulgation of Implementation Plans; Arkansas; Revisions to Minor New Source Review Program | |
| 83 FR 30668 - ELDT; Commercial Driver's License Upgrade From Class B to Class A | |
| 83 FR 30771 - Notice of Availability of the Draft San Pedro Riparian National Conservation Area Resource Management Plan and Associated Environmental Impact Statement, Arizona | |
| 83 FR 30695 - Utility Scale Wind Towers From the People's Republic of China: Rescission of Countervailing Duty Administrative Review; 2017 | |
| 83 FR 30708 - Submission for OMB Review; Comment Request | |
| 83 FR 30628 - Updating the Intercarrier Compensation Regime To Eliminate Access Arbitrage | |
| 83 FR 30699 - Certain Quartz Surface Products From the People's Republic of China: Postponement of Preliminary Determination in the Countervailing Duty Investigation | |
| 83 FR 30706 - Notice of Intent To Adopt U.S. Bureau of Reclamation's December 2015 Final Environmental Impact Report/Environmental Impact Statement/Environmental Impact Statement, Prepare Corps Record of Decision, and Reimburse the Sponsor for the Upper Truckee River and Marsh Restoration Project, City of South Lake Tahoe, El Dorado County, CA | |
| 83 FR 30695 - Large Diameter Welded Pipe From the People's Republic of China: Preliminary Affirmative Countervailing Duty Determination and Alignment of Final Determination With Final Antidumping Determination | |
| 83 FR 30693 - Large Diameter Welded Pipe From the Republic of Korea: Preliminary Affirmative Countervailing Duty Determination and Alignment of Final Determination With Final Antidumping Duty Determination | |
| 83 FR 30697 - Large Diameter Welded Pipe From the Republic of Turkey: Preliminary Affirmative Countervailing Duty Determination and Alignment of Final Determination With Final Antidumping Duty Determination | |
| 83 FR 30690 - Large Diameter Welded Pipe From India: Preliminary Affirmative Countervailing Duty Determination and Alignment of Final Determination With Final Antidumping Duty Determination | |
| 83 FR 30533 - Adaptation of Regulations to Incorporate Swaps; Correction |
Issue
Agricultural Marketing Service
Animal and Plant Health Inspection Service
Foreign-Trade Zones Board
International Trade Administration
National Institute of Standards and Technology
National Oceanic and Atmospheric Administration
Defense Acquisition Regulations System
Engineers Corps
Navy Department
Federal Energy Regulatory Commission
Centers for Disease Control and Prevention
Centers for Medicare & Medicaid Services
Children and Families Administration
Food and Drug Administration
Health Resources and Services Administration
National Institutes of Health
Coast Guard
Federal Emergency Management Agency
Land Management Bureau
National Park Service
Ocean Energy Management Bureau
Foreign Claims Settlement Commission
Occupational Safety and Health Administration
Workers Compensation Programs Office
Federal Aviation Administration
Federal Motor Carrier Safety Administration
Maritime Administration
Alcohol and Tobacco Tax and Trade Bureau
Foreign Assets Control Office
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Federal Aviation Administration (FAA), DOT.
Final special conditions; request for comments.
These special conditions are issued for the Bombardier Inc. (Bombardier) Model BD-500-1A10 and BD-500-1A11 airplanes. These airplanes will have a novel or unusual design feature when compared to the state of technology envisioned in the airworthiness standards for transport category airplanes. This design feature is installation of inflatable lap belts on seats. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
This action is effective on Bombardier on June 29, 2018. Send comments on or before August 13, 2018.
Send comments identified by Docket No. FAA-2018-0320 using any of the following methods:
•
•
•
•
Alan Sinclair, Airframe and Cabin Section, AIR-675, Transport Standards Branch, Policy and Innovation Division, Aircraft Certification Service, Federal Aviation Administration, 2200 South 216th Street, Des Moines, Washington 98198; telephone and fax 206-231-3215; email
The substance of these special conditions previously has been published in the
We invite interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data.
We will consider all comments we receive by the closing date for comments. We may change these special conditions based on the comments we receive.
On December 6, 2017, Bombardier applied for an amendment to Type Certificate No. T00008NY to include the new Model BD-500-1A10 and BD-500-1A11 airplanes. These airplanes, which are a derivative of the Model BD-500 currently approved under Type Certificate No. T00008NY, are transport-category, twin-engine airplanes. The BD-500-1A10 has seating for 110 to 130 passengers and an estimated maximum take-off weight of 129,000 lbs. The BD-500-1A11 has seating for 130-150 passengers and an estimated maximum take-off weight of 144,000 lbs.
Under the provisions of title 14, Code of Federal Regulations (14 CFR) 21.101, Bombardier must show that the Model BD-500-1A10 and BD-500-1A11 airplanes meet the applicable provisions of the regulations listed in Type Certificate No. T00008NY, or the applicable regulations in effect on the date of application for the change except for earlier amendments as agreed upon by the FAA.
If the Administrator finds that the applicable airworthiness regulations (
Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same novel or unusual design feature, or should any other model already included on the same
In addition to the applicable airworthiness regulations and special conditions, the Bombardier Model BD-500-1A10 and BD-500-1A11 airplanes must comply with the fuel-vent and exhaust-emission requirements of 14 CFR part 34, and the noise-certification requirements of 14 CFR part 36.
The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type certification basis under § 21.101.
The Bombardier Model BD-500-1A10 and BD-500-1A11 airplanes will incorporate the following novel or unusual design feature:
Installation of inflatable lap belts on seats.
The inflatable lap belt has two potential advantages over other means of head-impact protection. First, it can provide significantly greater protection than would be expected with energy-absorbing pads, and second, it can provide essentially equivalent protection for occupants of all stature. These are significant advantages from a safety standpoint, because such devices will likely provide a level of safety that exceeds the minimum standards of part 25. Conversely, inflatable lap belts in general are active systems and must be relied upon to activate properly when needed, as opposed to an energy-absorbing pad or upper torso restraint that is passive and always available. Therefore, the potential advantages must be balanced against this and other potential disadvantages to develop standards for this design feature.
The FAA has considered the installation of inflatable lap belts to have two primary safety concerns: First, that they perform properly under foreseeable operating conditions; and second, that they do not perform in a manner or at such times as would constitute a hazard to the airplane or occupants. This latter point has the potential to be the more rigorous of the requirements, owing to the active nature of the system.
The inflatable lap belt will rely on electronic sensors for signaling, and will employ an automatic inflation mechanism for activation, so that it is available when needed. These same devices could be susceptible to inadvertent activation, causing deployment in a potentially unsafe manner. The consequences of such deployment must be considered in establishing the reliability of the system. The applicant must substantiate that the effects of an inadvertent deployment in flight are either not a hazard to the airplane, or that such deployment is an extremely improbable occurrence (less than 10
The potential for an inadvertent deployment could be increased as a result of conditions in service. The installation must take into account wear and tear so that the likelihood of an inadvertent deployment is not increased to an unacceptable level. In this context, an appropriate inspection interval and self-test capability are considered necessary. Other outside influences are lightning and high-intensity radiated fields (HIRF). Existing regulations regarding lightning, § 25.1316, and HIRF, § 25.1317, are applicable. For compliance with those conditions, if inadvertent deployment could cause a hazard to the airplane, the inflatable lap belt is considered a critical system; if inadvertent deployment could cause injuries to persons, the inflatable lap belt should be considered an essential system. Finally, the inflatable lap-belt installation should be protected from the effects of fire, so that an additional hazard is not created by, for example, a rupture of a pyrotechnic squib.
To function as an effective safety system, the inflatable lap belt must function properly and must not introduce any additional hazards to occupants as a result of its functioning. The inflatable lap belt differs variously from traditional occupant-protection systems and requires special conditions to ensure adequate performance.
Because the inflatable lap belt is essentially a single-use device, it could potentially deploy under crash conditions that are not sufficiently severe as to require head-injury protection from the inflatable lap belt. And because an actual crash is frequently composed of a series of impacts before the airplane comes to rest, this could render the inflatable lap belt useless if a larger impact follows the initial impact. This situation does not exist with energy-absorbing pads or upper-torso restraints, which tend to provide continuous protection regardless of severity or number of impacts in a crash event. Therefore, the inflatable lap-belt installation should be such that the inflatable lap belt will provide protection when it is required, by not expending its protection during a less-severe impact. Also, it is possible to have several large impact events during the course of a crash, but there will be no requirement for the inflatable lap belt to provide protection for multiple impacts.
Given that each occupant's restraint system provides protection for that occupant only, the installation must address unoccupied seats. It will be necessary to show that the required protection is provided for each occupant regardless of the number of occupied seats, and that unoccupied seats may have lap belts that are active.
The inflatable lap belt should be effective for a wide range of occupants. The FAA has historically considered the range from the 5th percentile female to the 95th percentile male as the range of occupants that must be taken into account. In this case, the FAA is proposing consideration of a broader range of occupants due to the nature of the lap-belt installation and its close proximity to the occupant. In a similar vein, these persons could have assumed the brace position for those accidents where an impact is anticipated. Test data indicate that occupants in the brace position do not require supplemental protection, so it would not be necessary to show that the inflatable lap belt will enhance the brace position. However, the inflatable lap belt must not introduce a hazard when it is deployed into a seated, braced occupant.
Another area of concern is the use of seats so equipped by children, whether they are lap-held, sitting in approved child-safety seats, or occupying the seat directly. Although specifically prohibited by FAA operating regulations, the use of the supplementary loop belt (“belly belt”) may be required by other civil aviation authorities, and should also be considered with the purpose of meeting those regulations. Similarly, if the seat is occupied by a pregnant woman, the installation needs to address such usage, either by demonstrating that it will function properly, or by adding appropriate limitation on usage.
The inflatable lap belt will be electrically powered. Likewise, the system could possibly fail due to a separation in the fuselage. Because this system is intended as crash/post-crash protection means, failure due to fuselage separation is not acceptable. As with emergency lighting, the restraint system should function properly if such a
Because the inflatable lap belt is likely to have a large volume displacement, the inflated bag could potentially impede egress of passengers. However, the lap-belt bag deflates to absorb energy, so it is likely that an inflatable lap belt would be deflated by the time passengers begin to leave their seats. Nonetheless, it is appropriate to specify a time interval after which the inflatable lap belt may not impede rapid egress. The maximum time allowed for an exit to open fully after actuation is 10 seconds, according to § 25.809(b)(2). Therefore, the FAA has established 10 seconds as the time interval that the inflatable lap belt must not impede rapid egress from the seat after it is deployed. In actuality, it is unlikely that a flight attendant would prepare an exit this quickly in an accident severe enough to warrant deployment of the inflatable lap belt. The inflatable lap belt will likely deflate much more quickly than 10 seconds.
This potential impediment to rapid egress is even more critical at the seats installed in the emergency-exit rows. Installation of inflatable restraints at the Type III exit rows presents different egress concerns as compared with front-row seats. However, the need to address egress is already part of the special conditions, so the special conditions are not changed at this time. As noted below, the method of compliance with the special conditions may involve specific considerations when an inflatable restraint is installed at Type III exits. Section 25.813 clearly requires access to the exit from the main aisle in the form of an unobstructed passageway, and no interference in opening the exit. The restraint system must not create an impediment to the access to, and the opening of, the exit. These lap belts should be evaluated in the exit row under existing regulations (§§ 25.809 and 25.813) and guidance material. The inflatable lap belts must also be evaluated in post-crash conditions, and should be evaluated using representative restraint systems in the bag-deployed condition.
This evaluation would include reviewing the access to, and opening of, the exit, specifically for obstructions in the egress path; and any interferences in opening the exit. Each unique interior configuration must be considered,
Note that the special conditions are applicable to the inflatable lap-belt system as installed. The special conditions are not an installation approval. Therefore, while the special conditions relate to each such system installed, the overall installation approval is separate, and must consider the combined effects of all such systems installed.
Bombardier will install inflatable lap belts, a novel design feature, on certain seats of their Model BD-500-1A10 and BD-500-1A11 airplanes, to reduce the potential for head injury if an accident occurs. The inflatable lap belt works similar to an automotive inflatable air bag, except that the air bag in the applicant's design is integrated into the lap belt of the restraint system.
The performance criteria for head-injury protection in objective terms is stated in § 25.562. However, none of these criteria are adequate to address the specific issues raised concerning seats with inflatable lap belts. The FAA therefore has determined that, in addition to the requirements of part 25, special conditions are needed to address requirements particular to the installation of seats with inflatable lap belts.
Accordingly, in addition to the passenger-injury criteria specified in § 25.785, these special conditions are for Bombardier Model BD-500-1A10 and BD-500-1A11 airplanes equipped with inflatable lap belts. Other conditions may be developed, as needed, based on further FAA review and discussions with the manufacturer and civil-aviation authorities.
Part I of part 25, appendix F specifies the flammability requirements for interior materials and components. There is no reference to inflatable restraint systems in appendix F, because such devices did not exist at the time the flammability requirements were written. The existing requirements are based on material types as well as use, and have been specified in light of state-of-the-art materials available to perform a given function. Without a specific reference, the default requirement would apply to the type of material used in making the inflatable restraint, which is a fabric in this case. However, in writing special conditions, the FAA must also consider the use of the material, and whether the default requirement is appropriate. In this case, the specialized function of the inflatable restraint means that highly specialized materials are needed. The standard normally applied to fabrics is a 12-second vertical ignition test. However, materials that meet this standard do not perform adequately as inflatable restraints. Because the safety benefit of the inflatable restraint is significant, the flammability standard appropriate for these devices should not screen out suitable materials and thereby effectively eliminate the use of inflatable restraints. The FAA must establish a balance between the safety benefit of the inflatable restraint and its flammability performance. Presently, the 2.5-inch-per-minute horizontal test is considered to provide that balance. As the state-of-the-art in materials progresses (which is expected), the FAA may change this standard in subsequent special conditions to account for improved materials.
These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
As discussed above, these special conditions are applicable to Bombardier Model BD-500-1A10 and BD-500-1A11 airplanes. Should Bombardier apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, these special conditions would apply to that model as well.
This action affects only a certain novel or unusual design feature on one model series of airplanes. It is not a rule of general applicability.
Aircraft, Aviation safety, Reporting and recordkeeping requirements.
The authority citation for these special conditions is as follows:
49 U.S.C. 106(f), 106(g), 40113, 44701, 44702, 44704.
Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for Bombardier Model BD-500-1A10 and BD-500-1A11 airplanes.
1. The inflatable lap belt must be shown to deploy and provide protection under crash conditions where it is necessary to prevent serious head
The seat occupant is:
2. The inflatable lap belt must provide adequate protection for each occupant regardless of the number of occupants of the seat assembly, considering that unoccupied seats may have an active airbag system in the lap belt.
3. The design must prevent the inflatable lap belt from being either incorrectly buckled or incorrectly installed such that the inflatable lap belt would not properly deploy. Alternatively, it must be shown that such deployment is not hazardous to the occupant, and will provide the required head-injury protection.
4. The inflatable lap-belt system must be shown not to be susceptible to inadvertent deployment as a result of wear and tear, or inertial loads resulting from in-flight or ground maneuvers (including gusts and hard landings), likely to be experienced in service.
5. Deployment of the inflatable lap belt must not introduce injury mechanisms to the seated occupant, nor result in injuries that could impede rapid egress. This assessment should include an occupant who is in the brace position when it deploys, and an occupant whose inflatable lap belt is loosely fastened.
6. An inadvertent deployment that could cause injury to a standing or sitting person must be shown to be improbable.
7. It must be shown that inadvertent deployment of the airbag system in the lap belt, during the most critical part of the flight, either will not cause a hazard to the airplane or its occupants, or meets the requirement of § 25.1309(b).
8. The inflatable lap belt must be shown to not impede rapid egress of occupants 10 seconds after its deployment.
9. The inflatable lap-belt system must be protected from lightning and HIRF. The threats specified in existing regulations regarding lightning, § 25.1316, and HIRF, § 25.1317, are incorporated by reference for the purpose of measuring lightning and HIRF protection. For the purposes of complying with HIRF requirements, the inflatable lap-belt system is considered a “critical system” if its deployment could have a hazardous effect on the airplane; otherwise it is considered an “essential” system.
10. The inflatable lap belt must function properly after loss of normal airplane electrical power, and after a transverse separation of the fuselage at the most critical location. A separation at the location of the lap belt does not have to be considered.
11. The inflatable lap belt must be shown to not release hazardous quantities of gas or particulate matter into the cabin.
12. The inflatable lap-belt installation must be protected from the effects of fire such that no hazard to occupants will result.
13. A means must be available for a crewmember to verify the integrity of the inflatable-lap-belt-activation system prior to each flight, or it must be demonstrated to reliably operate between inspection intervals.
14. The inflatable material may not have an average burn rate of greater than 2.5 inches per minute when tested using the horizontal-flammability test as defined in 14 CFR part 25, appendix F, section I(b)(5).
15. The airbag system in the lap belt, once deployed, must not adversely affect the emergency-lighting system (
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Final rule.
NMFS issues regulations to modify specific provisions of the North Pacific Observer Program. The first two elements of this final rule implement requirements for an observer to obtain a nontrawl lead level 2 (LL2) deployment endorsement and implement a pre-cruise meeting requirement for vessels required to carry an observer with a nontrawl LL2 deployment endorsement. These two elements are intended to increase the number of observers that qualify for a nontrawl LL2 deployment endorsement and maintain observer safety and data quality. The third element of this final rule removes duplicative and unnecessary reporting requirements and makes minor changes to reduce observer requirements for specific vessels when participating in the Western Alaska Community Development Quota (CDQ) Program. This action is intended to promote the goals and objectives of the Magnuson-Stevens Fishery Conservation and Management Act, the Fishery Management Plan for Groundfish of the Gulf of Alaska, and the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area, and other applicable law.
Effective July 30, 2018.
Electronic copies of the Regulatory Impact Review (RIR) and the Categorical Exclusion prepared for this action are available from
Written comments regarding the burden-hour estimates or other aspects of the collection-of-information requirements contained in this final rule may be submitted by mail to NMFS Alaska Region, P.O. Box 21668, Juneau, AK 99802-1668, Attn: Ellen Sebastian, Records Officer; in person at NMFS Alaska Region, 709 West 9th Street, Room 420A, Juneau, AK; and to OIRA by email to
Alicia M Miller, (907) 586-7228 or
NMFS manages the groundfish fisheries in the exclusive economic zone under the Fishery Management Plan for Groundfish of the Gulf of Alaska (GOA FMP) and under the Fishery Management Plan for Groundfish of the
NMFS published the proposed rule for this action on December 27, 2017 (82 FR 61243), with comments invited through January 26, 2018.
NMFS received five comment letters during the applicable comment period. Four of these comment letters were on topics that were outside the scope of this action. One comment letter addressed the proposed rule and contained five substantive comments which are summarized and responded to under the heading “Response to Comments” below.
A detailed review of the provisions of the regulations to modify specific provisions of the North Pacific Observer Program (Observer Program) and the rationale for these regulations are provided in the preamble to the proposed rule (82 FR 61243, December 27, 2017) and are briefly summarized in this final rule.
Regulations at subpart E of 50 CFR part 679 require that most vessels fishing for groundfish or halibut must carry an observer for some or all fishing activities to ensure the collection of data necessary to manage the groundfish and halibut fisheries.
The Observer Program is an integral component in the management of North Pacific fisheries. The Observer Program has two observer coverage categories: Partial and full. Regulations at 50 CFR 679.51 require vessels and processors in the full coverage category to carry an observer at all times when fish are caught or processed. This final rule affects catcher/processors in the full coverage category (
The first group of vessels includes vessels named on a License Limitation Program license with a Pacific cod catcher/processor hook-and-line endorsement for the Bering Sea, Aleutian Islands, or both the Bering Sea and Aleutian Islands (BSAI). These vessels are subject to monitoring requirements at 50 CFR 679.100 and are referred to as “freezer longline vessels” throughout this final rule. Pursuant to 50 CFR 679.100, a freezer longline vessel must carry an observer with a nontrawl LL2 deployment endorsement when the vessel (1) operates in either the BSAI or Gulf of Alaska groundfish fisheries and directed fishing for Pacific cod is open in the BSAI, or (2) when the vessel participates in the CDQ groundfish fisheries. These monitoring requirements for freezer longline vessels were implemented in 2012 and require freezer longline vessel owners and operators to select between one of two monitoring options: Either carry two observers so that all catch can be sampled, or carry one observer and use a motion-compensated flow scale to weigh Pacific cod before it is processed. Both monitoring options require the vessel to carry one observer endorsed as a nontrawl LL2 observer (77 FR 59053; September 26, 2012).
The second group of vessels that is required to carry an observer with a nontrawl LL2 deployment endorsement includes catcher/processors that use pot gear when participating in the CDQ groundfish fisheries (groundfish CDQ fishing) (77 FR 6492; February 8, 2012). These pot catcher/processors are required to carry an observer with a nontrawl LL2 deployment endorsement when groundfish CDQ fishing and may participate in other fisheries that do not require a nontrawl LL2 observer. Regulations at 50 CFR 679.32 describe the specific monitoring requirements for vessels when participating in the sablefish CDQ, pollock CDQ, and other groundfish CDQ fisheries.
Since 2014, observer providers contracted by vessels in the full coverage category have reported that they have been unable to create and retain an adequate pool of qualified nontrawl LL2 observers resulting in a diminishing pool of qualified observers employed by those observer providers. The requirements in this final rule are intended to increase the number of observers that qualify for a nontrawl LL2 deployment endorsement and thereby minimize additional costs to affected entities for an observer to obtain a nontrawl LL2 deployment endorsement. This final rule also implements provisions that are intended to maintain observer safety and data quality.
This final rule includes three elements. The first element implements new sampling experience requirements for an observer to obtain a nontrawl LL2 deployment endorsement. These sampling requirements allow sampling experience on a trawl catcher/processor or mothership vessel to count toward a nontrawl LL2 deployment endorsement. These requirements also authorize the Observer Program to require additional training for observers as necessary to adequately prepare them to safely perform data collection duties relevant to the nontrawl LL2 deployment endorsement.
The second element of this final rule requires the operator or manager of a vessel that carries nontrawl LL2 observers to participate in a pre-cruise meeting with the observer assigned to the vessel if notified to do so by NMFS. This final rule requires freezer longline vessels and pot catcher/processors when groundfish CDQ fishing to notify the Observer Program prior to embarking on a trip with a nontrawl LL2 observer who has not deployed on that vessel in the past 12 months. Subsequently, the Observer Program may contact the vessel and require the vessel operator or manager and the observer assigned to the vessel to participate in a pre-cruise meeting prior to embarking on a trip.
The third element of this final rule removes duplicative and unnecessary reporting requirements and makes minor changes to reduce observer requirements for specific vessels participating in the CDQ Program.
NMFS received five comment letters during the comment period. Four of these comment letters were outside the scope of this action. These letters raised issues not relevant to this rulemaking and are not addressed in this final rule. One comment letter directly addressed the proposed rule and contained five substantive comments that are summarized and responded to below. This comment letter was from the Freezer Longline Coalition (FLC) that represents members of the Freezer Longline Conservation Cooperative (FLCC), which includes freezer longline vessels impacted by this action.
In addition, the proposed rule cites the best scientific information available, and Section 3.3.5 of the RIR provided a description of the estimated costs to the freezer longline fleet due to the shortage of nontrawl LL2 endorsed observers. Specifically, Section 3.3.5 of the RIR summarizes the costs of voluntarily carrying a second observer to allow the observer to gain experience required for a nontrawl LL2 deployment endorsement. That cost is estimated to be $11,130 per observer for a 30-day trip. NMFS estimated this cost per trip by using information provided in Table 16 of the RIR. NMFS multiplied the estimated length of a freezer longline trip (30 days) by the estimated cost per day to deploy an observer ($371). NMFS then multiplied that total by the number of trips for which a freezer longline vessel voluntarily carried a second observer to obtain the total annual estimated cost.
NMFS expects that the cost for an observer with the requisite experience aboard a vessel using trawl gear to obtain a LL2 deployment endorsement through a two to three day training course will be significantly lower than the cost associated with a 30-day deployment. Based on the best available scientific information, NMFS anticipates that providing at least one nontrawl LL2 observer training class annually will meet the demand for additional nontrawl LL2 deployment endorsements, and freezer longline vessels will not need to voluntarily carry a second observer and incur associated additional costs.
In addition, the Observer Program routinely determines the training necessary for an observer to receive certification, annual endorsements and deployment endorsements, and responds to requests from observer providers to schedule training classes at NMFS facilities. The Observer Program may adjust the number of nontrawl LL2 training classes offered each year if required to meet demand.
Based on the contractual relationships, recognized since the formation of the FLCC in August 2010, NMFS determined that all members of the FLCC are affiliated as described under 13 CFR 121.103(f) for the purpose of analyses prepared under the RFA. This application of the SBA principles of affiliation is consistent with how NMFS has applied this size standard to vessels and processors in fishing cooperatives in the North Pacific since at least 2001 (66 FR 65028; December 17, 2001). NMFS has applied this same determination to vessels and processors in fishing cooperatives under the American Fisheries Act, the Crab Rationalization Program, the Amendment 80 Program, the Gulf of Alaska Rockfish Program, and for the FLCC.
The FLCC is a registered active non-profit corporation in the State of Washington and, through the FLC, maintains an active website identifying all member vessels (
Thus, NMFS maintains that the members of the FLCC are recognized as members of a voluntary fishing cooperative with a single identity of interest in the harvest of the annual allocation of Pacific cod to the BSAI freezer longline vessels such that interests should be aggregated for the purpose of analysis prepared under the RFA. The contractual relationship among vessels in the cooperative allows members to work together to more efficiently harvest fishery allocations. The ability to plan ahead, cooperate in harvest decisions, and share some expenses constitutes a degree of economic dependence not available to independent fishing vessels. In addition, the conclusion that the members of the FLCC are affiliated for purposes of the RFA is consistent with previous actions implemented since the formation of the FLCC in 2010 and impacting the same fleet prosecuting the same resources (77 FR 59053, September 26, 2012; 77 FR 58775, September 24, 2012; 79 FR 603, January 6, 2014; 79 FR 68610, November 18, 2014).
NMFS made three changes to this final rule. These changes provide minor clarifications that do not substantively modify the regulations as proposed.
The first change adds the word “either” and the regulatory text in paragraph (a)(5)(v)(C)(
The second change adds the words “at least” to § 679.53(a)(5)(v)(C)(
The third change correctly identifies the locations in 50 CFR part 679 where the term “Observer Program Office” will be replaced with the term “Observer Program” by including § 679.52(a)(2), (b)(1)(iii)(A), (b)(2)(iv), (b)(3)(ii)(B), and (b)(8) introductory text. These paragraphs were inadvertently incorrectly listed in the table as paragraphs of § 679.51 in the proposed rule.
Section 3507(c)(B)(i) of the Paperwork Reduction Act (PRA) requires that agencies inventory and display a current control number assigned by the Director of the Office of Management and Budget (OMB), for each agency information collection. Section 902.1(b) identifies the location of NOAA regulations for which OMB control numbers have been issued. Because this final rule revises and adds data elements within a collection-of-information for recordkeeping and reporting requirements, this final rule includes revisions to 15 CFR 902.1(b) to correctly reference the control number and associated regulation sections included in this final rule.
The Administrator, Alaska Region, NMFS, has determined that this final rule is necessary for the conservation and management of the groundfish fishery and is consistent with the GOA and BSAI FMPs, the Magnuson-Stevens Act, and other applicable law.
This final rule has been determined to be not significant for the purposes of Executive Order 12866.
The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration (SBA) that this final rule will not have a significant economic impact on a substantial number of small entities. NMFS published a proposed rule on December 27, 2017 (82 FR 61243). An IRFA was prepared and included in the “Classification” section of the preamble to the proposed rule. The comment period closed on January 26, 2018. NMFS received five letters of comment on the proposed rule. One comment letter contained two comments on the IRFA, which are summarized in the “Response to Comments” section (Comments 4 and 5). The comments on the IRFA were considered by NMFS in the decision to certify this final rule. The Chief Counsel for Advocacy of the SBA did not file any comments on the proposed rule.
The factual basis for certification of this final rule is described below. This action includes three elements that modify specific provisions of the Observer Program. The first element modifies sampling experience requirements for an observer to obtain a nontrawl LL2 deployment endorsement. The second element requires the operator or manager of a vessel required to carry an observer with a nontrawl LL2 deployment endorsement to participate in a pre-cruise meeting when notified to do so by NMFS. The third element removes duplicative and unnecessary reporting requirements and makes minor changes to reduce or remove observer-related requirements for specific vessels when participating in the CDQ Program.
This action directly regulates observers and owners and operators of the following vessels: (1) Freezer longline vessels that participate in the BSAI hook-and-line Pacific cod fishery; and (2) pot catcher/processors, trawl catcher/processors, nontrawl catcher/processors, and motherships when groundfish CDQ fishing. For reasons explained in more detail in the IRFA and in responses to Comment 4 and Comment 5 in the preamble to this final rule, NMFS has determined that there are no small entities directly regulated by this final rule.
In addition, this action is expected to reduce the cost for vessels to comply with observer coverage requirements and is not expected to impose significant costs of complying with new reporting requirements. This action will benefit all affected vessels by increasing the number of observers that may qualify for a nontrawl LL2 deployment endorsement and will remove observer-related requirements for specific vessels when participating in the CDQ Program.
For all of these reasons, this action is not expected to have a significant economic impact on a substantial number of small entities. As a result, a final regulatory flexibility analysis is not required, and none has been prepared. The economic analysis contained in the RIR (see
This final rule contains collection-of-information requirements subject to the Paperwork Reduction Act (PRA) and which have been approved by the Office of Management and Budget (OMB) under OMB control number 0648-0318 (North Pacific Observer Program). The public reporting burden for these
This final rule will require that the Observer Program be notified by phone at least 24 hours prior to departure when a vessel will carry an observer who has not deployed on that vessel in the past 12 months. Public reporting burden per response to notify the Observer Program by phone is estimated to be five minutes.
Send comments on these burden estimates or any other aspect of this data collection, including suggestions for reducing the burden, to NMFS Alaska Region (see
Notwithstanding any other provision of the law, no person is required to respond to, and no person shall be subject to penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB control number. All currently approved NOAA collections of information may be viewed at
Reporting and recordkeeping requirements.
Alaska, Fisheries, Recordkeeping and reporting requirements.
For the reasons set out in the preamble, NMFS amends 15 CFR part 902 and 50 CFR part 679 as follows:
44 U.S.C. 3501
(b) * * *
16 U.S.C. 773
(c) * * *
(3) * * *
(i) * * *
(E) * * *
(
(a) * * *
(2)
(a) * * *
(2) * * *
(vi) * * *
(A) * * *
(
(a) * * *
(5) * * *
(v) * * *
(C) A lead level 2 observer on a vessel using nontrawl gear must have completed the following:
(
(
(
(c) * * *
(7)
(c) * * *
(7)
(b) * * *
(1) * * *
(v) The Observer Program is notified by phone at 1 (907) 581-2060 (Dutch Harbor, AK) or 1 (907) 481-1770 (Kodiak, AK) at least 24 hours prior to departure when the vessel will be carrying an observer who has not previously been deployed on that vessel within the last 12 months. Subsequent to the vessel's departure notification, but prior to departure, NMFS may contact the vessel to arrange for a pre-cruise meeting. The pre-cruise meeting must minimally include the vessel operator or manager and any observers assigned to the vessel.
(2) * * *
(i) * * *
(E) The Observer Program is notified by phone at 1 (907) 581-2060 (Dutch Harbor, AK) or 1 (907) 481-1770 (Kodiak, AK) at least 24 hours prior to departure when the vessel will be carrying an observer who has not previously been deployed on that vessel within the last 12 months. Subsequent to the vessel's departure notification, but prior to departure, NMFS may contact the vessel to arrange for a pre-cruise meeting. The pre-cruise meeting must minimally include the vessel operator or manager and any observers assigned to the vessel.
Commodity Futures Trading Commission.
Correcting amendments.
On November 2, 2012, the Commodity Futures Trading Commission revised its rules. That document inadvertently failed to remove several obsolete provisions in the regulation. This document corrects the final regulations.
Effective on June 29, 2018.
Jacob Chachkin, Special Counsel, 202-418-5496, email:
In the
Agricultural commodity, Agriculture, Brokers, Committees, Commodity futures, Conflicts of interest, Consumer protection, Definitions, Designated contract markets, Directors, Major swap participants, Minimum financial requirements for intermediaries, Reporting and recordkeeping requirements, Swap dealers, Swaps.
Accordingly, 17 CFR part 1 is corrected by making the following correcting amendments:
7 U.S.C. 1a, 2, 5, 6, 6a, 6b, 6c, 6d, 6e, 6f, 6g, 6h, 6i, 6k, 6l, 6m, 6n, 6o, 6p, 6r, 6s, 7, 7a-1, 7a-2, 7b, 7b-3, 8, 9, 10a, 12, 12a, 12c, 13a, 13a-1, 16, 16a, 19, 21, 23, and 24 (2012).
The revisions read as follows:
(a) * * *
(2) For each commodity option position and foreign option position—
(i) All commodity options and foreign options purchased, sold, exercised, or expired during the monthly reporting period, identified by underlying futures contract or underlying commodity, strike price, transaction date, and expiration date;
(ii) The open commodity option and foreign option positions carried for such customer or foreign futures or foreign options customer as of the end of the monthly reporting period, identified by underlying futures contract or underlying commodity, strike price, transaction date, and expiration date;
(iii) All open commodity option and foreign option positions marked to the market and the amount each position is in the money, if any; and
(iv) Any related customer funds carried in such customer's account(s) or any related foreign futures or foreign options secured amount carried in the account(s) of a foreign futures or foreign options customer.
(b) * * *
(3) A written confirmation of each commodity option transaction, containing at least the following information:
Food and Drug Administration, HHS.
Notification of availability.
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry #252 entitled “Antimicrobial Animal Drug Sales and Distribution Reporting Small Entity Compliance Guide.” The small entity compliance guide (SECG) is intended to help small entities comply with the final rule we issued in the
The announcement of the guidance is published in the
You may submit either electronic or written comments on Agency guidances at any time as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” We will review this copy, including the claimed confidential information, in our 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 SECG to the Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send two self-addressed adhesive labels to assist that office in processing your request. See the
Sujaya Dessai, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5671,
Sponsors of approved or conditionally approved applications for new animal drugs containing an antimicrobial active ingredient are required by section 512 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b), as amended by section 105 of the Animal Drug Use Fee Amendments of 2008 (ADUFA 105) (Pub. L. 110-316), to submit to us an annual report on the amount of each such ingredient in the drug that is sold or distributed for use in food-producing animals. We are also required by ADUFA 105 to publish annual summary reports of the data we receive from animal drug sponsors. In accordance with the law, sponsors of the affected antimicrobial new animal drug products began submitting their sales and distribution data to us on an annual basis, and we have published summaries of such data for each calendar year beginning with 2009.
In the
We examined the economic implications of the final rule as required by the Regulatory Flexibility Act (5 U.S.C. 601-612) and determined that the final rule will not have a significant economic impact on a substantial number of small entities (81 FR 29129 at 29138). Nonetheless, we determined not to certify that finding due to the remote possibility that, in the future, a very small company could enter the market and sponsor an application for an antimicrobial new animal drug product that would be sold or distributed for use in food-producing animals. Thus, in compliance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Pub. L. 104-121, as amended by Pub. L. 110-28), we are making available this SECG to explain the actions that a potential future market entrant small entity must take to comply with the rule.
We are issuing this SECG consistent with our good guidance practices regulation (21 CFR 10.115(c)(2)). The SECG represents 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 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 § 514.87 have been approved under OMB control number 0910-0659. The collections of information in § 514.80 have been approved under OMB control number 0910-0284.
Persons with access to the internet may obtain the SECG at either
Alcohol and Tobacco Tax and Trade Bureau, Treasury.
Final rule; Treasury decision.
The Alcohol and Tobacco Tax and Trade Bureau (TTB) establishes the approximately 133-square mile Dahlonega Plateau viticultural area in portions of Lumpkin and White counties in Georgia. The Dahlonega Plateau viticultural area is not located within any other established viticultural area. TTB designates viticultural areas to allow vintners to better describe the origin of their wines and to allow consumers to better identify wines they may purchase.
This final rule is effective July 30, 2018.
Dana Register, Regulations and Rulings Division, Alcohol and Tobacco Tax and Trade Bureau, 1310 G Street NW, Box 12, Washington, DC 20005; phone 202-453-1039, ext. 022.
Section 105(e) of the Federal Alcohol Administration Act (FAA Act), 27 U.S.C. 205(e), authorizes the Secretary of the Treasury to prescribe regulations for the labeling of wine, distilled spirits, and malt beverages. The FAA Act provides that these regulations should, among other things, prohibit consumer deception and the use of misleading statements on labels and ensure that labels provide the consumer with adequate information as to the identity and quality of the product. The Alcohol and Tobacco Tax and Trade Bureau (TTB) administers the FAA Act pursuant to section 1111(d) of the Homeland Security Act of 2002, codified at 6 U.S.C. 531(d). The Secretary has delegated various authorities through Treasury Department Order 120-01, dated December 10, 2013 (superseding Treasury Order 120-01, dated January 24, 2003), to the TTB Administrator to perform the functions and duties in the administration and enforcement of these laws.
Part 4 of the TTB regulations (27 CFR part 4) authorizes the establishment of definitive viticultural areas and regulates the use of their names as appellations of origin on wine labels and in wine advertisements. Part 9 of the TTB regulations (27 CFR part 9) sets forth standards for the preparation and submission of petitions for the establishment or modification of American viticultural areas (AVAs) and lists the approved AVAs.
Section 4.25(e)(1)(i) of the TTB regulations (27 CFR 4.25(e)(1)(i)) defines a viticultural area for American wine as a delimited grape-growing region having distinguishing features, as described in part 9 of the regulations, and a name and a delineated boundary, as established in part 9 of the regulations. These designations allow vintners and consumers to attribute a given quality, reputation, or other characteristic of a wine made from grapes grown in an area to the wine's geographic origin. The establishment of AVAs allows vintners to describe more accurately the origin of their wines to consumers and helps consumers to identify wines they may purchase. Establishment of an AVA is neither an approval nor an endorsement by TTB of the wine produced in that area.
Section 4.25(e)(2) of the TTB regulations (27 CFR 4.25(e)(2)) outlines the procedure for proposing an AVA and provides that any interested party may petition TTB to establish a grape-growing region as an AVA. Section 9.12 of the TTB regulations (27 CFR 9.12) prescribes standards for petitions for the establishment or modification of AVAs. Petitions to establish an AVA must include the following:
• Evidence that the area within the proposed AVA boundary is nationally or locally known by the AVA name specified in the petition;
• An explanation of the basis for defining the boundary of the proposed AVA;
• A narrative description of the features of the proposed AVA affecting viticulture, such as climate, geology, soils, physical features, and elevation, that make the proposed AVA distinctive and distinguish it from adjacent areas outside the proposed AVA boundary;
• The appropriate United States Geological Survey (USGS) map(s) showing the location of the proposed AVA, with the boundary of the proposed AVA clearly drawn thereon; and
• A detailed narrative description of the proposed AVA boundary based on USGS map markings.
TTB received a petition from Amy Booker, President of the Dahlonega-Lumpkin Chamber & Visitors Bureau, on behalf of the Vineyard and Winery Operators of the Dahlonega Region of Northern Georgia. The petitioner is proposing the establishment of the “Dahlonega Plateau” AVA in portions of Lumpkin and White counties in Georgia.
The proposed Dahlonega Plateau AVA derives its name from a long, narrow, northeast-southwest trending plateau in the northern foothills of the Georgia Piedmont known as the Dahlonega Plateau. The plateau covers most of Lumpkin, Dawson, White, Pickens, and Cherokee Counties. However, the proposed AVA is limited to the northeastern portion of the plateau, in Lumpkin and White Counties, due to a lack of viticulture in the southwestern region of the plateau, as well topographical and climatic differences.
The proposed Dahlonega Plateau AVA covers approximately 133 square miles and is not located within any other AVA. The petition notes that, at present, there are 7 wineries and 8 commercial vineyards covering a total of approximately 110 acres distributed throughout the proposed AVA. In the next few years, the proposed AVA would likely be expanded by an additional 12 acres of vineyards. According to the petition, the distinguishing features of the proposed Dahlonega Plateau AVA are its topography and climate. Unless otherwise noted, all information and data pertaining to the proposed AVA contained in this final rule comes from the petition for the proposed Dahlonega Plateau AVA and its supporting exhibits.
According to the petition, the distinctive topography of the proposed AVA is due to the underlying geology, which is comprised of layers of rocks that weather uniformly and are moderately resistant to erosion. Over time, wind and water have gradually worn down the underlying rocks and formed a gently rolling landscape with an average elevation of approximately 1,554 feet above sea level. The resulting broad, rounded hilltops separated by wide valleys have moderate slope angles and adequate sunlight for the cultivation of vineyards.
By contrast, the petition states that the topography of the regions surrounding the proposed AVA are less suitable for vineyards. The Blue Ridge Mountains and Hightower Ridges to the north, east, and southeast of the proposed AVA generally have higher elevations and narrow valleys that are often shadowed by the surrounding steep, high slopes. The steep, high slopes allow less light to reach any vineyard planted on the valley floors, when compared to vineyards planted in the proposed AVA. The steepness of the slopes would also make mechanical cultivation of any vineyard planted on the sides of the mountains impractical. In the lower elevations of the regions to the south and west of the proposed AVA, the cool air draining from higher elevations eventually settles and pools and would increase the risk of frost damage in any vineyard planted there.
The petition for the proposed Dahlonega Plateau AVA provided climate information including length of the growing season, growing degree day accumulations, and precipitation amounts from within the proposed AVA and the surrounding regions.
According to the petition, the proposed Dahlonega Plateau AVA has a mean growing season length of 195 days. Over 60 percent of the terrain
The petition also provided the growing season lengths for the areas surrounding the proposed AVA. The regions to the north and northeast each have a mean growing season of 164 days. Regions to the west and south, have growing seasons of 201 and 203 to 205 days, respectively. The proposed AVA has a higher percentage of terrain with a growing season length between 190 and 200 days than all surrounding areas except the Hightower Ridges to the east, where approximately 76 percent of the terrain is within this range of growing season lengths.
The petition noted that although growing season length is important because it reflects the number of frost-free days, the temperatures that are reached during that frost-free period are just as important to viticulture. The petition further stated that grape vines do not grow and fruit does not mature when temperatures are below 50 degrees Fahrenheit (F). Therefore, a region that has a 180-day frost-free growing season would still be unsuitable for viticulture if temperatures seldom or never rise above 50 degrees F.
The petition presented growing degree days (GDD) data using the Winkler zone scale
According to the petition, the rising elevations of the proposed Dahlonega Plateau AVA and the regions to the north and east cause the moisture-laden winds travelling inland from the Gulf of Mexico and Atlantic Ocean to drop their rain in the proposed AVA. Annual rainfall amounts within the proposed AVA are approximately 62 inches per year and 17 inches during the winter months. The regions to the north and east generally receive more rainfall annually and during winter than the proposed AVA, and the regions to the south and west generally receive less. The petition stated that the proposed AVA receives adequate annual rainfall amounts, which make vineyard irrigation seldom necessary. Furthermore, the petition provides data collected from the proposed AVA and surrounding regions showing that the low winter rainfall amounts within the proposed AVA are relevant to viticulture because, when compared to the data from the surrounding regions, low levels of rain in winter in the proposed AVA reduce the possibility of a delayed bud break and subsequent later harvest.
TTB published Notice No. 166 in the
In response to Notice No. 166, TTB received one comment, which supported the proposed AVA. The commenter stated that the Dahlonega plateau is a “gorgeous mountain region” that has “unique wine-growing characteristics” that qualify it as an AVA.
After careful review of the petition and the comment received in response to Notice No. 166, TTB finds that the evidence provided by the petitioner supports the establishment of the Dahlonega Plateau AVA. Accordingly, under the authority of the FAA Act, section 1111(d) of the Homeland Security Act of 2002, and parts 4 and 9 of the TTB regulations, TTB establishes the “Dahlonega Plateau” AVA in Lumpkin and Whites counties of Georgia, effective 30 days from the publication date of this document.
See the narrative description of the boundary of the Dahlonega AVA in the regulatory text published at the end of this final rule.
The petitioner provided the required maps, and they are listed below in the regulatory text.
Part 4 of the TTB regulations prohibits any label reference on a wine that indicates or implies an origin other than the wine's true place of origin. For a wine to be labeled with an AVA name or with a brand name that includes an AVA name, at least 85 percent of the wine must be derived from grapes grown within the area represented by that name, and the wine must meet the other conditions listed in 27 CFR 4.25(e)(3). If the wine is not eligible for labeling with an AVA name and that name appears in the brand name, then the label is not in compliance and the bottler must change the brand name and obtain approval of a new label. Similarly, if the AVA name appears in another reference on the label in a misleading manner, the bottler would have to obtain approval of a new label. Different rules apply if a wine has a brand name containing an AVA name that was used as a brand name on a label approved before July 7, 1986. See 27 CFR 4.39(i)(2) for details.
With the establishment of this AVA, its name, “Dahlonega Plateau,” will be recognized as a name of viticultural significance under § 4.39(i)(3) of the TTB regulations. The text of the regulation clarifies this point. Consequently, wine bottlers using the name “Dahlonega Plateau” in a brand name, including a trademark, or in another label reference as to the origin of the wine, will have to ensure that the product is eligible to use the AVA name as an appellation of origin. The establishment of the Dahlonega Plateau AVA will not affect any existing AVA. The establishment of the Dahlonega Plateau AVA will allow vintners to use “Dahlonega Plateau” as an appellation of origin for wines made primarily from grapes grown within the Dahlonega Plateau AVA if the wines meet the eligibility requirements for the appellation.
TTB certifies that this regulation will not have a significant economic impact on a substantial number of small entities. The regulation imposes no new reporting, recordkeeping, or other administrative requirement. Any benefit derived from the use of an AVA name would be the result of a proprietor's efforts and consumer acceptance of wines from that area. Therefore, no regulatory flexibility analysis is required.
It has been determined that this final rule is not a significant regulatory action as defined by Executive Order 12866 of September 30, 1993. Therefore, no regulatory assessment is required.
Dana Register of the Regulations and Rulings Division drafted this final rule.
Wine.
For the reasons discussed in the preamble, TTB amends title 27, chapter I, part 9, Code of Federal Regulations, as follows:
27 U.S.C. 205.
(a)
(b)
(1) Dawsonville, GA, 1997;
(2) Campbell Mountain, GA, 2014;
(3) Nimblewill, GA, 1997;
(4) Noontootla, GA, 1988;
(5) Suches, GA, 1988;
(6) Neels Gap, GA, 1988;
(7) Dahlonega, GA, 1951;
(8) Cowrock, GA, 1988; and
(9) Cleveland, GA, 1951; photo revised 1973; photo inspected 1981.
(c)
(1) The beginning point is found on the Dawsonville map at the marked 1,412-foot elevation point at the intersection of an unnamed light-duty road known locally as Castleberry Bridge Road and an unimproved road known locally as McDuffie River Road.
(2) From the beginning point, proceed north-northeast in a straight line approximately 0.89 mile to the marked 1,453-foot elevation point; then
(3) Proceed northwest in a straight line approximately 1.94 miles, crossing onto the Campbell Mountain map, to the intersection of Arrendale Road and Windy Oaks Road; then
(4) Proceed northwest in a straight line approximately 0.77 mile to the intersection of the 1,400-foot elevation contour and Dennson Branch; then
(5) Proceed northwest in a straight line approximately 0.79 mile to the intersection of the 1,360-foot elevation contour and Mill Creek; then
(6) Proceed northwest in a straight line approximately 0.48 mile to the intersection of the 1,500-foot elevation contour and Sheep Wallow Road; then
(7) Proceed northwest in a straight line approximately 1.74 miles to the intersection of State Route 52 and the Chattahoochee National Forest boundary; then
(8) Proceed northwest in a straight line approximately 1.89 miles, crossing onto the Nimblewill map and then crossing over the marked 1,749-foot elevation point along an unnamed light duty road known locally as Nimblewill Church Road, to the line's intersection with the 1,800-foot elevation contour; then
(9) Proceed generally east-northeast along the 1,800-foot elevation contour approximately 170.72 miles (straight line distance between points is approximately 20.43 miles), crossing over the Noontootla, Suches, Neels Gap and Dahlonega maps and onto the Cowrock map, to the intersection of the 1,800-foot elevation contour with Tom White Branch; then
(10) Proceed southeast along Tom White Branch approximately 0.73 mile to the 1,600-foot elevation contour; then
(11) Proceed southeast in a straight line approximately 1.10 miles to the intersection of Cathey Creek and the secondary highway marked Alt. 75; then
(12) Proceed southwest in a straight line approximately 3.77 miles, crossing into the Cleveland map, to the intersection of two unnamed light-duty roads known locally as Dockery Road and Town Creek Road; then
(13) Proceed south in a straight line approximately 0.58 mile to the marked 1,774-foot elevation point; then
(14) Proceed southwest in a straight line approximately 0.60 mile to the 1,623-foot benchmark; then
(15) Proceed southwest in a straight line approximately 2.73 miles, crossing into the Dahlonega map, to the 1,562-foot benchmark, then
(16) Proceed southwest in a straight line approximately 3.46 miles to the marked 1,480-foot elevation point near the Mt. Sinai Church; then
(17) Proceed southwest in a straight line approximately 2.13 miles to the summit of Crown Mountain; then
(18) Proceed west in a straight line approximately 1.28 miles, crossing onto the Campbell Mountain map, to the intersection of the 1,160-foot elevation contour and Cane Creek; then
(19) Proceed southwest in a straight line approximately 1.61 miles to the intersection of the 1,300-foot elevation contour and Camp Creek; then
(20) Proceed southwest in a straight line approximately 2.02 miles, crossing into the Dawsonville map, to the intersection of the 1,200-foot elevation contour with the Etowah River, then
(21) Proceed southwest in a straight line approximately 1.29 miles to the beginning point.
In Title 29 of the Code of Federal Regulations, Parts 1910 to § 1910.999, revised as of July 1, 2017, on page 247, in § 1910.106, paragraph (d)(2)(iii) introductory text is revised to read as follows:
(d) * * *
(1) * * *
(2) * * *
(iii)
Office of Foreign Assets Control, Treasury.
Final rule.
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is removing from the Code of Federal Regulations the Sudanese Sanctions Regulations as a result of the revocation of certain provisions of one Executive Order and the entirety of another Executive Order on which the regulations were based. OFAC is also amending the Terrorism List Government Sanctions Regulations to incorporate a general license authorizing certain transactions related to exports of agricultural commodities, medicines, and medical devices, which has, until now, appeared only on OFAC's website.
The Department of the Treasury's Office of Foreign Assets Control: Assistant Director for Licensing, tel.: 202-622-2480; Assistant Director for Regulatory Affairs, tel.: 202-622-4855; Assistant Director for Sanctions Compliance & Evaluation, tel.: 202-622-2490; or the Department of the Treasury's Office of the General Counsel: Office of the Chief Counsel (Foreign Assets Control); tel.: 202-622-2410.
This document and additional information concerning OFAC are available from OFAC's website (
On November 3, 1997, the President issued Executive Order 13067, “Blocking Sudanese Government Property and Prohibiting Transactions With Sudan” (E.O. 13067), declaring a national emergency to deal with the unusual and extraordinary threat to the national security and foreign policy of the United States posed by the policies and actions of the Government of Sudan. E.O. 13067 blocked all property and interests in property of the Government of Sudan that were in the United States, that thereafter came within the United States, or that thereafter came within the possession or control of United States persons. E.O. 13067 also prohibited: (a) The importation into the United States of any goods or services of Sudanese origin; (b) the exportation or reexportation, directly or indirectly, to Sudan of goods, technology, or services from the United States or by a United States person, wherever located, or requiring the issuance of a license by a Federal agency; (c) the facilitation by a United States person of the exportation or reexportation of goods, technology, or services to or from Sudan; (d) the performance by any United States person of any contract, including a financing contract, in support of an industrial, commercial, public utility, or governmental project in Sudan; (e) the grant or extension of credits or loans by any United States person to the Government of Sudan; (f) any transaction by a United States person relating to transportation of cargo to or from Sudan; and (g) any transaction by any United States person, or within the United States that evaded or avoided, or had the purpose of evading or avoiding, or attempted to violate any of the prohibitions set forth in E.O. 13067.
On July 1, 1998, OFAC issued the Sudanese Sanctions Regulations, 31 CFR part 538 (SSR), as a final rule to implement E.O. 13067. The SSR were amended on various occasions to, among other things, implement further Executive orders and add additional authorizations.
On April 26, 2006, in Executive Order 13400 (E.O. 13400), the President determined that the conflict in Sudan's Darfur region posed an unusual and extraordinary threat to the national security and foreign policy of the United States, expanded the scope of the national emergency declared in E.O. 13067 to deal with that threat, and ordered the blocking of property of certain persons connected to the conflict. On May 28, 2009, OFAC issued the Darfur Sanctions Regulations, 31 CFR part 546 (DSR), as a final rule to implement E.O. 13400. On October 13, 2006, the President issued Executive Order 13412 (E.O. 13412) to take additional steps with respect to the national emergency and to implement the Darfur Peace and Accountability Act of 2006, Public Law 109-344, 120 Stat. 1869.
On January 13, 2017, President Obama issued Executive Order 13761, “Recognizing Positive Actions by the Government of Sudan and Providing for the Revocation of Certain Sudan-Related Sanctions” (E.O. 13761). In E.O. 13761, President Obama found that the situation that gave rise to the actions taken in E.O.s 13067 and 13412 related to the policies and actions of the Government of Sudan had been altered by Sudan's positive actions over the prior six months. These actions included a marked reduction in offensive military activity, culminating in a pledge to maintain a cessation of hostilities in conflict areas in Sudan, and steps toward the improvement of humanitarian access throughout Sudan, as well as cooperation with the United States on addressing regional conflicts and the threat of terrorism. Given these developments, and in order to see these efforts sustained and enhanced by the Government of Sudan, President Obama ordered that, effective July 12, 2017, sections 1 and 2 of E.O. 13067 be revoked, and E.O. 13412 be revoked in its entirety, provided that a review before that date determined certain criteria were met.
On July 11, 2017, President Trump issued Executive Order 13804, “Allowing Additional Time for Recognizing Positive Actions by the Government of Sudan and Amending Executive Order 13761” (E.O. 13804). In E.O. 13804, President Trump amended E.O. 13761, extending until October 12,
On October 11, 2017, the Secretary of State, in consultation with the Secretary of the Treasury, the Director of National Intelligence, and the Administrator of the U.S. Agency for International Development, published notice in the
The emergency declared by the President with respect to Sudan in E.O. 13067, and expanded in E.O. 13400, has not been terminated. These authorities remain the basis for the DSR, which remain in effect with respect to Darfur and continues to block the property and interests in property of certain persons connected with the conflict in Darfur.
Pursuant to section 1 of E.O. 13761, as amended by E.O. 13804, the revocation of sections 1 and 2 of E.O. 13067 and the entirety of E.O. 13412 shall not affect any violation of any rules, regulations, orders, licenses, or other forms of administrative action under those orders during the period that those provisions were in effect.
Pursuant to Section 906 of the Trade Sanctions Reform and Export Enhancement Act of 2000, 22 U.S.C. 7205 (TSRA), an OFAC license is still required for certain exports and reexports to Sudan of agricultural commodities, medicine, and medical devices as a result of Sudan's inclusion on the State Sponsors of Terrorism List. Effective October 12, 2017, OFAC issued and made available on its website General License A. This general license authorized exports and reexports of these items to Sudan. Today, OFAC is incorporating General License A into the Terrorism List Government Sanctions Regulations, 31 CFR part 596, as new § 596.506. No OFAC license is required for financing of these exports and reexports.
U.S. persons and non-U.S. persons will still need to obtain any licenses required by the Department of Commerce's Bureau of Industry and Security (BIS) to export or reexport to Sudan certain items (commodities, software, and technology) that are on the Commerce Control List (CCL), Supp. No. 1 to part 774 of the Export Administration Regulations, 15 CFR parts 730 through 774 (EAR). In limited circumstances, U.S. persons and non-U.S. persons may also need to obtain licenses from BIS to export or reexport to Sudan items that are subject to the EAR but not specifically listed on the CCL (“EAR99” items) if such transactions implicate certain end-use or end-user concerns (see 15 CFR part 744).
Because the Regulations involve a foreign affairs function, the provisions of Executive Order 12866 and the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, opportunity for public participation, and delay in effective date, as well as the provisions of Executive Order 13771, are inapplicable. Because no notice of proposed rulemaking is required for this rule, the Regulatory Flexibility Act (5 U.S.C. 601-612) does not apply.
The Paperwork Reduction Act does not apply because this rule does not impose information collection requirements that would require the approval of the Office of Management and Budget under 44 U.S.C. 3501
Administrative practice and procedure, Banks, Banking, Blocking of assets, Sudan, Credit, Foreign Trade, Penalties, Reporting and recordkeeping requirements, Securities, Services.
Administrative practice and procedure, Banks, Banking, Blocking of assets, Foreign Trade, Penalties, Reporting and recordkeeping requirements, Terrorism.
For the reasons set forth in the preamble, and under the authority of 3 U.S.C. 301; 50 U.S.C. 1601-1651; E.O. 13067, 62 FR 59989, 3 CFR, 1997 Comp., p. 230; E.O. 13412, 71 FR 61369, 3 CFR, 2006 Comp., p. 244; E.O. 13761, 82 FR 5331, as amended by E.O. 13804, 82 FR 23611, OFAC amends 31 CFR parts 538 and 596 as follows:
18 U.S.C. 2332d; 22 U.S.C. 7201-7211; 31 U.S.C. 321(b).
(a) Effective October 12, 2017, pursuant to section 906(a)(l) of the Trade Sanctions Reform and Export Enhancement Act of 2000 (22 U.S.C. 7205) (TSRA), all exports and reexports of agricultural commodities, medicine, or medical devices to the Government of Sudan or to any entity in Sudan or to any person in a third country purchasing specifically for resale to any of the foregoing are authorized, provided that the exports and reexports are shipped within the 12-month period beginning on the date of the signing of the contract for export or reexport.
(b) Consistent with section 906(a)(l) of TSRA, each year the Office of Foreign Assets Control will determine whether to revoke this general license. Unless revoked, the general license will remain in effect.
This authorization does not eliminate the need to comply with other provisions of 31 CFR chapter V, including 31 CFR part 596, or other applicable provisions of law, including any requirements of agencies other than the Department of the Treasury's Office of Foreign Assets Control. Such requirements include the Export Administration Regulations (15 CFR parts 730 through 774) administered by the Bureau of Industry and
Office of Foreign Assets Control, Treasury.
Final rule.
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is adding regulations to implement the Global Magnitsky Human Rights Accountability Act and Executive Order 13818 of December 20, 2017 (“Blocking the Property of Persons Involved in Serious Human Rights Abuse or Corruption”). OFAC intends to supplement these regulations with a more comprehensive set of regulations, which may include additional interpretive and definitional guidance, general licenses, and statements of licensing policy.
OFAC: Assistant Director for Licensing, tel.: 202-622-2480; Assistant Director for Regulatory Affairs, tel.: 202-622-4855; Assistant Director for Sanctions Compliance & Evaluation, tel.: 202-622-2490; or the Department of the Treasury's Office of the Chief Counsel (Foreign Assets Control), Office of the General Counsel, tel.: 202-622-2410.
This document and additional information concerning OFAC are available from OFAC's website (
On December 23, 2016, the President signed the Global Magnitsky Human Rights Accountability Act (Pub. L. 114-328, Title XII, Subtitle F) (the “Act”) into law. The Act authorized the President to impose targeted sanctions on any foreign person the President determines is, among other things, responsible for extrajudicial killings, torture, or other gross violations of internationally recognized human rights, or a government official, or a senior associate of such an official, responsible for, or complicit in, ordering, controlling, or otherwise directing, acts of significant corruption.
On December 20, 2017, the President, invoking the authority of,
In E.O. 13818, the President determined that serious human rights abuse and corruption around the world constitute an unusual and extraordinary threat to the national security, foreign policy, and economy of the United States and declared a national emergency to deal with that threat.
OFAC is issuing the Global Magnitsky Sanctions Regulations, 31 CFR part 583 (the “Regulations”), to implement the Act and E.O. 13818, pursuant to authorities delegated to the Secretary of the Treasury in E.O. 13818. A copy of E.O. 13818 appears in appendix A to this part.
The Regulations are being published in abbreviated form at this time for the purpose of providing immediate guidance to the public. OFAC intends to supplement this part 583 with a more comprehensive set of regulations, which may include additional interpretive and definitional guidance, general licenses, and statements of licensing policy. The appendix to the Regulations will be removed when OFAC supplements this part with a more comprehensive set of regulations.
Because the Regulations involve a foreign affairs function, the provisions of Executive Order 12866 and the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, opportunity for public participation, and delay in effective date, as well as the provisions of Executive Order 13771, are inapplicable. Because no notice of proposed rulemaking is required for this rule, the Regulatory Flexibility Act (5 U.S.C. 601-612) does not apply.
The collections of information related to the Regulations are contained in 31 CFR part 501 (the “Reporting, Procedures and Penalties Regulations”). Pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), those collections of information have been approved by the Office of Management and Budget under control number 1505-0164. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid control number.
Administrative practice and procedure, Banks, Banking, Blocking of assets, Global Magnitsky, Penalties, Reporting and recordkeeping requirements, Sanctions.
3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601-1651, 1701-1706; Pub. L. 101-410, 104 Stat. 890 (28 U.S.C. 2461 note); Pub. L. 110-96, 121 Stat. 1011 (50 U.S.C. 1705 note); Pub. L. 114-328, Title XII, Subtitle F, 130 Stat. 2533 (22 U.S.C. 2656 note); E.O. 13818, 82 FR 60839, December 26, 2017.
This part is separate from, and independent of, the other parts of this chapter, with the exception of part 501 of this chapter, the recordkeeping and reporting requirements and license application and other procedures of which apply to this part. Actions taken pursuant to part 501 of this chapter with respect to the prohibitions contained in this part are considered actions taken pursuant to this part. Differing foreign policy and national security circumstances may result in differing interpretations of similar language among the parts of this chapter. No license or authorization contained in or issued pursuant to those other parts authorizes any transaction prohibited by this part. No license or authorization contained in or issued pursuant to any other provision of law or regulation authorizes any transaction prohibited by this part. No license or authorization contained in or issued pursuant to this part relieves the involved parties from complying with any other applicable laws or regulations.
This part has been published in abbreviated form for the purpose of providing immediate guidance to the public. OFAC intends to supplement this part with a more comprehensive set of regulations, which may include additional interpretive and definitional guidance, general licenses, and statements of licensing policy.
All transactions prohibited pursuant to Executive Order 13818 of December 20, 2017 are also prohibited pursuant to this part.
The names of persons listed in or designated pursuant to Executive Order 13818, whose property and interests in property therefore are blocked pursuant to this section, are published in the
The International Emergency Economic Powers Act (50 U.S.C. 1701-1706), in section 203 (50 U.S.C. 1702), authorizes the blocking of property and interests in property of a person during the pendency of an investigation. The names of persons whose property and interests in property are blocked pending investigation pursuant to this section also are published in the
Sections 501.806 and 501.807 of this chapter describe the procedures to be followed by persons seeking, respectively, the unblocking of funds that they believe were blocked due to mistaken identity, and administrative reconsideration of their status as persons whose property and interests in property are blocked pursuant to this section.
(a) Any transfer after the effective date that is in violation of any provision of this part or of any regulation, order, directive, ruling, instruction, or license issued pursuant to this part, and that involves any property or interest in property blocked pursuant to § 583.201, is null and void and shall not be the basis for the assertion or recognition of any interest in or right, remedy, power, or privilege with respect to such property or interests in property.
(b) No transfer before the effective date shall be the basis for the assertion or recognition of any right, remedy, power, or privilege with respect to, or any interest in, any property or interests in property blocked pursuant to § 583.201, unless the person who holds or maintains such property, prior to that date, had written notice of the transfer or by any written evidence had recognized such transfer.
(c) Unless otherwise provided, a license or other authorization issued by OFAC before, during, or after a transfer shall validate such transfer or make it enforceable to the same extent that it would be valid or enforceable but for the provisions of this part and any regulation, order, directive, ruling, instruction, or license issued pursuant to this part.
(d) Transfers of property that otherwise would be null and void or unenforceable by virtue of the provisions of this section shall not be deemed to be null and void or unenforceable as to any person with whom such property is or was held or maintained (and as to such person only) in cases in which such person is able to establish to the satisfaction of OFAC each of the following:
(1) Such transfer did not represent a willful violation of the provisions of this part by the person with whom such property is or was held or maintained (and as to such person only);
(2) The person with whom such property is or was held or maintained did not have reasonable cause to know or suspect, in view of all the facts and circumstances known or available to such person, that such transfer required a license or authorization issued pursuant to this part and was not so licensed or authorized, or, if a license or authorization did purport to cover the transfer, that such license or authorization had been obtained by misrepresentation of a third party or withholding of material facts or was otherwise fraudulently obtained; and
(3) The person with whom such property is or was held or maintained filed with OFAC a report setting forth in full the circumstances relating to such transfer promptly upon discovery that:
(i) Such transfer was in violation of the provisions of this part or any regulation, ruling, instruction, license, or other directive or authorization issued pursuant to this part;
(ii) Such transfer was not licensed or authorized by OFAC; or
(iii) If a license did purport to cover the transfer, such license had been obtained by misrepresentation of a third
(e) The filing of a report in accordance with the provisions of paragraph (d)(3) of this section shall not be deemed evidence that the terms of paragraphs (d)(1) and (2) of this section have been satisfied.
(f) Unless licensed pursuant to this part, any attachment, judgment, decree, lien, execution, garnishment, or other judicial process is null and void with respect to any property and interests in property blocked pursuant to § 583.201.
(a) Except as provided in paragraph (e) or (f) of this section, or as otherwise directed or authorized by OFAC, any U.S. person holding funds, such as currency, bank deposits, or liquidated financial obligations, subject to § 583.201 shall hold or place such funds in a blocked interest-bearing account located in the United States.
(b)(1) For purposes of this section, the term
(i) In a federally insured U.S. bank, thrift institution, or credit union, provided the funds are earning interest at rates that are commercially reasonable; or
(ii) With a broker or dealer registered with the Securities and Exchange Commission under the Securities Exchange Act of 1934 (15 U.S.C. 78a
(2) Funds held or placed in a blocked account pursuant to paragraph (a) of this section may not be invested in instruments the maturity of which exceeds 180 days.
(c) For purposes of this section, a rate is commercially reasonable if it is the rate currently offered to other depositors on deposits or instruments of comparable size and maturity.
(d) For purposes of this section, if interest is credited to a separate blocked account or subaccount, the name of the account party on each account must be the same.
(e) Blocked funds held in instruments the maturity of which exceeds 180 days at the time the funds become subject to § 583.201 may continue to be held until maturity in the original instrument, provided any interest, earnings, or other proceeds derived therefrom are paid into a blocked interest-bearing account in accordance with paragraph (a) or (f) of this section.
(f) Blocked funds held in accounts or instruments outside the United States at the time the funds become subject to § 583.201 may continue to be held in the same type of accounts or instruments, provided the funds earn interest at rates that are commercially reasonable.
(g) This section does not create an affirmative obligation for the holder of blocked tangible property, such as real or personal property, or of other blocked property, such as debt or equity securities, to sell or liquidate such property. However, OFAC may issue licenses permitting or directing such sales or liquidation in appropriate cases.
(h) Funds subject to this section may not be held, invested, or reinvested in a manner that provides financial or economic benefit or access to any person whose property and interests in property are blocked pursuant to § 583.201, nor may their holder cooperate in or facilitate the pledging or other attempted use as collateral of blocked funds or other assets.
(a) Except as otherwise authorized, and notwithstanding the existence of any rights or obligations conferred or imposed by any international agreement or contract entered into or any license or permit granted prior to the effective date, all expenses incident to the maintenance of tangible property blocked pursuant to § 583.201 shall be the responsibility of the owners or operators of such property, which expenses shall not be met from blocked funds.
(b) Property blocked pursuant to § 583.201 may, in the discretion of OFAC, be sold or liquidated and the net proceeds placed in a blocked interest-bearing account in the name of the owner of the property.
(a)
(b)
(2) This section does not exempt from regulation transactions related to information or informational materials not fully created and in existence at the date of the transactions, or to the substantive or artistic alteration or enhancement of information or informational materials, or to the provision of marketing and business consulting services. Such prohibited transactions include payment of advances for information or informational materials not yet created and completed (with the exception of prepaid subscriptions for widely circulated magazines and other periodical publications); provision of services to market, produce or co-produce, create, or assist in the creation of information or informational materials; and payment of royalties with respect to income received for enhancements or alterations made by U.S. persons to such information or informational materials.
(3) This section does not exempt transactions incident to the exportation of software subject to the Export Administration Regulations, 15 CFR parts 730 through 774, or to the exportation of goods (including software) or technology for use in the transmission of any data, or to the provision, sale, or leasing of capacity on telecommunications transmission facilities (such as satellite or terrestrial network connectivity) for use in the transmission of any data. The exportation of such items or services and the provision, sale, or leasing of such capacity or facilities to a person whose property and interests in property are blocked pursuant to § 583.201 are prohibited.
(c)
The definitions in this subpart apply throughout the entire part.
The terms
See § 583.406 concerning the blocked status of property and interests in property of an entity that is directly or indirectly owned, whether individually or in the aggregate, 50 percent or more by one or more persons whose property and interests in property are blocked pursuant to § 583.201.
(a) The term
(1) With respect to a person listed in the Annex to Executive Order 13818 of December 20, 2017, 12:01 a.m. eastern standard time on December 21, 2017; and
(2) With respect to a person whose property and interests in property are otherwise blocked pursuant to § 583.201, the earlier of the date of actual or constructive notice that such person's property and interests in property are blocked.
(b) For the purposes of this section,
The term
The term
The term
(a)(1) The term
(2) To be considered information or informational materials, artworks must be classified under heading 9701, 9702, or 9703 of the Harmonized Tariff Schedule of the United States.
(b) The term
(1) That were, as of April 30, 1994, or that thereafter become, controlled for export pursuant to section 5 of the Export Administration Act of 1979, 50 U.S.C. App. 2401-2420 (1979) (EAA), or section 6 of the EAA to the extent that such controls promote the nonproliferation or antiterrorism policies of the United States; or
(2) With respect to which acts are prohibited by 18 U.S.C. chapter 37.
Except as otherwise provided in this part, the term
(a) Except as otherwise provided in this part, the term
(b) The term
(c) The term
See § 501.801 of this chapter on licensing procedures.
The term
The term
The terms
The term
The term
The term
The term
Unless otherwise specifically provided, any amendment, modification, or revocation of any provision in or appendix to this part or chapter or of any order, regulation, ruling, instruction, or license issued by OFAC does not affect any act done or omitted, or any civil or criminal proceeding commenced or pending, prior to such amendment, modification, or revocation. All penalties, forfeitures, and liabilities under any such order, regulation, ruling, instruction, or license continue and may be enforced as if such amendment, modification, or revocation had not been made.
(a) Whenever a transaction licensed or authorized by or pursuant to this part results in the transfer of property (including any property interest) away from a person whose property and interests in property are blocked pursuant to § 583.201, such property shall no longer be deemed to be property blocked pursuant to § 583.201, unless there exists in the property another interest that is blocked pursuant to § 583.201, the transfer of which has not been effected pursuant to license or other authorization.
(b) Unless otherwise specifically provided in a license or authorization issued pursuant to this part, if property (including any property interest) is transferred or attempted to be transferred to a person whose property and interests in property are blocked pursuant to § 583.201, such property shall be deemed to be property in which such person has an interest and therefore blocked.
Any transaction ordinarily incident to a licensed transaction and necessary to give effect thereto is also authorized, except:
(a) An ordinarily incident transaction, not explicitly authorized within the terms of the license, by or with a person whose property and interests in property are blocked pursuant to § 583.201; or
(b) An ordinarily incident transaction, not explicitly authorized within the terms of the license, involving a debit to a blocked account or a transfer of blocked property.
A setoff against blocked property (including a blocked account), whether by a U.S. bank or other U.S. person, is a prohibited transfer under § 583.201 if effected after the effective date.
Persons whose property and interests in property are blocked pursuant to § 583.201 have an interest in all property and interests in property of an entity in which such persons directly or indirectly own, whether individually or in the aggregate, a 50 percent or greater interest. The property and interests in property of such an entity, therefore, are blocked, and such an entity is a person whose property and interests in property are blocked pursuant to § 583.201, regardless of whether the name of the entity is incorporated into OFAC's Specially Designated Nationals and Blocked Persons List (SDN List).
For provisions relating to licensing procedures, see part 501, subpart E, of this chapter. Licensing actions taken pursuant to part 501 of this chapter with respect to the prohibitions contained in this part are considered actions taken pursuant to this part. General licenses and statements of licensing policy relating to this part also may be available through the Global Magnitsky sanctions page on OFAC's website:
OFAC reserves the right to exclude any person, property, transaction, or class thereof from the operation of any license or from the privileges conferred by any license. OFAC also reserves the right to restrict the applicability of any license to particular persons, property, transactions, or classes thereof. Such actions are binding upon actual or constructive notice of the exclusions or restrictions.
Any payment of funds or transfer of credit in which a person whose property and interests in property are blocked pursuant to § 583.201 has any interest that comes within the possession or control of a U.S. financial institution must be blocked in an account on the books of that financial institution. A transfer of funds or credit by a U.S. financial institution between blocked accounts in its branches or offices is authorized, provided that no transfer is made from an account within the United States to an account held outside the United States, and further provided that a transfer from a blocked account may be made only to another blocked account held in the same name.
See § 501.603 of this chapter for mandatory reporting requirements regarding financial transfers. See also § 583.203 concerning the obligation to hold blocked funds in interest-bearing accounts.
(a) A U.S. financial institution is authorized to debit any blocked account held at that financial institution in payment or reimbursement for normal service charges owed it by the owner of that blocked account.
(b) As used in this section, the term
(a) The provision of the following legal services to or on behalf of persons whose property and interests in property are blocked pursuant to § 583.201 or any further Executive orders relating to the national emergency declared in Executive Order 13818 of December 20, 2017, is authorized, provided that receipt of payment of professional fees and reimbursement of incurred expenses must be authorized pursuant to § 583.507, which authorizes certain payments for legal services from funds originating outside the United States; via specific license; or otherwise pursuant to this part:
(1) Provision of legal advice and counseling on the requirements of and compliance with the laws of the United States or any jurisdiction within the United States, provided that such advice and counseling are not provided to facilitate transactions in violation of this part;
(2) Representation of persons named as defendants in or otherwise made parties to legal, arbitration, or administrative proceedings before any U.S. federal, state, or local court or agency;
(3) Initiation and conduct of legal, arbitration, or administrative proceedings before any U.S. federal, state, or local court or agency;
(4) Representation of persons before any U.S. federal, state, or local court or agency with respect to the imposition, administration, or enforcement of U.S. sanctions against such persons; and
(5) Provision of legal services in any other context in which prevailing U.S. law requires access to legal counsel at public expense.
(b) The provision of any other legal services to or on behalf of persons whose property and interests in property are blocked pursuant to § 583.201 or any further Executive orders relating to the national emergency declared in Executive Order 13818 of December 20, 2017, not otherwise authorized in this part, requires the issuance of a specific license.
(c) U.S. persons do not need to obtain specific authorization to provide related services, such as making filings and providing other administrative services, that are ordinarily incident to the provision of services authorized by this section. Additionally, U.S. persons who provide services authorized by this section do not need to obtain specific authorization to contract for related services that are ordinarily incident to the provision of those legal services, such as those provided by private investigators or expert witnesses, or to pay for such services. See § 583.404.
(d) Entry into a settlement agreement or the enforcement of any lien, judgment, arbitral award, decree, or other order through execution, garnishment, or other judicial process purporting to transfer or otherwise alter or affect property or interests in property blocked pursuant to § 583.201 or any further Executive orders relating to the national emergency declared in Executive Order 13818 of December 20, 2017 is prohibited unless licensed pursuant to this part.
Pursuant to part 501, subpart E, of this chapter, U.S. persons seeking administrative reconsideration or judicial review of their designation or the blocking of their property and interests in property may apply for a specific license from OFAC to authorize the release of certain blocked funds for the payment of professional fees and reimbursement of incurred expenses for the provision of such legal services where alternative funding sources are not available. For more information, see OFAC's
(a)
(1) A source within the United States;
(2) Any source, wherever located, within the possession or control of a U.S. person; or
(3) Any individual or entity, other than the person on whose behalf the legal services authorized pursuant to § 583.506(a) are to be provided, whose property and interests in property are blocked pursuant to any part of this chapter or any Executive order or statute.
Nothing in this paragraph authorizes payments for legal services using funds in which any other person whose property and interests in property are blocked pursuant to § 583.201, any other part of this chapter, or any Executive order has an interest.
(b)
(i) The individual or entity from whom the funds originated and the amount of funds received; and
(ii) If applicable:
(A) The names of any individuals or entities providing related services to the U.S. person receiving payment in connection with authorized legal services, such as private investigators or expert witnesses;
(B) A general description of the services provided; and
(C) The amount of funds paid in connection with such services.
(2) The reports, which must reference this section, are to be submitted to OFAC using one of the following methods:
(i) Email (preferred method):
(ii) U.S. mail: OFAC Regulations Reports, Office of Foreign Assets Control, U.S. Department of the Treasury, 1500 Pennsylvania Avenue NW, Freedman's Bank Building, Washington, DC 20220.
The provision and receipt of nonscheduled emergency medical services that are otherwise prohibited by this part or any further Executive orders relating to the national emergency declared in Executive Order 13818 of December 20, 2017 are authorized.
For provisions relating to required records and reports, see part 501, subpart C, of this chapter. Recordkeeping and reporting requirements imposed by part 501 of this chapter with respect to the prohibitions contained in this part are considered requirements arising pursuant to this part.
(a) The penalties available under section 206 of the International Emergency Economic Powers Act (50 U.S.C. 1701-1706) (IEEPA), as adjusted annually pursuant to the Federal Civil Penalties Inflation Adjustment Act of 1990 (Pub. L. 101-410, as amended, 28 U.S.C. 2461 note) or, in the case of criminal violations, as adjusted pursuant to 18 U.S.C. 3571, are applicable to violations of the provisions of this part.
(b) OFAC has the authority, pursuant to IEEPA, to issue Pre-Penalty Notices, Penalty Notices, and Findings of Violation; impose monetary penalties; engage in settlement discussions and enter into settlements; refer matters to the United States Department of Justice for administrative collection; and, in appropriate circumstances, refer matters to appropriate law enforcement agencies for criminal investigation and/or prosecution. For more information, see appendix A to part 501 of this chapter, which provides a general framework for the enforcement of all economic sanctions programs administered by OFAC, including enforcement-related definitions, types of responses to apparent violations, general factors affecting administrative actions, civil penalties for failure to comply with a requirement to furnish information or keep records, and other general civil penalties information.
For license application procedures and procedures relating to amendments, modifications, or revocations of licenses; administrative decisions; rulemaking; and requests for documents pursuant to the Freedom of Information and Privacy Acts (5 U.S.C. 552 and 552a), see part 501, subpart E, of this chapter.
Any action that the Secretary of the Treasury is authorized to take pursuant to Executive Order 13818 of December 20, 2017 and any further Executive orders relating to the national emergency declared therein, may be taken by the Director of OFAC or by any other person to whom the Secretary of the Treasury has delegated authority so to act.
For approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3507) of information collections relating to recordkeeping and reporting requirements, licensing procedures, and other procedures, see § 501.901 of this chapter. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by OMB.
By the authority vested in me as President by the Constitution and the laws of the United States of America, including the International Emergency Economic Powers Act (50 U.S.C. 1701
I, DONALD J. TRUMP, President of the United States of America, find that the prevalence and severity of human rights abuse and corruption that have their source, in whole or in substantial part, outside the United States, such as those committed or directed by persons listed in the Annex to this order, have reached such scope and gravity that they threaten the stability of international political and economic systems. Human rights abuse and corruption undermine the values that form an essential foundation of stable, secure, and functioning societies; have devastating impacts on individuals; weaken democratic institutions; degrade the rule of law; perpetuate violent conflicts; facilitate the activities of dangerous persons; and undermine economic markets. The United States seeks to impose tangible and significant consequences on those who commit serious human rights abuse or engage in corruption, as well as to protect the financial system of the United States from abuse by these same persons.
I therefore determine that serious human rights abuse and corruption around the world constitute an unusual and extraordinary threat to the national security, foreign policy, and economy of the United States, and I hereby declare a national emergency to deal with that threat.
I hereby determine and order:
(i) The persons listed in the Annex to this order;
(ii) any foreign person determined by the Secretary of the Treasury, in consultation with the Secretary of State and the Attorney General:
(A) To be responsible for or complicit in, or to have directly or indirectly engaged in, serious human rights abuse;
(B) to be a current or former government official, or a person acting for or on behalf of such an official, who is responsible for or complicit in, or has directly or indirectly engaged in:
(1) Corruption, including the misappropriation of state assets, the expropriation of private assets for personal gain, corruption related to government contracts or the extraction of natural resources, or bribery; or
(2) the transfer or the facilitation of the transfer of the proceeds of corruption;
(C) to be or have been a leader or official of:
(1) An entity, including any government entity, that has engaged in, or whose members have engaged in, any of the activities described in subsections (ii)(A), (ii)(B)(1), or (ii)(B)(2) of this section relating to the leader's or official's tenure; or
(2) an entity whose property and interests in property are blocked pursuant to this order as a result of activities related to the leader's or official's tenure; or
(D) to have attempted to engage in any of the activities described in subsections (ii)(A), (ii)(B)(1), or (ii)(B)(2) of this section; and
(iii) any person determined by the Secretary of the Treasury, in consultation with the Secretary of State and the Attorney General:
(A) To have materially assisted, sponsored, or provided financial, material, or technological support for, or goods or services to or in support of:
(1) Any activity described in subsections (ii)(A), (ii)(B)(1), or (ii)(B)(2) of this section that is conducted by a foreign person;
(2) any person whose property and interests in property are blocked pursuant to this order; or
(3) any entity, including any government entity, that has engaged in, or whose members have engaged in, any of the activities described in subsections (ii)(A), (ii)(B)(1), or (ii)(B)(2) of this section, where the activity is conducted by a foreign person;
(B) to be owned or controlled by, or to have acted or purported to act for or on behalf of, directly or indirectly, any person whose property and interests in property are blocked pursuant to this order; or
(C) to have attempted to engage in any of the activities described in subsections (iii)(A) or (B) of this section.
(b) The prohibitions in subsection (a) of this section apply except to the extent provided by statutes, or in regulations, orders, directives, or licenses that may be issued pursuant to this order, and notwithstanding any contract entered into or any license or permit granted before the effective date of this order.
(a) The making of any contribution or provision of funds, goods, or services by, to, or for the benefit of any person whose property and interests in property are blocked pursuant to this order; and
(b) the receipt of any contribution or provision of funds, goods, or services from any such person.
(b) Any conspiracy formed to violate any of the prohibitions set forth in this order is prohibited.
(a) The term “person” means an individual or entity;
(b) the term “entity” means a partnership, association, trust, joint venture, corporation, group, subgroup, or other organization; and
(c) the term “United States person” means any United States citizen, permanent resident alien, entity organized under the laws of the United States or any jurisdiction within the United States (including foreign branches), or any person in the United States.
Approved:
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary special local regulation for certain navigable waters of Corpus Christi Bay. This action is necessary to protect marine event participants, spectators and transiting vessels on these navigable waters during the Youth World's Championship regatta held at the Corpus Christi Yacht Club. Entry of vessels or persons into this regulated area is prohibited unless authorized by the Captain of the Port Sector Corpus Christi or designated representative.
This rule is effective from 6:15 a.m. on July 14, 2018 through 3 p.m. on July 21, 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 Kevin Kyles, Waterways Management Division, U.S. Coast Guard; telephone 361-939-5125, 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 because it would be impracticable. This regulated area must be established by July 14, 2018 and we lack sufficient time to provide a reasonable comment period and then consider those comments before issuing this rule. The NPRM process would delay the establishment of the special local regulation until after the scheduled date of the regatta and compromise public safety.
Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the
The Coast Guard is issuing this rule under authority in 33 U.S.C. 1233. The Captain of the Port Sector Corpus Christi (COTP) has determined that potential hazards associated with the vessel traffic occurring on July 14, 2018 through July 21, 2018 will be a safety concern for participants within the boating course. Potential hazards include risk of injury or death resulting from near or actual contact among participant vessels and spectator vessels or waterway users if normal vessel traffic were to interfere with the event. The purpose of this rule is to ensure safety of participants, spectators, and transiting vessels in the regulated area before, during, and after the Youth World's Championship regatta.
This rule establishes a temporary special local regulation from 6:15 a.m. through 3 p.m. each day from July 14, 2018 through July 21, 2018 in Corpus Christi Bay, approximately 3,000 feet east of People's Street T-Head in Corpus Christi, TX. The regatta will be inside a rectangular area with the most northwestern point located at 027°47′31″ N, 097°22′33.05″ W, most northeastern point located at 027°47′29.46″ N, 097°19′44.26″ W, most southeastern point located at 027°46′12.06″ N, 097°19′44.78″ W, and the most southwestern located at 027°46′09.55″ N, 097°22′28.78″ W. The duration of the special local regulation is intended to protect the public from potential navigation hazards before, during, and after the event. No vessel or person is permitted to enter the regulated area without obtaining permission from the COTP or a designated representative. A designated representative may be a Patrol Commander (PATCOM). The PATCOM will be aboard either a Coast Guard or Coast Guard Auxiliary vessel. The PATCOM may be contacted on Channel 16 VHF-FM (156.8 MHz) by the call sign “PATCOM”.
All persons and vessels not registered with the sponsor as participants or official patrol vessels are considered spectators. The “official patrol vessels” consist of any Coast Guard, state, or local law enforcement and sponsor provided vessels assigned or approved by the COTP to patrol the regulated area.
Spectator vessels desiring to enter, transit through or within, or exit the regulated area may do so only with permission from the COTP or a designated representative, and when permitted, must operate at a minimum safe navigation speed in a manner which will not endanger participants in the regulated area or any other vessels. No spectator vessel shall anchor, block, loiter, or impede the through transit of participants or official patrol vessels in the regulated area during the effective dates and times, unless cleared for entry by or through an official patrol vessel. Any spectator vessel may anchor outside the regulated area, but may not anchor in, block, or loiter in a navigable channel.
The COTP or a designated representative may forbid and control the movement of all vessels in the regulated area. When hailed or signaled by an official patrol vessel, a vessel shall come to an immediate stop and comply with the directions given. Failure to do so may result in expulsion from the area, citation for failure to comply, or both.
The COTP or a designated representative may terminate the event or the operation of any vessel at any time it is deemed necessary for the protection of life or property. The COTP or a designated representative can terminate enforcement of the special local regulations at the conclusion of the event.
The COTP or a designated representative would inform the public of the enforcement times for this regulated area 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 based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.
This regulatory action determination is based on size, location, duration, and time-of-day for the special local regulation. Vessel traffic will be able to safely navigate around the regulated area, which will impact only a small portion of the Laguna Madre for 3 hours and 15 minutes on one day. Moreover, the Coast Guard will issue Broadcast Notices to Mariners (BNMs) via VHF-FM marine channel 16 about the
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 regulated area may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
This rule would not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this 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 would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this 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 would 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 made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule is a special local regulation that limits daily access to certain navigable waters of Corpus Christi Bay over eight days. Normally such actions are categorically excluded from further review under paragraph L61 of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A preliminary Record of Environmental Consideration supporting this determination is available in the docket where indicated under
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Marine safety, Navigation (water), Reporting and recordkeeping requirements, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 100 as follows:
33 U.S.C. 1233; 33 CFR 1.05-1.
(a)
(b)
(c)
(d)
(2) All persons and vessels not registered with the sponsor as participants or official patrol vessels are considered spectators. The “official patrol vessels” consist of any Coast Guard, state, or local law enforcement and sponsor provided vessels assigned or approved by the COTP or a designated representative to patrol the regulated area.
(3) Spectator vessels desiring to transit the regulated area may do so only with prior approval of the COTP or a designated representative and when so directed by that officer will be operated at a minimum safe navigation speed in a manner which will not endanger participants in the regulated area or any other vessels.
(4) No spectator vessel shall anchor, block, loiter, or impede the through transit of participants or official patrol vessels in the regulated area during the effective dates and times, unless cleared for entry by or through an official patrol vessel.
(5) Spectator vessels may anchor outside the regulated area, but may not anchor in, block, or loiter in a navigable channel.
(6) The COTP or a designated representative may forbid and control the movement of all vessels in the regulated area. When hailed or signaled by an official patrol vessel, a vessel shall come to an immediate stop and comply with the directions given. Failure to do so may result in expulsion from the area, citation for failure to comply, or both.
(7) The COTP or a designated representative may terminate the event or the operation of any vessel at any time it is deemed necessary for the protection of life or property.
(8) The COTP or a designated representative will terminate enforcement of the special local regulations at the conclusion of the event.
(e)
Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce the safety zone for the LaPointe Fireworks in LaPointe, WI from 9:30 p.m. through 11:30 p.m. on July 4, 2018, with a rain date of 9:30 p.m. through 11:30 p.m. on July 5, 2018. This action is necessary to protect participants and spectators during the LaPointe Fireworks. During the enforcement period, entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Duluth or designated on-scene representative.
The regulations in 33 CFR 165.943(b) will be enforced from 9:30 p.m. through 11:30 p.m. on July 4, 2018, with a rain date of 9:30 p.m. through 11:30 p.m. on July 5, 2018, for the LaPointe Fireworks safety zone, § 165.943(a)(5).
If you have questions on this document, call or email LT John Mack, Chief of Waterways Management, Coast Guard; telephone (218)725-3818, email
The Coast Guard will enforce the safety zone for the annual LaPointe Fireworks in 33 CFR 165.943(a)(5) from 9:30 p.m. through 11:30 p.m. on July 4, 2018, with a rain date of 9:30 p.m. through 11:30 p.m. on July 5, 2018, on all waters of Lake Superior bounded by the arc of a circle with a 350-foot radius from the fireworks launch site with its center in position 46°46′40″ N, 090°47′22″ W.
Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Duluth or their designated on-scene representative. The Captain of the Port's designated on-scene representative may be contacted via VHF Channel 16.
This document is issued under authority of 33 CFR 165.943 and 5 U.S.C. 552(a). In addition to this publication in the
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone for certain waters of the Tennessee River. This action is necessary to provide for the safety of life on these navigable waters near the Kentucky Dam Marina, Gilbertsville, KY, during a fireworks display. 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 6:50 p.m. through 10:10 p.m. on June 30, 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 MST3 Joseph Stranc, Marine Safety Unit Paducah Waterways Division, U.S. Coast Guard; telephone 270-442-1621 ext. 2124, email
On January 17, 2018, the Kentucky Dam Marina notified the Coast Guard that it would be conducting a fireworks display from 7 p.m. through 10 p.m. on June 30, 2018. The fireworks are to be launched from the break wall of Kentucky Dam Marina. In response, on April 26, 2018, the Coast Guard published a notice of proposed rulemaking (NPRM) titled Safety Zone; Tennessee River, Gilbertsville, KY (83 FR 18241). There we stated why we issued the NPRM, and invited comments on our proposed regulatory action related to this fireworks display. During the comment period that ended May 29, 2018, we received no comments.
Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the
The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port Sector Ohio Valley (COTP) has determined that potential hazards associated with the fireworks to be used in this June 30, 2018 display will be a safety concern for anyone within a 350-foot radius from the fireworks launch site on the Kentucky Dam Marina break wall in Gilbertsville, KY. Hazards from firework displays include accidental discharge of fireworks, dangerous projectiles, and falling hot embers or other debris. The purpose of this rule is to ensure safety of vessels and the navigable waters in the safety zone before, during, and after the scheduled event.
As noted above, we received no comments on our NPRM published April 26, 2018. However, we have noticed an error in the title of the proposed rule, which included “Ohio” River, instead of “Tennessee” River. The regulatory text of this rule corrects an error in the title of the regulatory text of this temporary final rule.
This rule establishes a temporary safety zone from 6:50 p.m. through 10:10 p.m. on June 30, 2018. The safety zone will cover all navigable waters within a 350-foot radius from the fireworks launch site on the Kentucky Dam Marina break wall in Gilbertsville, KY. The duration of the zone is intended to ensure the safety of vessels on these navigable waters before, during, and after the scheduled fireworks display. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative. Persons or vessels desiring to enter into or pass through the zone must request permission from the COTP or a designated representative. They may be contacted on VHF-FM Channel 16 or by phone at 1-800-253-7465. If permission is granted, all persons and vessels must transit at their slowest safe speed and comply with all lawful directions issued by the COTP or a designated representative. The COTP or a designated representative will inform the public through Broadcast Notice to Mariners (BNMs) of the enforcement period for the safety zone as well as the date and time of enforcement.
We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.
This regulatory action determination is based on the size, location, duration and time-of-day of the safety zone. Vessel traffic would be able to safely transit around this safety zone, which will impact a 350-foot designated area of the Tennessee River for approximately three hours on one evening. Moreover, the Coast Guard will issue a Broadcast Notice to Mariners (BNMs) via VHF-FM marine channel 16 about the zone, and the rule 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 received no comments from the Small Business Administration on this rulemaking. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the 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 involves a safety zone lasting approximately three hours that will prohibit entry within 350 feet of a break wall at Kentucky Dam Marina in Gilbertsville, KY. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
(a)
(b)
(c)
(2) Persons or vessels desiring to enter into or pass through the zone must request permission from the COTP or a designated representative. They may be contacted on VHF-FM Channel 16 or by phone at 1-800-253-7465.
(3) If permission is granted, all persons and vessels must transit at their slowest safe speed and comply with all lawful directions issued by the COTP or a designated representative.
(d)
Environmental Protection Agency (EPA).
Final rule.
Pursuant to the Federal Clean Air Act (CAA or the Act), the Environmental Protection Agency (EPA) is approving revisions to the Arkansas State Implementation Plan (SIP) minor New Source Review (NSR) program submitted on July 26, 2010, and March 24, 2017, including supplemental information provided on November 30, 2015, May 26, 2016, July 5, 2017, July 27, 2017, and March 16, 2018. Specifically, we are proposing to approve revisions that revise the minor NSR permitting thresholds and
This rule is effective on July 30, 2018.
The EPA has established a docket for this action under Docket ID No. EPA-R06-OAR-2017-0435. All documents in the docket are listed on the
Ashley Mohr, 214-665-7289,
Throughout this document “we,” “us,” and “our” means the EPA.
The background for this action is discussed in detail in our September 18, 2017 proposal (82 FR 43506). In that document we proposed to approve revisions to the Arkansas SIP submitted on July 26, 2010, and March 24, 2017, including supplemental information submitted on November 30, 2015, May 26, 2016, July 5, 2017, July 27, 2017, and March 16, 2018. The revisions addressed in our proposal included revisions to the Arkansas minor NSR permitting thresholds and
We received one set of comments on the proposal. The full text of the comment letter received during the public comment period, which closed on October 18, 2017, is included in the publicly posted docket associated with this action at
While the comments regarding the applicability determination basis are not relevant to this rulemaking, we will respond to the commenter's assertion that any attempt to determine if the revised minor NSR permitting thresholds meet the referenced federal requirements is problematic. We do not agree with this statement. As outlined in our proposed rulemaking, we evaluated several analyses submitted by Arkansas in support of the revised thresholds, including an emissions inventory analysis, a monitoring trends analysis, and a modeling analysis. Based on our evaluation of those analyses along with the SIP revisions submittals documentation (found in the Technical Support Document (TSD)), we find that the proposed thresholds will meet applicable federal requirements and not interfere with NAAQS attainment or maintenance or violate the control strategy. As required by Reg. 19.401, a source with actual emissions greater than the applicability thresholds would be required to obtain a permit and is subject to enforcement action if the source fails to do so. The emissions from a new source to be compared with the permitting thresholds would be based on controlled emission factors and projected operations (hours of operation and/or amounts of material processed). This approach allows permitting applicability to be based on emissions that are close to actual emissions. The regulation specifically does not allow construction and operation of sources with actual emissions in excess of the thresholds, and any source that did underestimate their emissions and exceed the emissions thresholds would be in violation of the regulations and beyond the scope of the analyses conducted to demonstrate the regulation's compliance with applicable federal requirements for minor NSR programs.
The portion of the comment raised regarding permit application requirements for
As discussed in the Technical Support Document accompanying our proposed action, ADEQ conducted both regional scale photochemical modeling using CMAQ and local-scale dispersion modeling using AERMOD to examine the predicted impacts from sources or
Further, the entirety of the additional analyses provided by ADEQ in the March 24, 2017 SIP revision submittal, including the NAAQS non-interference modeling demonstration, was the basis of the EPA's finding that the revised thresholds were approvable. As such, a linkage to the PSD significant emission rate values and/or comparison of modeled impacts to percentage thresholds relied upon during the EPA's development of the significant emission rates in 1980, 1987, and 2008 for the PSD program was not applicable to our proposed approval of the revised minor NSR permitting thresholds and
The SIP-approved Arkansas NSR program is comprised of two types of review: “Minor Source Review” and “Major Source Review”. Arkansas operates a so-called “merged, one permit” system, which is divided into these two types of review based on whether a source is required to obtain a title V operating permit. As such, “Minor Source Review”, which is contained in Reg. 19, Chapter 4, applies only to those sources that are not subject to title V permitting and require only a title I NSR authorization.
The state did not rely solely on the emissions inventory analysis to demonstrate NAAQS compliance. This emissions inventory analysis was coupled with additional analyses specifically looking at ambient concentrations (monitoring trends analysis) and potential ambient impacts (modeling analysis) that were completed by ADEQ as part of the 110(l) demonstration. The results from the modeling analysis indicate that while the addition of the exempt emissions did result in slight increases in the model predicted impacts, it did not violate the NAAQS. As such, the modeling analysis portion of the 110(l) demonstration shows that revised minor NSR program will continue to ensure NAAQS protection.
EPA's intent at the time of promulgation of the 2002 revisions to the major source NSR rules is not relevant here. What is relevant here is the approvability of these revisions in the context of the current regulatory framework as promulgated. The commenter has not cited any ambiguous regulatory language in order to justify an examination of EPA's intent. In the absence of any ambiguity in regulatory language it is not necessary to address EPA's intent here as there is no dispute regarding interpretation on the applicable rules.
Regarding the commenter's statement that EPA should take action to disapprove Reg. 19.407(C) as it is currently approved into the SIP, aside from the revisions to 407(C)(2)(a) and 407(C)(2)(b) which are clearly annotated in Section IV of the TSD, the other portions of Reg. 19.407 are not being revised by our current rulemaking.
As stated above, Arkansas conducted the emissions review as a part of the 110(l) demonstration to determine the scope of emissions that were previously subject to minor NSR permitting that would be exempt from permitting under the revised thresholds. As stated above, Arkansas reviewed their entire minor NSR permitting universe, which included all active permits that had historically been issued by ADEQ, to determine the currently permitted emissions that would be exempt from minor NSR permitting under the revised permitting thresholds.
In the case of a new source that has actual emissions in excess of the minor NSR permitting thresholds without an issued permit authorizing those emissions, the source would be in violation of the minor NSR permitting requirements contained in Reg. 19, Chapter 4, and they could be subject to an enforcement action. For example, if a source was initially constructed as a seasonal source with emission below the de minimis levels, it is exempt from permitting. However, if the source's actual emissions rise above those levels without first obtaining a permit, it would be in violation of minor NSR. It is reasonable (for the purposes of demonstrating compliance with 110(l)) to assume a new source would be required to obtain a permit to authorize the emissions and demonstrate they will not cause or contribute to a violation of a NAAQS if they have actual emissions above the minor NSR permitting thresholds. Therefore, the scenarios involving potentially violating sources are not a reasonable scenario to be included in an analysis conducted to support the minor NSR permitting thresholds.
In the case of a
Regarding the commenter's statement regarding the modeling of worst-case conditions, we do not agree with the commenter. The modeling of the worst case conditions such as terrain, stack height, stack temperature and velocity is inappropriate for assessing whether the relaxed applicability to Arkansas' minor NSR rule would violate the NAAQs. The hypothetical sources included in the 110(l) demonstration modeling were meant to represent the exempt emissions that could occur from a variety of sources and were being modeled to examine the potential impacts from exempt emissions as part of the demonstration of non-interference with attainment or maintenance of the NAAQS under CAA section 110(l). Arkansas determined representative values to be used as model inputs for the hypothetical sources by reviewing real world stack parameters available through their emissions inventory data. Based on their review, the state chose the average stack conditions from the emissions inventory data as the representative inputs for the modeled hypothetical sources. As stated in the modeling report included in the March 24, 2017 SIP revision submittal and in our proposed rulemaking, the state modeled the hypothetical sources with the maximum emissions exempt by the rule (
The use of the worst case conditions (as referenced by the commenter) is typically applied in modeling for an existing source or a proposed source of known type/size and location as part of a case-by-case NSR modeling analysis, such as a modeling analysis completed as part of a PSD permit action. In the case of the modeling analysis conducted by Arkansas to support the proposed SIP revisions, the state was examining the potential impacts of emissions exempt from minor NSR permitting by adding hypothetical exempt sources to represent those added emissions in the modeled emissions inventory. The modeling conducted by Arkansas as part of the 110(l) demonstration modeling serves a different purpose, and therefore is inherently different than PSD permit modeling. PSD permit modeling is conducted as part of the source analysis PSD requirement (40 CFR 51.21(k)) to examine the impacts from the construction or major modification of a specific, known PSD source where model inputs are based on the actual design and operational parameters of the emission points located at the source. That said, we do not agree that the modeling analysis conducted by Arkansas did not take terrain into account. As discussed previously in this response, at least one of the modeled hypothetical sources was located in each of the AQCRs. This allowed the examination of model predicted impacts across the different geographic and topographic areas in the state, including those areas in NW Arkansas with more elevated/complex terrain (1 source located in AQCR 17 and 2 sources located in AQCR 21), which are expected to have higher impacts. As discussed in our evaluation of the photochemical modeling conducted by Arkansas, the model predicted impacts from the hypothetical sources did not indicate any model predicted violations of the NAAQS for any pollutant or averaging period. The photochemical modeling approach was one element of the 110(l) demonstration provided by the state to support the proposed SIP revisions. The approaches used by Arkansas in their modeling demonstration to determine the potential impacts from the newly exempt emissions were reasonable and appropriate for 110(l) analysis being conducted to demonstrate non-interference, especially considering the small amounts of emissions expected to be exempt from minor NSR permitting based on the revised rule relative to the current statewide emissions.
Regarding the modeling of impacts from startup, shutdown and malfunction emissions, the evaluation of impacts from routine and/or predictable startup and shutdown emissions would be associated with modeling an existing source or a proposed source of known type/size and operation as part of a case-by-case NSR modeling analysis, such as PSD permit modeling.
In this action, EPA is approving revisions to the minor NSR permitting program as submitted as revisions to the Arkansas SIP on July 26, 2010, and March 24, 2017, including supplemental information submitted on November 30, 2015, May 26, 2016, July 5, 2017, July 27, 2017, and March 16, 2018. Our approval includes the following revisions to the Arkansas SIP:
• Revisions to Reg. 19.401 (submitted 07/26/2010 and 03/24/2017);
• Revisions to Reg. 19.407(C)(2)(a) and (b) (submitted 07/26/2010 and 03/24/2017); and
• Revisions to Reg. 19.417(A) and (B) (submitted 07/26/2010).
As previously stated in our proposed rulemaking, this final action does not remove or modify the existing federal and state requirements that each NSR permit action issued by ADEQ include an analysis completed by the Department and their determination that the proposed construction or modification authorized by the permit action will not interfere with attainment or maintenance of a national ambient air quality standard.
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 revisions to the Arkansas regulations as described in the Final Action section above. The EPA has made, and will continue to make, these materials generally available through
Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this 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 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866;
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 28, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)
Environmental protection, Air pollution control, Incorporation by reference, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
40 CFR part 52 is amended as follows:
42 U.S.C. 7401
The amendments read as follows:
(c) * * *
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is approving revised rules submitted by the State of Michigan as State Implementation Plan (SIP) revisions. The main revision specifies volatile organic compound (VOC) limits for cutback and emulsified asphalts as well as the test methods for determining the VOC content of these products. Michigan also moved the adoption by reference citations from Part 6. Emission Limitations and Prohibitions—Existing Sources of Volatile Organic Emissions to Part 9. Emission Limitations and Prohibitions—Miscellaneous and updated references to federal test methods in several of its Part 6 rules.
This final rule is effective on July 30, 2018.
EPA has established a docket for this action under Docket ID No. EPA-R05-OAR-2017-0100 and EPA-R05-OAR-2017-0501. All documents in the docket are listed on the
Steven Rosenthal, Environmental Engineer, Attainment Planning and Maintenance Section, Air Programs Branch (AR-18J), Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604, (312) 886-6052,
Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA. This supplementary information section is arranged as follows:
Michigan revised its rule R 336.1618 “Use of cutback or emulsified paving asphalt” along with several other of its VOC rules. Michigan also revised rules R 336.1611 to R 336.1614, R 336.1619, R 336.1622, R 336.1625, R336.1627 to R 336.1629, R 336.1632, R 336.1651, R 336.1660, and R 336.1661 for the purpose of removing adoptions by reference which have been moved to and consolidated in R 336.1902 “Adoption of standards by reference.” Revisions to R 336.1622, R 336.1627 to R 336.1629, and R 336.1632 update references to federal test methods.
On March 30, 2018 (83 FR 13710) EPA published a notice of proposed rulemaking (NPR) proposing approval of Michigan's VOC revisions. The specific details of Michigan's VOC revisions and the rationale for EPA's approval are discussed in the NPR and will not be restated here. EPA received no relevant comments on this proposal.
EPA is approving Michigan's VOC revisions in Part 6 and Part 9 because they satisfy the EPA's requirement of reasonably available control technology.
In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of the Michigan Regulations described in the amendments to 40 CFR part 52 set forth below. EPA has made, and will continue to make, these documents generally available through
Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Clean Air Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866;
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 28, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Ozone, Reporting and recordkeeping requirements, and Volatile organic compounds.
40 CFR part 52 is amended as follows:
42 U.S.C. 7401
The addition and revisions read as follows:
(c) * * *
▪ In Title 40 of the Code of Federal Regulations, Parts 82 to 86, revised as of July 1, 2017, on page 1134, following paragraph (b) of § 86.1917, the section heading of § 86.1920 is inserted to read as follows:
Federal Communications Commission.
Final rule.
In this document, the Federal Communications Commission (the Commission or FCC) addresses the current funding shortfall in the Rural Health Care (RHC) Program, including by raising the annual Program funding cap and applying it to the current
Effective June 29, 2018.
Elizabeth Drogula,
This is a summary of the Commission's Report and Order (R&O) in WC Docket No. 17-310; FCC 18-82, adopted on June 19, 2018, and released on June 25, 2018. The full text of this document is available for public inspection during regular business hours in the FCC Reference Center, Room CY-A257, 445 12th Street SW, Washington, DC 20554, or at the following internet address:
1. Technology and telemedicine have assumed an increasingly important role in health care delivery, particularly in rural and remote areas of the country. For Americans living in rural and isolated areas, doctor shortages and hospital closures are endemic, and obtaining access to high-quality health care is a constant challenge. Broadband greatly changes that equation, however, by enabling a wide range of telemedicine services—from specialists providing consultations via video conferencing to radiologists remotely reading X-rays via high-speed connectivity. Today, the Commission takes steps to help ensure that health care providers participating in the Commission's RHC Program can continue providing these and other essential telemedicine services to their communities.
2. In 1996, Congress recognized the value of providing rural health care providers with “an affordable rate for the services necessary for the provision of telemedicine,” and the Commission established the RHC Program the following year. At that time, the Commission capped RHC Program funding at $400 million annually, and for many years, the $400 million funding cap was sufficient to fulfill Program demand. More recently, however, funding requests for high-speed broadband from health care providers have outpaced the RHC Program funding cap, placing a strain on the Program's ability to increase access to broadband for health care providers, particularly in rural areas, and foster the deployment of broadband health care networks. Further, rural health care providers face imminent financial hardship in FY 2017 due to the significant, automatic proration of their funding requests pursuant to RHC Program rules. These funding reductions have forced providers to assume additional costs of providing critical health care services to their communities.
3. Given rural health care providers' urgent need for funding, the Commission takes immediate action in the R&O to address the current funding shortfall in the RHC Program, including by raising the annual Program funding cap to $571 million and applying it to the current funding year to fully fund eligible funding requests for FY 2017. The Commission takes this action consistent with the goals of ensuring that rural health care providers are able to get the funding they need from the RHC Program. At the same time, the Commission is mindful of the need to guard against Program waste, fraud, and abuse to ensure that this funding is being spent appropriately. The Commission remains committed to this goal and for that reason, have proposed and sought comment in this proceeding on measures to ensure compliance and to reduce waste, fraud, and abuse in the RHC Program.
4. In the R&O, the Commission adopts measures to address the increased demand for funding from the RHC Program and thereby promote health care delivery and telemedicine in rural America. Specifically, the Commission (1) increases the annual RHC Program funding cap to $571 million and apply it to FY 2017; (2) decides to annually adjust the RHC Program funding cap to reflect inflation, beginning with FY 2018; and (3) establishes a process to carry-forward unused funds from past funding years for use in future funding years. These actions will provide rural health care providers with a sufficient and more predictable source of universal service funding to deliver vital telemedicine services to their communities.
5.
6. The majority of commenters agree that the Commission should raise the RHC Program funding cap. Of those commenters, most argue that setting the cap at $571 million, the level it would be had the Program been indexed for inflation since its inception, is a sufficient and appropriate metric for establishing a new funding cap today. Some commenters instead argue that the cap should be raised beyond $571 million to account for the expansion of eligible services and entities since the Program's inception, as well as advances in telehealth capabilities and technologies, and increased broadband requirements. Other commenters contend that the GDP-CPI index does not sufficiently represent Program demand because the costs of providing health care services have historically outpaced inflation, or they assert that the funding cap should simply be doubled to $800 million to account for inflation, the increased number of eligible entities, and advances in technology.
7. Additionally, some parties assert that the Commission's analysis in setting the original cap of $400 million was arbitrary or based on incorrect estimates of the number of qualifying rural health care providers. Despite this, these commenters advocate raising the annual funding cap based on the broadband communications requirements for health care providers, the increased demand for the services that such broadband can support, other potential sources of funding of rural health care broadband needs, or indexing the $400 million cap to GDP-CPI.
8.
9. The Commission disagrees with those commenters who advocate doubling the RHC Program funding cap to $800 million at this time. The $171 million increase in the annual funding cap exceeds the current demand of $521 million, and commenters fail to provide reliable data justifying a $400 million increase. Moreover, the Commission believes that adopting such a substantial increase at this time is especially imprudent given the concerns in this proceeding about whether potential waste in the RHC Telecommunications Program has contributed to reaching the cap sooner than anticipated and what steps the Commission should take to reduce such waste.
10. Accordingly, the Commission concludes that increasing the cap to $571 million strikes the appropriate balance between ensuring adequate funding for vital telehealth services while minimizing the burden placed on USF contributors and consumers. As necessary, the Commission will assess the need for any future increases in the cap to ensure that the RHC Program is sufficiently funded to achieve the Program's goals of increasing access to broadband for health care providers, particularly in rural areas, and fostering the deployment of broadband health care networks. For these reasons, the Commission is not persuaded by the arguments submitted by SHLB, ACS, and others that raising the cap to $571 million is insufficient to address RHC Program demand. By raising the cap by $171 million and taking the other steps discussed in this R&O (
11. The Commission is also unpersuaded by AT&T's arguments that until the Telecommunications Program is fundamentally reformed, it is premature to consider increasing the annual RHC Program funding cap. In light of the current funding shortfall in the RHC Program, the Commission believes that raising the funding cap to $571 million now is necessary to ensure that sufficient funding is available for eligible health care providers to maintain their current network connections and telehealth services, and to provide additional certainty as health care providers consider their future bandwidth needs. The Commission does, however, agree with AT&T and other commenters that managing waste, fraud, and abuse in the RHC Program is essential to ensuring efficient Program disbursements, and that the Commission should consider additional measures to ensure Program compliance. For that very reason, the
12. In addition to raising the annual RHC Program funding cap, the Commission addresses the immediate needs of participating health care providers by applying the increased cap to the current funding year (FY 2017). Given the significant financial hardship faced by rural health care providers due to the scarcity of Program funding and the substantial proration of FY 2017 funding requests, it is incumbent on the Commission to make available the additional funding in this funding year. This decision will eliminate the need to prorate the amount of qualified FY 2017 funding requests and relieve rural health care providers of burdensome service cost increases resulting from the required proration.
13. None of the commenters who support raising the annual funding cap oppose applying the funding cap to FY 2017. In the
14. By taking this action, the Commission makes significant funding available to issue commitments for the full amount approved for FY 2017 funding requests prior to proration. The Commission directs USAC to collect the additional funds needed to fully fund FY 2017 demand over the next two quarters in accordance with the standard process for calculating and announcing the quarterly contribution factor to reduce the impact on ratepayers. The Commission further directs USAC to take any other steps necessary to reverse the proration of approved FY 2017 funding requests, consistent with this R&O.
15.
16.
17. The Commission concludes that it is appropriate to rely upon the GDP-CPI index for the RHC Program's inflation adjustment. There is no index that specifically examines the cost of services funded under the RHC Program. Given that GDP-CPI is the same index the Commission uses to inflation-adjust the E-Rate Program cap, the high-cost loop support mechanism cap, and in other contexts to estimate inflation of carrier costs, the Commission concludes that it is reasonable to use the GDP-CPI to approximate the impact of inflation on RHC Program supported services. In the event of periods of deflation, the Commission will maintain the prior-year cap to maintain predictability.
18. To compute the annual inflation adjustment, the percentage increase in the GDP-CPI from the previous year will be used. The increase shall be rounded to the nearest 0.1 percent. The increase in the inflation index will then be used to calculate the maximum amount of funding for the next RHC Program funding year which runs from July 1 to June 30. When the calculation of the yearly average GDP-CPI is determined, the Wireline Competition Bureau (Bureau) will publish a Public Notice in the
19.
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21. Additionally, as in the E-Rate Program, the Commission will require USAC to provide quarterly estimates to the Commission regarding the amount of unused funds that will be available for carryover in subsequent years. This requirement codifies USAC's existing reporting practice and reporting cycle. The quarterly estimate will also provide stakeholders of the RHC Program with general notice regarding the estimated amount of unused funds that may be made available in the subsequent year.
22. Further, the Commission will make unused funds available annually in the second quarter of each calendar year for use in the next full funding year of the RHC Program. Based on the estimates provided by USAC, the Commission will announce a specific amount of unused funds from prior funding years to be carried forward to increase available funding for future funding years. This unused funding may be used to commit to eligible services in excess of the annual funding cap in the event demand in a given year exceeds the cap, or it may be used to reduce collections for the RHC Program in a year when demand is less than the cap. The Bureau will announce the availability and amount of carryover funds during the second quarter of the calendar year.
23. Finally, the Commission finds it is in the public interest to carry forward unused funds for disbursement on an annual basis. Distribution of unused funds on an annual basis allows USAC to refine its calculation of available funds over four reporting quarters as the funding year progresses. The Commission also believes that the timing of this process provides certainty regarding when unused funds will be carried forward for use in the RHC Program with minimal disruption to the administration of the Program.
24. This document contains no new information collection requirements subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. In addition, the Commission notes that pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198,
25. The Commission will send a copy of the R&O to Congress and the Government Accountability Office, pursuant to the Congressional Review Act,
26. The Regulatory Flexibility Act of 1980 (RFA) requires that an agency prepare a regulatory flexibility analysis for notice and comment rulemakings, unless the agency certifies that “the rule will not, if promulgated, have a significant economic impact on a substantial number of small entities.” Accordingly, we have prepared a Final Regulatory Flexibility Analysis (FRFA) concerning the possible impact of the rule changes contained in the R&O on small entities. The Commission will send a copy of the R&O, including the FRFA below, in a report to be sent to Congress and the Government Accountability Office pursuant to the Small Business Regulatory Enforcement Fairness Act of 1996. In addition, the Commission will send a copy of the R&O, including the FRFA, to the Chief Counsel for Advocacy of the Small Business Administration. A copy of the R&O and FRFA (or summaries thereof) will also be published in the
27. As required by the Regulatory Flexibility Act of 1980, as amended (RFA), an Initial Regulatory Flexibility Analysis (IRFA) of the possible significant economic impact on a substantial number of small entities by the policies and rules was incorporated into the 2017 Notice of Proposed Rulemaking. Written comments were requested on this IRFA. This present FRFA conforms to the RFA.
28. Through the R&O, the Commission seeks to improve the Rural Health Care (RHC) Program's capacity to distribute telecommunications and broadband support to health care providers—especially small, rural
29. There were no comments filed that specifically addressed the rules and policies proposed in the IRFA.
30. The Chief Counsel did not file any comments in response to the proposed rules in this proceeding.
31. The RFA directs agencies to provide a description of and, where feasible, an estimate of the number of small entities that may be affected by the proposed rules, if adopted. The 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 that: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the Small Business Administration (SBA).
32.
33. Next, the type of small entity described as a “small organization” is generally “any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.” Nationwide, as of August 2016, there were approximately 356,494 small organizations based on registration and tax data filed by nonprofits with the Internal Revenue Service (IRS).
34. Finally, the small entity described as a “small governmental jurisdiction” is defined generally as “governments of cities, counties, towns, townships, villages, school districts, or special districts, with a population of less than fifty thousand.” U.S. Census Bureau data from the 2012 Census of Governments indicate that there were 90,056 local governmental jurisdictions consisting of general purpose governments and special purpose governments in the United States. Of this number, there were 37,132 General purpose governments (county, municipal and town or township) with populations of less than 50,000 and 12,184 Special purpose governments (independent school districts and special districts) with populations of less than 50,000. The 2012 U.S. Census Bureau data for most types of governments in the local government category show that the majority of these governments have populations of less than 50,000. Based on this data the Commission estimates that at least 49,316 local government jurisdictions fall in the category of “small governmental jurisdictions.”
35. Small entities potentially affected by the reforms adopted herein include eligible non-profit and public health care providers and the eligible service providers offering them services, including telecommunications service providers, Internet Service Providers (ISPs), and vendors of the services and equipment used for dedicated broadband networks.
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66. 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 these actions. 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 (PCS), and Specialized Mobile Radio (SMR) 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, the Commission estimates that the majority of wireless firms can be considered small.
67.
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76. There are no new or different reporting, recordkeeping, or other compliance requirements adopted in this R&O that would likely financially impact either large or small entities, including health care providers and service providers.
77. 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 rule for such small entities; (3) the use of performance rather than design standards; and (4) an exemption from coverage of the rule, or any part thereof, for such small entities.”
78. In the R&O, the Commission increases available funding for all eligible RHC Program entities including small entities. Specifically, the Commission increases RHC Program support, and thereby increases support available for rural, mostly small, health care providers, by: (1) Increasing the RHC Program support cap to $571 million to apply to FY 2017; (2) prospectively increasing the $571 million RHC Program support cap
79. In the R&O, the Commission carefully balanced the significant financial hardship faced by rural health care providers due to the otherwise scarcity of funding and the public health consequences that could result from lack of broadband service with the increase in funding needed to meet the new cap. The Commission considered and rejected arguments to double the cap or to increase it beyond the $571 million adopted in the R&O. The increased cap, indexed to inflation, and the carry forward of unused funds will make more funding available to eligible health care providers including small entities, while minimizing the amount of funds that are needed to be collected. No commenters proposed significant small business alternatives.
80. The Commission will send a copy of the R&O, including this FRFA, in a report to be sent to Congress pursuant to the Congressional Review Act. In addition, the Commission will send a copy of the R&O, including this FRFA, to the Chief Counsel for Advocacy of the SBA. A copy of the R&O and FRFA (or summaries thereof) will also be published in the
81. The Commission finds good cause to make the rule changes herein effective June 29, 2018, pursuant to section 553(d) of the Administrative Procedure Act. Agencies determining whether there is good cause to make a new rule or rule revision take effect less than 30 days after
82. Further, making these rule changes effective upon publication will not burden contributors or RHC Program participants. As a practical matter, contributors pass through their contribution obligations to their end users by a line item on the end user's invoice, which they update quarterly based on the contribution factor. The additional funding required by the R&O to be applied to FY 2017 will be collected over the next two quarters in accordance with our regular course of business for calculating and announcing the quarterly contribution factor, thus requiring no additional or different administrative burden on contributors. No additional time is needed for affected parties to prepare for the rules' effectiveness because USAC and interested parties have already applied for and processed the requests for funding for the current RHC Program year (FY 2017). Additionally, the rule change to increase the funding cap enables eligible health care providers to benefit from increased funding in the current funding year and does not oblige them to take any particular action. The rule changes that index the funding cap to inflation and carry forward unused funds do not impose any additional requirement on RHC Program participants and will be implemented by Commission staff and USAC during FY 2018. Thus, the Commission finds good cause to make these rule changes effective June 29, 2018.
83. Accordingly,
84.
85.
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87.
88.
Communications common carriers, Health facilities, internet, Telecommunications.
For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR part 54 as follows:
47 U.S.C. 151, 154(i), 155, 201, 205, 214, 219, 220, 254, 303(r), 403, and 1302 unless otherwise noted.
(a)
(1)
(2)
(3)
(4)
(5)
Defense Acquisition Regulations System, Department of Defense (DoD).
Final rule.
DoD is issuing a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to provide a more transparent means of documenting the impact of costs incurred during the undefinitized period of an undefinitized contract action on allowable profit.
Effective June 29, 2018.
Mr. Mark Gomersall, telephone 571-372-6176.
DoD published a proposed rule in the
Two respondents submitted public comments in response to the proposed rule. DoD reviewed the public comments in the development of this final rule. An analysis of the comments is provided as follows:
The following changes were made to the language published in the proposed rule:
1. The term “auditable proposal” in 215.404-71-2 is revised as “qualifying proposal as defined in 217.7401(c)” for consistency with 10 U.S.C. 2326.
2. The instructions for completing blocks 24a and 24b have been revised for clarity.
3. The language at 215.404-71-3(d)(2)(ii) is revised for clarity.
This rule amends the DFARS to provide a more transparent means of documenting the impact of costs incurred during the undefinitized period of an undefinitized contract action on allowable profit. The revisions do not add any new burdens or impact applicability of clauses and provisions at or below the simplified acquisition threshold, or to commercial items.
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.
This rule is not an E.O. 13771, Reducing and Controlling Regulatory Costs, regulatory action, because this rule is not significant under E.O. 12866.
This rule will not have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601
The objective of the rule is to gain visibility into the contracting officer's rationale for the contract type risk values entered on the DD Form 1547, Record of Weighted Guidelines Application. The rule requires contracting officers to document in the price negotiation memorandum their rationale for assigning a specific contract type risk value. In addition, Item 24 on the DD Form 1547 is separated into Item 24a, Contract Type Risk (based on contractor incurred costs under a UCA) and Item 24b, Contract Type Risk (based on Government projected costs).
This rule will not have a significant economic impact on a substantial number of small entities. This rule only
There is no change to reporting or recordkeeping as a result of this rule. The rule does not duplicate, overlap, or conflict with any other Federal rules.
There are no known significant alternative approaches to the rule that would meet the requirements. DoD considers the approach described in the proposed rule to be the most practical and beneficial for both Government and industry.
The rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).
Government procurement.
Therefore, 48 CFR parts 215, 217, and 243 are amended as follows:
41 U.S.C. 1303 and 48 CFR chapter 1.
(e) * * *
(2) * * *
(iii) If the contractor demonstrates efficient management and cost control through the submittal of a timely, qualifying proposal (as defined in 217.7401(c)) in furtherance of definitization of an undefinitized contract action, and the proposal demonstrates effective cost control from the time of award to the present, the contracting officer may add 1 percentage point to the value determined for management/cost control up to the maximum of 7 percent.
(b)
(1) Select a value from the list of contract types in paragraph (c) of this section using the evaluation criteria in paragraph (d) of this section. See paragraph (d)(2) of this section.
(2)(i) Insert the amount of costs incurred as of the date the contractor submits a qualifying proposal, such as under an undefinitized contract action, (excluding facilities capital cost of money) into the Block 24a column titled Base.
(ii) Insert the amount of Government estimated cost to complete (excluding facilities capital cost of money) into the Block 24b column titled Base.
(3) Multiply (1) by (2)(i) and (2)(ii), respectively for Blocks 24a and 24b. Add Blocks 24a and 24b and insert the totals in Block 24c.
(d) * * *
(2)
(ii) Contracting officers shall document in the price negotiation memorandum the reason for assigning a specific contract type risk value, to include the extent to which any reduced cost risk during the undefinitized period of performance was considered, in determining the negotiation objective.
Defense Acquisition Regulations System, Department of Defense (DoD).
Final rule.
DoD is issuing a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to remove a clause that is duplicative of an existing Federal Acquisition Regulation (FAR) clause.
Effective June 29, 2018.
Ms. Carrie Moore, telephone 571-372-6093.
DoD is amending the DFARS to remove the DFARS clause 252.216-7010, Requirements, the Alternate clause, the associated clause prescription at DFARS 216.506, and a cross-reference to the clause at DFARS 247.271-3(p).
The DFARS clause is included in contracts for preparation of personal property for movement or storage, or for intra-city or intra-area movement; advises contractors that a requirements contract has been issued and how quantities work under the contract; that the delivery of items or performance of work is subject to the issuance of orders; and, that the Government shall order all requirements covered by the contract from the contractor, unless certain circumstances apply.
FAR clause, 52.216-21, Requirements, advises contractors of the same information in the DFARS clause, and also provides a date after which the contractor is not required to make any deliveries under the contract. The DFARS clause is no longer necessary, because the FAR clause applies to the situations in which the DFARS clause is prescribed for use and covers the information contained in the DFARS clause. As such, this DFARS clause is now redundant and can be removed.
The removal of this DFARS clause supports a recommendation from the DoD Regulatory Reform Task Force. On February 24, 2017, the President signed Executive Order (E.O.) 13777, “Enforcing the Regulatory Reform Agenda,” which established a Federal policy “to alleviate unnecessary regulatory burdens” on the American people. In accordance with E.O. 13777, DoD established a Regulatory Reform Task Force to review and validate DoD regulations, including the DFARS. A public notification of the establishment of the DFARS Subgroup to the DoD Regulatory Reform Task Force, for the purpose of reviewing DFARS provisions and clauses, was published in the
This rule does not add any new solicitation provisions or contract clauses. This rule only removes obsolete DFARS provision 252.216-7010, Requirements. Therefore, the rule does not impose any new requirements on contracts at or below the simplified acquisition threshold and for commercial items, including commercially available off-the-shelf items.
Executive Order (E.O.) 12866, Regulatory Planning and Review; and E.O. 13563, Improving Regulation and Regulatory Review, 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). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. The Office of Management and Budget, Office of Information and Regulatory Affairs (OIRA), has determined that this is not a significant regulatory action as defined under section 3(f) of E.O. 12866 and, therefore, was not subject to review under section 6(b). This rule is not a major rule as defined at 5 U.S.C. 804(2).
This rule is not an E.O. 13771, Reducing Regulation and Controlling Regulatory Costs, regulatory action, because this rule is not significant under E.O. 12866.
The statute that applies to the publication of the Federal Acquisition Regulation (FAR) is the Office of Federal Procurement Policy statute (codified at title 41 of the United States Code). Specifically, 41 U.S.C 1707(a)(1) requires that a procurement policy, regulation, procedure or form (including an amendment or modification thereof) must be published for public comment if it relates to the expenditure of appropriated funds, and has either a significant effect beyond the internal operating procedures of the agency issuing the policy, regulation, procedure, or form, or has a significant cost or administrative impact on contractors or offerors. This final rule is not required to be published for public comment, because DoD is not issuing a new regulation; rather, this rule merely removes an obsolete clause from the DFARS.
Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule under 41 U.S.C. 1707(a)(1) (see section V. of this preamble), the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601
The rule does not contain any information collection requirements that
Government procurement.
Therefore, 48 CFR parts 216, 247, and 252 are amended as follows:
41 U.S.C. 1303 and 48 CFR chapter 1.
Office of Personnel Management.
Proposed rule.
The Office of Personnel Management (OPM) is issuing a proposed rule to amend the Federal Employees' Group Life Insurance (FEGLI) regulations to clarify the definition of annual rates of pay for insured employees and to clarify the status of judges of the United States Court of Appeals for Veterans Claims.
Comments are due on or before August 28, 2018.
Send written comments to Ronald Brown, Policy Analyst, Healthcare and Insurance, U.S. Office of Personnel Management, Room 4316, 1900 E Street NW, Washington, DC. You may also submit comments identified by the RIN number stated above using the Federal eRulemaking Portal (
Ronald Brown, Policy Analyst, (202) 606-2128, or by email to
The Federal Employees' Group Life Insurance Program (FEGLI) is administered by the United States Office of Personnel Management (OPM) in accordance with Chapter 87 of Title 5 of the U.S. Code and our implementing regulations (title 5, part 87, and title 48, part 21, of the Code of Federal Regulations). The FEGLI enabling legislation was signed August 17, 1954. As of September 30, 2017, FEGLI covers an estimated 4,231,000 employees and annuitants enrolled in Basic insurance, including 1,144,000 employees and annuitants with Option B insurance that has not reduced to zero, 1,187,000 employees and annuitants enrolled in Option A insurance, and 933,000 employees and annuitants enrolled in Option C insurance that has not reduced to zero.
The FEGLI statute establishes the basic rules for benefits, enrollment, and participation, and provides that OPM “shall specify the types of pay included in annual pay.” See 5 U.S.C. 8704(c). In accordance, OPM has promulgated regulations defining the “basic insurance amount” for all Program enrollees. Further, the “basic insurance amount” is defined by law using the term “annual rate of basic pay.” See 5 U.S.C. 8701(c). For Program purposes, the basic insurance amount applies to Basic and Option B insurance.
This proposed rule clarifies what is considered annual basic pay for FEGLI Program purposes, but does not change how the annual rate of basic pay is computed, provide additional enrollment or change opportunities, or make other changes not in the existing Program regulations. The proposed rule makes this clear in the revised sections of part 870 by aligning the Program and retirement regulations, and, in the process, eliminating certain outdated regulatory provisions on basic pay.
OPM is issuing a proposed regulation to clarify that (1) annual basic pay for FEGLI includes any type of pay treated as basic pay for purposes of the retirement systems established under 5 U.S.C. chapters 83 and 84 consistent with applicable law or OPM regulation, and (2) basic pay for FEGLI purposes does not include bonuses, allowances, overtime pay, or any other pay to a covered civilian employee given in addition to the base pay of the position except as otherwise provided by specific provision of law or OPM regulation.
The proposed rule changes existing paragraphs 5 CFR 870.204(a)(1) and (a)(2) to clarify that basic pay for FEGLI purposes includes all payments that are retirement-creditable basic pay under 5 U.S.C. chapters 83 and 84. The proposed rule also deletes paragraphs that are obsolete or creditable by other provisions of law or covered as exceptions to existing law. This includes a revised paragraph on locality pay, special pay supplements, and customs officer pay.
The proposed regulation updates FEGLI regulations to state that (1) judges of the United States Court of Appeals for Veterans Claims, formerly judges of the United States Court of Veterans Appeals, are covered under applicable provisions of 5 U.S.C. chapter 87, and (2) any such judge who is in regular active service and a judge who is retired under chapter 72 of title 38 or under chapter 83 or 84 of title 5 shall be treated as an employee under FEGLI law and regulation.
The proposed regulation updates 5 CFR 870.101 with the correct title of the United States Court of Appeals for Veterans Claims and updates paragraph 5 CFR 870.101 with the correct title of the United States Court of Appeals for Veterans Claims. The proposed regulation also updates paragraph 5 CFR 870.703(e)(1) to state that a judge of the United States Court of Appeals for Veterans Claims who is in regular active service and a judge who is retired under 38 U.S.C. 7296 is considered an employee under the FEGLI Program as required by Public Law 114-315.
The Regulatory Flexibility Act of 1980 (Pub. L. 96-354) (RFA) establishes “as a principle of regulatory issuance that agencies shall endeavor, consistent with the objectives of the rule and of applicable statutes, to fit regulatory and informational requirements to the scale of the businesses, organizations, and governmental jurisdictions subject to regulation.” To achieve this principle, agencies are required to solicit and consider flexible regulatory proposals and to explain the rationale for their actions to assure that such proposals are given serious consideration.” The RFA covers a wide range of small entities, including small businesses, not-for-profit organizations, and small governmental jurisdictions.
Agencies must perform a review to determine whether a rule will have a significant economic impact on a substantial number of small entities. If the agency determines that it will, the agency must prepare a regulatory flexibility analysis as described in the RFA. I certify that this regulation will not have a significant economic impact on a substantial number of small entities because the regulation only affects a small number of Federal employees and annuitants.
This proposed rule has been reviewed by the Office of Management and Budget in accordance with Executive Orders 13563 and 12866.
This proposed rule is not expected to be an E.O. 13771 regulatory action because this proposed rule is not significant under Executive Order 12866. The proposed rule makes minimal changes to coverage for certain judges, and clarifies that annual basic pay for FEGLI includes any type of pay treated as basic pay for purposes of the retirement systems established under 5 U.S.C. chapters 83 and 84 consistent with applicable law or OPM regulation.
This proposed rule is not subject to the requirements of E.O. 13771 (82 FR 9339, February 3, 2017) because it is related to agency organization, management, or personnel and affects only a small number of federal employees and annuitants.
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.
The Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3507(d); see 5 CFR part 1320) requires that the U.S. Office of Management and Budget (OMB) approve all collections of information by a Federal agency from the public before they can be implemented. Respondents are not required to respond to any collection of information unless it displays a current valid OMB control number. OPM is not proposing any additional collections in this rule. This rule does not affect any existing collections.
Administrative practice and procedure, Government employees, Hostages, Iraq, Kuwait, Lebanon, Life Insurance, Retirement.
For the reasons stated in the preamble, OPM is proposing to amend part 870 of title 5 of the Code of Federal Regulations as follows:
5 U.S.C. 8716; Subpart J also issued under section 599C of Pub. L. 101-513, 104 Stat. 2064, as amended; Sec. 870.302(a)(3)(ii) also issued under section 153 of Pub. L. 104-134, 110 Stat. 1321; Sec. 870.302(a)(3) also issued under sections 11202(f), 11232(e), and 11246(b) and (c) of Pub. L. 105-33, 111 Stat. 251, and section 7(e) of Pub. L. 105-274, 112 Stat. 2419; Sec. 870.302(a)(3) also issued under section 145 of Pub. L. 106-522, 114 Stat. 2472; Secs. 870.302(b)(8), 870.601(a), and 870.602(b) also issued under Pub. L. 110-279, 122 Stat. 2604; Subpart E also issued under 5 U.S.C. 8702(c); Sec. 870.601(d)(3) also issued under 5 U.S.C. 8706(d); Sec. 870.703(e)(1) also issued under section 502 of Pub. L. 110-177, 121 Stat. Start Printed Page 773662542; Sec. 870.705 also issued under 5 U.S.C. 8714b(c) and 8714c(c); Public Law 104-106, 110 Stat. 521.
(4) The United States Court of Appeals for Veterans Claims is the employing office for judges of the United States Court of Appeals for Veterans Claims.
(a)(1) An employee's annual pay is the annual basic pay of the position as fixed by law or regulation, except as otherwise provided by specific provision of law or OPM regulation. Annual pay for this purpose includes the following:
(i) Any pay of a type that is treated as basic pay for purposes of the retirement systems established under 5 U.S.C. chapters 83 and 84, consistent with 5 U.S.C. 8331(3);
(ii) Any geographic-based pay supplement that is equivalent to a locality-based comparability payment under 5 U.S.C. 5304; and
(iii) Any special pay supplement for a defined subcategory of employees that is equivalent to a special rate supplement under 5 U.S.C. 5305.
(2) Notwithstanding paragraph (a)(1) of this section, annual basic pay does not include the following:
(i) Bonuses, allowances, overtime pay, or any other pay to a covered civilian employee given in addition to the base pay of the position, except as otherwise provided by specific provision of law or OPM regulation.
(ii) Physicians comparability allowances under 5 U.S.C. 5948.
(e) * * *
(1) * * *
(vii) 38 U.S.C. 7296.
Agricultural Marketing Service, USDA.
Request for information.
The United States Department of Agriculture's (USDA) Agricultural
We will consider comments we receive by August 28, 2018.
Submit comments or notice of intent to submit comments by any of the following methods:
•
•
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Patrick McCluskey, USDA AMS; Telephone: (816) 659-8403; Email:
Section 4 of the USGSA (7 U.S.C. 76(a)) grants the Secretary of Agriculture the authority to establish standards for canola and other grains regarding kind, class, quality, and condition. The canola standards were established by USDA on February 28, 1992 (57 FR 3271) and appear in the USGSA regulations at 7 CFR 810.301-810.306. The standards facilitate canola marketing and define U.S. canola quality in the domestic and global marketplace. The standards define commonly used industry terms; contain basic principles governing the application of standards, such as the type of sample used for a particular quality analysis; the basis of determination; and specify grades and grade requirements. Official procedures for determining grading factors are provided in Grain Inspection Handbook, Book II, Chapter 3, “Canola”. The Handbook also includes standardized procedures for additional quality attributes not used to determine grade, such as dockage and moisture content. Together, the grading standards and official procedures allow buyers and sellers to communicate quality requirements, compare canola quality using equivalent forms of measurement, and assist in price discovery.
The realignment of offices within the U.S. Department of Agriculture authorized by the Secretary's Memorandum dated November 14, 2017, “Improving Customer Service and Efficiency”, eliminates the Grain Inspection, Packers and Stockyards Administration (GIPSA) as a standalone agency. Federal Grain Inspection Service (FGIS) activities, formerly part of GIPSA, are now organized under AMS. FGIS grading and inspection services are provided through a network of federal, state, and private laboratories that conduct tests to determine the quality and condition of canola. These tests are conducted in accordance with applicable standards using approved methodologies and can be applied at any point in the marketing chain. Furthermore the tests yield rapid, reliable, and consistent results. In addition, FGIS-issued certificates describing the quality and condition of graded canola are accepted as
In order for U.S. standards and grading procedures for canola to remain relevant, AMS is issuing this request for information to invite interested parties to submit comments, ideas, and suggestions on all aspects of the U.S. Standards for Canola and official procedures.
7 U.S.C. 71-87k.
Agricultural Marketing Service, USDA.
Request for information.
The United States Department of Agriculture's (USDA) Agricultural Marketing Service (AMS) is seeking comments from the public regarding the United States (U.S.) Standards for Corn under the United States Grain Standards Act (USGSA). To ensure that standards and official grading practices remain relevant, AMS invites interested parties to comment on whether the current corn standards and grading practices need to be changed.
We will consider comments we receive by August 28, 2018.
Submit comments or notice of intent to submit comments by any of the following methods:
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Patrick McCluskey, USDA AMS; Telephone: (816) 659-8403; Email:
Section 4 of the USGSA (7 U.S.C. 76(a)) grants the Secretary of Agriculture the authority to establish standards for corn and other grains regarding kind, class, quality, and condition. The corn standards, established by USDA on December 1, 1916, were last revised in 1995 (60 FR 61194) and appear in the USGSA regulations at 7 CFR 810.401-810.405. The standards facilitate corn marketing and define U.S. corn quality in the domestic and global marketplace. The standards define commonly used industry terms; contain basic principles governing the application of standards, such as the type of sample used for a particular quality analysis; the basis of determination; and specify grades and grade requirements. Official procedures for determining grading factors are provided in Grain Inspection Handbook, Book II, Chapter 4, “Corn”. The Handbook also includes standardized procedures for additional quality attributes not used to determine grade, such as stress crack analysis and moisture content. Together, the grading standards and official procedures allow buyers and sellers to communicate quality requirements, compare corn quality using equivalent forms of measurement, and assist in price discovery.
The realignment of offices within the U.S. Department of Agriculture authorized by the Secretary's Memorandum dated November 14, 2017, “Improving Customer Service and Efficiency”, eliminates the Grain Inspection, Packers and Stockyards Administration (GIPSA) as a standalone agency. Federal Grain Inspection Service (FGIS) activities, formerly part of GIPSA, are now organized under
In order for U.S. standards and grading procedures for corn to remain relevant, AMS is issuing this request for information to invite interested parties to submit comments, ideas, and suggestions on all aspects of the U.S. Standards for Corn and official procedures.
7 U.S.C. 71-87k.
Agricultural Marketing Service, USDA.
Request for information.
The United States Department of Agriculture's (USDA) Agricultural Marketing Service (AMS) is seeking comments from the public regarding the United States (U.S.) Standards for Soybeans under the United States Grain Standards Act (USGSA). To ensure that standards and official grading practices remain relevant, AMS invites interested parties to comment on whether the current soybean standards and grading practices need to be changed.
We will consider comments we receive by August 28, 2018.
Submit comments or notice of intent to submit comments by any of the following methods:
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Patrick McCluskey, USDA AMS; Telephone: (816) 659-8403; Email:
Section 4 of the USGSA (7 U.S.C. 76(a)) grants the Secretary of Agriculture the authority to establish standards for soybeans and other grains regarding kind, class, quality, and condition. The soybean standards, established by USDA on November 20, 1940, were last revised in 2006 (71 FR 52403) and appear in the USGSA regulations at 7 CFR 810.1601-810.1605. The standards facilitate soybean marketing and define U.S. soybean quality in the domestic and global marketplace. The standards define commonly used industry terms; contain basic principles governing the application of standards, such as the type of sample used for a particular quality analysis; the basis of determination; and specify grades and grade requirements. Official procedures for determining grading factors are provided in Grain Inspection Handbook, Book II, Chapter 10, “Soybeans”. The Handbook also includes standardized procedures for additional quality attributes not used to determine grade, such as oil and protein content. Together, the grading standards and official procedures allow buyers and sellers to communicate quality requirements, compare soybean quality using equivalent forms of measurement, and assist in price discovery.
The realignment of offices within the U.S. Department of Agriculture authorized by the Secretary's Memorandum dated November 14, 2017, “Improving Customer Service and Efficiency”, eliminates the Grain Inspection, Packers and Stockyards Administration (GIPSA) as a standalone agency. Federal Grain Inspection Service (FGIS) activities, formerly part of GIPSA, are now organized under AMS. FGIS grading and inspection services are provided through a network of federal, state, and private laboratories that conduct tests to determine the quality and condition of soybeans. These tests are conducted in accordance with applicable standards using approved methodologies and can be applied at any point in the marketing chain. Furthermore the tests yield rapid, reliable, and consistent results. In addition, FGIS-issued certificates describing the quality and condition of graded soybeans are accepted as
In order for U.S. standards and grading procedures for soybeans to remain relevant, AMS is issuing this request for information to invite interested parties to submit comments, ideas, and suggestions on all aspects of the U.S. Standards for Soybeans and official procedures.
7 U.S.C. 71-87k.
National Environmental Satellite, Data, and Information Service (NESDIS), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (Department, or Commerce).
Advance notice of proposed rulemaking.
Commerce is considering revisions to its regulations for the licensing of private remote sensing space systems, currently administered by NOAA. These revisions would facilitate the continued growth of this critical industry and update the regulatory regime to address significant technological developments, new business models, and increased foreign competition since their last update in 2006. In support of this effort, the Department through NOAA seeks public comment on substantive and procedural matters involved in commercial remote
Comments must be received by August 28, 2018.
You may send comments by the following method:
Tahara Dawkins, Commercial Remote Sensing Regulatory Affairs, at 301-713-3385, or Glenn Tallia, NOAA Office of General Counsel, at 301-628-1622.
Per Article VI of the Treaty on Principles Governing the Activities of States in the Exploration and Use of Outer Space, including the Moon and Other Celestial Bodies (“Outer Space Treaty”), activities of private U.S. entities in outer space require the “authorization and continuing supervision” of the United States Government. Subchapter VI of Title 51, National and Commercial Space Programs (51 U.S.C. 60121
Through the National Space Council, the Administration has made clear that long-term U.S. national security and foreign policy interests are best served by ensuring that U.S. industry continues to lead this rapidly maturing and highly competitive market. The priorities for the National Space Council and the Department are to: Encourage companies to do business in the United States; help businesses maintain a competitive advantage here; facilitate the growth of this important industry; and support innovation within it. To that end, the Department and NOAA wish to relieve any unnecessary regulatory burdens in the remote sensing area.
Additionally, technological and other developments have highlighted ambiguities in the current regulatory regime, many of which were unforeseeable even just a few years ago. Specific examples include:
The Department recognizes that there have been many proposals to improve the commercial remote sensing regulatory regime, some of which may require new or revised statutory authority to implement. However, the Department may be able to make significant improvements to the licensing of remote sensing even under the existing statute, simply by revising its regulations. Therefore, to support the Administration's above-mentioned priorities and to reflect the dramatic changes in the remote sensing industry since the last update of remote sensing regulations, the Department plans to revise its regulations. Before drafting specific provisions, the Department is seeking input from stakeholders regarding how it should best address a variety of important issues.
The Department welcomes input on any matters related to commercial remote sensing regulation, including specific examples of industry standards, alternative regulatory approaches, and legal definitions that work well in other areas. The Department also invites comment on the overall cost of complying with NOAA's existing regulations and any specific regulatory requirements that are particularly burdensome.
In addition, the Department seeks input on the following specific topics:
The Statute authorizes the Secretary of Commerce to license “private sector parties to operate private remote sensing space systems” and prohibits a “person that is subject to the jurisdiction or control of the United States” from “operat[ing] any private remote sensing space system” without a license (51 U.S.C. 60121(a), 60122(a)).
In pursuit of the Department's goal to facilitate innovation, the Department seeks input on how to define these and other statutory terms in its regulations, and at what level of specificity. Definitions that are more specific would provide greater certainty to industry in determining whether a license is required, but specific definitions could quickly be outpaced by technological change, becoming obsolete or burdensome. Alternatively, less specific definitions could adapt as technology and business models develop, but might provide insufficient certainty to industry. The Department may be able to augment less specific definitions in its regulations with interpretive guidance, which could be updated more regularly to reflect industry developments.
With this background in mind, the Department seeks general comments on this topic. In addition, the Department seeks input in response to the following specific questions:
a. How should Commerce define the statutory terms “private sector party” and “person subject to the jurisdiction or control of the United States?”
b. How should Commerce define the statutory term “private remote sensing space system?”
c. How should Commerce determine which entity is the operator of a private remote sensing system (the operator is required to obtain a license under the
Before a license can be granted, the Statute requires the Secretary to determine that the applicant will comply with the Statute, the regulations, and any international obligations and national security concerns (51 U.S.C. 60121(b)(1)). The Statute also requires the Secretary to consult with the Secretaries of Defense and State (51 U.S.C. 60147(a), (b)).
The Department seeks to expedite review of applications as much as possible within statutory constraints. Commerce recognizes that modern remote sensing space systems present a broad range of technical capabilities and possible risks to national security, foreign policy, and international obligations of the United States. Commerce would prefer that the majority of applicants, whose systems present few, if any, such risks, could be reviewed more quickly and be subject to a lighter regulatory approach overall. In addition to providing certainty and quicker review for most applicants, this approach would allow Commerce and its interagency partners to work with industry to focus resources on mitigating only the most critical risks posed by the most capable proposed systems.
With this background in mind, the Department seeks general comments on this topic. In addition, Commerce seeks input in response to the following specific questions:
a. Commerce is considering grouping proposed systems into two or more categories based on the potential risk presented by their capabilities. Those systems categorized as posing only a de minimis risk would be subject to an expedited review process, less restrictive license conditions, and less burdensome compliance requirements (note: Comments are sought on factors potentially relevant for defining review categories and review processes for different categories (Topic 2, below), on license conditions (Topic 3), and on compliance requirements (Topic 4)). The Department seeks input on whether such a strategy is advisable, and if so, how to implement it.
1. Would the proposed category system be advisable?
2. How should Commerce define categories in such a system? Consider the following factors, for example:
3. What application information should Commerce collect from applicants in different categories (
4. How should the review process for the different categories differ, including interagency consultation? Should Commerce issue a license based solely on notification by the applicant and confirmation by Commerce that the proposed system satisfies the criteria for the de minimis category?
5. How and how often should Commerce reevaluate its definition of these categories over time?
b. Should all applications or only applications for some categories of commercial remote sensing licenses enjoy a “presumption of approval?” If so, how should Commerce implement this presumption?
c. Would it be helpful to require a pre-application consultation? If so, under which circumstances?
d. How can the Department improve transparency during the application review process?
e. Noting that new technologies can require extensive study, how can Commerce work proactively with the other reviewing agencies and potential future licensees to ensure that the Department is prepared to swiftly review any submitted applications?
While some license conditions are required by statute or regulation, the Secretaries of Defense and State also determine additional individual conditions addressing national security, foreign policy, and international obligations (51 U.S.C. 60122, 60147; 15 CFR 960.11). The Secretary of Commerce, through NOAA, ultimately implements and enforces all license conditions.
Listing standard license conditions in Commerce's regulations would provide applicants with certainty. However, some flexibility may be necessary to allow the Department to tailor conditions to specific systems, as appropriate. Additionally, the Department recognizes that some license conditions can impose a heavy cost burden, which harms industry and frustrates U.S. policy. Commerce seeks to impose those conditions only when legally required or when critical risks to national security, foreign policy, and international obligations are identified. Finally, Commerce recognizes that once a license is issued, permanent retroactive changes to license conditions can be disruptive to a licensee's operations and business.
With this background in mind, the Department seeks general comments on this topic. In addition, the Department seeks input in response to the following specific questions:
a. Considering the default conditions in 15 CFR 960.11, are there any conditions that should be added, removed, or modified in light of technological changes or impacts to the industry?
b. Should there be different default conditions for the different “categories” of systems as described in Topic 2?
c. When considering license conditions, how should NOAA think about the cost and benefit of conditions? What information could licensees provide to NOAA to inform that analysis?
d. How should Commerce respond to emerging and unforeseeable national security, foreign policy, and international obligation issues for existing licensed systems (
e. Should the U.S. Government be required to attempt to mitigate any national security or other risks before imposing conditions? If such mitigation would be costly, how should Commerce balance the taxpayer cost with any avoided cost to licensees?
f. Under the Convention on International Liability for Damage Caused by Space Objects, the U.S. Government and taxpayers may be liable for damage caused by a licensee to a space object, person, or property of another nation. The U.S. Government would not be liable if a licensee damages a space object, person, or property of another U.S. entity, but the licensee may lack the financial means to pay damages to an aggrieved entity. NOAA currently requires licensees to submit an orbital debris assessment report and spacecraft disposal plan, but should Commerce also consider a license condition requiring licensees to obtain some level of insurance to cover these potential liabilities? If such insurance is prohibitively expensive, should Commerce consider other, less burdensome means to protect U.S. taxpayers and other U.S. satellite owners?
g. How should Commerce adjust conditions in response to the increasing capabilities of non-U.S. entities? How frequently should NOAA evaluate those increasing capabilities?
h. How can Commerce best provide transparency to licensees regarding classified national security risks?
The Secretary is required to ensure compliance with the regulations and with licenses (51 U.S.C. 60123, 15 CFR 960.13-960.15). To meet this obligation, NOAA must collect information, but it seeks to minimize the burden on licensees.
With this background in mind, the Department seeks general comments on this topic. In addition, the Department seeks input in response to the following specific questions:
a. What are appropriate mechanisms for ensuring compliance? Currently, Commerce uses site visits, virtual inspections, quarterly and annual audits, and no-notice inspections as needed.
b. How should Commerce ensure compliance when multiple parties (including investors) play a role in a single licensed system? Options could include licensing all involved parties, or holding a single licensee responsible for the entire system.
c. Are there any improvements the Department could make to its formal adjudication procedures in the regulations?
d. Should Commerce mandate licensees to use certain technical standards, or particular software, for compliance purposes? If so, what standards or software should Commerce require?
e. Should Commerce adopt different compliance policies and procedures for the different categories described in Topic 2? If so, what policies and procedures would be appropriate for the different categories?
The Department recognizes that many NOAA-licensed systems also require licenses from other U.S. Government agencies, and occasionally from agencies in other countries. The Department seeks to reduce the overall regulatory burden to licensees, when possible.
With this background in mind, Commerce seeks general comments on this topic. In addition, the Department seeks input in response to the following specific questions:
a. Within statutory constraints, how can Commerce avoid redundancies and inconsistencies between domestic regulatory regimes?
b. Within statutory constraints, how can Commerce minimize burdens to licensees who operate in multiple countries and are subject to multiple countries' regulatory regimes?
This advance notice of proposed rulemaking was determined to be significant for purposes of E.O. 12866.
Food and Drug Administration, HHS.
Notification of public hearing; request for comments.
The Food and Drug Administration (FDA or Agency) is announcing a public hearing to solicit comments on FDA's Predictive Toxicology Roadmap, which was issued by FDA on December 6, 2017. FDA is seeking comments on how to foster the development and evaluation of emerging toxicological methods and new technologies and incorporate these methods and technologies into regulatory review, as applicable.
The public hearing will be held on Wednesday, September 12, 2018, from 9 a.m. to 4 p.m. Persons seeking to attend or to present at the public hearing must register by Wednesday, August 29, 2018. Section III provides attendance and registration information. Electronic or written comments will be accepted after the public hearing until Friday, October 12, 2018.
The public hearing will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503A), Silver Spring, MD 20993-0002. Entrance for public hearing participants (non-FDA employees) is through Building 1, where routine security check procedures will be performed. For parking and security information, please refer to:
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted via the
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• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
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• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked, and identified as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions: To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Tracy Chen, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4309A, Silver Spring, MD 20993,
The scientific discipline of toxicology is particularly essential to FDA's mission because it is applied across the breadth of FDA-regulated product areas. Toxicological testing is performed during the development and evaluation of FDA-regulated products, ranging from human and animal drugs and medical devices to food and food ingredients, human biologics, and tobacco products. Advances in systems biology, stem cells, engineered tissues, and mathematical modeling are creating unique opportunities to improve toxicology's predictive ability, potentially enhancing FDA's ability to predict risk. Also critical is the potential of these advances for replacing, reducing, and/or refining animal testing. Today, novel methods such as organs on a chip and mathematical modeling are generating unique opportunities that may improve our ability to quickly and more accurately predict potential toxicities and reduce associated risks to the public.
FDA centers have each taken significant steps to enhance the use and evaluation of cutting-edge toxicological assays. However, more work needs to be done to achieve broad acceptance of new toxicology methodologies and technologies. FDA's six product centers have different legal authorities for evaluating product safety or toxicity. Nevertheless, more robust methodological evaluation and datasets can help speed the acceptance of emerging predictive toxicology methods across the regulatory product areas.
FDA recognized that a comprehensive strategy was needed to evaluate new methodologies and technologies for their potential to offer greater predictive ability and to protect public health. Acceptance of any new toxicology testing method will require convincing data as well as continuous dialogue and feedback among all relevant stakeholders, from development to implementation, including qualification and acceptance by regulatory authorities.
To ensure that FDA continues to employ cutting-edge science to assess the toxicity of its regulated products and to leverage advances being made in toxicology, the Commissioner of Food and Drugs (the Commissioner) tasked the Agency's Toxicology Working Group with developing a more efficient process for identifying and qualifying emerging predictive toxicology technologies. Established in 2015 and comprised of senior FDA toxicologists from across the Agency, the Working Group has deep expertise in the various FDA product areas and knowledge of the differing legal authorities for evaluating toxicity in those product areas.
For a new testing method to be accepted for use in determining the toxicity of an FDA-regulated product there must be convincing data to ensure that the method can be relied upon for both product development and regulatory decision-making. FDA evaluates the test or series of tests for their applicability, limitations, relevance, reliability, accuracy, reproducibility, and sensitivity in the evaluation of human response and toxicity. Undergoing this process requires continuous dialogue and feedback among all relevant stakeholders, beginning with developers and ending with qualification and acceptance by regulatory authorities.
FDA's Predictive Toxicology Roadmap (
The purpose of this public meeting is to invite public comment on how FDA can better work with its stakeholders to implement the goals of its Predictive Toxicology Roadmap. We invite interested parties to submit comments, especially on the questions listed below on each of the six parts in the roadmap. Comments on additional areas are also welcome.
FDA has formed a senior-level Toxicology Working Group under the direction of the Commissioner to foster enhanced communication among FDA product centers and researchers and leverage FDA resources to advance the evaluation and integration of emerging predictive toxicology methods and new technologies into regulatory safety and risk assessments.
1. Which goals of the FDA Roadmap are most important to FDA stakeholders?
2. What role could FDA stakeholders play in achieving these goals?
Continuing current education in new predictive toxicology methods is essential for FDA regulators.
1. What training topics and approaches do you think would help FDA staff to appropriately implement new alternative methods?
2. Are there relevant courses that you can recommend?
3. Should FDA partner with its stakeholders for these training courses and how might this be achieved?
FDA will continue to reaffirm its commitment to and support for incorporating data from newly qualified toxicology methods into regulatory submissions and encourage discussions with stakeholders as part of the regulatory submission process.
1. How can FDA better communicate with stakeholders to encourage discussion on the use of qualified new toxicology methods early in the regulatory process?
2. How can new toxicology methods and approaches be integrated into FDA's review of regulated products?
3. What information do stakeholders need from FDA to qualify alternative methods for a specific context of use?
FDA will continue its long practice of fostering collaborations across disciplines nationally and internationally.
1. What partnerships could be useful to FDA to advance the roadmap?
2. Are there existing partnerships that FDA should be involved in to achieve the roadmap's goals?
FDA's research programs will identify data gaps and support research to ensure that the most promising technologies are identified, evaluated, and integrated into product development and assessment.
1. What data gaps should be addressed by FDA research and research conducted by external groups?
2. How can FDA encourage and support research in areas of importance to its mission?
3. How could FDA and stakeholders evaluate whether alternative methods are appropriately qualified for a specific context of use?
The Toxicology Working Group, with representation from each FDA center, will track the progress of these recommendations and report to FDA's Chief Scientist annually.
1. How can FDA ensure transparency in its progress?
2. How can FDA better foster opportunities to share ideas and knowledge with its stakeholders?
3. How can FDA highlight collaborations on the development and testing of new methods?
FDA will try to accommodate all persons who wish to make a presentation. Individuals wishing to present should identify the number of the specific question, or questions, they wish to address. This will help FDA organize the presentations. Individuals and organizations with common interests should consolidate or coordinate their presentations and request time for a joint presentation. FDA will notify registered presenters of their scheduled presentation times. The time allotted for each presentation will depend on the number of individuals who wish to speak but should last a maximum of 10 minutes. Presenters are encouraged to submit an electronic copy of their presentation to
If you need special accommodations because of a disability, please contact Shari Solomon (
The Commissioner is announcing that the public hearing will be held in accordance with 21 CFR part 15. The hearing will be conducted by a presiding officer, who will be accompanied by FDA senior management from the Office of the Commissioner and the relevant Centers/Offices. Under § 15.30(f), the hearing is informal and the rules of evidence do not apply. No participant may interrupt the presentation of another participant. Only the presiding officer and panel members can pose questions; they can question any person during or after each presentation. Public hearings under part 15 are subject to FDA's policy and procedures for electronic media coverage of FDA's public administrative proceedings (21 CFR part 10, subpart C). Under § 10.205, representatives of the media may be permitted, subject to certain limitations, to videotape, film, or otherwise record FDA's public administrative proceedings, including presentations by participants. The hearing will be transcribed as stipulated in § 15.30(b) (see
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve elements of a State Implementation Plan (SIP) submission from Vermont that addresses the infrastructure requirements of the Clean Air Act (CAA or Act)—including the interstate transport provisions—for the 2012 fine particle (PM
Written comments must be received on or before July 30, 2018.
Submit your comments, identified by Docket ID No. EPA-R01-OAR-2017-0696, to the
Alison C. Simcox, Air Quality Unit, U.S. Environmental Protection Agency, EPA New England Regional Office, 5 Post Office Square—Suite 100, (Mail code OEP05-2), Boston, MA 02109-3912, tel. (617) 918-1684;
Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.
This rulemaking addresses a SIP submission from the Vermont Department of Environmental Conservation (VT DEC). The state submitted its infrastructure SIP for the 2012 fine particle (PM
EPA is acting on a SIP submission from Vermont that addresses the infrastructure requirements of CAA sections 110(a)(1) and 110(a)(2) for the 2012 PM
The requirement for states to make a SIP submission of this type arises out of CAA sections 110(a)(1) and 110(a)(2). Pursuant to these sections, each state must submit a SIP that provides for the implementation, maintenance, and enforcement of each primary or secondary NAAQS. States must make such SIP submission “within 3 years (or such shorter period as the Administrator may prescribe) after the promulgation of a new or revised NAAQS.” This requirement is triggered by the promulgation of a new or revised NAAQS and is not conditioned upon EPA's taking any other action. Section 110(a)(2) includes the specific elements that “each such plan” must address.
EPA commonly refers to such SIP submissions intended to satisfy the requirements of CAA sections 110(a)(1) and 110(a)(2) as “infrastructure SIP” submissions. Although the term “infrastructure SIP” does not appear in the CAA, EPA uses the term to distinguish this type of SIP submission from submissions that are intended to satisfy other SIP requirements under the CAA, such as “nonattainment SIP” or “attainment plan SIP” submissions to address the nonattainment planning requirements of part D of title I of the CAA.
This rulemaking will not cover three substantive areas that are not integral to acting on a state's infrastructure SIP submission: (i) Existing provisions related to excess emissions during periods of start-up, shutdown, or malfunction at sources (“SSM” emissions) that may be contrary to the CAA and EPA's policies addressing such excess emissions; (ii) existing provisions related to “director's variance” or “director's discretion” that purport to permit revisions to SIP-approved emissions limits with limited public process or without requiring further approval by EPA, that may be contrary to the CAA (“director's discretion”); and, (iii) existing provisions for Prevention of Significant Deterioration (PSD) programs that may be inconsistent with current requirements of EPA's “Final New Source Review (NSR) Improvement Rule,” 67 FR 80186 (December 31, 2002), as amended by 72 FR 32526 (June 13, 2007) (“NSR Reform”). Instead, EPA has the authority to address each one of these substantive areas separately. A detailed history, interpretation, and rationale for EPA's approach to infrastructure SIP requirements can be found in EPA's May 13, 2014, proposed rule entitled, “Infrastructure SIP Requirements for the 2008 Lead NAAQS” in the section, “What is the scope of this rulemaking?”
EPA highlighted the statutory requirement to submit infrastructure SIPs within 3 years of promulgation of a new NAAQS in an October 2, 2007, guidance document entitled “Guidance on SIP Elements Required Under Sections 110(a)(1) and (2) for the 1997 8-hour Ozone and PM
With respect to the Good Neighbor provision, the most recent relevant document was a memorandum published on March 17, 2016, entitled “Information on the Interstate Transport `Good Neighbor' Provision for the 2012 Fine Particulate Matter National Ambient Air Quality Standards under Clean Air Act Section 110(a)(2)(D)(i)(I)” (2016 memorandum). The 2016 memorandum describes EPA's past approach to addressing interstate transport, and provides EPA's general review of relevant modeling data and air quality projections as they relate to the 2012 annual PM
In this notice of proposed rulemaking, EPA is proposing action on a SIP submission from the state of Vermont. In its submission, Vermont presents a detailed list of Vermont Laws and previously SIP-approved Air Quality Regulations showing how the various components of its EPA-approved SIP meet each of the requirements of section 110(a)(2) of the CAA for the 2012 PM
For Vermont's October 31, 2017 submission addressing the 2012 PM
This section (also referred to in this action as an element) of the Act requires SIPs to include enforceable emission limits and other control measures, means or techniques, schedules for compliance, and other related matters. However, EPA has long interpreted emission limits and control measures for attaining the standards as being due when nonattainment planning requirements are due.
Vermont's infrastructure submittal for this element cites Vermont Statutes Annotated (V.S.A) and several Vermont Air Pollution Control Regulations (VT APCR) as follows: Vermont's 10 V.S.A. § 554, “Powers,” authorizes the Secretary of the Vermont Agency of Natural Resources (ANR) to “[a]dopt, amend and repeal rules, implementing the provisions” of Vermont's air pollution control laws set forth in 10 V.S.A. chapter 23. It also authorizes the Secretary to “conduct studies, investigations and research relating to air contamination and air pollution” and to “[d]etermine by appropriate means the degree of air contamination and air pollution in the state and the several parts thereof.” Ten V.S.A. § 556, “Permits for the construction or modification of air contaminant sources,” requires applicants to obtain permits for constructing or modifying air contaminant sources, and 10 V.S.A. § 558, “Emission control requirements,” authorizes the Secretary “to establish emission control requirements . . . necessary to prevent, abate, or control
The Vermont submittal cites more than 20 specific rules that the state has adopted to control the emissions of PM
Based upon EPA's review of the submittals, EPA proposes that Vermont meets the infrastructure SIP requirements of section 110(a)(2)(A) with respect to the 2012 PM
As previously noted, EPA is not proposing to approve or disapprove any existing state provisions or rules related to SSM or director's discretion in the context of section 110(a)(2)(A).
This section requires SIPs to provide for establishing and operating ambient air quality monitors, collecting and analyzing ambient air quality data, and making these data available to EPA upon request. Each year, states submit annual air monitoring network plans to EPA for review and approval. EPA's review of these annual monitoring plans includes our evaluation of whether the state: (i) Monitors air quality at appropriate locations throughout the state using EPA-approved Federal Reference Methods or Federal Equivalent Method monitors; (ii) submits data to EPA's Air Quality System (AQS) in a timely manner; and (iii) provides EPA Regional Offices with prior notification of any planned changes to monitoring sites or the network plan.
State law authorizes the Secretary of ANR, or authorized representative, to “conduct studies, investigations and research relating to air contamination and air pollution” and to “[d]etermine by appropriate means the degree of air contamination and air pollution in the state and the several parts thereof.”
States are required to include a program providing for enforcement of the emission limits and control measures described in section 110(a)(2)(A) and for the regulation of construction of new or modified stationary sources to meet NSR requirements under PSD and nonattainment new source review (NNSR) programs. Part C of the CAA (sections 160-169B) addresses PSD, while part D of the CAA (sections 171-193) addresses NNSR requirements.
State law provides the Secretary of ANR with the authority to enforce air pollution control requirements, including SIP-approved 10 V.S.A. § 554, which authorizes the Secretary of ANR to “[i]ssue orders as may be necessary to effectuate the purposes of [the state's air pollution control laws] and enforce the same by all appropriate administrative and judicial proceedings.” In addition, Vermont's SIP-approved regulations VT APCR § 5-501, “Review of Construction or Modification of Air Contaminant Sources,” and VT APCR § 5-502, “Major Stationary Sources and Major Modifications,” establish requirements for permits to construct, modify or operate major air contaminant sources.
EPA proposes that Vermont has met the enforcement of SIP measures requirements of section 110(a)(2)(C) with respect to the 2012 PM
PSD applies to new major sources or modifications made to major sources for pollutants where the area in which the source is located is in attainment of, or unclassifiable with regard to, the relevant NAAQS. The EPA interprets the CAA to require each state to make an infrastructure SIP submission for a new or revised NAAQS demonstrating that the air agency has a complete PSD permitting program in place satisfying the current requirements for all regulated NSR pollutants. VT DEC's EPA-approved PSD rules, contained at VT APCR Subchapters I, IV, and V, contain provisions that address applicable requirements for all regulated NSR pollutants, including GHGs.
With respect to current requirements for PM
The second is a final rule issued October 20, 2010, entitled “Prevention of Significant Deterioration (PSD) for Particulate Matter Less Than 2.5 Micrometers (PM
On August 1, 2016 (81 FR 50342) and September 14, 2016 (81 FR 63102), EPA approved revisions to the Vermont SIP that address certain aspects of EPA's 2010 NSR rule. In addition, on March 19, 2018, EPA approved the state's method for determining the amount of PSD increments available to a new or modified major source.
On March 19, 2018 (83 FR 11884), EPA also approved revisions to Vermont's PSD program that addressed the PSD requirements of EPA's “Final Rule to Implement the 8- Hour Ozone National Ambient Air Quality Standard—Phase 2; Final Rule To Implement Certain Aspects of the 1990 Amendments Relating to New Source Review and Prevention of Significant Deterioration as They Apply in Carbon Monoxide, Particulate Matter, and Ozone NAAQS; Final Rule for Reformulated Gasoline,” which obligated states to revise their PSD programs to explicitly identify NO
With respect to GHGs, on June 23, 2014, the United States Supreme Court issued a decision addressing the application of PSD permitting requirements to GHG emissions.
In accordance with the Supreme Court decision, on April 10, 2015, the U.S. Court of Appeals for the District of Columbia Circuit (the D.C. Circuit) issued an amended judgment vacating the regulations that implemented Step 2 of the EPA's PSD and Title V Greenhouse Gas Tailoring Rule, but not the regulations that implement Step 1 of that rule. Step 1 of the Tailoring Rule covers sources that are required to obtain a PSD permit based on emissions of pollutants other than GHGs. Step 2 applied to sources that emitted only GHGs above the thresholds triggering the requirement to obtain a PSD permit. The amended judgment preserves, without the need for additional rulemaking by EPA, the application of the BACT requirement to GHG emissions from Step 1 or “anyway” sources. With respect to Step 2 sources, the D.C. Circuit's amended judgment vacated the regulations at issue in the litigation, including 40 CFR 51.166(b)(48)(v), “to the extent they require a stationary source to obtain a PSD permit if greenhouse gases are the only pollutant (i) that the source emits or has the potential to emit above the applicable major source thresholds, or (ii) for which there is a significant emission increase from a modification.”
On August 19, 2015 (80 FR 50199), EPA amended its PSD and Title V regulations to remove from the Code of Federal Regulations portions of those regulations that the D.C. Circuit specifically identified as vacated. EPA intends to further revise the PSD and Title V regulations to fully implement the Supreme Court and D.C. Circuit rulings in a separate rulemaking. This future rulemaking will include revisions to additional definitions in the PSD regulations.
Some states have begun to revise their existing SIP-approved PSD programs in light of these court decisions, and some states may prefer not to initiate this process until they have more information about the additional planned revisions to EPA's PSD regulations. EPA is not expecting states to have revised their PSD programs in anticipation of EPA's additional actions to revise its PSD program rules in response to the court decisions for purposes of infrastructure SIP submissions. At present, EPA has determined that Vermont's SIP is sufficient to satisfy element C with respect to GHGs because the PSD permitting program previously approved by EPA into the SIP continues to require that PSD permits (otherwise required based on emissions of pollutants other than GHGs) contain limitations on GHG emissions based on the application of BACT. Although the approved Vermont PSD permitting program may currently contain provisions that are no longer necessary in light of the Supreme Court decision, this does not render the infrastructure SIP submission inadequate to satisfy element C. The SIP contains the necessary PSD requirements at this time, and the application of those requirements is not impeded by the presence of other previously-approved provisions regarding the permitting of sources of GHGs that EPA does not consider necessary at this time in light of the Supreme Court decision. Accordingly, the Supreme Court decision does not affect EPA's proposed approval of Vermont's infrastructure SIP as to the requirements of element C.
For the purposes of the 2012 PM
The EPA is proposing to approve Vermont's infrastructure SIP for the 2012 PM
To address the pre-construction regulation of the modification and construction of minor stationary sources and minor modifications of major stationary sources, an infrastructure SIP submission should identify the existing EPA-approved SIP provisions and/or include new provisions that govern the minor source pre-construction program that regulate emissions of the relevant NAAQS pollutants. EPA approved revisions to Vermont's minor NSR program on August 1, 2016 (81 FR 50342). Vermont and EPA rely on the existing minor NSR program to ensure that new and modified sources not captured by the major NSR permitting programs, VT APCR § 5-502, do not interfere with attainment and maintenance of the 2012 PM
We are proposing to find that Vermont has met the requirement to have a SIP-approved minor new source review permit program as required under Section 110(a)(2)(C) for the 2012 PM
This section contains a comprehensive set of air quality management elements pertaining to the transport of air pollution with which states must comply. It covers the following five topics, categorized as sub-elements: Sub-element 1, Significant contribution to nonattainment, and interference with maintenance of a NAAQS; Sub-element 2, PSD; Sub-element 3, Visibility protection; Sub-element 4, Interstate pollution abatement; and Sub-element 5, International pollution abatement. Sub-elements 1 through 3 above are found under section 110(a)(2)(D)(i) of the Act, and these items are further categorized into the four prongs discussed below, two of which are found within sub-element 1. Sub-elements 4 and 5 are found under section 110(a)(2)(D)(ii) of the Act and include provisions insuring compliance with sections 115 and 126 of the Act relating to interstate and international pollution abatement.
Section 110(a)(2)(D)(i)(I) of the CAA requires a SIP to prohibit any emissions activity in the state that will contribute significantly to nonattainment or interfere with maintenance of the NAAQS in any downwind state. EPA commonly refers to these requirements as prong 1 (significant contribution to nonattainment) and prong 2 (interference with maintenance), or jointly as the “Good Neighbor” or “transport” provisions of the CAA. This rulemaking proposes action on the portion of Vermont's October 31, 2017 SIP submission that addresses the prong 1 and 2 requirements with respect to the 2012 PM
EPA has developed a consistent framework for addressing the prong 1 and 2 interstate-transport requirements with respect to the PM
EPA's analysis for CSAPR, conducted consistent with the four-step framework, included air-quality modeling that evaluated the impacts of 38 eastern states on identified receptors in the eastern United States. EPA indicated that, for step 2 of the framework, states with impacts on downwind receptors that are below the contribution threshold of 1% of the relevant NAAQS would not be considered to significantly contribute to nonattainment or interfere with maintenance of the relevant NAAQS, and would, therefore, not be included in CSAPR.
In addition, as noted above, on March 17, 2016, EPA released the 2016 memorandum to provide information to states as they develop SIPs addressing the Good Neighbor provision as it pertains to the 2012 PM
For all, but one, monitoring sites in the eastern United States, the modeling data provided in the 2016 memorandum showed that monitors were expected to both attain and maintain the 2012 PM
To develop the projected values presented in the memorandum, EPA used the results of nationwide photochemical air-quality modeling that it recently performed to support several rulemakings related to the ozone NAAQS. Base-year modeling was performed for 2011. Future-year modeling was performed for 2017 to support the proposed CSAPR Update for the 2008 Ozone NAAQS.
On October 31, 2017, VT DEC submitted an infrastructure SIP for the 2012 PM
EPA analyzed the state's October 2017 submittal to determine whether it fully addressed the prong 1 and 2 transport provisions with respect to the 2012 PM
As noted, the modeling discussed in EPA's 2016 memorandum identified one potential maintenance receptor for the 2012 PM
While developing the 2011 CSAPR rulemaking, EPA modeled the impacts of all 38 eastern states in its modeling domain on fine particulate matter concentrations at downwind receptors in other states in the 2012 analysis year in order to evaluate the contribution of upwind states on downwind states with respect to the 1997 and 2006 PM
This CSAPR modeling showed that Vermont had a very small impact (0.002 μg/m
In addition, the Liberty monitor is already close to attaining the 2012 PM
Specifically, previous CSAPR modeling showed that regional emissions from upwind states, particularly SO
In addition to regional emissions reductions and plant closures,
EPA modeling projections, the recent downward trend in local and upwind emissions reductions, the expected continued downward trend in emissions between 2017 and 2021, and the downward trend in monitored PM
As noted in the 2016 memorandum, several states have had recent data-quality issues identified as part of the PM
Information in Enclosure 5 of Vermont's October 2017 SIP submission (Vermont Good Neighbor SIP) corroborates EPA's proposed conclusion that Vermont's SIP meets its obligations under CAA section 110(a)(2)(D)(i)(I). This enclosure includes 2011-2015 design values for the 2012 PM
This technical analysis is supported by additional indications that air quality is improving and emissions are falling in Vermont. Specifically, certified annual PM
Second, Vermont's sources are well-controlled. Vermont's 2017 submission indicates that the state has many SIP-approved rules and programs that limit emissions of PM
It should also be noted that Vermont is not in the CSAPR program because EPA analyses show that the state does not emit ozone-season NO
For the reasons explained herein, EPA agrees with Vermont's conclusions and proposes to determine that Vermont will not significantly contribute to nonattainment or interfere with maintenance of the 2012 PM
To prevent significant deterioration of air quality, this sub-element requires SIPs to include provisions that prohibit any source or other type of emissions activity in one state from interfering with measures that are required in any other state's SIP under Part C of the CAA. As explained in the 2013 Guidance, a state may meet this requirement with respect to in-state sources and pollutants that are subject to PSD permitting through a comprehensive PSD permitting program that applies to all regulated NSR pollutants and that satisfies the requirements of EPA's PSD implementation rules. As discussed above under element C, Vermont has such a PSD permitting program. For in-state sources not subject to PSD, this requirement can be satisfied through a fully-approved nonattainment new source review (NNSR) program with respect to any previous NAAQS. EPA's latest approval of some revisions to Vermont's NNSR regulations was on August 1, 2016 (81 FR 50342). Therefore, we are proposing to approve this sub-element for the 2012 PM
With regard to applicable requirements for visibility protection of section 110(a)(2)(D)(i)(II), states are subject to visibility and regional-haze program requirements under part C of the CAA (which includes sections 169A and 169B). The 2009 Guidance, 2011 Guidance, and 2013 Guidance recommend that these requirements can be satisfied by an approved SIP addressing reasonably attributable visibility impairment, if required, or an approved SIP addressing regional haze. A fully approved regional haze SIP meeting the requirements of 40 CFR 51.308 will ensure that emissions from sources under an air agency's jurisdiction are not interfering with measures required to be included in other air agencies' plans to protect visibility. Vermont's Regional Haze SIP was approved by EPA on May 22, 2012 (77 FR 30212). Accordingly, EPA proposes that Vermont has met the
This sub-element requires that each SIP contain provisions requiring compliance with requirements of section 126 relating to interstate pollution abatement. Section 126(a) requires new or modified sources to notify neighboring states of potential impacts from the source. The statute does not specify the method by which the source should provide the notification. States with SIP-approved PSD programs must have a provision requiring such notification by new or modified sources.
On August 1, 2016 (81 FR 50342), EPA approved revisions to VT APCR § 5-501, which includes a provision that requires VT ANR to provide notice of a draft PSD permit to, among other entities, any state whose lands may be affected by emissions from the source. VT APCR § 5-501(7)(c). Vermont's public notice requirements are consistent with the Federal PSD program's public notice requirements for affected states under 40 CFR 51.166(q). Therefore, we propose to approve Vermont's compliance with the infrastructure SIP requirements of section 126(a) with respect to with respect to the 2012 PM
This sub-element also requires each SIP to contain provisions requiring compliance with the applicable requirements of section 115 relating to international pollution abatement. There are no final findings under section 115 of the CAA against Vermont with respect to the 2012 PM
Section 110(a)(2)(E)(i) requires each SIP to provide assurances that the state will have adequate personnel, funding, and legal authority under state law to carry out its SIP. In addition, section 110(a)(2)(E)(ii) requires each state to comply with the requirements under CAA section 128 about state boards. Finally, section 110(a)(2)(E)(iii) requires that, where a state relies upon local or regional governments or agencies for the implementation of its SIP provisions, the state retain responsibility for ensuring implementation of SIP obligations with respect to relevant NAAQS. Section 110(a)(2)(E)(iii), however, does not apply to this action because Vermont does not rely upon local or regional governments or agencies for the implementation of its SIP provisions.
Vermont, through its infrastructure SIP submittals, has documented that its air agency has the requisite authority and resources to carry out its SIP obligations. Vermont cites 10 V.S.A. § 553, which designates ANR as the air pollution control agency of the state, and 10 V.S.A § 554, which provides the Secretary of ANR with the power to “[a]dopt, amend and repeal rules, implementing the provisions” of 10 V.S.A. Chapter 23, Air Pollution Control, and to “[a]ppoint and employ personnel and consultants as may be necessary for the administration of” 10 V.S.A. Chapter 23. Section 554 also authorizes the Secretary of ANR to “[a]ccept, receive and administer grants or other funds or gifts from public and private agencies, including the federal government, for the purposes of carrying out any of the functions of” 10 V.S.A. Chapter 23. Additionally, 3 V.S.A. § 2822 provides the Secretary of ANR with the authority to assess air permit and registration fees, which fund state air programs. In addition to Federal funding and permit and registration fees, Vermont notes that the Vermont Air Quality and Climate Division (AQCD) receives state funding to implement its air programs.
EPA proposes that Vermont has met the infrastructure SIP requirements of this portion of section 110(a)(2)(E) with respect to the 2012 PM
Section 110(a)(2)(E)(ii) requires each SIP to contain provisions that comply with the state board requirements of section 128 of the CAA. That provision contains two explicit requirements: (1) That any board or body which approves permits or enforcement orders under this chapter shall have at least a majority of members who represent the public interest and do not derive any significant portion of their income from persons subject to permits and enforcement orders under this chapter, and (2) that any potential conflicts of interest by members of such board or body or the head of an executive agency with similar powers be adequately disclosed.
In Vermont, no board or body approves permits or enforcement orders; these are approved by the Secretary of Vermont ANR. Thus, with respect to this sub-element, Vermont is subject only to the requirements of paragraph (a)(2) of section 128 of the CAA (regarding conflicts of interest). On June 27, 2017, EPA approved Vermont's SIP revision addressing the conflict of interest requirements of section 128.
EPA proposes that Vermont has met the applicable infrastructure SIP requirements for this sub-element for the 2012 PM
States must establish a system to monitor emissions from stationary sources and submit periodic emissions reports. Each plan shall also require the installation, maintenance, and replacement of equipment, and the implementation of other necessary steps, by owners or operators of stationary sources to monitor emissions from such sources. The state plan shall also require periodic reports on the nature and amounts of emissions and emissions-related data from such sources, and correlation of such reports by each state agency with any emission limitations or standards. Lastly, the reports shall be available at reasonable times for public inspection.
Vermont's infrastructure submittal references existing state regulations previously approved by EPA that require sources to monitor emissions and submit reports. In particular, VT APCR § 5-405, Required Air Monitoring, (45 FR 10775, February 19, 1980), provides that ANR “may require the owner or operator of any air contaminant source to install, use and maintain such monitoring equipment and records, establish and maintain such records, and make such periodic
Vermont's infrastructure SIP submittal for the 2012 PM
Regarding the section 110(a)(2)(F) requirement that the SIP ensure that the public has availability to emission reports, Vermont certified in its October 31, 2017 submittal for the 2012 PM
Consequently, EPA proposes that Vermont has met the infrastructure SIP requirements of section 110(a)(2)(F) for the 2012 PM
This section requires that a plan provide for state authority analogous to that provided to the EPA Administrator in section 303 of the CAA, and adequate contingency plans to implement such authority. Section 303 of the CAA provides authority to the EPA Administrator to seek a court order to restrain any source from causing or contributing to emissions that present an “imminent and substantial endangerment to public health or welfare, or the environment.” Section 303 further authorizes the Administrator to issue “such orders as may be necessary to protect public health or welfare or the environment” in the event that “it is not practicable to assure prompt protection . . . by commencement of such civil action.”
On June 27, 2017, EPA approved a Vermont SIP revision addressing the requirement that the plan provide for state authority comparable to that in section 303 of the CAA.
Section 110(a)(2)(G) also requires that Vermont have an approved contingency plan for any Air Quality Control Region (AQCR) within the state that is classified as Priority I, IA, or II for certain pollutants.
In addition, as stated in Vermont's infrastructure SIP submittal under the discussion of public notification (Element J), Vermont posts near real-time air quality data, air quality predictions and a record of historical data on the VT DEC website and distributes air quality alerts by email to many parties, including the media. Alerts include information about the health implications of elevated pollutant levels and list actions to reduce emissions and to reduce the public's exposure. In addition, daily forecasted fine particle levels are also made available on the internet through the EPA AirNow and EnviroFlash systems. Information regarding these two systems is available on EPA's
EPA proposes that Vermont has met the applicable infrastructure SIP requirements for section 110(a)(2)(G) with respect to contingency plans for the 2012 PM
This section requires that a state's SIP provide for revision from time to time as may be necessary to take account of changes in the NAAQS or availability of improved methods for attaining the NAAQS and whenever the EPA finds that the SIP is substantially inadequate. To address this requirement, Vermont's infrastructure submittal references 10 V.S.A § 554, which provides the Secretary of Vermont ANR with the power to “[p]repare and develop a comprehensive plan or plans for the prevention, abatement and control of air pollution in this state” and to “[a]dopt, amend and repeal rules, implementing the provisions” of Vermont's air pollution control laws set forth in 10 V.S.A. chapter 23. EPA approved 10 V.S.A. § 554 on June 27, 2017 (82 FR 29005). EPA proposes that Vermont has met the infrastructure SIP requirements of CAA section 110(a)(2)(H) with respect to the 2012 PM
The CAA requires that each plan or plan revision for an area designated as a nonattainment area meet the applicable requirements of part D of the CAA. Part D relates to nonattainment areas. EPA has determined that section 110(a)(2)(I) is not applicable to the infrastructure SIP process. Instead, EPA takes action on part D attainment plans through separate processes.
Section 110(a)(2)(J) of the CAA requires that each SIP “meet the applicable requirements of section 121 of this title (relating to consultation), section 127 of this title (relating to public notification), and part C of this subchapter (relating to PSD of air quality and visibility protection).” The evaluation of the submission from Vermont with respect to these requirements is described below.
Pursuant to CAA section 121, a state must provide a satisfactory process for consultation with local governments and Federal Land Managers (FLMs) in carrying out its NAAQS implementation requirements.
Vermont's 10 V.S.A § 554 specifies that the Secretary of Vermont ANR shall have the power to “[a]dvise, consult, contract and cooperate with other agencies of the state, local governments, industries, other states, interstate or interlocal agencies, and the federal government, and with interested persons or groups.” EPA approved 10 V.S.A. § 554 on June 27, 2017 (82 FR 29005). In addition, VT APCR § 5-501(7)(c) requires VT ANR to provide notice to local governments and federal land managers of a determination by ANR to issue a draft PSD permit for a major stationary source or major modification. On August 1, 2016 (81 FR 50342), EPA approved VT APCR § 5-501(7)(c) into Vermont's SIP. Therefore, EPA proposes that Vermont has met the infrastructure SIP requirements of this portion of section 110(a)(2)(J) with respect to the 2012 PM
Pursuant to CAA section 127, states must notify the public if NAAQS are exceeded in an area, advise the public of health hazards associated with exceedances, and enhance public awareness of measures that can be taken to prevent exceedances and of ways in which the public can participate in regulatory and other efforts to improve air quality.
Vermont's 10 V.S.A § 554 authorizes the Secretary of Vermont ANR to “[c]ollect and disseminate information and conduct educational and training programs relating to air contamination and air pollution.” In addition, the VT DEC Air Quality and Climate Division website includes near real-time air quality data, and a record of historical data. Air quality forecasts are distributed daily via email to interested parties. Air quality alerts are sent by email to a large number of affected parties, including the media. Alerts include information about the health implications of elevated pollutant levels and list actions to reduce emissions and to reduce the public's exposure. Also, Air Quality Data Summaries of the year's air quality monitoring results are issued annually and posted on the VT DEC Air Quality and Climate Division website. Vermont is also an active partner in EPA's AirNow and EnviroFlash air quality alert programs.
EPA proposes that Vermont has met the infrastructure SIP requirements of this portion of section 110(a)(2)(J) with respect to the 2012 PM
EPA has already discussed Vermont's PSD program in the context of infrastructure SIPs in the paragraphs addressing section 110(a)(2)(C) and 110(a)(2)(D)(i)(II) and determined that it satisfies the requirements of EPA's PSD implementation rules. Therefore, the SIP also satisfies the PSD sub-element of section 110(a)(2)(J) for the 2012 PM
With regard to the applicable requirements for visibility protection, states are subject to visibility and regional haze program requirements under part C of the CAA (which includes sections 169A and 169B). In the event of the establishment of a new NAAQS, however, the visibility and regional haze program requirements under part C do not change. Thus, as noted in EPA's 2013 guidance, we find that there is no new visibility obligation “triggered” under section 110(a)(2)(J) when a new NAAQS becomes effective. In other words, the visibility protection requirements of section 110(a)(2)(J) are not germane to infrastructure SIPs for the 2012 PM
Based on the above analysis, EPA proposes that Vermont has met the infrastructure SIP requirements of section 110(a)(2)(J) with respect to the 2012 PM
Section 110(a)(2)(K) of the Act requires that a SIP provide for the performance of such air quality modeling as the EPA Administrator may prescribe for the purpose of predicting the effect on ambient air quality of any emissions of any air pollutant for which EPA has established a NAAQS, and the submission, upon request, of data related to such air quality modeling. EPA has published modeling guidelines at 40 CFR part 51, appendix W, for predicting the effects of emissions of criteria pollutants on ambient air quality. EPA also recommends in the 2013 Guidance that, to meet section 110(a)(2)(K), a state submit or reference the statutory or regulatory provisions that provide the air agency with the authority to conduct such air quality modeling and to provide such modeling data to EPA upon request.
In its submittal, Vermont cites to VT APCR § 5-406, Required Air Modeling,
The state also collaborates with the Ozone Transport Commission (OTC) and the Mid-Atlantic Regional Air Management Association and EPA in order to perform large-scale urban air shed modeling for ozone and PM, if necessary. EPA proposes that Vermont has met the infrastructure SIP requirements of section 110(a)(2)(K) with respect to the 2012 PM
This section requires SIPs to mandate that each major stationary source pay permitting fees to cover the costs of reviewing, approving, implementing, and enforcing a permit.
Vermont implements and operates a Title V permit program.
EPA proposes that Vermont has met the infrastructure SIP requirements of section 110(a)(2)(L) for the 2012 PM
To satisfy Element M, states must provide for consultation with, and participation by, local political subdivisions affected by the SIP. Vermont's infrastructure submittal references 10 V.S.A § 554, which was approved into the VT SIP on June 27, 2017 (82 FR 29005). This statute authorizes the Secretary of Vermont ANR to “[a]dvise, consult, contract and cooperate with other agencies of the state, local governments, industries, other states, interstate or interlocal agencies, and the federal government, and with interested persons or groups.” In addition, VT APCR § 5-501(7) provides for notification to local officials and agencies about the opportunity for participating in permitting determinations for the construction or modification of major sources. EPA proposes that Vermont has met the infrastructure SIP requirements of section 110(a)(2)(M) with respect to the 2012 PM
EPA is proposing to approve the elements of the infrastructure SIP submitted by Vermont on October 31, 2017 for the 2012 PM
EPA is soliciting public comments on the issues discussed in this proposal or on other relevant matters. These comments will be considered before EPA takes final action. Interested parties may participate in the Federal rulemaking procedure by submitting comments to this proposed rule by following the instructions listed in the
Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this proposed 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 proposed action:
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• 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 EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
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.
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve a State Implementation Plan (SIP) revision submitted by the State of Tennessee, through the Tennessee Department of Environment and Conservation (TDEC), to EPA on May 12, 2017, for attaining the 2010 1-hour sulfur dioxide (SO
Comments must be received on or before July 30, 2018.
Submit your comments, identified by Docket ID No. EPA-R04-OAR-2017-0626 at
D. Brad Akers, Air Regulatory Management Section, Air Planning and Implementation Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia 30303-8960. Mr. Akers can be reached via telephone at (404) 562-9089 or via electronic mail at
On June 22, 2010, EPA promulgated a new 1-hour primary SO
For the Sullivan County Area (and many other areas), EPA published a notice on March 18, 2016, that Tennessee (and other pertinent states) had failed to submit the required SO
To be approved by EPA, nonattainment areas must provide SIPs meeting the applicable requirements of the CAA, and specifically CAA sections 110(a), 172, 191 and 192 for SO
For EPA to fully approve a SIP as meeting the requirements of CAA sections 110, 172 and 191-192, and EPA's regulations at 40 CFR part 51, the SIP for the affected area needs to demonstrate to EPA's satisfaction that each of the aforementioned requirements have been met. Under CAA sections 110(l) and 193, EPA may not approve a SIP that would interfere with any applicable requirement concerning NAAQS attainment and RFP, or any other applicable requirement, and no requirement in effect (or required to be adopted by an order, settlement, agreement, or plan in effect before November 15, 1990) in any area which is a nonattainment area for any air pollutant, may be modified in any manner unless it insures equivalent or greater emission reductions of such air pollutant.
CAA sections 172(c)(1) and (6) direct states with areas designated as nonattainment to demonstrate that the submitted plan provides for attainment of the NAAQS. 40 CFR part 51, subpart G further delineates the control strategy requirements that SIPs must meet, and EPA has long required that all SIPs and control strategies reflect four fundamental principles of quantification, enforceability, replicability, and accountability. General Preamble, at 13567-68. SO
EPA's April 2014 SO
EPA's April 2014 SO
As specified in 40 CFR 50.17(b), the 1-hour primary SO
For SO
EPA recognizes that some sources have highly variable emissions, for example due to variations in fuel sulfur content and operating rate, that can make it extremely difficult, even with a well-designed control strategy, to ensure in practice that emissions for any given hour do not exceed the critical emission value. EPA also acknowledges the concern that longer term emission limits can allow short periods with emissions above the “critical emissions value,” which, if coincident with meteorological conditions conducive to high SO
Second, from a more theoretical perspective, EPA has compared the likely air quality with a source having maximum allowable emissions under an appropriately set longer term limit, as compared to the likely air quality with the source having maximum allowable emissions under the comparable 1-hour limit. In this comparison, in the 1-hour average limit scenario, the source is presumed at all times to emit at the critical emission level, and in the longer term average limit scenario the source is presumed to occasionally emit more than the critical emission value but on average, and presumably at most times, to emit well below the critical emission value. In an “average year,” compliance with the 1-hour limit is expected to result in three exceedance days (
As a hypothetical example to illustrate these points, suppose a source that always emits 1,000 pounds of SO
This simplified example illustrates the findings of a more complicated statistical analysis that EPA conducted using a range of scenarios using actual plant data. As described in Appendix B of EPA's April 2014 SO
The question then becomes whether this approach—which is likely to produce a lower number of overall exceedances even though it may produce some unexpected exceedances above the critical emission value—meets the requirements in sections 110(a)(1) and (2), 172(c)(1) and (6) for SIPs to contain enforceable emissions limitations and other control measures to “provide for attainment” of the NAAQS. For SO
The April 2014 SO
Preferred air quality models for use in regulatory applications are described in Appendix A of EPA's
As stated previously, attainment demonstrations for the 2010 1-hour primary SO
The meteorological data used in the analysis should generally be processed with the most recent version of AERMET. Estimated concentrations should include ambient background concentrations, should follow the form of the NAAQS, and should be calculated as described in section 2.6.1.2 of the August 23, 2010 clarification memo on “Applicability of appendix W Modeling Guidance for the 1-hr SO
The emissions inventory and source emission rate data for an area serve as the foundation for air quality modeling and other analyses that enable states to: (1) Estimate the degree to which different sources within a nonattainment area contribute to violations within the affected area; and (2) assess the expected improvement in air quality within the nonattainment area due to the adoption and implementation of control measures. As noted above, the State must develop and submit to EPA a comprehensive, accurate and current inventory of actual emissions from all sources of SO
The primary SO
• Powerhouse B-83 consists of Boilers 18-24, denoted B-18—B-24, which fire coal to provide steam for facility operations. Each of the seven emissions units has the following capacities: Boilers B-18—B-20 are rated at 246 million British thermal units per hour (MMBtu/hr); Boilers B-21—B-22 have a rated capacity of 249 MMBtu/hr; and Boilers B-23—B-24 have a rated capacity of 501 MMBtu/hr. All seven B-83 boilers have existing limits on SO
• Powerhouse B-253 consists of units B-25—B-29 which fire coal to provide steam for facility operations. Each emissions unit, B-25—B-29 has a rated capacity of 655 MMBtu/hr and an existing limit on SO
• Powerhouse B-325 consists of Boilers B-30 and B-31, which fire coal to provide steam for facility operations. Boiler B-30 has a rated capacity of 780 MMBtu/hr and an existing emission limit on SO
• The B-248 unit consists of three hazardous waste combustors, one liquid chemical waste incinerator and two rotary kilns that can burn solid or liquid chemical waste, B-248-2, Vent A, and B-248-1, Vents D and E, respectively. According to the attainment SIP submitted by TDEC in May 2017, each of these units is subject to an existing limit on SO
• Eastman has 31 other smaller emission units that provide various services to other parts of the facility, and these units account for 194.56 tpy of the allowable emissions across the facility. Actual emissions from the remaining units were 40.9 tpy in 2011. For more information on these miscellaneous units, see the May 12, 2017, submittal.
The emissions at units for Eastman were recorded either by using data collected from CEMS or by material balances based on feed rates and other parameters and are quality-assured by TDEC.
The next largest SO
The next largest SO
TDEC utilized EPA's 2011 National Emissions Inventory (NEI), Version 2 as the starting point for compiling point source emissions for the base year emissions inventory. The hazardous waste incinerators at Eastman in B-248 were erroneously reported as 20 tpy each for B-248-1 and B-248-2. TDEC corrected this information from the 2011 NEI with information submitted by Eastman.
TDEC also used the 2011 NEI, Version 2 to obtain estimates of the area and nonroad sources. For onroad mobile source emissions, TDEC utilized EPA's Motor Vehicle Emissions Simulator (MOVES2014). A more detailed discussion of the emissions inventory development for the Sullivan County Area can be found in Tennessee's May 12, 2017, submittal.
Table 1 below shows the level of emissions, expressed in tpy, in the Sullivan County Area for the 2011 base year by emissions source category. The point source category includes all sources within the nonattainment area.
Domtar is not included in the base year inventory for the Sullivan County Area because it is outside of the boundary of the nonattainment area. However, TDEC evaluated 2011 emissions from this facility to evaluate its impact on the area. Domtar's emissions were reported for the 2011 NEI, but TDEC determined that emissions from HFB1-1, the biomass boiler, were initially reported in error as 2.06 tons. Actual emissions were determined from fuel usage data supplied by Domtar, leading to 44.1 tpy SO
EPA has evaluated Tennessee's 2011 base year emissions inventory for the Sullivan County Area and has made the preliminary determination that this inventory was developed consistent with EPA's guidance. Therefore, pursuant to section 172(c)(3), EPA is proposing to approve Tennessee's 2011 base year emissions inventory for the Sullivan County Area.
The attainment demonstration also provides for a projected attainment year inventory that includes estimated emissions for all emission sources of SO
TDEC provided a future year projected emissions inventory for all known sources included in the 2011 base year inventory, discussed above, that were determined to impact the Sullivan County Area. The projected emissions are set to be accurate beyond October 1, 2018, when the control strategy for the attainment demonstration will be fully implemented. Therefore, as an annual future year inventory, the point source portion is accurate beyond October 1, 2018, and would represent an annual inventory for 2019 or beyond. The projected emissions in Table 2 are estimated actual emissions, representing a 67.6 percent reduction from the base year SO
Per EPA's April 2014 SO
Eastman operates a large manufacturing facility in Kingsport that includes major SO
These boilers, along with three other backup natural gas-fired boilers with minimal SO
Tennessee's attainment demonstration used AERMOD, the preferred model for this application, and the associated pre-processor modeling programs. The State used the 16216r version of AERMOD with regulatory default options and urban dispersion coefficients.
The Sullivan County nonattainment area is in a wide valley surrounded by complex terrain ridges. Eastman evaluated available surface meteorological data in the area and determined that none of nearby National Weather Surface (NWS) stations in area were representative of the site-specific winds that occur in the nonattainment area valley. Therefore, Eastman installed and operated a site-specific 100-meter meteorological data tower and Doppler SODAR system to collect profiles of meteorological data (wind speed, wind direction, temperature). One year of site-specific data was collected from April 1, 2012 through March 31, 2013.
The surface roughness (zo), albedo (r), and Bowen ratio (Bo) required surface parameters were determined for the area around the site-specific meteorological surface station using AERSURFACE version 13016. Eastman processed the meteorological data and surface parameters into AERMOD-ready files using AERMET version 16216 with the regulatory adjusted U* option. Complete details of the meteorological data collection and processing are available in sections 3.1-3.8 of Attachment G1, “NAAQS Attainment Demonstration Modeling Analysis,” in Tennessee's final SIP submittal. EPA preliminarily finds that the meteorological data collection and processing is appropriate for the modeled attainment demonstration.
The emission inputs to Tennessee's attainment demonstration modeling reflect 1-hour emissions that correspond to allowable emissions from sulfur dioxide emission units at the Eastman facility and other nearby emissions sources located within and outside the
Two additional SO
An important prerequisite for approval of an attainment plan is that the emission limits that provide for attainment be quantifiable, fully enforceable, replicable, and accountable.
Section 172(c)(6) provides that emission limits and other control measures in the attainment SIP shall be enforceable. Tennessee's attainment SIP for the Sullivan County nonattainment area relies on control measures and enforceable emission limits for Powerhouses B-253, B-83 and B-325 (for more discussion on these boilers, please refer to section IV.A above). These emission reduction measures were accounted for in the attainment modeling for the Eastman facility which demonstrates attainment for the 2010 NAAQS.
Tennessee's control strategy for B-253 relies on compliance with the State's Regional Haze SIP to install BART for SO
In conjunction with the natural gas conversion control strategy at B-253, Tennessee also established a 30-day combined SO
Tennessee's May 11, 2017, attainment SIP requests EPA approve into the SIP the authorization for alternative BART repowering of Boilers 25-29 at B-253 at Condition 4(f) of Regional Haze permit 066116H
Tennessee has developed a single, combined emission limit of 1,753 lbs/hr of SO
After establishment of this combined-source CEV, Tennessee used the procedures recommended in Appendix C of EPA's April 2014 SO
EPA's April 2014 SO
The historical emissions data do not provide a direct measure of the frequency and magnitude of elevated emissions to expect once Eastman complies with the 30-day limit. The historical Eastman emissions data that Tennessee used is from a period in which emissions frequently were higher than the new limit. During the 2013 to 2015 period, Eastman's total emissions exceeded the subsequently adopted limit (1,753 lbs/hr) in approximately 32.4 percent of 30-day averages, and exceeded the 1-hour CEV (1,905 lbs/hr) in approximately 21.5 percent of hours. Thus, Eastman will be required to make emission reductions sufficient to comply with the new 30-day limit (1,753 lb/hr), which would both eliminate the occasions of 30-day average emissions above 1,753 lbs/hr and reduce the number and possibly eliminate the occasions when 1-hour emission levels exceed 1,905 lbs/hr. The question then is how frequently and with what associated emission levels can 1-hour emissions levels be expected to exceed the CEV once Eastman complies with the 30-day average limit.
Since Tennessee has permitted a combined, multi-stack emission limit (1,753 lb/hr) for the nine coal-fired boilers, there are multiple compliance scenarios possible. Consequently, there is also a range of frequencies that the hourly emissions can exceed the CEV while still meeting the 30-day permit limit. To forecast the frequency and magnitude of emissions of occasions with emissions above the CEV, EPA asked Tennessee for information regarding how Eastman expects to comply with the new limit. Tennessee responded
Based on a review of the State's submittal, EPA believes that the single, combined 30-day average limit for the nine boilers in Powerhouses B-83 and B-325, in conjunction with the existing individual 30-day average limits for Boilers B-30 and B-31, provides a suitable alternative to establishing a 1-hour average emission limit for each unit or for the collected units at this source. Further discussion of Tennessee's modeling analysis of its set of limits, along with discussion of pertinent considerations in applying the procedures of Appendix C of EPA's guidance in determining appropriate longer term limits, is provided in section IV.B.6 below. In summary, EPA believes that the State has used a suitable data base in an appropriate manner and has thereby applied an appropriate adjustment, yielding an emission limit that has comparable stringency to the 1-hour average limit that the State determined would otherwise have been necessary to provide for attainment. While the 30-day average limit allows for occasions in which emissions may be higher than the level that would be allowed with the combined-unit 1-hour limit, the State's limit compensates by requiring average emissions to be lower than the level that would otherwise have been required by a 1-hour average limit. As described above in this section, in section III and explained in more detail in EPA's April 2014 SO
In accordance with section 8.3 of 40 CFR part 51, appendix W, Tennessee's attainment demonstration addresses the impacts from all SO
The use of a limit governing the sum of emissions from multiple stacks, in lieu of individual limits for each stack, calls for a demonstration that the worst-case distribution of these emissions provides for attainment. To provide this demonstration, Tennessee conducted thirty-four (34) AERMOD modeling runs using varying combinations of boiler load and emissions scenarios for the nine coal-fired boilers to verify that the modeling includes the worst-case operational scenarios allowed under the single, thirty-day rolling average, emissions limit of 1,753 lbs/hr for the nine coal-fired boilers. The 34 modeling scenarios were performed to derive the single, combined 1,905 lbs/hr CEV for the nine coal-fired boilers (two stacks at the B-83 Powerhouse and one stack at the B-325 Powerhouse) that results in modeled attainment of the NAAQS. As defined in EPA's April 2014 SO
With these 34 AERMOD modeling runs, Tennessee and Eastman evaluated a wide range of future potential operational scenarios, considering boiler steam load demands for Eastman's production processes and boiler load-shifting that is projected to occur once the conversion of the five coal-fired boilers at B-253 (Boilers 25-29) from burning coal to natural gas is completed by October 2018. Based upon this evaluation, 34 operational scenarios were selected by Tennessee and Eastman for the CEV modeling analysis. Four of these 34 operation scenarios reflected all of the SO
As noted earlier, in calculating the adjustment factor to multiply times the collective CEV (the 1-hour sum of emissions providing for attainment in the full range of distribution of the emissions) to determine a comparably stringent collective 30-day emission limit, Tennessee used statistics for the sum of emissions from all the stacks governed by this limit. EPA's guidance does not expressly recommend how to address comparable stringency for limits that address the sum of emissions across multiple stacks. However, EPA's guidance at page 32 states:
The selection of data handling procedures influences the longer term averages that are computed and thus influences the relationship between a 1-hour limit and a comparably stringent longer term average limit. Therefore, . . . all analyses for determining comparably stringent longer term average limits should then apply those data handling procedures.
The AERMOD modeling analysis contained in Tennessee's Attainment Demonstration submittal resulted in a maximum modeled design value of 195.37 µg/m
EPA has evaluated the modeling procedures, inputs and results and proposes to find that the results of the State's modeling analysis demonstrate that there are no modeled violations of the NAAQS within the nonattainment area when the combined emissions from the nine coal-fired boilers are no greater that the 1,905 lbs/hr CEV. Additionally, EPA proposes to find that the 34 modeling scenarios are adequate to address the range of possible future operating scenarios of the boilers at the Eastman facility and, therefore, support that the 1,905 lbs/hr combined CEV is appropriate. Section IV.B.4.ii. of this notice explains how Tennessee and Eastman developed the 1,753 lbs/hr 30-day rolling average permit limit following the procedures in EPA's April 2014 SO
CAA section 172(c)(1) requires that each attainment plan provide for the implementation of all RACM as expeditiously as practicable (including such reductions in emissions from existing sources in the area as may be obtained through the adoption, at a minimum, of RACT) and shall provide for attainment of the NAAQS. EPA interprets RACM, including RACT, under section 172, as measures that a state determines to be reasonably available and which contribute to attainment as expeditiously as practicable for existing sources in the area.
Tennessee's plan for attaining the 1-hour SO
Tennessee considered various other measures for the remaining B-83 and B-325 boilers. The State evaluated a range of measures to reduce SO
Tennessee has determined that repowering B-253 to natural gas constitutes RACT and EPA proposes to concur with the state's RACT analysis. Based on the attainment modeling, described herein, for the B-253 control measures combined with the 30-day SO
Tennessee's SIP-approved NSR rules for nonattainment areas (NNSR) are at TAPCR 1200-03-09-.01(5), last approved by EPA on July 30, 2012.
The CAA section 172(c)(2) requires the SIP provide reasonable further progress towards attainment of the applicable NAAQS. Regarding part D nonattainment plans, section 171(1) of the CAA defines RFP as the annual incremental reduction in emissions of the relevant pollutant as are required for the purpose of ensuring attainment of the applicable NAAQS by the applicable date. As discussed above, Tennessee's 2008 regional haze SIP required Eastman implement BART at B-253 (Boilers 25-29). The State revised its SIP to establish an alternative BART option to repower/convert all five coal-fired boilers at B-253 to natural gas units and changed the compliance deadline to the 1-hour SO
Based
Tennessee's May 2017 attainment SIP also provides estimated incremental emission reductions during the conversion of all five boilers at B-253. Table 6-2 in TDEC's submittal
The control measures for attainment of the 2010 SO
As noted above, EPA guidance describes special features of SO
Specifically, upon notification by Tennessee that a reference monitor for the Area has registered four validated ambient SO
To verify that the 30-day limit is resulting in continued attainment of the 1-hour SO
EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is proposing to incorporate by reference into Tennessee's SIP a natural gas fuel restriction, a new SO
EPA is proposing to approve Tennessee's SO
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations.
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866;
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
The SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.
Environmental protection, Air pollution control, Incorporation by Reference, Intergovernmental relations, Reporting and recordkeeping requirements, Sulfur oxides.
42 U.S.C. 7401
Environmental Protection Agency (EPA).
Proposed rule.
Pursuant to the Clean Air Act (CAA or Act), the Environmental Protection Agency (EPA) is proposing to approve portions of the Arkansas State Implementation Plan (SIP) submittal addressing the CAA requirement that SIPs address the potential for interstate transport of air pollution to significantly contribute to nonattainment or interfere with maintenance of the 2012 fine particulate matter (PM
Written comments must be received on or before July 30, 2018.
Submit your comments, identified by Docket Number EPA-R06-OAR-2017-0435, at
Sherry Fuerst, 214-665-6454,
Throughout this document wherever “we,” “us,” or “our” is used, we mean the EPA.
Under Section 109 of the CAA, we establish NAAQS to protect human health and public welfare. In 2012, we established a new annual NAAQS for PM
The EPA has addressed the interstate transport requirements of CAA section 110(a)(2)(D)(i)(I) with respect to PM
On March 24, 2017, Arkansas submitted a SIP revision to address the requirements of CAA section 110(a)(2)(D)(i)(I) for the 2012 PM
We previously approved the portions of Arkansas's 2006 PM
Included in the March 24, 2017 submission were updates to Regulation 19, Chapter 2 and Appendix B (Regulations of the Arkansas Plan of Implementation for Air Pollution Control) of the Arkansas Code Annotated § 8-4-201. We are proposing to approve the revised definition of “National Ambient Air Quality Standards” in Chapter 2 that changes the effective date to January 15, 2013. We also are proposing to approve the changes in Appendix B under “Particle Pollution, PM
As stated above, Section 110(a)(2)(D)(i) requires SIPs to include adequate provisions prohibiting any source or other type of emissions activity in one state that will (I) contribute significantly to nonattainment, or interfere with maintenance of the NAAQS in another state, and (II) interfere with measures required to prevent significant deterioration of air quality, or to protect visibility in another state. This action addresses only CAA Section 110(a)(2)(D)(i)(I).
EPA issued the 2016 memo about the steps states should follow and we will be following the framework outlined in the memo for our evaluation. The 2016 EPA memo outlined the four-step framework EPA has historically used to evaluate interstate transport under section 110(a)(2)(D)(i)(I), including the EPA's CSAPR.
(1) Identification of potential downwind nonattainment and maintenance receptors;
(2) Identification of upwind states contributing to downwind nonattainment and maintenance receptors;
(3) For states identified as contributing to downwind air quality problem, identification of upwind emissions reductions necessary to prevent upwind states from significantly contributing to nonattainment or interfering with maintenance of receptors, and;
(4) For states that are found to have emissions that significantly contribute to non-attainment or interfere with maintenance downwind, reducing the
Based on this approach, the potential receptors are outlined in Table 1 in the memo. Most of the potential receptors are in California, located in the San Joaquin Valley or South Coast nonattainment areas. However, there is also one potential receptor in Shoshone County, Idaho, and one potential receptor in Allegheny County, Pennsylvania.
The 2016 memo did note that because of data quality problems nonattainment and maintenance projections were not done for all or portions of Florida, Illinois, Idaho, Tennessee and Kentucky. After issuance of the memo, data quality problems were resolved for Idaho, Tennessee, Kentucky and most of Florida, identifying no additional potential receptors, with those areas having design values (DV) below the 2012 PM
For “Step 1” of this evaluation, the areas identified as “potential downwind nonattainment and maintenance receptors” are:
• Seventeen potential receptors in California, located in the San Joaquin Valley or South Coast nonattainment areas;
• Shoshone County, Idaho;
• Allegheny County, Pennsylvania;
• All of Illinois
As stated above, “Step 2” is the identification of states contributing to downwind nonattainment and maintenance receptors, such that further analysis is required to identify necessary upwind reductions. For this step, we will be specifically determining if Arkansas emissions contribute to downwind nonattainment and maintenance receptors.
Each of the potential receptors is discussed below, with a more in-depth discussion provided in the TSD for this action. For additional information, links to the documents relied upon for this analysis can be found throughout the document, more information is available in the TSD and the documents can be found in the docket for this action.
As described in our TSD, our analysis shows that Arkansas's PM
For these reasons, we propose to find that Arkansas does not significantly contribute to nonattainment, nor will it interfere with maintenance of the 2012 PM
As discussed in the TSD, our analysis shows that Arkansas's PM
For these reasons, we propose to find that Arkansas does not significantly contribute to nonattainment, nor will it interfere with maintenance of the 2012 PM
As discussed in the TSD, our analysis shows that Arkansas's PM
Another compelling fact is that in previous modeling, nonattainment in Allegheny County, Pennsylvania was linked to significant contributions from other states.
For these reasons, we propose to find that Arkansas does not significantly contribute to nonattainment, nor will it interfere with maintenance of the 2012 PM
Due to ambient monitoring data gaps in the 2009-2013 data that would have been used to identify potential PM
Arkansas was included in the CSAPR modeling analysis for the 1997 PM
As further evidence, recent 3-year averages for the monitors in Madison, Illinois have shown downward trends. There are three active monitors in Madison. The 3-year averages for the monitors are shown in Table 1 below. Because of data gaps, the data cannot be used to establish a valid design value but can be used to show a downward trend. Also, as noted in the TSD for this action, Illinois has been collecting valid data for 2015 and 2016. This data, while not a complete three-year period indicates that air quality in Illinois is meeting the 2012 p.m. 2.5 NAAQS.
For these reasons, we propose that Arkansas will not significantly contribute to nonattainment, nor will it interfere with maintenance of the 2012 PM
Since we determined that Arkansas's SIP includes provisions prohibiting any source or other type of emissions activity from contributing significantly to nonattainment in, or interfering with maintenance of the NAAQS, in another state, steps 3 and 4 of this evaluation are not necessary.
In conclusion, based on our review of the potential receptors presented in the March 17, 2016 informational memo, an evaluation identifying likely emission sources affecting these potential receptors, and the 2014 base case modeling in CSAPR final rule, we propose to determine that emissions from Arkansas sources will not contribute significantly to nonattainment in, nor interfere with maintenance by, any other state with regard to the 2012 annual PM
The ADEQ submitted a collection of revisions to the Arkansas SIP on March 24, 2017. Included in these revisions is an update to the Arkansas SIP definition for the National Ambient Air Quality Standards. The definition in Chapter 2 of Regulation 19 updates the incorporation by reference date included in 40 CFR part 50 from July 27, 2012 to January 15, 2013. The changes in the revised Appendix B to Regulation 19 titled the “National Ambient Air Quality Standards List” reflect the definition update and applies it to all Chapters of Regulation 19.
We have determined that the revisions submitted on March 24, 2017, were developed in accordance with the CAA and EPA's regulations. Therefore, under section 110 of the Act, the EPA proposes approval of the following revisions to the Arkansas SIP:
• The portion of the Arkansas SIP submittal, pertaining to interstate transport of air pollution demonstrating emissions from Arkansas will not significantly contribute to nonattainment or interfere with maintenance of the 2012 PM
• The portion of the Arkansas SIP submittal where the definition of National Ambient Air Quality Standards in Regulation 19, Chapter 2 is revised to be the effective date of January 15, 2013 and Appendix B to Regulation 19, “National Ambient Air Quality Standards List” at “Particle Pollution, PM
In this action, we are proposing to include in a final rule regulatory text that includes incorporation by reference. In accordance with the requirements of 1 CFR 51.5, we are proposing to incorporate by reference revisions to the Arkansas regulations as described in the Proposed Action section above. We have made, and will continue to make, these documents generally available electronically through
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely proposes to approve state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866;
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the proposed rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
Environmental protection, Air pollution control, Incorporation by reference, Particulate matter.
42 U.S.C. 7401
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) proposes to approve state implementation plan (SIP) revisions submitted by the Idaho Department of Environmental Quality (IDEQ) on March 20, 2018 and April 12, 2018. The submitted revisions update incorporation by reference (IBR) of Federal regulations in the Idaho's rules. The revisions also remove an interim regulation that expired in 2003.
Comments must be received on or before July 30, 2018.
Submit your comments, identified by Docket ID No. EPA-R10-OAR-2018-0214, at
Randall Ruddick at (206) 553-1999, or
Throughout this document, wherever “we,” “us,” or “our” is used, it is intended to refer to EPA.
Section 110 of the Clean Air Act (CAA) specifies the general requirements for states to submit SIPs to attain and maintain the National Ambient Air Quality Standards (NAAQS) and the EPA's actions regarding approval of those SIPs. Idaho incorporates by reference (IBR) various portions of Federal regulations codified in the Code of Federal Regulations (CFR) into the Rules for the Control of Air Pollution in Idaho (IDAPA 58.01.01). Idaho then submits parts of IDAPA 58.01.01 to the EPA for approval into the Federally-approved Idaho SIP (generally those provisions that relate to the criteria pollutants regulated under section 110 of the CAA for which the EPA has promulgated NAAQS or other specific requirements of section 110).
To ensure that its rules remain consistent with the EPA requirements, Idaho generally updates the IBR citations in IDAPA 58.01.01 on an annual basis and submits a SIP revision to reflect any changes made to the Federal regulations during that year. Idaho's current SIP includes the approved incorporation by reference of specific Federal regulations, revised as of July 1, 2015, at IDAPA 58.01.01.107 “Incorporation by Reference.” On March 20, 2018, the State of Idaho submitted SIP revisions to the EPA to account for more recent Federal regulatory changes adopted by Idaho.
Additionally, on April 12, 2018, Idaho submitted a separate SIP revision to remove an expired interim transportation conformity provision. Transportation conformity is required under section 176(c) of the CAA to ensure Federally supported highway, transit projects, and other activities are consistent with (“conform to”) the purpose of the SIP.
Idaho submitted several state dockets (rulemakings) for approval to the EPA. We note that the dockets also include revisions to Idaho's regulations relating to its Title V operating permits, hazardous air pollutants (referred to as “toxic air pollutants” in Idaho regulations), and other air requirements that do not implement section 110 of the CAA. Idaho submitted these regulations for informational purposes only, in order to provide a complete record of each docket. In the cover letter to the March 20, 2018, submittal, Idaho specifically stated that the identified provisions (IDAPA 58.01.01.107.03.f-n) were not being submitted to update Idaho's SIP. We provide our analysis of the revisions below.
Docket 58-0101-1603 “2016 Federal Rule IBR” revises IDAPA 58.01.01.107.03 “Documents Incorporated by Reference” to update the citation dates for specific provisions incorporated by reference into the Idaho SIP as of July 1, 2016. Although Idaho requested approval of this docket, it has
Docket 58-0101-1702 “2017 Federal Rule IBR Update” revises IDAPA 58.01.01.107 “Incorporations by Reference” to update the citation dates for specific provisions incorporated by reference in IDAPA 58.01.01.107.03 “Documents Incorporated by Reference” as of July 1, 2017. Subparagraph (a) of IDAPA 58.01.01.107.03 incorporates by reference the Requirements for Preparation, Adoption, and Submittal of Implementation Plans, 40 CFR part 51, with the exception of certain visibility-related provisions, revised as of July 1, 2017. Importantly, Idaho's update to the incorporation by reference of 40 CFR part 51 includes nonattainment new source review (NNSR) requirements at 40 CFR 51.165.
Idaho has two designated PM
As a result, Idaho's NNSR program now regulates the four precursors to PM
Subparagraph (b) of IDAPA 58.01.01.107.03 incorporates by reference the National Primary and Secondary Ambient Air Quality Standards, 40 CFR part 50. The current Idaho SIP approved version of subparagraph (b) includes NAAQS revised as of July 1, 2015. On October 1, 2015, EPA signed a notice of final rulemaking revising the 8-hour primary and secondary ozone NAAQS (80 FR 65292; October 26, 2015). While both standards retain the same general form and averaging time (annual fourth-highest daily maximum 8-hour average concentration, averaged over three years
Subparagraph (c) of IDAPA 58.01.01.107.03 incorporates the Approval and Promulgation of Implementation Plans, 40 CFR part 52, subparts A and N, and appendices D and E. This includes the Federal Prevention of Significant Deterioration (PSD) permitting rules at 40 CFR 52.21 and 52.22 as of July 15, 2017. The current Idaho SIP approved version of subparagraph (c) incorporates these Federal rules as effective July 1, 2015.
Since July 1, 2015, EPA promulgated revisions to 40 CFR 52.21 and repealed 52.22 in response to a court remand and vacatur. Specifically, on June 23, 2014, the United States Supreme Court, in Utility Air Regulatory Group (UARG) v. EPA, issued a decision addressing the application of PSD permitting to greenhouse gas (GHG) emissions. The Supreme Court said EPA may not treat GHGs as air pollutants for purposes of determining whether a source is a major source (or modification thereof) required to obtain a PSD permit. The Court also said EPA could continue to require that PSD permits, otherwise required based on emissions of pollutants other than GHGs, contain limits on GHG emissions based on the application of Best Available Control Technology (BACT). In response to the UARG decision, and the subsequent Amended Judgment issued by the D.C. Circuit (Amended Judgment), EPA revised the Federal PSD rules to allow for the rescission of PSD permits that are no longer required under these decisions, 80 FR 26183 (May 7, 2015), and to remove the regulatory provisions that were specifically vacated by the Amended Judgment, 80 FR 50199 (August 19, 2015). In addition, EPA has proposed to revise provisions in the PSD permitting regulations applicable to GHGs to fully conform with UARG and the Amended Judgment, but those revisions have not been finalized. 81 FR 68110 (Oct. 3, 2016).
Idaho's incorporation by reference of 40 CFR 52.21 and 52.22 as of July 1, 2015, included the May 7, 2015 revisions to 40 CFR 52.21(w), providing a mechanism for Idaho to rescind PSD permits that are no longer required in light of UARG and the Amended Judgment, but did not include the August 19, 2015 revisions to the Federal PSD program removing the PSD provisions vacated by the Amended Judgment. Idaho's March 20, 2018 SIP submittal updates the IBR citation date to July 1, 2017 and thereby encompasses the August 19, 2015 revisions to the Federal PSD program. The Idaho SIP will still contain some of the vacated GHG provisions (EPA has not finalized the actions proposed in 81 FR 68110), so EPA's approval of the Idaho's CFR incorporation by reference update to July 1, 2017 does not change the Idaho SIP with respect to the remaining vacated provisions. However, the remaining vacated portions of 40 CFR 52.21 incorporated into the Idaho SIP-approved PSD program are no longer enforceable.
EPA believes this portion of the Idaho SIP should be revised in light of the D.C. Circuit's Amended Judgment, but EPA also notes that these provisions may not be implemented even prior to their removal from the Idaho SIP because the court decisions described above have determined these parts of EPA's regulations are unlawful. Further, Idaho has advised EPA that it is not currently enforcing these provisions in light of the Supreme Court decision. See 82 FR 22083, May 12, 2017. We are therefore proposing to approve subparagraph (c) with the understanding that the GHG provisions vacated by the court decisions cannot be implemented and are not being enforced by Idaho.
Subparagraphs (d) and (e) of IDAPA 58.01.01.107.03 incorporate by reference the following provisions revised as of July 1, 2017: (d) Ambient Air Monitoring Reference and Equivalent Methods, 40 CFR part 53; and (e) Ambient Air Quality Surveillance, 40 CFR part 58. These provisions relate to the criteria pollutants regulated under section 110 of title I of the CAA or other specific requirements of section 110 and make the Idaho SIP consistent with Federal law. The EPA is proposing to approve the revisions to IDAPA 58.01.01.107.03 (d) and (e).
Idaho submitted Docket 58-0101-1602 that repealed IDAPA 58.01.01.582 “Interim Conformity Provisions for Northern Ada County Former Nonattainment Area for PM-10” (section 582) because it was outdated and no longer applicable. Section 582 was promulgated in 2001 as a temporary measure that was necessary only until a required maintenance plan could be developed to address CAA transportation conformity requirements for the PM
EPA is proposing to approve, and incorporate by reference where appropriate, in Idaho's SIP all revisions to IDAPA 58.01.01.107
EPA is also proposing, as requested by Idaho on April 12, 2018, to remove IDAPA 58.01.01.582
We have made the preliminary determination that the submitted SIP revisions are consistent with section 110 and part C of Title I of the CAA.
In this rule, EPA is proposing to include in a final rule, regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is proposing to incorporate by reference the provisions described above in Section III. Also in this rule, EPA is proposing to remove, in a final EPA rule, regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is proposing to remove the incorporation by reference of IDAPA 58.01.01.582 as described in Section III. EPA has made, and will continue to make, these documents generally available electronically through
Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this proposed action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this proposed action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866;
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because it does not involve technical standards; and
• Does not provide the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
The proposed SIP would not be approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the proposed rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
42 U.S.C. 7401
Federal Communications Commission.
Proposed rule.
In this document, the Commission proposed to adopt rules to curb the financial incentive to engage in access stimulation by giving access-stimulating LECs two choices for receiving calls. The access-stimulating LEC can choose either: To be financially responsible for the delivery of calls to its network, in which case intermediate access providers would charge the access-stimulating LEC for the delivery of calls; or to accept direct connections from long distance carriers seeking to terminate telephone calls to the LEC or from intermediate access providers of the long distance carriers' choosing, which would allow the long distance carriers to bypass intermediate access providers chosen by the access-stimulating LEC. This document seeks comment on several alternatives, including requiring LECs engaged in access stimulation to immediately transition their terminating access
Comments are due on or before July 20, 2018; reply comments are due on or before August 3, 2018.
You may submit comments, identified by WC Docket No. 18-155, by any of the following methods:
•
•
For detailed instructions for submitting comments and additional information on the rulemaking process, see the
Edward Krachmer, FCC Wireline Competition Bureau, Pricing Policy Division at 202-418-1525, or at
This is a summary of the Commission's Notice of Proposed Rulemaking (NPRM), WC Docket No. 18-155; FCC 18-68, adopted on June 4, 2018 and released on June 5, 2018. The full text of this document may be obtained at the following internet address:
1. To reduce access stimulation, as part of the
2. A LEC that is engaged in access stimulation is required by our rules to reduce its access charges either by adjusting its rates to account for its high traffic volumes (if a rate-of-return LEC) or to reduce its access charges to those of the price cap LEC with the lowest switched access rates in the state (if a competitive LEC). These reduced rates lower the cost to interexchange carriers (IXCs) and the amount received by the LEC and the provider of high call volume services with which it has a revenue sharing agreement.
3. Last year, the Wireline Competition Bureau (Bureau) issued a public notification, 82 FR 44754, seeking to refresh the record on ICC issues raised by the Commission in the
4. Recent complaint activity suggests that much of the post-
5. We propose solutions to the persistent, costly, and inefficient access stimulation arbitrage scheme described here and seek comment on how to prevent other types of arbitrage. We are mindful of the fact that practices adjust to regulatory change; therefore we invite comment on how to avoid introducing incentives for new types of arbitrage to arise.
6. To rid the ICC system of the inefficiencies caused by access stimulation relating to intermediate access providers, we propose to require access-stimulating LECs to choose either to: (i) Bear the financial responsibility for the delivery of terminating traffic to their end office, or functional equivalent, or; (ii) accept direct connections from either the IXC or an intermediate access provider of the IXC's choice.
7.
8. What implementation issues does this part of our proposal raise? What steps would intermediate access providers need to take to bill access-stimulating LECs for terminating access
9. For purposes of this proposal, we propose to define “intermediate access provider” as “any entity that carries or processes traffic at any point between the final interexchange carrier in a call path and the carrier providing end office access service.” We seek comment on the use of this definition in this context. Does it adequately capture the types of intermediate access providers currently benefiting from access stimulation schemes? Is it too narrow or too broad?
10.
11. For direct connections between an IXC (or an intermediate access provider of the IXC's choosing) and an access-stimulating LEC to be established, not only must the access-stimulating LEC be willing and able to accept direct connections, but arrangements need to be made between the IXCs seeking to avail themselves of such connections and the LEC. If we adopt the approach we propose today, how long should we give existing access-stimulating LECs to indicate their willingness to accept direct connections and how long should we give them to implement those direct connections? How detailed a timeline should we adopt for this process? Should we adopt rules regarding the
12. We propose to adopt a rule that makes clear that allowing access-stimulating LECs to accept direct connection as a means of not bearing financial responsibility for intermediate access provider charges does not carry with it an obligation for such LECs to extend their networks absent a request and an independent obligation to do so. Is this a reasonable limitation? Are there any other limitations or exceptions we should apply? Are there other rules we should adopt to help providers implement the option to accept direct connections if a provider makes that choice? For example, because IXCs are not currently directly connected to access-stimulating LECs in the scenario to which our proposal applies, a third-party vendor may need to connect the two networks via dedicated transport such as, perhaps, the current intermediate access provider. Are there any rules that we should adopt to facilitate such arrangements?
13. One result of permitting access-stimulating LECs that subtend CEA providers to connect with IXCs directly (or an intermediate access provider of an IXC's choice) would be to end the “mandatory use” policy applicable to some CEA providers, at least with respect to access-stimulating LECs. Historically, this mandatory use policy has permitted the CEA providers in Iowa and South Dakota to require IXCs to connect to LECs that subtend the CEA provider indirectly through the CEA provider's tandem switch rather than indirectly through another intermediate access provider or directly to the subtending LEC. In initially permitting this practice almost thirty years ago, the Commission concluded that it “[did] not believe that the mandatory termination requirement for interstate traffic is unreasonable or differs substantially from the normal way access is provided, as both an originating and terminating service by the local exchange company.”
14. It appears that access stimulation, particularly when practiced by competitive LECs, which were formed well after CEA providers were established, presents a reasonable circumstance for departing from the policy of permitting mandatory use requirements because delivery of such traffic, particularly in the pertinent volumes, was not the purpose for which CEA providers were formed. We seek comment on this assumption, and on the impact of this proposal on CEA providers, on the LECs that subtend CEA providers, and on the customers of such subtending LECs. For example, to the extent that creating the opportunity for access-stimulation traffic to bypass CEA providers threatens the viability of CEA providers, we seek comment on whether and how this potential effect should be addressed. Are there other companies that can perform the traditional functions of CEA providers, including equal access implementation and traffic measurement and billing? Recognizing that most states do not have CEA providers, are there ways that equal access and traffic identification and measurement are handled by small LECs in those states that can inform our decision making in this proceeding?
15.
16.
17. How will our proposal affect incentives for carriers to migrate their services to IP? To what extent do parties expect that direct connections would be provided in time division multiplexed (TDM) format rather than IP? Are there circumstances under which an access-stimulating LEC should be required, upon request, to interconnect using IP rather than TDM and bear any costs necessary to do so? Are calls bound for high call volume service providers ultimately converted to IP for delivery? Would requiring IP interconnection obviate the need to convert TDM traffic to IP for delivery?
18.
19. Although the NTCA et al. proposal does not preclude an access-stimulating LEC from avoiding incurring intermediate access provider charges by beginning to accept direct connections, it also does not provide IXCs any incentive to accept offers of direct connection from such LECs. By permitting access-stimulating LECs to elect to accept direct connections, our proposal seeks to provide a formal means by which access-stimulating LECs may eventually avoid incurring intermediate access provider charges. We seek comment on the NTCA et al. proposal both as an independent proposal and also as it relates to our proposal above.
20.
21. If we do not adopt rules requiring access-stimulating LECs to either choose to accept financial responsibility for the delivery of calls or to accept direct connections, should we reduce all terminating tandem switching, common transport, and tandem-switched transport rate elements for access stimulators to bill-and-keep? Moving these access charges to bill-and-keep would be consistent with our overarching goals of discouraging arbitrage, in particular access stimulation, and ultimately transitioning all traffic to bill-and-keep. It would also be consistent with the Commission's finding in the
22. We also seek comment on whether to require an access-stimulating LEC to transition its dedicated transport and originating rates to bill-and-keep. The only potential access arbitrage scheme of which we are aware regarding originating access concerns 8YY traffic, which we leave for separate consideration. Outside the 8YY context, are there arbitrage schemes involving originating access about which we should be concerned? Can they be addressed by a transition to bill-and-keep or by other proposals in this NPRM?
23. Given evidence that access stimulation schemes are still being perpetrated notwithstanding our existing rules, we seek comment on whether, and if so how, to revise the current definition of access stimulation to more accurately and effectively target harmful access stimulation practices. What has been the impact of the current definition over the last seven years? Has it proved effective at identifying actors that are distorting the ICC system for their own gain? If not, how can we revise the definition to more accurately identify these types of harmful practices? Should we, for example, modify the ratios or triggers in the definition? If so, how should those ratios or triggers be modified? Should we adopt triggers that relate to the stimulation of tandem and transport services? If so, what should those triggers be? Is the current revenue sharing agreement requirement in our rules sufficiently broad or should it be revised, and if so how? Or, should we remove the revenue sharing portion of the definition, because access stimulation seems to be occurring in some instances even in the absence of revenue sharing? Do commenters believe that revenue sharing alone is an indication of access stimulation? If so, should we revise our rules so that the existence of a revenue sharing agreement triggers the access stimulation rule? How will we know if parties are engaged in revenue sharing? Should we require these parties to self-report? If so, we seek comment on how to implement a self-reporting requirement.
24. Alternatively, based on parties' experience with our existing access stimulation rules, is there reason to find that access stimulation itself is unjust and unreasonable because of the imposition of excess charges on IXCs, wireless carriers, and their customers? Or, is there a subset of such activities that we should separately identify as unlawful?
25. To address specific concerns identified in the record, commenters should also consider the extent to which the access stimulation definition should be revised to address intermediate access providers. Do intermediate access providers that are not engaged in access stimulation as defined in our current rules nevertheless benefit from access stimulation schemes? To remove incentives for intermediate access providers to enable access arbitrage schemes, aside from the proposals discussed above, should we adopt new access stimulation rules, or modify our existing rules, to apply specifically to intermediate access providers? Would doing so be unduly burdensome to intermediate access providers or small LECs who subtend them? Are there technical obstacles that would make it infeasible for intermediate access providers to comply with the Commission's current, or any modified, access stimulation rules? Would a requirement that access-stimulating subtending LECs notify the intermediate access provider that they are engaged in access stimulation and identify the traffic that is being stimulated provide a practical solution?
26. The record indicates the existence of at least three other types of arbitrage schemes. We seek comment on the prevalence and impact of these types of schemes described in more detail below. Will any of the rules we propose today help retard these schemes? Are there other rules we should adopt to prevent these schemes?
27. First, parties describe an access arbitrage scheme involving a revenue sharing or other type of agreement between an intermediate access provider and a terminating carrier that may not meet the definition of access stimulation under our rules, such as a Commercial Mobile Radio Service (CMRS) carrier. CMRS carriers are prohibited from tariffing access charges. However, intermediate access providers that transport traffic from an IXC to CMRS carriers can charge for access services through filed tariffs or negotiated agreements. Some IXCs claim that certain CMRS carriers that previously offered direct connections between their networks and the IXCs' networks have begun to use intermediate access providers to terminate their traffic from IXCs, to reap the benefit of alleged revenue sharing
28. Second, because LECs and intermediate access providers receive greater compensation from IXCs the further the LEC or intermediate access provider carries the traffic to reach a POI with the IXC, some commenters allege that LECs have changed their POI with IXCs for the sole purpose of artificially inflating their per-MOU, per-mile transport rates and revenue. This scheme is often referred to as mileage pumping. Shortly after the
29. Third, some commenters raise concerns about the addition of superfluous network facilities for which the LEC can bill switched access charges, but the rates for which are not subject to the current transition to bill-and-keep. This practice is sometimes referred to as “daisy chaining.” This practice may inefficiently inflate per-mile charges and insert unnecessary facilities to justify assessment of additional rate elements, such as remote switches that subtend end offices. What actions can we take to prevent daisy chaining?
30. Would the CenturyLink suggestion of shifting financial responsibility to LECs that decline to accept direct connections eliminate or reduce the three types of inefficient routing schemes described above? Even if an IXC chose not to seek a direct connection, would the risk of IXCs seeking direct connections provide a disciplining counterweight to some providers' incentives to engage in mileage pumping or daisy-chaining? What would be the impact on affected parties?
31. We recognize that any action we take to address access arbitrage may affect the costs to carriers and their customers and the choices they make, as they provide and receive telecommunications services. Consumers that enjoy high call volume services could be affected by regulatory adjustments targeting arbitrage. Are there efficiencies that are in the public's interest in what some describe as arbitrage? Would addressing the arbitrage described here unfairly advantage any particular competitor or class of competitors? If so, are there alternative means to address the arbitrage issues described here and presented in the record? How would the changes proposed herein affect small businesses?
32. In the
33. The proposals in this NPRM, targeted to address the particular issues described in the record, continue the work the Commission began in the
34. We seek comment on the rule changes proposed at the end of this document. What, if any, other rule additions or modifications should we make to codify these proposals? Are there any conforming rule changes that commenters consider necessary? For example, we intend for any rules that we adopt to apply not only to interstate traffic, but also intrastate traffic. Do our proposed rules adequately address this? Are there any conflicts or inconsistencies between existing rules and those proposed herein? We ask commenters to provide any other proposed actions and rule additions or modifications we should consider to address the access arbitrage schemes described in this NPRM including updates to any relevant comments or proposals made in response to the
35.
Filings can be sent by hand or messenger delivery, by commercial overnight courier, or by first-class or overnight U.S. Postal Service mail. All
• 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
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• U.S. Postal Service first-class, Express, and Priority mail must be addressed to 445 12th Street SW, Washington, DC 20554.
36.
37.
38.
39.
40.
41. As required by the Regulatory Flexibility Act of 1980, as amended (RFA), we have 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 Notice of Proposed Rulemaking (NPRM). We request written public comments on this IRFA. Comments must be identified as responses to the IRFA and must be filed by the deadlines for comments provided on the first page of the NPRM. We will send a copy of the NPRM, including this IRFA, to the Chief Counsel for Advocacy of the Small Business Administration (SBA). In addition, the NPRM and IRFA (or summaries thereof) will be published in the
42. In the
43. The legal basis for any action that may be taken pursuant to this NPRM is contained in sections 1, 2, 4(i), 201-206, 214, 218-220, 251, 252, 254, 256, 303(r), and 403 of the Communications Act of 1934, as amended, 47 U.S.C. 151, 152, 154(i), 201-206, 214, 218-220, 251, 252, 254, 256, 303(r), and 403.
44. 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 additional criteria established by the SBA.
45.
46.
47.
48.
49.
50. We have included small incumbent LECs in this present RFA analysis. As noted above, a “small business” under the RFA is one that, inter alia, meets the pertinent small business size standard (
51.
52.
53.
54.
55.
56.
57. The Commission's own data—available in its Universal Licensing System—indicate that, as of October 25, 2016, there are 280 Cellular licensees that may 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
58.
59.
60.
61.
62.
63.
64. The NPRM proposes and seeks comment on rule changes that will affect LECs and intermediate access providers, including CEA providers. The NPRM proposes rules to further limit or eliminate the occurrence of access arbitrage, including access stimulation, which could reduce potential reporting requirements. One possible result of the proposed rules would be greater availability of direct connections between IXCs and access-stimulating LECs to avoid the use of intervening third parties, including CEA providers, and thus create more efficient and economical network connections. Direct connections would also likely reduce recordkeeping requirements. Specifically, we propose amending our rules to allow access-stimulating LECs to choose either to be financially responsible for the delivery of calls to their networks or to accept direct connections from IXCs or from intermediate access providers of the IXC's choosing. The proposed rules also contain notification requirements for access-stimulating LECs, which may impact small entities. Some of these requirements may also involve tariff changes.
65. The NPRM also seeks comment on other actions the Commission could take to further discourage or eliminate access arbitrage activity. Rules which achieve these objectives could potentially affect recordkeeping and reporting requirements.
66. 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.
67. This NPRM invites comment on a number of proposals and alternatives to modify or adopt access arbitrage rules and on the legality of access stimulation generally. The Commission has found these arbitrage practices inefficient and to ultimately increase consumer telecommunications rates. The NPRM proposes rules to further limit or eliminate the occurrence of access stimulation as well as other access arbitrage in turn promoting the efficient function of the nation's telecommunications network. We believe that if companies are able to operate with greater efficiency this will benefit the communications network as a whole, and its users, by allowing companies to increase their investment in broadband deployment. Thus, we propose to adopt rules to give access-stimulating LECs two choices about how they connect to IXCs. First, an access-stimulating LEC can choose to be financially responsible for calls delivered to its networks so it, rather than IXCs, pays for the delivery of calls to its end office or the functional equivalent. Or, second, instead of accepting this financial responsibility, an access-stimulating LEC can choose to accept direct connections from either the IXC or an intermediate access provider of the IXC's choosing. In the alternative, we seek comment on moving all traffic bound for an access-stimulating LEC to bill-and-keep. The NPRM also seeks comment on potential revisions to the definition of access stimulation, in particular to address intermediate access providers. The record in this proceeding suggests additional access arbitrage activities are occurring, including: (1) Use of intermediate access providers by Commercial Mobile Radio Carriers; (2) mileage pumping; and (3) daisy chaining. Comment is sought on how best to address these activities. The NPRM seeks comment on the costs and benefits of these proposals. Providing carriers, especially small carriers, with options will enable them to best assess the financial effects on their operation allowing them to determine how best to respond.
68. The NPRM also seeks comment on other actions we can take to further discourage or eliminate access arbitrage activity. Comment is sought on alternatives to our proposal that could be considered to achieve our objectives with potentially less impact on small entities.
69. None.
70. Accordingly,
71.
72.
Common carriers, Communications.
For the reasons discussed in the preamble, the Federal Communications Commission proposes to amend 47 CFR part 51 as follows:
47 U.S.C. 151-55, 201-05, 207-09, 218, 220, 225-27, 251-54, 256, 271, 303(r), 332, 1302.
(k)
(l)
(m)
(a) Notwithstanding any other provision of the Commission's rules, if a local exchange carrier is engaged in Access Stimulation, it shall within 45 days of commencing Access Stimulation, or by [date 45 days after the effective date of the final rule], whichever is later:
(1)(i) Not bill any affected Interexchange Carrier or any Intermediate Access Provider for the terminating switched access tandem switching or any terminating switched access transport charges for any traffic between such local exchange carrier's terminating end office or equivalent and the associated access tandem switch; and
(ii) Assume financial responsibility for the applicable Intermediate Access Provider terminating tandem switching and terminating switched transport access charges relating to traffic bound for the access-stimulating local exchange carrier; or
(2) Upon request of an Interexchange Carrier for direct-trunked transport service, provision and enable direct-trunked transport service to either the Interexchange Carrier or an Intermediate Access Provider of the Interexchange Carrier's choosing within [period of time to be determined] of such a request.
(b) Notwithstanding any other provision of the Commission's rules, if a local exchange carrier is engaged in
(1) That it is a local exchange carrier engaged in Access Stimulation;
(2) That it will either:
(i) Obtain and pay for terminating access services from Intermediate Access Providers for such traffic as of that date; or
(ii) Offer direct-trunked transport service to any affected Interexchange Carrier (or to an Intermediate Access Provider of the Interexchange Carrier's choosing); and
(3) To the extent that the local exchange carrier engaged in Access Stimulation intends to comply with paragraph (a) of this section through electing the option described in paragraph (a)(2) of this section, designate where on its network it will accept the requested direct connection.
(c) Nothing in this section creates an independent obligation for a local exchange carrier to construct new facilities other than, as necessary, adding switch trunk ports.
(d) In the event that an Intermediate Access Provider receives notice under paragraph (b) of this section that a local exchange carrier engaged in Access Stimulation will be obtaining and paying for terminating access service from such Intermediate Access Provider, an Intermediate Access Provider shall not bill Interexchange Carriers terminating tandem switching and terminating switched transport access for traffic bound for such local exchange carrier but, instead bill such local exchange carrier for such services.
(e) Notwithstanding any provision of this section, any carrier that is not itself engaged in Access Stimulation, as that term is defined in § 61.3(bbb) of this chapter, but serves as an Intermediate Access Provider with respect to traffic bound for an access-stimulating local exchange carrier, shall not itself be deemed a local exchange carrier engaged in Access Stimulation or be affected by this rule other than paragraph (d) of this section.
(c)
Federal Communications Commission.
Proposed rule.
In this document, the Commission seeks to update its leased access rules as part of its Modernization of Media Regulation Initiative. First, the Commission tentatively concludes that it should vacate its
Comments are due on or before July 30, 2018; reply comments are due on or before August 13, 2018.
You may submit comments, identified by MB Docket Nos. 18-80 and 17-105, by any of the following methods:
•
•
•
•
For additional information on this proceeding, contact Diana Sokolow,
This is a summary of the Commission's Further Notice of Proposed Rulemaking, FCC 18-80, adopted on June 7, 2018 and released on June 8, 2017. The full text is available for public inspection and copying during regular business hours in the FCC Reference Center, Federal Communications Commission, 445 12th Street SW, Room CY-A257, Washington, DC 20554. This document will also be available via ECFS at
1. In this Further Notice of Proposed Rulemaking (FNPRM), we seek to update our leased access rules as part of the Commission's Modernization of Media Regulation Initiative. In response to the public notice initiating the media modernization proceeding, some commenters made proposals related to the Commission's leased access rules, which require cable operators to set aside channel capacity for commercial use by unaffiliated video programmers.
2. We tentatively conclude that we should vacate the
3. In making this tentative conclusion, we note the concerns the Sixth Circuit expressed in its Stay Order regarding the leased access rules that were adopted in the
4. Further support for our tentative finding that we should vacate the
5. We also tentatively find that vacating the
6. We seek comment on our tentative conclusions. Is there any policy justification for not vacating the entire order? Is there any policy justification for retaining any particular rules adopted therein? Parties urging us not to vacate the entire order or particular rules should specify how the Commission should overcome both the judicial concerns noted in the Sixth Circuit Stay Order and those raised in the OMB Notice. We also ask parties to address any benefits associated with the 2008 rules and whether these benefits outweigh the costs.
7. We next seek comment on any updates and improvements we should make to our existing leased access rules. The stated purpose of the leased access statute “is to promote competition in the delivery of diverse sources of video programming and to assure that the widest possible diversity of information sources are made available to the public from cable systems in a manner consistent with growth and development of cable systems.” The statute also specifies that the price, terms, and conditions for commercial leased access should be “at least sufficient to assure that such use will not adversely affect the operation, financial condition, or market development of the cable system.” We note that the video distribution marketplace has become much more competitive since Congress first established the leased access regime in 1984. For example, at that time, direct broadcast satellite (DBS) service was not available to consumers as an alternative to cable. While consumers previously had access to only one pay television service, today they have access to multiple pay television services as well as online video programming. In addition, the number of channels offered by cable operators has increased.
8. Against this backdrop, we invite comment on the current state of the leased access marketplace generally and on whether, and if so how, the prevalence of alternative means of video distribution should influence our actions in this proceeding. How many leased access programmers are currently in existence, and is that number increasing or decreasing? What portion of a cable system's programming consists of leased access? Do the leased access rules currently in effect facilitate the successful leasing of time by leased access programmers, and if not, what issues do programmers experience? To what extent do leased access programmers continue to rely on cable carriage versus alternative means of distribution? Does the widespread availability of DBS service today or the proliferation of online video distributors provide programmers, including leased access programmers, with more options for content distribution?
9. As discussed below, we also seek comment on specific proposals raised in the media modernization proceeding to update and improve the Commission's existing leased access rules as well as on any other proposals we should consider.
10. First, as supported by several commenters in the media modernization proceeding, we propose to revise § 76.970(i) of our rules to provide that all cable operators, and not just those that qualify as “small systems” under that rule, are required to provide the information specified in paragraph (i)(1) only in response to a bona fide request for leased access information from a prospective leased access programmer.
11. Section 76.970(i)(1) directs cable operators to provide prospective leased access programmers with the following information: “(i) How much of the operator's leased access set-aside capacity is available; (ii) A complete schedule of the operator's full-time and part-time leased access rates; (iii) Rates associated with technical and studio costs; and (iv) If specifically requested, a sample leased access contract.” Current rules require operators of small cable systems to provide the information only in response to a bona fide request from a prospective leased access programmer, whereas other cable system operators must provide the information in response to any request for leased access information.
12. We seek comment on our proposal to extend the bona fide request limitation to all leased access requests. Is there any reason not to provide all cable operators with the flexibility of responding only to a bona fide request? We ask commenters to provide information on the costs that cable operators currently face in responding to non-bona fide leased access requests. How often do cable operators receive non-bona fide leased access requests, and how much time does it take to provide the required information in response to such a request? Does the bona fide request limitation that currently applies to operators of small cable systems in any way discourage prospective leased access programmers, including small programmers, from seeking to lease access and if so, how? If we extend the bona fide request limitation to all leased access requests, should we adopt any modifications to the current definition of a bona fide request?
13. Second, we invite comment on whether we should extend the time within which cable operators must provide prospective leased access programmers with the information specified in § 76.970(i)(1) of our rules. Current rules require cable system operators to provide the required information “within 15 calendar days of the date on which a request for leased access information is made,” while operators of systems that are subject to small system relief must provide the required information “within 30 calendar days of a bona fide request from a prospective leased access programmer.” We invite comment on whether cable operators have found it difficult to comply with the current deadlines for providing the required information, and if so, why. What steps must cable operators take to compile the information listed in § 76.970(i)(1) of the Commission's rules, and what costs do cable operators face in doing so under the current timeframe? Is the information readily available to cable operators? We also seek input on whether leased access programmers have found that the required information is generally provided on a timely basis in accordance with current rules. If, as discussed above, we revise our rules to provide that all cable operators, and not just those with small systems, are required to provide the listed information only in response to a bona fide request from a prospective leased access programmer, then is there any basis for extending the deadline to provide the information?
14. NCTA asks the Commission to provide cable operators with additional time, such as 45 days, within which “to respond to requests to lease time on multiple systems.” Is a 45-day response period reasonable for leased access requests covering multiple systems, and if not, what response time period is appropriate? Is it necessary to also provide additional response time for single cable systems? Do leased access requests typically involve multiple systems or are single-system requests often made? Would lengthening the deadline serve as a deterrent to or create a hardship for potential leased access programmers? Should we maintain a longer deadline for operators of small cable systems as compared to other cable operators?
15. Third, as urged by several commenters in the media modernization proceeding, we seek comment on whether we should permit cable operators to require leased access programmers to pay a nominal application fee
16. We seek comment on whether it would be preferable to permit a nominal application fee or a deposit, or both, and on the costs and benefits of each option. If we adopt our proposal to require all cable operators to respond only to bona fide leased access requests, is there any justification for requiring a deposit or application fee? Would requiring a deposit or application fee prior to obtaining the information set forth in § 76.970(i)(1) dissuade potential leased access programmers, particularly small entities, from seeking to lease access? Finally, should the Commission permit all cable operators, or permit only small cable operators, to require a nominal application fee or deposit before the
17. Fourth, we invite comment on modifications to our procedures for addressing leased access disputes. Congress has provided the Commission with authority to adjudicate leased access disputes. Parties previously have contacted Commission staff to express confusion about inconsistencies between the leased access dispute resolution rule (§ 76.975) and the Commission's more general rule governing complaints (§ 76.7). Accordingly, to promote consistency between the two rules, we propose to revise § 76.975 of our rules as follows. First, we propose to revise our terminology by referencing an answer to a petition, rather than a response to a petition. Second, we propose that the 30-day timeframe for filing an answer to a leased access petition should be calculated from the date of service of the petition, rather than the date on which the petition was filed. Third, whereas § 76.975 currently does not include any allowance for replies, we propose adding a provision stating that replies to answers must be filed within 15 days after submission of the answer. Fourth, we propose adding a statement that § 76.7 applies to petitions for relief filed under § 76.975, unless otherwise provided in § 76.975. We invite comment on these proposals, which we intend to alleviate any ongoing confusion about how both §§ 76.7 and 76.975 govern leased access proceedings. Is 15 days the appropriate timeframe for submitting a reply to an answer to a leased access petition? We note that the general complaint-filing rule provides 10 days for filing replies, but it also provides only 20 days for filing an answer, whereas the leased access rule provides 30 days for an answer. Are there any other changes we should make to our rules in order to make the adjudication of leased access disputes more efficient?
18. Finally, we invite comment on any other ways in which we should modernize our leased access rules. For example, are any new rules needed to govern the relationship between leased access programmers and cable operators, such as a rule requiring cable operators to provide programmers with contact information for the person responsible for leased access matters? Should we adopt any new rules governing leased access rates or part-time leased access? Commenters supporting additional rules governing leased access rates should explain why additional rate rules are needed and what issues the rules should address. We ask commenters to explain the relative costs and benefits of any additional proposals.
19. In seeking comment on updating the FCC's leased access rules, we also seek comment on whether our rules implicate First Amendment interests. If so, what level of First Amendment scrutiny is appropriate, and how does that analysis apply to our existing rules and the potential changes we seek comment on here, in light of the statutory obligations of section 612? In this context, we also seek comment on whether there have been any changes in the video distribution market since Congress and the FCC first addressed these issues that are relevant to the First Amendment analysis. For instance, are there relevant changes in the distribution market that we should now consider? Is the FCC's 2015 decision regarding effective competition relevant to this analysis?
20. As required by the Regulatory Flexibility Act of 1980, as amended (RFA), the Commission has prepared an Initial Regulatory Flexibility Analysis (IRFA) concerning the possible significant economic impact on small entities by the policies and rules proposed in the FNPRM. Written public comments are requested on the IRFA. Comments must be identified as responses to the IRFA and must be filed by the deadlines for comments provided on the first page of the FNPRM. The Commission will send a copy of the FNPRM, including the IRFA, to the Chief Counsel for Advocacy of the Small Business Administration (SBA). In summary, the FNPRM seeks to update the Commission's leased access rules as part of its Modernization of Media Regulation Initiative. First, it tentatively concludes that we should vacate the Commission's
21. We note that the FNPRM tentatively finds that vacating the
22. Regarding specific proposals involving the leased access rules, the Commission invites comment on alternative ways it can reduce burdens on small entities. For example, the Commission proposes to extend the current bona fide request limitation, which only applies to operators of small cable systems, to all operators. The FNPRM seeks information on whether the current bona fide request limitation in any way discourages prospective leased access programmers, including small programmers, from seeking to lease access and if so, how. For example, if prospective leased access programmers indicate that they find it difficult to prepare a request that constitutes a “bona fide” request, the Commission will consider such difficulties in determining how to
23. This document contains proposed new or revised information collection requirements, including the proposal that all cable operators are required to provide the information specified in § 76.970(i)(1) only in response to a bona fide request from a prospective leased access programmer, and the addition of a provision governing replies to answers to leased access complaints. 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 (44 U.S.C. 3501-3520). In addition, pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198,
24.
25. The proposed action is authorized pursuant to sections 4(i), 303, and 612 of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 303, and 532.
Administrative practice and procedure, Cable television, Reporting and recordkeeping requirements.
For the reasons discussed in the preamble, the Federal Communications Commission proposes to amend 47 CFR part 76 as follows:
47 U.S.C. 151, 152, 153, 154, 301, 302, 302a, 303, 303a, 307, 308, 309, 312, 315, 317, 325, 338, 339, 340, 341, 503, 521, 522, 531, 532, 534, 535, 536, 537, 543, 544, 544a, 545, 548, 549, 552, 554, 556, 558, 560, 561, 571, 572, 573.
(i)(1) Cable system operators shall provide prospective leased access programmers with the following information within 15 calendar days of the date on which a bona fide request for leased access information is made:
(i) How much of the operator's leased access set-aside capacity is available;
(ii) A complete schedule of the operator's full-time and part-time leased access rates;
(iii) Rates associated with technical and studio costs; and
(iv) If specifically requested, a sample leased access contract.
(2) Operators of systems subject to small system relief shall provide the information required in paragraph (i)(1) of this section within 30 calendar days of a bona fide request from a prospective leased access programmer. For these purposes, systems subject to small system relief are systems that either:
(i) Qualify as small systems under § 76.901(c) and are owned by a small cable company as defined under § 76.901(e); or
(ii) Have been granted special relief.
(e) The cable operator or other respondent will have 30 days from service of the petition to file an answer. If a leased access rate is disputed, the answer must show that the rate charged is not higher than the maximum permitted rate for such leased access, and must be supported by the affidavit of a responsible company official. If, after an answer is submitted, the staff finds a prima facie violation of our rules, the staff may require a respondent to produce additional information, or
(i) Section 76.7 applies to petitions for relief filed under this section, except as otherwise provided in this section.
Defense Acquisition Regulations System, Department of Defense (DoD).
Proposed rule.
DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) implement a section of the National Defense Authorization Act for Fiscal Year 2017 (Pub. L. 114-328), which requires DoD to revise the DFARS to encourage contractors to propose commercial or non-Government standards and industry-wide practices that meet the intent of military specifications and standards.
Comments on the proposed rule should be submitted in writing to the address shown below on or before August 28, 2018, to be considered in the formation of a final rule.
Submit comments identified by DFARS Case 2017-D014, using any of the following methods:
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Comments received generally will be posted without change to
Mr. Mark Gomersall, telephone 571-372-6099.
DoD is proposing to amend the DFARS to implement section 875(c) of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2017 (Pub. L. 114-328). Section 875(c) requires DoD to revise the DFARS to encourage contractors to propose commercial or non-Government standards and industry-wide practices that meet the intent of military specifications and standards.
DoD is proposing to amend DFARS 211.107(b) to require the use of Federal Acquisition Regulation (FAR) provision 52.211-7, Alternatives to Government-Unique Standards, in DoD solicitations and contracts that include military or Government-unique specifications and standards; and, in so doing, encourage and permit offerors to propose alternatives to Government-unique standards using an existing FAR provision.
The use of FAR provision 52.211-7 is optional for agencies that report their use of voluntary consensus standards to the National Institute of Standards and Technology using the categorical reporting method. However, Office of Management and Budget (OMB) Circular A-119, Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities, requires, at paragraph 12.a.(4), that agencies using the categorical method of reporting method must “Enable potential offerors to suggest voluntary consensus standards that can replace Government-unique standards.” Use of this existing FAR provision will enable DoD to meet the intent of section 875(c).
In response to OMB Circular A-119, the National Institute of Standards and Technology collects reports from Federal Agencies on their use of Government-unique standards, which is reported annually to Congress. DoD statistics used for that report do not differentiate among the many different types of Government-unique Standards. The overriding conceptual approach is to reduce Government reliance on standards produced by Government entities for their own use.
As a matter of existing policy, DoD discourages the use of military specifications and standards in solicitations. As stated in DoD Directive 5000.01: “When using performance-based strategies, contract requirements shall be stated in performance terms, limiting the use of military specifications and standards to Government-unique requirements only.” However, to meet the intent of section 875(c) of the NDAA for FY 2017, DoD is proposing to amend DFARS 211.107(b) to require the use of FAR provision 52.211-7, Alternatives to Government-Unique Standards, in DoD solicitations and contracts that include military or Government-unique specifications and standards to encourage and permit offerors to propose alternatives to Government-unique standards.
The purpose of this rule is to implement section 875(c) of the NDAA for FY 2017, which requires DoD to revise the DFARS to encourage contractors to propose commercial or non-Government standards and industry-wide practices that meet the intent of military specifications and standards. DoD does not intend to apply the requirements of section 875(c) to solicitations for contracts valued at or below the SAT or to contracts for commercial items, including COTS items, because such contracts do not generally include or require use of military or Government-unique standards or specifications.
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of
This rule is not an E.O. 13771, Reducing Regulation and Controlling Regulatory Costs, regulatory action, because this rule is not significant under E.O. 12866.
DoD does not expect this proposed rule to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, at 5 U.S.C. 601
This proposed rule implements section 875(c) of the National Defense Authorization Act (NDAA) for FY 2017 (Pub. L. 114-328).
The objective of this rule is to clarify the use of FAR 52.211-7, Alternatives to Government-Unique Standards, in DoD solicitations and contracts that include military or Government-unique specifications and standards. This will encourage and permit Offerors to propose alternatives to Government-unique standards by using an existing FAR provision. The legal basis for this rule is section 875(c) of the NDAA for FY 2017 (Pub. L. 114-328).
The rule will apply to both large and small entities to the extent that such entities receive Government solicitations containing Government-unique standards and FAR provision 52.211-7, Alternatives to Government-unique Standards. Such entities may already be familiar with this provision as it has been in place since its publication in 1998 (63 FR 68344, December 10, 1998).
As a matter of policy, DoD discourages the use of military specifications and standards in solicitations. As stated in DoD Directive 5000.01: “When using performance-based strategies, contract requirements shall be stated in performance terms, limiting the use of military specifications and standards to Government-unique requirements only.”
In addition, between 1994 and 2000, over 29,000 military specifications and standards were cancelled. Of those, 6,100 were canceled without replacement, and 3,500 were superseded by nongovernment standards. Moreover, DoD participates in over 120 private sector standards-developing organizations such as ASTM, ANSI, ISO and IEEE. Voluntary consensus standards adopted by DoD are also listed in the Defense Logistics Agency ASSIST database to identify the source for obtaining the adopted standards.
Based on Federal Procurement Data System data for product service code (PSC) 5342 (hardware, weapon systems), this rule could potentially apply to approximately 757 unique entities, of which 585 are small businesses. This is based on the number of DoD contract awards in fiscal year 2016 for PSC 5342. It cannot be discerned how many of the contract awards required the use of a military specification or standard. Further, given the DoD policy of discouraging the use of military specifications and standards in solicitations, this rule would likely impact no more than 40 offerors or potential contractors (the approximate number of DoD contractors involved in major weapons systems, which are more likely to require Government specifications).
Accordingly, DoD estimates that this rule will have limited application. However, given the fact that some small number of DoD solicitations may include a military specification or standard—generally limited to those involving a major weapons system, this rule would provide a permissive means for offerors to propose reducing regulatory burden on a given solicitation.
This rule does not contain reporting and recordkeeping requirements, since it merely revises guidance to contracting officers for use of FAR clause 52.211-7, Alternatives to Government-unique Standards.
As an alternative to this proposed rule, DoD could create a stand-alone DoD provision. Such a provision, however, would largely duplicate, overlap, and potentially conflict with the requirements of the existing provision at FAR 52.211-7.
DoD does not expect this proposed rule to have a significant economic impact on small entities. The rule will have a positive impact on both large and small contractors, in that they will now be permitted to propose alternatives to Government standards using an existing FAR provision, the same provision used for other,
The rule does not duplicate, overlap, or conflict with any other Federal rules. There are no significant alternatives that meet the requirement of the statute.
DoD will also consider comments from small entities concerning the existing regulations in subparts affected by this rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C. 610 (DFARS Case 2017-D014), in correspondence.
The Paperwork Reduction Act (44 U.S.C. chapter 35) applies. The rule contains information collection requirements. OMB has cleared this information collection requirement under OMB control number 9000-0153, titled, OMB Circular A-119; FAR Sections Affected: 52.211-7 and 53.105.
Government procurement.
Therefore, 48 CFR part 211 is proposed to be amended as follows:
41 U.S.C. 1303 and 48 CFR chapter 1.
(b) Use the provision at FAR 52.211-7, Alternatives to Government-Unique Standards, in DoD solicitations that include military or Government-unique specifications and standards.
Follow the procedures at PGI 211.201 for obtaining specifications, standards, and data item descriptions from the DLA ASSIST database, including DoD adoption notices on voluntary consensus standards.
Defense Acquisition Regulations System, Department of Defense (DoD).
Proposed rule.
DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to implement a section of the National Defense Authorization Act for Fiscal Year 2017 that addresses the inapplicability of certain laws and regulations to the acquisition of commercial items, including commercially available off-the-shelf items.
Comments on the proposed rule should be submitted in writing to the address shown below on or before August 28, 2018, to be considered in the formation of a final rule.
Submit comments identified by DFARS Case 2017-D010, using any of the following methods:
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Ms. Amy G. Williams, telephone 571-372-6106.
DoD is proposing to amend the DFARS to implement section 874 of the National Defense Authorization Act for Fiscal Year 2017. Section 874—
• Amends 10 U.S.C. 2375, Relationship of commercial item provisions to other provisions of law, to provide that—
○ No contract for the acquisition of a commercial item, subcontract under a contract for the procurement of a commercial item, or contract for the procurement of a commercially available off-the-shelf (COTS) item shall be subject to any law properly listed in the Federal Acquisition Regulation (FAR) pursuant to 41 U.S.C. 1906 or 1907, respectively; and
○ The DFARS shall include lists of defense-unique provisions of law and contract clause requirements based on Governmentwide acquisition regulations, policies, or Executive orders not expressly authorized in law, that are inapplicable to—
The acquisition of a commercial item;
Subcontracts for commercial items under a contract for the procurement of commercial items; or
Contracts for the procurement of a COTS item;
• Provides that a covered provision of law or contract clause requirement is a provision of law or contract clause requirement that the Under Secretary of Defense for Acquisition, Technology, and Logistics determines sets forth policies, procedures, requirements, or restrictions for the procurement of property or services by the Federal Government, except for a provision of law or contract clause requirement that—
○ Provides for civil or criminal penalties;
○ Requires that certain articles be bought from American sources pursuant to 10 U.S.C. 2533a; or requires that strategic materials critical to national security be bought from American sources pursuant to 10 U.S.C. 2533b; or
○ Specifically refers to this section and provides that, notwithstanding this section, it shall be applicable to contracts for the procurement of commercial items.
• Provides that a covered provision of law or contract clause requirement shall be included on the list unless the Under Secretary of Defense for Acquisition, Technology, and Logistics makes a written determination that such exemption would not be in the best interest of DoD.
• Requires the Under Secretary of Defense for Acquisition, Technology, and Logistics to ensure that, to the maximum extent practicable—
○ The DFARS shall not require the inclusion of contract clauses in contracts for the procurement of commercial items (including COTS items), unless such clauses are required to implement provisions of law or Executive orders applicable to such contracts, or determined to be consistent with standard commercial practice; and
○ The flowdown of contract clauses to subcontracts under contracts for the procurement of commercial items (including COTS items) is prohibited unless such flowdown is required to implement provisions of law or Executive orders applicable to such subcontracts; and
• Defines the term “subcontract” to exclude agreements entered into by a contractor for the supply of commodities that are intended for use in the performance of multiple contracts with the DoD and other parties, and are not identifiable to any particular contract.
10 U.S.C. 2375(b)(2) limits the required review of applicability of provisions of law and contract clauses to prime contracts for commercial items to those provisions of law and contract clauses enacted after January 1, 2015. Although the subsequent paragraphs (c) and (d) relating to applicability of provisions of law and contract clauses to subcontracts for commercial items and contracts for COTS items are in all other regards parallel, the date of January 1, 2015, is not repeated in the subsequent paragraphs. DoD has interpreted the date as equally applicable to all three paragraphs, because the three paragraphs are closely inter-related. Any law or clause that is inapplicable to a contract for commercial items is also inapplicable to a contract for COTS items (which are commercial items). The COTS list builds on the list of laws and clauses inapplicable to commercial items in general. Further, laws and clauses that are inapplicable to contracts for commercial items will also be inapplicable to subcontracts for commercial items, even though there may be a few additional laws or clauses that are just inapplicable at the subcontract level.
Therefore, as the first step toward implementation of section 874 of the NDAA for FY 2017 in the DFARS, DoD identified all new DFARS and FAR provisions and clauses published as interim or final rules after January 1, 2015; determined whether these provisions and clauses were based on statute or Executive order, and reviewed their applicability to commercial items.
Since the DFARS supplements the FAR, the lists of inapplicable statutes at FAR 12.503 through 12.505 are applicable to DoD. This rule proposes language at DFARS 212.503, 212.504, and 212.505, to emphasize that the DFARS lists of statutes are in addition to the FAR lists, not in place of them.
Although the following defense-unique statutes were all enacted prior to January 1, 2015, and are therefore not covered statutes as defined in section 874, they are the basis for DFARS provisions and clauses issued after January 1, 2015, and have therefore been reviewed.
1. The Director of Defense Procurement and Acquisition Policy, acting under authority delegated by the Under Secretary of Defense for Acquisition, Technology, and Logistics, has determined that the following statutes apply to the acquisition of commercial items, except for the acquisition of COTS items. Note that services are not COTS items, so no determination is required to exclude applicability to COTS items when acquiring services and the clause prescription and flowdown paragraph of the clause do not specify exclusion of COTS items.
a. Section 941 of the NDAA for FY 2013 and section 1632 of NDAA for FY 2015 (DFARS Case 2013-D018, Network Penetration Reporting and Contracting of Cloud Services (80 FR 51739 and 81 FR 72986); DFARS 252.204-7008, 252.204-7009, and 252.204-7012). This rule proposes to clarify that the flowdown requirement in paragraph (m) of the clause at DFARS 252.204-7012 excludes flowdown to COTS items. Although the final rule under DFARS case 2013-D018 stated the exclusion of applicability to COTS items for all provisions and clauses under the case and the clause prescriptions were amended, the corresponding amendment to paragraph (m) of the clause at DFARS 252.204-7012 did not explicitly exclude flowdown to COTS items. This statute has been added to the proposed list at DFARS 212.505.
b. Section 862 of the NDAA for FY 2008 (DFARS Case 2015-D021, Defense Contractors Performing Private Security Functions (80 FR 81496 and 81 FR 42559); DFARS 252.225-7039). This statute was not added to the proposed list at DFARS 212.505 because it is for the acquisition of services.
2. The Director of Defense Procurement and Acquisition Policy, acting under authority delegated by the Under Secretary of Defense for Acquisition, Technology, and Logistics, determined that section 818(c)(3) of the NDAA for FY 2012, as amended (DFARS Case 2014-D005, Detection and Avoidance of Counterfeit Parts—Further Implementation (80 FR 63735 and 81 FR 50635); DFARS 252.246-7008) applies to the acquisition of commercial items, including COTS items.
3. The following two statutes are currently applied in the DFARS to the acquisition of commercial items, including COTS items. However, continued application to commercial items is dependent upon a determination by the Director of Defense Procurement and Acquisition Policy, acting under authority delegated by the Under Secretary of Defense for Acquisition and Sustainment, with regard to the applicability to commercial items:
a. Section 1611 of the NDAA for FY 2014 (10 U.S.C. 2419) (DFARS Case 2014-D009, Advancing Small Business Growth (79 FR 65917 and 80 FR 30115); DFARS 252.219-7000). The provision at DFARS 252.219-7000, Advancing Small Business Growth, is prescribed at DFARS 219.309 for use in solicitations, including solicitations using FAR part 12 procedures for acquisition of commercial items, when the estimated annual value of the contract is expected to exceed—
• The small business size standard, if expressed in dollars, for the North American Industry Classification System (NAICS) code assigned by the contracting officer; or
• $70 million, if the small business size standard is expressed as number of employees for the NAICS code assigned by the contracting officer.
The provision is also listed at DFARS 212.301(f)(vii) as applicable to the acquisition of commercial items. The provision is inapplicable to subcontracts. This provision does not impose any burden on offerors, but is intended only to advise small businesses that entering into a DoD contract may eventually cause such businesses to exceed the small business size standard.
b. Section 8123 of the DoD Appropriations Act and the same provision in subsequent annual defense appropriations acts (DFARS Case 2015-D005, Acquisition of the American Flag (80 FR 10452 and 80 FR 51748); DFARS 252.225-7006). The clause at DFARS 252.225-7006, Acquisition of the American Flag, is prescribed at 225.7002-3 for use in solicitations and contracts, including solicitations and contracts using FAR part 12 procedures for the acquisition of commercial items, that are for the acquisition of the American flag, with an estimated value that exceeds the simplified acquisition threshold, unless an exception at 225.7002-2 applies. The clause is also listed at 212.301(f)(x)(C) as applicable to acquisition of commercial items. The clause does not flow down to subcontracts. Since most, if not all, flags are commercial items, this statute would be without affect if not applied to commercial items. Furthermore, this is an appropriations act restriction, which specifically prohibits the expenditure of any funds appropriated under these acts, unless the flags to be acquired are manufactured in the United States (regardless of whether the flags are commercial items).
1. The following DFARS and FAR provisions are not required for use in solicitations for the acquisition of commercial items, including COTS items. FAR 12.301(e) provides for discretionary use of provisions and clause not required for use solicitations and contracts using FAR part 12 procedures for the acquisition of commercial items, when their use is consistent with the limitations contained in FAR 12.302. These provisions do not apply to subcontracts. Both provisions are proposed for addition to the proposed list at DFARS 212.370. DoD welcomes comments as to whether use of these provisions in solicitations for commercial items should be prohibited, or whether their use might be appropriate for discretionary use.
a. 252.219-7010, Notification of Competition Limited to Eligible 8(a) Concerns—Partnership Agreement (DFARS Case 2015-D017, 80 FR 58669 and 81 FR 17045), is prescribed at DFARS 219.811-3 for use in lieu of the clause at FAR 52.219-18, Notification of Competition Limited to Eligible 8(a) Concerns, in competitive solicitations and contracts when the acquisition is accomplished using the procedures of FAR 19.805 and processed in accordance with the partnership agreement cited in DFARS 219.800. It is
This rule proposes to modify the clause prescription to specifically exclude applicability to acquisitions using FAR part 12 procedures for the acquisition of commercial items.
b. 52.204-22, Alternative Line Item Proposals (FAR Case 2013-014, 79 FR 45408 and 82 FR 4709), is prescribed at FAR 4.1008 for use in all solicitations. However, this provision is not prescribed for use in FAR part 12. In accordance with FAR 12.301(d), notwithstanding prescriptions contained elsewhere in the FAR, when acquiring commercial items, contracting officers are only required to use those provisions and clauses prescribed in FAR part 12. This rule proposes to modify the clause prescription to specifically exclude applicability to acquisitions using FAR part 12 procedures for the acquisition of commercial items.
2. The following DFARS and FAR provisions and clause are applicable to the acquisition of commercial items, except for COTS items. In accordance with section 874, continued applicability to commercial items is dependent upon a determination by the Director of Defense Procurement and Acquisition Policy, acting under authority delegated by the Under Secretary of Defense for Acquisition, Technology, and Logistics, with regard to the applicability to commercial items:
a. DFARS 252.239-7009, Representation of Use of Cloud Computing, and 252.239-7010, Cloud Computing Services (DFARS Case 2013-D018, 80 FR 51739, 80 FR 81472, and 81 FR 50635), are prescribed at DFARS 239.7604 for use in solicitations and contracts using FAR part 12 procedures for the acquisition of commercial items, for information technology services and are also listed at DFARS 212.301(f)(xvi)(A) and (B) as applicable to acquisitions of commercial items. The clause also flows down to all subcontracts that involve or may involve cloud services, including subcontracts for commercial items. This provision and clause are not listed at proposed DFARS 212.371 because this provision and clause apply to the acquisition of services, which are not COTS items.
DoD applies this provision and clause to the acquisition of commercial items, excluding COTS items, because the harm that could result from the loss or compromise of defense information is the same under a FAR part 12 contract as it would be under any other contract. Recent high-profile breaches of Federal information show the need to ensure that information security protections are clearly, effectively, and consistently addressed in contracts. Failure to apply this provision and clause to acquisition of cloud services may cause harm to the Government which could directly impact national security. The information collection requirement for this provision and clause is approved under OMB clearance 0704-0478, Safeguarding Covered Defense Information, Cyber Incident Reporting, and Cloud Computing, in the amount of 250,850 total annual burden hours, which also includes burden hours associated with Safeguarding and cyber incident reporting.
b. FAR 52.204-21, Basic Safeguarding of Covered Contractor Information Systems (FAR Case 2011-020, 77 FR 51496 and 82 FR 4709), is prescribed at FAR 4.1903, for use when the contractor or a subcontractor at any tier may have Federal contract information residing in or transiting through the information system. FAR 12.301(d)(3) requires use in solicitations and contracts for commercial items (except for acquisitions of COTS items), as prescribed in FAR 4.1903. Paragraph (c) of FAR 52.204-21 requires flowdown to subcontracts, including subcontracts for the acquisition of commercial items, other than COTS items, in which the contractor may have Federal contract information residing in or transiting through its information system. Flowdown to subcontracts for commercial item, other than subcontracts for COTS items, is also required at FAR 52.244-6(c)(1)(iv), if flowdown is required in accordance with FAR 52.204-21(c).
This clause requires only a basic level of safeguarding of contractor information systems reflective of actions any prudent business person would employ. The exclusion of COTS items was incorporated in the final rule in response to public comments. This clause does not impose any information collection burden on contractors.
c. FAR 52.222-62, Paid Sick Leave Under Executive Order 13706 (FAR Case 2017-001, 81 FR 91627, interim rule), is prescribed at FAR 22.2110, for use in solicitations and contracts that include the clause 52.222-6, Construction Wage Rate Requirements, or 52.222-41, Service Contract Labor Standards, where work is to be performed, in whole or in part, in the United States. Use of the clause when using part 12 procedures for the acquisition of commercial items is provided at FAR 52.212-5(c)(9). The clause flows down to all subcontracts, regardless of dollar value, that are subject to the Service Contract Labor Standards statute or the Wage Rate Requirements (Construction) statute and are also to be performed in whole or in part in the United States. Flowdown to commercial subcontracts (excluding COTS items) is provided at FAR 52.212-5(e)(1)(xix) and 52.244-6(c).
This rule implements Executive Order 13706, which does not exempt contracts for the acquisition of commercial items. The implementing regulations by the Department of Labor were issued on September 30, 2016 (81 FR 67598). The rule applies to contracts that are covered by the Service Contract Labor Standards statute or the Wage Rate Requirements (Construction) statute, and meet or exceed the thresholds specified in those statutes. However, since these statutes do not apply to contracts for acquisition of supplies, the rule does not cover acquisitions of COTS items.
The Executive Order seeks to increase efficiency and cost savings in the work performed by parties who contract with the Government by ensuring that employees on those contracts can earn up to 7 days or more of paid sick leave annually. The Executive order was first implemented in Department of Labor regulations (81 FR 67598), which OIRA declared to be an economically significant rule and a major rule. Most of the costs associated with this rule are transfer costs from employers to employees. The information collection requirements associated with the Department of Labor final rule were cleared under OMB clearances 1235-0018, 1235-0021, 1235-0029. The FAR rule does not impose any additional burdens.
3. The following DFARS and FAR provisions and clause are applicable to the acquisition of commercial items, including COTS items. In accordance with section 874, continued applicability to commercial items is dependent upon a determination by the Director of Defense Procurement and Acquisition Policy, acting under authority delegated by the Under Secretary of Defense for Acquisition, Technology, and Logistics, with regard to the applicability to commercial items:
a. DFARS 252.213-7000, Notice to Prospective Suppliers on Use of Past Performance Information Retrieval System—Statistical Reporting in Past Performance Evaluation (DFARS Case 2014-D015, 80 FR 4848 and 80 FR 30117), is prescribed at DFARS 213.106-2-70, in competitive solicitations for supplies when using FAR part 13 simplified acquisition procedures, including competitive solicitations using FAR part 12
DoD developed and deployed the Past Performance Information Retrieval System—Statistical Reporting (PPIRS- SR) module to fill the need for past performance data on lower dollar value contracts. This objective data on past performance will assist contracting officers in making better-informed best value award decisions on small dollar value acquisitions for supplies, while also eliminating the burden of collecting subjective past performance information on contractors for smaller dollar value contracts. This benefit is equally applicable, whether or not the items to be acquired are commercial. There is no information collection burden on offerors.
b. DFARS 252.229-7014, Taxes—Foreign Contracts in Afghanistan, and 252.229-7015, Taxes—Foreign Contracts in Afghanistan (North Atlantic treaty Organization Status of Forces Agreement) (DFARS Case 2014-D003, 79 FR 35715 and 80 FR 81467), are prescribed at 229.402-70 (k) and (l), respectively.
• DFARS 252.229-7014, Taxes—Foreign Contracts in Afghanistan, is for use in solicitations and contracts, including solicitations and contracts using FAR part 12 procedures for the acquisition of commercial items, with performance in Afghanistan, unless the clause at 252.229-7015 is used.
• DFARS 252.229-7015, Taxes—Foreign Contracts in Afghanistan (North Atlantic Treaty Organization Status of Forces Agreement), is for use instead of the clause at 252.229-7014, Taxes—Foreign Contracts in Afghanistan, in solicitations and contracts, including solicitations and contracts using FAR part 12 procedures for the acquisition of commercial items, with performance in Afghanistan awarded on behalf of the North Atlantic Treaty Organization (NATO), which are governed by the NATO Status of Forces Agreement (SOFA), if approval from the Director, Defense Procurement and Acquisition Policy, Office of the Under Secretary of Defense for Acquisition, Technology, and Logistics, has been obtained prior to each use.
These clause are also listed at DFARS 212.301(f)(xiii) as applicable to solicitations and contracts using FAR part 12 procedures for the acquisition of commercial items. Both clauses flow down to all subcontracts, including subcontracts for commercial items.
The objective of these clauses is to exempt DoD contracts performed in Afghanistan from payment liability for Afghan taxes pursuant to the bilateral security agreement between Afghanistan and the United States and the North Atlantic Treaty Organization (NATO) Status of Forces Agreement (SOFA). DoD applies these two clauses to solicitations and contracts for the acquisition of commercial items, including COTS items, for contracts performed in Afghanistan. Not applying this guidance to contracts for the acquisition of commercial items, including COTS items, would result in DoD paying unnecessary taxes, reducing the funds available for pursuing the war effort in Afghanistan. These clauses do not impose any information collection burden on offerors or contractors.
c. FAR 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons; FAR 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioner; FAR 52.223-20, Aerosols; and FAR 52.223-21, Foams (FAR Case 2014-026, 80 FR 26883 and 81 FR 30429), are prescribed at FAR 23.804(a) for use as follows:
(1) FAR 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons, in solicitations and contracts for—
(i) Refrigeration equipment (in product or service code (PSC) 4110);
(ii) Air conditioning equipment (PSC 4120);
(iii) Clean agent fire suppression systems/equipment (
(iv) Bulk refrigerants and fire suppressants (in PSC 6830);
(v) Solvents, dusters, freezing compounds, mold release agents, and any other miscellaneous chemical specialty that may contain ozone-depleting substances or high global warming potential hydrofluorocarbons (in PSC 6850);
(vi) Corrosion prevention compounds, foam sealants, aerosol mold release agents, and any other preservative or sealing compound that may contain ozone-depleting substances or high global warming potential hydrofluorocarbons (in PSC 8030);
(vii) Fluorocarbon lubricants (primarily aerosols) (in PSC 9150); and
(viii) Any other manufactured end products that may contain or be manufactured with ozone-depleting substances.
(2) FAR 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners, in solicitations and contracts that include the maintenance, service, repair, or disposal of—
(i) Refrigeration equipment, such as refrigerators, chillers, or freezers; or
(ii) Air conditioners, including air conditioning systems in motor vehicles.
(3) FAR 52.223-20, Aerosols, in solicitations and contracts—
(i) For products that may contain high global warming potential hydrofluorocarbons as a propellant, or as a solvent; or
(ii) That involve maintenance or repair of electronic or mechanical devices.
(4) FAR 52.223-21, Foams, in solicitations and contracts for—
(i) Products that may contain high global warming potential hydrofluorocarbons or refrigerant blends containing hydrofluorocarbons as a foam blowing agent, such as building foam insulation or appliance foam insulation; or
(ii) Construction of buildings or facilities. A majority of the acquisitions involving high GWP HFCs involve the acquisition of commercial items. Applicability of the requirements to commercial items is necessary to be effective. The information collection requirements associated with this case are covered under OMB clearance 9000-0191, High Global Warming Potential Hydrofluorocarbons, in the amount of 25,376 total annual burden hours.
d. FAR 52.223-22, Public Disclosure of Greenhouse Gas Emissions and Reduction Goals—Representation (FAR Case 2015-024, 81 FR 33192 and 81 FR 83092), is prescribed for use at FAR 23.804(b). The provision at 52.223-22, Public Disclosure of Greenhouse Gas Emissions and Reduction Goals—Representation, is required only when 52.204-7, System for Award Management, is included in the solicitation (see 52.204-8, Annual Representations and Certifications).
The information obtained from these representations will assist agencies in developing strategies to engage with offerors to reduce supply chain emissions, as directed in Executive Order 13693, Planning for Federal Sustainability in the Next Decade. In response to the proposed rule, one respondent remarked that the rule should not exclude commercial item or COTS item vendors from the disclosure requirements, because then the benefits of the rule would be “sub-optimal.”
The Federal Acquisition Regulatory Council determined that the rule would apply to acquisitions of commercial items, including commercially available off-the-shelf (COTS) items, if the contractor has been awarded contracts of more than $7.5 million in goods and services during the prior Government fiscal year. The FAR Council considered (i) The benefits of the policy in furthering Administration goals; (ii) the extent to which the benefits of the policy would be reduced if exemptions are provided; and (iii) the burden on contractors if the policy is applied to these categories of spend. By developing an inventory of contractor greenhouse gas (GHG) management practices, the Government can more fully understand the current state of activity by companies doing business with the Government and work with contractors over time to develop appropriate strategies to reduce supply chain emissions. GHG reporting is becoming increasingly commonplace in the commercial marketplace. If an exclusion were provided to sellers of commercial items and COTS, a large number of contractors that sell in both the commercial and Federal marketplace would be exempted and the rule would fail at providing the type of information and insight that is needed to help agencies assess supplier GHG management practices. With respect to the third factor, the FAR Council sought to minimize burden associated with the disclosure requirement. Specifically, the disclosure will apply only to major Federal suppliers who have been awarded contracts totaling more than $7.5 million in goods and services in the prior Government fiscal year. Based on fiscal year (FY) 2015 data, the FAR Council estimated this requirement would cover approximately 5,500 unique entities, including about 2,700 small businesses. This represents approximately 3.5 percent of total entities that did business with the Federal Government in FY 2015, and 2.6 percent of small businesses. The FAR Council projected a minimal paperwork burden associated with the disclosure, approximately .25 hours per response for annual reporting for the 5,500 contractor, or 1,375 hours (OMB clearance 9000-0194, Public Disclosure of Greenhouse Gas Emissions and Reduction Goals). Accordingly, the FAR Council determined that it would not be in the best interest of the Government to exclude application of the rule for acquisitions, or sellers, of commercial items or COTS.
Section 874(b) requires that the Under Secretary of Defense for Acquisition, Technology, and Logistics (now Under Secretary of Defense for Acquisition and Sustainment) shall ensure that the DFARS does not require inclusion of contract clauses in contracts for the procurement of commercial items or contracts for the procurement of COTS items, unless those clauses are required to implement provisions of law or executive orders applicable to such contracts, or determined to be consistent with standard commercial practice. This requirement is essentially the same as the requirement at 41 U.S.C. 3307, which is implemented at FAR 12.301(a). Since the DFARS supplements the FAR, FAR 12.301(a) is already applicable to DoD.
Currently, FAR clauses 52.212-5, 52.244-6, and DFARS clause 52.244-7000, require flowdown of certain clauses to subcontracts for commercial items, but allow the contractor to flow down “a minimal number of additional clauses necessary to satisfy its contractual obligations.” One of the respondents to the proposed rule under DFARS Case 2011-D056, Solicitation Provisions and Contract Clauses for the Acquisition of Commercial Items, (Proprietary Industries Association) commented back in May of 2012 that this allowance of a minimal number of necessary clauses was being abused by contractors, who were overloading commercial item subcontracts “with whatever flowdown clauses they felt were even remotely deemed necessary, regardless of any harmful consequences to the Governments commercial item acquisition process.” We now have a statutory prohibition on such discretionary overloading of commercial item subcontracts (although still providing “to the maximum extent practicable). This rule proposes that any discretion to impose flowdown of clauses that are not based on statute or Executive order shall rest with the Government, not with the contractors. They will be prohibited from flowing down FAR or DFARS clauses to commercial items, unless flow down is specifically required in the FAR or DFARS. A contractor can, of course, still impose its own requirements on subcontractors, but cannot just flow down FAR and DFARS clauses as a whole. DoD invites specific comment on the extent to which FAR and DFARS clauses are flowed down to subcontracts on an optional basis and the expected burden reduction that may result from this prohibition.
10 U.S.C. 2375(c)(3) provides a definition of “subcontract” that includes transfers of commercial items between divisions, subsidiaries, or affiliates, of a contractor or subcontractor, but excludes supplier agreements entered into by a contractor for the supply of commodities that are intended for use in the performance of multiple contracts with DoD and other parties and are not identifiable to any particular contract. This definition is similar to the definition of “subcontract” at FAR 44.101, which states that the subcontract is “entered into by a subcontractor to furnish supplies or services for performance of a prime contract or subcontract,” but is more explicit in the exclusion of supplier agreements that are not associated with a single contract. This definition has been added to the clause at DFARS 252.244-7000 and each DFARS clause that requires flowdown to subcontracts for the acquisition of commercial items, with specified applicability to the flowdown paragraph of the clause. In general, the clauses now clearly exclude flowdown to supplier agreements that are not identifiable to any particular contract.
However, DoD has determined that the provisions of section 818 of Public Law 112-81 for the prohibitions against counterfeit and suspect counterfeit electronic items and the requirements for systems to detect such parts must flow down to all levels of the supply chain without exception for any contractual instrument that could be used to acquire electronic parts. Therefore, with regard to the DFARS clauses 252.246-7007, Contractor Counterfeit Electronic Part Detection and Avoidance System, and 252.246-7008, Sources of Electronic Parts, the flowdown has been modified to include flowdown to contractual instruments other than subcontracts (such supplier agreements), because electronic commodity types are often acquired from suppliers through supplier agreements that do not meet the new definition of “subcontract.” Exempting acquisitions of such electronic parts from the DFARS 252.246-7007 and 252.246-7008 flowdown requirements would create unacceptable risks of introducing counterfeit or suspect counterfeit electronic parts into the
This rule reviews the current applicability of defense-unique statute and Governmentwide provisions and clause, issued since January 1, 2015, not expressly authorized in law. DoD solicits public comments, especially with regard to the applicability of the two defense-unique statutes at section II.B.3 of this preamble and the FAR and DFARS provisions and clauses at section II.C.2. and II.C.3., for which the Director of Defense Procurement and Acquisition Policy is considering whether to sign a determination and finding in support of continued applicability to commercial items, or whether all commercial items or just COTS items should be exempt from a particular requirement. Please provide specific rationale for any recommendations.
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.
This rule is not an E.O. 13771, Reducing Regulation and Controlling Regulatory Costs, regulatory action, because this rule is not significant under E.O. 12866.
DoD does not expect this proposed rule to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601
This proposed rule is required in order to implement section 874 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2017, which amended 10 U.S.C. 2375 and required certain changes to the Defense Federal Acquisition Regulation Supplement (DFARS).
The objective of the rule is to reduce any unnecessary burdens on contractors and subcontractors that were awarded DoD contracts or subcontracts for the acquisition of commercial items, including commercially available off-the-shelf items. The legal basis for the rule is section 874 of the NDAA for FY 2017.
There were 29,833 unique entities awarded DoD contracts exceeding the micro-purchase threshold and using FAR part 12 procedures in FY 2016, of which 21,857 were unique small entities. DoD estimates there may be at least twice that many small entities receiving subcontracts for commercial items. Any reductions in the applicability of provisions and clauses to contracts and subcontracts for the acquisition of commercial items may be beneficial to these small entities.
There are no projected reporting, recordkeeping, or other compliance requirements associated with this rule. The final rule may result in some reductions of reporting or recordkeeping requirements, currently approved under—
• OMB Control Number 0704-0478, Safeguarding Covered Defense Information, Cyber Incident Reporting, and Cloud Computing.
• OMB Control Number 9000-0191, High Global Warming Potential Hydrofluorocarbons.
• OMB Control Number 9000-0194, Public Disclosure of Greenhouse Gas Emissions and Reduction Goals.
The rule does not duplicate, overlap, or conflict with any other Federal rules.
Any impacts of this rule will have a positive impact on small business entities.
DoD invites comments from small business concerns and other interested parties on the expected impact of this rule on small entities.
DoD will also consider comments from small entities concerning the existing regulations in subparts affected by this rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C. 610 (DFARS Case 2017-D010), in correspondence.
The rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35). However, if some of the requirements are made inapplicable to the acquisition of all commercial items, or just COTS items, then the estimated burden of the following information collection requirements could be reduced:
• OMB Control Number 0704-0478, Safeguarding Covered Defense Information, Cyber Incident Reporting, and Cloud Computing.
• OMB Control Number 9000-0191, High Global Warming Potential Hydrofluorocarbons.
• OMB Control Number 9000-0194, Public Disclosure of Greenhouse Gas Emissions and Reduction Goals.
Government procurement.
Therefore, 48 CFR parts 212, 219, and 252 are proposed to be amended as follows:
41 U.S.C. 1303 and 48 chapter 1.
(1) Includes a transfer of commercial items between divisions, subsidiaries, or affiliates of a contractors or subcontractor; and
(2) Does not include agreements entered into by a contractor for the supply of commodities that are intended for use in the performance of multiple contracts with the Department of Defense and other parties and are not identifiable to any particular contract. (10 U.S.C. 2375(c)(3))
The following provisions and clauses, not expressly authorized in law, are inapplicable to contracts for the acquisition of commercial items:
(a) FAR 52.204-22, Alternative Line Item Proposal.
(b) 252.219-7010, Notification of Competition Limited to Eligible 8(a) Concerns—Partnership Agreement.
Commercially available off-the-shelf (COTS) items are a subset of commercial items. Therefore, any provisions and clauses are inapplicable to contracts or subcontracts for the acquisition of COTS items if listed in section 212.370 of this subpart as inapplicable to contracts or subcontracts for the acquisition of commercial items. In addition, the following provisions and clauses published after January 1, 2015, not expressly authorized in law, are inapplicable to the acquisition of COTS items (provisions and clauses for the acquisition of services, which by definition are not COTS items, are not listed):
(a) FAR 52.204-21, Basic Safeguarding of Covered Contractor Information Systems.
(b) Reserved
(a) In addition to the laws listed at FAR 12.503, the following laws are not applicable to contracts for the acquisition of commercial items:
(a) In addition to the laws listed at FAR 12.504, the following laws are not applicable to subcontracts at any tier for the acquisition of commercial items or commercial components:
Commercially available off-the-shelf (COTS) items are a subset of commercial items. Therefore, any laws listed at FAR 12.503, FAR 12.504, 212.503, or 212.504 are also inapplicable or modified in their applicability to contracts or subcontracts for the acquisition of COTS items. In addition to the laws listed at FAR 12.505 as specifically inapplicable to COTS items, the following laws are inapplicable to contracts or subcontracts for the acquisition of COTS items:
(1) Paragraph (a)(1) of 10 U.S.C. 2533b, Requirement to buy strategic materials critical to national security from American sources, except as provided at 225.7003-3(b)(2)(i).
(2) Section 941 of the National Defense Authorization Act for Fiscal Year 2013 (Reports to Department of Defense on penetration of networks and information systems of certain contractors) and section 1632 of the National Defense Authorization Act for Fiscal year 2015 (Reporting on cyber incidents with respect to networks and information systems of operationally critical contractors).
(2) Use the clause at 252.219-7010, Notification of Competition Limited to Eligible 8(a) Concerns-Partnership Agreement, in lieu of the clause at FAR 52.219-18, Notification of Competition Limited to Eligible 8(a) Concerns, in competitive solicitations and contracts, excluding solicitations and contracts using FAR part 12 procedures for the acquisition of commercial items, when the acquisition is accomplished using the procedures of FAR 19.805 and processed in accordance with the partnership agreement cited in 219.800.
(a) * * *
(1) Includes a transfer of commercial items between divisions, subsidiaries, or affiliates of a contractors or subcontractor; and
(2) Does not include agreements entered into by a contractor for the supply of commodities that are intended for use in the performance of multiple contracts with the Department of Defense and other parties and are not identifiable to any particular contract. (10 U.S.C. 2375(c)(3))
The addition and revision reads as follows:
(a) * * *
(1) Includes a transfer of commercial items between divisions, subsidiaries, or affiliates of a contractors or subcontractor; and
(2) Does not include agreements entered into by a contractor for the supply of commodities that are intended for use in the performance of multiple contracts with the Department of Defense and other parties and are not identifiable to any particular contract. (10 U.S.C. 2375(c)(3))
(m) * * *
(1) Include this clause, including this paragraph (m), without alteration except to identify the parties, in subcontracts, or similar contractual instruments, for operationally critical support, or for
(a) * * *
(1) Includes a transfer of commercial items between divisions, subsidiaries, or affiliates of a contractors or subcontractor; and
(2) Does not include agreements entered into by a contractor for the supply of commodities that are intended for use in the performance of multiple contracts with the Department of Defense and other parties and are not identifiable to any particular contract. (10 U.S.C. 2375(c)(3))
(a) * * *
(1) Includes a transfer of commercial items between divisions, subsidiaries, or affiliates of a contractors or subcontractor; and
(2) Does not include agreements entered into by a contractor for the supply of commodities that are intended for use in the performance of multiple contracts with the Department of Defense and other parties and are not identifiable to any particular contract. (10 U.S.C. 2375(c)(3))
(a) * * *
(1) Includes a transfer of commercial items between divisions, subsidiaries, or affiliates of a contractors or subcontractor; and
(2) Does not include agreements entered into by a contractor for the supply of commodities that are intended for use in the performance of multiple contracts with the Department of Defense and other parties and are not identifiable to any particular contract. (10 U.S.C. 2375(c)(3)
(a) * * *
(1) Includes a transfer of commercial items between divisions, subsidiaries, or affiliates of a contractors or subcontractor; and
(2) Does not include agreements entered into by a contractor for the supply of commodities that are intended for use in the performance of multiple contracts with the Department of Defense and other parties and are not identifiable to any particular contract. (10 U.S.C. 2375(c)(3))
(a) * * *
(1) Includes a transfer of commercial items between divisions, subsidiaries, or affiliates of a contractors or subcontractor; and
(2) Does not include agreements entered into by a contractor for the supply of commodities that are intended for use in the performance of multiple contracts with the Department of Defense and other parties and are not identifiable to any particular contract. (10 U.S.C. 2375(c)(3))
(a) * * *
(1) Includes a transfer of commercial items between divisions, subsidiaries, or affiliates of a contractors or subcontractor; and
(2) Does not include agreements entered into by a contractor for the supply of commodities that are intended for use in the performance of multiple contracts with the Department of Defense and other parties and are not identifiable to any particular contract. (10 U.S.C. 2375(c)(3))
The additions read as follows:
(a)
(1) Includes a transfer of commercial items between divisions, subsidiaries, or affiliates of a contractors or subcontractor; and
(2) Does not include agreements entered into by a contractor for the supply of commodities that are intended for use in the performance of multiple contracts with the Department of Defense and other parties and are not identifiable to any particular contract.
(e)
The additions read as follows:
(a)
(1) Includes a transfer of commercial items between divisions, subsidiaries, or affiliates of a contractors or subcontractor; and
(2) Does not include agreements entered into by a contractor for the supply of commodities that are intended for use in the performance of multiple contracts with the Department of Defense and other parties and are not identifiable to any particular contract. (10 U.S.C. 2375(c)(3))
(e)
(a) * * *
(1) Includes a transfer of commercial items between divisions, subsidiaries, or affiliates of a contractors or subcontractor; and
(2) Does not include agreements entered into by a contractor for the supply of commodities that are intended for use in the performance of multiple contracts with the Department of Defense and other parties and are not identifiable to any particular contract. (10 U.S.C. 2375(c)(3))
(a) * * *
(1) Includes a transfer of commercial items between divisions, subsidiaries, or affiliates of a contractors or subcontractor; and
(2) Does not include agreements entered into by a contractor for the supply of commodities that are intended for use in the performance of multiple contracts with the Department of Defense and other parties and are not identifiable to any particular contract. (10 U.S.C. 2375(c)(3))
(a) * * *
(1) Includes a transfer of commercial items between divisions, subsidiaries, or affiliates of a contractors or subcontractor; and
(2) Does not include agreements entered into by a contractor for the supply of commodities that are intended for use in the performance of multiple contracts with the Department of Defense and other parties and are not identifiable to any particular contract. (10 U.S.C. 2375(c)(3))
The additions read as follows:
(a)
(1) Includes a transfer of commercial items between divisions, subsidiaries, or affiliates of a contractors or subcontractor; and
(2) Does not include agreements entered into by a contractor for the supply of commodities that are intended for use in the performance of multiple contracts with the Department of Defense and other parties and are not identifiable to any particular contract. (10 U.S.C. 2375(c)(3))
(b) The Contractor shall not flow down the terms of any Federal Acquisition Regulation (FAR) clause or Defense Federal Acquisition Regulation Supplement (DFARS) clause in subcontracts for commercial items at any tier under this contract, unless—
(1) For DFARS clauses, it is so specified in the particular clause; or
(2) For FAR clauses, the clause is listed at FAR 12.301(d) or it is so specified in paragraph (e)(1) of the clause at FAR 52.212-5 or paragraph (b)(1) of the clause at FAR 542.244-6, as applicable.
(c)
The additions and revision read as follows:
(a) * * *
(1) Includes a transfer of commercial items between divisions, subsidiaries, or affiliates of a contractors or subcontractor; and
(2) Does not include agreements entered into by a contractor for the supply of commodities that are intended for use in the performance of multiple contracts with the Department of Defense and other parties and are not identifiable to any particular contract. (10 U.S.C. 2375(c)(3))
(f)(1)
The addition and revision read as follows:
(a) * * *
(1) Includes a transfer of commercial items between divisions, subsidiaries, or affiliates of a contractors or subcontractor; and
(2) Does not include agreements entered into by a contractor for the supply of commodities that are intended for use in the performance of multiple contracts with the Department of Defense and other parties and are not identifiable to any particular contract. (10 U.S.C. 2375(c)(3))
(e)
The addition and revision read as follows:
(a) * * *
(1) Includes a transfer of commercial items between divisions, subsidiaries, or affiliates of a contractors or subcontractor; and
(2) Does not include agreements entered into by a contractor for the supply of commodities that are intended for use in the performance of multiple contracts with the Department of Defense and other parties and are not identifiable to any particular contract. (10 U.S.C. 2375(c)(3))
(e)
The additions read as follows:
(a)
(1) Includes a transfer of commercial items between divisions, subsidiaries, or affiliates of a contractors or subcontractor; and
(2) Does not include agreements entered into by a contractor for the supply of commodities that are intended for use in the performance of multiple contracts with the Department of Defense and other parties and are not identifiable to any particular contract. (10 U.S.C. 2375(c)(3))
(d)
The additions read as follows:
(a) * * *
(1) Includes a transfer of commercial items between divisions, subsidiaries, or affiliates of a contractors or subcontractor; and
(2) Does not include agreements entered into by a contractor for the supply of commodities that are intended for use in the performance of multiple contracts with the Department of Defense and other parties and are not identifiable to any particular contract.
(h)
(a) * * *
(1) Includes a transfer of commercial items between divisions, subsidiaries, or affiliates of a contractors or subcontractor; and
(2) Does not include agreements entered into by a contractor for the supply of commodities that are intended for use in the performance of multiple contracts with the Department of Defense and other parties and are not identifiable to any particular contract. (10 U.S.C. 2375(c)(3))
(h)
(a) * * *
(1) Includes a transfer of commercial items between divisions, subsidiaries, or affiliates of a contractors or subcontractor; and
(2) Does not include agreements entered into by a contractor for the supply of commodities that are intended for use in the performance of multiple contracts with the Department of Defense and other parties and are not identifiable to any particular contract. (10 U.S.C. 2375(c)(3))
(h)
Defense Acquisition Regulations System, Department of Defense (DoD).
Proposed rule.
DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to partially implement a section of the National Defense Authorization Act for Fiscal Year 2017 to address the requirement for certification of cost or pricing data and potential submission of additional certified cost or pricing data when only one offer is received in response to a competitive solicitation.
Comments on the proposed rule should be submitted in writing to the address shown below on or before August 28, 2018, to be considered in the formation of a final rule.
Submit comments identified by DFARS Case 2017-D009, using any of the following methods:
○
○
○
○
Comments received generally will be posted without change to
Ms. Amy G. Williams, telephone 571-372-6106.
DoD is proposing to revise the DFARS to partially implement section 822 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2017 (Pub. L. 114-328) to (1) address the potential requirement for certification of cost or pricing data and potential requirement for additional certified cost or pricing data when only one offer is received in response to a competitive solicitation and (2) make prime contractors responsible for determining whether a subcontract qualifies for an exception from the requirement for submission of certified cost based on adequate price competition. This DFARS rule supplements the rule proposed under FAR Case 2017-006, Exception from Certified Cost or Pricing Data Requirements-Adequate Price Competition, which proposes to modify the standards for adequate price competition at FAR 15.403-1(c) for DoD, NASA, and the Coast Guard (83 FR 27303, June 12, 2018). Section 822 requires that for DoD, NASA, and the Coast Guard, adequate price competition requires a price that is based on adequate competition that results in at least two or more responsive and viable offers from independently competing offerors.
DoD published a final rule in the
Once it has been determined that only one offer was received, the exception to the requirement for certified cost or pricing data based on adequate price competition at FAR 15.403-1(b)(1) can no longer apply. Therefore, cross references to FAR 15.403-1(b) are limited to the other exceptions at paragraphs (b)(2) through (5) of that section (see DFARS 215.371-3(a) and (b) and 252.215-7008(a)(2)).
When there is a reasonable expectation of competition, but only one offer is received, FAR 15.403-1(c)(1)(ii) allows in limited circumstances, with approval at a level above the contracting officer, a determination that the proposed price was based on adequate price competition and was reasonable. Without such determination, certified cost or pricing data would be required for acquisitions that exceed the threshold for obtaining certified cost or pricing data, unless another exception at FAR 15.403-1(b) applies. This limited exception, based on a determination at a level above the contracting officer, is no longer applicable to DoD. Therefore, DFARS 215.371-3(a) is removed.
The requirements at DFARS 215.371-3(b) are streamlined (proposed as DFARS 215.371-3(a) through (d)), with additional emphasis on the requirement to obtain certified cost or pricing data when only one offer is received. The introductory text is also revised to exempt contracts valued at or below simplified acquisition threshold.
The prescription at DFARS 215.408(3)(i) for DFARS provision 252.215-7008 is also being revised to exempt contracts valued at or below simplified acquisition threshold and remove the reference to the exceptions at DFARS 215.371-4(a), which are not applicable to the requirement to obtain certified cost or pricing data. In addition, paragraph (3)(ii) of the prescription is removed; the requirement to use the provision at DFARS 252.215-7010 (previously FAR 52.215-20) in solicitations that include DFARS 252.215-7008 is relocated to the prescription for DFARS 252.215-7010 at DFARS 215.408(5).
DFARS provision 252.215-7008 covers the requirements for when only one offer is received in response to a DoD solicitation, but also contains much of the same text as FAR provision 52.215-20, Requirements for Certified Cost or Pricing Data and Data Other Than Certified Cost or Pricing Data, because this provision was prescribed for use in lieu of the FAR provision. However, on January 31, 2018, DoD published a final rule in the
In addition, a new paragraph is added to DFARS 252.215-7010 (basic and alternate), to state that the offeror is responsible for determining whether a subcontractor qualifies for an exception from the requirement for submission of certified cost on the basis of adequate price competition.
This rule does not create a new provision, but amends the existing provisions at DFARS 252.215-7008 and 252.215-7010. Although the existing provisions apply to solicitations for the acquisition of commercial items (including COTS items), the changes due to this rule do not impact the acquisition of commercial item, including COTS items, because the rule retains the exceptions to the requirements for certified cost or pricing data relating to acquisition of commercial items. In addition, DFARS 252.215-7010 already applies to contracts valued at or below the SAT, while DFARS 252.215-7008 does not.
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.
This final rule is not subject to E.O. 13771, Reducing Regulation and controlling Regulatory Costs, because this rule is not a significant regulatory action under E.O. 12866.
DoD does not expect this proposed rule to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601,
The reason for this rule is to further implement section 822 of the National Defense Authorization Act for Fiscal Year 2017 (Pub. L. 114-328) to (1) address the potential requirement for certified cost or pricing data when only one offer is received in response to a competitive solicitation, if no other exception to the requirements for certified cost or pricing data applies; and (2) make prime contractors responsible for determining whether a subcontract qualifies for an exception from the requirement for submission of certified cost based on adequate price competition. This DFARS rule
The objective of this rule is to implement the new and more restrictive standard for “adequate price competition” as the basis for an exception to the requirement to provide certified cost or pricing data. The statutory basis is 10 U.S.C. 2306a, as amended by section 822 of the NDAA for FY 2017. DoD will now be required to obtain certified cost or pricing data from an offeror when only one offer is received and no other exception applies.
According to data for FY 2016 from the Federal Procurement Data System, there were 918 noncommercial, competitive new DoD awards valued at greater than $750,000 (the certified cost or pricing data threshold) that were awarded on the basis of a solicitation that received only one offer. Of the 918 awards, 549 were awarded to small businesses (428 unique small entities). DoD estimates that of these awards, all would require certification under the new rule, and might also require submission of additional data. With regard to subcontracts, DoD estimates that when certification or additional certified cost or pricing data are requested from the prime contractor, 1386 subcontract awards may be affected, of which 1,505 are awarded to small businesses (1,141 unique small entities). In addition, DoD awarded 839 negotiated contracts and orders valued as more than $750,000, for which certified cost or pricing data were required. DoD estimates that for each prime contractor providing certified cost or pricing data, there may be an average of one additional competitive subcontract for which certified cost or pricing data will now be required because there is only one offer on that subcontract. DoD estimated that 703 of those subcontracts are awarded to small businesses (504 unique small entities).
The rule does not duplicate, overlap, or conflict with any other Federal rules.
DoD was unable to identify any alternatives that would reduce burden on small business and still meet the requirements of the statute. Impact on small businesses is lessened because the requirement for certified cost or pricing data only applies to acquisitions that exceed $750,000 and there is an exception for the acquisition of commercial items, including COTS items.
DoD invites comments from small business concerns and other interested parties on the expected impact of this rule on small entities.
DoD will also consider comments from small entities concerning the existing regulations in subparts affected by this rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C 610 (DFARS Case 2017-D009), in correspondence.
The rule contains information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35). Accordingly, DoD has submitted a request for approval of a new information collection requirement concerning Only One Offer (DFARS Case 2017-D009) to the Office of Management and Budget.
The annual reporting burden estimated as follows:
Written comments and recommendations on the proposed information collection, including suggestions for reducing this burden, should be sent to Ms. Jasmeet Seehra at the Office of Management and Budget, Desk Officer for DoD, Room 10236, New Executive Office Building, Washington, DC 20503, or email
Public comments are particularly invited on: Whether this collection of information is necessary for the proper performance of functions of the DFARS, and will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.
To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to the Defense Acquisition Regulations System, Attn: Ms. Amy G. Williams, OUSD(AT&L)DPAP/DARS, Room 3B941, 3060 Defense Pentagon, Washington, DC 20301-3060, or email
Government procurement.
Therefore, 48 CFR parts 215 and 252 are proposed to be amended as follows:
41 U.S.C. 1303 and 48 CFR chapter 1.
For acquisitions that exceed the simplified acquisition threshold, if only one offer is received when competitive procedures were used and it is not necessary to resolicit in accordance with 215.371-2(a), then—
(a) If no additional cost or pricing data are required to determine through cost or price analysis that the offered price is fair and reasonable, the contracting officer shall require that any cost or pricing data provided in the proposal be certified if the acquisition exceeds the certified cost or pricing data threshold and an exception to the requirement for certified cost or pricing data at FAR 15.403-1(b)(2) through (5) does not apply.
(b) Otherwise, the contracting officer shall obtain additional cost or pricing
(c) If the contracting officer is still unable to determine that the offered price is fair and reasonable, the contracting officer shall enter into negotiations with the offeror to establish a fair and reasonable price. The negotiated price should not exceed the offered price.
(d) If the contracting officer is unable to negotiate a fair and reasonable price, see FAR 15.405(d).
The revision reads as follows:
(3) Use the provision at 252.215-7008, Only One Offer, in competitive solicitations that exceed the simplified acquisition threshold, including solicitations using FAR part 12 procedures for the acquisition of commercial items.
The revision and addition read as follows:
(a) After initial submission of offers, if the Contracting Officer notifies the Offeror that only one offer was received, the Offeror agrees to—
(1) Submit any additional cost or pricing data that is required in order to determine whether the price is fair and reasonable or to comply with the statutory requirement for certified cost or pricing data (10 U.S.C. 2306a and FAR 15.403-3); and
(2) Except as provided in paragraph (b) of this provision, if the acquisition exceeds the certified cost of pricing data threshold and an exception to the requirement for certified cost or pricing data at FAR 15.403-1(b)(2) through (5) does not apply, certify all cost or pricing data in accordance with paragraph (c) of provision 252.215-7010, Requirements for Certified Cost or Pricing Data and Data Other Than Certified Cost or Pricing Data, of this solicitation.
(c)
(End of provision)
The additions read as follows:
(c) * * *
(3) The Offeror is responsible for determining whether a subcontractor qualifies for an exception from the requirement for submission of certified cost or pricing data on the basis of adequate price competition,
(c) * * *
(3) The Offeror is responsible for determining whether a subcontractor qualifies for an exception from the requirement for submission of certified cost or pricing data on the basis of adequate price competition,
Defense Acquisition Regulations System, Department of Defense (DoD).
Proposed rule.
DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to revise a clause to reflect current terminology and industry practices, pursuant to action taken by the Regulatory Reform Task Force.
Comments on the proposed rule should be submitted in writing to the address shown below on or before August 28, 2018, to be considered in the formation of a final rule.
Submit comments identified by DFARS Case 2018-D025, using any of the following methods:
•
•
•
•
Comments received generally will be posted without change to
Ms. Carrie Moore, telephone 571-372-6093.
This rule proposes to revise the DFARS by modifying DFARS clause 252.217-7001, Surge Option, to replace the term “Production Surge Plan (DI-MGMT-80969)” with “Capabilities Analysis Plan (CAP)” and add text to permit the option increase of supplies or services called for under the clause to be expressed as a specific number. The associated clause prescription at DFARS 217.208-70(b) is proposed to be amended to reflect that the option increase of supplies or services may also be expressed as a specific number.
This clause is incorporated into contracts that support industrial planning for selected essential military items in the event of a national emergency. Currently, the clause advises contractors that the Government has the option to increase the supplies or services delivered under the contract up to a specified percentage or accelerate the rate of delivery. It also instructs contractors to follow the Production Surge Plan (DI MGMT 80969) included in the contract or, if no plan is in the contract, to provide a delivery schedule to the Government within 30 days of contract award. A review of the clause text indicates that it should be modified to reflect current practices in the marketplace.
Paragraphs (b)(1) and (2) of DFARS clause 252.217-7001 include a reference to a Production Surge Plan (DI MGMT 80969). DoD subject matter experts advise that Production Surge Plan (DI MGMT 80969) is no longer an up-to-date reference and that Capabilities Analysis Plan (CAP) is the current terminology used in industrial planning efforts. This rule will update the clause paragraphs to reflect the current industry terminology.
Paragraph (a) of the DFARS clause provides contractors with a maximum quantity of supplies or services by which the Government may increase the contract in order to support a surge need. This quantity is expressed as a percentage of the supplies or services currently being provided for under the contract. Supply chains supporting surge needs more commonly express increases of supplies or services as a specific number of additional supplies or services to be provided under the contract, as opposed to an additional percentage of the supplies or services already being provided under the contract. In order to reflect current supply chain practices, this rule proposes to permit the contracting officer to express DoD's surge need as a specific quantity of supplies or services needed, or utilize the existing method of expressing the surge need as a percentage of contracted supplies or services.
The proposed revision to this DFARS clause supports a recommendation from the DoD Regulatory Reform Task Force. On February 24, 2017, the President signed Executive Order (E.O.) 13777, “Enforcing the Regulatory Reform Agenda,” which established a Federal policy “to alleviate unnecessary regulatory burdens” on the American people. In accordance with E.O. 13777, DoD established a Regulatory Reform Task Force to review and validate DoD regulations, including the DFARS. A public notice of the establishment of the DFARS Subgroup to the DoD Regulatory Reform Task Force, for the purpose of reviewing DFARS provisions and clauses, was published in the
This rule does not propose to create any new provisions or clauses. The proposed changes to DFARS clause 252.217-7001, Surge Option, are minimal and reflect only updates required to mirror current industry terminology and practice for support that may be required for industrial planning for selected essential military items in the event of a national emergency. The rule applies to contracts below the SAT, however, the rule does not apply to commercial items and COTS items.
Executive Order (E.O.) 12866, Regulatory Planning and Review; and E.O. 13563, Improving Regulation and Regulatory Review, 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). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. The Office of Management and Budget, Office of Information and Regulatory Affairs (OIRA), has determined that this is not a significant regulatory action as defined under section 3(f) of E.O. 12866 and, therefore, was not subject to review under section 6(b). This rule is not a major rule as defined at 5 U.S.C. 804(2).
This rule is not an E.O. 13771, Reducing Regulation and Controlling Regulatory Costs, regulatory action, because this rule is not significant under E.O. 12866.
DoD does not expect this proposed rule to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601
The Department of Defense is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to revise a clause to reflect current terminology and industry practices, pursuant to action taken by the Regulatory Reform Task Force.
The objective of this proposed rule is to improve the flexibility offered to contractors when submitting pricing by giving the option to quote prices by percentage or quantity increases and update the terminology used from “Production Surge Plan” to “Capability Analysis Plan” (CAP). The modification of this DFARS text supports a recommendation from the DoD Regulatory Reform Task Force.
This rule is not expected to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601,
This proposed rule does not include any new reporting, recordkeeping, or other compliance requirements for small businesses. This rule does not duplicate, overlap, or conflict with any other Federal rules. There are no known significant alternative approaches to the
The rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).
Government procurement.
Therefore, 48 CFR parts 217 and 252 are proposed to be amended as follows:
41 U.S.C. 1303 and 48 CFR chapter 1.
The revision reads as follows:
(a) * * *
(1) Increase the quantity of supplies or services called for under this contract by no more than __ percent or __
Defense Acquisition Regulations System, Department of Defense (DoD).
Proposed rule.
DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to clarify policies and procedures for submission of payment requests and receiving reports in electronic form.
Comments on the proposed rule should be submitted in writing to the address shown below on or before August 28, 2018, to be considered in the formation of a final rule.
Submit comments identified by DFARS Case 2016-D032, using any of the following methods:
•
•
•
•
Comments received generally will be posted without change to
Ms. Jennifer D. Johnson, telephone 571-372-6100.
This proposed rule clarifies and, where necessary, updates policies and procedures for providing electronic payment-related documents and for processing payment requests and receiving reports in Wide Area WorkFlow (WAWF). Title 10 of the United States Code (U.S.C.), section 2227, Electronic Submission and Processing of Claims for Contract Payments, requires that any claim for payment under a DoD contract be in electronic format. If electronic submission is unduly burdensome, 10 U.S.C. 2227 allows an exemption. DoD published a final rule in the
Some contractors have been prevented from using WAWF for some contracts because of a misinterpretation of the exemptions in DFARS subpart 232.70, Electronic Submission and Processing of Payment Requests and Receiving Reports. This proposed rule clarifies those exemptions and allows contractors to request permission from the contracting officer, in writing, to submit payment requests and receiving reports using temporary alternative methods, other than in electronic form.
DoD is proposing to amend DFARS parts 232, 246, 252, and Appendix F to clarify and, where necessary, update the policies and procedures for electronic submission of payment requests and receiving reports. The following is a summary of the proposed changes:
• DFARS subpart 232.70, Electronic Submission and Processing of Payment Requests and Receiving Reports. Definitions of the terms “electronic form,” “payment request,” and “receiving report” are inserted in their entirety in lieu of the reference stating that the terms are defined in the clause at DFARS 252.232-7003, Electronic Submission of Payment Requests. The policy on exceptions to submission of payment requests in electronic form is clarified by deleting the current list of exceptions at DFARS 232.7002(a)(ii) and providing a more general exception for cases in which contractor submission of electronic payment requests is not feasible (
• DFARS 246.370, Material Inspection and Receiving Report. This section, which contains the prescription for the clause at DFARS 252.246-7000, Material Inspection and Receiving Reports, is deleted, because the clause is being deleted.
• DFARS 246.471, Authorizing Shipment of Supplies. This section is revised to prevent the use of alternative procedures (
• DFARS 252.232-7003, Electronic Submission and Processing of Payment Requests and Receiving Reports. This clause is revised to clarify that a contractor may use methods other than WAWF to submit a payment request and receiving report when the contracting officer has authorized and provided instructions for the use of nonelectronic methods in the contract administration data section of the contract. The requirement for contractors to submit a receiving report at the time of each delivery of supplies or services under a contract is relocated to this clause from DFARS 252.246-7000, which is being deleted. In addition, policy statements are removed from the definition of “electronic form;” and in the definition of “receiving report,” a reference to the deleted clause 252.246-7000 is replaced with a reference to DFARS Appendix F, Material Inspection and Receiving Report.
• DFARS 252.232-7006, Wide Area WorkFlow Payment Instructions. This clause is revised to clarify the type of payment request to be used for cost-type line items, fixed-price line items, and various contract financing payments. The use of the WAWF “combo” document type and the use of Department of Defense Activity Address Codes are also clarified. The requirement to ensure a receiving report complies with DFARS Appendix F is relocated to this clause from DFARS 252.246-7000, which is being deleted.
• DFARS 252.246-7000, Material Inspection and Receiving Report. This clause is deleted in its entirety because its procedures predate the WAWF automated procedures and processes. Therefore, much of this clause is now obsolete. The relevant text has been relocated to DFARS 252.232-7003, Electronic Submission and Processing of Payment Requests and Receiving Reports.
• Appendix F: Material Inspection and Receiving Report. This appendix is revised to remove a reference to the deleted clause 242.246-7000, to clarify the requirement to enter unit prices on WAWF receiving reports, and to include the requirement to enter estimated prices for foreign military sales shipments if actual prices are not available. Invoice submission and packing list instructions are also clarified.
This rule proposes to amend the clauses at DFARS 252.232-7003, Electronic Submission and Processing of Payment Requests and Receiving Reports, and 252.232-7006, Wide Area WorkFlow Payment Instructions. The objective of the rule is to clarify and, where necessary, update the policies and procedures for electronic submission of payment requests and receiving reports and amends the two clauses listed below.
DoD plans to continue to apply both clauses to contracts at or below the SAT and to the acquisition of commercial items, including COTS items, as defined at FAR 2.101. This rule clarifies and updates policies and procedures for electronic submission of payment requests and receiving reports. Not applying this guidance to contracts at or below the SAT and for the acquisition of commercial items, including COTS items, would exclude contracts intended to be covered by this rule and undermine the overarching purpose of the rule. Consequently, DoD plans to apply the rule to contracts at or below the SAT and for the acquisition of commercial items, including COTS items.
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.
This rule is not an E.O. 13771, Reducing Regulation and Controlling Regulatory Costs, regulatory action, because this rule is not significant under E.O. 12866.
DoD does not expect this proposed rule to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act 5 U.S.C. 601
The objective of the rule is to clarify and, where necessary, update policies and procedures for submission of payment requests and receiving reports in electronic form, which is accomplished through Wide Area WorkFlow (WAWF). The requirement for DoD contractors to submit payment requests in electronic form is already a requirement in existing DFARS clauses. This rule clarifies the exemptions in DFARS subpart 232.70, Electronic Submission and Processing of Payment Requests and Receiving Reports.
In fiscal year 2016, approximately 71,910 small businesses were registered to use WAWF.
This rule allows contractors to request permission, in writing, to submit payment requests and receiving reports using methods other than WAWF. Most small businesses that are DoD contractors are expected to prefer WAWF over other methods because of the advantages of using WAWF. Therefore, DoD estimates that approximately 70 small businesses may submit, on an annual basis, one request each for use of a temporary alternative method of submission of payment requests and receiving reports.
The rule does not duplicate, overlap, or conflict with any other Federal rules. There are no known significant
DoD invites comments from small business concerns and other interested parties on the expected impact of this rule on small entities. DoD will also consider comments from small entities concerning the existing regulations in subparts affected by this rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C. 610 (DFARS Case 2016-D032), in correspondence.
The paperwork Reduction Act (44 U.S.C. chapter 35) does apply; however, these proposed changes to the DFARS do not impose additional information collection requirements to the paperwork burden previously approved under Office of Management and Budget (OMB) Control Number 0704-0248, Defense Federal Acquisition Regulation Supplement, Appendix F, Inspection and Receiving Report.
Government procurement.
Therefore, 48 CFR parts 232, 246, 252, and appendix F to chapter 2 are proposed to be amended as follows:
41 U.S.C. 1303 and 48 CFR chapter 1.
As used in this subpart—
(a) Payment requests and receiving reports are required to be submitted in electronic form, except for—
(1) Classified contracts or purchases when electronic submission and processing of payment requests and receiving reports could compromise the safeguarding of classified information or national security;
(2) Cases in which contractor submission of electronic payment requests and receiving reports is not feasible (
(3) Cases in which DoD is unable to receive payment requests or provide acceptance in electronic form;
(4) Cases in which [the contractor has requested permission in writing to submit payment requests and receiving reports by nonelectronic means, and] the contracting officer [has provided instructions for a temporary alternative method of submission of payment requests and receiving reports in the contract administration data section of the contract or task or delivery order (
(5) When the Governmentwide commercial purchase card is used as the method of payment, only submission of the receiving report in electronic form is required.
(b)(1) The only acceptable electronic form for submission of payment requests and receiving reports is Wide Area WorkFlow (
(i) For payment of commercial transportation services provided under a Government rate tender, contract, or task or delivery order for transportation services, the use of a DoD-approved electronic third party payment system or other exempted vendor payment/invoicing system (
(ii) For submitting and processing payment requests and receiving reports for contracts or task or delivery orders for rendered health care services, the use of TRICARE Encounter Data System as the electronic form is permitted.
(2) Facsimile, email, and scanned documents are not acceptable electronic forms of payment requests or receiving reports.
(a) DoD officials receiving payment requests in electronic form shall process the payment requests in electronic form. The WAWF system provides the method to electronically process payment requests and receiving reports.
(1) Documents necessary for payment, such as receiving reports, invoice approvals, contracts, contract modifications, and required certifications, shall also be processed in electronic form.
(2) Scanned documents and other commonly used file formats are only acceptable for processing supporting documentation.
(b) If one of the exceptions to submission in electronic form at 232.7002(a) applies, the contracting officer shall—
(1) Consult the payment office and the contract administration office regarding the alternative method to be used for submission of payment requests or receiving reports (
(2) Provide procedures for invoicing in the contract administration data section of the contract or task or delivery order (
(a) Unless an exception to submission in electronic form at 232.7002(a) applies and instructions for invoices are contained in the contract administration data section of the contract or task or delivery order, use the clause at 252.232-7003, Electronic Submission of Payment Requests and Receiving Reports, in solicitations and contracts, including solicitations and contracts using FAR part 12 procedures for the acquisition of commercial items.
(b) Use the clause at 252.232-7006, Wide Area WorkFlow Payment Instructions, in solicitations and contracts or task or delivery orders, including solicitations and contracts using FAR part 12 procedures for the acquisition of commercial items, when 252.232-7003 is used and none of the exceptions at 232.7002(b)(1) apply. See PGI 232.7004 for instructions on completing the clause.
(b) * * *
(1) For foreign military sales (FMS) contracts, do not use alternative procedures.
As prescribed in 232.7004(a), use the following clause:
(a)
(b) Except as provided in paragraph (d) of this clause, the Contractor shall submit payment requests and receiving reports in electronic form using Wide Area WorkFlow (WAWF). The Contractor shall prepare and furnish to the Government a receiving report at the time of each delivery of supplies or services under this contract or task or delivery order.
(c) Submit payment requests and receiving reports to WAWF in one of the following electronic formats—
(1) Electronic Data Interchange;
(2) Secure File Transfer Protocol; or
(3) Direct input through the WAWF website.
(d) The Contractor may submit a payment request and receiving report using methods other than WAWF only when—
(1) The Contractor has requested permission in writing to do so, and the Contracting Officer has provided instructions for a temporary alternative method of submission of payment requests and receiving reports in the contract administration data section of this contract or task or delivery order;
(2) DoD makes payment for commercial transportation services provided under a Government rate tender or a contract for transportation services using a DoD-approved electronic third party payment system or other exempted vendor payment/invoicing system (
(3) DoD makes payment on a contract or task or delivery order for rendered health care services using the TRICARE Encounter Data System; or
(4) The Governmentwide commercial purchase card is used as the method of payment, in which case submission of only the receiving report in WAWF is required.
(e) Information regarding WAWF is available at
(f) In addition to the requirements of this clause, the Contractor shall meet the requirements of the appropriate payment clauses in this contract when submitting payment requests.
The revisions read as follows:
(f)
(1)
(i) For cost-type line items, including labor-hour or time-and-materials, submit a cost voucher.
(ii) For fixed price line items—
(A) That require shipment of a deliverable, submit the invoice and receiving report specified by the Contracting Officer;
(B) For services that do not require shipment of a deliverable, submit either the Invoice 2in1, which meets the requirements for the invoice and receiving report, or the applicable invoice and receiving report, as specified by the Contracting Officer.
(iii) For customary progress payments based on costs incurred, submit a progress payment request.
(iv) For performance based payments, submit a performance based payment request.
(v) For commercial item financing, submit a commercial item financing request.
(2) Fast Pay requests are only permitted when Federal Acquisition Regulation (FAR) 52.213-1 is included in the contract.
(3)
(4)
(5)
(g) * * *
(2) Contact the WAWF helpdesk at 866-618-5988, if assistance is needed.
The revisions read as follows:
(b) * * *
(18) UNIT PRICE. When using the WAWF RRR, the unit price is the price of the repair, overhaul, or maintenance service from the contract.
(i) The contractor may, at its option, enter unit prices on the WAWF RR, except when the contract has Item Unique Identification (IUID) requirements and the receiving report is being processed in WAWF, the unit price must represent the acquisition cost that will be recorded in the IUID registry. Therefore, in such cases, the unit price is required. See DFARS 252.211-7003, Item Unique Identification and Valuation).
(ii) The contractor shall enter unit prices for each item of property fabricated or acquired for the Government and delivered to a contractor as Government furnished property (GFP). Get the unit price from Section B of the contract. If the unit price is not available, use an estimate. The estimated price should be the contractor's estimate of what the items cost the Government. When the price is estimated, enter “Estimated Unit Price” in the description field. When delivering GFP via WAWF to another contractor, WAWF will initiate a property transfer if the vendor who is initiating the WAWF RR is also registered as a vendor property shipper in WAWF and the vendor receiving the property is also a vendor property receiver in WAWF.
(iii) For clothing and textile contracts containing a bailment clause, enter the cited Government furnished property unit value as “GFP UNIT VALUE” in the description field.
(iv) For all copies of DD Forms 250 for FMS shipments, enter actual prices, if available. If actual prices are not available, use estimated prices. When the price is estimated, enter an “E” after the price.
Contractors shall submit payment requests and receiving reports in accordance with paragraph (b) of the clause at DFARS
(a) Contractors may use a WAWF processed RR or the WAWF RRR, as a packing list. WAWF provides an option to print the RR or RRR. Contractors can print a RR or RRR from a system other than WAWF if a signed copy is required. In such cases, the contractor shall print the WAWF RR or RRR only after a signature is applied by the Government inspector or authorized acceptor in WAWF. Copies printed from the contractor's system shall be annotated with “\\original signed in WAWF\\” in lieu of the inspector or acceptor's signature. Ensure a copy is visible on the outside and one is placed inside the package.
(b) If the contract requires Government source inspection and acceptance at origin, the contractor shall ensure that its packaging documentation includes a RR or RRR that documents inspection, acceptance, or both by the Government inspector or authorized acceptor. A paper DD Form 250 may be used in lieu of WAWF generated RRs or RRRs when one of the exceptions in paragraph (d) of the clause at DFARS 252.232-7003 applies.
Defense Acquisition Regulations System, Department of Defense (DoD).
Proposed rule.
DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to clarify the entity to which contractors submit Summary Subcontract Reports in the Electronic Subcontracting Reporting System (eSRS) and to clarify the entity that acknowledges receipt of, or rejects, the reports in eSRS.
Comments on the proposed rule should be submitted in writing to the address shown below on or before August 28, 2018, to be considered in the formation of a final rule.
Submit comments identified by DFARS Case 2017-D005, using any of the following methods:
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○
○
○
Comments received generally will be posted without change to
Ms. Jennifer D. Johnson, telephone 571-372-6100.
DoD is proposing to revise the DFARS to implement a policy that streamlines the submission and review of Summary Subcontract Reports (SSRs) for DoD contractors and brings the DFARS into compliance with changes to the Federal Acquisition Regulation (FAR). Instead of submitting multiple SSRs to departments and agencies within DoD, contractors with individual subcontracting plans will submit a single, consolidated SSR in eSRS at the DoD level. The consolidated SSR will be acknowledged or rejected in eSRS at the DoD level.
The clause at DFARS 252.219-7003, Small Business Subcontracting Plan (DoD Contracts), and its Alternate I currently require contractors to submit SSRs to departments or agencies within DoD. DFARS 252.219-7003 and its Alternate I also inform contractors that the authority to acknowledge receipt of, or reject, SSRs resides with the SSR Coordinator at departments or agencies within DoD. This rule proposes to amend the DFARS clause to require contractors with individual subcontracting plans to submit a consolidated SSR at the DoD level, and to inform contractors that the authority to acknowledge receipt of or reject SSRs under individual subcontracting plans resides with the SSR Coordinator at the DoD level. These amendments will bring DFARS clause 252.219-7003 into compliance with the requirement for a consolidated SSR in FAR clause 52.219-9, Small Business Subcontracting Plan.
This rule proposes to amend the clause at DFARS 252.219-7003, Small Business Subcontracting Plan (DoD Contracts), and its Alternate I. The objective of the rule is to provide clarification on the submission and review of SSRs in eSRS.
DoD does not apply the clause and its Alternate I to solicitations and contracts with a value at or below the SAT, because subcontracting plans are not required at that dollar value.
DoD currently applies the clause and its Alternate I to solicitations and contracts for the acquisition of commercial items, including COTS items, as defined at FAR 2.101. Not applying this guidance to contracts for the acquisition of commercial items, including COTS items, would exclude contracts intended to be included in the streamlined SSRs and undermine the overarching purpose of the rule. Consequently, DoD plans to apply the rule to contracts for the acquisition of commercial items, including COTS items.
This rule amends the DFARS to implement a policy that streamlines the submission and review of SSRs for DoD contractors. Instead of the current practice of submitting multiple SSRs to various departments or agencies within DoD, contractors with individual subcontracting plans will submit one consolidated SSR at the DoD level in the eSRS. The consolidated SSR will be acknowledged or rejected in eSRS at the DoD level.
This rule impacts only large businesses that have individual subcontracting plans and at least one contract with DoD. Although the clause at DFARS 252.219-7003, Small Business Subcontracting Plan (DoD Contracts), and its Alternate I currently require large business contractors to submit SSRs to the department or agency within DoD that administers the majority of the contractor's individual subcontracting plans, these contractors frequently must submit SSRs to each department or agency within DoD with which they have contracts. This results in extra work for the contractors and
The following is a summary of the estimated public cost savings calculated in 2016 dollars at a 7-percent discount rate and in perpetuity:
To access the full Regulatory Cost Analysis for this rule, go to the Federal eRulemaking Portal at
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.
This rule is expected to be an E.O. 13771 deregulatory action. Details on the estimated cost savings can be found in section IV. of this preamble.
DoD does not expect this proposed rule to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601,
DoD is proposing to revise the Defense Federal Acquisition Regulation Supplement (DFARS) to streamline the submission and review of Summary Subcontract Reports (SSRs) in the Electronic Subcontracting Reporting System (eSRS). Instead of submitting multiple SSRs to departments and agencies within DoD, contractors with individual subcontracting plans will submit a single, consolidated SSR in eSRS at the DoD level. The consolidated SSR will be acknowledged or rejected in eSRS at the DoD level.
The objective of the rule is to provide clarification on the submission and review of SSRs in eSRS. The rule will bring the clause at DFARS 252.219-7003 and its Alternate I into compliance with the requirement for a consolidated SSR in the Federal Acquisition Regulation clause FAR 52.219-9, Small Business Subcontracting Plan.
The rule applies to DoD contractors who have individual subcontracting plans and must comply with the clause at DFARS 252.219-7003. Small entities are not required to comply with this clause and, therefore, will not be affected by the rule.
The rule does not impose any reporting or recordkeeping requirements on any small entities.
The rule does not duplicate, overlap, or conflict with any other Federal rules.
There are no known, significant, alternative approaches to the proposed rule that would meet the requirements of the applicable statute.
DoD invites comments from small business concerns and other interested parties on the expected impact of this rule on small entities.
DoD will also consider comments from small entities concerning the existing regulations in subparts affected by this rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C 610 (DFARS Case 2017-D005), in correspondence.
The rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).
Government procurement.
Therefore, 48 CFR 252 is proposed to be amended as follows:
41 U.S.C. 1303 and 48 CFR chapter 1.
The revisions read as follows:
(a)
(b) Subcontracts awarded qualified nonprofit agencies designated by the Committee for Purchase From People Who Are Blind or Severely Disabled (41 U.S.C. 8502-8504), may be counted toward the Contractor's small business subcontracting goal.
(f)(1) For DoD, the Contractor shall submit reports in eSRS as follows:
(i) The Individual Subcontract Report (ISR) shall be submitted to the contracting officer at the procuring contracting office, even when contract administration has been delegated to the Defense Contract Management Agency.
(ii) Submit the consolidated SSR for an individual subcontracting plan to the “Department of Defense.”
(2) For DoD, the authority to acknowledge receipt or reject reports in eSRS is as follows:
(i) The authority to acknowledge receipt or reject the ISR resides with the contracting officer who receives it, as described in paragraph (f)(1)(i) of this clause.
(ii) The authority to acknowledge receipt of or reject SSRs submitted under an individual subcontracting plan resides with the SSR Coordinator.
Alternate I. * * *
(a)
(b) Subcontracts awarded to qualified nonprofit agencies designated by the Committee for Purchase From People Who Are Blind or Severely Disabled (41 U.S.C. 8502-8504), may be counted toward the Contractor's small business subcontracting goal.
(f)(1) For DoD, the Contractor shall submit reports in eSRS as follows:
(i) The Standard Form 294, Subcontracting Report for Individual Contracts, shall be submitted in accordance with the instructions on that form.
(ii) Submit the consolidated SSR to the “Department of Defense.”
(2) For DoD, the authority to acknowledge receipt of or reject SSRs submitted under an individual subcontracting plan in eSRS resides with the SSR Coordinator.
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of proposed rulemaking.
FMCSA proposes to amend the entry-level driver training (ELDT) regulations published on December 8, 2016, titled “Minimum Training Requirements for Entry-Level Commercial Motor Vehicle Operators” by adopting a new Class A theory instruction upgrade curriculum to reduce the training time and costs incurred by Class B commercial driver's license (CDL) holders upgrading to a Class A CDL. This NPRM does not propose any changes to behind-the-wheel (BTW) training requirements set forth in the ELDT final rule. This proposal would be a deregulatory action as defined by Executive Order (E.O.) 13771, “Reducing Regulation and Controlling Regulatory Costs.” The Agency believes that this modest change in the Class A theory training requirements for Class B CDL holders upgrading to a Class A CDL would maintain the same level of safety established by the ELDT final rule.
Comments on this notice must be received on or before August 28, 2018.
You may submit comments identified by Docket Number FMCSA-2017-0371 using any of the following methods:
•
•
•
•
To avoid duplication, please use only one of these four methods. See the “Public Participation and Request for Comments” portion of the
Mr. Richard Clemente, Driver and Carrier Operations (MC-PSD) Division, FMCSA, 1200 New Jersey Ave SE, Washington, DC 20590-0001, by telephone at 202-366-4325, or by email at
This notice of proposed rulemaking (NPRM) is organized as follows:
If you submit a comment, please include the docket number for this NPRM (Docket No. FMCSA-2017-0371), indicate the specific section of this document to which each section applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so that FMCSA can contact you if there are questions regarding your submission.
To submit your comment online, go to
If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 8
FMCSA will consider all comments and material received during the comment period and may change this proposed rule based on your comments. FMCSA may issue a final rule at any time after the close of the comment period.
Confidential Business Information (CBI) is commercial or financial
FMCSA will consider all comments and material received during the comment period.
To view comments, as well as any documents mentioned in this preamble as being available in the docket, go to
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, including any personal information the commenter provides, to
Under the Fixing America's Surface Transportation Act (FAST Act) (Pub. L. 114-94), FMCSA is required to publish an advance notice of proposed rulemaking (ANPRM) or conduct a negotiated rulemaking “if a proposed rule is likely to lead to the promulgation of a major rule” (49 U.S.C. 31136(g)(1)). As this proposed rule is not likely to result in the promulgation of a major rule, the Agency is not required to issue an ANPRM or to proceed with a negotiated rulemaking.
MAP-21 required the issuance of final regulations establishing minimum entry-level driver training requirements addressing the knowledge and skills necessary for the safe operation of a CMV that must be acquired before obtaining a CDL for the first time or upgrading from one class of CDL to another (49 U.S.C. 31305(c)(1)). On December 8, 2016 (81 FR 88732), FMCSA published a final rule establishing minimum ELDT requirements meeting the MAP-21 mandate. Today, as part of the Agency's ongoing effort to review existing regulations to evaluate their continued necessity and effectiveness, FMCSA proposes a new theory instruction upgrade curriculum for Class B CDL holders upgrading to a Class A CDL.
The ELDT final rule required the same level of
The proposed theory instruction upgrade curriculum for Class B CDL holders would not have a required minimum number of instruction hours, but the training provider would be required to cover all topics in the curriculum and driver-trainees would be required to receive an overall minimum score of 80 percent on the written theory assessment. This approach is consistent with the theory curricula requirements in the ELDT final rule. This NPRM does not propose any changes to BTW (range and public road) training requirements set forth in the ELDT final rule. All driver-trainees, including those who hold a Class B CDL, must demonstrate proficiency in all elements of the BTW curriculum in a Class A vehicle.
The Agency estimates that an annual average of approximately 11,340 driver-trainees would be affected by the proposed rule, with each experiencing a reduction of 27 hours in time spent completing their theory instruction. This results in a substantial cost savings to these driver-trainees, as well as a cost savings to the motor carriers that employ these drivers. The proposed rule would not result in any
In the regulatory evaluation for the ELDT final rule, FMCSA estimated that not only would driver-trainees and motor carriers incur costs, but that training providers, SDLAs, and the Federal government would also incur costs as a result of the ELDT final rule. For this proposed rule, FMCSA does not anticipate any change in costs relative to the ELDT final rule for training providers, SDLAs, or the Federal government because the regulatory obligations of these entities, as set forth in the ELDT final rule, are not affected.
The Agency anticipates that there would be no change in the benefits of the ELDT final rule as a result of the proposed rule. In the regulatory evaluation for the ELDT final rule, the Agency estimated quantified benefits for three categories of non-safety benefits, including savings from reductions in fuel consumption, reductions in CO
The regulatory evaluation for the ELDT final rule addressed the potential safety benefits of ELDT. In considering the potential safety impacts from today's proposed rule, the Agency notes that Class B CDL holders have prior training or experience in the CMV industry, which serves as an adequate substitute for the eight non-driving instructional units that would be removed from the theory instruction upgrade curriculum. Therefore, the Agency does not anticipate any change in potential safety benefits associated with the proposed rule.
As noted above, FMCSA's publication of the final rule, “Minimum Training Requirements for Entry-Level Commercial Vehicle Operators” (81 FR 88732 (Dec. 8, 2016)), satisfied the MAP-21 requirement that the Agency issue ELDT regulations. Today's proposal to amend regulations established by that final rule is based on the authority of the Motor Carrier Act of 1935 and the Motor Carrier Act of 1984 (the 1984 Act), both as amended, and the Commercial Motor Vehicle Safety Act of 1986 (CMVSA).
The Motor Carrier Act of 1935, codified at 49 U.S.C. 31502(b), provides that “The Secretary of Transportation may prescribe requirements for—(1) qualifications and maximum hours of service of employees of, and safety of operation and equipment of, a motor carrier; and (2) qualifications and maximum hours of service of employees of, and standards of equipment of, a motor private carrier, when needed to promote safety of operation.” This NPRM addresses the qualifications of certain motor carrier employees, consistent with the safe operation of CMVs.
The 1984 Act provides concurrent authority to regulate drivers, motor carriers, and vehicle equipment. Section 211(b) of the 1984 Act (Pub. L. 98-554, 98 Stat. 9851 (Oct. 30, 1984), codified at 49 U.S.C. 31133(a)(10)), grants the Secretary of Transportation broad power in carrying out motor carrier safety statutes and regulations. The 1984 Act grants the Secretary broad authority to issue regulations “on commercial motor vehicle safety,” including to ensure that “commercial motor vehicles are . . . operated safely.” 49 U.S.C. 31136(a)(1). The remaining statutory factors and requirements in section 31136(a), to the extent they are relevant, are also satisfied here. In accordance with section 31136(a)(2), the elimination of duplicative theory training would not impose any “responsibilities . . . on
The CMVSA provides, among other things, that the Secretary shall prescribe regulations on minimum standards for testing and ensuring the fitness of an individual operating a CMV (49 U.S.C. 31305(a)). This proposed amendment to the ELDT theory training curriculum for the Class A CDL addresses the fitness of specified individuals operating a CMV.
Finally, the Administrator of FMCSA is delegated authority under 49 CFR 1.87 to carry out the functions vested in the Secretary of Transportation by 49 U.S.C. Chapters 311, 313, and 315 as they relate to commercial motor vehicle operators, programs and safety.
On December 8, 2016, FMCSA published a final rule establishing minimum training standards for certain individuals applying for their CDL for the first time; an upgrade of their CDL (
The Department has longstanding processes, which provide that regulations and other agency actions are periodically reviewed and, if appropriate, are revised to ensure that they continue to meet the needs for which they were originally designed, and that they remain cost-effective and cost-justified.
The ELDT final rule required the same level of theory training for individuals obtaining a CDL for the first time as those who already hold a Class B CDL and are upgrading to a Class A CDL. FMCSA concludes that this approach imposes an unnecessary regulatory burden because, due to prior training or experience in the CMV industry, Class B CDL holders do not require the same level of theory training as individuals who have never held a CDL. Accordingly, the Agency proposes the following change: Class B CDL holders upgrading to a Class A CDL would not be required to complete eight instructional units currently included in Section A.1.5, “Non-Driving Activities,” of the Theory Instruction portion of the Class A CDL Training Curriculum as set forth in Appendix A to 49 CFR part 380. The theory instructional units that, under this proposal, would no longer be required for Class B CDL holders upgrading to a Class A CDL are: Handling and Documenting Cargo, Environmental Compliance Issues, Post-Crash Procedures, External Communications, Whistleblower/Coercion, Trip Planning, Drugs/Alcohol, and Medical Requirements. These units would, however, remain required elements of the theory instruction standard curriculum for any individual obtaining a Class A CDL who does not already hold a Class B CDL. These units, which provide instruction in activities that do not involve actually operating a CMV, are identical, but for minor editorial differences in some of the topic descriptions, to the above-specified instructional units included in Section B.1.5, “Non-Driving Activities,” of the Theory Instruction portion of the Class B CDL Curriculum as set forth in Appendix B to 49 CFR part 380.
Driver-trainees affected by this proposal fall into one of two categories: Those who obtain a Class B CDL in accordance with the training requirements set forth in the ELDT final rule (
The first category, drivers who obtain a Class B CDL by completing ELDT training after February 7, 2020, will have already demonstrated proficiency in the eight non-driving theory topics, identified above, included in the Section B.1.5 of the Class B training curriculum, the content of which is virtually identical to the content of section A.1.5. Consequently, the Agency believes that requiring Class B CDL holders who are upgrading to Class A to be re-trained in those topics, which they have already mastered by successfully completing the Class B Theory Instruction, imposes an unnecessary
On the other hand, FMCSA believes that instruction in two “non-driving” theory topics—Hours of Service (HOS) Requirements and Fatigue and Wellness Awareness—will vary, to some extent, depending on the vehicle group. Class B CDL holders driving straight trucks may be more likely to drive CMVs for shorter distances, thereby spending less time at the driving controls, than drivers operating combination vehicles for which a Class A CDL is required. For example, drivers engaged in short-haul operations, as defined in 49 CFR 395.1(e)(1), are permitted to record their hours-of-service using timecards in lieu of electronic logging devices or paper records of duty status, and thus may not use and retain HOS-related instruction they obtained when completing the Class B theory curriculum. Therefore, in light of the safety importance of compliance with HOS requirements, the Agency believes that Class B CDL holders upgrading to a Class A CDL will benefit from additional training in this essential theory topic.
It is also true that some Class B CDL holders operating straight trucks for comparatively shorter distances than Class A CDL holders operating combination vehicles may not be as prone to fatigue and wellness concerns associated with long-haul driving. For example, the extensive time away from home experienced by many long-haul drivers may impact their ability to sleep well, exercise regularly, and eat healthy meals. In terms of alertness and fatigue management, the uninterrupted stretches of driving time experienced by some drivers of combination vehicles will likely present new challenges to some Class B CDL holders. Accordingly, the Agency believes that Class B CDL holders upgrading to Class A CDL would benefit from fatigue and wellness training focused specifically on the operation of Group A vehicles.
FMCSA also believes that instruction will vary, depending on the underlying vehicle group, for the theory topics identified in Sections A.1.1 and B.1.1 (Basic Operation), A.1.2 and B.1.2 (Safe Operating Procedures), A.1.3 and B.1.3 (Advanced Operating Practices) and A.1.4 and B.1.4 (Vehicle Systems and Reporting Malfunctions)—all of which address, to varying degrees, operational characteristics of the two vehicle groups. FMCSA therefore proposes to retain those theory topics in the Theory Instruction Upgrade Curriculum.
The second category of driver-trainees affected by this proposal are drivers who obtained their Class B CDL prior to the February 7, 2020, compliance date of the final rule (or who obtained a Class B CLP prior to the compliance date and obtained the Class B CDL after the compliance date, but before the CLP or renewed CLP expired in accordance with § 380.603(c)(1)). FMCSA presumes that these Class B holders seeking to upgrade to a Class A CDL would already have varying levels of CMV driving experience and pre-CDL training, and thus knowledge of the commercial motor carrier industry.
Further, drivers who obtain a Class B CDL prior to the compliance date of the ELDT final rule, but after July 20, 2003, will have received employer-provided training in driver qualification requirements, hours of service, driver wellness, and whistleblower protection in accordance with § 380.503.
FMCSA reiterates that the Class A BTW range and public road curriculum remains unchanged for all driver-trainees, including those who hold a Class B CDL. In the preamble to the final rule, FMCSA thoroughly explained the basis for the Agency's adoption of a performance-based standard for BTW range and public road training curricula for Class A and Class B CDLs, in lieu of a required minimum number of BTW hours, as proposed. FMCSA noted its intent to evaluate data that will be submitted to the Training Provider Registry, which will assist FMCSA in assessing, over time, whether minimum BTW hours for entry-drivers correlate to safer driving outcomes. Shortly after publication of the final rule, several
The Agency believes that this modest change in the Class A theory training requirements for Class B CDL holders upgrading to a Class A CDL would maintain the same level of safety established in the ELDT final rule. FMCSA invites comments on this issue and welcomes the submission of qualitative or quantitative data addressing the safety impacts of this NPRM. The Agency also requests comment on whether additional Class A theory instructional units should be removed from the proposed upgrade theory curriculum applicable to Class B CDL holders.
The purpose of this proposal is to address the narrow issue of theory training requirements for Class B CDL holders wishing to upgrade to a Class A CDL. Accordingly, FMCSA will not respond to comments on broader aspects of the ELDT final rule. This proposed change, if adopted, would have no impact on driver-trainees other than Class B CDL holders upgrading to a Class A CDL; it imposes virtually no new requirements on State Driver Licensing Agencies (SDLAs), the Federal government, or training providers eligible for listing on the Training Provider Registry (TPR).
Finally, the Agency notes that this proposal sets forth
In § 380.707(a), FMCSA proposes to add “or Class A theory instruction upgrade curriculum applicants” to the last sentence in the paragraph to account for the fact that training providers must verify that Class A CDL theory instruction upgrade curriculum training applicants possess a valid Class B CDL.
In Appendix A to part 380, Class A CDL Training Curriculum, FMCSA proposes to add a sentence to the introductory text that states, “Class A CDL applicants who possess a valid Class B CDL may complete the Theory Instruction Upgrade Curriculum in lieu of the Theory Instruction Standard Curriculum.” Additionally, the Agency proposes to rename the Class A “Theory Instruction” as “Theory Instruction Standard Curriculum.” Finally, the Agency proposes to add a new section, “Theory Instruction Upgrade Curriculum.”
FMCSA performed an analysis of the impacts of the proposed rule and determined it is not a significant regulatory action under section 3(f) of E.O. 12866 (58 FR 51735, October 4, 1993), Regulatory Planning and Review, as supplemented by E.O. 13563 (76 FR 3821, January 21, 2011), Improving Regulation and Regulatory Review. Accordingly, the Office of Management and Budget (OMB) has not reviewed it under that Order. It is also not significant within the meaning of DOT regulatory policies and procedures (DOT Order 2100.5 dated May 22, 1980; 44 FR 11034 (Feb. 26, 1979)).
As discussed earlier, because Class B CDL holders have previous training or experience in the CMV industry, the proposed rule would establish a new theory instruction upgrade curriculum that removes eight instructional units involving “Non-Driving Activities” for Class B CDL holders upgrading to a Class A CDL. The proposed rule does not change the BTW training requirements set forth in the ELDT final rule. Consistent with the ELDT final rule, the proposed theory instruction curriculum for Class B CDL holders upgrading to a Class A CDL would not have a required minimum number of instruction hours, but the training provider must cover all topics in the curriculum, and driver-trainees must receive an overall minimum score of 80 percent on the written theory assessment. FMCSA estimates that this new curriculum would result in cost savings by taking less time to complete, without impacting the benefits of the ELDT final rule.
The Agency estimates that an annual average of approximately 11,340 driver-trainees would be affected by the proposed rule, with each experiencing a reduction of 27 hours to complete the theory instruction. This results in a substantial cost savings to these driver-trainees, as well as a cost savings to the motor carriers that ultimately employ these drivers. The proposed rule does not result in any
The proposed rule revises regulations established in the ELDT final rule and, therefore, the ELDT final rule serves as the baseline against which the effects of the proposed rule are evaluated. The compliance date of the regulations established by the ELDT final rule remains February 7, 2020; therefore, the same analysis period of 2020 to 2029, used in evaluating the effects of the ELDT final rule, is used in evaluating the effects of this proposed rule. Furthermore, to ensure that meaningful relative comparisons can be made between the results of the regulatory analysis for this proposed rule and the baseline represented by the ELDT final rule, all monetary values are expressed in 2014 dollars, the same base year used to express monetary values in the evaluation of the ELDT final rule.
Many of the key inputs to this analysis are based on the same data sources as those developed and used in the evaluation of the ELDT final rule. Therefore, a copy of the regulatory evaluation for the ELDT final rule is available in the docket for the proposed rule,
The Agency estimates that an annual average of 11,340 driver-trainees would be affected by the proposed rule, totaling approximately 113,000 driver-trainees affected over the 10-year analysis period. Annual estimates of the number of driver-trainees affected by the proposed rule are presented below in Table 2.
The estimated number of driver-trainees affected by the proposed rule is a key input in determining the potential cost savings to driver-trainees and to the motor carriers that ultimately employ these drivers.
To derive the estimates presented above in Table 2, FMCSA first estimated the total annual number of Class B CDL holders upgrading to a Class A CDL. These estimates are based on a June 2015 information collection, performed as part of the regulatory evaluation for the ELDT final rule, requesting data from the 51 SDLAs, including information regarding the number of upgrades of Class B CDLs to Class A CDLs issued in 2014.
This 2014 baseline value of 67,000 upgrades from Class B CDLs to Class A CDLs was then used to develop projections of the number of Class B CDL to Class A CDL upgrades issued annually for the 2020 to 2029 analysis period. These future projections were developed by increasing the current baseline 2014 value consistent with occupation-specific employment growth projections for several commercial vehicle related occupations obtained from the Bureau of Labor Statistics (BLS) Employment Projections program.
Finally, the resulting annual projections of the overall number of upgrades from Class B CDLs to Class A CDLs are then adjusted to account for the portion of these drivers that are not affected by the ELDT final rule because these drivers are already receiving training in the absence of that rule. These drivers would not be affected by the proposed rule. In the regulatory evaluation for the ELDT final rule, FMCSA estimated that 84% of driver-trainees obtaining a Class A CDL already receive training in the absence of that rule and therefore are not affected by the ELDT final rule.
The estimated number of hours necessary to complete the proposed theory instruction upgrade curriculum, and the resulting time savings compared to the estimated time necessary to complete the Class A theory instruction curriculum that was set forth in the ELDT final rule, provide key inputs in determining the potential cost savings to driver-trainees and to the motor carriers that ultimately employ these drivers. Under both the ELDT final rule and this proposed rule, there is no minimum number of hours that driver-trainees are required to spend on the theory portions of any of the training curricula. The training provider must, however, cover all topics in the theory instruction curriculum, and driver-trainees must receive an overall minimum score of at least 80 percent on the written theory assessment. The Agency estimated that, on average, driver-trainees would need 60 hours to complete the Class A theory instruction curriculum set forth in the ELDT final rule,
The Class A theory instruction curriculum set forth in the ELDT final rule included 30 instructional units,
Therefore, in order to develop an estimate of the number of hours necessary to complete the proposed theory instruction upgrade curriculum and the resulting time savings compared to the estimated time necessary to complete the Class A theory instruction curriculum in the ELDT final rule, the Agency examined the theory instructional units of the curricula standards for driver-trainees as established by the Professional Truck Driver Institute (PTDI).
The reduction of 27 hours in theory training for each of the driver-trainees affected by the proposed rule results in a change in the costs incurred by these driver-trainees, relative to the baseline of the ELDT final rule. This change in cost is comprised of two components, a reduction in tuition costs incurred by these driver-trainees, and a reduction in the opportunity cost of time for these driver-trainees.
FMCSA evaluated tuition costs using an average hourly cost of training of $26 per hour, based on a review of nearly nine hundred CDL driver training programs as discussed in the regulatory evaluation for the ELDT final rule.
The Agency evaluated changes in the opportunity cost of time for driver-trainees using the driver wage rate to represent the value of driver-trainee time that, in the absence of the proposed rule, would have been spent in training but now would be available to driver-trainees for other uses, such as productive employment. FMCSA uses a driver wage rate of $30 per hour, representing the median hourly base wage rate for truck drivers plus fringe benefits, as discussed in the regulatory evaluation of the ELDT final rule.
Finally, the reduction of 27 hours in theory training for each of the driver-trainees affected by the proposed rule would also reduce the opportunity costs incurred by motor carriers that ultimately employ these driver-trainees. The opportunity cost to motor carriers from a regulatory action represents the value of the best alternative to the firm that must be forgone by, or is now made available to, the firm as a result of that regulatory action.
The proposed rule would not result in any increase in costs. In the regulatory evaluation for the ELDT final rule, the Agency estimated that not only would driver-trainees and motor carriers incur costs, but that training providers, SDLAs, and the Federal government would also incur costs as a result of the ELDT final rule. For this proposed rule, the Agency does not anticipate any change in costs relative to the ELDT final rule for training providers, SDLAs, or the Federal government because it does not affect the regulatory obligations of these entities as set forth in the ELDT final rule.
Costs to training providers resulting from the ELDT final rule included costs for submitting a Training Provider Registration Form (TPRF) for each training location to the Training Provider Registry (TPR), costs for electronically submitting training certification information to the TPR for driver-trainees who have completed training, and costs for preparing for and being subject to compliance audits.
Costs to SDLAs resulting from the ELDT final rule included costs for updates to SDLA information technology (IT) systems to be able to receive driver training completion information from CDLIS and store this information in the driver history record. Under the proposed rule, SDLAs would continue to receive and store the same information. Therefore, FMCSA does not anticipate any change in costs to SDLAs resulting from the proposed rule.
Finally, costs to the Federal government resulting from the ELDT final rule included costs for FMCSA to create and manage the TPR and to enforce the regulations established by the final rule. Under the proposed rule, the TPR must be developed and maintained in the same manner as under the ELDT final rule. In addition, training program enforcement activities, such as compliance audits performed on training providers, would remain unchanged under the proposed rule as compared to the ELDT final rule, and FMCSA's review of training provider registration forms would also remain unchanged. Accordingly, FMCSA does not anticipate any change in costs to the Federal government resulting from the proposed rule.
As discussed above, FMCSA estimates a reduction in costs incurred by driver-trainees and motor carriers affected by the proposed rule. Because there is an estimated reduction of 27 hours of training for each driver-trainee affected by the proposed rule, the Agency estimates that both driver-trainees and motor carriers would experience negative costs, that is, a decrease in costs or a cost savings. The proposed rule would not result in any
For each year of the 10-year analysis period, FMCSA multiplied the estimated number of driver-trainees annually that would be affected by the proposed rule, as presented in Table 2, by the estimated reduction of 27 hours in theory training for each of these driver-trainees. FMCSA then multiplied the resulting total aggregate reduction in theory training hours by $26 per hour (the estimated average hourly cost of training),
The development of the key inputs necessary to estimate the change in cost to motor-carriers, described earlier, includes the marginal cost of operating a CMV, an estimate of a typical average motor carrier profit margin, and the estimated 27-hour reduction in theory training for each of the driver-trainees affected by the proposed rule. For each year of the 10-year analysis period, the estimated number of driver-trainees who would be affected by the proposed rule as presented earlier in Table 2 is multiplied by the estimated reduction of 27 hours in theory training for each of these driver-trainees. The resulting total reduction in theory training hours is then multiplied by the estimated marginal cost of operating a CMV of $68 per hour, and the estimated profit margin of 5% for motor carriers. As presented in Table 3, the Agency estimates that the proposed rule would result in a 10-year opportunity cost savings to motor carriers of $10 million on an undiscounted basis, and $1.04 million on an annualized basis at a 7% discount rate, representing a decrease in opportunity cost, or an opportunity cost savings to motor carriers.
As presented in Table 3, the Agency estimates that the proposed rule would result in a 10-year cost savings of $182 million on an undiscounted basis, $155 million discounted at 3%, $127 million discounted at 7%, and $18 million on an annualized basis at a 7% discount rate, representing a decrease in cost or a cost savings. Most of this annualized cost savings ($17.10 million) is realized by driver-trainees, with the remainder of the annualized cost savings ($1.04 million) realized by motor carriers.
The Agency anticipates no change in the benefits of the ELDT final rule as a result of the proposed rule. In the regulatory evaluation for the ELDT final rule, the Agency estimated quantified benefits for three categories of non-safety benefits, including savings from reductions in fuel consumption, reductions in CO
The regulatory evaluation for the ELDT final rule addressed the potential safety benefits of entry-level driver training. In considering the potential impacts on safety from today's proposed rule, the Agency notes that Class B holders have previous training or experience in the CMV industry, which serves as an adequate substitute for the eight non-driving instructional units that are not included in the proposed theory instruction upgrade curriculum. Therefore, the Agency anticipates that there would be no change in potential safety benefits associated with the proposed rule.
FMCSA invites comments and the submission of qualitative or quantitative data addressing the potential impacts to both non-safety benefits and safety benefits from the proposed rule.
This proposed rule is expected to be an E.O. 13771 deregulatory action.
The Regulatory Flexibility Act of 1980 (RFA) (5 U.S.C. 601,
This rule would affect a subset of driver-trainees and motor carriers. Driver-trainees are not considered small entities because they do not meet the definition of a small entity in Section 601 of the RFA. Specifically, driver-trainees are considered neither a small business under Section 601(3) of the RFA, nor are they considered a small organization under Section 601(4) of the RFA.
Motor carriers affected by this rulemaking would most likely be those that hire Class A CDL drivers. Passenger motor carriers generally rely on Group B CMVs that do not require a Class A CDL to operate, and thus would not be affected by this rule. In the regulatory evaluation for the ELDT final rule, FMCSA estimated that there were approximately 1.1 million inter- and intrastate freight motor carriers, of which a subset operate Group A vehicles, and thus would be affected by this rule. FMCSA estimates that this proposed rule would affect between 11,000 and 12,000 CMV driver-trainees per year, resulting in fewer than 12,000 motor carriers affected per year, which is approximately 0.9% of the total number of inter- and intrastate freight motor carriers. FMCSA does not know how many of these motor carriers would be considered “small.”
The U.S. Small Business Administration (SBA) defines the size standards used to classify entities as small. SBA establishes separate standards for each industry, as defined by the North American Industry Classification System (NAICS).
As discussed earlier in the Regulatory Analyses section, FMCSA estimates the impact to the affected motor carriers as a reduction in opportunity cost, or a cost savings, relative to the baseline of the ELDT final rule. This rule would remove some of the training requirements accounted for in the regulatory evaluation for the ELDT final rule, allowing those drivers who are upgrading from a Class B CDL to a Class A CDL to begin working and earning a profit for the motor carrier earlier than under the current training procedures. Therefore, this rule would provide affected motor carriers with increased access to labor hours, and consequently profit, resulting in an opportunity cost savings to the motor carrier. FMCSA estimated the opportunity cost to the motor carrier as a function of the number of hours previously spent in training that are now available for labor, an estimate of the profit margin, and the marginal hourly operational costs of the CMV. As discussed earlier in the Regulatory Analyses section, the Agency estimates that the proposed rule would result in a cost savings to all motor carriers of $1.04 million on an annualized basis at a 7% discount rate. On a per driver basis for those drivers affected by the proposed rule, the cost savings realized by the motor carriers would be approximately $92 (27 hours × 0.05 profit margin × $68 marginal operating costs).
The RFA does not define a threshold for determining whether a specific regulation would result in a significant impact. However, the SBA, in guidance to government agencies, provides some objective measures of significance that the agencies can consider using.
Accordingly, I hereby certify that the action does not have a significant economic impact on a substantial number of small entities. FMCSA requests comments on this certification.
In accordance with section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996, FMCSA wants to assist small entities in understanding this proposed rule so that they can better evaluate its effects and participate in the rulemaking initiative. If the proposed rule would affect your small business, organization, or governmental jurisdiction, and you have questions concerning its provisions or options for compliance, please consult the FMCSA point of contact, Mr. Richard Clemente, 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 Administration's 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 FMCSA, call 1-888-REG-FAIR (1-888-734-3247). The DOT has a policy regarding the rights of small entities to regulatory enforcement fairness and an explicit policy against retaliation for exercising these rights.
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of
The Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) (PRA) requires Agencies to provide estimates of the information-collection (IC) burden of its regulations. This proposed rule does not alter the Agency's estimates of the paperwork burden outlined on page 88788 of the final ELDT rule. Since publication of the ELDT final rule, the OMB, on April 19, 2017, approved the Agency's estimate of 66,250 hours for the IC collection titled “Training Certification for Entry-Level Commercial Motor Vehicle Drivers” (2126-0028). The approval expires on April 30, 2020. If this notice generates public comment on Agency PRA estimates, the Agency will respond accordingly.
A rule has implications for Federalism under Section 1(a) of E.O. 13132 if it has “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” In assessing the federalism implications of the ELDT final rule, FMCSA stated that, because the CDL program is voluntary, it does not have preemptive effect on the States. The Agency therefore concluded that the ELDT final rule would not have substantial direct costs on or for States, nor would it limit the policymaking discretion of States.
This proposed rule meets applicable standards in sections 3(a) and 3(b)(2) of E.O. 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.
Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), requires agencies issuing “economically significant” rules, if the regulation also concerns an environmental health or safety risk that an agency has reason to believe may disproportionately affect children, to include an evaluation of the regulation's environmental health and safety effects on children. The Agency determined this proposed rule is not economically significant. Therefore, no analysis of the impacts on children is required. In any event, the Agency does not anticipate that this regulatory action could in any respect present an environmental or safety risk that could disproportionately affect children.
FMCSA reviewed this proposed rule in accordance with E.O. 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights, and has determined it would not effect a taking of private property or otherwise have taking implications.
Section 522 of title I of division H of the Consolidated Appropriations Act, 2005, enacted December 8, 2004 (Pub. L. 108-447, 118 Stat. 2809, 3268, 5 U.S.C. 552a note), requires the Agency to conduct a Privacy Impact Assessment (PIA) of a regulation that will affect the privacy of individuals. The assessment considers impacts of the rule on the privacy of information in an identifiable form and related matters. The FMCSA Privacy Officer has evaluated the risks and effects the rulemaking might have on collecting, storing, and sharing personally identifiable information (PII), as well as protections and alternative information handling processes to mitigate potential privacy risks. FMCSA determined that, while this rule does require the collection of individual PII, it does not result in a change in collection, process, or the data elements previously identified in the ELDT final rule.
The privacy analysis of the ELDT final rule, which conforms to the DOT standard Privacy Impact Assessment (PIA), is published on the DOT website (
The Agency submitted a Privacy Threshold Assessment (PTA) analyzing the new rulemaking and the specific process for collection of personal information to the Department of Transportation's Privacy Office. As required by the Privacy Act, FMCSA and the Department will be publishing, with request for comment, a system of records notice (SORN) addressing the collection of information affected by this NPRM and the ELDT final rule. This SORN will be published in the
The regulations implementing E.O. 12372 regarding intergovernmental consultation on Federal programs and activities do not apply to this program.
FMCSA has analyzed this proposed rule under E.O. 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. The Agency has determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” likely to have a significant adverse effect on the supply, distribution, or use of energy. Therefore, it does not require a Statement of Energy Effects under E.O. 13211.
Executive Order 13783 directs executive departments and agencies to review existing regulations that potentially burden the development or use of domestically produced energy resources, and to appropriately suspend, revise, or rescind those that unduly burden the development of domestic energy resources.
This rule does not have tribal implications under E.O. 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.
The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through OMB, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards (
FMCSA analyzed this NPRM for the purpose of the National Environmental Policy Act of 1969 (42 U.S.C. 4321
FMCSA also analyzed this rule under the Clean Air Act, as amended (CAA), section 176(c) (42 U.S.C. 7401,
Under E.O. 12898, each Federal agency must identify and address, as appropriate, “disproportionately high and adverse human health or environmental effects of its programs, policies, and activities on minority populations and low-income populations” in the United States, its possessions, and territories. FMCSA evaluated the environmental justice effects of this proposed rule in accordance with the E.O. and has determined that no environmental justice issue is associated with this proposed rule, nor is there any collective environmental impact that would result from its promulgation.
Administrative practice and procedure, Highway safety, Motor carriers, Reporting and recordkeeping requirements.
In consideration of the foregoing, FMCSA proposes to amend 49 CFR chapter 3, part 380 to read as follows:
49 U.S.C. 31133, 31136, 31305, 31307, 31308, and 31502; sec. 4007(a) and (b) of Pub. L. 102-240 (105 Stat. 2151-2152); sec. 32304 of Pub. L.112-141; and 49 CFR 1.87.
The revision and addition to read as follows:
Class A CDL applicants must complete the Class A CDL curriculum outlined in this Appendix. The curriculum for Class A applicants pertains to combination vehicles (Group A) as defined in 49 CFR 383.91(a)(1). Class A CDL applicants who possess a valid Class B CDL may complete the Theory Instruction Upgrade Curriculum in lieu of the Theory Instruction Standard Curriculum. There is no required minimum number of instruction hours for theory training, but the training instructor must cover all topics set forth in the curriculum. There is no required minimum number of instruction hours for BTW (range and public road) training, but the training instructor must cover all topics set forth in the BTW curriculum. BTW training must be conducted in a CMV for which a Class A CDL is required. The instructor must determine and document that each driver-trainee has demonstrated proficiency in all elements of the BTW curriculum, unless otherwise noted. Consistent with the definitions of BTW range training and BTW public road training in § 380.605, a simulation device cannot be used to conduct such training or to demonstrate proficiency. Training instructors must document the total number of clock hours each driver-trainee spends to complete the BTW curriculum. The Class A curriculum must, at a minimum, include the following:
This section must cover the interaction between driver-trainees and the CMV. Driver-trainees will receive instruction in the Federal Motor Carrier Safety Regulations (FMCSRs) and will be introduced to the basic CMV instruments and controls. Training providers will teach driver-trainees the basic operating characteristics of a CMV. This section must also teach driver-trainees how to properly perform vehicle inspections, control the motion of CMVs under various road and traffic conditions, employ shifting and backing techniques, and properly couple and uncouple combination vehicles. Driver-trainees must familiarize themselves with the basic operating characteristics of a CMV.
This unit must introduce driver-trainees to the combination vehicle driver training curriculum and the components of a combination vehicle. The training providers must teach the safety fundamentals, essential regulatory requirements (
This unit must introduce driver-trainees to vehicle instruments, controls, and safety components. The training providers must teach driver-trainees to read gauges and instruments correctly and the proper use of vehicle safety components, including safety belts and mirrors. The training providers
This unit must teach the driver-trainees to conduct pre-trip and post-trip inspections as specified in §§ 392.7 and 396.11, including appropriate inspection locations. Instruction must also be provided on en route vehicle inspections.
This unit must introduce basic vehicular control and handling as it applies to combination vehicles. This unit must include instruction addressing basic combination vehicle controls in areas such as executing sharp left and right turns, centering the vehicle, maneuvering in restricted areas, and entering and exiting the interstate or controlled access highway.
This unit must introduce shifting patterns and procedures to driver-trainees to prepare them to safely and competently perform basic shifting maneuvers. This unit must include training driver-trainees to execute up and down shifting techniques on multi-speed dual range transmissions, if appropriate. The training providers must teach the importance of increased vehicle control and improved fuel economy achieved by utilizing proper shifting techniques.
This unit must teach driver-trainees to back and dock the combination vehicle safely. This unit must cover “Get Out and Look” (GOAL), evaluation of backing/loading facilities, knowledge of backing set ups, as well as instruction in how to back with the use of spotters.
This unit must provide instruction for driver-trainees to develop the skills necessary to conduct the procedures for safe coupling and uncoupling of combination vehicle units, as applicable.
This section must teach the practices required for safe operation of the combination vehicle on the highway under various road, weather, and traffic conditions. The training providers must teach driver-trainees the Federal rules governing the proper use of seat belt assemblies (§ 392.16).
This unit must teach driver-trainees to visually search the road for potential hazards and critical objects, including instruction on recognizing distracted pedestrians or distracted drivers.
This unit must instruct driver-trainees on how to communicate their intentions to other road users. Driver-trainees must be instructed in techniques for different types of communication on the road, including proper use of headlights, turn signals, four-way flashers, and horns. This unit must cover instruction in proper utilization of eye contact techniques with other drivers, bicyclists, and pedestrians.
This unit must instruct driver-trainees in FMCSRs related to distracted driving and other key driver distraction driving issues, including improper cell phone use, texting, and use of in-cab technology (
This unit must teach driver-trainees how to manage speed effectively in response to various road, weather, and traffic conditions. The instruction must include methods for calibrating safe following distances taking into account CMV braking distances under an array of conditions including traffic, weather, and CMV weight and length.
This unit must teach driver-trainees about the importance of managing the space surrounding the vehicle under various traffic and road conditions.
This unit must instruct driver-trainees in the factors affecting the safe operation of CMVs at night and in darkness. Additionally, driver-trainees must be instructed in changes in vision, communications, speed space management, and proper use of lights, as needed, to deal with the special problems night driving presents.
This unit must teach driver-trainees about the specific problems presented by extreme driving conditions. The training provide will emphasize the factors affecting the operation of CMVs in cold, hot, and inclement weather and on steep grades and sharp curves. The training provider must teach proper tire chaining procedures.
This section must introduce higher-level skills that can be acquired only after the more fundamental skills and knowledge taught in the prior two sections have been mastered. The training providers must teach driver-trainees about the advanced skills necessary to recognize potential hazards and must teach the driver-trainees the procedures needed to handle a CMV when faced with a hazard.
The unit must teach driver-trainees to recognize potential hazards in the driving environment in order to reduce the severity of the hazard and neutralize possible emergency situations. The training providers must teach driver-trainees to identify road conditions and other road users that are a potential threat to the safety of the combination vehicle and suggest appropriate adjustments. The instruction must emphasize hazard recognition, visual search, adequate surveillance, and response to possible emergency-producing situations encountered by CMV drivers in various traffic situations. The training providers must teach driver-trainees to recognize potential dangers and the safety procedures that must be utilized while driving in construction/work zones.
This unit must teach the causes of skidding and jackknifing and techniques for avoiding and recovering from them. The training providers must teach the importance of maintaining directional control and bringing the CMV to a stop in the shortest possible distance while operating over a slippery surface. This unit must provide instruction in appropriate responses when faced with CMV emergencies. This instruction must include evasive steering, emergency braking, and off-road recovery, as well as the proper response to brake failures, tire blowouts, hydroplaning, and rollovers. The instruction must include a review of unsafe acts and the role the acts play in producing or worsening hazardous situations.
This unit must teach driver-trainees to recognize potential dangers and the appropriate safety procedures to utilize at railroad (RR)-highway grade crossings. This instruction must include an overview of various Federal/State RR grade crossing regulations, RR grade crossing environments, obstructed view conditions, clearance around the tracks, and rail signs and signals. The training providers must instruct driver-trainees that railroads have personnel available (“Emergency Notification Systems”) to receive notification of any information relating to an unsafe condition at the RR-highway grade crossing or a disabled vehicle or other obstruction blocking a railroad track at the RR-highway grade crossing.
This section must provide entry-level driver-trainees with sufficient knowledge of the combination vehicle and its systems and subsystems to ensure that they understand and respect their role in vehicle inspection, operation, and maintenance and the impact of those factors upon highway safety and operational efficiency.
This unit must teach driver-trainees to identify major combination vehicle systems. The goal is to explain their function and how to check all key vehicle systems, (
This unit must instruct driver-trainees on what to expect during a standard roadside inspection conducted by authorized personnel. The training providers must teach driver-trainees on what vehicle and driver violations are classified as out-of-service (OOS), including the ramifications and penalties for operating a CMV when subject to an OOS order as defined in section 390.5.
This unit must introduce driver-trainees to the basic servicing and checking procedures for various engine and vehicle components and to help develop their ability to perform preventive maintenance and simple emergency repairs.
This section must teach driver-trainees the activities that do not involve actually operating the CMV.
This unit must teach driver-trainees to understand that there are different hours-of-service (HOS) requirements applicable to different industries. The training providers must teach driver-trainees all applicable HOS regulatory requirements. The training providers must teach driver-trainees to complete a Driver's Daily Log (electronic and paper), timesheet, and logbook recap, as appropriate. The training providers must teach driver-trainees the consequences (safety, legal, and personal) of violating the HOS regulations, including the fines and penalties imposed for these types of violations.
This unit must teach driver-trainees about the issues and consequences of chronic and acute driver fatigue and the importance of staying alert. The training providers must teach driver-trainees wellness and basic health maintenance information that affect a driver's ability to safely operate a CMV.
Administrative Conference of the United States.
Notice.
The Administrative Conference of the United States adopted three recommendations at its Sixty-Ninth Plenary Session. The appended recommendations address: Paperwork Reduction Act Efficiencies; Severability in Agency Rulemaking (formerly titled Minimizing the Cost of Judicial Review; and Electronic Case Management in Federal Administrative Adjudication. A fourth recommendation on the topic of Administrative Judges was recommitted to the committee of jurisdiction for further consideration. A working group convened by the Office of the Chairman presented the Conference's Model Adjudication Rules (rev. 2018).
Gisselle Bourns for Recommendations 2018-1 and 2018-2, and Gavin Young for Recommendation 2018-3. For each Recommendation and general information about other projects referenced in this notice, the address and telephone number are: Administrative Conference of the United States, Suite 706 South, 1120 20th Street NW, Washington, DC 20036; Telephone 202-480-2080.
The Administrative Conference Act, 5 U.S.C. 591-596, established the Administrative Conference of the United States. The Conference studies the efficiency, adequacy, and fairness of the administrative procedures used by Federal agencies and makes recommendations to agencies, the President, Congress, and the Judicial Conference of the United States for procedural improvements (5 U.S.C. 594(1)). For further information about the Conference and its activities, see
Recommendation 2018-1,
Recommendation 2018-2,
Recommendation 2018-3,
A proposed recommendation addressing agency practices related to the selection, oversight, evaluation, discipline, and removal of administrative judges who are not administrative law judges was also on the agenda of the Sixty-Ninth Plenary Session; however, the Assembly voted to recommit the proposed recommendation to the Committee on Adjudication for further consideration—particularly in light of a then-pending Supreme Court decision that may have had bearing on the recommendation (
In addition to adopting three recommendations, the Assembly received and commented on a revised version of the Model Adjudication Rules (rev. 2018) prepared by a working group convened by the Conference's Office of the Chairman. The revised Rules offer agencies a complete set of model procedural rules—governing prehearing proceedings, hearings, and appellate review—to improve the fairness and efficiency of their adjudication programs. Once completed, the Rules will be published on the Conference's website and noticed in the
The Appendix below sets forth the full texts of the three adopted recommendations. The Conference will transmit them to affected entities, which may include Federal agencies, Congress, and the Judicial Conference of the United States. The recommendations are not binding, so the entities to which they are addressed will make decisions on their implementation.
The Conference based these recommendations on research reports that are posted at:
The Paperwork Reduction Act (PRA) created the Office of Information and Regulatory Affairs (OIRA) within the Office of Management and Budget to oversee information policy in the executive branch.
Under the OIRA review process, when an agency seeks to collect structured information from ten or more members of the public,
The process of obtaining OIRA approval for an information collection can be lengthy.
Agencies have used the expedited clearance processes offered by OIRA in varying degrees. Agencies' use of new generic clearances and fast tracks increased after OIRA publicized them and provided training to agencies on their use in 2011, but has since decreased (although agencies continue to seek OIRA approvals extensively under preexisting generic clearances).
Common forms could also be used to expedite approval of collections and to promote data sharing among agencies, limiting the need for duplicative information collection. Agencies have not used common forms, however, as often as fast-tracks and generic clearances. This may be due to barriers that make it difficult for agencies to collaborate with one another to develop common forms.
Aside from the expedited clearance processes outlined by OIRA, there are other opportunities for making the information collection clearance process more efficient, while still maintaining its integrity. One possibility would be for an agency to review all of the collections that are coming up for renewal without changes for a particular time period and to consolidate the
Another opportunity to achieve efficiencies is to update the supporting statement that agencies must submit with each submission of a proposed information collection to OIRA for review.
Finally, some agencies have also reported difficulties and confusion in using ROCIS.
1. To the extent practicable, the Office of Information and Regulatory Affairs (OIRA) should provide training opportunities for agencies on the Paperwork Reduction Act (PRA). The training topics could include basic administration of the PRA; expedited clearance processes, including generic clearances and the use of common forms; and other new and emerging topics in information collection. The method of training could include in-person training of PRA clearance officers, as well as new training materials.
2. Agencies should make greater use of generic clearances to comply with the PRA when engaging in usability testing of websites and other applications.
3. OIRA should encourage the development of common forms. OIRA should ask agencies to provide a list of potential common forms, and facilitate agency coordination and implementation of promising candidates. This list should be included in the Annual Information Collection Budget report that OIRA submits to Congress every year.
4. For information collection requests without changes from previous approvals, OIRA should clarify that agencies may consolidate the first
a. The agency would choose a time period (
b. The agency would then place a single notice in the
5. OIRA, in consultation with agency PRA clearance officers, should revise the supporting statement requirements on information collection submissions to ensure the requirements minimize preparation time and remain practically useful.
6. OIRA, in consultation with agency PRA clearance officers, should make improvements to ROCIS, the internal computer system used to submit information collections to OIRA. OIRA should consider, for example, improvements to the user interface, workflow, and the usability of ROCIS, data to agencies and to the public.
7. OIRA should continue to consult with a working group consisting of agency PRA clearance officers, and with other appropriate experts, to continue improving the PRA clearance process.
If a court holds portions of a rule unlawful, and the agency has been silent about severability, then the default remedy is to vacate the entire rule, including those portions that the court did not hold unlawful.
In recent years, as administrative rules have become more complex,
This Recommendation suggests best practices for agencies in addressing severability in a rulemaking. Addressing severability is not appropriate in every rulemaking. Indeed, if agencies include severability clauses without a reasoned discussion of the rationale behind them and how severability might apply to a particular rule, the courts will be less likely to give them much weight. By contrast, addressing severability can be particularly valuable when an agency recognizes that some portions of its proposed rule are more likely to be challenged than others and that the remaining portions of the rule can and should function independently.
It is not yet clear how principles of severability developed in the context of judicial review of legislation should be adapted to judicial review of agency rules. Nor is it clear how much weight the courts will or should give to an agency's expression of its views on severability. The Supreme Court has never addressed the issue, and the lower courts have reached different results in the context of particular rulemakings.
General principles of administrative law suggest that the agency's views on severability should be most persuasive when: (1) The agency includes its severability proposal in the text of the proposed rule and the agency's initial rationale for severability is explained in the preamble to the proposed rule; (2) these initial positions are made available for comment by interested parties; (3) the agency addresses its determination of severability in the text of the final rule; (4) the agency addresses the rationale for severability in the statement of basis and purpose accompanying the final rule (in the same manner as any other substantive policy issue in the rulemaking); and (5) the agency explains how specific portions of the rule would operate independently. While courts may also be willing to consider the agency's view on severability as expressed in agency briefs or at oral argument,
Sometimes courts have concluded that an agency's intentions are sufficiently clear to support severability, despite the absence of a severability clause or discussion of the issue in the rulemaking.
A separate but related question is how parties to a challenge to an agency rule should address the question of severability during litigation. Litigants may be reluctant to address the issue of severability in their briefs because: (1) It is often not clear in advance which portions of a rule a court may hold unlawful and on what basis; or (2) they may fear that addressing severability would suggest weakness in their positions on the merits.
1. Early in the process of developing a rule, in addition to other programmatic considerations, agencies that anticipate litigation should consider whether a rule is divisible into portions that could and should function independently if other portions were to be held unlawful on judicial review.
a. If the agency intends that portions of the rule should continue in effect even if other portions are later held unlawful on judicial review, it should draft the rule so that it is divisible into independent portions that reflect this purpose.
b. In order to provide members of the public an opportunity for comment, agencies should address the issue of severability in the text of the proposed rule and provide a reasoned explanation for the proposal.
c. Agencies should likewise address their determination of severability in the text of the final rule and provide a reasoned explanation for that determination in the statement of basis and purpose. Agencies should identify which portions, if any, they intend to be severable and explain how they relate to other portions in the event a court holds some portions of the rule unlawful.
2. When severability becomes an issue on judicial review, and it has not been previously briefed, courts should solicit the parties' views on severability.
Courts and adjudicative agencies have increasingly come to rely on technology to manage various aspects of their adjudicative activities. Some of these federal agencies have adopted and implemented a form of electronic management for their casework, but others have not done so. Although practical considerations or resource constraints may sometimes weigh against the use of an electronic case management system (eCMS), agencies can often realize considerable efficiencies and reap other benefits by adopting such a system.
As referred to here, an electronic case management system includes the functions usually associated with a paper-based case management system from the filing of a case to its resolution and beyond, such as: The initial receipt of the claim, complaint, or petition; the receipt, organization, and secure storage of evidence and briefs; the scheduling of hearings or other proceedings; the maintenance of tools to facilitate the analysis and resolution of the case; and the collection and reporting of data relating to the case, including when evidence was received, the time the case has remained pending, employees who have processed the case, and the outcome of the case, including any agency decision.
An eCMS, properly implemented, may perform these functions in a more efficient and cost-effective manner than a paper-based management system.
Perhaps more importantly, an eCMS can assist adjudicative agencies in fulfilling their duties under various laws that impose requirements related to paperwork reduction, agency efficiency, public access to records, and technology management. For example, the Government Paperwork Elimination Act requires that federal agencies use electronic forms, electronic filing, and electronic signatures to conduct official business with the public, when practicable.
Despite the advantages of an eCMS, the decision to implement an eCMS must be carefully considered. It may not be cost efficient for every adjudicative agency to implement an eCMS given agency-specific factors such as caseload volume. For example, there may be significant costs associated with the development, purchase, and maintenance of new hardware and software. Further, the need to train agency staff in new business processes associated with the eCMS may also be significant, as the new operations may be substantially different. In addition, an agency may need to allocate resources to ensure that any new eCMS complies with existing legal requirements, such as the protection of private information about individuals, as required by the Privacy Act.
If, after considering the costs, an agency decides to implement an eCMS to partially or fully replace a paper-based case management system, the agency must consider a number of factors in deciding
The implementation or expansion of an eCMS deserves full and careful consideration by federal adjudicative agencies, with recognition that each agency is unique in terms of its mission, caseload, and challenges. This Recommendation suggests that agencies implement or expand an eCMS only when they conclude, after conducting a thorough consideration of the costs and benefits, that doing so would lead to benefits such as reduced costs and improved efficiency, accuracy, public access, and transparency without impairing the fairness of the proceedings or the participants' satisfaction with them.
1. Federal adjudicative agencies should consider implementing electronic case management systems (eCMS) in order to reduce costs, expand public access and transparency, increase both efficiency and accuracy in the processing of cases, identify opportunities for improvement through the analysis of captured data, and honor statutory requirements such as the protection of personally identifiable information.
2. Federal adjudicative agencies should consider whether their proceedings are conducive to an eCMS and whether their facilities and staff can support the eCMS technology. If so, agencies should then consider the costs and benefits to determine
a. Whether the agency's budget would allow for investment in appropriate and secure technology as well as adequate training for agency staff.
b. Whether the use of an eCMS would reduce case processing times and save costs, including printing of paper and the use of staff resources to store, track, retrieve, and maintain paper records.
c. Whether the use of an eCMS would foster greater accessibility and better public service.
d. Whether users of an eCMS, such as administrative law judges, other adjudicators, other agency staff, parties, witnesses, attorneys or other party representatives, and reviewing officials would find the eCMS beneficial.
e. Whether the experiences of other agencies' eCMS implementations provide insight regarding other factors which may bear on the manner of an eCMS implementation.
3. The following possible eCMS features, currently implemented by some federal adjudicative agencies, should be considered by other agencies for their potential benefits:
a. Web access to the eCMS that allows parties the flexibility to file a claim, complaint, or petition; submit documents; and obtain case information at any time.
b. Streamlining of agency tasks in maintaining a case file, such as sorting and organizing case files, providing simultaneous access to files and documents by authorized users, tracking deadlines and elapsed age of a case, notifying parties of new activity in a case, and pre-populating forms with data from the case file.
c. The comprehensive capture of structured and unstructured data that allows for robust data analysis to identify opportunities for improving an agency's operations, budget formulation, and reporting.
d. Streamlined publication of summary data on agency operations.
4. Federal adjudicative agencies that decide to implement or expand an eCMS should plan and manage their budgets and operations in a way that balances the needs of a sustainable eCMS with the possibility of future funding limitations. Those agencies should also:
a. Consider the costs associated with building, maintaining, and improving the eCMS.
b. Consider whether the adoption of an eCMS requires modifications of an agency's procedural rules. This would include addressing whether the paper or electronic version of a case file will constitute the official record of a case and whether filing methods and deadlines need to be changed.
c. Consider whether to require non-agency individuals to file claims, complaints, petitions, and other papers using the eCMS. Such consideration should include the accessibility, suitability, usability, and burden of the eCMS for its likely user population, and whether creating exceptions to electronic filing procedures would assist in maintaining sufficient public access.
d. Create a map or flow chart of their adjudicative processes in order to identify the needs of an eCMS. This involves listing the tasks performed by employees at each step in the process to ensure the eCMS captures all of the activities that occur while the case is pending, from initial filing to final resolution. It also includes identifying how members of the public or other non-agency users will access and interact with the eCMS. To the extent practical, this effort should also involve mapping or flow-charting the legal and policy requirements to decisional outcomes.
e. Put in place a management structure capable of: (1) Restoring normal operations after an eCMS goes down (incident management); (2) eliminating recurring problems and minimizing the impact of problems that cannot be prevented (problem management); (3) overseeing a new release of an eCMS with multiple technical or functional changes (release management); (4) handling modifications, improvements, and repairs to the eCMS to minimize service interruptions (change management); and (5) identifying, controlling, and maintaining the versions of all of the components of the eCMS (configuration management).
f. Establish a “service desk,” which is a central hub for reporting issues with the eCMS, providing support to eCMS users, and receiving feedback on the resolution of problems. A service desk should gather statistics of eCMS issues in order to help guide future improvements of the eCMS. A service desk could also enable eCMS users to offer suggestions for improving the eCMS.
g. Plan adequate and timely training for staff on the use of the eCMS.
5. Federal adjudicative agencies that decide to implement or expand an eCMS must do so in such a way that appropriate protections for privacy, transparency, and security are preserved by:
a. Ensuring that the agency's compliance with the Privacy Act, other statutes protecting privacy, and the agency's own privacy regulations and policies remains undiminished by the implementation or expansion of an eCMS.
b. To the extent it is consistent with Recommendation 5(a) above, making case information available online to parties and, when appropriate, the public, taking into account both the interests of transparency (as embodied in, for example, the Freedom of Information Act's proactive disclosure requirements) as well as the benefits of having important adjudicative documents publicly available.
c. Adopting security measures, such as encryption, to ensure that information held in an eCMS cannot be accessed or changed by unauthorized persons.
d. Ensuring that sensitive information is not provided to unintended third parties through private email services, unsecured data transmission, insider threats, or otherwise.
e. Keeping track of the evolution of security technologies and considering the adoption of those technologies as they mature in order to ensure the integrity of agency information systems.
6. Federal adjudicative agencies that decide to implement or expand an eCMS should consider how to analyze and leverage data that is captured by the eCMS to improve their adjudicative processes, including through the use of natural language processing, machine learning, and predictive algorithms. Agencies should consider:
a. Evaluating how eCMS features could generate the types of data that would be useful for evaluating the effectiveness of their adjudicative processes and policies.
b. Capturing and analyzing such data about adjudicative processes and policies to detect and define problem areas that present opportunities for improvement.
c. Upon identification of areas for improvement in the adjudication process, taking corrective action, refining performance goals, and measuring performance under the newly improved process.
d. Hiring staff trained in data science to facilitate data analysis and giving that staff access to subject matter experts within agencies.
e. Collaborating with other agencies on best practices for data analytics.
Office of the Secretary, USDA.
Notice.
The Office of the Secretary of the Department of Agriculture (the Secretary) announces the establishment of the Fiscal Year (FY) 2019 (October 1, 2018-September 30, 2019) in-quota aggregate quantity of raw cane sugar at 1,117,195 metric tons raw value (MTRV), and the establishment of the FY 2019 in-quota aggregate quantity of certain sugars, syrups, and molasses (also referred to as refined sugar) at 192,000 MTRV.
These quantities are established as of June 29, 2018.
Souleymane Diaby, Import Policies and Export Reporting Division, Foreign Agricultural Service, U.S. Department of Agriculture, Stop 1021, 1400 Independence Avenue SW, Washington, DC 20250-1021.
Souleymane Diaby, (202) 720-2916,
The provisions of paragraph (a)(i) of the
Section 359(k) of the Agricultural Adjustment Act of 1938, as amended, requires that at the beginning of the quota year the Secretary of Agriculture establish the TRQs for raw cane sugar and refined sugars at the minimum levels necessary to comply with obligations under international trade agreements, with the exception of specialty sugar.
The Secretary's authority under paragraph (a)(i) of the Additional U.S. Note 5, Chapter 17 in the U.S. Harmonized Tariff Schedule (HTS) and Section 359(k) of the Agricultural Adjustment Act of 1938, as amended, has been delegated to the Under Secretary for Trade and Foreign Agricultural Affairs (7 CFR 2.26).
Notice is hereby given that I have determined, in accordance with paragraph (a)(i) of the Additional U.S. Note 5, Chapter 17 in the HTS and section 359(k) of the 1938 Act, that an aggregate quantity of up to 1,117,195 MTRV of raw cane sugar may be entered or withdrawn from warehouse for consumption during FY 2019. This is the minimum amount to which the United States is committed under the WTO Uruguay Round Agreements. I have further determined that an aggregate quantity of 192,000 MTRV of sugars, syrups, and molasses may be entered or withdrawn from warehouse for consumption during FY 2019. This quantity includes the minimum amount to which the United States is committed under the WTO Uruguay Round Agreements, 22,000 MTRV, of which 20,344 MTRV is established for any sugars, syrups and molasses, and 1,656 MTRV is reserved for specialty sugar. An additional amount of 170,000 MTRV is added to the specialty sugar TRQ for a total of 171,656 MTRV.
Because the specialty sugar TRQ is first-come, first-served, tranches are needed to allow for orderly marketing throughout the year. The FY 2019 specialty sugar TRQ will be opened in five tranches. The first tranche, totaling 1,656 MTRV, will open October 1, 2018. All specialty sugars are eligible for entry under this tranche. The second tranche will open on October 10, 2018, and be equal to 50,000 MTRV. The third tranche of 50,000 MTRV will open on January 23, 2019. The fourth tranche of 35,000 MTRV will open on April 17, 2019. The fifth tranche will open on July 17, 2019, and be equal to 35,000 MTRV. The second, third, fourth, and fifth tranches will be reserved for organic sugar and other specialty sugars not currently produced commercially in the United States or reasonably available from domestic sources.
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Animal and Plant Health Inspection Service, USDA.
Notice of intent to prepare a programmatic environmental impact statement.
We are advising the public that the Animal and Plant Health Inspection Service (APHIS) plans to prepare a programmatic environmental impact statement (EIS) in connection with potential changes to the regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered organisms. This notice identifies potential issues to be evaluated in the EIS and requests public comments to define the scope of the alternatives and environmental impacts and issues for APHIS to consider.
We will consider all comments that we receive on or before July 30, 2018.
You may submit comments by either of the following methods:
•
•
Any comments we receive may be viewed at
Ms. Joanne Serrels, Biotechnologist, Biotechnology Regulatory Services, APHIS, 4700 River Road, Unit 147, Riverdale, MD 20737-1238; (301) 851-3867.
The Plant Protection Act (PPA) authorizes the Animal and Plant Health Inspection Service (APHIS) to protect plant health in the United States. Under that authority, APHIS currently regulates the introduction (movement into the United States or interstate, or release into the environment) of genetically engineered (GE) organisms that may present a plant pest risk through its regulations in 7 CFR part 340, “Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which Are Plant Pests or Which There Is Reason to Believe Are Plant Pests.” These regulations are intended to protect against plant pest risks to plant health by providing for the safe importation, interstate movement, or release into the environment of certain GE organisms.
APHIS' regulation of certain GE organisms to protect plant health is aligned with the Federal Coordinated Framework for the Regulation of Biotechnology (henceforth referred to as the Coordinated Framework), the comprehensive Federal regulatory policy for ensuring the safety of biotechnology research and products in the United States. The Coordinated Framework describes how Federal agencies will use their regulatory authorities under existing Federal statutes to ensure public health and environmental safety while maintaining regulatory flexibility to avoid impeding the growth of the biotechnology industry. The Coordinated Framework sets forth a science- and risk-based approach for the oversight of activities that introduce biotechnology products into the environment and describes the roles and responsibilities for the three major Federal agencies involved in
During the past 30 years, there have been major advances in the science of biotechnology, and new issues have been brought to APHIS' attention by a range of stakeholders. Over this period, APHIS has also gained considerable experience in assessing the plant health risks of GE organisms. Accordingly, APHIS is considering amending the regulations pertaining to movement and outdoor use of certain GE organisms to address the advances in biotechnology and APHIS' understanding of the issues raised by stakeholders. The proposed revisions would allow APHIS to more effectively protect plant health under the PPA by focusing APHIS' regulations in 7 CFR part 340 on risks that may be posed by certain GE organisms rather than on the methods used to produce the products and would also make the regulatory processes more transparent while removing unnecessary regulatory burdens.
Under the provisions of the National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321
• U.S. agriculture and forestry production (
• Current and future uses of certain GE organisms in agriculture and forestry;
• Agronomic practices employed in GE crop production that may have environmental consequences or effects (
• Aspects of the physical environment, including soil quality, water resources, and air quality, with consideration given to the effects of dynamic climate conditions;
• Aspects of the biological environment, such as animal and plant communities, the development of weed, pathogen, and insect resistance to pesticides, the potential gene flow from certain GE organisms to sexually compatible species, the weediness of GE crop plants, and biodiversity;
• Consumer health and agricultural worker safety; and
• Animal feed safety, availability, quality, and animal health.
We will also examine socioeconomic considerations, such as the potential impacts of crop plants that are GE organisms on the domestic economic environment, international trade, and coexistence among all forms of U.S. agriculture—conventional, biotechnology-based, and organic—and on market demand for food, feed, fiber, and fuel.
The EIS will be prepared in accordance with: (1) NEPA, (2) regulations of the Council on Environmental Quality for implementing the procedural provisions of NEPA (40 CFR parts 1500-1508), (3) U.S. Department of Agriculture regulations implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA Implementing Procedures (7 CFR part 372).
This notice identifies the potential issues that will be evaluated in the EIS, and requests public comment to help APHIS further define the issues and alternatives that should be considered and to help APHIS identify additional impacts, both positive and negative, to the human environment that should be examined in the EIS. Public input will also be helpful in developing our proposed regulations. All comments received during the comment period will be carefully considered. A notice will be published in the
U.S. Commission on Civil Rights.
Notice of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Tennessee Advisory Committee will hold a meeting on Wednesday, August 8, 2018 to work on post-report planning for the Civil Asset Forfeiture report and discuss potential future work on legal financial obligations and civil rights issues.
The meeting will be held on Wednesday August 8, 2018 12:30 p.m. EST. Public Call Information: The meeting will be by teleconference. Toll-free call-in number: 888-334-3032, conference ID: 5510752.
Jeff Hinton, DFO, at
Members of the public can listen to the discussion. This meeting is available to the public through the following toll-free call-in number: 888-334-3032, conference ID: 5510752. 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 1-800-977-8339 and providing the Service with the conference call number and conference ID number.
Written comments may be mailed to the Regional Program Unit Office, U.S. Commission on Civil Rights, 230 S. Dearborn, Suite 2120, Chicago, IL 60604. They may also be faxed to the Commission at (312) 353-8324 or may be emailed to the Regional Director, Jeff Hinton at
Agenda:
U.S. Commission on Civil Rights.
Announcement of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Michigan Advisory Committee (Committee) will hold a meeting on Wednesday July 18, 2018, at 3 p.m. EDT for the purpose discussing civil rights concerns in the state.
The meeting will be held on Wednesday July 18, 2018, at 3 p.m. EDT.
Melissa Wojnaroski, DFO, at
Members of the public can listen to the discussion. This meeting is available to the public through the above toll-free call-in number. Any interested member of the public may call this number and listen to the meeting. An open comment period will be provided to allow members of the public to make a statement as time allows. The conference call operator will ask callers to identify themselves, the organization they are affiliated with (if any), and an email address prior to placing callers into the conference room. Callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-877-8339 and providing the Service with the conference call number and conference ID number.
Members of the public are also entitled to submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be mailed to the Midwestern Regional Office, U.S. Commission on Civil Rights, 230 S Dearborn St., Suite 2120, Chicago, IL 60604. They may also be faxed to the Commission at (312) 353-8324, or emailed to Carolyn Allen at
Records generated from this meeting may be inspected and reproduced at the Midwestern Regional Office, as they become available, both before and after the meeting. Records of the meeting will be available via
On May 1, 2018 the Executive Secretary of the Foreign-Trade Zones (FTZ) Board docketed an application submitted by the Louisville & Jefferson County Riverport Authority, grantee of FTZ 29, requesting subzone status subject to the existing activation limit of FTZ 29, on behalf of Amcor Flexibles LLC, in Shelbyville, Kentucky.
The application was processed in accordance with the FTZ Act and Regulations, including notice in the
On April 30, 2018, the Executive Secretary of the Foreign-Trade Zones (FTZ) Board docketed an application submitted by the Eastern Distribution Center, Inc., grantee of FTZ 24, requesting an expansion of Subzone 24E on behalf of Brake Parts Inc in Hazleton, Pennsylvania.
The application was processed in accordance with the FTZ Act and Regulations, including notice in the
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) preliminarily determines that countervailable subsidies are being provided to producers and exporters of large diameter welded pipe (welded pipe) from India for the period of investigation of January 1, 2017, through December 31, 2017. Interested parties are invited to comment on this preliminary determination.
Applicable June 29, 2018.
Suzanne Lam or Robert Palmer, AD/CVD Operations, Office VIII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-0783 or (202) 482-9068, respectively.
This preliminary determination is made in accordance with section 703(b) of the Tariff Act of 1930, as amended (the Act). Commerce published the notice of initiation of this investigation on February 20, 2018.
The product covered by this investigation is welded pipe from India. For a complete description of the scope of this investigation,
In accordance with the preamble to Commerce's regulations,
For a summary of the product coverage comments and rebuttal responses submitted to the record for this preliminary determination, and accompanying discussion and analysis of all comments timely received,
Commerce is conducting this investigation in accordance with section 701 of the Act. For each of the subsidy programs found countervailable, Commerce preliminarily determines that there is a subsidy,
Commerce notes that, in making these findings, it relied, in part, on facts available and, because it finds that one or more respondents did not act to the best of their ability to respond to Commerce's requests for information, it drew an adverse inference where appropriate in selecting from among the facts otherwise available.
In accordance with section 705(a)(1) of the Act and 19 CFR 351.210(b)(4), Commerce is aligning the final countervailing duty (CVD) determination in this investigation with the final determination in the companion antidumping duty (AD) investigation of welded pipe from India, based on a request made by American Cast Iron Pipe Company, Berg Steel Pipe Corp./Berg Spiral Pipe Corp, Dura-Bond Industries, Skyline Steel, Stupp Corporation, Greens Bayou Pipe Mill, LP, JSW Steel (USA) Inc., and Trinity Products LLC (collectively, the petitioners).
Sections 703(d) and 705(c)(5)(A) of the Act provide that in the preliminary determination, Commerce shall determine an estimated all-others rate for companies not individually investigated. This rate shall be an amount equal to the weighted average of the estimated subsidy rates established for those companies individually investigated, excluding any zero and
Pursuant to section 705(c)(5)(A)(ii) of the Act, if the individual estimated countervailable subsidy rates established for all exporters and producers individually investigated are zero,
Commerce preliminarily determines that the following estimated countervailable subsidy rates exist:
In accordance with section 703(d)(1)(B) and (d)(2) of the Act, Commerce will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of entries of subject merchandise as described in the scope of the investigation section entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the
Normally, Commerce discloses to interested parties the calculations performed in connection with a preliminary determination within five days of its public announcement, or if there is no public announcement, within five days of the date of publication of the notice of preliminary determination in the
Because the examined respondents in this investigation did not provide information requested by Commerce, and Commerce preliminarily determines each of the examined respondents to have been uncooperative, it will not conduct verification of the mandatory respondents. The Government of India (GOI) did provide some information requested by Commerce; Commerce intends to seek additional information after the preliminary determination concerning certain programs the GOI claimed the mandatory respondents did not use, and may verify any information received, if appropriate.
Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance at a date to be determined. Rebuttal briefs, limited to issues raised in case briefs, may be submitted no later than five days after the deadline date for case briefs.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce within 30 days after the date of publication of this notice. Requests should contain the party's name, address, and telephone number, the number of participants, whether any participant is a foreign national, and a list of the issues to be discussed. If a request for a hearing is made, Commerce intends to hold the hearing at the U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230, at a time and date to be determined. Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.
In accordance with section 703(f) of the Act, Commerce will notify the International Trade Commission (ITC) of its preliminary determination. Pursuant to section 705(b)(2) of the Act, if the final determination is affirmative, the ITC will make its final injury determination before the later of 120 days after the date of Commerce's affirmative preliminary determination or 45 days after the date of Commerce's affirmative final determination.
This determination is issued and published pursuant to sections 703(f) and 777(i) of the Act and 19 CFR 351.205(c).
The merchandise covered by this investigation is welded carbon and alloy steel pipe (including stainless steel pipe), more than 406.4 mm (16 inches) in nominal outside diameter (large diameter welded pipe), regardless of wall thickness, length, surface finish, grade, end finish, or stenciling. Large diameter welded pipe may be used to transport oil, gas, slurry, steam, or other fluids, liquids, or gases. It may also be used for structural purposes, including, but not limited to, piling. Specifically, not included is large diameter welded pipe produced only to specifications of the American Water Works Association (AWWA) for water and sewage pipe.
Large diameter welded pipe used to transport oil, gas, or natural gas liquids is normally produced to the American Petroleum Institute (API) specification 5L. Large diameter welded pipe may also be produced to American Society for Testing and Materials (ASTM) standards A500, A252, or A53, or other relevant domestic specifications, grades and/or standards. Large diameter welded pipe can be produced to comparable foreign specifications, grades and/or standards or to proprietary specifications, grades and/or standards, or can be non-graded material. All pipe meeting the physical description set forth above is covered by the scope of this investigation, whether or not produced according to a particular standard.
Subject merchandise also includes large diameter welded pipe that has been further processed in a third country, including but not limited to coating, painting, notching, beveling, cutting, punching, welding, or any other processing that would not otherwise remove the merchandise from the scope of the investigation if performed in the country of manufacture of the in-scope large diameter welded pipe.
The large diameter welded pipe that is subject to this investigation is currently classifiable in the Harmonized Tariff Schedule of the United States (HTSUS) under subheadings 7305.11.1030, 7305.11.1060, 7305.11.5000, 7305.12.1030, 7305.12.1060, 7305.12.5000, 7305.19.1030, 7305.19.1060, 7305.19.5000, 7305.31.4000, 7305.31.6010, 7305.31.6090, 7305.39.1000 and 7305.39.5000. While the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of this investigation is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) preliminarily determines that countervailable subsidies are being provided to producers and exporters of large diameter welded pipe (welded pipe) from the Republic of Korea (Korea) for the period of investigation of January 1, 2017, through December 31, 2017. Interested parties are invited to comment on this preliminary determination.
Applicable June 29, 2018.
George Ayache, Irene Gorelik, or Robert Palmer, AD/CVD Operations, Office VIII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-2623, (202) 482-6905, or (202) 482-9068, respectively.
This preliminary determination is made in accordance with section 703(b) of the Tariff Act of 1930, as amended (the Act). Commerce published the notice of initiation of this investigation on February 20, 2018.
The product covered by this investigation is welded pipe from Korea. For a complete description of the scope of this investigation,
In accordance with the preamble to Commerce's regulations,
For a summary of the product coverage comments and rebuttal responses submitted to the record for this preliminary determination, and accompanying discussion and analysis of all comments timely received,
Commerce is conducting this investigation in accordance with section 701 of the Act. For each of the subsidy programs found countervailable, Commerce preliminarily determines that there is a subsidy,
Commerce notes that, in making these findings, it relied, in part, on facts available and, because it finds that one or more respondents did not act to the best of their ability to respond to Commerce's requests for information, it drew an adverse inference where appropriate in selecting from among the facts otherwise available.
In accordance with section 705(a)(1) of the Act and 19 CFR 351.210(b)(4), Commerce is aligning the final countervailing duty (CVD) determination in this investigation with the final determination in the companion antidumping duty (AD) investigation of welded pipe from Korea based on a request made by American Cast Iron Pipe Company, Berg Steel Pipe Corp./Berg Spiral Pipe Corp, Dura-Bond Industries, Skyline Steel, Stupp Corporation, Greens Bayou Pipe Mill, LP, JSW Steel (USA) Inc., and Trinity Products LLC (collectively, the petitioners).
Sections 703(d) and 705(c)(5)(A) of the Act provide that in the preliminary determination, Commerce shall determine an estimated all-others rate for companies not individually investigated. This rate shall be an
In this investigation, Commerce preliminarily found
Commerce preliminarily determines that the following estimated countervailable subsidy rates exist:
In accordance with section 703(d)(1)(B) and (d)(2) of the Act, Commerce will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of entries of subject merchandise as described in the scope of the investigation section entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the
Commerce intends to disclose its calculations and analysis performed to interested parties in this preliminary determination within five days of its public announcement, or if there is no public announcement, within five days of the date of publication of the notice of preliminary determination in the
As provided in section 782(i)(1) of the Act, Commerce intends to verify the information relied upon in making its final determination.
Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the last verification report is issued in this investigation. Rebuttal briefs, limited to issues raised in case briefs, may be submitted no later than five days after the deadline date for case briefs.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce within 30 days after the date of publication of this notice. Requests should contain the party's name, address, and telephone number, the number of participants, whether any participant is a foreign national, and a list of the issues to be discussed. If a request for a hearing is made, Commerce intends to hold the hearing at the U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230, at a time and date to be determined. Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.
In accordance with section 703(f) of the Act, Commerce will notify the International Trade Commission (ITC) of its preliminary determination. Pursuant to section 705(b)(2) of the Act, if the final determination is affirmative, the ITC will make its final injury determination before the later of 120 days after the date of this preliminary determination or 45 days after the final determination.
This determination is issued and published pursuant to sections 703(f) and 777(i) of the Act and 19 CFR 351.205(c).
The merchandise covered by this investigation is welded carbon and alloy steel pipe (including stainless steel pipe), more than 406.4 mm (16 inches) in nominal outside diameter (large diameter welded pipe), regardless of wall thickness, length, surface finish, grade, end finish, or stenciling. Large diameter welded pipe may be used to transport oil, gas, slurry, steam, or other fluids, liquids, or gases. It may also be used for structural purposes, including, but not limited to, piling. Specifically, not included is large diameter welded pipe produced only to specifications of the American Water Works Association (AWWA) for water and sewage pipe.
Large diameter welded pipe used to transport oil, gas, or natural gas liquids is normally produced to the American Petroleum Institute (API) specification 5L. Large diameter welded pipe may also be produced to American Society for Testing and Materials (ASTM) standards A500, A252, or A53, or other relevant domestic specifications, grades and/or standards. Large diameter welded pipe can be produced to comparable foreign specifications, grades and/or standards or to proprietary specifications, grades and/or standards, or can be non-graded material. All pipe meeting the physical description set forth above is covered by the scope of this investigation, whether or not produced according to a particular standard.
Subject merchandise also includes large diameter welded pipe that has been further processed in a third country, including but not limited to coating, painting, notching, beveling, cutting, punching, welding, or any other processing that would not otherwise remove the merchandise from the scope of the investigation if performed in the country of manufacture of the in-scope large diameter welded pipe.
The large diameter welded pipe that is subject to this investigation is currently classifiable in the Harmonized Tariff Schedule of the United States (HTSUS) under subheadings 7305.11.1030, 7305.11.1060, 7305.11.5000, 7305.12.1030, 7305.12.1060, 7305.12.5000, 7305.19.1030, 7305.19.1060, 7305.19.5000, 7305.31.4000, 7305.31.6010, 7305.31.6090, 7305.39.1000 and 7305.39.5000. While the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of this investigation is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) is rescinding the administrative review of the countervailing duty order on utility scale wind towers from the People's Republic of China (China) for the period January 1, 2017, through December 31, 2017.
Applicable June 29, 2018.
John Conniff, AD/CVD Operations, Office III, Enforcement and Compliance, International Trade Administration, Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-1009.
On April 16, 2018, based on a timely request for review by the Wind Tower Trade Coalition (the petitioner),
Pursuant to 19 CFR 351.213(d)(1), Commerce will rescind an administrative review, in whole or in part, if the party that requested the review withdraws its request within 90 days of the date of publication of the notice of initiation of the requested review. In this case, the petitioner timely withdrew its request for review within the 90-day deadline, and no other party requested an administrative review of the countervailing duty order. As a result, pursuant to 19 CFR 351.213(d)(1), we are rescinding the administrative review of the countervailing duty order on utility scale wind towers from China for the period January 1, 2017, through December 31, 2017, in its entirety.
Commerce will instruct U.S. Customs and Border Protection (CBP) to assess countervailing duties on all appropriate entries. Because Commerce is rescinding this administrative review in its entirety, entries of utility scale wind towers from China during the period January 1, 2017, through December 31, 2017, shall be assessed countervailing duties at rates equal to the cash deposit of estimated countervailing duties required at the time of entry, or withdrawal from warehouse, for consumption, in accordance with 19 CFR 351.212(c)(1)(i). Commerce intends to issue appropriate assessment instructions to CBP 15 days after the publication of this notice in the
This notice also serves as a final reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO, in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return or destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.
This notice is issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Tariff Act of 1930, as amended, and 19 CFR 351.213(d)(4).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) preliminarily determines that countervailable subsidies are being provided to producers/exporters of large diameter welded pipe (welded pipe) from the People's Republic of China (China) for the period of investigation of January 1, 2017, through December 31, 2017. Interested parties are invited to comment on this preliminary determination.
Applicable June 29, 2018.
Justin Neuman or Benito Ballesteros, AD/CVD Operations, Office V, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone (202) 482-0486 or (202) 482-7425, respectively.
This preliminary determination is made in accordance with section 703(b) of the Tariff Act of 1930, as amended (the Act). Commerce published the notice of initiation of this investigation on February 20, 2018.
The product covered by this investigation is welded pipe from China. For a complete description of the scope of this investigation, see Appendix I.
In accordance with the preamble to Commerce's regulations,
For a summary of the product coverage comments and rebuttal responses submitted to the record for this preliminary determination, and accompanying discussion and analysis of all comments timely received,
Commerce is conducting this investigation in accordance with section 701 of the Act. For each of the subsidy programs found countervailable, Commerce preliminarily determines that there is a subsidy,
In making these findings, Commerce relied totally on facts available, because neither the GOC nor any of the selected mandatory respondent companies responded to the questionnaire. Further, because these parties did not act to the best of their ability to respond to Commerce's requests for information, Commerce drew an adverse inference in selecting from among the facts otherwise available.
In accordance with section 705(a)(1) of the Act and 19 CFR 351.210(b)(4), Commerce is aligning the final countervailing duty (CVD) determination in this investigation with the final determination in the companion antidumping duty (AD) investigation of welded pipe from China based on a request made by American Cast Iron Pipe Company, Berg Steel Pipe Corp./Berg Spiral Pipe Corp, Dura-Bond Industries, Skyline Steel, Stupp Corporation, Greens Bayou Pipe Mill, LP, JSW Steel (USA) Inc., and Trinity Products LLC (collectively, the petitioners).
Sections 703(d) and 705(c)(5)(A) of the Act provide that in the preliminary determination, Commerce shall determine an estimated all-others rate for companies not individually investigated. This rate shall be an amount equal to the weighted average of the estimated subsidy rates established for those companies individually investigated, excluding any zero and
Pursuant to section 705(c)(5)(A)(ii) of the Act, if the individual estimated countervailable subsidy rates established for all exporters and producers individually investigated are zero,
Commerce preliminarily determines that the following estimated countervailable subsidy rates exist:
In accordance with section 703(d)(1)(B) and (d)(2) of the Act, Commerce will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of entries of subject merchandise as described in the Scope of the Investigation section, entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the
Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than thirty days after the date of publication of this notice in the
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce within 30 days after the date of publication of this notice. Requests should contain the party's name, address, and telephone number, the number of participants, whether any participant is a foreign national, and a list of the issues to be discussed. If a request for a hearing is made, Commerce intends to hold the hearing at the U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230, at a time and date to be determined. Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.
In accordance with section 703(f) of the Act, Commerce will notify the International Trade Commission (ITC) of its preliminary determination. Pursuant to section 705(b)(2) of the Act, if the final determination is affirmative, the ITC will make its final injury determination before the later of 120 days after the date of this preliminary determination or 45 days after the final determination.
This determination is issued and published pursuant to sections 703(f) and 777(i) of the Act and 19 CFR 351.205(c).
The merchandise covered by this investigation is welded carbon and alloy steel pipe (including stainless steel pipe), more than 406.4 mm (16 inches) in nominal outside diameter (large diameter welded pipe), regardless of wall thickness, length, surface finish, grade, end finish, or stenciling. Large diameter welded pipe may be used to transport oil, gas, slurry, steam, or other fluids, liquids, or gases. It may also be used for structural purposes, including, but not limited to, piling. Specifically, not included is large diameter welded pipe produced only to specifications of the American Water Works Association (AWWA) for water and sewage pipe.
Large diameter welded pipe used to transport oil, gas, or natural gas liquids is normally produced to the American Petroleum Institute (API) specification 5L. Large diameter welded pipe may also be produced to American Society for Testing and Materials (ASTM) standards A500, A252, or A53, or other relevant domestic specifications, grades and/or standards. Large diameter welded pipe can be produced to comparable foreign specifications, grades and/or standards or to proprietary specifications, grades and/or standards, or can be non-graded material. All pipe meeting the physical description set forth above is covered by the scope of this investigation, whether or not produced according to a particular standard.
Subject merchandise also includes large diameter welded pipe that has been further processed in a third country, including but not limited to coating, painting, notching, beveling, cutting, punching, welding, or any other processing that would not otherwise remove the merchandise from the scope of the investigation if performed in the country of manufacture of the in-scope large diameter welded pipe.
The large diameter welded pipe that is subject to this investigation is currently classifiable in the Harmonized Tariff Schedule of the United States (HTSUS) under subheadings 7305.11.1030, 7305.11.1060, 7305.11.5000, 7305.12.1030, 7305.12.1060, 7305.12.5000, 7305.19.1030, 7305.19.1060, 7305.19.5000, 7305.31.4000, 7305.31.6010, 7305.31.6090, 7305.39.1000 and 7305.39.5000. While the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of this investigation is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) preliminarily determines that countervailable subsidies are being provided to producers and exporters of large diameter welded pipe (welded pipe) from the Republic of Turkey (Turkey) for the period of investigation of January 1, 2017, through December 31, 2017. Interested parties are invited to comment on this preliminary determination.
Applicable June 29, 2018.
Ross Belliveau or Ajay Menon, AD/CVD Operations, Office II, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-4952 or (202) 482-1993, respectively.
This preliminary determination is made in accordance with section 703(b) of the Tariff Act of 1930, as amended (the Act). Commerce published the notice of initiation of this investigation on February 20, 2018.
The product covered by this investigation is welded pipe from Turkey. For a complete description of the scope of this investigation,
In accordance with the preamble to Commerce's regulations,
For a summary of the product coverage comments and rebuttal responses submitted to the record for this preliminary determination, and accompanying discussion and analysis of all comments timely received,
Commerce is conducting this investigation in accordance with section 701 of the Act. For each of the subsidy programs found countervailable, Commerce preliminarily determines that there is a subsidy,
In accordance with section 705(a)(1) of the Act and 19 CFR 351.210(b)(4), Commerce is aligning the final countervailing duty (CVD) determination in this investigation with the final determination in the companion antidumping duty (AD) investigation of welded pipe from Turkey based on a request made by American Cast Iron Pipe Company, Berg Steel Pipe Corp./Berg Spiral Pipe Corp, Dura-Bond Industries, Skyline Steel, Stupp Corporation, Greens Bayou Pipe Mill, LP, JSW Steel (USA) Inc., and Trinity Products LLC (collectively, the petitioners).
Sections 703(d) and 705(c)(5)(A) of the Act provide that in the preliminary determination, Commerce shall determine an estimated all-others rate for companies not individually investigated. This rate shall be an amount equal to the weighted average of the estimated subsidy rates established for those companies individually investigated, excluding any zero and
In this investigation, Commerce calculated individual estimated countervailable subsidy rates for Borusan Mannesmann Boru Sanayi ve Ticaret A.S. (Borusan) and HDM Çelik Boru Sanayi ve Ticaret A.S. (HDM Celik) that are not zero,
Commerce preliminarily determines that the following estimated countervailable subsidy rates exist:
In accordance
Commerce intends to disclose its calculations and analysis performed to
As provided in section 782(i)(1) of the Act, Commerce intends to verify the information relied upon in making its final determination.
Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the last verification report is issued in this investigation. Rebuttal briefs, limited to issues raised in case briefs, may be submitted no later than five days after the deadline date for case briefs.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce within 30 days after the date of publication of this notice. Requests should contain the party's name, address, and telephone number, the number of participants, whether any participant is a foreign national, and a list of the issues to be discussed. If a request for a hearing is made, Commerce intends to hold the hearing at the U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230, at a time and date to be determined. Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.
In accordance with section 703(f) of the Act, Commerce will notify the International Trade Commission (ITC) of its preliminary determination. Pursuant to section 705(b)(2) of the Act, if the final determination is affirmative, the ITC will make its final injury determination before the later of 120 days after the date of this preliminary determination or 45 days after the final determination.
This determination is issued and published pursuant to sections 703(f) and 777(i) of the Act and 19 CFR 351.205(c).
The merchandise covered by this investigation is welded carbon and alloy steel pipe (including stainless steel pipe), more than 406.4 mm (16 inches) in nominal outside diameter (large diameter welded pipe), regardless of wall thickness, length, surface finish, grade, end finish, or stenciling. Large diameter welded pipe may be used to transport oil, gas, slurry, steam, or other fluids, liquids, or gases. It may also be used for structural purposes, including, but not limited to, piling. Specifically, not included is large diameter welded pipe produced only to specifications of the American Water Works Association (AWWA) for water and sewage pipe.
Large diameter welded pipe used to transport oil, gas, or natural gas liquids is normally produced to the American Petroleum Institute (API) specification 5L. Large diameter welded pipe may also be produced to American Society for Testing and Materials (ASTM) standards A500, A252, or A53, or other relevant domestic specifications, grades and/or standards. Large diameter welded pipe can be produced to comparable foreign specifications, grades and/or standards or to proprietary specifications, grades and/or standards, or can be non-graded material. All pipe meeting the physical description set forth above is covered by the scope of this investigation, whether or not produced according to a particular standard.
Subject merchandise also includes large diameter welded pipe that has been further processed in a third country, including but not limited to coating, painting, notching, beveling, cutting, punching, welding, or any other processing that would not otherwise remove the merchandise from the scope of the investigation if performed in the country of manufacture of the in-scope large diameter welded pipe.
Excluded from the scope are any products covered by the existing countervailing duty order on welded line pipe from the Republic of Turkey.
The large diameter welded pipe that is subject to this investigation is currently classifiable in the Harmonized Tariff Schedule of the United States (HTSUS) under subheadings 7305.11.1030, 7305.11.1060, 7305.11.5000, 7305.12.1030, 7305.12.1060, 7305.12.5000, 7305.19.1030, 7305.19.1060, 7305.19.5000, 7305.31.4000, 7305.31.6010, 7305.31.6090, 7305.39.1000 and 7305.39.5000. While the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of this investigation is dispositive.
Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce.
Applicable June 29, 2018.
Darla Brown or Terre Keaton Stefanova, AD/CVD Operations, Office II, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-1791, or (202) 482-1280, respectively.
On May 7, 2018, the Department of Commerce (Commerce) initiated a countervailing duty (CVD) investigation on certain quartz surface products from the People's Republic of China.
Section 703(b)(1) of the Tariff Act of 1930, as amended (the Act), requires Commerce to issue the preliminary
On June 11, 2018, the petitioner, Cambria Company LLC, submitted a timely request that we postpone the preliminary CVD determination because: (1) Commerce was not able to issue its respondent selection memorandum until June 8, 2018; and (2) as a result, responses to the CVD questionnaire are not due until July 16, 2018 (
In accordance with 19 CFR 351.205(e), the petitioner has stated the reasons for requesting a postponement of the preliminary determination, and Commerce finds no compelling reason to deny the request. Therefore, pursuant to section 703(c)(1)(A) of the Act, we are extending the due date for the preliminary determination to no later than 130 days after the date on which this investigation was initiated,
This notice is issued and published pursuant to section 703(c)(2) of the Act and 19 CFR 351.205(f)(l).
National Institute of Standards and Technology, Commerce.
Notice.
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Written comments must be submitted on or before August 28, 2018.
Direct all written comments to Jennifer Jessup, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 1401 Constitution Avenue NW, Washington, DC 20230 (or via the internet at
Requests for additional information or copies of the information collection instrument and instructions should be directed to Elizabeth Reinhart, NIST Management and Organization Office, 100 Bureau Drive, Gaithersburg, MD 20899; 301-975-8707;
Exoskeletons—sometimes called wearable robots—are a very rapidly expanding domain with a range of applications and a broad diversity of designs. NIST's Engineering Laboratory will be developing methods to evaluate performance of exoskeletons in two key areas (1) The fit and motion of the exoskeleton device with respect to the users' body and (2) The impact that using an exoskeleton has on the performance of users executing tasks that are representative of activities in industrial settings. The results of these experiments will inform future test method development at NIST, other organizations, and under the purview of the new American Society for Testing Materials (ASTM) Committee F48 on Exoskeletons and Exosuits.
For the first research topic, NIST will evaluate the usefulness of a NIST prototype apparatus for measuring the difference in performance of a person wearing an exoskeleton versus the person's baseline without the exoskeleton while positioning loads and tools. The NIST Position and Load Test Apparatus for Exoskelons (PoLoTAE), which presents abstractions of industrial task challenges, will be evaluated in this research.
For the second research topic, NIST will evaluate a method for measuring the alignment of an exoskeleton to human joint (knee) and any relative movement between the exoskeleton and user. Measurement methods prototyped by NIST for evaluating exoskeleton on mannequin position and motion will be applied to human subjects to verify the usefulness of optical tracking system and designed artifacts worn by users as measurement methods.
Participants will be chosen from volunteers within NIST and adult NIST visitors to participate in the study. Gender and size diversity will be sought in the population of participants. No personally identifiable information (PII) will be recorded unless subject consent for PII disclosure is received. NIST intends to publish information on the analysis and results.
Participants will give informed consent prior to participating in the research. Information may be collected via a paper background questionnaire which may include disclosure of health information which may be relevant for safety and research reasons. Data will be collected using a combination of heart rate monitor, and video and still cameras to collect time and subject activity to correlate heart rate with activity and an optical tracking system which detects markers. Participants will be asked to complete a paper survey once data is collected for the research.
NIST invites comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; receipt of application.
Notice is hereby given that Jooke Robbins, Ph.D., Center for Coastal Studies, 5 Holway Avenue, Provincetown, MA 02657, has applied in due form for a permit to conduct research on cetaceans.
Written, telefaxed, or email comments must be received on or before July 30, 2018.
The application and related documents are available for review by selecting “Records Open for Public Comment” from the “Features” box on the Applications and Permits for Protected Species (APPS) home page,
These documents are also available upon written request or by appointment in the Permits and Conservation Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone (301) 427-8401; fax (301) 713-0376.
Written comments on this application should be submitted to the Chief, Permits and Conservation Division, at the address listed above. Comments may also be submitted by facsimile to (301) 713-0376, or by email to
Those individuals requesting a public hearing should submit a written request to the Chief, Permits and Conservation Division at the address listed above. The request should set forth the specific reasons why a hearing on this application would be appropriate.
Carrie Hubard or Amy Hapeman, (301) 427-8401.
The subject permit is requested under the authority of the Marine Mammal Protection Act of 1972, as amended (MMPA; 16 U.S.C. 1361
The applicant proposes to continue a long-term study of large whales in the Western Atlantic Ocean. The focus of the research would be on humpback (
In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321
Concurrent with the publication of this notice in the
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; receipt of application for permit amendment.
Notice is hereby given that Linnea Pearson, California Polytechnic State University, 1 Grand Ave., San Luis Obispo, CA 93407, has applied for an amendment to Scientific Research Permit No. 21006.
Written, telefaxed, or email comments must be received on or before July 30, 2018.
The application and related documents are available for review by selecting “Records Open for Public Comment” from the “Features” box on the Applications and Permits for Protected Species home page,
These documents are also available upon written request or by appointment in the Permits and Conservation
Written comments on this application should be submitted to the Chief, Permits and Conservation Division, at the address listed above. Comments may also be submitted by facsimile to (301)713-0376, or by email to
Those individuals requesting a public hearing should submit a written request to the Chief, Permits and Conservation Division at the address listed above. The request should set forth the specific reasons why a hearing on this application would be appropriate.
Sara Young or Amy Sloan, (301) 427-8401.
The subject amendment to Permit No. 21006 is requested under the authority of the Marine Mammal Protection Act of 1972, as amended (16 U.S.C. 1361
Permit No. 21006, issued on September 15, 2017 (82 FR 48985; October 23, 2017), authorizes the permit holder to conduct research on Weddell seals in the Antarctic. The permit holder is requesting the permit be amended to include authorization for: Increased take of pups to twelve total, sedation of six additional pups at one week of age, collection of blood samples at four time points for six additional pups, use of a cannulated needle for biopsy instead of a biopsy punch, attachment of flipper mounted VHF and accelerometer tags to pups at one week of age, and use of antibiotics to treat local or systemic infection.
In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321
Concurrent with the publication of this notice in the
Committee for Purchase From People Who Are Blind or Severely Disabled.
Proposed additions to and deletions from the Procurement List.
The Committee is proposing to add products to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities, and deletes products and a service previously provided by such agencies.
Comments must be received on or before July 29, 2018.
Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S Clark Street, Suite 715, Arlington, Virginia 22202-4149.
For further information or to submit comments contact: Amy B. Jensen, Telephone: (703) 603-7740, Fax: (703) 603-0655, or email
This notice is published pursuant to 41 U.S.C. 8503(a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.
If the Committee approves the proposed additions, the entities of the Federal Government identified in this notice will be required to procure the products listed below from nonprofit agencies employing persons who are blind or have other severe disabilities.
The following products are proposed for addition to the Procurement List for production by the nonprofit agencies listed:
The following products and service are proposed for deletion from the Procurement List:
Office of the Under Secretary of Defense for Personnel and Readiness, DoD.
30-Day information collection notice.
The Department of Defense has submitted to OMB for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.
Consideration will be given to all comments received by July 30, 2018.
Comments and recommendations on the proposed information collection should be emailed to Ms. Jasmeet Seehra, DoD Desk Officer, at
Fred Licari, 571-372-0493, or
You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:
•
Requests for copies of the information collection proposal should be sent to Mr. Licari at
Office of the Chief Information Officer, DoD.
30-Day information collection notice.
The Department of Defense has submitted to OMB for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.
Consideration will be given to all comments received by July 30, 2018.
Comments and recommendations on the proposed information collection should be emailed to Ms. Jasmeet Seehra, DoD Desk Officer, at
Fred Licari, 571-372-0493, or
You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:
•
Requests for copies of the information collection proposal should be sent to Mr. Licari at
Office of the Under Secretary of Defense for Personnel and Readiness, DoD.
30-Day information collection notice.
The Department of Defense has submitted to OMB for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.
Consideration will be given to all comments received by July 30, 2018.
Comments and recommendations on the proposed information collection should be emailed to Ms. Jasmeet Seehra, DoD Desk Officer, at
Fred Licari, 571-372-0493, or
You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:
•
Requests for copies of the information collection proposal should be sent to Mr. Licari at
Office of the Under Secretary of Defense for Personnel and Readiness, DoD.
Information collection notice.
In compliance with the
Consideration will be given to all comments received by August 28, 2018.
You may submit comments, identified by docket number and title, by any of the following methods:
•
•
To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to Office of the Under Secretary of Defense for Personnel and Readiness (Military Personnel Policy)/Accession Policy, ATTN: LTC Aaron Wellman, 4000 Defense Pentagon, Washington, DC 20301-4000, or call 703-697-7594.
U.S. Army Corps of Engineers, DoD.
Notice of intent to initiate public scoping and prepare an Environmental Assessment (EA).
The St. Paul District, Army Corps of Engineers (MVP) is conducting a study regarding the disposition of the Upper St. Anthony Falls Lock and Dam, Lower St. Anthony Falls Lock and Dam, and Lock and Dam 1 located in the Upper Mississippi River, Hennepin and Ramsey Counties, Minnesota. The study will include an environmental assessment and consider opportunities regarding deauthorization and disposal of any or all of the three lock and dam sites. The study will evaluate two primary alternatives: (1) No action; and, (2) deauthorization by Congress of the Federal missions at the sites and disposal according to Federal law. Deauthorization would include portions of the Mississippi River 9-foot navigation channel and the lands and structures associated with each lock and dam site. It is anticipated that a draft report of the integrated Disposition Study and Environmental Assessment (EA) will be available for a 30-day public comment period in the Spring of 2019. The St. Paul District of the Army Corps of Engineers is soliciting public comments on the proposed study, potential interest in future ownership if disposal of the properties is warranted, and substantive issues that should be analyzed in the EA.
Monday, July 16th from 6:00 p.m. to 8:00 p.m. at the Mill City Museum, 704 South Second Street, Minneapolis, Minnesota 55401.
Tuesday, July 17th from 6:00 p.m. to 8:00 p.m. at the Highland Park Senior High School Auditorium, 1015 Snelling Avenue South, St. Paul, Minnesota, 55116.
At the scoping meetings, the public is encouraged to submit resource information, and identify topics to be considered in the development of the EA. Written and oral comments will be accepted at each meeting.
Comments may be submitted by one of the following methods:
If submitting comments by email, the following should be included in the subject line or first line of the message: “USAF, LSAF, L/D 1 Disposition Study Comments”.
To have your name added to a mailing list for notices related to the draft report and EA or additional public meetings, submit an email request to
The St. Paul District, Army Corps of Engineers (MVP) operates the Upper St. Anthony Falls Lock and Dam (USAF), Lower St. Anthony Falls Lock and Dam (LSAF), and Lock and Dam No. 1 (L/D 1), located on the Mississippi River in Minneapolis and St. Paul, Minnesota. MVP also maintains the navigation channel in proximity to these dams which involves periodic dredging. Section 2010 of the Water Resources Reform and Development Act of 2014 (WRRDA 2014), dated 10 June 2014, directed that USAF be closed within one year of the date of enactment of the Act, but did not deauthorize USAF. Prior to the closure of USAF, the three locks operated as a system to support navigation on the upper reaches of the Mississippi River 9-foot navigation channel. With the lock at USAF now closed to navigation, the demand for both commercial and recreational lockage has decreased due to the navigational disconnect in the Mississippi River at USAF. Deauthorization and disposal of one or more of the three sites may be warranted if the sites are deemed to not be fulfilling their authorized purposes. Deauthorization would also preclude maintenance activities of the navigation channel in proximity to these dams. The current authorized purposes are navigation and recreation.
Section 216 of the Flood Control Act of 1970 authorizes the Secretary of the Army to review operations of completed projects, when found advisable due to changed physical, economic, or environmental conditions. Disposition studies are a specific type of Section 216 study with the intent to determine whether a water resources development project operated and maintained by the Corps of Engineers should be deauthorized and the associated real property and Government-owned improvements disposed of. An Initial Appraisal (IA) was conducted by the Corps in 2015 to determine if conditions exist which may warrant further analysis on a completed project as authorized by Section 216. The IA recommended investigation under this authority regarding the future use or disposition of USAF, LSAF, and L/D 1.
The purpose of the Disposition Study is to determine what federal interest exists to retain USAF, LSAF, and/orL/D 1 for its authorized purpose(s) based on an evaluation and comparison of the benefits, costs, and impacts (positive and negative) of continued operation, maintenance, repair, replacement, and rehabilitation, compared to the deauthorization and disposal of the associated real properties. The Disposition Study ends when the final report is transmitted to the Corps of Engineers' Headquarters Office for review and processing of recommendations. Deauthorization would require Congressional Approval.
In accordance with the National Environmental Policy Act of 1969 (NEPA), an Environmental Assessment (EA) for this study is anticipated and will be prepared by MVP. The study will broadly evaluate two primary alternatives: (1) The no action; and, (2) deauthorization by Congress of the Federal navigation-related missions at the sites and disposal of the properties according to Federal law. Deauthorization would include portions of the Mississippi River 9-foot navigation channel associated with each lock and dam site. MVP is soliciting public comments on the scope of the EA and significant issues that should be addressed. MVP will also accept comments related to potential new ownership and management measures.
Two public scoping meetings are planned as discussed in the
Persons needing reasonable accommodations in order to attend and participate in the public scoping meetings should contact the person listed under the
Written comments, including email comments, should be sent to MVP at the address given in the
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—will be publicly available. While you can ask in your comment to have your personal identifying information withheld from public review, MVP cannot guarantee that we will be able to do so.
All submissions from organizations or businesses and from individuals identifying themselves as representatives or officials of organizations or businesses will be available for public review to the extent consistent with applicable law.
Department of the Army, U.S. Army Corps of Engineers, DoD.
Notice of intent.
The U.S. Army Corps of Engineers (Corps), Sacramento District, intends to adopt the Bureau of Reclamation's (BOR) December 2015 Final Environment Impact Report (FEIR)/Final Environmental Impact Statement (FEIS)/Final Environmental Impact Statement (FEIS) for the Upper Truckee River and Marsh Restoration Project and prepare its own Record of Decision (ROD) after the public review period for this Notice of Intent ends. The Corps will use its Tahoe Section 108 program authorization for participation in the restoration activities by reimbursing the California Tahoe Conservancy (CTC), the local sponsor, for final design, construction, and other applicable activities falling under the authorization. During final design and construction, the Corps will serve as the lead Federal agency for compliance with the National Environmental Policy Act (NEPA), and CTC will serve as the lead agency for compliance with the California Environmental Quality Act (CEQA) during the final design and construction activities if designs need to be modified or the river moves from its current alignment prior to design and construction. In the December 2015 Final EIR/EIS/EIS, the analysis for this ecosystem restoration project evaluated five alternatives to restore aquatic and riparian values and functions on the Upper Truckee River's marsh area near its terminus at Lake Tahoe, South Lake Tahoe in El Dorado County, CA with selection of a preferred alternative to be constructed. The Corps has reviewed the draft and Final EIR/EIS/EIS to ensure that all NEPA requirements have been met.
Written comments regarding the scope of the Corps adoption of the BOR's FEIR/FEIS/FEIS, preparation of the Corps ROD, and reimbursement to CTC should be received by the Corps on or before July 30, 2018.
Send written comments and suggestions to Mr. Mario Parker, Biological Sciences Study Manager, U.S. Army Corps of Engineers, Sacramento District, 1325 J Street, Sacramento, CA 95814, or email him at
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Sec. 108. Lake Tahoe Basin Restoration, Nevada and California. (a) Definition.—In this section, the term “Lake Tahoe Basin” means the entire watershed drainage of Lake Tahoe including that portion of the Truckee River 1,000 feet downstream from the United States Bureau of Reclamation dam in Tahoe City, California.
(b) Establishment of Program.—The Secretary [of the Army] may establish a program for providing environmental assistance to non-Federal interests in Lake Tahoe Basin.
(c) Form of Assistance.—Assistance under this section may be in the form of planning, design, and construction assistance for water-related environmental infrastructure and resource protection and development projects in Lake Tahoe Basin, which could include the following:
(1) Urban stormwater conveyance, treatment and related facilities;
(2) watershed planning, science and research;
(3) environmental restoration; and
(4) surface water resource protection and development.
(d) Public Ownership Requirement.—The Secretary [of the Army] may provide assistance for a project under this section only if the project is publicly owned.
(e) Local Cooperation Agreement.—(1) In general.—Before providing assistance under this section, the Secretary shall enter into a local cooperation agreement with a non-Federal interest to provide for design and construction of the project to be carried out with the assistance.
(2) Requirements.—Each local cooperation agreement entered into under this subsection shall provide for the following:
(A) Plan.—Development by the Secretary [of the Army], in consultation with appropriate Federal and State and Regional officials, of appropriate environmental documentation, engineering plans and specifications.
(B) Legal and institutional structures.—Establishment of such legal and institutional structures as are necessary to ensure the effective long-term operation of the project by the non-Federal interest.
(3) Cost sharing.—
(A) In general.—The Federal share of project costs under each local cooperation agreement entered into under this subsection shall be 75 percent. The Federal share may be in the form of grants or reimbursements of project costs.
(B) Credit for design work.—The non-Federal interest shall receive credit for the reasonable costs of planning and design work completed by the non-Federal interest before entering into a local cooperation agreement with the Secretary for a project.
(C) Land, easements, rights-of-way, and relocations.—The non-Federal interest shall receive credit for land, easements, rights-of-way, and relocations provided by the non-Federal interest toward the non-Federal share of project costs (including all reasonable costs associated with obtaining permits necessary for the construction, operation, and maintenance of the project on publicly owned or controlled land), but not to exceed 25 percent of total project costs.
(D) Operation and maintenance.—The non-Federal share of operation and maintenance costs for projects constructed with assistance provided under this section shall be 100 percent.
(F) Applicability of Other Federal and State Laws.—Nothing in this section waives, limits, or otherwise affects the applicability of any provision of Federal or State law that would otherwise apply to a project to be carried out with assistance provided under this section.
(G) Authorization of Appropriations.—There is authorized to be appropriated to carry out this section for the period beginning with fiscal year 2005, $25,000,000, to remain available until expended.
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The selected alternative proposes the most geomorphically appropriate channel configuration, allowing the pilot channel to strategically connect the current river alignment to historic channels and lagoons. The river would form its own pattern and spread over the expanse of the marsh, resulting in substantial benefits to habitats, wildlife, and long-term water quality. However, the preferred alternative could have a long-term, and significant unavoidable impact to fish passage through the project area during low flow periods if channel disconnectivity occurs.
The selected alternative also includes restoration of a portion of a marina, removal of fill placed during development to restore wet meadow, stabilization of streambanks, modification and/or relocation of two existing stormwater discharge locations, and restoration of sand ridges that were graded and leveled. The selected alternative would provide a moderate level of recreation infrastructure along the west side of the Upper Truckee Marsh that would include a modified American with Disabilities Act (ADA)-accessible pedestrian trail to Cove East Beach, viewpoints, and signage.
The preferred alternative would have short-term and interim impacts on water quality from increased turbidity and would have short-term impacts to sensitive habitats and wildlife during construction. It would also have short-term and interim impacts on water quality that could not be avoided because of the strict turbidity criteria used to determine a significant and unavoidable impact and to sensitive habitats and wildlife.
In compliance with NEPA and CEQA, a combination of best management practices and conservation measures would be used and included in the designs to avoid, reduce, and minimize any significant adverse effects on environmental resources that were identified in the December 2015 FEIR/FEIS/FEIS while meeting requirements for various Federal, State, and local statutes. The project is being designed to restore ecosystem values and riparian and fluvial functions that benefit many seasonal and resident fish and wildlife populations including Federally listed species such as the Lahontan cutthroat trout and species of concern such as willow flycatcher and Tahoe yellow-cress.
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Department of the Navy, DoD.
30-Day information collection notice.
The Department of Defense has submitted to OMB for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.
Consideration will be given to all comments received by July 30, 2018.
Comments and recommendations on the proposed information collection should be emailed to Ms. Jasmeet Seehra, DoD Desk Officer, at
Fred Licari, 571-372-0493, or
You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:
•
Requests for copies of the information collection proposal should be sent to Mr. Licari at
Office of Special Education and Rehabilitative Services, Department of Education.
Notice.
The Department of Education (Department) is issuing a notice inviting applications for a new award for fiscal year (FY) 2018 for Educational Technology, Media, and Materials for Individuals with Disabilities—Center on Early Science, Technology, Engineering, and Math Learning for Young Children with Disabilities, Catalog of Federal Domestic Assistance (CFDA) number 84.327G.
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
Dawn Ellis, U.S. Department of Education, 400 Maryland Avenue SW, Room 5137, Potomac Center Plaza, Washington, DC 20202-5108. Telephone: (202) 245-6417. Email:
If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.
This priority is:
The mission of the Office of Special Education and Rehabilitative Services (OSERS) is to improve early childhood, educational, and employment outcomes and raise expectations for all people with disabilities, their families, their communities, and the Nation.
As early as infancy, young children start developing and testing hypotheses about how things work. These inquiry-based skills and the quest for understanding form the foundation for early science, technology, engineering, and math (STEM) learning. Research shows that early exposure to STEM learning has positive impacts across developmental domains and can positively impact later learning and academic performance (Duncan et al., 2007; Mantzicopoulos, Patrick, & Samarapungavan, 2008).
Because of these impacts, experts have recommended that early childhood programs intentionally integrate STEM learning into the curricula and that it be considered an essential component of a high-quality early childhood experience (Brenneman, Stevenson-Boyd, & Frede, 2009; National Research Council, 2009). While there have been recent efforts to fund STEM initiatives for early childhood, there has been a lack of focus specifically on how to support STEM learning in infants, toddlers, and preschool children (young children) with disabilities.
This focus is necessary, however, because young children with disabilities often require specialized supports to engage in STEM learning, which can help young children achieve developmental and educational outcomes under Parts C and B of the IDEA. Many STEM activities require children to use fine and gross motor skills to physically engage with objects, have the mobility to participate in experiments, or use different senses to explore how something works. STEM activities also typically require children to ask questions, have focused attention, and solve problems. All of these may pose challenges for some young children with disabilities. Yet the hands-on approach and active engagement needed for STEM learning is an ideal way for young children with disabilities to develop skills and achieve goals within their individualized family service plans (IFSPs) or individualized education programs (IEPs). Identifying best practices in providing STEM learning to young children with disabilities, including through the use of technology, would help maximize the benefits to them.
To ensure that young children with disabilities can engage in and benefit from STEM learning, this priority will fund a cooperative agreement to establish and operate a Center on Early STEM Learning for Young Children with Disabilities (the Center). The Center will assemble a body of knowledge on the practices and supports, including the use of technology, necessary to improve STEM learning for young children with disabilities. The Center will also disseminate these practices and supports to early childhood programs, administrators, providers, families of children with disabilities, and institutions of higher education (IHEs).
This priority is consistent with three priorities from the Secretary's Final Supplemental Priorities and Definitions for Discretionary Grant Programs, which were published in the
The purpose of this priority is to fund a cooperative agreement to establish and operate a national Center on Early Science, Technology, Engineering, and Mathematics (STEM) Learning, for Young Children with Disabilities to achieve, at a minimum, the following expected outcomes:
(a) Increased body of knowledge of current evidence-based (as defined in this notice) practices (EBPs) for early STEM learning, including early computer science learning for young children with disabilities;
(b) Increased use by early childhood programs, providers, and families of the current EBPs in early STEM learning for young children with disabilities; and
(c) Increased awareness by faculty in IHEs of the current EBPs in early STEM learning for young children with disabilities and increased focus on early STEM learning within programs of study within IHEs.
In addition to these programmatic requirements, to be considered for funding under 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 need in the field for knowledge about early STEM learning for young children with disabilities and their families. To meet this requirement the applicant must—
(i) Demonstrate knowledge of the current and emerging EBPs in early STEM learning for all young children, and specifically around using technology to improve access to early STEM learning for young children with disabilities and their families; and
(ii) Demonstrate knowledge of current educational and policy issues and national initiatives relating to early STEM learning for all young children and their families, and specifically for young children with disabilities and their families;
(2) Address current and emerging capacity needs of early childhood programs, providers, and families to select and implement current EBPs that will improve early STEM learning for young children with disabilities, including using technology to improve their access to early STEM learning activities. To meet this requirement, the applicant must—
(i) Present information and data on the current capacity of early childhood providers to effectively support early STEM learning in young children with disabilities;
(ii) Present information and data on how early STEM learning is included within personnel preparation programs;
(iii) Demonstrate knowledge of the implementation supports (
(iv) Demonstrate knowledge of how to educate, engage, and support families of young children with disabilities to implement early STEM learning activities;
(3) Improve the potential for early STEM outcomes for young children with disabilities and indicate the likely magnitude or importance of these outcomes.
(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 intended recipients for technical assistance (TA) and information;
(ii) Ensure that services and products meet the needs of the intended recipients of the grant;
(iii) As appropriate, address the needs of young children with disabilities who are Native American or are dual language learners (
(iv) As appropriate, address the needs of military-connected young children with disabilities;
(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 practices to support early STEM learning for young children with disabilities and the use of technology to improve access to
(ii) The current research about adult learning principles and implementation science or improvement science that will inform the proposed products; 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 or develop the knowledge base on:
(A) EBPs on early STEM learning for young children with disabilities;
(B) Use of technology to improve access to early STEM learning for young children with disabilities;
(C) What young children should know or be able to do in early STEM at different ages;
(D) Integration of early STEM learning into IFSPs under Part C of the IDEA and IEPs under Part B of the IDEA; and
(E) Implementation supports needed for early childhood programs and providers to have the capacity to implement the early STEM learning practices, and educate, engage, and support families of young children with disabilities in implementing opportunities for early STEM learning.
(ii) Its proposed approach to universal, general TA,
(A) Developing and disseminating resources, materials, and tools for faculty at IHEs to embed current EBPs on early STEM learning for young children with disabilities within personnel preparation programs of study;
(B) Developing and disseminating resources, materials, and tools for early childhood programs and providers on current EBPs on early STEM learning for young children with disabilities, including: How to incorporate early STEM learning into IFSPs and IEPs to achieve child outcomes identified on the IFSP or IEP; how to use technology to increase opportunities for early STEM learning and deliver instruction or interventions that promote early STEM learning; and how to work with families to help promote early STEM learning with their child; and
(C) Partnering with national professional organizations, foundations, industry and research organizations and centers to disseminate information on how young children with disabilities can be included in broader early STEM research, policies, and practices, including within new curricula and learning materials.
(iii) Its proposed approach to targeted, specialized TA,
(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; and
(iii) 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 as described in the following paragraphs. The evaluation plan must describe: 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
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 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 and quality of project personnel,” 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 providers, 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 providers, consultants, and subcontractors, as applicable; and
(ii) Timelines and milestones for accomplishing the project tasks;
(2) Key project personnel and any consultants and subcontractors, 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, relevant, and useful to recipients; and
(4) The proposed project will benefit from a diversity of perspectives, including those of researchers, faculty, early childhood administrators, providers across different types of early childhood programs, families, and policy makers, among others, in its development and operation.
(f) Address the following application requirements. The applicant must—
(1) Include, in Appendix A, providers-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) Three trips annually 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.
(4) Describe how doctoral students or post-doctoral fellows will be engaged in the project to increase the number of future leaders in the field who are knowledgeable about early STEM learning for young children with disabilities, including the use of technology to increase access to early STEM learning; and
(5) Maintain a high-quality website, with an easy-to-navigate design, that meets government or industry-recognized standards for accessibility.
(6) Include, in Appendix A, an assurance that the project will assist OSEP with the transfer of pertinent resources and products and will maintain the continuity of services during the transition at the end of this award period, as appropriate.
In deciding whether to continue funding the project for the fourth and fifth years, the Secretary will consider
(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.
The following definitions are from 34 CFR 77.1:
(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 2.1 or 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 2.1 or 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 (
The regulations in 34 CFR part 79 apply to all applicants except federally recognized Indian tribes.
The regulations in 34 CFR part 86 apply to IHEs only.
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.
The Department is not bound by any estimates in this notice.
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(a) Recipients of funding under this competition must make positive efforts to employ and advance in employment qualified individuals with disabilities (see section 606 of IDEA).
(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 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;
(ii) The potential contribution of the proposed project to the development and advancement of theory, knowledge, and practices in the field of study; and
(iii) The extent to which the proposed project is likely to build local capacity to provide, improve, or expand services that address the needs of the target population.
(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 design of the proposed project includes a thorough, high-quality review of the relevant literature, a high-quality plan for project implementation, and the use of appropriate methodological tools to ensure successful achievement of project objectives; and
(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.
(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 provide for examining the effectiveness of project implementation strategies;
(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 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 for the proposed project.
(2) In determining the, 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 one or more of 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 adequacy of support, including facilities, equipment, supplies, and other resources, from the applicant organization or the lead applicant organization;
(iv) The relevance and demonstrated commitment of each partner in the proposed project to the implementation and success of the project; and
(v) 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
2.
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 (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).
3.
4.
5.
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.
1.
If your application is not evaluated or not selected for funding, we notify you.
2.
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 information as directed by the Secretary under 34 CFR 75.118. The Secretary may also require more frequent performance reports under 34 CFR 75.720(c). For specific requirements on reporting, please go to
5.
• Program Performance Measure #1: The percentage of Educational Technology, Media, and Materials Program products and services judged to be of high quality by an independent review panel of experts qualified to review the substantial content of the products and services;
• Program Performance Measure #2: The percentage of Educational Technology, Media, and Materials Program products and services judged to
• Program Performance Measure #3: The percentage of Educational Technology, Media, and Materials Program products and services judged to be of useful in improving results for infants, toddler, children and youth with disabilities;
• Program Performance Measure #4.1: The federal cost per unit of accessible educational materials funded by the Educational Technology, Media, and Materials Program;
• Program Performance Measure #4.2: The federal cost per unit of accessible educational materials from the National Instructional Materials Accessibility Center funded by the Educational Technology, Media, and Materials Program; and
• Program Performance Measure #4.3: The federal cost per unit of video description funded by the Educational Technology, Media, and Materials Program.
Projects funded under this competition are required to submit data on these measures as directed by OSEP.
Grantees will be required to report information on their project's performance in annual performance reports and additional performance data to the Department (34 CFR 75.590 and 75.591).
6.
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
Federal Student Aid (FSA), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995, ED is proposing a revision of an existing information collection.
Interested persons are invited to submit comments on or before July 30, 2018.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact Ian Foss, 202-377-3681.
The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
Office of Energy Efficiency and Renewable Energy, Department of Energy.
Notice of petition for waiver and grant of an interim waiver, and request for comments.
This document announces receipt of and publishes a petition for waiver from LG Electronics USA, Inc. (“LG”), which seeks an exemption from the U.S. Department of Energy (“DOE”) test procedure used for determining the efficiency of specified room air conditioner basic models. LG seeks to use an alternate test procedure to address issues involved in testing the basic models identified in its petition. According to LG, the current DOE test procedure for room air conditioners, which provides for testing at full-load performance only, does not take into account the benefits of room air conditioners that use variable-speed compressors (“variable speed air conditioners”), with their part-load performance characteristics, and misrepresents their actual energy consumption. LG requests that it be permitted to test the specified basic models at four rating conditions instead of a single rating condition and to calculate the test unit's weighted-average combined energy efficiency ratio (CEER), which can then be compared to the expected performance of a comparable single-speed room air conditioner across the same four rating conditions. The performance improvement would be applied to the measured performance of the variable-speed room air conditioner when tested under the high-temperature rating condition of the DOE test procedure for room air conditioners to determine the test unit's final rated CEER value. DOE grants LG an interim waiver from the DOE's room air conditioner test procedure for the specified basic models, subject to use of the alternate test procedure as set forth in the Interim Waiver Order. DOE solicits comments, data, and information concerning LG's petition and its suggested alternate test procedure to inform its final decision on LG's waiver request.
Written comments and information are requested and will be accepted on or before July 30, 2018.
Interested persons are encouraged to submit comments using the Federal eRulemaking Portal at
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No telefacsimilies (faxes) will be accepted. For detailed instructions on submitting comments and additional information on this process, see section V of this document.
The docket web page can be found at
Ms. Lucy deButts, U.S. Department of Energy, Office of Energy Efficiency and Renewable Energy, Building Technologies Office, Mailstop EE-5B, 1000 Independence Avenue SW, Washington, DC 20585-0121. E-mail:
Sarah Butler, U.S. Department of Energy, Office of the General Counsel, Mail Stop GC-33, Forrestal Building, 1000 Independence Avenue SW, Washington, DC 20585-0103. Telephone: (202) 586-1777. E-mail:
The Energy Policy and Conservation Act of 1975 (“EPCA” or “the Act”),
DOE regulations set forth at 10 CFR 430.27 contain provisions that allow any interested person to seek a waiver from test procedure requirements for a particular basic model when the petitioner's basic model for which the petition for waiver was submitted contains one or more design characteristics that either (1) prevent testing according to the prescribed test procedure, or (2) cause the prescribed test procedures to evaluate the basic model in a manner so unrepresentative of its true energy consumption characteristics as to provide materially inaccurate comparative data. 10 CFR
DOE may grant the waiver subject to conditions, including adherence to alternate test procedures. 10 CFR 430.27(f)(2). As soon as practicable after the granting of any waiver, DOE will publish in the
The waiver process also provides that DOE may grant an interim waiver if it appears likely that the underlying petition for waiver will be granted and/or if DOE determines that it would be desirable for public policy reasons to grant immediate relief pending a determination on the underlying petition for waiver. 10 CFR 430.27(e)(2). Within one year of issuance of an interim waiver, DOE will either: (i) Publish in the
On April 6, 2018, LG filed a petition for waiver and a petition for interim waiver from the test procedure applicable to room air conditioners set forth in appendix F. According to LG, the current DOE test procedure for room air conditioners, which provides for testing at full-load performance only (
LG states that variable-speed room air conditioners use frequency controls constantly to adjust the compressor rotation speed to maintain the desired temperature in the home without turning the motor on and off; that the compressor responds automatically to surrounding conditions to operate in the most efficient possible manner; and that this results in both dramatic energy savings and faster cooling compared to a room air conditioner without a variable-speed compressor. LG asserted that this ability to adjust to conditions results in both dramatic energy savings and faster cooling compared to products room air conditioners without variable-speed compressors. LG further stated that variable-speed room air conditioners also have a higher/lower operating range (10 Hz to 120 Hz). LG asserts that because the DOE test procedure does not account for part-load characteristics, the results of the test procedure are not representative of the actual energy consumption of variable-speed room air conditioners.
LG also requests an interim waiver from the existing DOE test procedure. DOE will grant an interim waiver if it appears likely that the petition for waiver will be granted, and/or if DOE determines that it would be desirable for public policy reasons to grant immediate relief pending a determination of the petition for waiver. See 10 CFR 430.27(e)(2).
DOE understands that, absent an interim waiver, the test procedure does not accurately measure the energy consumption of variable-speed room air conditioners, and without waiver relief, the part-load characteristics of the basic models identified in LG's petition would not be captured.
EPCA requires that manufacturers use DOE test procedures when making representations about the energy consumption and energy consumption costs of products covered by the statute. (42 U.S.C. 6293(c)). Consistent representations are important for manufacturers to use in making representations about the energy efficiency of their products and to demonstrate compliance with applicable DOE energy conservation standards. Pursuant to its regulations applicable to waivers and interim waivers from applicable test procedures at 10 CFR 430.27, and after consideration of public comments on the petition, DOE will consider setting an alternate test procedure for the equipment identified by LG in a subsequent Decision and Order.
In its petition, LG requests testing the basic models listed in the petition according to the test procedure for room air conditioners prescribed by DOE in appendix F, except that the variable-speed room air conditioner would be tested at four rating conditions instead of a single rating condition. The suggested test conditions are presented in Table III.1.
Under the suggested test procedure, the test unit's weighted-average combined energy efficiency ratio (CEER) metric is calculated from the individual CEER values obtained at the four rating conditions, with the weighting factors derived from the fractional temperature bin hours for each rating temperature provided in Table 19 of DOE's test
DOE has reviewed the marketing materials, website, and brochure for the specific basic models for which this petition applies. The materials that DOE reviewed support LG's assertion of the part-load characteristics of the variable-speed room air conditioners and that the DOE test procedure may evaluate the basic models in a manner unrepresentative of their true energy consumption characteristics. In particular, the DOE test procedure does not capture the relative efficiency improvements that can be achieved by variable-speed room air conditioners over a range of operating conditions compared to single-speed room air conditioners. In the absence of an alternate test procedure, the CEER values of variable-speed room air conditioners would suggest that such room air conditioners would consume at least as much energy annually as a comparable single-speed room air conditioner, despite the anticipated benefits of improved performance under part-load conditions. Furthermore, DOE has reviewed the alternate procedure suggested by LG, along with additional performance modeling and analysis performed by DOE using rating conditions specified in an industry standard for single-package air conditioning equipment with variable speed compressors, American National Standards Institute (“ANSI”)/Air-Conditioning, Heating, and Refrigeration Institute (“AHRI”) Standard 210/240:2008, “Performance Rating of Unitary Air-Conditioning & Air-Source Heat Pump Equipment.” Based on this review it appears that the suggested alternate test procedure, with additional specification regarding the required compressor speeds,
For the reasons stated, DOE has granted an interim waiver to LG for the specified room air conditioner basic models in LG's petition.
Therefore, DOE has issued an Order, stating:
(1) LG must test and rate the following room air conditioner basic models with the alternate test procedure set forth in paragraph (2):
(2) The alternate test procedure for the LG basic models listed in subparagraph (1)(A) is the test procedure for room air conditioners prescribed by DOE at appendix F to subpart B of 10 CFR part 430 (Appendix F), except the combined energy efficiency ratio (CEER) will be determined as detailed below. All other requirements of Appendix F and DOE's regulations remain applicable.
In Section 1,
1.8 “Single-speed” means a type of room air conditioner that does not automatically adjust either the compressor or fan speed, or both, based on the detected outdoor conditions.
1.9 “Variable-speed” means a type of room air conditioner that can automatically adjust compressor and fan speed, only compressor speed, or only fan speed, based on the detected outdoor conditions.
Add to the end of Section 2.1
For a variable-speed room air conditioner, the cooling mode test shall be repeated 3 additional times with alternate outdoor test conditions, as described in section 3.1 of this appendix. For a variable-speed room air conditioner, a psychrometric chamber may alternatively be used in accordance with ANSI/ASHRAE Standard 37-2009 (incorporated by reference; see § 430.3), in place of a calorimeter chamber, which is required in accordance with appendix F. If using the psychrometric chamber approach, set-up and instrument the variable-speed room air conditioner in accordance with Section 5 and Section 6 of ANSI/ASHRAE Standard 37-2009, measure the indoor cooling capacity in accordance with Section 7.3 of ANSI/ASHRAE Standard 37-2009, and measure the average electrical input power in Watts at the nameplate voltage for each of the rating test condition.
Add to the end of Section 3.1,
However, for variable-speed room air conditioners, the set of four cooling mode tests shall be conducted with the following test conditions, presented in Table 1 of this appendix.
Determine the intermediate compressor speed cited in Table 1 using:
Add to the end of Section 4.1,
If using the psychrometric chamber approach for a variable-speed room air conditioner, measure the indoor cooling capacity in accordance with Section 7.3 of ANSI/ASHRAE Standard 37-2009 and measured power input in cooling mode in accordance with Section 5.4 of ANSI/ASHRAE Standard 37-2009.
Add to the end of Section 5.1:
For variable-speed room air conditioners, determine cooling capacity, Capacity
Add to the end of Section 5.2:
For variable-speed room air conditioners, determine electrical power input, P
Add following Section 5.3,
5.4
5.4.1
5.4.2
5.4.3
5.4.4
5.4.5
5.4.6
5.4.7
5.4.8
5.4.9
(3)
(4) This interim waiver shall remain in effect according to the provisions of 10 CFR 430.27.
(5) This interim waiver is issued to LG on the condition that the statements, representations, and information provided by LG are valid. DOE may revoke or modify this waiver at any time if it determines the factual basis underlying the petition for waiver is incorrect, or the results from the alternate test procedure are unrepresentative of the basic models' true energy consumption characteristics. 10 CFR 430.27(k)(1). Likewise, LG may request that DOE rescind or modify the interim waiver if LG discovers an error in the information provided to DOE as part of its petition, determines that the interim waiver is no longer needed, or for other appropriate reasons. 10 CFR 430.27(k)(2).
(6) Granting of this interim waiver does not release LG from the certification requirements set forth at 10 CFR part 429.
DOE makes decisions on waivers and interim waivers for only those basic models specifically set out in the petition, not future models that may be manufactured by the petitioner. LG may submit a new or amended petition for waiver and request for grant of interim waiver, as appropriate, for additional basic models of room air conditioners. Alternatively, if appropriate, LG may request that DOE extend the scope of a waiver or an interim waiver to include additional basic models employing the same technology as the basic models set forth in the original petition consistent with 10 CFR 430.27(g).
DOE is publishing LG's petition for waiver in its entirety, pursuant to 10 CFR 430.27(b)(1)(iv).
DOE invites all interested parties to submit in writing by July 30, 2018, comments and information on all aspects of the petition, including the alternate test procedure. Pursuant to 10 CFR 430.27(d), any person submitting written comments to DOE must also send a copy of such comments to the petitioner. The contact information for the petitioner is Scott Blake Harris, Harris, Wiltshire & Grannis LLP, 1919 M Street NW, Eighth Floor, Washington, DC 20036.
Submitting comments via
However, your contact information will be publicly viewable if you include it in the comment or in any documents attached to your comment. Any information that you do not want to be publicly viewable should not be included in your comment, nor in any document attached to your comment. Persons viewing comments will see only first and last names, organization names, correspondence containing comments, and any documents submitted with the comments.
Do not submit to
DOE processes submissions made through
Submitting comments via email, hand delivery, or mail. Comments and documents submitted via email, hand delivery, or mail also will be posted to
Include contact information each time you submit comments, data, documents, and other information to DOE. If you submit via mail or hand delivery, please provide all items on a CD, if feasible. It is not necessary to submit printed copies. No facsimiles (faxes) will be accepted.
Comments, data, and other information submitted to DOE electronically should be provided in PDF (preferred), Microsoft Word or Excel, WordPerfect, or text (ASCII) file format. Provide documents that are not secured, written in English and free of any defects or viruses. Documents should not contain special characters or any form of encryption and, if possible, they should carry the electronic signature of the author.
Campaign form letters. Please submit campaign form letters by the originating organization in batches of between 50 to 500 form letters per PDF or as one form letter with a list of supporters' names compiled into one or more PDFs. This reduces comment processing and posting time.
Confidential Business Information. According to 10 CFR 1004.11, any person submitting information that he or she believes to be confidential and exempt by law from public disclosure should submit via email, postal mail, or hand delivery two well-marked copies: one copy of the document marked confidential including all the information believed to be confidential, and one copy of the document marked “non-confidential” with the information believed to be confidential deleted. Submit these documents via email or on
Factors of interest to DOE when evaluating requests to treat submitted information as confidential include (1) a description of the items, (2) whether and why such items are customarily treated as confidential within the industry, (3) whether the information is generally known by or available from other sources, (4) whether the information has previously been made available to others without obligation concerning its confidentiality, (5) an explanation of the competitive injury to the submitting person which would result from public disclosure, (6) when such information might lose its confidential character due to the passage of time, and (7) why disclosure of the information would be contrary to the public interest.
It is DOE's policy that all comments may be included in the public docket, without change and as received, including any personal information provided in the comments (except information deemed to be exempt from public disclosure).
LG Electronics, Inc. (LG) respectfully submits this Petition for Waiver and Application for Interim Waiver
LG is a manufacturer of room air conditioners and other products sold worldwide, including in the United States. LG's United States affiliate is LG Electronics USA, Inc., with headquarters at 1000 Sylvan Avenue, Englewood Cliffs, NJ 07632 (tel. 201-816-2000). Its worldwide headquarters are located at LG Twin Towers 20, Yoido-dong, Youngdungpo-gu Seoul, Korea 150-721; (tel. 011-82-2-3777-1114);
The basic models for which a waiver is requested are set forth in the Appendix. They are distributed in commerce under the LG brand name.
The LG RACs with VSC technology are advanced, energy efficient products. A VSC (inverter compressor) uses frequency controls constantly to adjust the compressor's rotation speed to maintain the desired temperature in the home without turning the motor on and off. The compressor responds automatically to surrounding conditions to operate in the most efficient possible manner. This results in both dramatic energy savings and faster cooling compared to products without VSCs. RACs with VSCs also have a higher/lower operating range (10Hz to 120Hz) than those without VSC.
Unfortunately, the current DOE test procedure for RACs provides that they be tested only with full-load performance.
DOE has recognized this serious shortcoming in its RAC test procedure. It has stated that this test procedure “does not measure the benefits of technologies that improve part-load performance.”
The current room AC test procedure measures only the full-load performance at outdoor ambient conditions of 95 °F dry-bulb and 75 °F wet-bulb. Therefore, technologies that improve part-load performance, such as multiple-speed compressors and variable-opening expansion devices, will not improve the rated performance of a room AC under the current test procedure.”
At the moment, however, the DOE test procedure for RACs does not include any provision to account for the benefits of the part-load performance of VSCs. Therefore, the test procedure evaluates the LG models with VSCs in a manner that misrepresents their actual energy consumption. LG urges that a waiver be granted, for the basic models in the Appendix, that will allow use of the alternate test procedure discussed below. The test procedure is designed to take into account the energy savings characteristics of VSCs, and will yield results more representative of the actual energy consumption of these products than the current DOE test procedure. And the rules provide that DOE “will grant a waiver from the test procedure requirements” in these circumstances.
LG proposes the following alternate test procedure to evaluate the performance of the basic models listed in the Appendix. The alternate test procedure is the same as the existing test procedure for RACs except that it takes into account VSC part-load characteristics. It does so by providing for tests at a variety of load conditions. Specifically:
LG shall be required to test the performance of the basic models listed in the Appendix hereto according to the test procedure for room air conditioners in 10 C.F.R. Part 430, Subpart B, Appendix F, except as follows:
“1.8 “Single-speed” means a type of room air conditioner that does not automatically adjust either the compressor or fan speed, or both, based on the detected outdoor conditions.
1.9 “Variable-speed” means a type of room air conditioner that can automatically adjust compressor and fan speed, only compressor speed, or only fan speed, based on the detected outdoor conditions.”
“For a variable-speed room air conditioner, the cooling mode test shall
“, except, for variable-speed room air conditioners, the set of four cooling mode tests shall be conducted with the following test conditions, presented in Table 1 of this appendix.
“If using the psychrometric chamber approach for a variable-speed room air conditioner, measure the indoor cooling capacity in accordance with Section 7.3 of ANSI/ASHRAE Standard 37-2009 and measured power input in cooling mode in accordance with Section 5.4 of ANSI/ASHRAE Standard 37-2009.”
“For variable-speed room air conditioners, determine cooling capacity, Capacity
“For variable-speed room air conditioners, determine electrical power input, P
“5.4
5.4.1
5.4.2
5.4.3
5.4.4
5.4.5
5.4.6
5.4.7
5.4.9
LG also hereby applies for an interim waiver of the applicable test procedure requirements for the LG basic models set forth in the Appendix. LG meets the criteria for an interim waiver.
LG's Petition for Waiver is likely to be granted because the test method contained in 10 C.F.R. Part 430, Subpart B, Appendix F clearly does not address the VSC characteristics of these LG basic models. Thus, the test procedure does not accurately measure their energy consumption. Without waiver relief, LG would be subject to requirements that are inapplicable to these products. Additionally, LG will suffer economic hardship and be at a competitive disadvantage if it must wait to rate these basic models pending a determination on the petition for waiver.
DOE approval of LG's interim waiver application is also supported by sound public policy. These LG products employ advanced technology that increases efficiency and reduces energy consumption, while offering a new level of affordable comfort to consumers.
LG respectfully requests that DOE grant its Petition for Waiver of the applicable test procedure for specified basic models, and also grant its Application for Interim Waiver.
LG requests expedited treatment of the Petition and Application.
The waiver and interim waiver requested herein should apply to testing and rating of the following basic models that are manufactured by LG:
Take notice that on June 22, 2018, Peter A. Vigue filed supplements to the April 24, 2018 and May 11, 2018 applications for authorization to hold interlocking positions, pursuant to section 305(b) of the Federal Power Act, 18 U.S.C. 825d(f), and section 45.4 of the Federal Energy Regulatory Commission's (Commission) Regulations, 18 CFR 45.8.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. On or before the comment date, it is not necessary to serve motions to intervene or protests on persons other than the Applicant.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the eFiling link at
This filing is accessible on-line at
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following electric securities filings:
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:
The staff of the Federal Energy Regulatory Commission (FERC or Commission) has prepared a draft environmental impact statement (EIS) for the Calcasieu Pass Project, proposed by Venture Global Calcasieu Pass, LLC (Venture Global Calcasieu Pass) and TransCameron Pipeline, LLC (TransCameron Pipeline) in the above-referenced dockets. Venture Global Calcasieu Pass requests authorization to site, construct, and operate a natural gas liquefaction and storage facility, and marine export terminal in Cameron Parish, Louisiana. TransCameron Pipeline requests authorization to construct, install, and operate certain natural gas pipeline facilities also in Cameron Parish, Louisiana. The new liquefaction facilities would have a design production capacity of 12 million metric ton of liquefied natural gas (LNG) per annum.
The draft EIS assesses the potential environmental effects of the construction and operation of the Calcasieu Pass Project in accordance with the requirements of the National Environmental Policy Act. The FERC staff concludes that approval of the proposed project would have some adverse environmental impacts; however, all of these impacts would be reduced to less-than-significant levels with the implementation of Venture Global Calcasieu Pass' and TransCameron Pipeline's proposed mitigation measures and the additional measures recommended in the draft EIS.
The U.S. Army Corps of Engineers, U.S. Coast Guard, U.S. Department of Energy, U.S. Environmental Protection Agency, and U.S. Department of Transportation participated as cooperating agencies in the preparation of the draft EIS. Cooperating agencies have jurisdiction by law or special expertise with respect to resources potentially affected by the proposal and participate in the National Environmental Policy Act analysis. Although the cooperating agencies provided input on the conclusions and recommendations presented in the draft EIS, the agencies will present their own conclusions and recommendations in their respective Records of Decision for the project.
The draft EIS addresses the potential environmental effects of the construction and operation of the following project facilities:
• Nine integrated pre-cooled single mixed refrigerant (SMR) blocks;
• two full-containment aboveground LNG storage tanks, each with a usable capacity of approximately 200,000 cubic meters;
• a 1,500-foot by 3,000-foot turning basin adjacent to the Calcasieu River Ship Channel;
• two LNG berthing docks, each designed to handle carriers of 120,000 to 210,000 cubic meter cargo capacity;
• a 720 megawatt natural gas-fired combined cycle gas turbine electric generation facility;
• approximately 23.4 miles of 42-inch-diameter pipeline to bring feed gas from interconnections with ANR Pipeline Company, Texas Eastern Transmission, LP, and Bridgeline Holdings, LP to the terminal site;
• one meter station;
• three mainline valves; and
• one pig launcher at the meter station and one pig receiver at the gas gate station on the terminal site.
The FERC staff mailed copies of the draft EIS to federal, state, and local government representatives and agencies; elected officials; environmental and public interest groups; Native American tribes; potentially affected landowners and other interested individuals and groups; libraries in the project area; and parties to this proceeding. Paper copy versions of this EIS were mailed to those specifically requesting them; all others received a CD version. In addition, the EIS is available for public viewing on the FERC's website (
Any person wishing to comment on the draft EIS may do so. To ensure consideration of your comments on the proposal in the draft EIS, it is important that the Commission receive your comments on or before 5:00 p.m. Eastern Time on August 13, 2018.
For your convenience, there are four methods you can use to submit your comments with the Commission. The Commission will provide equal consideration to all comments received, whether filed in written form or provided verbally. The Commission encourages electronic filing of comments and has staff available to assist you at (866) 208-3676 or
(1) You can file your comments electronically using the eComment feature located on the Commission's website (
(2) You can also file your comments electronically using the eFiling feature on the Commission's website (
(3) You can file a paper copy of your comments by mailing them to the following address. Be sure to reference the project docket numbers (CP15-550-000, CP15-551-000, and CP15-551-001) with your submission: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Room 1A, Washington, DC 20426.
(4) In lieu of sending written or electronic comments, the Commission invites you to attend the public comment session its staff will conduct in the project area to receive comments on the draft EIS, scheduled as follows:
The primary goal of this comment session is to have you identify the specific environmental issues and concerns with the draft EIS. Individual verbal comments will be taken on a one-on-one basis with a court reporter. This format is designed to receive the maximum amount of verbal comments, in a convenient way during the timeframe allotted.
The comment session is scheduled from 4 p.m. to 7 p.m. CST. You may arrive at any time after 4 p.m. There will not be a formal presentation by Commission staff when the session opens. If you wish to speak, the Commission staff will hand out numbers in the order of your arrival; distribution of numbers will be discontinued at 6 p.m. However, if no additional numbers have been handed out and all individuals who wish to provide comments have had an opportunity to do so, staff may conclude the session at 6 p.m. Please see appendix 1 for additional information on the session format and conduct.
Your verbal comments will be recorded by the court reporter (with FERC staff or representative present) and become part of the public record for this proceeding. Transcripts will be publicly available on FERC's eLibrary system (see below for instructions on using eLibrary). If a significant number of people are interested in providing verbal comments in the one-on-one settings, a time limit of 5 minutes may be implemented for each commentor.
It is important to note that verbal comments hold the same weight as written or electronically submitted comments. Although there will not be a formal presentation, Commission staff will be available throughout the comment session to answer your questions about the environmental review process.
Filing environmental comments will not give you intervenor status, but you do not need intervenor status to have your comments considered. However, only intervenors have the right to seek rehearing or judicial review of the Commission's decisions. Any person may seek to intervene on environmental grounds and thereby become a party to this proceeding by filing a motion to intervene that complies with the requirements in Rule 214 of the Commission's Rules of Practice and Procedures (18 CFR Part 385.214). Any such intervention must be filed within the comment period for the draft EIS to be deemed timely. Motions to intervene that are filed after the comment due date for the draft EIS are untimely and may be denied. Any late-filed motion to intervene must show good cause why the time limitation should be waived and provide justification by reference to factors set forth in Rule 214(d) of the Commission's Rules of Practice and Procedures (18 CFR part 385.214(b)(3) and (d)). The Commission strongly encourages electronic filing of interventions in lieu of paper using the eFiling feature described above, and available at
Additional information about the project is available from the Commission's Office of External Affairs, at (866) 208-FERC, or on the FERC website (
In addition, the Commission offers a free service called eSubscription that allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. Go to
Take notice that on June 14, 2018, ANR Pipeline Company (ANR), 700 Louisiana Street, Suite 700, Houston, Texas 77002-2700, filed in Docket No. CP18-503-000 a prior notice request pursuant to sections 157.205, 157.208, and 157.216 of the Commission's regulations under the Natural Gas Act (NGA), and ANR's blanket certificate issued in Docket No. CP82-480-000, to abandon 20 injection/withdrawal wells, one observation well, and related appurtenances in its Winfield Storage Field, located in Mecosta and Montcalm Counties Michigan (Winfield Storage Field Wells Abandonment Project).
ANR states that the well integrity risk assessments for these wells revealed integrity weaknesses, and to maintain these wells would require some form of remediation, the cost of which would likely exceed the cost of plugging, as well as exceed the value provided by the wells to storage operations. ANR claims many of the wells proposed for abandonment are poor performers in comparison with other wells in the Winfield Storage Field, contributing approximately 2.8 percent of the total field deliverability. Therefore, ANR concludes that plugging and abandoning the wells is the best course of action to maintain field integrity and efficiency. ANR affirms that there will be no change to the field's total inventory, reservoir pressure, reservoir and buffer boundaries, or the certificated capacity as a result of the proposed Winfield Storage Field Wells Abandonment Project. ANR estimates the cost of the Project to be approximately $2.8 million, all as more fully set forth in the application which is on file with the Commission and open to public inspection. The filing may also be viewed on the web at
Any questions concerning this application may be directed to Linda Farquhar, Manager, Project Determinations & Regulatory Administration, ANR Pipeline Company, 700 Louisiana Street, Suite 700, Houston, Texas 77002-2700, by telephone at (832) 320-5685, by facsimile at (832) 320-6685, or by email at
Any person or the Commission's staff may, within 60 days after issuance of the instant notice by the Commission, file pursuant to Rule 214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to intervene or notice of intervention and pursuant to section 157.205 of the regulations under the NGA (18 CFR 157.205), a protest to the request. If no protest is filed within the time allowed therefore, the proposed activity shall be deemed to be authorized effective the day after the time allowed for filing a protest. If a protest is filed and not withdrawn within 30 days after the allowed time for filing a protest, the instant request shall be treated as an application for authorization pursuant to section 7 of the NGA.
Pursuant to section 157.9 of the Commission's rules (18 CFR 157.9), within 90 days of this Notice, the Commission staff will either: Complete its environmental assessment (EA) and place it into the Commission's public record (eLibrary) for this proceeding; or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the EA for this proposal. The filing of the EA in the Commission's public record for this proceeding or the issuance of a Notice of Schedule for Environmental Review will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's EA.
Persons who wish to comment only on the environmental review of this project should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commenters will be placed on the Commission's environmental mailing list, will receive copies of the environmental documents, and will be notified of meetings associated with the Commission's environmental review process. Environmental commenters will not be required to serve copies of filed documents on all other parties. However, the non-party commenters, will not receive copies of all documents filed by other parties or issued by the Commission (except for the mailing of environmental documents issued by the Commission) and will not have the right to seek court review of the Commission's final order.
The Commission strongly encourages electronic filings of comments, protests and interventions in lieu of paper using the eFiling link at
Section 309(a) of the Clean Air Act requires that EPA make public its comments on EISs issued by other Federal agencies. EPA's comment letters on EISs are available at:
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice of charter renewal.
This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Board of
William Cibulas, Ph.D., Designated Federal Officer, Board of Scientific Counselors, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry, Department of Health and Human Services, 4770 Buford Highway, Mailstop F45, Chamblee, Georgia 30341, telephone (770) 488-0662 or fax (770) 488-3377.
The Director, Management Analysis and Services Office, has been delegated the authority to sign
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice of charter amendment.
This gives notice under (the Federal Advisory Committee Act of October 6, 1972, that the Healthcare Infection Control Practices Advisory Committee (HICPAC), Centers for Disease Control and Prevention, Department of Health and Human Services, has amended their charter to increase the number and meetings from approximately three times per year to up to eight times per year. Also, this amendment gives notice to change the name of the DNV Healthcare to DNV-GL; to add the American Society of Nephrology (ASN), the American Association of Kidney Patients (AAKP), the Pediatric Infectious Disease Society (PIDS), and the National Association of Directors of Nursing Administration (NADONA) as non-voting liaison organizations to the committee, and to include expertise in environmental microbiology; and increase the number of meetings up to eight times a year. The amended filing date is May 4, 2018.
Erin Stone, M.A., HICPAC, Division of Healthcare Quality Promotion, NCEZID, CDC, 1600 Clifton Road NE, Mailstop A-31, Atlanta, Georgia 30333; Email:
The Director, Management Analysis and Services Office, has been delegated the authority to sign
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice of charter renewal.
This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Safety and Occupational Health Study Section, Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through June 30, 2020.
Joanne Fairbanks, Designated Federal Officer, Safety and Occupational Health Study Section, Department of Health and Human Services, 1600 Clifton Road NE, Mailstop E74, Atlanta, Georgia 30329, telephone 304-285-6143 or fax 304-285-6147.
The Director, Management Analysis and Services Office, has been delegated the authority to sign
Notice.
The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the HICPAC. The HICPAC consists of 14 experts in fields including but not limited to, infectious diseases, infection prevention, healthcare epidemiology, nursing, clinical microbiology, surgery, hospitalist medicine, internal medicine, epidemiology, health policy, health services research, public health, and related medical fields. Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishments of the committee's objectives. Nominees will be selected based on expertise in the fields of infectious diseases, infection prevention, healthcare epidemiology, nursing, environmental and clinical microbiology, surgery, internal medicine, and public health. Federal employees will not be considered for membership. Members may be invited to serve for four-year terms.
Selection of members is based on candidates' qualifications to contribute to the accomplishment of HICPAC objectives
Nominations for membership on the HICPAC be received no later than November 1, 2018. Packages received after this time will not be considered for the current membership cycle.
All nominations should be mailed to HICPAC, Division of Healthcare Quality Promotion, NCEZID, CDC, 1600 Clifton Road NE, Mailstop A-07, Atlanta, Georgia 30333, emailed (recommended) to
Erin Stone, M.S., HICPAC, Division of
The U.S. Department of Health and Human Services policy stipulates that committee membership be balanced in terms of points of view represented, and the committee's function. Appointments shall be made without discrimination on the basis of age, race, ethnicity, gender, sexual orientation, gender identity, HIV status, disability, and cultural, religious, or socioeconomic status. Nominees must be U.S. citizens, and cannot be full-time employees of the U.S. Government. Current participation on federal workgroups or prior experience serving on a federal advisory committee does not disqualify a candidate; however, HHS policy is to avoid excessive individual service on advisory committees and multiple committee memberships. Committee members are Special Government Employees (SGEs), requiring the filing of financial disclosure reports at the beginning and annually during their terms. CDC reviews potential candidates for HICPAC membership each year, and provides a slate of nominees for consideration to the Secretary of HHS for final selection. HHS notifies selected candidates of their appointment near the start of the term in July 2019, or as soon as the HHS selection process is completed. Note that the need for different expertise varies from year to year and a candidate who is not selected in one year may be reconsidered in a subsequent year. SGE Nominees must be U.S. citizens, and cannot be full-time employees of the U.S. Government. Candidates should submit the following items:
The Director, Management Analysis and Services Office, has been delegated the authority to sign
Centers for Medicare & Medicaid Services, HHS.
Notice.
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the
Comments on the collection(s) of information must be received by the OMB desk officer by July 30, 2018.
When commenting on the proposed information collections, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be received by the OMB desk officer via one of the following transmissions: OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: (202) 395-5806
To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:
1. Access CMS' website address at
2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to
3. Call the Reports Clearance Office at (410) 786-1326.
Reports Clearance Office at (410) 786-1326.
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the
1.
Centers for Medicare & Medicaid Services, HHS.
Notice.
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the
Comments on the collection(s) of information must be received by the OMB desk officer by July 30, 2018.
When commenting on the proposed information collections, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be received by the OMB desk officer via one of the following transmissions:
OMB, Office of Information and Regulatory Affairs
To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:
1. Access CMS' website address at
2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to
3. Call the Reports Clearance Office at (410) 786-1326.
Reports Clearance Office at (410) 786-1326.
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the
1.
2.
NHTTAC hosts a variety of services, programs, and facilitated sessions to improve service provision to individuals who have been trafficked or who are at risk of trafficking, including The Human Trafficking Leadership Academy (HTLA); the Survivor Fellowship Program; the NHTTAC Customer Support Center; short-term and specialized T/TA requests (requests that take less than 3 hours or 3 or more hours to fulfill, respectively); OTIP-funded grantees; and information through NHTTAC's website, resources, and materials about trafficking.
Assessment, evaluation, and quality improvement are essential components of NHTTAC T/TA delivery and requires data collection from NHTTAC T/TA participants, consultants, and other stakeholders that are involved in NHTTAC activities. Data will be collected after each T/TA event to provide a feedback mechanism to improve the availability and delivery of coordinated and trauma-informed services before, during, and after an individual's trafficking exploitation. Whenever possible, data will be collected from participants and consultants electronically via a survey tailored to the specific T/TA event to maximize convenience and minimize the burden for participants. When appropriate, focus groups and interviews will also be leveraged to obtain contextual information about NHTTAC activities. The types of information collected tie directly to the outputs, short-term, and long-term objectives of NHTTAC.
Tier II of SOAR targets respondents through a blended online training to individuals who plan to incorporate the content into their organization's policies and best practices. Organizations can also add the SOAR Online training to their learning management systems.
Tier III of SOAR engages respondents through intensive, in-person T/TA via SOAR for Communities. The goal is to provide strategic planning and goal setting in communities looking to improve their response to trafficking.
Office of Planning, Research, and Evaluation; ACF; HHS.
Request for Public Comment.
Temporary Assistance for Needy Families (TANF) Data Innovations (TDI) Project (New Collection).
The Administration for Children and Families (ACF) within the U.S. Department of Health and Human Services (HHS) proposes to collect information as part of the TANF Data Innovations (TDI) project. TDI is an investment to expand the integration, analysis, and use of TANF data to improve program administration, payment integrity, and outcomes for participants.
TDI will start by assessing the needs and readiness of TANF agencies across the country to set up and operate data systems to support program improvement. A key goal of the needs assessment is to help categorize states' readiness to effectively use data and produce evidence. Informed by this assessment and discussions with key stakeholders, TDI will support a broad learning collaborative of state agencies and other entities related to the TANF program, including a range of Technical Assistance (TA) options to help states improve their use of TANF and other program data.
This information collection request will consist of a needs assessment survey to be completed by state TANF agency administrators and staff to gather detailed information about their capacities and needs. These data will help HHS to better understand the challenges and barriers states face in using data and research to inform program decision-making, and they will help the TDI team design future technical assistance activities for TANF agencies to address states' challenges.
Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research, and Evaluation, 330 C Street SW, Washington, DC 20201, Attn: OPRE Reports Clearance Officer. Email address:
The Department specifically requests comments 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 of the proposed collection of information; (c) 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. Consideration will be given to comments and suggestions submitted within 60 days of this publication.
Sec. 413, Pub. L. 115-31.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by July 30, 2018.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to
Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
The Administrative Procedures Act (5 U.S.C. 553(e)) provides that every Agency shall give an interested person the right to petition for issuance, amendment, or repeal of a rule. Section 10.30 (21 CFR 10.30) sets forth the format and procedures by which an interested person may submit to FDA, in accordance with § 10.20 (21 CFR 10.20), a citizen petition requesting the Commissioner of Food and Drugs (the Commissioner) to issue, amend, or revoke a regulation or order, or to take or refrain from taking any other form of administrative action.
The Commissioner may grant or deny such a petition, in whole or in part, and may grant such other relief or take other action as the petition warrants. Respondents are individuals or households, State or local governments, and not-for-profit institutions or groups.
Section 10.33 (21 CFR 10.33), issued under section 701(a) of the Federal, Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(a)), sets forth the format and procedures by which an interested person may request reconsideration of part or all of a decision of the Commissioner on a petition submitted under 21 CFR 10.25 (Initiation of administrative proceedings). A petition for reconsideration must contain a full statement in a well-organized format of the factual and legal grounds upon which the petition relies. The grounds must demonstrate that relevant information and views contained in the administrative record were not previously or not adequately considered by the Commissioner. The respondent must submit a petition no later than 30 days after the decision involved. However, the Commissioner may, for good cause, permit a petition to be filed after 30 days. An interested person who wishes to rely on information or views not included in the administrative record shall submit them with a new petition to modify the decision. FDA uses the information provided in the request to determine whether to grant
Section 10.35 (21 CFR 10.35), issued under section 701(a) of the FD&C Act, sets forth the format and procedures by which an interested person may request, in accordance with § 10.20, the Commissioner to stay the effective date of any administrative action.
Such a petition must do the following: (1) Identify the decision involved; (2) state the action requested, including the length of time for which a stay is requested; and (3) include a statement of the factual and legal grounds on which the interested person relies in seeking the stay. FDA uses the information provided in the request to determine whether to grant the petition for stay of action.
Respondents to this information collection are interested persons who choose to file a petition for an administrative stay of action.
Section 10.85 (21 CFR 10.85), issued under section 701(a) of the FD&C Act, sets forth the format and procedures by which an interested person may request, in accordance with § 10.20, an advisory opinion from the Commissioner on a matter of general applicability. When making a request, the petitioner must provide a concise statement of the issues and questions on which an opinion is requested, and a full statement of the facts and legal points relevant to the request. Respondents to this collection of information are interested persons seeking an advisory opinion from the Commissioner.
FDA has developed a method for electronic submission of citizen petitions. The Agency still allows for non-electronic submissions; however, electronic submissions of a citizen petition to a specific electronic docket presents a simpler and more straightforward approach. FDA has created a single docket on
The regulations in 21 CFR 12.22, issued under section 701(e)(2) of the FD&C Act, set forth the instructions for filing objections and requests for a hearing on a regulation or order under § 12.20(d) (21 CFR 12.20(d)). Objections and requests must be submitted within the time specified in § 12.20(e). Each objection, for which a hearing has been requested, must be separately numbered and specify the provision of the regulation or the proposed order. In addition, each objection must include a detailed description and analysis of the factual information and any other document, with some exceptions, supporting the objection. Failure to include this information constitutes a waiver of the right to a hearing on that objection. FDA uses the description and analysis to determine whether a hearing request is justified. The description and analysis may be used only for the purpose of determining whether a hearing has been justified under 21 CFR 12.24 and does not limit the evidence that may be presented if a hearing is granted.
Respondents to this information collection are those parties that may be adversely affected by an order or regulation.
Section 12.45 (21 CFR 12.45), issued under section 701 of the FD&C Act, sets forth the format and procedures for any interested person to file a petition to participate in a formal evidentiary hearing, either personally or through a representative. Section 12.45 requires that any person filing a notice of participation state their specific interest in the proceedings, including the specific issues of fact about which the person desires to be heard. This section also requires that the notice include a statement that the person will present testimony at the hearing and will comply with specific requirements in 21 CFR 12.85, or, in the case of a hearing before a Public Board of Inquiry, concerning disclosure of data and information by participants (21 CFR 13.25). In accordance with § 12.45(e) the presiding officer may omit a participant's appearance.
The presiding officer and other participants will use the collected information in a hearing to identify specific interests to be presented. This preliminary information serves to expedite the prehearing conference and commits participation.
The respondents are individuals or households, State or local governments, not-for-profit institutions and businesses, or other for-profit groups and institutions.
In the
FDA estimates the burden of this collection of information as follows:
The burden estimates for this collection of information are based on Agency records and experience over the past 3 years. The increase in burden hours is due to an increase in the number of respondents under several provisions.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the
Submit either electronic or written comments on the collection of information by August 28, 2018.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before August 28, 2018. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733,
Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information
The definition of “food” under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (see 21 U.S.C. 321(f)), includes “articles used for food or drink” and thus includes alcoholic beverages. As such, alcoholic beverages are subject to the FD&C Act's adulteration and misbranding provisions and implementing regulations related to food. For example, manufacturers of alcoholic beverages are responsible for adhering to the registration of food facilities requirements in 21 CFR part 1 and to the good manufacturing practice regulations in 21 CFR part 110. There are also certain requirements for nutrition labeling on menus, menu boards, and other written materials for alcohol beverages served in restaurants or similar retail food establishments in 21 CFR part 101. However, as reflected in a 1987 Memorandum of Understanding between FDA and the Alcohol and Tobacco Tax and Trade Bureau (TTB), TTB is responsible for the dissemination and enforcement of regulations with respect to the labeling of distilled spirits, certain wines, and malt beverages issued in the Federal Alcohol Administration Act (the FAA Act). In TTB Ruling 2008-3, dated July 7, 2008, TTB clarified that certain beers, which are not made from both malted barley and hops but are instead made from substitutes for malted barley (such as sorghum, rice, or wheat) or are made without hops, do not meet the definition of a “malt beverage” under the FAA Act. Accordingly, TTB stated in its ruling that such products (other than saké, which is classified as a wine under the FAA Act), are not subject to the labeling, advertising, or other provisions of TTB regulations issued under the FAA Act.
In cases where an alcoholic beverage is not covered by the labeling provisions of the FAA Act, the product is subject to ingredient and other labeling requirements under the FD&C Act and the implementing regulations that we administer. In addition, as provided for under the Fair Packaging and Labeling Act (FPLA), alcoholic beverages that are not covered by the labeling provisions of the FAA Act are subject to the provisions of the FPLA, which we administer.
Therefore, the beers described in TTB's ruling as not being a “malt beverage” are subject to the labeling requirements under the FD&C Act and FPLA, and our implementing regulations. In general, we require that food products under our jurisdiction be truthfully and informatively labeled in accordance with the FD&C Act, the FPLA, and FDA's regulations. Furthermore, some TTB labeling requirements, such as the Government Health Warning Statement under the Alcoholic Beverage Labeling Act and certain marking requirements under the Internal Revenue Code, continue to apply to these products.
Persons with access to the internet may obtain the guidance entitled, “Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration,” located at
Our food labeling regulations under parts 101, 102, 104, and 105 (21 CFR parts 101, 102, 104, and 105) were issued under the authority of sections 4, 5, and 6 of the FPLA (15 U.S.C. 1453, 1454, and 1455) and under sections 201, 301, 402, 403, 409, 411, 701, and 721 of the FD&C Act (21 U.S.C. 321, 331, 342, 343, 348, 350, 371, and 379e). Most of these regulations derive from section 403 of the FD&C Act, which provides that a food product shall be deemed to be misbranded if, among other things, its label or labeling fails to bear certain required information concerning the food product, is false or misleading in any particular, or bears certain types of unauthorized claims. The disclosure requirements and other collections of information in the regulations in parts 101, 102, 104, and 105 are necessary to ensure that food products produced or sold in the United States are in compliance with the labeling provisions of the FD&C Act and the FPLA.
The primary user of the information to be disclosed on the label or labeling of food products is the consumer that purchases the food product. Consumers will use the information to assist them in making choices concerning their purchase of a food product, including choices related to substances that the consumer must avoid to prevent adverse reactions. This information also enables the consumer to determine the role of the food product in a healthful diet. Additionally, FDA intends to use the information to determine whether a manufacturer or other supplier of food products is meeting its statutory and regulatory obligations. Failure of a manufacturer or other supplier of food products to label its products in compliance with section 403 of the FD& C Act and parts 101, 102, 104, and 105 of FDA's food labeling regulations may result in a product being misbranded under the FD&C Act, subjecting the firm and product to regulatory action.
Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate. Our estimate of the number of respondents is based on the number of regulatory submissions to TTB for beers that do not meet the definition of a “malt beverage” under the FAA Act. Based on its records of submissions received from manufacturers of such products, TTB estimates the annual number of respondents to be 12 and the annual number of disclosures to be 24. Thus, we adopt TTB's estimate of 12 annual respondents, and an annual number of disclosures per respondent of 2 in table 1.
Our estimates of the average burden per disclosure for each collection provision are based on our experience with food labeling under the Agency's jurisdiction. The estimated average burden per disclosure for §§ 101.3, 101.4, 101.5, 101.9, 101.22, and 101.105 in table 1 are equal to, and based upon, the estimated average burden per disclosure approved by OMB in OMB control number 0910-0381. We further estimate that the labeling burden of section 403(w)(1) of the FD&C Act, which specifies requirements for the declaration of food allergens, will be 1 hour based upon the similarity of the requirements to that of § 101.4. Finally, FDA estimates that a respondent will spend 1 hour reading the guidance.
Thus, we estimate that 12 respondents will each label 2 products annually, for a total of 24 labels. We estimate that the manufacturers will spend 7.25 hours (0.5 hours + 1 hour + 0.25 hour + 4 hours + 0.5 hour + 1 hour = 7.25 hours) on each label to comply with our labeling regulations and the requirements of section 403(w)(1) of the FD&C Act, for a total of 174 hours (24 labels × 7.25 hours = 174 hours). In addition, 12 respondents will each spend 1 hour reading the guidance document, for a total of 12 hours. Thus, we estimate the total hour burden of the proposed collection of information to be 186 hours (174 hours + 12 hours = 186 hours).
The guidance also refers to previously approved collections of information found in our regulations. The collections of information in §§ 101.3, 101.4, 101.5, 101.9, 101.22, and 101.105 have been approved under OMB control number 0910-0381. Allergen labeling of these beers under section 403(w)(1) of the FD&C Act, which was added by the Food Allergen Labeling and Consumer Protection Act of 2004, has been approved under OMB control number 0910-0792.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by July 30, 2018.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to
Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
We are seeking OMB approval of the National Agriculture and Food Defense Strategy (NAFDS) under the FDA Food Safety Modernization Act (FSMA), section 108. This is a voluntary survey of State governments intended to gauge government activities in food and agriculture defense from intentional contamination and emerging threats. The collected information will be included in the mandatory 2019 NAFDS followup Report to Congress. The authority for FDA to collect the information derives from the Commissioner of Food and Drugs' authority provided in section 1003(d)(2)(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)(c)).
Protecting the nation's food and agriculture supply against intentional contamination and other emerging threats is an important responsibility shared by Federal, State, local, tribal, and territorial governments as well as private sector partners. On January 4, 2011, the President signed FSMA.
In 2015, the initial NAFDS Report to Congress detailed the specific Federal response to food and agriculture defense goals, objectives, key initiatives, and activities that HHS, USDA, DHS, and other stakeholders planned to accomplish to meet the objectives outlined in FSMA. The NAFDS charts a direction for how the Federal Agencies, in cooperation with State, local, territorial, and tribal governments and private sector partners, protect the nation's food supply against intentional contamination. Not later than 4 years after the initial NAFDS Report to Congress (2015), and every 4 years thereafter (
HHS/FDA is primarily responsible for obtaining the information from Federal and State, local, territorial, and tribal partners to complete the NAFDS Report to Congress. An interagency working group will conduct the survey and collect and update the NAFDS as directed by FSMA, including developing metrics and measuring progress for the evaluation process.
The proposed survey of Federal and State partners will be used to determine what food defense activities, if any, Federal and/or State Agencies have completed (or are planning) from 2015 to 2019. Planning for the local, territorial, and tribal information collections will commence after the collection and reporting of Federal and State Agency level data.
This survey will be repeated approximately every 2 to 4 years, as described in section 108 of FSMA (NAFDS), for the purpose of monitoring progress in food and agricultural defense by government agencies.
A purposive sampling strategy will be employed, such that the government agencies participating in food and agricultural defense cooperative agreements with FDA (22 State Agencies) and USDA (27 State Agencies) will be asked to respond to the voluntary survey. Food defense leaders responsible for conducting food defense activities during a food emergency for their jurisdiction will be identified and will receive an emailed invitation to complete the survey online; they will be provided with a web link to the survey. The survey will be conducted electronically on the
In the
FDA estimates the burden of this collection of information as follows:
The total burden for this collection of information, therefore, is 16.17 hours.
The FDA Office of Partnerships reviewed the questionnaire and provided the amount of time to complete the survey. The total burden is based on our previous experiences conducting surveys.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by July 30, 2018.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to
Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed
This information collection is associated with requirements under § 501.22(k) (21 CFR 501.22(k)) in which animal food manufacturers must declare the presence of certified and noncertified color additives in their animal food products on the product label. We issued this regulation in response to the Nutrition Labeling and Education Act of 1990 (Pub. L. 101-535) to make animal food regulations consistent with the regulations regarding the declaration of color additives on human food labels and to provide animal owners with information on the color additives used in animal food. Animal owners use the information to become knowledgeable about the foods they purchase for their animals. Color additive information enables a consumer to comparison shop and to avoid substances to which their animals may be sensitive.
(Comment) One comment was received that supported FDA's need for the information collection and characterized the burden of the information collection as low compared to the importance of informative food labels. The comment did not suggest revising our estimate of the burden. However, it suggested we should provide greater detail about how we estimated the number of respondents and the flow of new products.
(Response) We based our estimate of the number of respondents on the number of pet food manufacturers subject to this regulation. The figure of 3,120 used in table 1 was derived from the number of establishments listed under North American Industrial Classification System codes 311111 and 311119, including very small establishments. As noted in the 60-day notice, we based our estimate of the flow of new products on A.C. Nielsen data for the number of animal food product units for sale (for which sales of the products are greater than zero) in the latest year for which data is available, stated to be 25,874. Then, we assumed that the flow of new products would be 10 percent per year, for a figure of 2,587 new products per year. That figure was used in table 1 as our estimate of the total annual disclosures. FDA estimates the burden of this collection of information as follows:
The requirement became effective November 18, 2013; thus, we estimate that the burden associated with the labeling requirements under § 501.22(k) applies only to new product labels. Because the vast majority of animal food products that contain certified color additives are pet foods, we limit our burden estimate to reviewing labels for the use of certified color additives to pet food manufacturers subject to this regulation. Based on A.C. Nielsen data, we estimate that the number of animal food product units subject to § 501.22(k) for which sales of the products are greater than zero is 25,874. Assuming that the flow of new products is 10 percent per year, then 2,587 new animal food products subject to § 501.22(k) will become available on the market each year. We also estimate that there are approximately 3,120 manufacturers of pet food subject to either § 501.22(k)(1) or (2). Assuming the approximately 2,587 new products are split equally among the firms, then each firm would prepare labels for approximately 0.8292 new products per year (2,587 new products—3,120 firms is approximately 0.8292 labels per firm). We expect that firms prepare the required labeling for their products in a manner that takes into account at one time all information required to be disclosed on their product labels. Based on our experience with reviewing pet food labeling, we estimate that firms would require less than 0.25 hour (15 minutes) per product to comply with the requirement to include the color additive information pursuant to § 501.22(k). The total burden of this activity is 647 hours (2,587 labels × 0.25 hour/label is approximately 647 hours). The burden for this information collection has not changed since the last OMB approval.
Food and Drug Administration, HHS.
Notice of public workshop; request for comments.
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled “Development of Non-Traditional Therapies for Bacterial Infections.” The purpose of the public workshop is to discuss the general development considerations of non-traditional therapies, including pre-clinical development, early clinical studies, and phase 3 clinical trial designs to evaluate safety and efficacy.
The public workshop will be held on August 21, 2018, from 8:30 a.m. to 4:30 p.m. and August 22, 2018, from
The public workshop will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Building 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
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before August 15, 2018. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Lori Benner and/or Jessica Barnes, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6221, Silver Spring, MD 20993-0002, 301-796-1300.
FDA is announcing a public workshop regarding development of non-traditional therapies for bacterial infections. Discussions will focus on pre-clinical development, early stage clinical trials, and phase 3 clinical trial designs to evaluate safety and efficacy of non-traditional therapies intended to serve as primary or adjunctive therapy to existing antibacterial drugs.
FDA is particularly interested in discussing pre-clinical and clinical development of several types of non-traditional therapies, including monoclonal antibodies, immunomodulators, lysins, and other non-traditional therapies.
The Agency encourages health care providers, other U.S. Government Agencies, academic experts, industry, and other stakeholders to attend this public workshop.
Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted. If time and space permit, onsite registration on the day of the public workshop will be provided beginning at 7:30 a.m. We will let registrants know if registration closes before the day of the public workshop.
If you need special accommodations due to a disability, please contact Jessica Barnes or Lori Benner (see
If you have never attended a Connect Pro event before, test your connection at
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.” This guidance concerns FDA's implementation of the Biosimilar User Fee Amendments of 2017 (BsUFA II) and certain changes in policies and procedures surrounding its application.
The announcement of the guidance is published in the
You may submit either electronic or written comments on Agency guidances at any time as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
Submit written requests for single copies of the guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or to the Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Beena Alex, Division of User Fee Management and Budget Formulation, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Rm. 2185, Silver Spring, MD 20993, 301-796-7900,
FDA is announcing the availability of a guidance for industry entitled “Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.” This guidance concerns the implementation of BsUFA II, including an explanation about the new fee structure and types of fees for which entities are responsible. BsUFA II extends FDA's authority to collect user fees from fiscal year (FY) 2018 to 2022 and introduces a number of technical revisions that affect what fees are collected and how fees are collected. Fees authorized by this legislation help fund the process for the review of biosimilar biological product applications and have played an important role in expediting the review and approval process.
BsUFA II authorizes biosimilar biological product development program fees (BPD fees), biosimilar biological product application fees, and biosimilar biological product program fees. This guidance describes when these fees are incurred and the process by which applicants can submit payments. The guidance also provides information on consequences of failing to pay BsUFA II fees and the processes for submitting reconsideration and appeal requests.
In the
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance, when finalized, will represent the current thinking of FDA on assessing user fees under the biosimilar user fee amendments of 2017. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.
This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The title, description, and respondent description of the information collection are given under this section with an estimate of the annual reporting burden. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.
With respect to the collection of information associated with this document, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
The burdens associated with requesting a small business waiver of BsUFA fees and the associated burdens for new activities as noted in the guidance are listed in table 1.
FDA estimates the annual burden of these new collections of information as follows:
This guidance also refers to previously approved collections of information found in FDA forms developed to support its user fee program. Specifically, the guidance refers to Form FDA 3792; Forms FDA 3913 and 3914; and Form FDA 3971, which have been approved under OMB control numbers 0910-0718, 0910-0719, 0910-0805, and 0910-0693, respectively. The guidance also refers to previously approved collections of information found in FDA regulations. The collections of information in 21 CFR part 312 are currently approved under OMB control number 0910-0014; the collections of information regarding new drug applications under the FD&C Act are approved under OMB control number 0910-0001; and biologics license applications under sections 351(a) or 351(k) of the Public Health Service Act are approved under OMB control numbers 0910-0338 and 0910-0719, respectively.
This final guidance contains information collection provisions subject to review by OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Except for the provisions listed in table 1, the information collections already have been approved. The applicable provisions are shaded in the guidance to identify those for which OMB approval has not yet been obtained. When approval of these provisions has been received, FDA will provide notice. BsUFA II provides the statutory authority to collect user fees from FY 2018 through FY 2022. Consistent with the statutory requirements of BsUFA II, FDA is issuing this guidance to facilitate understanding and enhancing implementation of the policies and processes in the assessment of biosimilar user fees in upcoming fiscal years.
Persons with access to the internet may obtain the guidance at either
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the
Submit either electronic or written comments on the collection of information by August 28, 2018.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before August 28, 2018. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the
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
Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733,
Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements for members of the public when submitting reports, keeping records, or providing information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
This information collection supports FDA's Biosimilars User Fee Program. The Biologics Price Competition and Innovation Act of 2009 (BPCI Act), amended the Public Health Service Act (PHS Act) by adding section 351(k) (42 U.S.C. 262(k)) to create an abbreviated approval pathway for biological products shown to be biosimilar to or interchangeable with an FDA-licensed reference biological product. This allows a company to apply for licensure of a biosimilar or interchangeable biological product (351(k) application). The BPCI Act also amended section 735 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g) to include 351(k) applications as a type of application under “human drug application” for the purposes of the prescription drug user fee provisions.
The Biosimilar User Fee Act of 2012 (BsUFA) authorized FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development (BPD). BsUFA was reauthorized for an additional 5 years in August 2017 (BsUFA II). FDA's biosimilar biological product user fee program requires FDA to assess and collect user fees for certain meetings concerning biosimilar BPD (BPD meetings), investigational new drug applications (INDs) intended to support a biosimilar biological product application, and biosimilar biologic license applications (BLAs).
Form FDA 3792, entitled “Biosimilars User Fee Cover Sheet”, is submitted by each new BPD entrant (identified via a new meeting request or IND submission) and new BLAs. Form FDA 3792 requests the minimum necessary information to identify the request and determine the amount of the fee to be assessed, and to account for and track user fees. The form provides a cross-reference of the fees submitted for an activity with the actual submission or activity by using a unique number tracking system. The information collected is used by FDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research to initiate the administrative screening of biosimilar biological product INDs, and BLAs, and to account for and track user fees associated with BPD meetings.
In addition to the Biosimilars User Fee Cover Sheet, the information collection includes an annual survey of all BsUFA II participants designed to provide information to FDA of anticipated BsUFA II activity in the upcoming fiscal year. This information helps FDA set appropriate annual BsUFA II fees.
FDA has also developed the draft guidance entitled, “Assessing User Fees Under the Biosimilar User Fee Amendments of 2017” to assist industry in understanding when fees are incurred and the process by which applicants can
We estimate the burden of this collection of information as follows:
We have increased our estimate by an additional 15 respondents since last OMB approval of the information collection. This estimated increase is based on our expectation that participation in the BPD program will continue to grow, consistent with our experience since establishment of the information collection in 2012.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA, Agency, or we) Center for Drug Evaluation and Research (CDER) is announcing two new efforts to gather feedback on the use of quality metrics to modernize pharmaceutical quality systems and advance innovation based on stakeholder feedback. These efforts include Type C formal meeting requests and pre-abbreviated new drug application (pre-ANDA) meeting requests, and a pilot study to gain feedback from those establishments for which Type C formal meetings or pre-ANDA meetings do not apply (
Submit a written request to participate in the program by July 29, 2019. See sections II and III.B of this notice for information to include in such requests. FDA will start accepting requests beginning July 30, 2018.
Tara Gooen Bizjak, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2109, Silver Spring, MD 20993, 301-796-3257,
More than a decade ago, FDA launched an initiative to encourage the implementation of a modern, risk-based pharmaceutical quality assessment system. As part of this initiative, and in recognition of the increasing complexity of pharmaceutical manufacturing, FDA developed a 21st century vision for manufacturing and quality with input from academia and industry. The desired state was described as follows: “A maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high-quality drug products without extensive regulatory oversight.”
There has been significant progress toward this vision in the intervening years, as evidenced by programs and guidance from FDA around major initiatives such as pharmaceutical development and quality by design, quality risk management and pharmaceutical quality systems, process validation, and process analytical technology, among other initiatives. These programs and guidances are intended to promote effective use of the most current pharmaceutical science and engineering principles and knowledge throughout the life cycle of a product.
While much progress has been made, we have not fully realized our 21st century vision for manufacturing and quality. Rather than focusing on use of science- and risk-based principles as described in current good manufacturing practices, many establishments continue to focus on minimum requirements (
FDA sought input from industry on the establishment of an FDA Quality Metrics Program as another mechanism to promote continual improvement in manufacturing quality. FDA has also consulted with other stakeholders to identify mutually useful and objective quality metrics. The Agency learned that it should perform further studies of the FDA Quality Metrics Program through a pilot program and additional discussions with stakeholders. Based on this input, FDA is initiating this Quality Metrics Feedback Program to assist the Agency in the development of a Quality Metrics Program. Stakeholders are encouraged to participate in these efforts by using the two feedback procedures described below. Additional references may be found at the FDA web page, Quality Metrics for Drug Manufacturing,
Based on stakeholder feedback, FDA is presenting two new methods for engaging industry. The approaches announced in this notice provide industry stakeholders with an opportunity to provide information to further the development of the Quality Metrics Program. CDER will also continue to engage with trade associations to gather feedback for industry subsectors.
FDA does not intend to publicly disclose information submitted to the Agency as part of this Quality Metrics Feedback Program that is exempt from disclosure under disclosure laws and regulations. The following types of information may be exempt from public disclosure if not made public by the owner: (1) Commercial relationships; (2) production and sales volume; (3) business plans; and (4) unapproved applications.
Applicants who have an interest in participating in this method of the FDA Quality Metrics Feedback Program should submit a written request. New drug application (NDA) applicants or sponsors should follow the procedures for submitting Type C meeting requests as described in the draft guidance for industry entitled “Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products (December 2017).”
In addition to the procedures and items outlined in the referenced guidances, a request for a meeting should include the following items:
1. A description of the quality metrics currently used for the product and process in the facility(ies) that are specific to the risks of the facility(ies), products, manufacturing processes, supply chain, and current business decisions (
2. A statement on whether the following quality metrics are measured using consistent definitions: Lot acceptance rate per product or rejection rate, invalidated out-of-specification rate per product, product quality complaint rate, process performance and process capability per product, corrective action and preventive action effectiveness, quality system timeliness, and on-time-in-full fulfillment of orders.
3. A statement that suitably detailed technical definitions for the quality metrics data elements in the previously mentioned items (1) and (2) are established to enable consistent measurement and comparison.
4. A description of the routine assessment and management oversight of quality culture. This assessment should include all levels of staff, from senior management to base level employees, to gauge and shape the behaviors, beliefs, values, morals, conventions, goals, and practices that characterize or are associated with manufacturing at the facility(ies).
5. A description of the ongoing site management and senior management review of the quality metrics program, including identification of areas for continual improvement.
To maximize the benefits of an in-person meeting, FDA prefers that the applicant or sponsor provide a statement of willingness for one or more of the following: (1) To provide access to certain current and historical product-specific measures and the data supporting the measures, including lot acceptance rate or rejection rate, product quality complaint rate, and invalidated out-of-specification rate; (2) to share available information supporting the categories (product specific measurements), where applicable, of process performance and process capability (product specific), corrective and preventive actions (CAPA) effectiveness, quality culture, quality system metrics (
We intend to accept as many meeting requests as Agency resources allow and to focus on establishments that show an interest in engaging in robust discussions regarding their quality metrics programs. FDA expects to notify companies in writing of its decision regarding meeting acceptance within 60 days of receipt of their requests. Although incomplete and/or unclear requests will generally be denied, FDA may contact the applicant to request additional information. Once a meeting is granted, the participant can engage with the Quality Metrics Program team in accordance with existing meeting procedures and guidance(s). FDA anticipates that discussions with stakeholders will help to further develop the Quality Metrics Program and will provide the Agency with information on existing industry practices using modern pharmaceutical quality systems.
Establishments eligible to participate in this voluntary Quality Metrics Pilot
1. The company must be a covered establishment. A covered establishment is an owner or operator of an establishment that is engaged in the manufacture, preparation, propagation, compounding, or processing of a covered drug product, or an API used in the manufacture of a covered drug product. A covered drug product is: (1) Subject to an approved application under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or under section 351 of the Public Health Service Act (42 U.S.C. 262); (2) marketed pursuant to an OTC monograph; or (3) a marketed unapproved finished drug product. A covered establishment does not need to be involved in the physical manipulation of a drug.
2. The company must have a quality metrics program that has been developed and implemented by the quality unit and that is used to support product and process quality improvement. The established quality metrics program must include product-specific measurements and include at a minimum: (1) Lot acceptance rate or rejection rate, (2) invalidated out-of-specification rate, and (3) product quality complaint rate. If a product is manufactured at more than one location, these product specific metrics could be limited to operations at the participating covered establishment. To provide feedback on recommended changes in the metrics definitions, send an email to
The ideal participant in the Quality Metrics Pilot Program will have the following elements in their quality metrics program:
1. Quantitative measurement of quality metrics for the products and processes in the facility(ies) that are specific to the risks of the facility(ies), products, manufacturing processes, supply chain, and current business decisions (
2. Certain quality metrics measured, such as lot acceptance rate or rejection rate per product, invalidated out-of-specification rate per product, product quality complaint rate, process performance and process capability per product, CAPA effectiveness, quality system timeliness, and on-time-in-full fulfillment of orders;
3. Suitably detailed technical definitions for the quality metrics data elements to enable consistent measurement and comparison;
4. routine assessment and management oversight of quality culture at multiple levels of staff, such as senior management to base level employees, to assess and shape the behaviors, beliefs, values, morals, conventions, goals, and practices that characterize or are associated with manufacturing at the facility(ies); and
5. Ongoing site management and senior management review of the quality metrics with identification of areas for continual improvement.
The establishments that will likely benefit most from the Quality Metrics Pilot Program and discussions with FDA are those that are able to: (1) Provide access to certain current and historical product-specific measures and the data supporting the measures, including lot acceptance rate or rejection rate, product quality complaint rate, and invalidated out-of-specification rate; (2) share available information supporting the following categories (product specific measurements), where applicable, of process performance and process capability (product specific), CAPA effectiveness, quality culture, quality system metrics (
To be considered for the voluntary Quality Metrics Pilot Program, a company should submit a statement of interest for participation to
The following captures the proposed process for the Quality Metrics Pilot Program selection:
1. FDA will collect statements of interest for participation in the pilot program beginning July 30, 2018.
2. FDA will select the first nine participants that submit a statement of interest in participation meeting the selection criteria in the first paragraph of section III.A. While any covered establishment meeting the criteria may request inclusion in the pilot program per the first paragraph of section III.A, FDA would prefer that establishments for which Type C formal meetings and pre-ANDA meetings are not applicable use this approach. Additionally, FDA is seeking participants that represent different sectors of the pharmaceutical industry, including companies that manufacture the following types of products: Brand, generics, biotechnology, APIs, and non-application products marketed under the OTC monograph system. Furthermore, we are looking for representation from contract development and manufacturing organizations, establishments with small and large portfolios, and establishments with past or current product availability issues (
3. Lessons learned from the initial participants in the pilot program (maximum of nine participants) will help inform FDA's thinking as it refines the Quality Metrics Program.
FDA intends to accept requests for participation in the voluntary Quality Metrics Pilot Program and Type C formal meetings and Pre-ANDA meetings beginning July 30, 2018. The pilot program will begin July 30, 2018 and will close July 29, 2019. The Type C formal meetings and pre-ANDA meetings will be granted based on the schedules described in the associated guidance documents.
This notice 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 505 have been approved under OMB control number 0910-0001 and the collections of information in 21 CFR parts 210 and 211 have been approved under OMB control number 0910-0139.
The collections of information to be included in a meeting request for a product submitted in an NDA is approved under OMB control number 0910-0429. The collections of information to be included in a meeting request for a product submitted in an ANDA is approved under OMB control number 0910-0797.
Food and Drug Administration, HHS.
Notice.
The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) in the Food and Drug Administration (FDA or Agency) are announcing a 2018 CDER and CBER staff experiential learning site visit program specific to FDA's Quality Metrics Program. FDA is proposing this program, in part, in response to input from a variety of stakeholders over the past couple of years. The purpose of this 2018 Quality Metrics Site Visit Program is to provide experiential and firsthand learning opportunities to FDA staff involved in the development of the FDA Quality Metrics Program and to provide stakeholders with an opportunity to explain the advantages and challenges associated with implementing and managing a robust Quality Metrics Program. This notice invites pharmaceutical companies interested in participating in this program to submit a Quality Metrics Site Visit proposal.
Submit either an electronic or written proposal to participate in this program by August 28, 2018. See section IV of this notice for information on what to include in such proposals.
Tara Gooen Bizjak, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2109, Silver Spring, MD 20993-0002, 301-796-3257, email:
More than a decade ago, FDA launched an initiative to encourage the implementation of a modern, risk-based pharmaceutical quality assessment system. As part of this initiative, and in recognition of the increasing complexity of pharmaceutical manufacturing, FDA developed a 21st century vision for manufacturing and quality with input from academia and industry. The desired state was described as follows: “A maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high-quality drug products without extensive regulatory oversight.”
There has been significant progress toward this vision in the intervening years as evidenced by programs and guidances from FDA around major initiatives such as pharmaceutical development and quality by design, quality risk management and pharmaceutical quality systems, process validation, and emerging technology, among others. These programs and guidances are intended to promote effective use of the modern pharmaceutical science and engineering principles and knowledge throughout the life cycle of a product.
FDA sought input from industry on the establishment of an FDA Quality Metrics Program as another mechanism to promote continual improvement in manufacturing quality. FDA has also consulted with other stakeholders to identify mutually useful and objective quality metrics. The Agency heard that it should perform further studies of existing quality metrics programs and conduct additional discussions with stakeholders. Based on this input, CDER and CBER are initiating this 2018 Quality Metrics Site Visit Program to assist the Agency in understanding existing programs. This voluntary site visit program is designed to offer experiential and firsthand learning opportunities to CDER and CBER staff involved in the development of FDA's Quality Metrics Program and to provide stakeholders with an opportunity to explain the advantages and challenges associated with implementing and managing a robust quality metrics program. One goal of these visits is to provide CDER and CBER staff exposure to existing quality metrics programs through onsite visits, tour of operations, and discussions with establishments to assist staff in further developing FDA's Quality Metrics Program. Another goal is to provide a forum for industry to engage in the process and provide additional feedback into improving the FDA Quality Metrics Program.
During a quality metrics site visit, CDER and CBER staff will observe how quality metrics data are gathered, collected, and reported to management. We anticipate 5 to 10 FDA representatives (involved in the development of FDA's Quality Metrics Program) would participate in a site visit taking place over a 1- to 2-day period. To facilitate the learning process, the host establishment may present overviews of the development and management of their quality metrics program. The presentation(s) will allow the participating establishments an opportunity to showcase technologies that support their program.
CDER and CBER encourage covered establishments, including establishments that do not perform physical manipulation of drugs, engaging in the development and manufacturing of both active pharmaceutical ingredients (small and large molecules) and drug products to submit quality metrics site visit proposals. A covered establishment is an owner or operator of an establishment that is engaged in the manufacture, preparation, propagation, compounding, or processing of a covered drug product, or an active pharmaceutical ingredient (API) used in the manufacture of a covered drug product. CDER and CBER staff participating in this program will benefit by gaining a better understanding of current industry practices, processes, and procedures for quality metrics programs.
CDER and CBER identified a number of establishment types that are of particular interest to their staff. The following list identifies some examples of these establishments but is not intended to be exhaustive, mutually exclusive, or to limit industry response to the notice:
• Manufacturer of brand, generic, biotechnology, APIs, and non-application product(s) marketed under the over-the-counter (OTC) monograph system, and any combination of these products;
• contract development and manufacturing organizations;
• establishments with small and large portfolios; and
• establishments with past or current product availability issues (
The Quality Metrics Site Visit Program does not supplement or replace a regulatory inspection (
Selection of potential facilities will be based on the priorities developed for CDER and CBER staff training, the facility's current compliance status with FDA, and in consultation with the appropriate FDA district office. All travel expenses associated with this program will be the responsibility of FDA; therefore, selection will be based on the availability of funds and resources for the fiscal year. FDA will not provide financial compensation to the pharmaceutical site as part of this program.
Companies interested in offering a site visit or learning more about this site visit program should respond by submitting a proposal directly to Tara Gooen Bizjak or Stephen Ripley (see
• A contact person;
• site visit location(s);
• Facility Establishment Identifier and Data Universal Numbering System numbers, as applicable;
• maximum number of FDA staff that can be accommodated during a site visit (maximum of 10),
• a description of the development, history, and ongoing management of the quality metrics program;
• a sample agenda outlining the proposed learning objectives and associated activities for the site visit; and
• preferred dates for a quality metrics site visit.
Proposals submitted without this minimum information will not be considered.
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 “Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations.” The purpose of this draft guidance is to assist sponsors in designing appropriate nonclinical studies before initiation of first-in-human (FIH) trials and through product approval. In addition, this draft guidance provides recommendations for product labeling, such as duration of contraception to minimize potential risk to a developing embryo/fetus and recommendations for lactating women to minimize potential risk to a nursing infant. This draft guidance intends to provide recommendations for nonclinical programs in a unique and challenging area of product development, provide a more consistent approach in nonclinical studies and product labeling, and reduce the conduct of nonclinical studies that are not informative for product use.
Submit either electronic or written comments on the draft guidance by August 28, 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. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Haleh Saber, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2117, Silver Spring, MD 20993-0002, 301-796-7550, or John Leighton, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2204, Silver Spring, MD 20993-0002, 301-796-7550.
FDA is announcing the availability of a draft guidance for industry entitled “Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations.” This draft guidance presents FDA's current thinking on nonclinical studies needed to support FIH studies and for approval for therapeutic radiopharmaceuticals. In this draft guidance, the term
Currently, no FDA or International Council for Harmonisation guidance addresses nonclinical studies supporting FIH trials and approval for radiopharmaceuticals for treatment of cancer. The guidance for industry entitled “Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals” (available at
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 nonclinical studies and labeling recommendations for oncology therapeutic radiopharmaceuticals. 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 collection of information in 21 CFR 312.23(a)(8) for submitting pharmacological and toxicology information has been approved under OMB control number 0910-0014; the collection of information in 21 CFR 201.56 and 201.57 for preparing human prescription drug labeling has been approved under OMB control number 0910-0572; and the collection of information in the “Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling” final rule has been approved under OMB control number 0910-0624.
Persons with access to the internet may obtain the draft guidance at either
Food and Drug Administration, HHS.
Notice; correction.
The Food and Drug Administration (FDA) is correcting a notice that appeared in the
Trang Tran, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire
In the
1. On page 11208, the entry for ANDA 076045 in the table is removed.
Health Resources and Services Administration, (HRSA), Department of Health and Human Services (HHS).
Notice.
In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Comments on this ICR should be received no later than July 30, 2018.
Submit your comments including the Information Collection Request Title, to the desk officer for HRSA, either by email to
To request a copy of the clearance requests submitted to OMB for review, email Lisa Wright-Solomon, the HRSA Information Collection Clearance Officer at
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
National Institutes of Health; Substance Abuse and Mental Health Services Administration, HHS.
Notice.
This Request for Information (RFI) is intended to gather broad public input on the conduct of a multi-site national research effort to develop and test approaches for the systematic implementation and sustainability of an integrated set of evidence-based interventions across healthcare, behavioral health, justice systems, state and local governments, and community organizations to prevent and treat opioid misuse and Opioid Use Disorders (OUD). The goals are to decrease fatal and non-fatal overdoses, decrease the incidence of OUD and related infectious diseases (
The RFI is open for public comment for a period of 21 days. Comments must be received by July 20, 2018 to ensure consideration.
Comments must be submitted electronically to the following email address:
Please direct all inquiries to Redonna K. Chandler, Ph.D., National Institute on Drug Abuse; Phone: 301-443-1470; email:
This RFI is for information and planning purposes only, and should not be construed as a solicitation or an obligation on the part of the federal government, the National Institutes of Health (NIH), the National Institute on Drug Abuse (NIDA), or the Substance Abuse and Mental Health Services Administration (SAMHSA). NIH does not intend to make any awards based on responses to this RFI or to otherwise pay for the preparation of any information submitted or for the government's use of such information.
NIDA, in partnership with SAMHSA, is exploring options for conducting a multi-site national research effort in up to three communities to develop and test approaches for the systematic implementation and sustainability of an integrated set of evidence-based interventions across healthcare, behavioral health, justice systems, state and local governments, and community organizations to prevent and treat opioid misuse and OUD. The goals are to decrease fatal and non-fatal overdoses, decrease the incidence of OUD and related infectious diseases (
• How can “heavily affected communities” be defined, including geospatial/geopolitical definitions to provide consistent boundaries for a multi-site study?
• What research designs might be appropriate to accomplish the overall goals of the study?
• How can effect size be estimated and what effect size might be expected in relation to candidate outcomes: Rates of non-fatal and fatal overdose; prevalence and incidence of opioid misuse, OUD and Hepatitis C; percent of patients screened for opioid misuse and OUD and who received a brief intervention or were referred to treatment; percent of patients initiated on MAT and retained in medication treatment beyond 6 months; rates of naloxone distribution and overdose reversals; opioid analgesic and benzodiazepine prescription rates; and implementation of prevention programs?
• What baseline data should be captured, what are potential existing sources for this data, and what challenges might exist with quality of existing data?
• How long would an integrated set of evidence-based interventions need to be in place before expecting a meaningful change in outcomes, and which combination of interventions should be implemented in communities with different characteristics?
• What confounding variables need to be considered?
• What are potential threats to internal and external study validity and what strategies could be deployed to mitigate threats?
• Are there particular strategies that can help the Coordinating Center overcome barriers to the facilitation of collaboration and coordination activities across Research Centers with regard to data harmonization, collection, integration, cleaning, analyses, and creating datasets for sharing with the research community at large?
• What target metrics would be feasible for outcomes? Candidate outcomes could include, but are not limited to those listed above: Rates of non-fatal and fatal overdose; prevalence and incidence of opioid misuse, OUD and Hepatitis C; percent of patients screened for opioid misuse and OUD and who received a brief intervention or were referred to treatment; percent of patients initiated on MAT and retained in medication treatment beyond 6 months; rates of naloxone distribution and overdose reversals; opioid analgesic and benzodiazepine prescription rates; and implementation of prevention programs?
• What is the best way to gather reliable data related to candidate outcomes listed above?
• What are essential interventions for an evidence-based integrated approach to opioid prevention and treatment services, including policies and practices?
• How could “evidence-based or evidence-informed” be defined?
• How can fidelity to an evidence-based integrated approach to opioid prevention and treatment services, including policies and practices be measured?
• What strategies and resources would be necessary, including training and technical assistance, to have meaningful penetration of the evidence-
• What economic questions should be included as part of the study to inform systems and policy change?
• What implementation research questions should be included to develop best practices for replication in other communities impacted by the opioid crisis?
• What data should be collected to help develop metrics for determining the quality of an integrated approach to opioid prevention and treatment services, including policies and practices?
• Are there examples of prior implementation research studies that highlight implementation tools that can be used to replicate and scale up integrated approaches?
• What research, prevention, and treatment infrastructure and partnerships are needed to support a community-based pragmatic trial assessing the impact of an evidence-based integrated approach to opioid prevention and treatment services?
• What is the best approach to fostering collaboration and meaningful participation between state, county, and local governments; community stakeholders; medical/clinical service providers; and researchers?
• How do we construct a research initiative with the highest likelihood of having sustainable prevention and treatment services?
• What data would be of most interest to state and community partners?
Responses to this RFI are voluntary and may be submitted anonymously. Please do not include any personally identifiable or other information that you do not wish to make public. Proprietary, classified, confidential, or sensitive information should not be included in responses. Comments submitted will be compiled for discussion and shared internally with NIDA, SAMHSA, NIH program staff, and participating leadership across the Department of Health and Human Services, as appropriate. Any personal identifiers (personal names, email addresses, etc.) will be removed when responses are compiled.
This RFI is for informational and planning purposes only and is not a solicitation for applications or an obligation on the part of the United States Government to provide support for any ideas identified in response to it. Please note that the United States Government will not pay for the preparation of any information submitted or for use of that information.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
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.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Federal Emergency Management Agency, DHS.
Notice and request for comments.
The Federal Emergency Management Agency, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public to take this opportunity to comment on an extension, without change, of a currently approved information collection. In accordance with the Paperwork Reduction Act of 1995, this notice seeks comments concerning this form which is used by regulated lending institutions, federal agency lenders, the Federal National Mortgage Association, the Federal Home Loan Mortgage Corporation, and the Government National Mortgage Association. Federally regulated lending institutions complete this form when making, increasing, extending, renewing or purchasing each loan for the purpose is of determining whether flood insurance is required and available. FEMA is responsible for maintaining the form and making it available.
Comments must be submitted on or before August 28, 2018.
To avoid duplicate submissions to the docket, please use only one of the following means to submit comments:
(1)
(2)
All submissions received must include the agency name and Docket ID. Regardless of the method used for submitting comments or material, all submissions will be posted, without change, to the Federal eRulemaking Portal at
Susan Bernstein, Insurance Specialist, FIMA, Marketing and Outreach Branch, 303-701-3595. You may contact the Information Management Division for copies of the proposed collection of information at email address:
Section 1365 of the National Flood Insurance Act of 1968 (NFIA) (42 U.S.C. 4104b), as added by Section 528 of the National Flood Insurance Reform Act of 1994 (Pub. L. 103-325, title V), requires that FEMA develop a standard hazard determination form for recording the determination of whether a structure is located within an identified Special Flood Hazard Area and whether flood insurance is available. Regulated lending institutions, federal agency lenders, the Federal National Mortgage Association, the Federal Home Loan Mortgage Corporation, and the Government National Mortgage Association must complete this form for any loan made, increased, extended, renewed or purchased by these entities. The requirement for federally regulated lending institutions to determine whether a building or mobile home securing a loan is located in an area having special flood hazards and whether flood insurance is available has been in effect since the enactment of the Flood Disaster Protection Act of 1973, although the use of a standard form was not required until the enactment of the Section 1365 of the NFIA. The establishment of the Standard Flood Hazard Determination form has enabled
Comments may be submitted as indicated in the
Federal Emergency Management Agency, DHS.
Notice and request for comments.
The Federal Emergency Management Agency, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public to take this opportunity to comment on an extension, without change, of a currently approved information collection. In accordance with the Paperwork Reduction Act of 1995, this notice seeks comments concerning the Community Disaster Loan (CDL) Program. This collection allows the government to make loans to communities that have suffered economic problems due to disasters.
Comments must be submitted on or before August 28, 2018.
To avoid duplicate submissions to the docket, please use only one of the following means to submit comments:
(1)
(2)
All submissions received must include the agency name and Docket ID. Regardless of the method used for submitting comments or material, all submissions will be posted, without change, to the Federal eRulemaking Portal at
Martha Polanco, Assistant Program Manager, Disaster Assistance Directorate, Public Assistance Division, (202) 212-5761. You may contact the Information Management Division for copies of the proposed collection of information at email address:
The Community Disaster Loan (CDL) Program is authorized by Section 417 of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, Public Law 93-288, as amended, 42 U.S.C. 5184, and implementing regulations at 44 CFR subpart K. The Assistant Administrator may make a CDL to any local government which has suffered a substantial loss of tax or other revenues as a result of a major disaster or emergency and which demonstrates a need for Federal financial assistance in order to perform its governmental functions. Local governments may indicate interest in acquiring a Community Disaster Loan by contacting their Governor's Authorized Representative. The Governor's Authorized Representative submits a letter to FEMA requesting the Community Disaster Loan Program for their State.
Comments may be submitted as indicated in the
Federal Emergency Management Agency, DHS.
Notice and request for comments.
The Federal Emergency Management Agency (FEMA) will submit the information collection abstracted below to the Office of Management and Budget for review and clearance in accordance with the requirements of the Paperwork Reduction Act of 1995. The submission will describe the nature of the information collection, the categories of respondents, the estimated burden (
Comments must be submitted on or before July 30, 2018.
Submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget. Comments should be addressed to the Desk Officer for the Department of Homeland Security, Federal Emergency Management Agency, and sent via electronic mail to
Requests for additional information or copies of the information collection should be made to Director, Information Management Division, 500 C Street SW, Washington, DC 20472, email address
This proposed information collection previously published in the
Comments may be submitted as indicated in the
Office of the General Counsel, HUD.
Notice.
Section 106 of the Department of Housing and Urban Development Reform Act of 1989 (the HUD Reform Act) requires HUD to publish quarterly
For general information about this notice, contact Aaron Santa Anna, Assistant General Counsel for Regulations, Department of Housing and Urban Development, 451 7th Street SW, Room 10276, Washington, DC 20410-0500, telephone 202-708-3055 (this is not a toll-free number). Persons with hearing- or speech-impairments may access this number through TTY by calling the toll-free Federal Relay Service at 800-877-8339.
For information concerning a particular waiver that was granted and for which public notice is provided in this document, contact the person whose name and address follow the description of the waiver granted in the accompanying list of waivers that have been granted in the first quarter of calendar year 2018.
Section 106 of the HUD Reform Act added a new section 7(q) to the Department of Housing and Urban Development Act (42 U.S.C. 3535(q)), which provides that:
1. Any waiver of a regulation must be in writing and must specify the grounds for approving the waiver;
2. Authority to approve a waiver of a regulation may be delegated by the Secretary only to an individual of Assistant Secretary or equivalent rank, and the person to whom authority to waive is delegated must also have authority to issue the particular regulation to be waived;
3. Not less than quarterly, the Secretary must notify the public of all waivers of regulations that HUD has approved, by publishing a notice in the
a. Identify the project, activity, or undertaking involved;
b. Describe the nature of the provision waived and the designation of the provision;
c. Indicate the name and title of the person who granted the waiver request;
d. Describe briefly the grounds for approval of the request; and
e. State how additional information about a particular waiver may be obtained.
Section 106 of the HUD Reform Act also contains requirements applicable to waivers of HUD handbook provisions that are not relevant to the purpose of this notice.
This notice follows procedures provided in HUD's Statement of Policy on Waiver of Regulations and Directives issued on April 22, 1991 (56 FR 16337). In accordance with those procedures and with the requirements of section 106 of the HUD Reform Act, waivers of regulations are granted by the Assistant Secretary with jurisdiction over the regulations for which a waiver was requested. In those cases in which a General Deputy Assistant Secretary granted the waiver, the General Deputy Assistant Secretary was serving in the absence of the Assistant Secretary in accordance with the office's Order of Succession.
This notice covers waivers of regulations granted by HUD from January 1, 2018 through March 31, 2018. For ease of reference, the waivers granted by HUD are listed by HUD program office (for example, the Office of Community Planning and Development, the Office of Fair Housing and Equal Opportunity, the Office of Housing, and the Office of Public and Indian Housing, etc.). Within each program office grouping, the waivers are listed sequentially by the regulatory section of title 24 of the Code of Federal Regulations (CFR) that is being waived. For example, a waiver of a provision in 24 CFR part 58 would be listed before a waiver of a provision in 24 CFR part 570.
Where more than one regulatory provision is involved in the grant of a particular waiver request, the action is listed under the section number of the first regulatory requirement that appears in 24 CFR and that is being waived. For example, a waiver of both § 58.73 and § 58.74 would appear sequentially in the listing under § 58.73.
Waiver of regulations that involve the same initial regulatory citation are in time sequence beginning with the earliest-dated regulatory waiver.
Should HUD receive additional information about waivers granted during the period covered by this report (the first quarter of calendar year 2018) before the next report is published (the second quarter of calendar year 2018), HUD will include any additional waivers granted for the first quarter in the next report.
Accordingly, information about approved waiver requests pertaining to HUD regulations is provided in the Appendix that follows this notice.
More information about the granting of these waivers, including a copy of the waiver request and approval, may be obtained by contacting the person whose name is listed as the contact person directly after each set of regulatory waivers granted.
The regulatory waivers granted appear in the following order:
I. Regulatory waivers granted by the Office of Community Planning and Development.
II. Regulatory waivers granted by the Office of Housing.
III. Regulatory waivers granted by the Office of Public and Indian Housing.
For further information about the following regulatory waivers, please see the name of the contact person that immediately follows the description of the waiver granted.
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This waiver will expedite efforts to identify suitable housing units in the declared-disaster area (see FEMA-DR-4344) for rent to HOPWA beneficiaries and HOPWA-eligible families that have been affected by the wildfires, and to provide assistance to families in the declared-disaster area that must rent units at rates that exceed the HOPWA grantee's normal rent standard as calculated in accordance with 24 CFR 574.320(a)(2).
For further information about the following regulatory waivers, please see the name of the contact person that immediately follows the description of the waiver granted.
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Specifically, according to the Bankruptcy Court's Order Authorizing and Approving the Sale, following the Section 363 sale, the Bankruptcy Court ordered that all liens, encumbrances, and other interests attach to the proceeds of the sale in the order of their priority, with the same validity, extent, force and effect that they had as of the closing date. The mortgage loan remains in default, and despite the sale of the hospital, the debt remains outstanding. Berkadia retained a first lien priority status to the sales proceeds and granting a waiver will allow Berkadia to file a claim in exchange for the assignment of the security to HUD.
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For further information about the following regulatory waivers, please see the name of the contact person that immediately follows the description of the waiver granted.
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Office of the Chief Information Officer, HUD.
Notice.
On April 10, 2018, HUD published a
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: Colette Pollard, Reports Management Officer, QMAC, Department of Housing and Urban Development, 451 7th Street SW, Washington, DC 20410; email
Colette Pollard, Reports Management Officer, QMAC, Department of Housing and Urban Development, 451 7th Street SW, Washington, DC 20410; email
Copies of available documents submitted to OMB may be obtained from Ms. Pollard.
On April 10, 2018, at 83 FR 15396, HUD published a
For the convenience of interested persons, HUD is republishing below the description of the proposed information collection contained in the April 10, 2018, notice. There have been no changes made to the posted documents since the April 10, 2018 notice.
A brief summary of the more significant changes per documentation category is provided below.
• Lender Narratives—The edits consist primarily of changes to remove program guidance from the narratives and to incorporate updated underwriting standards specific to, for example, special use facilities.
• Consolidated Certifications—The changes consist of streamlining the form and revising language to incorporate the changed policy in the new previous participation regulation with new definitions such as Controlling Participant.
• Construction documents—Several documents are proposed that will replace the current versions of the Multifamily forms still in use, such as a new Borrower Certification for Early Start/Early Commencement of Construction projects.
• Underwriting documents—A new form was added—New Fair Housing Marketing Plan document—which provides the Affirmative Fair Housing Marketing Plan Requirements. ORCF removed one obsolete document (Agreement for Payment of Real Property Taxes) that is more specific to multifamily housing, and not relevant to healthcare facilities, as well as the Certificate of Need for Health Facilities and Schedule of Facilities Owned, Operated or Managed, which both contained duplicative information provided in other documents. The new Affirmative Fair Housing Marketing Plans (AFHMPs) was vetted with Fair Housing and Equal Opportunity (FHEO); other HUD programs had unique AFHMPs for their programs, and this new form is meant to accomplish the same for healthcare facilities. Appraisal information will also, be collected via a new spreadsheet that is similar to a collection method used by the multifamily housing “wheelbarrow”.
• Accounts Receivable (AR) documents—Edits include changes made to the Inter-creditor Agreement form to address an ongoing issue of how operators should disclose any cross-defaults between the AR loan and the HUD loan.
• Master Lease documents—Changes include adding two new forms: Termination and Release of Cross-Default Guaranty of Subtenants—Proposed and Amendment to HUD Master Lease (Partial Termination and Release)—Proposed to reflect the 232 Handbook policy related to a release of a project from a master lease.
• Closing documents—Edits were made to the Surplus Cash Note and Subordination Agreement—(Financing) to restrict distributions when there is secondary financing. Security Instrument/Mortgage Deed Instrument/Mortgage Deed of Trust to reflect Multifamily's form and reduces the need to amend the document when the Regulatory Agreement—Borrower paragraph 38 is changed. New residential care facilities versions of Certificate of Actual Cost as well as a Rider to Security Instrument—LIHTC—were incorporated into the collection to replace Multifamily versions still in use which did not reflect ORCF policy.
• Regulatory Agreement for Fire Safety—A new Regulatory Agreement for Fire Safety projects and a Management Agreement Addendum, as well as formalization of a Lender Certification for Insurance Coverage, to incorporate current samples already in place was added to the documentation collection.
• Escrow documents—New proposed escrow forms for long-term debt service reserves and Off-Site Facilities were also added.
• Asset Management documents—Change of participant application documents were revised to streamline the documents needed for a change in title of mortgaged property, change of operator or management agent, or complete change of all the parties. Documents still being used in the Multifamily format were incorporated into this collection, to specifically address ORCF policy. New Lender Narratives were also added for the addition of Accounts Receivable, for Requests to Release or Modify Original Loan Collateral and Loan Modifications (along with a corresponding Certification). New forms were also added to incorporate existing samples in use for Section 232 HUD Healthcare Portal Access, and notification to ORCF, by the Servicer and Operator of developing concerns within a project.
• Supplemental Loan Documents—Section 241(a) Mortgage Insurance for Supplemental Loans for Multifamily Projects. All Section 241(a) loan documents that have been in use as samples are now made a part of the documentation collection for OMB approval.
This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:
(1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) The accuracy of the agency's estimate of the burden of the proposed collection of information;
(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) Ways to minimize the burden of the collection of information on those who are to respond: Including through the use of appropriate automated collection techniques or other forms of information technology,
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35.
Bureau of Land Management, Interior.
Notice of availability.
In accordance with the National Environmental Policy Act of 1969, as amended, and the Federal Land Policy and Management Act of 1976, as amended, the Bureau of Land Management (BLM) Tucson Field Office (TFO) has prepared a Draft Resource Management Plan (RMP) and Draft Environmental Impact Statement (EIS) for the San Pedro Riparian National Conservation Area (SPRNCA) and by this notice is announcing the opening of the comment period.
To ensure that comments will be considered, the BLM must receive written comments on the Draft RMP/Draft EIS within 90 days following the date the Environmental Protection Agency publishes its Notice of Availability of the Draft RMP/Draft EIS in the
You may submit comments related to the SPRNCA Draft RMP/Draft EIS by any of the following methods:
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Copies of the SPRNCA Draft RMP/Draft EIS are available in the Tucson Field Office at the above address and at the San Pedro Project Office, 4070 S Avenida Saracino, Hereford, AZ 85615.
Amy Markstein, Planning & Environmental Specialist, telephone 520-258-7231; address 3201 East Universal Way, Tucson, AZ 85756; email
Persons who use a telecommunications device for the deaf (TDD) may call the Federal Relay Service (FRS) at 1-800-877-8339 to contact the above individual during
The SPRNCA was established by Public Law 100-696 on November 18, 1988. The planning area is located in Cochise County in southeastern Arizona, and encompasses approximately 55,990 acres of public land administered by the BLM TFO. The SPRNCA is located adjacent to the City of Sierra Vista and is near Fort Huachuca, Arizona.
The SPRNCA is currently managed under the Safford District RMP (1992 and 1994), which incorporated RMP level decisions from the San Pedro River Riparian Management Plan (1989). This planning effort would update management guidance from the previous plans and create a new RMP for the SPRNCA. The planning effort is needed to identify goals, objectives, and management actions for the SPRNCA's resources and uses identified in the enabling legislation, including aquatic; wildlife; archaeological; paleontological; scientific; cultural; educational; and recreational resources and values.
The BLM used public scoping comments to help identify planning issues that directed the formulation of alternatives and framed the scope of analysis in the Draft RMP/Draft EIS. Issues identified included management of water, vegetation, and soil resources, fire management, Threatened and Endangered species management, livestock grazing, access, recreation, socio-economics, and lands and realty. The planning effort also considers lands with wilderness characteristics, wild and scenic rivers, and Areas of Critical Environmental Concern (ACECs).
The Draft RMP/Draft EIS evaluates four alternatives in detail. Alternative A is the No Action Alternative, which is a continuation of current management in the existing Safford District RMP and San Pedro River Riparian Management Plan. It is a continuation of current public use, resource protection, and conservation prescriptions without change. It neither sets desired outcomes for resource management or most uses, nor addresses new issues unforeseen or nonexistent when the Safford District RMP was prepared. Alternative B provides opportunities for increased public access, includes livestock grazing in sensitive riparian and cultural areas, allows recreation uses, and focuses on active resource management using the broadest array of management tools. This would include use of heavy equipment, herbicide, hand tools, and prescribed fire to achieve goals and objectives, to mitigate any effects from increased use, and for ecosystem restoration. Alternative B places an emphasis on opportunities for motorized access. Alternative C is the BLM's preferred alternative. Alternative C represents a balance between resource protection and public access, authorizes livestock grazing in areas compatible with the established conservation values, and provides for a diverse mix of recreation opportunities. As in Alternative B, Alternative C focuses on active resource management and would allow for use of the broadest array of management tools for ecosystem restoration and to meet goals and objectives. Alternative D emphasizes resource protection and conservation. It emphasizes primitive recreational experiences with limited motorized access, protection of wilderness characteristics, ACECs, and management of the San Pedro and Babocomari Wild and Scenic Rivers. It focuses on natural processes and use of “light on the land” management methods, such as the use of hand tools and prescribed fire, to help meet goals and objectives.
Pursuant to 43 CFR 1610.7-2(b), this notice announces a concurrent public comment period for potential ACECs. There are three existing ACECs under Alternative A, and three expanded and two new potential ACECs under Alternative D. ACECs are not proposed under Alternatives B and C. Pertinent information regarding these ACECs, including proposed designation acreage and resource use limitations are listed below.
Please note that public comments and information submitted including names, street addresses, and email addresses of persons who submit comments will be available for public review and disclosure at the above address during regular business hours (8 a.m. to 4 p.m.), Monday through Friday, except holidays.
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.
40 CFR 1506.6, 40 CFR 1506.10, 43 CFR 1610.2.
National Park Service, Interior.
Meeting notice.
Notice is hereby given in accordance with the Federal Advisory
The meeting will be held on Tuesday, July 17, 2018, in Washington, DC, from 9:30 a.m. to 4:00 p.m. (EASTERN).
The meeting will be held in the South Penthouse of the Stewart Lee Udall Department of the Interior Building located at 1849 C Street NW, Washington, DC 20240.
Alma Ripps, Designated Federal Officer, Office of Policy, National Park Service, telephone 202-354-3950, or email
The Committee was established on March 13, 2018, by authority of the Secretary of the Interior (Secretary) under 54 U.S.C. 100906, and is regulated by the Federal Advisory Committee Act. The Committee's duties are strictly advisory and include, but are not limited to, providing recommendations to the Secretary on policies and programs that: Expand and improve visitor infrastructure developed through public-private partnerships across all public lands; implement sustainable operations embracing fair, efficient, and convenient fee collection and strategic use of the collected fees; improve interpretation using technology; and create better tools and/or opportunities for Americans to discover their lands and waters. The Committee will also provide recommendations for implementation of Secretarial Order No. 3347: Conservation Stewardship and Outdoor Recreation, and other areas as requested by the Secretary.
The meeting is open to the public, but preregistration is required due to security requirements in the building and limited seating. Any individual who wishes to attend the meeting should register via email at
Detailed minutes of the meeting will be available for public inspection within 90 days of the meeting from the Office of Policy, National Park Service, 1849 C Street NW, Room 2659, Washington, DC 20240.
5 U.S.C. Appendix 2.
Bureau of Ocean Energy Management, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, the Bureau of Ocean Energy Management (BOEM) is proposing to renew an information collection.
Interested persons are invited to submit comments on or before July 30, 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 Anna Atkinson by email, or by telephone at 703-787-1025. You may also view the ICR at
In accordance with the Paperwork Reduction Act of 1995 (PRA), 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 BOEM? (2) Will this information be processed and used in a timely manner? (3) Is the estimate of burden accurate? (4) How might BOEM enhance the quality, utility, and clarity of the information to be collected? and (5) How might BOEM 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.
The OCS Lands Act authorizes the Secretary of the Interior (Secretary) to prescribe rules and regulations to administer leasing of mineral resources on the OCS. Section 8(k)(1) of the OCS Lands Act, 43 U.S.C. 1337(k)(1), authorizes the Secretary “. . . to grant to the qualified persons offering the highest cash bonuses on a basis of competitive bidding leases of any mineral other than oil, gas, and sulphur in any area of the [O]uter Continental Shelf not then under lease for such mineral upon such royalty, rental, and other terms and conditions as the Secretary may prescribe at the time of offering the area for lease.”
Section 11(a)(1) of the OCS Lands Act, 43 U.S.C. 1340(a)(1), states that “. . . any person authorized by the Secretary may conduct geological and geophysical explorations in the [O]uter Continental Shelf, which do not interfere with or endanger actual operations under any lease maintained or granted pursuant to this subchapter, and which are not unduly harmful to aquatic life in such area.” Under 30 CFR part 580, G&G exploration to be performed by any person on unleased lands or lands under lease to a third party requires issuance of a BOEM permit or submission of a scientific research notice. Section 1340(g) further requires that permits for geologic exploration will only be issued if it is determined that the applicant for such permit is qualified; the exploration will not interfere with or endanger operations under any lease; and the exploration will not be unduly harmful to aquatic life, result in pollution, create hazardous or unsafe conditions, unreasonably interfere with other uses of the area, or disturb any site, structure, or object of historical or archaeological significance.
Prospecting for marine minerals includes certain aspects of exploration as defined in the OCS Lands Act at 43 U.S.C. 1331(k). That section defines the term “exploration” to mean the process of searching for minerals, including conducting “geophysical surveys where magnetic, gravity, seismic, or other systems are used to detect or characterize the presence of such minerals. . . .”
As a Federal agency, BOEM has a responsibility to comply with the National Environmental Policy Act (42 U.S.C. 4321
Respondents are required to submit form BOEM-0134 to provide the information necessary to evaluate their request to conduct G&G prospecting, exploration or scientific research activities, and upon approval, respondents are issued a permit or authorization. BOEM uses the information to ensure there is no adverse effect to the marine, coastal, or human environment, nor personal harm, unsafe operations and conditions, or unreasonable interference with other uses; to analyze and evaluate preliminary or planned mining activities; to monitor progress of activities in the OCS; to acquire G&G data and information collected under a Federal permit offshore; and to determine eligibility for reimbursement from the Government for certain costs.
BOEM uses the information collected to understand the G&G characteristics of marine mineral-bearing physiographic regions of the OCS. The information aids BOEM in analyzing and weighing the potential for environmental damage, the discovery of marine minerals, and any associated impacts on affected coastal States.
The Independent Offices Appropriations Act (31 U.S.C. 9701), the Omnibus Appropriations Bill (Pub. L. 104-133, 110 Stat. 1321, April 26, 1996), and the OMB Circular A-25 authorize Federal agencies to recover the full cost of services that confer special benefits. Accordingly, all G&G permits for commercial prospecting are subject to cost recovery, and BOEM regulations at 30 CFR 580.12 specify the service fees for these requests.
BOEM protects proprietary information in accordance with the Freedom of Information Act (5 U.S.C. 552) and the Department of the Interior's implementing regulations (43 CFR part 2), and under regulations at 30 CFR 580.70, as well as applicable sections of 30 CFR parts 550 and 552.
In calculating the burden, requesting Governor(s) comments on activities pursuant to 30 CFR 580.31(b) and 30 CFR 580.73 does not constitute information collection under 5 CFR 1320.3(h)(4). These requests for comment are general solicitations of public comment, so BOEM has removed the burden hours associated with this burden.
The following table details the individual BOEM components and respective hour burden estimates of this ICR.
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
U.S. International Trade Commission.
Notice.
Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on May 24, 2018, under section 337 of the Tariff Act of 1930, as amended, on behalf of Bose Corporation of Framingham, Massachusetts. A supplemental exhibit was filed on June 8, 2018. The complaint alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain earpiece devices and components thereof by reason of infringement of U.S. Patent No. 9,036,852 (“the '852 patent”); U.S. Patent No. 9,036,853 (“the '853 patent”); U.S. Patent No. 9,042,590 (“the '590 patent”); U.S. Patent No. 8,311,253 (“the '253 patent”); U.S. Patent No. 8,249,287 (“the '287 patent”); and U.S. Patent No. 9,398,364 (“the '364 patent”). The complaint further alleges that an industry in the United States exists as required by the applicable Federal Statute.
The complainant requests that the Commission institute an investigation and, after the investigation, issue a general or limited exclusion order, or in the alternative a limited exclusion order, and cease and desist orders.
The complaint, except for any confidential information contained therein, is available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW, Room 112, Washington, DC 20436, telephone (202) 205-2000. Hearing impaired individuals are advised that information on this matter can be obtained by contacting the Commission's TDD terminal on (202) 205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at (202) 205-2000. General information concerning the Commission may also be obtained
Pathenia M. Proctor, The Office of Unfair Import Investigations, U.S. International Trade Commission, telephone (202) 205-2560.
(1) Pursuant to subsection (b) of section 337 of the Tariff Act of 1930, as amended, an investigation be instituted to determine whether there is a violation of subsection (a)(1)(B) of section 337 in the importation into the United States, the sale for importation, or the sale within the United States after importation of products identified in paragraph (2) by reason of infringement of one or more of claims 1, 5, 7, 9, and 14 of the '852 patent; claims 1-3, 6, 8, 10, and 11 of the '853 patent; claims 1, 3, 4, 6, 7, and 10 of the '590 patent; claims 1, 3, 4, and 6 of the '253 patent; claims 1 and 6-8 of the '287 patent; and claims 1, 2, 5, 8, 11, and 16 of the '364 patent; and whether an industry in the United States exists as required by subsection (a)(2) of section 337;
(2) Pursuant to section 210.10(b)(1) of the Commission's Rules of Practice and Procedure, 19 CFR 210.10(b)(1), the plain language description of the accused products or category of accused products, which defines the scope of the investigation, is “in-ear headphones and accessories using a retaining structure to secure the device in a user's ear”;
(3) For the purpose of the investigation so instituted, the following are hereby named as parties upon which this notice of investigation shall be served:
(a) The complainant is: Bose Corporation, 100 Mountain Road, Framingham, MA 01701.
(b) The respondents are the following entities alleged to be in violation of section 337, and are the parties upon which the complaint is to be served:
(c) The Office of Unfair Import Investigations, U.S. International Trade Commission, 500 E Street SW, Suite 401, Washington, DC 20436; and
(4) For the investigation so instituted, the Chief Administrative Law Judge, U.S. International Trade Commission, shall designate the presiding Administrative Law Judge.
Responses to the complaint and the notice of investigation must be submitted by the named respondents in accordance with section 210.13 of the Commission's Rules of Practice and Procedure, 19 CFR 210.13. Pursuant to 19 CFR 201.16(e) and 210.13(a), such responses will be considered by the Commission if received not later than 20 days after the date of service by the Commission of the complaint and the notice of investigation. Extensions of time for submitting responses to the complaint and the notice of investigation will not be granted unless good cause therefor is shown.
Failure of a respondent to file a timely response to each allegation in the complaint and in this notice may be deemed to constitute a waiver of the right to appear and contest the allegations of the complaint and this notice, and to authorize the administrative law judge and the Commission, without further notice to the respondent, to find the facts to be as alleged in the complaint and this notice and to enter an initial determination and a final determination containing such findings, and may result in the issuance of an exclusion order or a cease and desist order or both directed against the respondent.
By order of the Commission.
On the basis of the record
The Commission, pursuant to section 751(c) of the Act (19 U.S.C. 1675(c)), instituted this review on February 1, 2018 (83 FR 4679) and determined on May 7, 2018 that it would conduct an expedited review (83 FR 24341, May 25, 2018).
The Commission made this determination pursuant to section 751(c) of the Act (19 U.S.C. 1675(c)). It completed and filed its determination in this review on July 2, 2018. The views of the Commission are contained in USITC Publication 4800 (July 2018), entitled
By order of the Commission.
The Foreign Claims Settlement Commission, pursuant to its regulations (45 CFR part 503.25) and the Government in the Sunshine Act (5 U.S.C. 552b), hereby gives notice in regard to the scheduling of open meetings as follows:
11:00 a.m.—Issuance of Proposed Decisions under the Guam World War II Loyalty Recognition Act, Title XVII, Public Law 114-328.
All meetings are held at the Foreign Claims Settlement Commission, 601 D Street NW, Suite 10300, Washington, DC. Requests for information, or advance notices of intention to observe an open meeting, may be directed to: Patricia M. Hall, Foreign Claims Settlement Commission, 601 D Street NW, Suite 10300, Washington, DC 20579. Telephone: (202) 616-6975.
Notice of availability; request for comments.
The Department of Labor (DOL) is submitting the Bureau of Labor Statistics (BLS) sponsored information collection request (ICR) titled, “Job Openings and Labor Turnover Survey,” to the Office of Management and Budget (OMB) for review and approval for continued use, without change, in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.
The OMB will consider all written comments that agency receives on or before July 30, 2018.
A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the
Submit comments about this request by mail to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-BLS, Office of Management and Budget, Room 10235, 725 17th Street NW, Washington, DC 20503; by Fax: 202-395-5806 (this is not a toll-free number); or by email:
Michel Smyth by telephone at 202-693-4129, TTY 202-693-8064, (these are not toll-free numbers) or by email at
This ICR seeks to extend PRA authority for the Job Openings and Labor Turnover Survey information collection. The JOLTS collects data on job vacancies, labor hires, and labor separations. The data can be used as demand-side indicators of labor shortages. These indicators of labor shortages at the national level greatly enhance policy makers' understanding of imbalances between the demand and supply of labor. Presently there is no other economic indicator of labor demand with which to assess the presence of labor shortages in the U.S. labor market. The availability of unfilled jobs is an important measure of tightness of job markets, symmetrical to unemployment measures. BLS Authorizing Statute sections 1 and 2 authorize this information collection.
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number.
OMB authorization for an ICR cannot be for more than three (3) years without renewal, and the current approval for this collection is scheduled to expire on June 30, 2018. The DOL seeks to extend PRA authorization for this information collection for three (3) more years, without any change to existing requirements. The DOL notes that existing information collection requirements submitted to the OMB receive a month-to-month extension while they undergo review. For additional substantive information about this ICR, see the related notice published in the
Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
44 U.S.C. 3507(a)(1)(D).
Notice of availability; request for comments.
The Department of Labor (DOL) is submitting the Bureau of Labor Statistics (BLS) sponsored information collection request (ICR) revision titled, “Occupational Requirements Survey,” to the Office of Management and Budget (OMB) for review and approval for use in accordance with the Paperwork Reduction Act (PRA) of 1995. Public comments on the ICR are invited.
The OMB will consider all written comments that agency receives on or before July 30, 2018.
A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the
Submit comments about this request by mail to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-BLS, Office of Management and Budget, Room 10235, 725 17th Street NW, Washington, DC 20503; by Fax: 202-395-5806 (this is not a toll-free number); or by email:
Michel Smyth by telephone at 202-693-4129, TTY 202-693-8064, (these are not toll-free numbers) or sending an email to
This ICR seeks approval under the PRA for revisions to the Occupational Requirements Survey (ORS). The ORS is a nationwide survey the BLS is conducting at the request of the Social Security Administration (SSA). The ORS began in 2018 and will end in mid-2021. The currently approved portions of this data collection will continue as scheduled. This information collection has been classified as a revision, because of new cognitive questions and physical formatting changes to the collection form. The BLS Authorizing Statute and the Economy Act authorize this information collection.
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number.
Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
44 U.S.C. 3507(a)(1)(D).
Notice of availability; request for comments.
The Department of Labor (DOL) is submitting the Occupational Safety and Health Administration (OSHA) sponsored information collection request (ICR) revision titled,
The OMB will consider all written comments that agency receives on or before July 30, 2018.
A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the
Submit comments about this request by mail to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-OSHA, Office of Management and Budget, Room 10235, 725 17th Street NW, Washington, DC 20503; by Fax: 202-395-5806 (this is not a toll-free number); or by email:
Michel Smyth by telephone at 202-693-4129, TTY 202-693-8064, (these are not toll-free numbers) or sending an email to
This ICR seeks approval under the PRA for revisions to the Definition and Requirements for a Nationally Recognized Testing Laboratory (NRTL) information collection. A number of OSHA issued standards contain requirements that specify employers use only equipment, products, or material tested or approved by a NRTL. These requirements ensure that employers use safe and efficacious equipment, products, or materials in complying with the standards. Accordingly, the OSHA promulgated its Program Regulation for NRTLs, 29 CFR 1910.7, which specifies procedures an organization must follow to apply for and to maintain OSHA recognition to test and certify equipment, products, or material for safe use in the workplace. The OSHA has also developed standardized optional use forms to facilitate and simplify the information collection process. The forms correspond to the application, expansion, and renewal processes defined in the NRTL Program. This information collection has been classified as a revision, because the OSHA intends to change the NRTL Program's fee schedule associated with initial recognition, program expansion, renewals of recognition, and on-site audits. To facilitate the payment of fees and reduce the burden on NRTLs, the OSHA is in the process of established an electronic payment mechanism on
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number.
Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
44 U.S.C. 3507(a)(1)(D).
Notice of availability; request for comments.
On June 29, 2018, the Department of Labor (DOL) will submit the Occupational Safety and Health Administration (OSHA) sponsored information collection request (ICR) titled, “Bloodborne Pathogens Standard,” to the Office of Management and Budget (OMB) for review and approval for continued use, without change, in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.
The OMB will consider all written comments that agency receives on or before July 30, 2018.
A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the
Submit comments about this request by mail to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-OSHA, Office of Management and Budget, Room 10235, 725 17th Street NW, Washington, DC 20503; by Fax: 202-395-5806 (this is not a toll-free number); or by email:
Michel Smyth by telephone at 202-693-4129, TTY 202-693-8064, (these are not toll-free numbers) or by email at
This ICR seeks to extend PRA authority for the Bloodborne Pathogens Standard information collection requirements codified in regulations 29 CFR 1910.1030. The Bloodborne Pathogen Standard is an occupational safety and health standard that prevents occupational exposure to bloodborne pathogens. The standard's information collection requirements are essential components that protect workers from occupational exposure. The information is used by employers and workers to implement the protection required by the Standard. OSHA compliance officers will use some of the information in enforcing the Standard. The collections of information contained in the Bloodborne Pathogens Standard include a written exposure control plan, documentation of workers' hepatitis B vaccinations and post-exposure evaluations and follow-up medical visits, training, related recordkeeping and a sharps injury log. Information generated in accordance with these provisions provides the employer and the worker with means to provide protection from the adverse health effects associated with occupational exposure to bloodborne pathogens. Occupational Safety and Health Act sections 2(b)(9), 6, and 8(c) authorize this information collection.
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number.
The DOL seeks to extend PRA authorization for this information collection for three (3) more years, without any change to existing requirements. The DOL notes that existing information collection requirements submitted to the OMB receive a month-to-month extension while they undergo review. For additional substantive information about this ICR, see the related notice published in the
Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
44 U.S.C. 3507(a)(1)(D).
Notice of availability; request for comments.
The Department of Labor (DOL) is submitting the Bureau of Labor
The OMB will consider all written comments that agency receives on or before July 30, 2018.
A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the
Submit comments about this request by mail to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-BLS, Office of Management and Budget, Room 10235, 725 17th Street NW, Washington, DC 20503; by Fax: 202-395-5806 (this is not a toll-free number); or by email:
Michel Smyth by telephone at 202-693-4129, TTY 202-693-8064, (these are not toll-free numbers) or sending an email to
This ICR seeks approval under the PRA for revisions to the National Longitudinal Survey of Youth 1979 (NLSY79). The NLSY79 is a representative national sample of persons who were born in the years 1957 to 1964 and lived in the U.S. in 1978. These respondents were ages 14 to 22 when the first round of interviews began in 1979; they are ages 53-60 when the planned round twenty-eight of interviews is conducted in 2018 and 2019. The NLSY79 was conducted annually from 1979 to 1994 and has been conducted biennially since 1994. The longitudinal focus of this survey requires information to be collected from the same individuals over many years in order to trace their education, training, work experience, fertility, income, and program participation. In addition to the main NLSY79, the biological children of female NLSY79 respondents have been surveyed since 1986. A battery of child cognitive, socio-emotional, and physiological assessments has been administered biennially since 1986 to NLSY79 mothers and their children. Starting in 1994, children who had reached age 15 by December 31, of the survey year (the Young Adults) were interviewed about their work experiences, training, schooling, health, fertility, self-esteem, and other topics. One of the goals of the DOL is to produce and disseminate timely, accurate, and relevant information about the U.S. labor force. The BLS contributes to this goal by gathering information about the labor force and labor market and disseminating it to policymakers and the public so that participants in those markets can make more informed, and thus more efficient, choices. Research based on the NLSY79 contributes to the formation of national policy in the areas of education, training, employment programs, and school-to-work transitions. This information collection has been classified as a revision, because of changes to the questionnaire that make it longer and more “older young adult” respondents and young adult respondents with children, who tend to have longer interview times. BLS Authorizing Statute Title 29 sections 1 and 2 authorize this information collection.
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number.
Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
44 U.S.C. 3507(a)(1)(D).
Notice.
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Office of Workers' Compensation Programs is soliciting comments concerning the proposed collection: Notice of Termination, Suspension, Reduction or Increase in Benefit Payments (CM-908). A copy of the information collection request can be obtained by contacting the office listed below in the addresses section of this Notice.
Written comments must be submitted to the office listed in the
You may submit comments by mail, delivery service, or by hand to Ms. Yoon Ferguson, U.S. Department of Labor, 200 Constitution Ave. NW, Room S-3323, Washington, DC 20210; by fax to (202) 354-9647; or by Email to
* Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
* evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
* enhance the quality, utility and clarity of the information to be collected; and
* minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Comments submitted in response to this notice will be summarized and/or included in the request for Office of Management and Budget approval of the information collection request; they will also become a matter of public record.
Nuclear Regulatory Commission.
Final environmental assessment and finding of no significant impact; issuance.
The U.S. Nuclear Regulatory Commission (NRC) is considering an amendment to nuclear reactor licenses DPR-39 and DPR-48 to add a license condition that reflects the NRC's approval of the license termination plan (LTP) and provides criteria for when NRC approval is needed for LTP changes. The NRC has prepared a final environmental assessment (EA) and finding of no significant impact (FONSI) for this licensing action.
The final EA and FONSI referenced in this document are available on June 25, 2018.
Please refer to Docket ID NRC-2015-0082 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:
•
•
•
Jessie Muir Quintero, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-7476, email:
In December 2014, Zion
The proposed action is the NRC's review and approval of the ZNPS LTP. In its license amendment request, ZS requested amendment of the ZNPS licenses to add license conditions (1) reflecting the NRC staff's approval of the LTP and (2) providing criteria for when NRC approval is needed for LTP changes. If the NRC approves the LTP, the approval will be issued in the form of an amendment to the ZNPS licenses to add the requested license conditions.
The LTP describes the process the licensee will use to meet the requirements for terminating the operating licenses and to release the site for unrestricted use. The LTP outlines the remaining decommissioning and dismantling activities.
The purpose of and need for the proposed action is to allow for the completion of decommissioning of the ZNPS site by the licensee, the termination of the ZNPS license operating licenses by the NRC, and the subsequent release of the ZNPS site for unrestricted use. The NRC will terminate the licenses if it determines that the site meets the performance-based criteria for unrestricted site release, in accordance with 10 CFR 20.1402, and that the facility has been dismantled in accordance with the LTP.
The NRC assessed the environmental impacts of the license termination activities and remaining decommissioning activities and determined there would be no significant impact to the quality of the human environment.
During its review of the ZNPS LTP, the NRC concluded the impacts for most resource areas—land use, water resources, air quality, ecology, socioeconomics, historic and cultural resources, aesthetics, noise, and transportation—were still bounded by the previously issued Decommissioning Generic Environmental Impact Statement (GEIS). Therefore, the NRC does not expect impacts beyond those discussed in the GEIS, which concluded that the impact level for these issues was SMALL.
In the EA, the NRC evaluated the potential site-specific environmental impacts of the remaining decommissioning and license termination activities on climate change, public and occupational health, environmental justice, and waste management and did not identify any significant impacts. For protected species, the NRC determined that the proposed action may affect but not likely to adversely affect the rufa red knot (
As an alternative to the proposed action, the NRC staff considered denial of the proposed action (
On April 2, 2018, the NRC staff sent a copy of the draft EA to the Illinois Emergency Management Agency (IEMA) for review and comment. The IEMA responded on May 03, 2018, with several comments on the draft EA that were addressed in the final EA.
The NRC consulted with the U.S. Fish and Wildlife Service (FWS) on listed protected species at the ZNPS site. On April 5, 2018, the NRC requested FWS review and concurrence with the NRC's determination that the proposed action may affect, but is not likely to adversely affect three federally listed species. FWS concurred with the NRC's determination on May 31, 2018. In its letter, the FWS determined that the analysis of the piping plover in the EA was sufficient to conclude that the proposed action would not adversely modify the designated critical habitat for the piping plover. The NRC revised the EA to state that the designated critical habitat for the plover was present within the action area and that there would not be adverse modifications of designated critical habitat for the piping plover.
Based on its review of the proposed action, and in accordance with the requirements in 10 CFR part 51, the NRC staff has determined that pursuant to 10 CFR 51.31, preparation of an EIS is not required for the proposed action and, pursuant to 10 CFR 51.32, a FONSI is appropriate.
On the basis of the final EA, the NRC concludes that the proposed action will not have a significant effect on the quality of the human environment. Accordingly, the NRC has determined not to prepare an EIS for the proposed action.
The documents identified in the following table are available to interested persons through one or more of the following methods, as indicated.
For the Nuclear Regulatory Commission.
On December 18, 2017, The Depository Trust Company (“DTC”), Fixed Income Clearing Corporation (“FICC”), and National Securities Clearing Corporation (“NSCC”) (collectively, “Clearing Agencies”), each filed with the Securities and Exchange Commission (“Commission”) a proposed rule change to adopt a recovery and wind-down plan and related rules (SR-DTC-2017-021, SR-FICC-2017-021, and SR-NSCC-2017-017), respectively (“Proposed Rule Changes”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
Section 19(b)(2) of the Act
The Commission is extending the period for Commission action on the Proposed Rule Changes. The Commission finds that it is appropriate to designate a longer period within which to take action on the Proposed Rule Changes so that the Commission has sufficient time to consider the issues raised by the Proposed Rule Changes and to take action on the Proposed Rule Changes. The proposal shall not take effect until all regulatory actions required with respect to the proposal are completed.
Accordingly, pursuant to Section 19(b)(2)(B)(ii)(II) of the Act
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to the provisions of Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange is filing a proposal to amend Rule 510, Interpretations and Policies .01 to extend the pilot program for the quoting and trading of certain options in pennies.
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange is a participant in an industry-wide pilot program that provides for the quoting and trading of certain option classes in penny increments (the “Penny Pilot Program” or “Program”). The Penny Pilot Program allows the quoting and trading of certain option classes in minimum increments of $0.01 for all series in such option classes with a price of less than $3.00; and in minimum increments of $0.05 for all series in such option classes with a price of $3.00 or higher. Options overlying the PowerShares QQQ
In addition to the extension of the Penny Pilot Program through December 31, 2018, the Exchange proposes to extend one other date in the Rule. Currently, Interpretations and Policies .01 states that the Exchange will replace any Penny Pilot issues that have been delisted with the next most actively traded multiply listed option classes that are not yet included in the Penny Pilot Program, and that the replacement issues will be selected based on trading activity in the previous six months. Such option classes will be added to the Penny Pilot Program on the second trading day following January 1, 2018.
The purpose of this provision is to reflect the new date on which replacement issues may be added to the Penny Pilot Program.
The Exchange believes that its proposed rule change is consistent with Section 6(b) of the Act
In particular, the proposed rule change, which extends the Penny Pilot Program for six months, allows the Exchange to continue to participate in a program that has been viewed as beneficial to traders, investors and public customers and viewed as successful by the other options exchanges participating in it.
MIAX Options does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. Specifically, the Exchange believes that, by extending the expiration of the Pilot Program, the proposed rule change will allow for further analysis of the Penny Pilot Program and a determination of how the Program should be structured in the future. In doing so, the proposed rule change will also serve to promote regulatory clarity and consistency, thereby reducing burdens on the marketplace, facilitating investor protection, and fostering a competitive environment. In addition, consistent with previous practices, the Exchange believes the other options exchanges
Written comments were neither solicited nor received.
The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act
A proposed rule change filed under Rule 19b-4(f)(6)
At any time within 60 days of the filing of such proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings under Section 19(b)(2)(B)
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
All submissions should refer to File Number SR-MIAX-2018-12 and should be submitted on or before July 20, 2018. For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange proposes to amend Rule 6.2., Hybrid Opening (and Sometimes Closing) System (“HOSS”).
(a)-(b) (No change).
(c) Opening Rotation Period. After the System initiates the opening rotation procedure and sends the Rotation Notice, the System begins the opening rotation period. During the opening rotation period for a series:
(i)-(ii) (No change).
(iii) After a period of time determined by the Exchange for all classes
(A)
(B)
(C)
Subject to paragraph (d) below, the opening rotation period (including these intervals) may not exceed [60]
(d)-(h) (No change).
. . .
.01-.07 (No change).
The text of the proposed rule change is also available on the Exchange's website (
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The proposed rule change amends the order in which the System opens series for trading. Current Rule 6.2(c)(iii) states, after a period of time after the initiation of the opening rotation (which time is determined by the Exchange for all classes, and may be no longer than five seconds),
Pursuant to the proposed rule change, during an initial interval (the Exchange determines the length of this interval for all classes, which may be no longer than three seconds),
• ATM puts and a group of OTM puts with strike prices closest to the ATM strike price, in a random order;
• ATM calls and a group of OTM calls with strike prices closest to the ATM strike price, in a random order; and
• alternating groups of further OTM puts and further OTM calls, each in a random order.
After the first interval, the System opens all other series, and any OTM and ATM series with expirations of 29 to 31 days that did not open during the first interval, in a random order, staggered over regular intervals of time (the Exchange determines the length and number of these intervals for all classes, the length of which may be no longer than two seconds).
For purposes of this proposed rule change, a put (call) is ATM if its strike price equals or is the first strike above (below) the last disseminated transaction price in the underlying security or index value on the same trading day. If the System begins an opening rotation for a class prior to receiving a disseminated transaction price in the underlying security or index value, the System will open all series in the class pursuant to proposed subparagraph (B) (
Below are examples demonstrating the new opening sequence. For purposes of these examples, assume the ATM strike price is 50. Additionally, assume June expiration series are 30 days away and all other series are more than 31 days away. There will be a one second opening timer delay, an initial
After the one-second delay, the 500-millisecond interval starts. During that interval, the System opens in a random order the Jun ABC 50, 49, 48, 47, and 46 puts. The System then opens in a random order the Jun ABC 50, 51, 52, and 53 calls. Then, the System opens in a random order the Jun ABC 45, 44, 43, and 42 puts. Then, the System opens in a random order the Jun ABC 54, 55, and 56 calls. Next, the System opens in a random order the Jun ABC 41, 40, 39, and 38 puts. The System then opens in a random order the Jun ABC 57, 58, and 59 calls. After 500 milliseconds, the System opens in a random order over 10 100-millisecond intervals the remaining Jun puts and calls and all Jul and Aug puts and calls.
After the one-second delay, the 500-millisecond interval starts. During that interval, the System opens in a random order the Jun ABC 50, 49, 48, 47, and 46 puts. The System then opens in a random order the Jun ABC 50, 51, 52, and 53 calls. Then, the System opens in a random order the Jun ABC 45, 44, and 43, and attempts to but cannot open the Jun ABC 42 put. Then, the System opens in a random order the Jun ABC 54, 55, and 56 calls. Next, the System opens in a random order the Jun ABC 41, 40, 39, and 38 puts. The System then opens in a random order the Jun ABC 57, 58, and 59 calls. The System then opens the Jun ABC 42 put, which did not open on its first attempt. After 500 milliseconds, the System opens in a random order over 10 100-millisecond intervals the remaining Jun puts and calls and all Jul and Aug puts and calls.
After the one-second delay, the 500-millisecond interval starts. During that interval, the System opens in a random order the Jun ABC 50, 49, 48, 47, and 46 puts. The System then opens in a random order the Jun ABC 50, 51, 52, and 53 calls. Then, the System opens in a random order the Jun ABC 45, 44, and 43, and attempts to but cannot open the Jun ABC 42 put. Then, the System opens in a random order the Jun ABC 54, 55, and 56 calls. Next, the System opens in a random order the Jun ABC 41, 40, 39, and 38 puts. The System then opens in a random order the Jun ABC 57 and 58 calls, and attempts to but cannot open the Jun ABC 59 call. During the initial 500 milliseconds, the System continues to attempt to but cannot open the Jun ABC 59 call. After 500 milliseconds, the System opens in a random order over 10 100-millisecond intervals the Jun ABC 59 call, the remaining Jun puts and calls, and all Jul and Aug puts and calls.
While the System will continue to open series in a random order, during an initial longer interval, the System will open specific groups of series within a random order. The order in which the System opens series for trading is generally immaterial; however, on expiration days for volatility index derivatives, ATM and OTM series with expirations of approximately one month are used to calculate the exercise settlement value of expiring volatility index derivatives as part of the modified opening procedure. The Exchange believes opening these series first will enhance liquidity in those series on expiration days for volatility index derivatives.
Specifically, Market-Makers are the primary liquidity providers in the Exchange's market. The Exchange provides Market-Makers with a tool, the Quote Risk Monitor (“QRM”) they use to control risk of multiple, automatic executions. A QRM event in a class will cause a Market-Maker's quotes in all series in the class to be cancelled (certain events may cause a Market-Maker's quotes in all classes to be cancelled).
The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
In particular, the proposed rule change merely modifies the order in which the System opens series for trading on the Exchange. The System will continue to open series in a random order; however, initially, it will open series within specific groups in a random order. The Exchange believes the System can open series pursuant to the proposed maximum interval times, as current interval times are under these maximums, and because they are consistent with the proposed maximum of 30 seconds for the entire opening process. These interval times ensure a fast opening of all series, which will benefit investors.
While the order in which the System opens series is generally immaterial (and thus why the Exchange has opened them in a random order), the Exchange believes opening ATM and OTM series with expirations of approximately one month will permit series used to calculate exercise settlement values for expiring volatility index derivatives to open as soon as possible. As discussed above, the Exchange believes this may enhance liquidity in these series on expiration days for volatility index derivatives, which benefits market participants. Additionally, reducing the potential time during which all series in all classes will open benefits all market participants, because market participants will be able to begin trading in all series sooner.
Cboe Options does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The proposed rule change only modifies the order in which the System will open series for trading. The System will open groups of ATM and OTM series with expirations of approximately one month first, but will continue to open series within those groups in a random order, and then open all in-the-money series in a random order (as is case today with respect to those series). Additionally, pursuant to the proposed rule change, the opening process must be within a shorter time period. The proposed maximum interval times are consistent with current and proposed interval times, and are consistent with the proposed maximum of 30 seconds for the entire opening process (which is shorter than the current maximum). The proposed rule change applies to all classes in the same manner, and only applies to the order in which the System will open series for trading on the Exchange. As discussed above, the Exchange believes this may enhance liquidity in these series on expiration days for volatility index derivatives, which benefits market participants. Additionally, reducing the potential time during which all series in all classes will open benefits all market participants, because market participants will be able to begin trading in all series sooner.
The Exchange neither solicited nor received comments on the proposed rule change.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A)(iii) of the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is: (i) Necessary or appropriate in the public interest; (ii) for the protection of investors; or (iii) otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On December 18, 2017, The Depository Trust Company (“DTC”), Fixed Income Clearing Corporation (“FICC”), and National Securities Clearing Corporation (“NSCC”) (collectively, “Clearing Agencies”), each filed with the Securities and Exchange Commission (“Commission”) a proposed rule change to amend the loss allocation rules and make other changes (SR-DTC-2017-022, SR-FICC-2017-022, and SR-NSCC-2017-018), respectively (“Proposed Rule Changes”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
Section 19(b)(2) of the Act
The Commission is extending the period for Commission action on the Proposed Rule Changes. The Commission finds that it is appropriate to designate a longer period within which to take action on the Proposed Rule Changes so that the Commission has sufficient time to consider the issues raised by the Proposed Rule Changes and to take action on the Proposed Rule Changes. The proposal shall not take effect until all regulatory actions required with respect to the proposal are completed.
Accordingly, pursuant to Section 19(b)(2)(B)(ii)(II) of the Act
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to the provisions of Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange is filing a proposal to amend Rule 510, Interpretations and Policies .01, to extend the pilot program for the quoting and trading of certain options in pennies.
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange is a participant in an industry-wide pilot program that provides for the quoting and trading of certain option classes in penny increments (the “Penny Pilot Program” or “Program”). The Penny Pilot Program allows the quoting and trading of certain option classes in minimum increments of $0.01 for all series in such option classes with a price of less than $3.00; and in minimum increments of $0.05 for all series in such option classes with a price of $3.00 or higher. Options overlying the PowerShares QQQ
In addition to the extension of the Penny Pilot Program through December 31, 2018, the Exchange proposes to extend one other date in the Rule. Currently, Interpretations and Policies .01 states that the Exchange will replace any Penny Pilot issues that have been delisted with the next most actively traded multiply listed option classes that are not yet included in the Penny Pilot Program, and that the replacement issues will be selected based on trading activity in the previous six months. Such option classes will be added to the Penny Pilot Program on the second trading day following January 1, 2018.
The purpose of this provision is to reflect the new date on which replacement issues may be added to the Penny Pilot Program.
The Exchange believes that its proposed rule change is consistent with Section 6(b) of the Act
In particular, the proposed rule change, which extends the Penny Pilot Program for six months, allows the Exchange to continue to participate in a program that has been viewed as beneficial to traders, investors and public customers and viewed as successful by the other options exchanges participating in it.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. Specifically, the Exchange believes that, by extending the expiration of the Pilot Program, the proposed rule change will allow for further analysis of the Penny Pilot Program and a determination of how the Program should be structured in the future. In doing so, the proposed rule change will also serve to promote regulatory clarity and consistency, thereby reducing burdens on the marketplace, facilitating investor
Written comments were neither solicited nor received.
The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act
A proposed rule change filed under Rule 19b-4(f)(6)
At any time within 60 days of the filing of such proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings under Section 19(b)(2)(B)
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for website viewing and printing in the Commission's Public Reference Room, 100 F Street NE, Washington, DC 20549, on official business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of the filing also will be available for inspection and copying at the principal office of the Exchange. 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-PEARL-2018-14 and should be submitted on or before July 20, 2018.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
The Exchange proposes to amend Commentary .02 to Rule 6.72-O in order to extend the Penny Pilot in options classes in certain issues (“Pilot Program”) previously approved by the Securities and Exchange Commission (“Commission”) through December 31, 2018. The Pilot Program is currently scheduled to expire on June 30, 2018. The proposed rule change is available on the Exchange's website at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Exchange hereby proposes to amend Commentary .02 to Rule 6.72-O to extend the time period of the Pilot Program,
This filing does not propose any substantive changes to the Pilot Program: All classes currently participating will remain the same and all minimum increments will remain unchanged. The Exchange believes the benefits to public customers and other market participants who will be able to express their true prices to buy and sell options have been demonstrated to outweigh the increase in quote traffic.
The proposed rule change is consistent with Section 6(b)
In particular, the proposed rule change, which extends the Penny Pilot Program for six months, allows the Exchange to continue to participate in a program that has been viewed as beneficial to traders, investors and public customers and viewed as successful by the other options exchanges participating in it. Accordingly, the Exchange believes that the proposal is consistent with the Act because it will allow the Exchange to extend the Pilot Program prior to its expiration on June 30, 2018. The Exchange notes that this proposal does not propose any new policies or provisions that are unique or unproven, but instead relates to the continuation of an existing program that operates on a pilot basis.
The Exchange believes that the Pilot Program promotes just and equitable principles of trade by enabling public customers and other market participants to express their true prices to buy and sell options to the benefit of all market participants.
The proposal to extend the Pilot Program is designed to promote just and equitable principles of trade, to foster cooperation and coordination with persons engaged in facilitating transactions in securities, and to remove impediments to and perfect the mechanisms of a free and open market and a national market system, by allowing the Exchange and the Commission additional time to analyze the impact of the Pilot Program while also allowing the Exchange to continue to compete for order flow with other exchanges in option issues trading as part of the Pilot Program.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. Specifically, the Exchange believes that, by extending the expiration of the Pilot Program, the proposed rule change will allow for further analysis of the Pilot Program and a determination of how this Program should be structured in the future. In doing so, the proposed rule change will also serve to promote regulatory clarity and consistency, thereby reducing burdens on the marketplace and facilitating investor protection. The Pilot Program is an industry-wide initiative supported by all other option exchanges. The Exchange believes that extending the Pilot Program will allow for continued competition between Exchange market participants trading similar products as their counterparts on other exchanges, while at the same time allowing the Exchange to continue to compete for order flow with other exchanges in option issues trading as part of the Pilot Program.
No written comments were solicited or received with respect to the proposed rule change.
The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act
A proposed rule change filed under Rule 19b-4(f)(6)
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange proposes to amend Rule 6.2., Hybrid Opening (and Sometimes Closing) System (“HOSS”).
(a)-(h) (No change).
. . . Interpretations and Policies:
.01
(a)
(i)-(ii) (No change).
Whether orders are strategy orders for purposes of this Rule 6.2.01 depends
(b)
The text of the proposed rule change is also available on the Exchange's website (
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
Cboe Options and Cboe Futures Exchange, LLC (“CFE”) list options and futures, respectively, on different volatility indexes that are calculated using prices of options traded on Cboe Options.
The volatility index settlement process is patterned after the process used to settle SPX options. On the days SPX options expire, S&P calculates an SOQ of the S&P 500 Index using the opening prices of the component stocks in their primary markets. Market participants can replicate the exposure of their expiring SPX options by entering orders to buy and sell the component stocks of the S&P 500 Index at their opening prices. If they are successful, market participants can effectively construct a portfolio that matches the value of the SOQ. At this point, the derivatives and cash markets converge.
In a very similar way, the exercise settlement value for volatility index derivatives is an SOQ of the volatility index using opening prices of the constituent options used to determine the value of the index. With respect to VIX, the VIX exercise settlement value is calculated using the opening prices of SPX options that expire approximately 30 days later. Analogous to the settlement process for SPX options, market participants can replicate the exposure of their expiring VIX derivatives by entering buy and sell orders in constituent SPX options. If they are successful, market participants can effectively construct a portfolio of SPX options whose value matches the value of the VIX SOQ. By doing so, market participants may make or take delivery of the SPX options that will be used to settle VIX derivatives.
A tradable settlement creates the opportunity to convert the exposure of an expiring VIX derivative into the portfolio of SPX options that will be used to settle the expiring contract. Specifically, some market participants
Since the VIX settlement value converges with the value of the portfolio of SPX options used to calculate the settlement value of VIX derivatives, trading this SPX option portfolio mitigates settlement risk. This is because, if done properly, the vega exposure obtained in the SPX option portfolio will replicate the vega exposure of the expiring VIX derivative (
To replicate expiring volatility index derivatives on their expiration dates with portfolios of constituent options, market participants generally submit strategy orders to participate in the modified HOSS procedure on volatility index settlement dates. The Exchange understands that the entry of strategy orders may lead to order imbalances in the option series being used to determine the final settlement value. To the extent (1) market participants seeking to replicate an expiring VIX derivative position are on one side of the market (
To provide market participants with time to enter additional orders and quotes to offset any such imbalances prior to the opening of these series, the Exchange established a strategy order cut-off time.
In the options market, it is important for Market-Makers to provide liquidity to execute against orders submitted by other market participants. Pursuant to Rule 8.7, a Market-Maker has general obligations to, among other things, engage (to a reasonable degree under existing circumstances) in dealings for the Market-Maker's own account when there exists, or it is reasonably anticipated that there will exist, a lack of price continuity, a temporary disparity between the supply of and demand for an option (
The Exchange understands that some Market-Makers may hesitate to provide liquidity that could resolve order imbalances, out of a concern that adding such liquidity after the strategy order cut-off time could be deemed either a new strategy order or a modification to or cancellation of an existing strategy order. As a result, this perceived risk may lead to reduced liquidity and may exacerbate the time it takes to open a series at a competitive price.
Specifically, proposed Rule 6.2, Interpretation and Policy .01(c) states a Market-Maker with an appointment in a class with constituent option series may submit bids and offers in those series for bona fide market-making purposes in accordance with Rule 8.7 and the Securities Exchange Act of 1934 (the “Act”), for its market-maker account prior to the open of trading for participation in the modified opening
(i) The Trading Permit Holder with which the Market-Maker is affiliated has established, maintains, and enforces reasonably designed written policies and procedures (including information barriers, if applicable), taking into consideration the nature of the business of the Trading Permit Holder and other facts and circumstances, to prevent the misuse of material nonpublic information (including the submission of strategy orders); and
(ii) when submitting these bids and offers, the Market-Maker has no actual knowledge of any previously submitted strategy orders.
In other words, if a Market-Maker submits bids or offers in constituent options on a volatility index derivative settlement day, and if such bids and offers are for its market-maker account and submitted for purposes of its market-making activities on the Exchange (including in accordance with Market-Maker obligations, such as to offset imbalances or provide competitive pricing), the Market-Maker may submit those bids and offers any time prior to the open of trading, including both before and after the strategy order cut-off time. As long as the Trading Permit Holder has appropriate procedures in place both to prevent the Market-Maker from knowing about the submission of strategy orders by other persons within the Trading Permit Holder organization with which it is affiliated, and to prevent other persons from knowing about the Market-Maker's submission of bids and offers, the Exchange will not review such bids and offers for either potential impermissible entry of strategy orders, or cancellations of or modifications to previously submitted strategy orders.
Bona fide Market-Maker activity is generally activity consistent with Market-Maker requirements under the Act and Cboe Options Rules:
• Pursuant to the Act, a market-maker is a specialist permitted to act as a dealer, any dealer acting in the capacity of block positioner, and any dealer who, with respect to a security, holds himself out (by entering quotations in an inter-dealer communications system or otherwise) as being willing to buy and sell such security for his own account on a regular or continuous basis.
• Pursuant to Rule 8.7, a Market-Maker appointed to a class must, among other things, engage to a reasonable degree under existing circumstances in dealings for the Market-Maker's own account when there exists, or it is reasonably anticipated that there will exist, a lack of price continuity, a temporary disparity between the supply of and demand for an option (
• In addition to these obligations, Market-Makers also effect transactions for the purpose of hedging, reducing risk of, rebalancing, or liquidating their open positions.
As noted above, the Exchange implemented the strategy order cut-off time for the operational purpose of providing market participants with time to enter additional orders and quotes to offset any such imbalances prior to the opening of these series.
The Exchange believes Market-Makers are more likely to interact with and resolve order imbalances on volatility index settlement days if they can be confident that their bids and offers submitted for that purpose will not be deemed strategy orders or cancellations of or modifications to previously submitted strategy orders. As discussed above, the purpose of the strategy order cut-off time is to provide market participants, including Market-Makers, with sufficient time to address imbalances created by strategy orders. Additionally, as discussed above, pursuant to Rule 6.2(d), whether a series opens depends on the presence of Market-Maker quotes at prices no wider than an acceptable price range. Market-Makers are an important source of liquidity on the Exchange, and also have various obligations with which they must comply. The proposed rule change will provide a Market-Maker with an opportunity to provide liquidity on volatility settlement dates and to satisfy their Market-Maker obligations, without concern that the Exchange may consider such activity to constitute the placing of, or cancellations to or modifications of, strategy orders, even if the Trading Permit Holder organization with which the Market-Maker is affiliated submitted a strategy order.
The purpose of this proposed change is to accommodate the fact that the Trading Permit Holder with which the Market-Maker is affiliated may submit a strategy order while the Market-Maker may also be submitting bids and offers to accommodate a fair and orderly opening process, by among other things, resolving market order imbalances and submitting competitively priced bids and offers.
For example, a Trading Permit Holder organization may have an SPX Market-Maker and a separate volatility trading desk. During the modified opening procedure on a volatility settlement day, the trading strategy of the SPX Market-Maker is to provide markets in SPX options (both before and after the strategy order cut-off time), and the trading strategy of the volatility trading desk may be to replicate Vega exposure by replacing its expiring VIX options positions with positions in the SPX
The Exchange does not believe it is necessary to restrict the bona fide market-making activities of a Market-Maker within its appointed classes due to other unrelated trading activities that may involve submissions of orders deemed to be strategy orders of which the Market-Maker has no actual knowledge. The proposed rule change expressly provides that activity related to a Market-Maker's market-making activity in an appointed class will not constitute the submission of a strategy order or the cancellation of or modification to a previously submitted strategy order.
The proposed rule change makes clear that a Market-Maker's submission of bids and offers for bona fide market-making purposes in constituent series is permitted on volatility settlement days through the open of trading in the same manner as it is permitted in all in series in its appointed classes at all other times. This will encourage Market-Makers to continue to submit bids and offers through the open, despite other trading activity within the Trading Permit Holder organization. This will also ensure Market-Makers can respond to imbalances and update their quotes
The proposed rule change would not eliminate a Market-Maker's requirements to abide by Exchange Rules 4.1 (Just and Equitable Principles of Trade), 4.7 (Manipulation), and 4.18 (Prevention of the Misuse of Material, Nonpublic Information). The requirement in the proposed rule change that the Trading Permit Holder with which a Market-Maker is affiliated must establish, maintain, and enforce policies and procedures reasonably designed to ensure the Market-Maker will not have knowledge of the submission of strategy orders is consistent with requirements of Rule 4.18. The Exchange will continue to conduct surveillance to monitor trading in the option series used to calculate volatility index settlement values on expiration dates, including but not limited to, monitoring entry of strategy orders, or modifications to strategy orders, following the cut-off time, as well as compliance with other Rules.
The proposed rule change also makes nonsubstantive changes to add paragraph headings and numbering.
Additionally, the proposed rule change modifies Interpretation and Policy .01(a) to state that “strategy orders” means all orders for participation in the modified opening procedure that are related to positions in, or a trading strategy involving, expiring volatility index options or (security) futures. The addition of the word “expiring” is a codification of the Exchange's longstanding interpretation of the term strategy order. As discussed above, to replicate expiring volatility index derivatives on their expiration dates with options portfolios, market participants generally submit strategy orders to participate in the modified HOSS opening process on volatility index settlement dates. The addition of the word “expiring” is consistent with the introductory paragraph in Interpretation and Policy .01, which states the modified HOSS procedure applies to series used to calculate the exercise/final settlement value of the volatility index for expiring options and (security) futures, and demonstrates the rule is meant to refer to orders that relate to strategies involving expiring volatility index derivatives. Therefore, the proposed codification is consistent with this general practice, as well as the current rule.
The Exchange believes the proposed rule change is consistent with the Act and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
In particular, the Exchange believes the proposed change will increase liquidity on volatility index settlement dates, as it will remove an impediment that may discourage Market-Makers from submitting bids and offers to offset imbalances and update the prices of their quotes in response to changing market conditions prior to the open. The Exchange believes this additional liquidity may contribute to a fair and orderly opening by increasing execution opportunities, reducing imbalances in constituent options, and increasing the presence of quotes within the acceptable price range, which would benefit all market participants who trade in the volatility index derivatives and the constituent options. The Exchange does not believe it is necessary to restrict the bona fide market-maker activities of a Market-Maker due to other unrelated trading activities by the Trading Permit Holder organization with which it is affiliated. The Exchange notes that the proposed rule change would not impact a Market-Maker's requirements to abide by Exchange Rules 4.1 (Just and Equitable Principles of Trade), 4.7 (Manipulation), and 4.18 (Prevention of the Misuse of Material, Nonpublic Information). The requirement in the proposed rule change that the Trading Permit Holder with which a Market-Maker is affiliated must establish, maintain, and enforce policies and procedures reasonably designed to ensure the Market-Maker will not have knowledge of the submission of strategy orders is consistent with requirements
The Exchange believes the proposed rule change will contribute to price transparency and liquidity in the option series at the open, and thus a fair and orderly opening on volatility index settlement days. A fair and orderly opening in these series benefits all market participants who trade in the volatility index derivatives and the constituent options.
The proposed rule change to add the term “expiring” to the definition of strategy orders is merely a codification of a current Exchange interpretation and is consistent with the definition of constituent options in the current rule.
Cboe Options does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. Because of the importance of Market-Maker liquidity in the options market and the Exchange's need for competitive quotes to open a series, the Exchange believes it is appropriate for Market-Makers' bids and offers prior to the opening of trading, including after the strategy order cut-off time, not be considered strategy orders, or cancellations to or modifications of previously submitted strategy orders. As discussed above, Market-Makers are subject to various obligations under the Rules, and the proposed rule change provides them with the ability to satisfy these obligations without the risk of their market-making activity being deemed to constitute strategy orders or modifications to or cancellations of strategy orders. The requirement in the proposed rule change that the Trading Permit Holder with which a Market-Maker is affiliated must establish, maintain, and enforce policies and procedures reasonably designed to ensure the Market-Maker will not have knowledge of the submission of strategy orders is consistent with requirements of Rule 4.18. As a result, the Exchange does not believe the proposed rule change will be burdensome on Market-Makers. The Exchange does not believe it is necessary to restrict the bona fide market-maker activities of a Trading Permit Holder organization due to its other unrelated trading activities. The proposed rule change has no impact on intermarket competition, as it applies to orders and quotes submitted to an SOQ process the Exchange conducts prior to the open of trading in certain classes.
Cboe Options believes that the proposed rule change will relieve any burden on, or otherwise promote, competition. The Exchange believes the proposed rule change will contribute to price transparency and liquidity in constituent options at the open on volatility index settlement days, and thus to a fair and orderly opening on those days. A fair and orderly opening, and increased liquidity, in these series benefits all market participants who trade in the volatility index derivatives and the constituent options.
The proposed rule change to add the term “expiring” to the definition of strategy orders has no impact on competition, as it is merely a codification of a current Exchange interpretation and is consistent with the definition of constituent options in the current rule.
The Exchange neither solicited nor received comments on the proposed rule change.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A)(iii) of the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is: (i) Necessary or appropriate in the public interest; (ii) for the protection of investors; or (iii) otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to relocate the Exchange's rules pertaining to co-location and direct connectivity, which are presently at Section VI, subsections A (co-location) and B-D (direct connectivity) of the Exchange's Schedule of Fees, to the Exchange's new rulebook shell, entitled “General Rules,” at new General 8 (“Connectivity”), Sections 1 and 2, respectively.
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to relocate its rules governing co-location and direct connectivity services, which presently comprise Section VI, subsections A (co-location) and B-D (direct connectivity) of the Exchange's Schedule of Fees. The Exchange proposes to establish, within its new rulebook shell,
The Exchange considers it appropriate to relocate these Rules to better organize its Rulebook. The other Affiliated Exchanges intend to propose similar reorganizations of their co-location and direct connectivity rules so that these rules will be harmonized among all of the Affiliated Exchanges.
The relocation of the co-location and direct connectivity rules is part of the Exchange's continued effort to promote efficiency and conformity of its processes with those of its Affiliated Exchanges. The Exchange believes that moving the co-location and direct connectivity rules to their new location will facilitate the use of the Rulebook by Members of the Exchange who are members of other Affiliated Exchanges. Moreover, the proposed changes are of a non-substantive nature and will not amend the relocated rules other than to update their numbers and make conforming cross-reference changes.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Exchange does not believe that the proposed rule change will impose any burden on intermarket or intra-market competition that is not necessary or appropriate in furtherance of the purposes of the Act. The proposed changes do not impose a burden on competition because, as previously stated, they (i) are of a non-substantive nature, (ii) are intended to harmonize the Exchange's rules with those of its Affiliated Exchanges, and (iii) are intended to organize the Rulebook in a way that it will ease the Members' navigation and reading of the rules across the Affiliated Exchanges.
No written comments were either solicited or received.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act
A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule change should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
The principal purpose of the proposed changes is to make changes to the ICC Clearing Rules (the “ICC Rules”) to more clearly characterize Mark-to-Market Margin payments as settled-to-market rather than collateralized-to-market.
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 revisions to Chapters 4, 8, and 20 of the ICC Rules to more clearly characterize Mark-to-Market Margin payments as settlement payments (“settled-to-market”) rather
ICC previously revised the Rules in 2015 to clarify that Mark-to-Market Margin constituted a settlement payment. Such revisions did not result in a change in the manner in which Mark-to-Market Margin was calculated, paid or collected, and were intended to provide further clarity regarding the finality of ICC's settlement cycle.
ICC proposes revising Rule 401 to reference Mark-to-Market Margin Balance, a new term that is defined in Rule 404 and refers to the aggregate amount of Mark-to-Market Margin paid or received. The term is used in several calculations, avoids the need to repeat the definition, and allows ICC to more clearly and fully describe specifics pertaining to its Mark-to-Market Margin calculation in a single section without combining it with other concepts. ICC proposes adding language to Rule 401(a), which governs House Margin, to state that ICC calculates a net amount of Mark-to-Market Margin by subtracting a CP's Mark-to-Market Margin Balance from a CP's Mark-to-Market Margin Requirement. ICC proposes corresponding changes referencing Mark-to-Market Margin Balance in Rule 401(b)(ii), which covers Client-Related Mark-to-Market Margin. Such changes are not intended to modify the current calculation of Mark-to-Market Margin, or other operational practices, but, instead, replace certain specifics relating to ICC's Mark-to-Market Margin calculation with the defined term. The amendments do not change the manner in which Initial Margin is calculated, posted and held.
Further, ICC proposes to specify that a CP's Mark-to-Market Margin Balance is adjusted by an amount called the price alignment amount in revised Rule 401(g). Specifically, ICC proposes to state that it will pay or charge a CP price alignment amounts on any Mark-to-Market Margin and interest on any cash Initial Margin at a rate that may be negative. A price alignment amount is economically equivalent to the “interest” that ICC pays or charges a CP for any net Mark-to-Market Margin transferred between the parties under current Rule 401(g). However, since the term interest may be more typically associated with collateral, ICC proposes to refer to such an amount as price alignment to avoid confusion over the proper characterization of Mark-to-Market Margin as settlement payments.
ICC proposes to specifically reference the applicable category of margin to avoid confusion over the proper characterization of Mark-to-Market Margin under the ICC Rules. ICC proposes to update Rule 401(h) to refer to substitutions of Initial Margin, and Rule 401(l) to refer to settlement finality in relation to Mark-to-Market Margin. The proposed changes to Rule 402, which governs ICC's rights with respect to the use of margin, exclude Mark-to-Market Margin from subsections (a) and (b), remove details relating to Mark-to-Market Margin from subsection (b), and specify subsection (c)'s applicability to Initial Margin. ICC proposes adding language to Rule 402(e) to more clearly state that Mark-to-Market Margin payments constitute a settlement. Further, ICC proposes adding new subsection (c) to Rule 404 to define Mark-to-Market Margin Balance as a sum equal to the Mark-to-Market Margin value transferred by the CP to ICC minus the Mark-to-Market Margin value transferred by ICC to the CP. To avoid uncertainty, ICC also proposes to specifically reference the applicable category of margin in Rule 406(c). Namely, ICC proposes to clarify that the requirements set forth in Rule 406(c) regarding Client-Related Positions apply to Initial Margin.
ICC proposes clarifications and conforming changes to Chapters 8 and 20 of the ICC Rules. ICC proposes clarifying language in Rule 801(a)(i) to refer to the transfer of Mark-to-Market Margin to avoid confusion over the proper characterization of Mark-to-Market Margin as settlement payments, since ICC considers the loss after the application of Initial Margin and taking into account settlement of Mark-to-Market Margin to be uncollateralized loss. Under the proposed updates, Rule 808 includes a conforming reference to Mark-to-Market Margin Balance. The proposed changes to Rule 810(e) replace terminology that is commonly used in conjunction with collateral to avoid confusion over the proper characterization of Mark-to-Market Margin as settlement payments. ICC proposes to clarify in Rule 20-605(c)(i)(B), which specifies the resources to be used to cover losses with respect to Client-Related Positions, that ICC will use the defaulting CP's Client-Related Mark-to-Market Margin, to the extent not previously applied to pay Mark-to-Market Margin to other CPs.
Section 17A(b)(3)(F) of the Act
ICC does not believe the proposed rule changes would have any impact, or impose any burden, on competition. The changes, which further clarify that payments of Mark-to-Market Margin represent settlement rather than collateral payments, result in no operational changes and apply uniformly across all market participants. Therefore, ICC 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 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 relocate the Exchange's rules pertaining to co-location and direct connectivity, which are presently at Section IV, subsections D (co-location) and E-G (direct connectivity) of the Exchange's Schedule of Fees, to the Exchange's new rulebook shell, entitled “General Rules,” at new General 8 (“Connectivity”), Sections 1 and 2, respectively.
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to relocate its rules governing co-location and direct connectivity services, which presently comprise Section IV, subsections D (co-location) and E-G (direct connectivity) of the Exchange's Schedule of Fees. The Exchange proposes to establish, within its new rulebook shell,
The Exchange considers it appropriate to relocate these Rules to better organize its Rulebook. The other Affiliated Exchanges intend to propose similar reorganizations of their co-location and direct connectivity rules so that these rules will be harmonized among all of the Affiliated Exchanges.
The relocation of the co-location and direct connectivity rules is part of the Exchange's continued effort to promote efficiency and conformity of its processes with those of its Affiliated Exchanges. The Exchange believes that moving the co-location and direct connectivity rules to their new location will facilitate the use of the Rulebook by Members of the Exchange who are members of other Affiliated Exchanges. Moreover, the proposed changes are of a non-substantive nature and will not amend the relocated rules other than to update their numbers and make conforming cross-reference changes.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Exchange does not believe that the proposed rule change will impose any burden on intermarket or intra-market competition that is not necessary or appropriate in furtherance of the purposes of the Act. The proposed changes do not impose a burden on competition because, as previously stated, they (i) are of a non-substantive nature, (ii) are intended to harmonize the Exchange's rules with those of its Affiliated Exchanges, and (iii) are intended to organize the Rulebook in a way that it will ease the Members' navigation and reading of the rules across the Affiliated Exchanges.
No written comments were either solicited or received.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act
A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The proposed rule change
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 consists of proposed modifications to the OA to provide enhanced transparency within the DTC Procedures relating to DTC's requirements for Units to be processed through IVORS, as discussed below.
A unit investment trust is an investment company that buys and holds a generally fixed portfolio of stocks, bonds or other securities for a fixed period of time. Units are sold by a sponsor, which is the issuer of the Units, to investors who receive a share of principal and dividends, or interest. When Units mature, an investor may redeem matured Units with the transfer agent for the Units, or sell Units to the sponsor for a cash payment (such redemptions and sales jointly referred to herein as “Redemptions”).
Units that meet DTC's eligibility requirements
In this regard, and as approved in the 1998 Release, in order to be eligible for processing through IVORS, (i) Units must be DTC-eligible and held in DTC's FAST program,
As indicated above, the OA currently states the requirement that IVORS must be used for the processing of Redemptions and Rollovers for Units held at DTC. The applicable OA text does not include references to requirements relating to IVORS processing that were approved in the 1998 and 2004 Releases, in particular: (i) The use of Standing Instructions by a sponsor and/or FAST Agent
In addition, currently existing text in the OA relating to the processing of Units uses the term “UIT” interchangeably to describe both a unit investment trust and Units. In order to further enhance the transparency of the text of the Subject Section, as defined below, to more clearly distinguish between unit investment trusts and the securities issued by them, DTC would revise the applicable OA text to define Securities issued by unit investment trusts as “Units.” The text would continue to refer to unit investment trusts as UITs.
Pursuant to the proposed rule change, DTC would amend the OA to revise Section VI.C.1.a. (Use of DTC's Investor's Voluntary Redemptions and Sales to sponsor) (“Subject Section”), relating to Redemption and Rollover processing through IVORS, to add text stating (i) the IVORS Eligibility Requirements and (ii) a provision relating to the processing of Redemptions and Rollovers in accordance with Standing Instructions provided by the sponsor or FAST Agent for the Units, as described above. Specifically, the proposed rule change would add the following within the existing text of that section as it relates to the description of Redemption and Rollover activities:
“IVORS will only be available for these activities if (1) the subject Unit is DTC-eligible, (2) the subject Unit is held through the FAST program, (3) the FAST Agent for the Unit is a Participant of DTC, and (4) the Unit's lead sponsor or its clearing agent is a Participant. Redemptions and rollovers are processed in accordance with standing instructions provided by the FAST Agent and/or sponsor of the Unit through PTS.”
In addition, DTC would revise the text of the Subject Section to define Securities issued by unit investment trusts (
The proposed rule change would become effective upon filing with the Commission.
Section 17A(b)(3)(F) of the Securities Exchange Act of 1934 (“Act”)
DTC does not believe that the proposed rule change would have any impact on competition. The proposed rule change would merely provide enhanced transparency with respect to existing Procedures relating to the processing of Redemptions and Rollovers through IVORS by adding text to the OA that is consistent with requirements previously approved by the Commission.
Written comments relating to this proposed rule change have not been solicited or received. DTC will notify the Commission of any written comments received by DTC.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
The Exchange proposes to amend Commentary .02 to Rule 960NY in order to extend the Penny Pilot in options classes in certain issues (“Pilot Program”) previously approved by the Securities and Exchange Commission (“Commission”) through December 31, 2018. The Pilot Program is currently scheduled to expire on June 30, 2018. The proposed rule change is available on the Exchange's website at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Exchange hereby proposes to amend Commentary .02 to Rule 960NY to extend the time period of the Pilot Program,
This filing does not propose any substantive changes to the Pilot Program: All classes currently participating will remain the same and all minimum increments will remain unchanged. The Exchange believes the benefits to public customers and other market participants who will be able to express their true prices to buy and sell options have been demonstrated to outweigh the increase in quote traffic.
The proposed rule change is consistent with Section 6(b)
In particular, the proposed rule change, which extends the Penny Pilot Program for six months, allows the Exchange to continue to participate in a program that has been viewed as beneficial to traders, investors and public customers and viewed as successful by the other options exchanges participating in it. Accordingly, the Exchange believes that the proposal is consistent with the Act because it will allow the Exchange to extend the Pilot Program prior to its expiration on June 30, 2018. The Exchange notes that this proposal does not propose any new policies or provisions that are unique or unproven, but instead relates to the continuation of an existing program that operates on a pilot basis.
The Exchange believes that the Pilot Program promotes just and equitable principles of trade by enabling public customers and other market participants to express their true prices to buy and sell options to the benefit of all market participants.
The proposal to extend the Pilot Program is designed to promote just and equitable principles of trade, to foster cooperation and coordination with persons engaged in facilitating transactions in securities, and to remove impediments to and perfect the mechanisms of a free and open market and a national market system, by allowing the Exchange and the Commission additional time to analyze the impact of the Pilot Program while also allowing the Exchange to continue to compete for order flow with other exchanges in option issues trading as part of the Pilot Program.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. Specifically, the Exchange believes that, by extending the expiration of the Pilot Program, the proposed rule change will allow for further analysis of the Pilot Program and a determination of how this Program should be structured in the future. In doing so, the proposed rule change will also serve to promote regulatory clarity and consistency, thereby reducing burdens on the marketplace and facilitating investor protection. The Pilot Program is an industry-wide initiative supported by all other option exchanges. The Exchange believes that extending the Pilot Program will allow for continued competition between Exchange market participants trading similar products as their counterparts on other exchanges, while at the same time allowing the Exchange to continue to compete for order flow with other exchanges in option issues trading as part of the Pilot Program.
No written comments were solicited or received with respect to the proposed rule change.
The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act
A proposed rule change filed under Rule 19b-4(f)(6)
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.
60-Day notice and request for comments.
The Paperwork Reduction Act (PRA) requires federal agencies to publish a notice in the
Submit comments on or before August 28, 2018.
Send all comments to Adrienne Grierson, Deputy Director, Office of Credit Risk Management, Small Business Administration, at
Adrienne Grierson, Deputy Director, Office of Credit Risk Management at
SBA's Office of Credit Risk Management (OCRM) is responsible for the oversight and supervision of the SBA operations of approximately 4000 7(a) Lenders, Certified Development Companies (“CDCs”), and Microloan Intermediaries (“Intermediaries”), that participate in SBA's business loan programs and, for enforcement of the applicable rules and regulations. Currently, the agency guarantees more than $90 billion dollars in small business loans through these programs. The information collection described in detail below helps OCRM protect the safety and soundness of the business loan programs and taxpayer dollars.
In general, SBA collects information in connection with PARRiS
For all Analytical Reviews, Full Reviews, and Safety and Soundness examinations
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Further detail on the information SBA collects in Analytical and Full Reviews and Safety and Soundness Exams is contained in the SBA Supervised Lender Safety and Soundness Examination/Full Review Information Request; 7(a) Lender PARRiS Analytical Review Information Request; CDC SMART Analytical Review Information Request; 7(a) Lender PARRiS Full Review Information Request; and, CDC SMART Full Review Information Request. Each Information Request document is available upon request.
SBA is the primary federal regulator for SBA licensed SBLCs and NFRLs that participate in the 7(a) program.
SBA is also the primary federal regulator for CDCs. SBA guarantees 100% of 504 program debentures. Therefore, SBA also requests additional information to prudently oversee CDCs, as it does for SBA Supervised Lenders. The additional information generally requested includes corporate governance documents and information on lender's financial condition, internal controls and risk mitigation practices, and the CDC's plan for investment in other local economic development. In addition, SBA requests, as applicable, information on a CDC's Premier Certified Lenders Program (PCLP) Loan Loss Reserve Account and loans that a CDC packages for other 7(a) lenders. You may request a copy of the CDC SMART Analytical Review Information Request and CDC SMART Full Review Information Request for more details on this supplemental information request.
SBA collects information for Delegated Authority Reviews performed, in general, every two years for lenders applying or reapplying to SBA's Delegated Authority Programs (
For 7(a) delegated authority reviews, SBA requests information on organizational changes, staff training and experience, lender explanation for risk indicators triggered, lender risk mitigation efforts, lender's financial condition, lender's deficiencies underlying regulatory orders (if applicable and as appropriate), and loan sample files (as requested).
For CDC delegated authority reviews, SBA requests corporate governance documents and additional information on organization/staff, financial condition, internal controls and risk mitigation. SBA also requests a CDC's policies including its no-adverse-change determination, loan reviews, and lender explanation for its higher risk metrics.
For more detail on Delegated Authority Review collections, you may request a copy of the 7(a) Lender Nomination for Delegated Authority Information Request; and, the ALP/PCLP Renewal Guide and Information Request.
For Microloan Program Intermediary oversight, SBA District Offices perform an annual site visit for active Intermediaries. SBA requests information on SBA program management and operations including organizational chart with responsibilities, business plan, staff training on SBA lending, and risk mitigation practices. SBA primarily reviews the Intermediary's credit administration through a loan sample file request. Specifics on the information collected are contained in SBA's Microloan Intermediary Site Visit/Review Information Request document, a copy of which is available upon request.
SBA may pose additional information requests for its Other Reviews,
In general, for information that has already been provided by a 7(a) lender, a CDC, or a Microloan Intermediary but is unchanged, a lender may certify that the information was already provided and is unchanged in lieu of resubmitting the information. The certification must also state to whom and on what date the information was provided to SBA.
Susquehanna River Basin Commission.
Notice.
This notice lists the minor modifications approved for a previously
April 1-30, 2018.
Susquehanna River Basin Commission, 4423 North Front Street, Harrisburg, PA 17110-1788.
Jason E. Oyler, General Counsel, telephone: (717) 238-0423, ext. 1312; fax: (717) 238-2436; email:
This notice lists previously approved projects, receiving approval of minor modifications, described below, pursuant to 18 CFR 806.18 for the time period specified above:
1. Pro-Environmental, LLC, Docket No. 20140610-1, Lathrop Township, Susquehanna County, Pa.; approval to changes in the authorized water uses; Approval Date: April 27, 2018.
2. Ski Roundtop Operating Corp., Docket No. 20031209-1, Warrington Township, York County, Pa.; approval to changes in the authorized water uses; Approval Date: April 27, 2018.
Pub. L. 91-575, 84 Stat. 1509
Federal Aviation Administration (FAA), DOT.
Notice of petition for exemption received.
This notice contains a summary of a petition seeking relief from specified requirements of Federal Aviation Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Comments on this petition must identify the petition docket number and must be received on or before July 13, 2018.
Send comments identified by docket number FAA-2018-0592 using any of the following methods:
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Michael Harrison, AIR-673, Federal Aviation Administration, 2200 S. 216th Street, Des Moines, WA 98198, phone 206-231-3368, email
This notice is published pursuant to 14 CFR 11.85.
Federal Aviation Administration (FAA), DOT.
Notice.
This notice contains a summary of a petition seeking relief from specified requirements of Title 14 of the Code of Federal Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Comments on this petition must identify the petition docket number and must be received on or before July 19, 2018.
Send comments identified by docket number FAA-2018-0183 using any of the following methods:
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Jake Troutman, (202) 683-7788, 800 Independence Avenue SW, Washington, DC 20591.
This notice is published pursuant to 14 CFR 11.85.
Federal Aviation Administration (FAA), DOT.
Notice.
This notice contains a summary of a petition seeking relief from specified requirements of Federal Aviation Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Comments on this petition must identify the petition docket number and must be received on or before July 19, 2018.
Send comments identified by docket number FAA-2018-0307 using any of the following methods:
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Steven Barksdale (202) 267-7977, Office of Rulemaking, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591.
This notice is published pursuant to 14 CFR 11.85.
Federal Aviation Administration (FAA), DOT.
Notice.
This notice contains a summary of a petition seeking relief from specified requirements of Title 14 of the Code of Federal Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Comments on this petition must identify the petition docket number and must be received on or before July 19, 2018.
Send comments identified by docket number FAA-2018-0263 using any of the following methods:
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Jake Troutman, (202) 683-7788, 800 Independence Avenue SW, Washington, DC 20591.
This notice is published pursuant to 14 CFR 11.85.
Federal Aviation Administration (FAA), DOT.
Notice.
This notice contains a summary of a petition seeking relief from specified requirements of Title 14 of the Code of Federal Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Comments on this petition must identify the petition docket number and must be received on or before July 19, 2018.
Send comments identified by docket number FAA-2018-0240 using any of the following methods:
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Jake Troutman, (202) 683-7788, 800 Independence Avenue SW, Washington, DC 20591.
This notice is published pursuant to 14 CFR 11.85.
Federal Aviation Administration (FAA), DOT.
Notice; reopening of comment period.
This notice contains a summary of a petition seeking relief from specified requirements of Title 14 of the Code of Federal Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Comments on this petition must identify the petition docket number and must be received on or before July 13, 2018.
Send comments identified by docket number FAA-2017-1065 using any of the following methods:
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Jake Troutman, (202) 683-7788, 800 Independence Avenue SW, Washington, DC 20591.
On April 12, 2018, the FAA published a notice in the
This notice is published pursuant to 14 CFR 11.85.
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of advisory committee meeting.
FMCSA announces that its MCSAC will meet on Monday and Tuesday, July 30-31, 2018.
The meeting will be held Monday-Tuesday, July 30-31, 2018, from 9:15 a.m. to 4:30 p.m., Eastern Daylight Time (EDT).
This meeting will be held at the U.S. Department of Transportation, Oklahoma City Rooms A, B, and C, 1200 New Jersey Avenue SE, Washington, DC 20590. Copies of the MCSAC Task Statements and an agenda for the entire meeting will be made available in advance of the meeting at
Ms. Shannon L. Watson, Senior Advisor to the Associate Administrator for Policy, Federal Motor Carrier Safety Administration, U.S. Department of Transportation, at (202) 385-2395, or via email at
MCSAC was established to provide FMCSA with advice and recommendations on motor carrier safety programs and motor carrier safety regulations. MCSAC is composed of up to 20 voting representatives from safety advocacy, safety enforcement, labor, and industry stakeholders of motor carrier safety. The diversity of the Committee ensures the requisite range of views and expertise necessary to discharge its responsibilities. The Committee operates as a discretionary committee under the authority of the U.S. Department of Transportation (DOT), established in accordance with the provisions of the Federal Advisory Committee Act (FACA), as amended, 5 U.S.C. App. 2. See FMCSA's MCSAC website for additional information about the committee's activities at
The MCSAC will complete its deliberations from June 2017 and provide recommendations to the Agency concerning automated driving systems (ADS)-equipped commercial motor vehicles (CMVs), the development of the Agency's fiscal year (FY) 2018-2022 strategic plan, and the review of the Federal Motor Carrier Safety Regulations (FMCSRs) to identify potential opportunities to reduce regulatory burdens while ensuring that Federal safety programs continue to achieve safety outcomes.
On September 12, 2017, the Department published the
The Voluntary Guidance adopts the SAE International (SAE) published Standard J3016, “Taxonomy and Definitions for Terms Related to On-Road Motor Vehicle Automated Driving Systems” definitions for levels of automation. The SAE definitions divide vehicles into levels based on “who does what, when.” Generally:
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Using the SAE levels described above, the Department draws a distinction between Levels 0-2 and 3-5 based on whether the human driver or the automated system is primarily responsible for monitoring the driving environment. The term “automated vehicle systems” represents SAE Levels 3-5 vehicles that are responsible for monitoring the driving environment. For this task, the Agency's primary focus is SAE Levels 3-5 ADS, as delineated in its
Public discussions regarding ADS have become more prominent in recent months as developers continue efforts to demonstrate and test the viability of advanced driver assistance systems on large commercial vehicles. FMCSA encourages the development of these advanced safety technologies for use on commercial vehicles, while recognizing the need to work with the States to ensure that, from an operations standpoint, all testing and use of these advanced safety systems is conducted in a manner that ensures the safe operation of ADS-equipped CMVs.
FMCSA tasked the MCSAC in June 2017 with providing recommendations regarding the framework for considering temporary exemptions that entities may seek to operate an ADS-equipped CMV on a public roadway.
FMCSA is drafting a new strategic plan for release in 2018. The new strategic plan will provide a high-level overview of our mission, vision, strategic goals and outlook for FY2018-2022 based on Department's goals for the next several years. The Department released its Strategic Plan for FY 2018-2022 in February 2018 (
In June 2017, FMCSA tasked the MCSAC with providing recommendations to the Agency concerning implementation of Executive Orders 13771, “Reducing Regulation and Controlling Regulatory Costs” (82 FR 9339, February 3, 2017) and 13777, “Enforcing the Regulatory Reform Agenda” (82 FR 12285, March 1, 2017). The Agency requests that the MCSAC identify regulations that it believes to be (1) outdated, unnecessary, or ineffective or (2) impose costs that exceed benefits. The MCSAC's recommendations would be based on the members' understanding of the regulatory requirements, how the rules have been implemented by the industry and enforcement officials, and crash, injury, and fatality data. FMCSA will provide technical assistance to the MCSAC members, as needed.
The meeting will be open to the public for its entirety. Oral comments from the public will be heard throughout the meeting, at the discretion of the MCSAC chairman and designated federal officer. Members of the public may submit written comments on the topics to be considered during the meeting by Wednesday, July 18, 2018, to Federal Docket Management System (FDMC) Docket Number FMCSA-2006-26367 using any of the following methods:
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Maritime Administration, DOT.
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before July 30, 2018.
Comments should refer to docket number MARAD-2018-0104. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590. You may also send comments electronically via the internet at
Bianca Carr, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-453, Washington, DC 20590. Telephone 202-366-9309, Email
As described by the applicant the intended service of the vessel BELLA LUNA is:
The complete application is given in DOT docket MARAD-2018-0104 at
In accordance with 5 U.S.C. 553(c), DOT/MARAD solicits comments from the public to better inform its rulemaking process. DOT/MARAD posts these comments, without edit, to
49 CFR 1.93(a), 46 U.S.C. 55103, 46 U.S.C. 12121.
By order of the Maritime Administrator.
Maritime Administration, DOT.
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before July 30, 2018.
Comments should refer to docket number MARAD-2018-0106. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590. You may also send comments electronically via the internet at
Bianca Carr, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-453, Washington, DC 20590. Telephone 202-366-9309, Email
As described by the applicant the intended service of the vessel PRELUDE is:
The complete application is given in DOT docket MARAD-2018-0106 at
In accordance with 5 U.S.C. 553(c), DOT/MARAD solicits comments from the public to better inform its rulemaking process. DOT/MARAD posts these comments, without edit, to
49 CFR 1.93(a), 46 U.S.C. 55103, 46 U.S.C. 12121.
By order of the Maritime Administrator.
Maritime Administration, DOT.
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before July 30, 2018.
Comments should refer to docket number MARAD-2018-0105. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590. You may also send comments electronically via the internet at
Bianca Carr, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-453, Washington, DC 20590. Telephone 202-366-9309, email
As described by the applicant the intended service of the vessel MELISSA is:
The complete application is given in DOT docket MARAD-2018-0105 at
In accordance with 5 U.S.C. 553(c), DOT/MARAD solicits comments from the public to better inform its rulemaking process. DOT/MARAD posts these comments, without edit, to
49 CFR 1.93(a), 46 U.S.C. 55103, 46 U.S.C. 12121.
By order of the Maritime Administrator.
Department of Veterans Affairs.
Request for information.
The Department of Veterans Affairs (VA) is requesting information to assist in implementing section 1703B of title 38, United States Code (U.S.C.), as added by section 104(a) of the John S. McCain III, Daniel K. Akaka, and Samuel R. Johnson VA Maintaining Internal Systems and Strengthening Integrated Outside Networks (MISSION) Act of 2018 (the VA MISSION Act) which directs VA to establish access standards for furnishing hospital care, medical services, and extended care services to covered veterans for purposes of the Veterans Community Care Program. In establishing these access standards, VA is required to consult with all pertinent Federal, private sector, and non-governmental entities. VA requests information from the public regarding the development of these access standards, including but not limited to information with regard to health plans on the use of access standards for the design of health plan provider networks, referrals from network providers to out-of-network providers, the appeals process for exemptions from benefit limits to out-of-network providers, and the measurement of performance against federal or state regulatory standards. With regard to health systems, VA requests information from the public including but not limited to the existence of standards for appointment wait times, the use of travel distance for establishing service areas, the development or use of guidelines to refer patients to out of system providers, and the measurement of performance against federal or state regulatory standards. Responses to this notice will support industry research and VA's evaluation of access standards.
July 30, 2018.
Written comments may be submitted through
Christina Hosenfeld, Management
The John S. McCain III, Daniel K. Akaka, and Samuel R. Johnson VA Maintaining Internal Systems and Strengthening Integrated Outside Networks Act of 2018, Public Law 115-182, (the VA MISSION Act) creates a new 38 U.S.C. 1703B that contains requirements for VA to facilitate the establishment and use of access standards. Section 1703B(c) specifically requires VA to consult with all pertinent Federal entities, entities in the private sector, and other nongovernmental entities in establishing access standards. This notice and request for information serves as one of the means for VA to consult with these groups and entities. We note that VA will also hold a public hearing on Friday, July 13, 2018, to provide these groups and entities an opportunity to provide additional information. VA will use the comments it receives to help determine the access standards in compliance with the VA MISSION Act. VA will then submit a report, no later than March 3, 2019, as required by section 1703B(d)(1), detailing the access standards to the appropriate committees of Congress. The access standards will ultimately be published in the
In order to submit a report to Congress detailing the access standards by March 3, 2019, VA must expedite this consultation, which will be foundational to the process of determining the access standards. Hence, this notice and request for information has a comment period of 30 days. VA believes that 30 days is sufficient to provide comments, as the groups and entities with expertise in access standards will likely have the information readily available or can quickly compile and submit such information.
This notice is a request for information only. Commenters are encouraged to provide complete but concise responses to the questions outlined below. VA may choose to contact individual commenters, and such communications would serve to further clarify their written comments.
Specifically, VA requests information from health plans and systems related to the below:
1. Do health plans use internal access standards for the design of provider networks and the application of in network/out of network benefits that are more stringent than regulatory standards (time or distance of travel, appointment wait times, provider/member ratios)? If so, what are these internal standards? How does the health plan measure performance against regulatory and internal access standards? How does the health plan respond to findings when access standards are not being met? Are current regulatory access standards cost-effective while maintaining quality standards? Do health plans have a process to handle routine requests from members or referring providers for exemptions to benefit limits when members seek out of network care or a lower tier provider?
2. Do health plans allow for appeals by providers or members to request exemptions from benefit limits related to out of network care or care by a lower tier provider? Is external review allowed for such appeals?
3. What are health plan practices regarding internal, regulatory, and/or accreditation standards for appointment wait times, including variance by specialty or type of service? How does the health plan use travel distance or time and/or provider-to-population ratios in deciding which geographic areas to consider as primary or secondary service areas?
4. Are clinicians within the health system given guidelines or rules on when to refer patients to out of system providers? For example, are clinicians encouraged to refer out of system if in-system wait times are longer than standard, travel time or distance to an in-system provider is too long, the patient's ability to travel is compromised or the frequency of treatment makes travel to an in-network provider difficult?
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 25, 2018, for publication.
Department of Veterans Affairs.
Announcement of public meeting.
The Department of Veterans Affairs (VA) is holding a public meeting to seek information from pertinent entities relating to implementation of 1703B of title 38, United States Code, as added by section 104(a) of the John S. McCain III, Daniel K. Akaka, and Samuel R. Johnson VA Maintaining Internal Systems and Strengthening Integrated Outside Networks (MISSION) Act of 2018 (the VA MISSION Act) which directs VA to establish access standards for furnishing hospital care, medical services, and extended care services to covered veterans for purposes of the Veterans Community Care Program. In establishing these access standards, VA is required to consult with all pertinent Federal, private sector, and non-governmental entities. VA requests information from the public regarding the development of these access standards, including but not limited to information on the use of access standards for the design of health plan provider networks, referrals from network providers to out-of-network providers, the appeals process for exemptions from benefit limits to out-of-network providers, the existence of standards for appointment wait times, the use of travel distance for establishing service areas, the development or use of guidelines to
VA will hold the public meeting on July 13, 2018, in Arlington, VA. The meeting will start at 9:00 a.m. and conclude on or before 5:00 p.m. Check-in will begin at 8:00 a.m.
The meeting will be held at the VHA National Conference Center at 2011 Crystal Drive, Arlington, VA 22202. This facility is accessible to individuals with disabilities.
* In-person attendance will be limited to 50 individuals. Advanced registration for individuals and groups is strongly encouraged (see registration instructions below). For listening purposes only (phone lines will be muted), the meeting will be available via audio which can be accessed by dialing 1-800-767-1750 access code 21398.
Please submit all written comments no later than Monday, July 30, by any of the following methods:
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Christina Hosenfeld, Management Analyst, Office of the Deputy Under Secretary for Health for Community Care, Veterans Health Administration, Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420, (202) 461-4112. This is not a toll free number.
The John S. McCain III, Daniel K. Akaka, and Samuel R. Johnson VA Maintaining Internal Systems and Strengthening Integrated Outside Networks Act of 2018, Public Law 115-182, (the VA MISSION Act) created a new 1703B in title 38, United States Code (U.S.C.), that contains requirements for VA to facilitate the establishment and use of access standards. Section 1703B(c) specifically requires VA to consult with all pertinent Federal entities, entities in the private sector, and other nongovernmental entities in establishing access standards. This public meeting serves as one of the means for VA to consult with these groups and entities. We note that VA has published a request for information in the
In order to submit a report to Congress detailing the access standards by March 3, 2019, VA must expedite this consultation, which will be foundational to the process of determining the access standards.
Pursuant to section 1703B(c) of title 38, U.S.C., as added by section 104(a) of Public Law 115-182, (the VA MISSION Act), VA requests information that will assist in developing the access standards required by section 1703B(a)(1). This includes information regarding the development of these access standards, including but not limited to information on the use of access standards for the design of health plan provider networks, referrals from network providers to out-of-network providers, the appeals process for exemptions from benefit limits to out-of-network providers, the existence of standards for appointment wait times, the use of travel distance for establishing service areas, the development or use of guidelines to refer patients to out of system providers, and the measurement of performance against regulatory standards.
Specifically, VA requests information from health plans and systems related to the below:
1. Do health plans use internal access standards for the design of provider networks and the application of in network/out of network benefits that are more stringent than regulatory standards (time or distance of travel, appointment wait times, provider/member ratios)? If so, what are these internal standards? How does the health plan measure performance against regulatory and internal access standards? How does the health plan respond to findings when access standards are not being met? Are current regulatory access standards cost-effective while maintaining quality standards? Do health plans have a process to handle routine requests from members or referring providers for exemptions to benefit limits when members seek out of network care or a lower tier provider?
2. Do health plans allow for appeals by providers or members to request exemptions from benefit limits related to out of network care or care by a lower tier provider? Is external review allowed for such appeals?
3. What are health plan practices regarding internal, regulatory, and/or accreditation standards for appointment wait times, including variance by specialty or type of service? How does the health plan use travel distance or time and/or provider-to-population ratios in deciding which geographic areas to consider as primary or secondary service areas?
4. Are clinicians within the health system given guidelines or rules on when to refer patients to out of system providers? For example, are clinicians encouraged to refer out of system if in-system wait times are longer than standard, travel time or distance to an in-system provider is too long, the patient's ability to travel is compromised or the frequency of treatment makes travel to an in-network provider difficult?
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 25, 2018, for publication.
The Department of Veterans Affairs (VA) gives notice under the Federal Advisory Committee Act that the VA National Academic Affiliations Council (NAAC) will meet via conference call on July 11, 2018, from 10:00 a.m. to 12:00 p.m. EST. The meeting is open to the public.
The purpose of the Council is to advise the Secretary on matters affecting partnerships between VA and its academic affiliates.
On July 11, 2018, the Council will explore the current modernization effort within the Veterans Health Administration (VHA); receive a briefing on the VHA electronic health record modernization program; discuss provisions of the recently enacted Public Law 115-182 that impacts VA's clinical education mission; and receive updates on the waiver process for VA employees engaging in teaching activities with for-profit educational institutions; the activities of the Council's Subcommittee on Diversity and Inclusion; the June 13, 2018 Roundtable of Graduate Medical Education hosted by the House Committee on Veterans' Affairs; and the recent efforts of the VA Strategic Academic Advisory Council. The Council will receive public comments from 11:50 p.m. to 12:00 p.m. EST.
Interested persons may attend and/or present oral statements to the Council. The dial in number to attend the conference call is: 1-800-767-1750. At the prompt, enter access code 66983 then press #. Individuals seeking to present oral statements are invited to submit a 1-2 page summary of their comments at the time of the meeting for inclusion in the official meeting record. Oral presentations will be limited to five minutes or less, depending on the number of participants. Interested parties may also provide written comments for review by the Council prior to the meeting or at any time, by email to
Defense Acquisition Regulations System, Department of Defense (DoD).
Final rule.
DoD is issuing a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to remove a clause that is duplicative of an existing Federal Acquisition Regulation (FAR) clause rendering the DFARS clause unnecessary.
Effective June 29, 2018.
Ms. Carrie Moore, telephone 571-372-6093.
DoD is amending the DFARS to remove the DFARS clause 252.215-7000, Pricing Adjustments, the clause prescription at DFARS 215.408, and the associated cross-references at DFARS 208.404, 212.301, 214.201, 216.506, 225.870, and introductory text for various 252.215 clauses to adjust clause prescription references.
The DFARS clause is included in solicitations and contracts that contain the FAR clause 52.215-11, Price Reduction for Defective Certified Cost or Pricing Data—Modifications, FAR 52.215-12, Subcontractor Certified Cost or Pricing Data, or FAR 52.215-13, Subcontractor Certified Cost or Pricing Data—Modifications. DFARS clause 252.215-7000 defines the term “pricing adjustment” as the aggregate increases and/or decreases in cost plus applicable profits. This term is adequately defined in the associated FAR clauses and this DFARS clause can be removed.
The removal of this DFARS text supports a recommendation from the DoD Regulatory Reform Task Force. On February 24, 2017, the President signed Executive Order (E.O.) 13777, “Enforcing the Regulatory Reform Agenda,” which established a Federal policy “to alleviate unnecessary regulatory burdens” on the American people. In accordance with E.O. 13777, DoD established a Regulatory Reform Task Force to review and validate DoD regulations, including the DFARS. A public notification of the establishment of the DFARS Subgroup to the DoD Regulatory Reform Task Force, for the purpose of reviewing DFARS provisions and clauses, was published in the
This rule does not add any new solicitation provisions or contract clauses. This rule only removes obsolete DFARS clause 252.215-7010, Pricing Adjustments. Therefore, the rule does not impose any new requirements on contracts at or below the simplified acquisition threshold and for commercial items, including commercially available off-the-shelf items.
Executive Order (E.O.) 12866, Regulatory Planning and Review; and E.O. 13563, Improving Regulation and Regulatory Review, 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). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. The Office of Management and Budget, Office of Information and Regulatory Affairs (OIRA), has determined that this is not a significant regulatory action as defined under section 3(f) of E.O. 12866 and, therefore, was not subject to review under section 6(b). This rule is not a major rule as defined at 5 U.S.C. 804(2).
This rule is not an E.O. 13771, Reducing Regulation and Controlling Regulatory Costs, regulatory action, because this rule is not significant under E.O. 12866.
The statute that applies to the publication of the Federal Acquisition Regulation (FAR) is the Office of Federal Procurement Policy statute (codified at title 41 of the United States Code. Specifically, 41 U.S.C 1707(a)(1) requires that a procurement policy, regulation, procedure or form (including an amendment or modification thereof) must be published for public comment if it relates to the expenditure of appropriated funds, and has either a significant effect beyond the internal operating procedures of the agency issuing the policy, regulation, procedure, or form, or has a significant cost or administrative impact on contractors or offerors. This final rule is not required to be published for public comment, because DoD is not issuing a new regulation; rather, this rule merely removes an obsolete clause from the DFARS.
Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule under 41 U.S.C. 1707(a)(1) (see section V. of this preamble), the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601
The rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).
Government procurement.
Therefore, 48 CFR parts 208, 212, 214, 215, 216, 225, and 252 are amended as follows:
41 U.S.C. 1303 and 48 CFR chapter 1.
Defense Acquisition Regulations System, Department of Defense (DoD).
Final rule.
DoD is issuing a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to implement a section of the National Defense Authorization Act for Fiscal Year 2016 related to costs associated with indirect offsets under foreign military sales (FMS) agreements and expand on the prior interim rule guidance related to FMS offset costs.
Effective June 29, 2018.
Mr. Mark Gomersall, telephone 571-372-6176.
DoD published an interim rule in the
To expand on the interim rule guidance and incorporate the requirements of section 812 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2016, DoD
Section 812 of the NDAA for FY 2016 amended 10 U.S.C. 2306a(b)(1) to state that submission of certified cost or pricing data shall not be required in the case of a contract, a subcontract, or modification of a contract or subcontract to the extent such data—
(i) Relates to an offset agreement in connection with a contract for the sale of a weapon system or defense-related item to a foreign country or foreign firm; and
(ii) Does not relate to a contract or subcontract under the offset agreement for work performed in such foreign country or by such foreign firm that is directly related to the weapon system or defense-related item being purchased under the contract.
One respondent submitted public comments in response to the proposed rule. DoD reviewed the public comments in the development of this final rule. A discussion of the comments and the changes made to the rule as a result of those comments are provided as follows:
In addition to the interim rule revisions to DFARS 225.7303-2, Cost of doing business with a foreign government or an international organization, this final rule includes the proposed rule amendments to revise 215.403-1(b), Exceptions to certified cost or pricing data requirements, and adds clause 252.215-7014, Exception from Certified Cost or Pricing Data Requirements for Foreign Military Sales Indirect Offsets.
In response to public comments, the definitions of “direct offset” and “indirect offset” have been revised, and the title of DFARS Clause 252.215-7014 has been revised.
Moreover, although it is correct that direct offsets are “generally . . . performed within a specific period,” this is not necessarily a distinguishing characteristic for a direct offset, and may lead to confusion. The respondent, however, recommended adding the clarifying phrase “integral to the deliverable of the FMS contract” in the definition, because it reinforces that direct offsets are directly related to the system offered in the LOA.
The respondent concurs with prior public comments to the interim rule which stated that, “a country's offset guidelines may allow for both direct and indirect projects, but the defense contractor and foreign government might not decide on a specific mix of
The respondent explained that in practice, an offset agreement may not specify an indirect offset requirement, but rather the overall offset obligation that can be fulfilled with both direct and indirect offset projects. Moreover, many offset agreements do not require offset obligation percentages or minimum direct/indirect offset requirements. A country's offset requirements may also flow down to items (products or services) that are affiliated with sales that are being supplied by, but not limited to, Government-furnished equipment, or lower tier defense contractors. In such cases, a contractor may have no “evidence” to provide of the requirement related to the specific acquisition other than the requirements outlined in the foreign law, regulation, policy, or other general guidance.
The intent of section 812 of the NDAA for FY 2016 was to eliminate the need for an unnecessary and time-consuming review of offsets that are negotiated directly between the contractor and foreign customer. A combination of the “FMS customer's offset guidelines, requirements, regulations or law, policy or historical requirements” should be a sufficient showing of evidence for an offset requirement.
The respondent recommended that contracting officers accept that the contractor has an indirect offset requirement, if so stated, since a contractor claiming an offset requirement where none exists would be subject to other laws and regulations governing such false claims.
The respondent further stated that it is unclear what administration costs might be envisioned for further review. For example, travel and project execution costs might be deemed administrative costs. Since these costs would not be determined until the offset projects are defined, such costs might also not be determined until after the LOA is signed.
The respondent explained that the intent of the statutory and regulatory guidance related to indirect offset costs was to ensure that contracting officers did not have to conduct reasonableness analysis in these instances. Contracting officers should not have a greater requirement to parse out indirect administration costs for which they have no greater knowledge and expertise than the indirect offset costs in total.
The respondent suggested that the definitions for “direct” and “indirect” offsets should provide sufficient clarification for contracting officers to ensure that the final rule implements the statutory requirement that those costs not directly related to the system or item being purchased under the LOA are not subjected to certified pricing requirements.
Therefore, the respondent believed that it is not appropriate or necessary for a contracting officer to engage in cost reasonableness analysis for administration costs related to indirect offsets. The respondent recommended that the final rule should make clear that all indirect offset costs are deemed reasonable for the purposes of FAR parts 15 and 31 with no further analysis necessary on the part of the contracting officer, and that the rule applies to all indirect offset costs, including any administrative costs.
This rule clarifies requirements related to costs associated with indirect offsets under Foreign Military Sales agreements. The revisions do not add any new burdens or impact applicability of clauses and provisions at or below the simplified acquisition threshold, or to commercial items.
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.
This rule is not an E.O. 13771, Reducing Regulation and Controlling Regulatory Costs, regulatory action, because this rule is not significant under E.O. 12866.
A final regulatory flexibility analysis has been performed and is summarized as follows:
The objective of this rule is to incorporate the requirements of section 812 of the National Defense Authorization Act of 2016 to provide clarification to contracting officers when indirect offsets are a condition of an FMS acquisition. This rule revises DFARS 225.7303-2, “Cost of doing business with a foreign government or an international organization” by adding paragraph (a)(3)(iii) to provide guidelines to contracting officers when an indirect offset is a condition of a Foreign Military Sales (FMS) acquisition. This rule specifically addresses indirect offsets as they are applied to the Defense Security Cooperation Agency's FMS cases. This rule is necessitated by the recent and foreseeable trend of increasing numbers and complexity of indirect offsets desired by DoD FMS customers.
DoD administers FMS programs with partner nations to maintain and strengthen relationships with nations that if not nurtured through these partnerships may threaten national security. The Department's FMS program allows foreign customers to request, and pay for, through inclusion of the cost in the FMS Letter of Offer and Acceptance (LOA) and DoD contract, offsets that are directly related
DoD recognizes the need to have offsets embedded in DoD FMS contracts. However, the decision whether to engage in indirect offsets, and the responsibility for negotiating and implementing these offset arrangements, ultimately reside with the FMS customer and contractor(s) involved. Thus, the DoD contracting officer is not provided the information necessary to negotiate cost or price of the indirect offsets, particularly with respect to price reasonableness determinations pursuant to FAR part 15. This rule provides that under these circumstances, when the provision of an indirect offset is a condition of the FMS acquisition and provided that the U.S. defense contractor submits to the contracting officer an offset agreement or other substantiating documentation, those indirect offset costs are deemed reasonable for the purposes of FAR part 31.
There were no significant issues raised by the public in response to the initial regulatory flexibility analysis.
DoD does not expect this rule to have a significant impact on the small businesses that may be affected by this rule, because the DFARS amendments merely clarify that contracting officers are not responsible for making a determination of price reasonableness for indirect offset agreements for which they have no purview.
DoD does not expect this rule to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601,
There is no change to reporting or recordkeeping as a result of this rule. The rule does not duplicate, overlap, or conflict with any other Federal rules, and there are no known significant alternative approaches to the rule that would meet the requirements.
The rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).
Government procurement.
Therefore, 48 CFR parts 202, 215, 225, and 252 are amended as follows:
41 U.S.C. 1303 and 48 CFR chapter 1.
(1) A direct offset involves benefits or obligations, including supplies or services that are directly related to the item(s) being purchased and are integral to the deliverable of the FMS contract. For example, as a condition of a foreign military sale, the contractor may require or agree to permit the customer to produce in its country certain components or subsystems of the item being sold. Generally, direct offsets must be performed within a specified period, because they are integral to the deliverable of the FMS contract.
(2) An indirect offset involves benefits or obligations, including supplies or services that are not directly related to the specific item(s) being purchased and are not integral to the deliverable of the FMS contract. For example, as a condition of a foreign military sale, the contractor may agree to purchase certain manufactured products, agricultural commodities, raw materials, or services, or make an equity investment or grant of equipment required by the FMS customer, or may agree to build a school, road or other facility. Indirect offsets would also include projects that are related to the FMS contract but not purchased under said contract (
(b)
(ii) Submission of certified cost or pricing data shall not be required in the case of a contract, subcontract, or modification of a contract or subcontract to the extent such data relates to an indirect offset.
(7) Use the clause at 252.215-7014, Exception from Certified Cost or Pricing Data Requirements for Foreign Military Sales Indirect Offsets, in solicitations and contracts that contain the provision at FAR 52.215-20, Requirements for Certified Cost or Pricing Data and Data Other Than Certified Cost or Pricing Data, when it is reasonably certain that—
(i) The contract is expected to include costs associated with an indirect offset; and
(ii) The submission of certified cost or pricing data or data other than certified cost or pricing data will be required.
(a) * * *
(3)
(i) An offset agreement is the contractual arrangement between the FMS customer and the U.S. defense contractor that identifies the offset obligation imposed by the FMS customer that has been accepted by the U.S. defense contractor as a condition of the FMS customer's purchase. These
(ii) A U.S. defense contractor may recover all costs incurred for offset agreements with a foreign government or international organization if the LOA is financed wholly with foreign government or international organization customer cash or repayable foreign military finance credits.
(iii) The U.S. Government assumes no obligation to satisfy or administer the offset agreement or to bear any of the associated costs.
(iv) Indirect offset costs are deemed reasonable for purposes of FAR parts 15 and 31 with no further analysis necessary on the part of the contracting officer, provided that the U.S. defense contractor submits to the contracting officer a signed offset agreement or other documentation showing that the FMS customer has made the provision of an indirect offset a condition of the FMS acquisition. FMS customers are placed on notice through the LOA that indirect offset costs are deemed reasonable without any further analysis by the contracting officer.
As prescribed in 215.408(8), use the following clause:
(a)
(i) A direct offset involves benefits or obligations, including supplies or services that are directly related to the item being purchased and are integral to the deliverable of the FMS contract. For example, as a condition of a foreign military sale, the contractor may require or agree to permit the customer to produce in its country certain components or subsystems of the item being sold. Generally, direct offsets must be performed within a specified period, because they are integral to the deliverable of the FMS contract.
(ii) An indirect offset involves benefits or obligations, including supplies or services that are not directly related to the specific item(s) being purchased and are not integral to the deliverable of the FMS contract. For example, as a condition of a foreign military sale, the contractor may agree to purchase certain manufactured products, agricultural commodities, raw materials, or services, or make an equity investment or grant of equipment required by the FMS customer, or may agree to build a school, road or other facility. Indirect offsets would also include projects that are related to the FMS contract but not purchased under said contract (
(b)
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