Federal Register Vol. 81, No.70,
Federal Register Volume 81, Issue 70 (April 12, 2016)
Federal Register Volume 81, Issue 70 (April 12, 2016)
| Page Range | 21449-21697 | |
| FR Document |
Document Created: 2015-12-31 23:05:00
Document Modified: 2015-12-31 23:05:00
| Page and Subject | |
|---|---|
| 81 FR 21540 - Sunshine Act Notice | |
| 81 FR 21533 - Sunshine Act Meeting | |
| 81 FR 21592 - Sunshine Act Meeting | |
| 81 FR 21608 - Sunshine Act Meeting Notice | |
| 81 FR 21611 - In the Matter of Royale Globe Holding Inc., File No. 500-1; Order of Suspension of Trading | |
| 81 FR 21534 - Sunshine Act Meeting Notice | |
| 81 FR 21614 - Sunshine Act Meeting | |
| 81 FR 21635 - Sunshine Act Meeting | |
| 81 FR 21482 - Fisheries of the Exclusive Economic Zone off Alaska; Exchange of Flatfish in the Bering Sea and Aleutian Islands Management Area | |
| 81 FR 21548 - Sunshine Act Meetings | |
| 81 FR 21583 - Submission for OMB Review; 30-day Comment Request; The Agricultural Health Study: A Prospective Cohort Study of Cancer and Other Diseases Among Men and Women in Agriculture (NIEHS) | |
| 81 FR 21541 - Applications for New Awards; Advanced Placement Test Fee Program | |
| 81 FR 21643 - Notice of Information Collection Under OMB Emergency Review: Adoptive Family Relief Act Refund Application | |
| 81 FR 21538 - Export Trade Certificate of Review | |
| 81 FR 21539 - Quarterly Update to Annual Listing of Foreign Government Subsidies on Articles of Cheese Subject to an In-Quota Rate of Duty | |
| 81 FR 21449 - Aviation Training Device Credit for Pilot Certification | |
| 81 FR 21537 - Citric Acid and Certain Citrate Salts From the People's Republic of China: Notice of Court Decision Not in Harmony With Final Results of Countervailing Duty Administrative Review and Notice of Amended Final Results Pursuant to Court Decision; 2011 | |
| 81 FR 21481 - Atlantic Highly Migratory Species; Atlantic Bluefin Tuna Fisheries | |
| 81 FR 21536 - Polyethylene Retail Carrier Bags From Thailand: Preliminary Results of Antidumping Duty Administrative Review; 2014-2015 | |
| 81 FR 21607 - Sequoyah State-of-the-Art Reactor Consequence Analyses | |
| 81 FR 21465 - Servicemembers' Group Life Insurance and Veterans' Group Life Insurance-Slayer's Rule Exclusion | |
| 81 FR 21462 - Special Local Regulation; Chesapeake Bay, Between Sandy Point and Kent Island, MD | |
| 81 FR 21535 - Transportation and Related Equipment Technical Advisory Committee; Notice of Partially Closed Meeting | |
| 81 FR 21540 - US Air Force Exclusive Patent License | |
| 81 FR 21547 - Information Collections Being Reviewed by the Federal Communications Commission Under Delegated Authority | |
| 81 FR 21511 - Connect America Fund, ETC Annual Reports and Certification; Developing a Unified Intercarrier Compensation Regime | |
| 81 FR 21546 - Information Collection Being Reviewed by the Federal Communications Commission Under Delegated Authority | |
| 81 FR 21534 - Information Systems, Technical Advisory Committee; Notice of Partially Closed Meeting | |
| 81 FR 21535 - Sensors and Instrumentation Technical Advisory Committee; Notice of Partially Closed Meeting | |
| 81 FR 21534 - Materials Technical Advisory Committee; Notice of Partially Closed Meeting | |
| 81 FR 21593 - Submission for OMB Review, Comment Request, Proposed Collection; Guidelines for Grants to States Program Five-Year Evaluations | |
| 81 FR 21549 - Agency Information Collection Activities; Submission for OMB Review; Comment Request | |
| 81 FR 21479 - Medicaid Program; Deadline for Access Monitoring Review Plan Submissions | |
| 81 FR 21553 - Proposed Information Collection Activity; Comment Request | |
| 81 FR 21662 - Continental Tire the Americas, LLC, Grant of Petition for Decision of Inconsequential Noncompliance | |
| 81 FR 21660 - Mercedes-Benz USA LLC, Denial of Petition for Decision of Inconsequential Noncompliance | |
| 81 FR 21663 - Morgan 3 Wheeler Limited, Denial of Petition for Decision of Inconsequential Noncompliance | |
| 81 FR 21647 - Qualification of Drivers; Exemption Applications; Vision | |
| 81 FR 21548 - Notice of Termination; 10468 Westside Community Bank, University Place, Washington | |
| 81 FR 21589 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest | |
| 81 FR 21649 - Qualification of Drivers; Exemption Applications; Diabetes Mellitus | |
| 81 FR 21655 - Qualification of Drivers; Exemption Applications; Vision | |
| 81 FR 21659 - Stop Signal Overruns | |
| 81 FR 21497 - Airworthiness Directives; The Boeing Company Airplanes | |
| 81 FR 21667 - Proposed Information Collection (Civilian Health And Medical Program of the Department of Veterans Affairs (CHAMPVA) Benefits-Application, Claim, Other Health Insurance & Potential Liability); Activity: Comment Request | |
| 81 FR 21545 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Indian Education Professional Development Grants Program: GPRA and Service Payback Data Collection | |
| 81 FR 21585 - Endangered and Threatened Wildlife and Plants; Application To Amend Incidental Take Permit; Revised Diversified Pacific Low-Effect Habitat Conservation Plan and Associated Documents, City of Redlands, San Bernardino County, California | |
| 81 FR 21587 - Application for an Enhancement of Survival Permit for the Proposed Springs Preserve Safe Harbor Agreement, Las Vegas, Clark County, Nevada | |
| 81 FR 21548 - Notice of Termination; 10494 Syringa Bank, Boise, Idaho | |
| 81 FR 21548 - Notice of Termination; 10169 St. Stephen State Bank, St. Stephen, Minnesota | |
| 81 FR 21549 - Formations of, Acquisitions by, and Mergers of Bank Holding Companies | |
| 81 FR 21549 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company | |
| 81 FR 21533 - Submission for OMB Review; Comment Request | |
| 81 FR 21579 - Determination of Regulatory Review Period for Purposes of Patent Extension; GAZYVA | |
| 81 FR 21555 - Determination of Regulatory Review Period for Purposes of Patent Extension; ADEMPAS | |
| 81 FR 21558 - EMD Serono; Withdrawal of Approval of a New Drug Application for LUVERIS | |
| 81 FR 21576 - Safety Considerations for Product Design To Minimize Medication Errors; Guidance for Industry; Availability | |
| 81 FR 21574 - Determination of Regulatory Review Period for Purposes of Patent Extension; APTIOM | |
| 81 FR 21573 - Determination of Regulatory Review Period for Purposes of Patent Extension; APOQUEL | |
| 81 FR 21556 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Comparing Food Safety Knowledge, Attitude and Behavior Among English-Dominant Hispanics, Spanish-Dominant Hispanics, and Other Consumers | |
| 81 FR 21578 - Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Feed Regulatory Program Standards | |
| 81 FR 21577 - Donor Screening Recommendations To Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry; Availability; Correction | |
| 81 FR 21558 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens | |
| 81 FR 21559 - Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Opportunity for Hearing | |
| 81 FR 21480 - Migratory Bird Hunting; Final Frameworks for Migratory Bird Hunting Regulations | |
| 81 FR 21588 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest | |
| 81 FR 21449 - Cyber Security at Fuel Cycle Facilities | |
| 81 FR 21593 - Biweekly Notice; Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving No Significant Hazards Considerations | |
| 81 FR 21506 - Mail Classification Schedule | |
| 81 FR 21666 - Agency Information Collection Activities: Information Collection Renewal; Comment Request; Notice Regarding Unauthorized Access to Customer Information | |
| 81 FR 21645 - Petition for Exemption; Summary of Petition Received; Invictus Technical Solutions LLC | |
| 81 FR 21478 - RESTORE Act Spill Impact Component Allocation | |
| 81 FR 21550 - Emergency Funding for Puerto Rico Department of Health, Zika Virus Outbreak | |
| 81 FR 21646 - Petition for Exemption; Summary of Petition Received; Cirrus Design Corporation | |
| 81 FR 21642 - Reporting and Recordkeeping Requirements Under OMB Review | |
| 81 FR 21644 - Petition for Exemption; Summary of Petition Received; Martin UAV | |
| 81 FR 21644 - Petition for Exemption; Summary of Petition Received; The Dobbins Company | |
| 81 FR 21645 - Petition for Exemption; Summary of Petition Received; AeroLogix Consulting Inc. | |
| 81 FR 21646 - Petition for Exemption; Summary of Petition Received; Walt Disney Parks and Resorts U.S., Inc. | |
| 81 FR 21642 - District of Columbia Disaster #DC-00007 | |
| 81 FR 21642 - Mississippi Disaster Number MS-00084 | |
| 81 FR 21641 - Texas Disaster Number TX-00465 | |
| 81 FR 21626 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval of Proposed Rule Change, as Modified by Amendment Nos. 1, 2, and 3 Thereto, Relating to the Listing and Trading of the Shares of the First Trust RiverFront Dynamic Europe ETF, First Trust RiverFront Dynamic Asia Pacific ETF, First Trust RiverFront Dynamic Emerging Markets ETF, and First Trust RiverFront Dynamic Developed International ETF of First Trust Exchange-Traded Fund III | |
| 81 FR 21611 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Establish Fees for Options That Overlie a Reduced Value of the FTSE 100 Index and the FTSE China 50 Index | |
| 81 FR 21631 - Self-Regulatory Organizations; NASDAQ PHLX LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule ChangeTo Amend Rule 1064 | |
| 81 FR 21623 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing of Proposed Rule Change To Amend Rule 952NY With Respect to Opening Trading in an Options Series | |
| 81 FR 21639 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing of Proposed Rule Change to Rule 6.64 With Respect to Opening Trading in an Options Series | |
| 81 FR 21632 - Self-Regulatory Organizations; EDGX Exchange, Inc.; Order Approving Proposed Rule Change, as Modified by Amendment No. 1 Thereto, To Adopt an Early Trading Session and Three New Time-In-Force Instructions | |
| 81 FR 21620 - Self-Regulatory Organizations; EDGA Exchange, Inc.; Order Approving Proposed Rule Change, as Modified by Amendment No. 1 Thereto, To Adopt an Early Trading Session and Three New Time-in-Force Instructions | |
| 81 FR 21636 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing of Proposed Rule Change Amending the Eighth Amended and Restated Operating Agreement of the Exchange | |
| 81 FR 21615 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing of Proposed Rule Change, as Modified by Amendment No. 1 Thereto, Amending Section 4.01(a) of the NYSE Arca's Bylaws and NYSE Arca Rule 3.3 To Establish a Committee for Review as a Sub-Committee of the ROC and Making Conforming Changes to NYSE Arca Rules | |
| 81 FR 21609 - Türkiye Sinai Kalkinma Bankasi A.Ş.; Notice of Application | |
| 81 FR 21551 - Agency Forms Undergoing Paperwork Reduction Act Review | |
| 81 FR 21465 - Drawbridge Operation Regulation; Connecticut River, East Haddam, CT | |
| 81 FR 21659 - FY16 Competitive Funding Opportunity: Grants for Buses and Bus Facilities and Low or No Emission Grant Programs; 5339(b) Grants for Buses and Bus Facilities Program and 5339(c) Low or No Emission Program-Correction | |
| 81 FR 21582 - Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Meeting | |
| 81 FR 21584 - National Institute on Aging; Notice of Closed Meeting | |
| 81 FR 21583 - Fogarty International Center; Notice of Meeting | |
| 81 FR 21585 - Center for Scientific Review; Notice of Closed Meeting | |
| 81 FR 21582 - Center for Scientific Review; Notice of Closed Meetings | |
| 81 FR 21582 - Temporary Reassignment of State, Tribal, and Local Personnel During a Public Health Emergency; Correction | |
| 81 FR 21581 - Office of Global Affairs: Stakeholder Listening Session in Preparation for the 69th World Health Assembly | |
| 81 FR 21581 - Announcement of Establishment of the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030 and Solicitation of Nominations for Membership; Correction | |
| 81 FR 21554 - National Child Care Hotline and Web site; Comment request; Correction | |
| 81 FR 21472 - 1,2-Propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxanyl] propoxy]-; Exemption From the Requirement of a Tolerance | |
| 81 FR 21468 - Approval and Promulgation of Air Quality Implementation Plans; Colorado; Revisions to Common Provisions and Regulation Number 3; Corrections | |
| 81 FR 21470 - Approval and Promulgation of Implementation Plans; Spokane, Washington: Second 10-Year PM10 | |
| 81 FR 21491 - Airworthiness Directives; Bombardier, Inc. Airplanes | |
| 81 FR 21591 - Aluminum: Competitive Conditions Affecting the U.S. Industry Institution of Investigation and Scheduling of Hearing | |
| 81 FR 21590 - Silicomanganese From Australia | |
| 81 FR 21495 - Airworthiness Directives; Bombardier, Inc. Airplanes | |
| 81 FR 21489 - Airworthiness Directives; Pacific Aerospace Limited Airplanes | |
| 81 FR 21501 - Airworthiness Directives; Textron Aviation Inc. Airplanes | |
| 81 FR 21484 - Airworthiness Directives; Airbus Airplanes | |
| 81 FR 21486 - Airworthiness Directives; Airbus Airplanes | |
| 81 FR 21503 - Airworthiness Directives; Bombardier, Inc. Airplanes | |
| 81 FR 21493 - Airworthiness Directives; Airbus Helicopters | |
| 81 FR 21552 - Agency Information Collection Activities: Submission for OMB Review; Comment Request | |
| 81 FR 21671 - Air Plan Approval; Minnesota and Michigan; Revision to 2013 Taconite Federal Implementation Plan Establishing BART for Taconite Plants |
Issue
Rural Utilities Service
Industry and Security Bureau
International Trade Administration
National Oceanic and Atmospheric Administration
Air Force Department
Centers for Disease Control and Prevention
Centers for Medicare & Medicaid Services
Children and Families Administration
Food and Drug Administration
National Institutes of Health
Coast Guard
Fish and Wildlife Service
Institute of Museum and Library Services
Federal Aviation Administration
Federal Motor Carrier Safety Administration
Federal Transit Administration
National Highway Traffic Safety Administration
Comptroller of the Currency
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.thefederalregister.org and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions.
Nuclear Regulatory Commission.
Final regulatory basis; availability.
The U.S. Nuclear Regulatory Commission (NRC) is making available a final regulatory basis document to support a rulemaking that would amend its regulations by adopting new cyber security requirements for certain nuclear fuel cycle facility (FCF) licensees in order to address safety, security, and safeguards consequences of concern. The NRC is not seeking public comments on this document. There will be an opportunity for formal public comment on the proposed rule when it is published in the
The final regulatory basis is publicly available April 12, 2016.
Please refer to Docket ID NRC-2015-0179 when contacting the NRC about the availability of information for this document. You may obtain publicly-available information related to this document by any of the following methods:
•
•
•
Matthew Bartlett, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-7154; email
In a September 4, 2015,
As the NRC continues its ongoing proposed rulemaking effort to implement cyber security requirements for FCFs in part 73 of title 10 of the
The NRC may post additional materials relevant to this rulemaking at
The Plain Writing Act of 2010, (Pub. L. 111-274) requires Federal agencies to write documents in a clear, concise, well-organized manner that also follows other best practices appropriate to the subject or field and the intended audience. Although regulations are exempt under the Act, the NRC is applying the same principles to its rulemaking documents. Therefore, the NRC has written this document to be consistent with the Plain Writing Act.
For the Nuclear Regulatory Commission.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule.
This rulemaking relieves burdens on pilots seeking to obtain aeronautical experience, training, and certification by increasing the allowed use of aviation training devices. These actions are necessary to bring the regulations in line with the current
This rule is effective May 12, 2016.
For information on where to obtain copies of rulemaking documents and other information related to this final rule, see “How To Obtain Additional Information” in the
Marcel Bernard, Airmen Certification and Training Branch, Flight Standards Service, AFS-810, Federal Aviation Administration, 898 Airport Park Road, Suite 204, Glen Burnie, MD 21061; telephone: (410) 590-5364 x235 email
This rule finalizes the notice of proposed rulemaking (NPRM) regarding the use of aviation training devices for pilot certification. 80 FR 34338 (Jun. 16, 2015). The NPRM proposed to increase the maximum time that may be credited in an aviation training device (ATD) toward the aeronautical experience requirements for an instrument rating under § 61.65(i). The NPRM proposed to permit a person to credit a maximum of 20 hours of aeronautical experience acquired in an approved ATD toward the requirements for an instrument rating. By letter of authorization (LOA), devices that qualify as advanced aviation training devices (AATDs) were proposed to be authorized for up to 20 hours of experience to meet the instrument time requirements. Devices that qualify as basic aviation training devices (BATDs) were proposed to be authorized, by LOA, for a maximum of 10 hours of experience to meet the instrument time requirements.
Based on the comments received to the NPRM, the FAA is revising § 61.65 to include a specified allowance of 10 hours for BATDs and 20 hours for AATDs in part 61 (combined use not to exceed 20 hours) for the instrument rating.
The NPRM also addressed the use of ATDs in approved instrument rating courses. The NPRM proposed to amend appendix C to part 141 to increase the limit on the amount of training hours that may be accomplished in an ATD in an approved course for an instrument rating. The FAA proposed to allow ATDs to be used for no more than 40% of the total flight training hour requirements in an approved instrument rating course.
Based on the comments received to the NPRM, the FAA is revising appendix C to part 141 to include a specified allowance of 25% of creditable time in BATDs
Currently, § 61.65(i) requires a pilot who is logging instrument time in an ATD to wear a view-limiting device. The NPRM proposed to revise § 61.65(i)(4) to eliminate the requirement that pilots accomplishing instrument time in an ATD wear a view-limiting device. The FAA is finalizing this proposal without change.
The FAA's authority to issue rules on aviation safety is found in Title 49 of the United States Code (49 U.S.C.). Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in 49 U.S.C. 106(f), which establishes the authority of the Administrator to promulgate regulations and rules; 49 U.S.C. 44701(a)(5), which requires the Administrator to promote safe flight of civil aircraft in air commerce by prescribing regulations and setting minimum standards for other practices, methods, and procedures necessary for safety in air commerce and national security; and 49 U.S.C. 44703(a), which requires the Administrator to prescribe regulations for the issuance of airman certificates when the Administrator finds, after investigation, that an individual is qualified for, and physically able to perform the duties related to, the position authorized by the certificate.
Since the 1970s, the FAA has gradually expanded the permitted use of flight simulation for training—first permitting simulation to be used in air carrier training programs and eventually permitting pilots to credit time in devices toward the aeronautical experience requirements for airman certification and recency. Currently, title 14 of the Code of Federal Regulations (14 CFR) part 60 governs the qualification of flight simulation training devices (FSTDs), which include full flight simulators (FFSs) level A through D and flight training devices (FTDs) levels 4 through 7. The FAA has, however, approved other devices, including ATDs, for use in pilot certification training, under the authority provided in 14 CFR 61.4(c).
For over 30 years, the FAA has issued LOAs to manufacturers of ground trainers, personal computer-based aviation training devices (PCATD), FTDs (levels 1 through 3), BATDs, and AATDs. These LOAs were based on guidance provided in advisory circulars (ACs) that set forth the qualifications and capabilities for the devices. Prior to 2008, most LOAs were issued under the guidance provided in AC 61-126, Qualification and Approval of Personal Computer-Based Aviation Training Devices, and AC 120-45, Airplane Flight Training Device Qualification. Starting in July 2008, the FAA approved devices in accordance with AC 61-136, FAA Approval of Basic Aviation Training Devices (BATD) and Advanced Aviation Training Devices (AATD). More recently, on December 3, 2014, the FAA published a revision to AC 61-136A, Approval of Aviation Training Devices and Their Use for Training and Experience.
In 2009, the FAA issued a final rule that for the first time introduced the term “aviation training device” into the regulations and placed express limits on the amount of instrument time in an ATD that could be credited toward the aeronautical experience requirements for an instrument rating.
Since the 2009 final rule, § 61.65(i) has provided that no more than 10 hours of instrument time received in an ATD may be credited toward the instrument time requirements of that section. In addition, appendix C to part 141 permits an ATD to be used for no more than 10% of the total flight training hour requirements of an approved course for an instrument rating.
Prior to the 2009 final rule, the FAA had issued hundreds of LOAs to
On January 2, 2014, the FAA published a notice of policy requiring manufacturers of ATDs to obtain new LOAs reflecting the appropriate regulatory allowances for ATD use. 79 FR 20.
As stated in the notice of policy, this short term exemption expired on January 1, 2015. The FAA explained that after that date, no applicant training for an instrument rating under part 61 may use more than 10 hours of instrument time in an ATD toward the minimum aeronautical experience requirements required to take the practical test for an instrument rating.
To address the discrepancy between the level of ATD credit allowed historically by LOA and the lower allowances placed in the regulations, the FAA published a direct final rule that would have amended the regulations governing the use of ATDs.
In the direct final rule, the FAA stated its belief that permitting pilots to log increased time in ATDs would encourage pilots to practice maneuvers until they are performed to an acceptable level of proficiency. In an ATD, a pilot can replay the training scenario, identify any improper action, practice abnormal/emergency procedures, and determine corrective actions without undue hazard or risk to persons or property. In this fashion, a pilot can continue to practice tasks and maneuvers in a safe, effective, and cost efficient means of maintaining proficiency.
As described in the previous section, to address the discrepancy between FAA regulations and prior policy, on December 3, 2014, the FAA published a direct final rule that would have increased the allowed use of ATDs. The FAA received 20 comments to the direct final rule.
The purpose of a view-limiting device is to prevent a pilot (while training in an aircraft during flight) from having outside visual references that would naturally be present otherwise. These references are not available in a training device and a pilot has no opportunity to look outside for any useful visual references pertaining to the simulation. The FAA recognizes that the majority of these devices have a simulated visual
When the FAA introduced § 61.65(i)(4) requiring view-limiting devices in the 2009 final rule, the preamble was silent as to why a view-limiting device was necessary. 74 FR 42500, 42523. Based on comments from industry, the FAA has determined that due to the sophistication of the flight visual representation for ATDs and the capability of presenting various weather conditions appropriate to the training scenario, a view-limiting device is unnecessary. Because persons operating an ATD can simulate both instrument and visual conditions, FAA LOAs specifically reference § 61.51 that stipulates a pilot can log instrument time only when operating the aircraft solely by reference to the instruments in actual or simulated instrument flight conditions.
After consideration of the comments received to the direct final rule, on June 16, 2015, the FAA published a notice of proposed rulemaking (80 FR 34338) proposing the following changes to 14 CFR parts 61 and 141. These changes were the same as in the direct final rule, 79 FR 71634, (Dec. 3, 2014), withdrawn at 80 FR 2001, (Jan. 15, 2015).
The FAA received a total of 60 comments to the notice of proposed rulemaking, 50 from individuals; five from flight schools; three from organizations representing pilots and flight instructors, including the Society of Aviation and Flight Educators (SAFE), the Aircraft Owners and Pilots Association (AOPA), and the National Association of Flight Instructors (NAFI); one from an anonymous commenter purporting to represent Garmin International; and one from ATD manufacturer Redbird Flight Simulations. The proposed provisions, the comments received, and FAA's responses are discussed in the following sections.
The FAA proposed to increase the maximum time that may be credited in an ATD toward the instrument time requirements for an instrument rating under § 61.65(i). A person would be permitted to credit a maximum of 20 hours of instrument time in an approved ATD toward the requirements for an instrument rating.
The FAA also proposed to amend appendix C to part 141 to increase the limit on the amount of training hours that may be accomplished in an ATD in an approved course for an instrument rating. An ATD could be used for no more than 40% of the total flight training hour requirements in an instrument rating course. The proposed rule did not change the current provisions in appendix C which limit credit for training in FFSs, FTDs, and ATDs, that if used in combination, cannot exceed 50% of the total flight training hour requirements of an instrument rating course.
In addition, the FAA proposed to amend § 141.41 to clarify the existing qualification and approval requirement for FSTDs and to add the qualification and approval of ATDs by the FAA, which is currently conducted pursuant to § 61.4(c).
The FAA received 57 comments in support of these proposed provisions, with 47 from individuals and 10 from organizations. Of the 57 comments received in support of the proposed rule, five recommended changes to the proposed regulations.
Nineteen individual commenters provided general support for the proposed rule. Nine commenters who identified themselves as pilots who had used ATDs for their own training provided support for the rule. They emphasized the value of being able to have a flight instructor pause the training, discuss the scenario, provide instant feedback and additional instruction, and then continue the training session. These individuals also believed that their training was enhanced by the ability to focus on the specific training tasks and ensure accurate, appropriate learning of the lesson. Commenters also noted that in an ATD instructors can focus solely on teaching rather than dividing their focus between teaching important instrument skills and general aircraft operations.
Commenters also emphasized the value of being presented with training scenarios that cannot be accomplished safely in the aircraft. Commenters cited emergency procedures, flight into thunderstorms, icing, and turbulent conditions as primary examples of conditions that can be simulated safely in ATDs.
SAFE, NAFI, and Redbird Flight Simulations also noted the ability of current ATDs to simulate a variety of aircraft types and configurations, as well as to simulate various conditions inside and outside the aircraft.
A number of individual commenters also noted the value, both financial and time saving, of accomplishing more repetitions in the same amount of time when using an ATD as opposed to using an aircraft. Two individual commenters estimated that time in an approved simulator with an instructor costs about $100 per hour, while dual time in an instrument flight rules-certified aircraft is $200 per hour or more. These commenters asserted that adding an extra 10 hours of simulator time cuts $1,000 from the overall training cost. NAFI also noted that because the training is independent of weather and air traffic control conditions, a training syllabus can be followed more closely with use of the ATDs and the student can avoid unplanned, non-productive
Thirteen commenters who identified themselves as flight instructors supported the rule. They echoed the sentiments of those commenters who identified themselves as pilots who had used ATDs for their own training. Commenters discussed the belief that ATDs save lives, reduce training time and cost, reduce atmospheric and noise pollution, and produce safer pilots. They particularly noted the ability to train scenarios that would not be trained using an aircraft—thunderstorms, icing, etc. They emphasized the value of scenario-based training, followed closely by training in an aircraft. These commenters noted the importance of being able to train students regarding emergency procedures using meaningful repetition, until the commenters confirm the student's mastery of those skills. AOPA supported this view, stating that simulator training for an instrument rating allows instructors to provide a safer, more effective training experience. Redbird Flight Simulations also supported this view, stating that the ATD is the ideal place to learn, ask questions and practice, and the aircraft is the place where the student demonstrates what he or she has learned and can focus on gaining real-world flying experience with the basic fundamental instrument skills already engrained.
A few commenters noted that students whom they had trained initially in ATDs found the experience so useful that they returned for recurrent training in those same ATDs. One commenter noted FAA's inferred endorsement of the use of AATDs in Instrument Practical Test Standard (FAA-S-8081-4E, Chg 5) by the inclusion of tasks for an instrument proficiency check which may be credited using an AATD.
Five commenters commenting on behalf of flight schools also concurred with these comments. These commenters discussed the ability for pilots to practice situations and procedures that would not “normally” be possible to accomplish safely in an aircraft, including various weather conditions and simulated instrument failures. Commenters focused on the unique training that ATDs allow instructors to provide. As two commenters noted,
Aircraft are not classrooms and as such they are poor environments for learning. The AATDs allow for students experiencing difficult learning situations the opportunity to repeat the lesson easily, safely and as frequently as needed. Importantly, the instructor is able to focus entirely on teaching rather than splitting his/her attention on traffic, ATC instructions and safe aircraft operation.
These commenters emphasized that ATDs are only one component of the training curriculum and process, and that all learning in an ATD would be accompanied by training in the aircraft. They also noted that ATDs and aircraft do not replace each other. NAFI agreed, pointing out that a significant portion of training would still be required in an aircraft under the proposed regulations.
Commenters, including SAFE and several individuals, noted the use of simulators by other industries, including the United States military and air carriers. SAFE specifically cited a 1998 United States Air Force study regarding the transfer of training effectiveness.
One commenter noted the safety benefit of ATDs related to decommissioning of very high frequency omni-directional radio range (VORs), non-directional beacons (NDBs), the scarcity of localizer back-courses, and scarcity of outer markers. The commenter noted that the practical test standards still require the demonstration of a VOR approach for an instrument candidate. As the commenter explained:
Thus, instrument instructors must use a more limited set of VORs to conduct VOR instrument approach training, resulting in greater congestion around VORs during training maneuvers. Numerous FAA publications suggest avoiding concentrations around VORS, such as FAA-P-8740-51, `How to Avoid a Midair Collision.' When one considers finding VOR approaches located on the airport (without a final approach fix) and those conducted off airport (those with a final approach fix), the amount of time an instructor must spend exposed to the risk of a midair collision is quite large. The risk of a midair collision is non-existent in an ATD.
In the NPRM, the FAA specifically sought “. . . comment regarding any additional relevant data or institutional research that supports the training and safety advantages when using ATDs, or establishes that such devices do not enhance pilot training and flight safety.”
The FAA received two comments that specifically addressed this request.
One individual commenter cited an unpublished dissertation
In her dissertation study, Kearns compared simulators far less capable then [sic] ATDs to a guided mental practice experimental technique. Though her results did not specifically evaluate ATDs, Kearn [sic] demonstrated how ATD-level simulators (and guided mental practice) effectively train skills enhancing mental workload and situational awareness.
The study author described the study as follows:
The purpose of this investigation was to assess the feasibility of guided mental practice, as an instructional strategy, embedded within an asynchronous computer-based non-technical training program for pilots. Two asynchronous computer-based single pilot resource management (SRM) training programs were developed for the study, varying only in the
The study author defined guided mental practice as:
Three groups were formed in the study (a) SRM training with hands-on practice, (b) SRM training with mental practice, and (c) a control group that received no training. The study used a sample size of 12 participants per condition.
The study found that although no difference existed between the practice conditions, groups that completed training with either hands-on or mental practice demonstrated improved situation awareness over the group that did not receive any training as measured by the situation awareness global assessment technique (SAGAT). Significant findings were not found with either of the metrics meant to assess workload: The National Aeronautics and Space Administration's task load index (NASA-TLX), and secondary task (ST) metrics.
While this study did not directly address whether ATDs or other simulators provide benefit by increasing learning of piloting skills, it does appear to indicate that deliberate practice is important to pilot training, and that any practice, whether in a simulator or watching a video of a simulation and imagining oneself as the pilot, is more beneficial than no use of simulation at all in advance of the skill evaluation. While the FAA believes that this study may provide useful information for its area of interest, the study was not focused on the decision point the FAA was considering regarding whether to move forward with this regulatory change—that is, data or institutional research that supports the training and safety advantages when using ATDs, or establishes that such devices do not enhance pilot training and flight safety. Situational awareness is one of many elements to be considered in evaluating pilot training and safety. The study did not consider whether skill sets were better learned by use of either guided mental practice or hands-on use of a simulator as compared with training in an aircraft only.
SAFE asserted that research shows that when properly utilized as part of a comprehensive training program such training devices actually speed up the learning process by allowing students to bypass areas of successful understanding and to concentrate on areas where more understanding and practice is required.
The purpose of this report was to review recent studies regarding the effectiveness of flight simulators as augmentation for “hands-on” flying training. Simulation-based training has been proposed to reduce costs, extend aircraft life, maintain flying proficiency, and provide more effective training, especially in areas difficult to train in operational aircraft. A review of the literature from 1986 to 1997 identified 67 articles, conference papers, and technical reports regarding simulator flying training and transfer. Of these, only 13 were related directly to transfer of training from the simulator to the aircraft. Studies of simulator effectiveness for training landing skills constituted a majority of the transfer studies, although a few examined other flying skills such as radial bombing accuracy and instrument and flight control. Results indicate that simulators are useful for training landing skills, bombing accuracy, and instrument and flight control. Generally, as the number of simulated sorties increases, performance improves, but this gain levels off after approximately 25 missions. Further, several studies indicate that successful transfer may not require high-fidelity simulators or whole-task training, thus reducing simulator development costs.
Evaluation of this literature is difficult for many reasons. Typically, researchers fail to report sufficient detail regarding research methods, training characteristics, and simulator fidelity. In addition to these methodological concerns, there is a lack of true simulator-to-aircraft transfer studies involving complex pilot skills. This may be due to problems such as inadequate simulator design, cost, and availability, and access to simulators in operational flying units. Future directions in simulator transfer of training are discussed.
Their literature review found that numerous studies conducted between 1986 and 1997 indicated that simulators were found to be useful for training landing skills. As the number of simulated sorties increased, performance increased, but the performance gain appeared to level off after approximately 25 missions. Two other studies considered for the literature review suggest that simulators provide an effective means to train instrument procedures and flight control. The results suggest that in order to produce transfer to the aircraft it may be necessary to train only the critical components of the task rather than the whole task. Authors emphasized the limitations of the literature review, including a lack of information regarding the simulator fidelity characteristics, research methods, and training characteristics among other challenges.
While the FAA found this literature review to provide some limited support for the agency's position, the review did not provide significant support for this position. Given the lack of information regarding simulators used, the effectiveness of the skills transfer, and the age of the review itself, it is likely that the literature review cannot be used to directly support the FAA's position. The FAA notes that FSTD and ATD technology has evolved significantly since this literature review was written and for that reason alone it is possible that studies conducted today would show different conclusions regarding the effectiveness of skill transfer, as simulators at all levels are more realistic and have greater information from which to provide simulation than that which existed 20 years ago.
Nonetheless, the FAA agrees that the use of ground based training devices in advance of flight training in an aircraft speeds up the overall process of learning. The FAA believes that practice decreases the time required in an actual aircraft to reach a level of proficiency required to successfully complete a practical test for a pilot certificate or rating. The Air Force research paper referenced by SAFE supports this assertion, but does not directly address the current capabilities of ATDs.
The individual commenter also believed that allowing increased hours in ATDs would increase economic demand for ATDs, thereby increasing competition and resulting in lower ATD
As noted previously, the intent of the specific request for information was to seek any additional relevant data or institutional research that supports the training and safety advantages when using ATDs, or establishes that such devices do not enhance pilot training and flight safety. The intent of this regulation is not to foster development of ATDs. The FAA emphasizes that even without this regulation persons are permitted to use ATDs and FSTDs to gain further experience in addition to any time that may be expressly creditable when using ATDs or FSTDs under the regulations.
Finally, the commenter asserted that economic growth of ATDs will offer enhanced applications of ATDs by researchers and innovators, contributing to aviation safety.
The FAA received five comments supporting the proposed rule but recommending changes to the proposed regulations. One commenter noted that in the proposed rule the FAA differentiated between the number of hours that were proposed to be credited toward the aeronautical experience requirements in an AATD (20 hours) versus a BATD (10 hours). The commenter noted that these differences were not stipulated in the proposed text of 14 CFR 61.65(i) regarding credit for aeronautical experience for the instrument rating, and that no differentiation was made between AATDs and BATDs in part 141 regarding approved instrument rating courses—either in the preamble or the regulatory text.
Currently, under the conditions and limitations set forth in the LOAs, training providers must provide copies of LOAs to people who receive training in the device. By providing a copy of the LOA, pilots who receive training will know the amount of training that may be logged in the device for the purpose of meeting the aeronautical experience requirements for a certificate or rating.
The same commenter believed that there could be confusion regarding the amount of time that can be credited when using a BATD, and when using percentages of simulator, FTD, AATD and BATD time that can be used in combination. For example, the commenter asserted that under appendix C to part 141, section 4(b)(4) as proposed, providing 40% of the required training in a BATD and 10% in a simulator would satisfy the letter of the rule.
The same commenter believed that the FAA was being inconsistent in its treatment of time that could be credited when using a BATD in part 61 versus part 141. The commenter noted that the FAA had proposed that 10 hours of the 40 hours required could be obtained using a BATD under part 61 (25% of the hours needed), whereas the FAA had proposed that 10% of the hours could be credited in a BATD under part 141 (3.5 hours).
One commenter noted that the FAA does not differentiate regarding the use of AATDs versus BATDs anywhere else in part 141. The commenter believed that by differentiating AATDs from BATDs, it would now be possible to allow credit for AATD use toward flight times for private pilot, commercial pilot, flight instructor and additional rating courses. Another commenter requested that the FAA consider expanding the utilization of these devices for the private pilot rating as well from the current 2.5 hours to 10 hours. Another
One commenter asserted that current regulations regarding the use of ATDs for instrument proficiency checks under 14 CFR 61.57 is confusing. The commenter noted that § 61.57(d)(1)(i) specifies that the instrument proficiency check must be conducted in an aircraft while the Instrument Practical Test Standard specifies that both FSTDs or AATDs may be used for part or all of the instrument proficiency check. The commenter recommended that the regulations be clarified to correspond to the practical test standard.
One commenter requested a variety of changes to § 61.57(c) regarding instrument experience and recency for pilots in command. The commenter highlighted differences between current requirements for completing instrument experience using an ATD to maintain instrument experience (§ 61.57(c)(3)); completing instrument recency experience using a combination of an aircraft and a full flight simulator, FTD, and ATD (§ 61.57(c)(4)); and completing instrument experience using a combination of a flight simulator or FTD, and an ATD (§ 61.57(c)(5)).
Finally, one commenter recommended changes to permit ground instructors to use ATDs to train their students.
Three commenters opposed the proposed provisions.
One commenter, who identified himself as a flight instructor, believed that new instrument pilots need the stress, noise, and feeling of the real airplane when forming their habits and acquiring their skills, not the quiet, controlled, sterile atmosphere of a simulator. While the commenter supported the use of simulators later, he did not believe they are appropriate for new pilots.
The FAA also contends that because a significant portion of the instrument time must be accomplished in an aircraft, the stress and noise experience and the feeling for the real environment discussed by the commenter will be provided during that time. Additionally, the FAA notes that § 61.65(d)(2)(i) (airplane) and § 61.65(e)(2)(i) (helicopter) currently require that three hours of training must be accomplished in an aircraft within two months of the practical test. The required instrument training on cross country procedures under instrument flight rules, including a flight of 250 nautical miles with at least three different instrument approaches and an instrument approach at each airport, must also be accomplished in an aircraft.
The FAA believes that training in FSTDs and ATDs, when used in conjunction with training in an aircraft, teach an instrument student to trust the appropriate sense, vision, in order to successfully operate an aircraft in low visibility conditions. Training in an ATD reinforces this necessary skill. Any reliance on “sounds or feel” may ultimately lead to loss of control when operating an aircraft in instrument meteorological conditions (IMC). Because ignoring the postural senses involves relying on visual clues, the ATD provides an excellent platform for a pilot to develop this portion of his or her instrument flying skills. A person must use his or her vision and focus on the flight instruments to successfully operate an aircraft, FSTD, or ATD in IMC conditions. The FAA recognizes that training devices do not require motion in order to be approved as an ATD; thus, these devices are limited in that they cannot completely train the pilot to ignore outside sensory perceptions. However, the FAA finds that a pilot can develop this ability during the aeronautical experience that an applicant for an instrument rating must obtain in an aircraft.
Another commenter, who also identified himself as a flight instructor, believed that FTDs and simulators do a good job at pretending to be an airplane in terms of learning procedures, but
The third commenter addressed specific comments relating to a particular ATD. The commenter referenced Redbird ATDs, and asserted that:
[T]heir panels are limiting in the sense that switches are not the same in the simulator as it is [sic] in the airplane. . . . The Redbird simulator does not provide a volume knob for either the COM or NAV which contains the ID mode. This is a required step in order to properly identify a VOR station. . . . The standby instruments is graphically depicted but the position of these instruments does not reflect the real location of where these instruments are installed.
The commenter also expressed concern regarding updated databases to these training devices. The commenter believed that any ATD should be required to have the latest navigation database running on the ATD.
Two commenters expressed strong objections to the path the FAA took regarding this rulemaking. They objected to the withdrawal of the direct final rule, and believed that the adverse comments the FAA received during the comment period for the direct final rule should not have caused the agency to withdraw the rulemaking. They also believed the FAA should have acted more quickly once the original discrepancy between the regulations and policy was identified.
The FAA proposed to revise § 61.65(i)(4) to eliminate the requirement that pilots accomplishing instrument time in an ATD wear a view-limiting device. The FAA emphasizes, however, that a pilot—whether in an aircraft, FFS, FTD, or ATD—may log instrument time only when the pilot is operating solely by reference to the instruments under actual or simulated conditions. If a pilot is using an ATD and the device is providing visual references upon which the pilot is relying, this would not constitute instrument time under § 61.51(g).
While considering these changes, the FAA became aware that other appendices in part 141 reference § 141.41(a) when discussing FFS, and § 141.41(b) when discussing FTDs and ATDs. As this rule consolidates requirements related to FFS and FTDs into § 141.41(a), and adds new paragraph (b) related to ATDs, the FAA
Further, while considering these regulatory changes, the FAA noted that the nomenclature regarding flight simulators has changed. The definition as found in § 1.1 references a “full flight simulator” whereas the regulations often use the older nomenclature “flight simulator.” Therefore, in the sections the FAA has determined need to be revised as part of the final rule, the FAA is removing the words “flight simulator” wherever they appear and replacing them with the words “full flight simulator.”
To further implement this rule, the FAA is revising the following FAA Order: FAA Order 8900.1, Flight Standards Information Management System, Volume 11, Chapter 10, Section 1, (Basic and Advanced Aviation Training Device) Approval and Authorized Use under 14 CFR parts 61 and 141.
Changes to Federal regulations must undergo several economic analyses. First, Executive Order 12866 and Executive Order 13563 direct that each Federal agency shall propose or adopt a regulation only upon a reasoned determination that the benefits of the intended regulation justify its costs. Second, the Regulatory Flexibility Act of 1980 (Pub. L. 96-354), as codified in 5 U.S.C. 603
In conducting these analyses, FAA has determined that this rule: (1) Has benefits that justify its costs; (2) is not an economically “significant regulatory action” as defined in section 3(f) of Executive Order 12866; (3) is not “significant” as defined in DOT's Regulatory Policies and Procedures; (4) will not have a significant economic impact on a substantial number of small entities; (5) will not create unnecessary obstacles to the foreign commerce of the United States; and (6) will not impose an unfunded mandate on State, local, or tribal governments, or on the private sector by exceeding the threshold identified above. These analyses are summarized below.
Department of Transportation DOT Order 2100.5 prescribes policies and procedures for simplification, analysis, and review of regulations. If the expected cost impact is so minimal that a proposed or final rule does not warrant a full evaluation, this order permits that a statement to that effect and the basis for it be included in the preamble if a full regulatory evaluation of the costs and benefits is not prepared. Such a determination has been made for this final rule. The reasoning for this determination follows.
The provisions included in this rule are either relieving or voluntary. The elimination of the requirement to use a view-limiting device is a relieving provision. The other two provisions are voluntary and cost relieving—additional ATD credit for instrument time for an instrument rating and additional ATD credit for approved instrument courses, if acted upon, is less expensive than flight training time. The FAA made the same cost-benefit determination as part of the direct final rule (79 FR 71634, Dec. 3, 2014) and on this part of the notice of proposed rulemaking (80 FR 34338, Jun. 16, 2015) and received no comments.
Two commenters, both of whom identified themselves as private pilots working toward their instrument ratings, discussed the potential for cost relief provided by the proposed rule. Both commenters estimated that time in an approved simulator with an instructor costs about $100 per hour, while dual time in an instrument flight rules-certified aircraft is $200 per hour or more. These commenters asserted that adding an extra 10 hours of simulator time reduces $1,000 from the overall training cost.
Persons who use the new provisions will do so only if the benefit they will accrue from their use exceeds the costs they might incur to comply. Given the hundreds of LOAs issued, industry's high usage of ATDs, and SAFE's, AOPA's, and NAFI's endorsements of ATDs, the change in requirements is likely to be relieving. Benefits will exceed the costs of a voluntary rule if just one person voluntarily complies.
Since this rule will offer a lower cost alternative, will provide regulatory relief for the use of view-limiting devices, and will allow greater voluntary use of ATDs, the expected outcome will be cost relieving to minimal impact with positive net benefits.
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.
However, if an agency determines that a rule is not expected to have a significant economic impact on a substantial number of small entities, section 605(b) of the RFA provides that the head of the agency may so certify and a regulatory flexibility analysis is not required. The certification must include a statement providing the factual basis for this determination, and the reasoning should be clear.
Most of the parties affected by this rule will be small businesses such as flight instructors, aviation schools, and fixed base operators. The general lack of publicly available financial information from these small businesses precludes a financial analysis of these small businesses. While there is likely a substantial number of small entities affected, the provisions of this rule are either relieving (directly provides cost relief) or voluntary (provides benefits or costs only if a person voluntarily chooses to use the rule provision). Thus,
If an agency determines that a rulemaking will not result in a significant economic impact on a substantial number of small entities, the head of the agency may so certify under section 605(b) of the RFA. Therefore, as provided in section 605(b), the head of the FAA certifies that this rulemaking will not result in a significant economic impact on a substantial number of small entities.
The Trade Agreements Act of 1979 (Pub. L. 96-39), as amended by the Uruguay Round Agreements Act (Pub. L. 103-465), prohibits Federal agencies from establishing standards or engaging in related activities that create unnecessary obstacles to the foreign commerce of the United States. Pursuant to these Acts, the establishment of standards is not considered an unnecessary obstacle to the foreign commerce of the United States, so long as the standard has a legitimate domestic objective, such as the protection of safety, and does not operate in a manner that excludes imports that meet this objective. The statute also requires consideration of international standards and, where appropriate, that they be the basis for U.S. standards.
The FAA has assessed the potential effect of this rule and determined that it will have only a domestic impact and therefore will not create unnecessary obstacles to the foreign commerce of the United States.
Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires each Federal agency to prepare a written statement assessing the effects of any Federal mandate in a proposed or final agency rule that may result in an expenditure of $100 million or more (in 1995 dollars) in any one year by State, local, and tribal governments, in the aggregate, or by the private sector; such a mandate is deemed to be a “significant regulatory action.” The FAA currently uses an inflation-adjusted value of $155.0 million in lieu of $100 million.
This rule does not contain such a mandate. Therefore, the requirements of Title II of the Act do not apply.
The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires that the FAA consider the impact of paperwork and other information collection burdens imposed on the public. The FAA has determined that there is no new requirement for information collection associated with this rule.
In keeping with U.S. obligations under the Convention on International Civil Aviation, it is FAA policy to conform to International Civil Aviation Organization (ICAO) Standards and Recommended Practices to the maximum extent practicable. The FAA has reviewed the corresponding ICAO Standards and Recommended Practices and has identified no differences with these regulations.
FAA Order 1050.1F identifies FAA actions that are categorically excluded from preparation of an environmental assessment or environmental impact statement under the National Environmental Policy Act in the absence of extraordinary circumstances. The FAA has determined this rulemaking action qualifies for the categorical exclusion identified in paragraph 5-6.6 and involves no extraordinary circumstances.
The FAA has analyzed this rule under the principles and criteria of Executive Order 13132, Federalism. The agency has determined that this action will not have a substantial direct effect on the States, or the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of government, and, therefore, would not have Federalism implications.
The FAA analyzed this rule under Executive Order 13211, Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use (May 18, 2001). The agency has determined that it will not be a “significant energy action” under the executive order and will not be likely to have a significant adverse effect on the supply, distribution, or use of energy.
Executive Order 13609, Promoting International Regulatory Cooperation, (77 FR 26413, May 4, 2012) promotes international regulatory cooperation to meet shared challenges involving health, safety, labor, security, environmental, and other issues and to reduce, eliminate, or prevent unnecessary differences in regulatory requirements. The FAA has analyzed this action under the policies and agency responsibilities of Executive Order 13609, and has determined that this action would have no effect on international regulatory cooperation.
An electronic copy of rulemaking documents may be obtained from the Internet by—
• Searching the Federal eRulemaking Portal (
• Visiting the FAA's Regulations and Policies Web page at
• Accessing the Government Publishing Office's Web page at
Copies may also be obtained by sending a request (identified by docket or amendment number of the rule) to the Federal Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence Avenue SW., Washington, DC 20591, or by calling (202) 267-9677.
All documents the FAA considered in developing this rule, including economic analyses and technical reports, may be accessed from the Internet through the Federal eRulemaking Portal referenced previously.
Comments received may be viewed by going to
The Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA) requires FAA to comply with
Aircraft, Airmen, Aviation safety, Teachers.
Airmen, Educational facilities, Reporting and recordkeeping requirements, Schools.
In consideration of the foregoing, the Federal Aviation Administration amends chapter I of title 14, Code of Federal Regulations as follows:
49 U.S.C. 106(f), 106(g), 40113, 44701-44703, 44707, 44709-44711, 44729, 44903, 45102-45103, 45301-45302.
The revision and addition read as follows:
(i)
(1) The device is approved and authorized by the FAA;
(2) An authorized instructor provides the instrument time in the device; and
(3) The FAA approved the instrument training and instrument tasks performed in the device.
(j) Except as provided in paragraph (h)(1) of this section, a person may not credit more than 20 total hours of instrument time in a full flight simulator, flight training device, aviation training device, or a combination towards the instrument time requirements of this section.
49 U.S.C. 106(f), 106(g), 40113, 44701-44703, 44707, 44709, 44711, 45102-45103, 45301-45302.
An applicant for a pilot school certificate or a provisional pilot school certificate must show that its full flight simulators, flight training devices, aviation training devices, training aids, and equipment meet the following requirements:
(a)
(1) Qualified under part 60 of this chapter, or a previously qualified device, as permitted in accordance with § 60.17 of this chapter; and
(2) Approved by the Administrator for the tasks and maneuvers.
(b)
(c)
4.
(c) For use of full flight simulators or flight training devices:
(1) The course may include training in a full flight simulator or flight training device, provided it is representative of the aircraft for which the course is approved, meets the requirements of this paragraph, and the training is given by an authorized instructor.
(2) Training in a full flight simulator that meets the requirements of § 141.41(a) may be credited for a maximum of 20 percent of the total flight training hour requirements of the approved course, or of this section, whichever is less.
(3) Training in a flight training device that meets the requirements of § 141.41(a) may be credited for a maximum of 15 percent of the total flight training hour requirements of the approved course, or of this section, whichever is less.
(4) Training in full flight simulators or flight training devices described in paragraphs (c)(2) and (3) of this section, if used in combination, may be credited for a maximum of 20 percent of the total flight training hour requirements of the approved course, or of this section, whichever is less. However, credit for training in a flight training device that meets the requirements of § 141.41(a) cannot exceed the limitation provided for in paragraph (c)(3) of this section.
4.
(b) For the use of full flight simulators, flight training devices, or aviation training devices—
(1) The course may include training in a full flight simulator, flight training device, or aviation training device, provided it is representative of the aircraft for which the course is approved, meets the requirements of this paragraph, and the training is given by an authorized instructor.
(2) Credit for training in a full flight simulator that meets the requirements of § 141.41(a) cannot exceed 50 percent of the total flight training hour requirements of the course or of this section, whichever is less.
(3) Credit for training in a flight training device that meets the requirements of § 141.41(a), an advanced aviation training device that meets the requirements of § 141.41(b), or a combination of these devices cannot exceed 40 percent of the total flight training hour requirements of the course or of this section, whichever is less. Credit for training in a basic aviation training device that meets the requirements of § 141.41(b) cannot exceed 25 percent of the total training hour requirements permitted under this paragraph.
(4) Credit for training in full flight simulators, flight training devices, and aviation training devices if used in
4.
(c) For the use of full flight simulators or flight training devices:
(1) The course may include training in a full flight simulator or flight training device, provided it is representative of the aircraft for which the course is approved, meets the requirements of this paragraph, and is given by an authorized instructor.
(2) Training in a full flight simulator that meets the requirements of § 141.41(a) may be credited for a maximum of 30 percent of the total flight training hour requirements of the approved course, or of this section, whichever is less.
(3) Training in a flight training device that meets the requirements of § 141.41(a) may be credited for a maximum of 20 percent of the total flight training hour requirements of the approved course, or of this section, whichever is less.
(4) Training in the flight training devices described in paragraphs (c)(2) and (3) of this section, if used in combination, may be credited for a maximum of 30 percent of the total flight training hour requirements of the approved course, or of this section, whichever is less. However, credit for training in a flight training device that meets the requirements of § 141.41(a) cannot exceed the limitation provided for in paragraph (c)(3) of this section.
4.
(b) For the use of full flight simulators or flight training devices—
(1) The course may include training in a full flight simulator or flight training device, provided it is representative of the aircraft for which the course is approved, meets the requirements of this paragraph, and the training is given by an authorized instructor.
(2) Training in a full flight simulator that meets the requirements of § 141.41(a) may be credited for a maximum of 50 percent of the total flight training hour requirements of the approved course, or of this section, whichever is less.
(3) Training in a flight training device that meets the requirements of § 141.41(a) may be credited for a maximum of 25 percent of the total flight training hour requirements of the approved course, or of this section, whichever is less.
(4) Training in full flight simulators or flight training devices described in paragraphs (b)(2) and (3) of this section, if used in combination, may be credited for a maximum of 50 percent of the total flight training hour requirements of the approved course, or of this section, whichever is less. However, credit for training in a flight training device that meets the requirements of § 141.41(a) cannot exceed the limitation provided for in paragraph (b)(3) of this section.
4.
(b) For the use of flight simulators or flight training devices:
(1) The course may include training in a full flight simulator or flight training device, provided it is representative of the aircraft for which the course is approved, meets the requirements of this paragraph, and the training is given by an authorized instructor.
(2) Training in a full flight simulator that meets the requirements of § 141.41(a), may be credited for a maximum of 10 percent of the total flight training hour requirements of the approved course, or of this section, whichever is less.
(3) Training in a flight training device that meets the requirements of § 141.41(a), may be credited for a maximum of 5 percent of the total flight training hour requirements of the approved course, or of this section, whichever is less.
(4) Training in full flight simulators or flight training devices described in paragraphs (b)(2) and (3) of this section, if used in combination, may be credited for a maximum of 10 percent of the total flight training hour requirements of the approved course, or of this section, whichever is less. However, credit for training in a flight training device that meets the requirements of § 141.41(a) cannot exceed the limitation provided for in paragraph (b)(3) of this section.
4.
(b) For the use of full flight simulators or flight training devices:
(1) The course may include training in a full flight simulator or flight training device, provided it is representative of the aircraft for which the course is approved for, meets requirements of this paragraph, and the training is given by an instructor.
(2) Training in a full flight simulator that meets the requirements of § 141.41(a), may be credited for a maximum of 10 percent of the total flight training hour requirements of the approved course, or of this section, whichever is less.
(3) Training in a flight training device that meets the requirements of § 141.41(a), may be credited for a maximum of 5 percent of the total flight training hour requirements of the approved course, or of this section, whichever is less.
(4) Training in full flight simulators or flight training devices described in paragraphs (b)(2) and (3) of this section, if used in combination, may be credited for a maximum of 10 percent of the total flight training hour requirements of the approved course, or of this section, whichever is less. However, credit for training in a flight training device that meets the requirements of § 141.41(b) cannot exceed the limitation provided for in paragraph (b)(3) of this section.
4.
(b) For the use of full flight simulators or flight training devices:
(1) The course may include training in a full flight simulator or flight training device, provided it is representative of the aircraft for which the course is approved, meets requirements of this
(2) Training in a full flight simulator that meets the requirements of § 141.41(a), may be credited for a maximum of 50 percent of the total flight training hour requirements of the approved course, or of this section, whichever is less.
(3) Training in a flight training device that meets the requirements of § 141.41(a), may be credited for a maximum of 25 percent of the total flight training hour requirements of the approved course, or of this section, whichever is less.
(4) Training in the full flight simulators or flight training devices described in paragraphs (b)(2) and (3) of this section, if used in combination, may be credited for a maximum of 50 percent of the total flight training hour requirements of the approved course, or of this section, whichever is less. However, credit training in a flight training device that meets the requirements of § 141.41(a) cannot exceed the limitation provided for in paragraph (b)(3) of this section.
4.
(b) Except for the airline transport pilot certification program in section 13 of this appendix, training in a full flight simulator that meets the requirements of § 141.41(a), may be credited for a maximum of 10 percent of the total flight training hour requirements of the approved course, or of this section, whichever is less.
(c) Except for the airline transport pilot certification program in section 13 of this appendix, training in a flight training device that meets the requirements of § 141.41(a), may be credited for a maximum of 5 percent of the total flight training hour requirements of the approved course, or of this section, whichever is less.
(d) Training in the full flight simulators or flight training devices described in paragraphs (b) and (c) of this section, if used in combination, may be credited for a maximum of 10 percent of the total flight training hour requirements of the approved course, or of this section, whichever is less. However, credit for training in a flight training device that meets the requirements of § 141.41(a) cannot exceed the limitation provided for in paragraph (c) of this section.
4.
(c) For use of full flight simulators or flight training devices:
(1) The course may include training in a combination of full flight simulators, flight training devices, and aviation training devices, provided it is representative of the aircraft for which the course is approved, meets the requirements of this section, and the training is given by an authorized instructor.
(2) Training in a full flight simulator that meets the requirements of § 141.41(a) may be credited for a maximum of 35 percent of the total flight training hour requirements of the approved course, or of this section, whichever is less.
(3) Training in a flight training device that meets the requirements of § 141.41(a) or an aviation training device that meets the requirements of § 141.41(b) may be credited for a maximum of 25 percent of the total flight training hour requirements of the approved course, or of this section, whichever is less.
(4) Training in a combination of flight simulators, flight training devices, or aviation training devices, described in paragraphs (c)(2) and (3) of this section, may be credited for a maximum of 35 percent of the total flight training hour requirements of the approved course, or of this section, whichever is less. However, credit for training in a flight training device and aviation training device, that meets the requirements of § 141.41(b), cannot exceed the limitation provided for in paragraph (c)(3) of this section.
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing special local regulations for certain waters of the Chesapeake Bay. This action is necessary to provide for the safety of life on these navigable waters located between Sandy Point, Anne Arundel County, MD and Kent Island, Queen Anne's County, MD, during a paddling event on May 14, 2016. This rulemaking will prohibit persons and vessels from being in the regulated area unless authorized by the Captain of the Port Baltimore or Coast Guard Patrol Commander.
This rule is effective from 7:30 a.m. on May 14, 2016 through 12:30 p.m. on May 15, 2016.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, call or email Mr. Ronald Houck, U.S. Coast Guard Sector Baltimore, MD; telephone 410-576-2674, email
On December 28, 2015, ABC Events, Inc. notified the Coast Guard that from 8 a.m. until noon on May 14, 2016, it will be conducting the Bay Bridge Paddle race in the Chesapeake Bay, under and between the north and south spans of the William P. Lane, Jr. (US-50/301) Memorial Bridges, located between Sandy Point, Anne Arundel County, MD and Kent Island, Queen Anne's County, MD. In response, on February 12, 2016, the Coast Guard published a notice of proposed rulemaking (NPRM) titled “Special Local Regulation; Chesapeake Bay, between Sandy Point and Kent Island, MD” in the
The Coast Guard is issuing this rule under authority in 33 U.S.C. 1233. The COTP Baltimore has determined that potential hazards associated with the paddle race on May 14, 2016 will be a safety concern for anyone intending to operate within certain waters of the Chesapeake Bay between Sandy Point and Kent Island, MD. The purpose of this rule is to protect event participants, spectators and transiting vessels on certain waters of the Chesapeake Bay before, during, and after the scheduled event.
As noted above, we received 2 comments on our NPRM published on February 12, 2016. There are no changes in the regulatory text of this rule from the proposed rule in the NPRM.
One commenter, the Sailing Club of the Chesapeake, stated that the regulated area for this event would impact its planned annual sailing regatta held on the Chesapeake Bay, between a location south of the south span of the William P. Lane, Jr. (US-50/301) Memorial Bridges and a location north of the north span.
The COTP Baltimore had no prior notifications of this annual sailing regatta in previous years. The Coast Guard will only enforce the regulated area during the enforcement period. However, should the event sponsor develop a schedule that would help predict when and where gaps in the race course may exist during the event, and vessel traffic would be able to safely transit the regulated area once the Coast Guard Patrol Commander deems it safe to do so, then such actions could be permitted after authorization is obtained.
The second commenter, the Baltimore Port Alliance, stated that, as proposed, the regulated area for this event would block ship access to and from the Port of Baltimore for five hours, and that any restrictions on vessel traffic in or out of the port could result in a significant economic hardship for port stakeholders by disrupting committed schedules. Additionally, the commenter recommended redesigning the paddle race course as to not block the main shipping channel or to change the date of the paddle race to coincide with the annual Great Chesapeake Bay Swim event a month later, so that only one blockage of the main shipping channel would occur.
The Coast Guard agrees that waterway restrictions, when necessary, should be as limited in scope and duration. For this event, enough notice has been provided for persons to schedule, coordinate and adjust their ship schedules. As it currently does with the annual Great Chesapeake Bay Swim event, the Coast Guard will work with the port stakeholders to monitor potential impacts to commercial vessel movements in the vicinity of the event area. Additionally, it is impractical to conduct the events concurrently; as the two events are of different types, each having hundreds of participants occupying the same navigable waters. Since the times for the Great Chesapeake Bay Swim event are also dependent upon tidal current predictions, the possibility exists, should both events be conducted on the same day, the waterway restrictions would last for a significantly longer period of time having a greater impact on the public and the use of the waterway.
This rule establishes special local regulations from 7:30 a.m. until 12:30 p.m. on May 14, 2016, and, if necessary due to inclement weather, from 7:30 a.m. until 12:30 p.m. on May 15, 2016. The regulated area will cover all navigable waters of the Chesapeake Bay between and adjacent to the spans of the William P. Lane Jr. Memorial Bridges from shoreline to shoreline, bounded to the north by a line drawn parallel and 500 yards north of the north bridge span that originates from the western shoreline at latitude 39°00′36″ N., longitude 076°23′05″ W. and thence eastward to the eastern shoreline at latitude 38°59′14″ N., longitude 076°20′00″ W., and bounded to the south by a line drawn parallel and 500 yards south of the south bridge span that originates from the western shoreline at latitude 39°00′16″ N., longitude 076°24′30″ W. and thence eastward to the eastern shoreline at latitude 38°58′38.5″ N., longitude 076°20′06″ W. The duration of the regulated area is intended to ensure the safety of vessels and these navigable waters before, during, and after the event, currently scheduled to being at 8 a.m. and last until noon. Except for Bay Bridge Paddle participants, no vessel or person will be permitted to enter the regulated area without obtaining permission from the COTP Baltimore or designated Coast Guard Patrol Commander.
We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.
This regulatory action determination is based on the size and duration of the regulated area, which would impact a small designated area of the Chesapeake Bay for only 5 hours. Although the regulated area cuts off one portion of the Chesapeake Bay from the other, the closure is temporary, and notice has been provided well in advance to permit mariners to plan their transit. The Coast Guard would issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the status of the regulated area. Moreover, the rule would allow vessels to seek permission to enter the regulated area, and vessel traffic would be able to safely transit the regulated area once the Coast Guard Patrol Commander deems it safe to do so.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the regulated area may be small entities, for the reasons stated in section IV.A above this rule will not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969(42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves implementation of regulations within 33 CFR part 100 applicable to organized marine events on the navigable waters of the United States that could negatively impact the safety of waterway users and shore side activities in the event area lasting for 5 hours. The category of water activities includes but is not limited to sail boat regattas, boat parades, power boat racing, swimming events, crew racing, canoe and sail board racing. It is categorically excluded from further review under paragraph 34(h) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are 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.
(a)
(b)
(2)
(3)
(4)
(c)
(2) Except for participants and vessels already at berth, mooring, or anchor, all persons and vessels within the regulated area at the time it is implemented are to depart the regulated area.
(3) Persons desiring to transit the regulated area must first obtain authorization from the Captain of the Port Baltimore or Coast Guard Patrol Commander. Prior to the enforcement period, to seek permission to transit the area, the Captain of the Port Baltimore can be contacted at telephone number 410-576-2693 or on Marine Band Radio, VHF-FM channel 16 (156.8 MHz). During the enforcement period, to seek permission to transit the area, the Coast Guard Patrol Commander can be contacted on Marine Band Radio, VHF-FM channel 16 (156.8 MHz) for direction.
(4) The Coast Guard may be assisted in the patrol and enforcement of the regulated area by other Federal, State, and local agencies. The Coast Guard Patrol Commander and official patrol vessels enforcing this regulated area can be contacted on marine band radio VHF-FM channel 16 (156.8 MHz) and channel 22A (157.1 MHz).
(5) The Coast Guard will publish a notice in the Fifth Coast Guard District Local Notice to Mariners and issue a marine information broadcast on VHF-FM marine band radio announcing specific event date and times.
(d)
Coast Guard, DHS.
Notice of deviation from drawbridge regulation.
The Coast Guard has issued a temporary deviation from the operating schedule that governs the Route 82 Bridge across the Connecticut River, mile 16.8, at East Haddam, Connecticut. This deviation is necessary to allow the bridge owner to perform emergency repairs at the bridge.
This deviation is effective from 7 a.m. on April 18, 2016 to 3 p.m. on June 30, 2016.
The docket for this deviation, [USCG-2016-0293] is available at
If you have questions on this temporary deviation, call or email Judy Leung-Yee, Project Officer, First Coast Guard District, telephone (212) 514-4330, email
The Route 82 Bridge, mile 16.8, across the Connecticut River, has a vertical clearance in the closed position of 22 feet at mean high water and 25 feet at mean low water. The existing bridge operating regulations are found at 33 CFR 117.205(c).
The waterway is transited by seasonal recreational traffic and some commercial barge traffic of various sizes.
The bridge owner, Connecticut Department of Transportation, requested a temporary deviation from the normal operating schedule to perform emergency repairs at the bridge.
Under this temporary deviation, the Route 82 Bridge shall open on signal from April 18, 2016 to June 30, 2016, Monday to Friday between 7 a.m. and 3 p.m. if at least two-hour notice is given by calling the number posted at the bridge.
Vessels able to pass under the bridge in the closed position may do so at anytime. The bridge will not be able to open for emergencies and there is no immediate alternate route for vessels to pass.
The Coast Guard will inform the users of the waterways through our Local Notice and Broadcast to Mariners of the change in operating schedule for the bridge so that vessel operations can arrange their transits to minimize any impact caused by the temporary deviation.
In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Department of Veterans Affairs.
Final rule.
The Department of Veterans Affairs adopts as final, without change, the final rule seeking comments published on October 3, 2012, amending its regulations governing Servicemembers' Group Life Insurance (SGLI) and Veterans' Group Life Insurance (VGLI). Specifically, this rule prohibits paying insurance proceeds because of the death of a person (decedent) whose life was insured under SGLI or VGLI, or paying a SGLI Traumatic Injury Protection (TSGLI) benefit to a person (slayer) convicted of
Monica Keitt, Attorney/Advisor, Department of Veterans Affairs, Insurance Center, 5000 Wissahickon Avenue, Philadelphia, PA 19144, (215) 842-2000, ext. 2905. (This is not a toll-free number.)
On October 3, 2012, VA published in the
Two commenters noted that some federal agencies, including VA, have expanded their program definitions of family members to include domestic partners. One commenter noted that a Presidential Memorandum directed Federal agencies to extend certain benefits currently available to Federal employees' spouses and their children to Federal employees' same-sex domestic partners and their children. See Presidential Memorandum—Extension of Benefits to Same-Sex Domestic Partners of Federal Employees (June 2, 2010). One commenter noted that other Federal agencies, such as the General Services Administration, have established through regulations definitions of family members that include domestic partners.
One commenter also stated that failure to include domestic partners in the definition of “member of the family” would allow a same-sex domestic partner of a slayer to circumvent the regulation, while prohibiting heterosexual spouses of a slayer from receiving insurance benefits. This commenter also stated that “. . . [i]ncluding domestic partners is important to prevent an aberration in the rule . . .” and to “. . . prevent[ ] the unjust collection of life insurance benefits.”
Two commenters noted that the Department of Defense changed its military policies regarding openly gay and lesbian servicemembers, thus VA should change its policy here, since VA is a related agency that serves servicemembers and their families.
Two commenters also noted that VA has recognized domestic partnerships in other VA related matters. Specifically, the commenters pointed to VA's hospital visitation policy allowing persons designated as domestic partners to be beneficiaries for SGLI and VGLI benefits.
Lastly, one commenter noted that removal of the term domestic partner “sends a message that VA may not be willing to recognize domestic partners as family in any context.” However, recent Supreme Court cases and the United States Attorney General help to clarify legally accepted definitions. On June 26, 2013, the Supreme Court in
On June 26, 2015, the Supreme Court in
In light of
The comments we received essentially concern equal treatment of same-sex couples and opposite-sex couples. The Supreme Court in
Two commenters suggested that VA could establish its own uniform definition of “domestic partnership” rather than relying upon varying state laws. The commenters pointed to regulations of other federal agencies establishing definitions of “domestic partnerships.” We decline that suggestion for the following reasons. First, it would create inconsistency between VA's recognition of marriages, which, under 38 U.S.C. 103(c), is expressly based on state laws recognizing marriages, and VA's recognition of domestic partnerships or civil unions, which, under the commenters' suggestion, could be inconsistent with state laws governing recognition of such relationships. Second, defining the term “domestic partner” without regard to state law would require VA to undertake difficult and burdensome fact-finding actions under imprecise standards. We note that the other agency regulations cited by the commenters are varied and often employ vague and subjective standards, such as requiring a finding that the individuals are in a “committed relationship” or “agree to be responsible for each other's common welfare,” which may lead to inconsistency in application. Third, VA likely would face difficulty in developing evidence to establish that such standards are satisfied. The primary evidence of whether individuals were in a “committed relationship” often may be the testimony of the individuals in that relationship. Such evidence may be difficult to obtain or may be unreliable in relation to this rule, which, unlike the examples cited by the commenters, would preclude, rather than extend, benefits based upon the relationship.
Regarding a comment that excluding domestic partnerships from the definition of “family members” may result in unjust enrichment to certain domestic partners of persons causing the death of an insured individual, we acknowledge that this is a potential consequence of the rule. However, the alternative standards we have considered, including following varied state laws governing domestic partnerships or establishing our own definition of “domestic partnership” based in part on subjective standards, would also pose a risk of yielding inconsistent results and possibly allowing unjust enrichment to certain individuals in specific cases. We believe we have appropriately balanced those risks with the interests of clarity, consistency, and administrative efficiency in determinations made under this rule. Accordingly, VA declines to make any changes to this rulemaking based on the above comments.
One commenter noted that VA failed to provide good cause for dispensing with advance public notice and the opportunity for public comment. Specifically, the commenter stated that VA failed to provide a sufficient justification for citing “public interest” and “impracticability” as reasons for proceeding without providing an opportunity for advance notice and comment. We correctly identified public interest as grounds for proceeding with final rule seeking comments, but could have been clearer in explaining that it would have been against the public's interest to delay implementation of the slayer provisions for the purpose of receiving comments on the definition of “member of the family.” We designed the rule to prevent slayers from benefiting from their wrongdoing, and any delay in finalizing the rule would have potentially permitted slayers to receive benefits in violation of public policy and ethical concerns. Nonetheless, on October 3, 2012, VA provided the public formal notice and an opportunity to comment on the exclusion of the term “domestic partner” through publication of the final rule seeking comments. VA received comments on the exclusion, and we considered those comments in issuing this final rule. Additionally, we note that, since the publication of the October 3, 2012, rule, no case has been affected by the exclusion of “domestic partner” from the definition of “member of the family.”
Based on the rationale set forth above and the preamble in the final rule seeking comments, VA adopts, without change, the rule published on October 3, 2012, at 77 FR 60304.
The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in an expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year. This final rule will have no such effect on State, local, and tribal governments or on the private sector.
This final rule contains no provisions constituting a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and other advantages; distributive impacts; and equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Executive Order 12866 (Regulatory Planning and Review) defines a “significant regulatory action” requiring review by the Office of Management and Budget (OMB), unless OMB waives such review, as “any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) Create a serious inconsistency or
The economic, interagency, budgetary, legal, and policy implications of this regulatory action have been examined, and it has been determined not to be a significant regulatory action under Executive Order 12866. VA's impact analysis can be found as a supporting document at
The Secretary of Veterans Affairs hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. This final rule will directly affect only individuals and will not directly affect any small entities. Therefore, this rulemaking is also exempt pursuant to 5 U.S.C. 605(b), from the initial and final regulatory flexibility analysis requirements of sections 603 and 604.
The Catalog of Federal Domestic Assistance number and title for the program affected by this document is 64.103, Life Insurance for Veterans.
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. On April 6, 2016, Robert D. Snyder, Chief of Staff, Department of Veterans Affairs, approved this document for publication.
Life insurance, Military personnel, Veterans.
For the reasons set forth out in the preamble, VA adopts the final rule seeking comments published in the
Environmental Protection Agency (EPA).
Correcting amendments.
The Environmental Protection Agency (EPA) published in the January 25, 2016
This correcting amendment is effective on April 12, 2016.
Jaslyn Dobrahner, Air Program, U.S. Environmental Protection Agency (EPA), Region 8, Mail Code 8P-AR, 1595 Wynkoop Street, Denver, Colorado 80202-1129, (303) 312-6252,
The EPA published a document in the January 25, 2016
Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Greenhouse gases, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
Accordingly, 40 CFR part 52 is corrected by making the following correcting amendments:
42 U.S.C. 7401
The revisions read as follows:
(c) * * *
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is approving the limited maintenance plan submitted on January 4, 2016, by the State of Washington for the Spokane area, which includes the cities of Spokane, Spokane Valley, Millwood and surrounding unincorporated areas in Spokane County, Washington. This plan addresses the second 10-year maintenance period for particulate matter with an aerodynamic diameter less than or equal to a nominal 10 micrometers (PM
This final rule is effective May 12, 2016.
The EPA has established a docket for this action under Docket ID No. EPA-R10-OAR-2016-0003. All documents in the docket are listed on the
For information please contact Jeff Hunt at (206) 553-0256,
On February 26, 2016, the EPA proposed to approve the limited maintenance plan submitted by the State of Washington, on January 4, 2016, for the Spokane PM
The EPA is approving the limited maintenance plan submitted by the State of Washington, on January 4, 2016, for the Spokane PM
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 regulations described in the amendments to 40 CFR part 52 set forth below. The 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 Clean Air 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);
• 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 this action 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).
In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because it will not impose substantial direct costs on tribal governments or preempt tribal law. This SIP revision is not approved to apply in Indian reservations in the State or any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. Consistent with EPA policy, the EPA provided a consultation opportunity to the Spokane Tribe in a letter dated May 21, 2015. The EPA did not receive a request for consultation.
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by June 13, 2016. 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, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
For the reasons set forth in the preamble, 40 CFR part 52 is amended as follows:
42 U.S.C. 7401
The revisions and addition read as follows:
(c) * * *
(e) * * *
Environmental Protection Agency (EPA).
Final rule.
This regulation establishes an exemption from the requirement of a tolerance for residues of 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- (CAS Reg. No. 70280-68-1) when used as an inert ingredient (antifoaming agent) in pesticide formulations applied to growing crops at a maximum concentration not to exceed 5% by weight. Exponent, on behalf of ISK Biosciences submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]-.
This regulation is effective April 12, 2016. Objections and requests for hearings must be received on or before June 13, 2016, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2014-0449, is available at
Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2014-0449 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before June 13, 2016. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2014-0449, by one of the following methods:
•
•
•
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
In the
Based upon review of the data supporting the petition, EPA has modified the limitation on the maximum concentration in the pesticide formulation from 10% to 5%. This limitation is based on the Agency's risk assessment which can be found at
Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients.
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . .”
EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.
Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-
EPA has evaluated the available toxicity data and considered their validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in this unit.
There is currently limited data available for 1,2-propanediol, 3-[3-[1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxanyl]propoxy]-. The Agency received three studies specifically testing 1,2-propanediol, 3-[3-[1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxanyl]propoxy]-: acute oral toxicity, acute dermal toxicity, and an Ames assay. Those studies showed that 1,2-propanediol, 3-[3-[1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxanyl]propoxy]- was non-toxic via acute oral and acute dermal exposures and was negative for mutagenicity. To assess the remaining potential toxicity of 1,2-propanediol, 3-[3-[1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxanyl]propoxy]-, the Agency relied on data for a suitable cluster of structurally related linear short chain siloxane (Si-2 to Si-5) compounds. Based on the similar structures and physicochemical properties of these compounds to 1,2-propanediol, 3-[3-[1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxanyl]propoxy]-, which primarily differ only in the number of siloxane units, the Agency has determined that the toxicological properties of these compounds is representative of the toxicity of 3-[3-[1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxanyl]propoxy]-. The Agency has also determined that these data adequately address the physicochemical, mammalian metabolism, mammalian toxicological, and environmental fate endpoints of 1,2-propanediol,3-[3-[1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxanyl]propoxy]-.
Oral repeat dose toxicity studies are available for structurally similar linear short chain siloxane chemicals, for durations ranging from 28 days up to one year in rats, rabbits, and dogs. The lowest NOAELs were in the 25 milligram/kilogram/day (mg/kg/day) range for two 28-day oral repeat dose rat studies and a 90-day dog study. LOAELs for these studies were based mainly on liver effects which were present in all of these studies.
Dermal repeated dose toxicity studies are available for two of the structurally similar linear short chain siloxane compounds. A 28-day dermal toxicity study in rats and rabbits showed no adverse effects up to limit dose of 1,000 mg/kg/day. The NOAEL was 1,000 mg/kg/day; the highest dose tested in both studies.
Inhalation repeated dose toxicity studies are available for three of the structurally similar linear short chain siloxane compounds. Both 28-day and 90-day rat inhalation studies are available as well as a one-year chronic inhalation study. The lowest inhalation NOAEL was 3.9 milligrams per Liter (mg/L) in a 90-day study, equivalent to a dose of greater than 1,000 mg/kg/day, a limit dose value.
A carcinogenicity study is available on one structurally-related short chain siloxane compound. An increase incidence of Leydig cell tumors (LCTs) in males was observed at all doses. However, due to the high background incidence of LCTs in Fischer 344 rats, this effect has been determined to not be treatment-related. Renal tubular adenomas and carcinomas were also observed in the study but are attributable to male rat specific alpha-2μ-globulin mediated nephrotoxicity and therefore not relevant to cancer risk concerns in humans. Genotoxicity studies on 1,2-propanediol,3-[3-[1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxanyl]propoxy]- and structurally-related compounds were negative for genotoxic effects. A DEREK (structure-activity modeling) analysis was conducted and identified no structural alerts for possible carcinogenicity among the linear short chain siloxane compounds. Therefore, based on the lack of human-relevant carcinogenicity in the available study, and the results of the genotoxicity studies and DEREK analysis, 1,2-propanediol,3-[3-[1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxanyl]propoxy]- is not expected to be carcinogenic.
Reproductive and developmental toxicity studies with linear short chain siloxane compounds demonstrated no adverse effects at doses at or below limit dose levels. No evidence of immunotoxicity or neuro toxicity at doses below the limit dose was observed in the available studies for the structurally related linear short chain siloxane (Si-2 to Si-5) compounds at up to limit dose levels.
There are currently no publically-available metabolism studies for 1,2-propanediol,3-[3-[1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxanyl]propoxy]-, however, the expected mammalian metabolic pathways which may be involved in the degradation of 1,2-propanediol,3-[3-[1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxanyl]propoxy]- include a combination of ether hydrolysis followed by ß-oxidation of the carbon chain followed by methyl oxidation of the silyl methyl groups. Methyl oxidation would result in the formation of a mixture of primary and alcohol metabolites. The more polar primary alcohol functionalities can both be conjugated and excreted directly or further oxidized to form a mixture of more polar carboxylic acid metabolites that are readily conjugated and excreted.
Specific information on the studies received and the nature of the adverse effects caused by 1,2-propanediol,3-[3-[1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxanyl]propoxy]- as well as the NOAEL and the LOAEL from the toxicity studies can be found at
Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each
A summary of the toxicological endpoints for 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- used for human risk assessment is shown in Table 1 of this unit.
The 28-day studies in rats the NOAEL was 25 mg/kg/day with a LOAEL of 250 mg/kg/day based on based on increases in absolute liver weights, hepatocellular hypertrophy and protoporphyrin accumulation with associated bile duct proliferation and periportal chronic inflammation. A 90-day dog study had a NOAEL of 24 mg/kg/day with a LOAEL of 77 mg/kg/day based on increased relative liver weight in females and lower relative testes weight in males with slight testicular atrophy or hypoplasia in males. A NOAEL of 25 mg/kg/day was selected for use as the endpoint for dietary exposure in this risk assessment. An additional uncertainty factor of 3X was applied for the use of shorter term study for a chronic risk assessment.
Dermal and inhalation exposure endpoints were not selected as there were no adverse effects observed up to limit dose levels in both rat and rabbit dermal and inhalation toxicity studies.
1.
i.
ii.
iii.
2.
3.
Residential use patterns are possible for pesticide products containing 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]-. Residential exposure could occur via the dermal and inhalation routes of exposure. However, there are no concerns for dermal or inhalation exposure because no effects were seen in dermal or inhalation toxicity studies up to the limit dose. Incidental oral exposure for children is possible either by hand-to-mouth or object-to-mouth ingestion resulting from contact with treated surfaces.
4.
EPA has not found 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- to share a common mechanism of toxicity with any other substances, and 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at
1.
2.
3.
i. Although only limited data on 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- is available, the Agency has reliable data based on the structurally related linear short chain siloxane (Si-2 to Si-5) compounds to adequately characterize the toxicity and assess the risk from dietary exposure to 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]-.
ii. There is no indication that 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- is a neurotoxic chemical at doses below the limit dose and there is no need for a developmental neurotoxicity study or additional uncertainty factors (UFs) to account for neurotoxicity.
iii. There is no indication that 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- is a immunotoxic chemical and there is no need for a immunotoxicity study or additional UFs to account for immunotoxicity.
iv. As discussed in Unit IV.D.2., there is no need to retain the FQPA 10x to address any concern for potential increased susceptibility in infants and children from prenatal or postnatal exposure to 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]-.
v. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on a highly conservative model that assumes 100 percent crop treated (PCT) for all crops and that every food eaten by a person each day has residues of inert ingredient equivalent to the residue level of the highest established tolerance for an active ingredient on a given commodity. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]-.
EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate
1.
2.
3.
1,2-Propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- may be used as an inert ingredient in pesticide products that would result in short-term residential exposure. Short-term risk is assessed based on short-term residential exposure plus chronic dietary exposure. Although short-term residential exposure is possible, there was no endpoint of concern identified in both dermal and inhalation toxicity studies. However the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures for children. EPA has concluded the combined short-term aggregated food, water, and residential exposures results in an aggregate MOE of 334 for children. Children's aggregate MOE combines average food and water exposure from the chronic dietary exposure with residential exposure associated with contact with treated lawns (hand-to-mouth + object-to-mouth). As the level of concern is for MOEs that are lower than 300, these MOEs are not of concern.
4.
1,2-Propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- may be used as an inert ingredient in pesticide products that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure. Although intermediate-term residential exposure is possible, there was no endpoint of concern identified in both dermal and inhalation toxicity. However the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with intermediate-term residential exposures for children. EPA has concluded the combined intermediate-term aggregated food, water, and residential exposures results in an aggregate MOE of 342 for children. Children's aggregate MOE combines average food and water exposure from the chronic dietary exposure with residential exposure associated with contact with treated lawns (hand-to-mouth + object-to-mouth). As the level of concern is for MOEs that are lower than 300, these MOEs are not of concern.
5.
6.
Although EPA is establishing a limitation on the amount of 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- that may be used in pesticide formulations, an analytical enforcement methodology is not necessary for this exemption from the requirement of tolerance. The limitation will be enforced through the pesticide registration process under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136
Based upon an evaluation of the data included in the petition, EPA is establishing an exemption from the requirement of a tolerance for residues of 1,2-propanediol 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- when used in pesticide formulations as an inert ingredient (antifoaming agent), not to exceed 5% by weight of the formulation, instead of the 10% limit requested. The basis for this revision can be found at
Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.920 for 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- (CAS Reg. No. 70280-68-1) when used as an inert ingredient (antifoaming agent) in pesticide formulations applied to growing crops at a maximum concentration not to exceed 5% by weight in formulation.
This action establishes an exemption from the requirement of a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501
This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, 40 CFR chapter I is amended as follows:
21 U.S.C. 321(q), 346a and 371.
Gulf Coast Ecosystem Restoration Council.
Notice of effective date of final rule.
This document confirms that on April 4, 2016, the United States District Court for the Eastern District of Louisiana entered a consent decree (Consent Decree) among the United States; the states of Alabama, Florida, Louisiana, Mississippi and Texas; and BP Exploration and Production Inc. with respect to the civil penalty and natural resource damages in case number MDL No. 2179. The Gulf Coast Ecosystem Restoration Council (Council) regulation (Spill Impact Regulation) that implements the Spill Impact Component Allocation of the Resources and Ecosystems Sustainability, Tourist Opportunities, and Revived Economies of the Gulf Coast States Act of 2012 (RESTORE Act) is effective as of the date of publication of this document.
The Spill Impact Regulation is effective on April 12, 2016.
Will Spoon at (504) 239-9814.
On December 15, 2015, the Council published the Spill Impact Regulation in the
On April 4, 2016, the United States District Court for the Eastern District of Louisiana entered the Consent Decree. The Council confirms such entry by publication of this document, and the Spill Impact Regulation is therefore effective.
For more information on the Spill Impact Regulation, please see the final rule (80 FR 77580, December 15, 2015).
As an independent Federal entity that is comprised, in part, of the Secretaries of the Departments of the Interior, Agriculture, Commerce and Homeland Security; the Secretary of the Army; and the Administrator of Environmental Protection Agency, the requirements of Executive Orders 12866 and 13563 do not apply to this document.
This document contains no collection of information requirements. Therefore the Paperwork Reduction Act does not apply to this document.
Centers for Medicare & Medicaid Services (CMS), HHS.
Final rule.
In the November 2, 2015
Jeremy Silanskis, (410) 786-1592.
In the November 2, 2015
In the November 2, 2015 final rule with comment period, we solicited comments on § 447.203(b)(5). Specifically, we solicited comments on the scope of services required for ongoing review in the review plans, the elements of review required through the plans, whether we should allow exemptions to the rule based on state program characteristics (for example, high managed care enrollment), and the deadline for submission of the initial access monitoring review plan. We received many comments that were outside of the scope of issues on which we solicited comments. Several commenters raised concerns over CMS's characterization in the regulatory preamble of the Supreme Court Decision:
The following is a summary of the comments and our responses on § 447.203(b)(5).
Under section 553(b) of the Administrative Procedure Act (APA), the agency is required to publish a notice of the proposed rule in the
Because the deadlines for submission of access monitoring review plans are rules of procedure, the notice and comment requirements of 5 U.S.C. 553 do not apply to this delay of the submission date.
The November 2, 2015 final rule with comment period stipulated that states must develop and submit (to CMS) their initial access monitoring review plan by July 1, 2016. We are now extending the submission deadline to October 1, 2016. Similarly, we are revising the deadline for subsequent review periods from July 1 to October 1. Otherwise, this final rule does not impose any new or revised information collection requirements or burden. The November 2, 2015, information collection requirements and burden are approved by OMB under control number 0938-1134 (CMS-10391).
In the November 2, 2015 final rule with comment period, we discussed the impact of the access monitoring review plan requirements on states. We do not believe this delay of the deadline for submission of the access monitoring review plans will change any of the discussion in the impact statement of the November 2, 2015 final rule with comment period.
In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget.
Accounting, Administrative practice and procedure, Drugs, Grant programs-health, Health facilities, Health professions, Medicaid, Reporting and recordkeeping requirements, Rural areas.
For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services amends 42 CFR chapter IV as set forth below:
Sec. 1102 of the Social Security Act (42 U.S.C. 1302).
Fish and Wildlife Service, Interior.
Final rule; correction.
We, the U.S. Fish and Wildlife Service, published a final rule in the
This correction is effective April 12, 2016.
Ron W. Kokel, (703) 358-1714.
In a final rule that published in the
1. On page 17317, in the second column, under the heading “Alaska” and the subheading “Daily Bag and Possession Limits,” the third sentence under “Ducks:” is amended by removing the words “1 canvasback”' and adding in their place the words “2 canvasbacks”.
2. On page 17330, in the first column, under the heading “South Dakota” and the subheading “Early Canada Goose Seasons,” remove the entire paragraph beginning with the words “Special Early Canada Goose Unit:” and add in its place the following paragraph: “Special Early Canada Goose Unit: The Counties of Campbell, Marshall, Roberts, Day, Clark, Codington, Grant, Hamlin, Deuel, Walworth; that portion of Perkins County west of State Highway 75 and south of State Highway 20; that portion of Dewey County north of Bureau of Indian Affairs Road 8, Bureau of Indian Affairs Road 9, and the section of U.S. Highway 212 east of the Bureau of Indian Affairs Road 8 junction; that portion of Potter County east of U.S. Highway 83; that portion of Sully County east of U.S. Highway 83; portions of Hyde, Buffalo, Brule, and Charles Mix counties north and east of a line beginning at the Hughes-Hyde County line on State Highway 34, east to Lees Boulevard, southeast to State Highway 34, east 7 miles to 350th Avenue, south to Interstate 90 on 350th Avenue, south and east on State Highway 50 to Geddes, east on 285th Street to U.S. Highway 281, and north on U.S. Highway 281 to the Charles Mix-Douglas County boundary; that portion of Bon Homme County north of State Highway 50; those portions of Yankton and Clay Counties north of a line beginning at the junction of State Highway 50 and 306th Street/County Highway 585 in Bon Homme County, east to U.S. Highway 81, then north on U.S. Highway 81 to 303rd Street, then east on 303rd Street to 444th Avenue, then south on 444th Avenue to 305th Street, then east on 305th Street/Bluff Road to State Highway 19, then south to State Highway 50 and east to the Clay/Union County Line; McPherson, Edmunds, Kingsbury, Brookings, Lake, Moody, Miner, Faulk, Hand, Jerauld, Douglas, Hutchinson, Turner, Aurora, Beadle, Davison, Hanson, Sanborn, Spink, Brown, Harding, Butte, Lawrence, Meade, Oglala Lakota (formerly Shannon), Jackson, Mellette, Todd, Jones, Haakon, Corson, Ziebach, and McCook Counties; and those portions of Minnehaha and Lincoln counties outside of an area bounded by a line beginning at the junction of the South Dakota-Minnesota State line and Minnehaha County Highway 122 (254th Street) west to its junction with Minnehaha County Highway 149 (464th Avenue), south on Minnehaha County Highway 149 (464th Avenue) to Hartford, then south on Minnehaha County Highway 151 (463rd Avenue) to State Highway 42, east on State Highway 42 to State Highway 17, south on State Highway 17 to its junction with Lincoln County Highway 116 (Klondike Road), and east on Lincoln County Highway 116 (Klondike Road) to the South Dakota-Iowa State line, then north along the South Dakota-Iowa and South Dakota-Minnesota border to the junction of the South Dakota-Minnesota State line and Minnehaha County Highway 122 (254th Street).”
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; closure of Angling category southern area trophy fishery.
NMFS closes the southern area Angling category fishery for large medium and giant (“trophy” (
Effective 11:30 p.m., local time, April 10, 2016, through December 31, 2016.
Sarah McLaughlin or Brad McHale, 978-281-9260.
Regulations implemented under the authority of the Atlantic Tunas Convention Act (ATCA; 16 U.S.C. 971
NMFS is required, under § 635.28(a)(1), to file a closure notice with the Office of the Federal Register for publication when a BFT quota is reached or is projected to be reached. On and after the effective date and time of such notification, for the remainder of the fishing year or for a specified period as indicated in the notification, retaining, possessing, or landing BFT under that quota category is prohibited until the opening of the subsequent quota period or until such date as specified in the notice.
The 2016 BFT fishing year, which is managed on a calendar-year basis and subject to an annual calendar-year quota, began January 1, 2016. The Angling category season opened January 1, 2016, and continues through December 31, 2016. The currently codified Angling category quota is 195.2 mt, of which 4.5 mt is allocated for the harvest of large medium and giant (trophy) BFT from the regulatory area by vessels fishing under the Angling
As of April 4, 2016, reported landings from the NMFS Automated Catch Reporting System and the North Carolina Tagging Program total approximately 1.6 mt. NMFS has determined that the codified Angling category southern area trophy BFT subquota has been reached and that a closure of the southern area trophy BFT fishery is warranted at this time. Therefore, retaining, possessing, or landing large medium or giant BFT south of 39°18′ N. lat. and outside the Gulf of Mexico by persons aboard vessels permitted in the HMS Angling category and the HMS Charter/Headboat category must cease at 11:30 p.m. local time on April 10, 2016. This closure will remain effective through December 31, 2016. This action is intended to prevent any further overharvest of the Angling category southern area trophy BFT subquota, and is taken consistent with the regulations at § 635.28(a)(1).
If needed, subsequent Angling category adjustments will be published in the
HMS Angling and HMS Charter/Headboat category permit holders may catch and release (or tag and release) BFT of all sizes, subject to the requirements of the catch-and-release and tag-and-release programs at § 635.26. Anglers are also reminded that all BFT that are released must be handled in a manner that will maximize survival, and without removing the fish from the water, consistent with requirements at § 635.21(a)(1). For additional information on safe handling, see the “Careful Catch and Release” brochure available at
The Assistant Administrator for NMFS (AA) finds that it is impracticable and contrary to the public interest to provide prior notice of, and an opportunity for public comment on, this action for the following reasons:
The regulations implementing the 2006 Consolidated HMS FMP, as amended, provide for inseason retention limit adjustments and fishery closures to respond to the unpredictable nature of BFT availability on the fishing grounds, the migratory nature of this species, and the regional variations in the BFT fishery. The closure of the southern area Angling category trophy fishery is necessary to prevent any further overharvest of the southern area trophy fishery subquota. NMFS provides notification of closures by publishing the notice in the
These fisheries are currently underway and delaying this action would be contrary to the public interest as it could result in excessive trophy BFT landings that may result in future potential quota reductions for the Angling category, depending on the magnitude of a potential Angling category overharvest. NMFS must close the southern area trophy BFT fishery before additional landings of these sizes of BFT accumulate. Therefore, the AA finds good cause under 5 U.S.C. 553(b)(B) to waive prior notice and the opportunity for public comment. For all of the above reasons, there is good cause under 5 U.S.C. 553(d) to waive the 30-day delay in effectiveness.
This action is being taken under 50 CFR 635.28(a)(1), and is exempt from review under Executive Order 12866.
16 U.S.C. 971
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; reallocation.
NMFS is exchanging unused rock sole Community Development Quota (CDQ) for yellowfin sole CDQ acceptable biological catch (ABC) reserves in the Bering Sea and Aleutian Islands management area. This action is necessary to allow the 2016 total allowable catch of rock sole, and yellowfin sole in the Bering Sea and Aleutian Islands management area to be harvested.
Effective April 12, 2016, through December 31, 2016.
Steve Whitney, 907-586-7228.
NMFS manages the groundfish fishery in the Bering Sea and Aleutian Islands management area (BSAI) according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.
The 2016 rock sole and yellowfin sole CDQ reserves specified in the BSAI are 6,110 mt, and 15,408 mt as established by the final 2016 and 2017 harvest specifications for groundfish in the BSAI (81 FR 14773, March 18, 2016). The 2016 rock sole and yellowfin sole CDQ ABC reserves are 11,128 mt and 7,244 mt as established by the final 2016 and 2017 harvest specifications for groundfish in the BSAI (81 FR 14773, March 18, 2016).
The Norton Sound Economic Development Corporation has requested that NMFS exchange 400 mt of rock sole CDQ reserves for 400 mt of yellowfin sole CDQ ABC reserves under § 679.31(d). Therefore, in accordance with § 679.31(d), NMFS exchanges 400 mt of rock sole CDQ reserves for 400 mt of yellowfin sole CDQ ABC reserves in the BSAI. This action also decreases and increases the TACs and CDQ ABC reserves by the corresponding amounts. Tables 11 and 13 of the final 2016 and 2017 harvest specifications for groundfish in the BSAI (81 FR 14773, March 18, 2016) are revised as follows:
This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the flatfish exchange by the Norton Sound Economic Development Corporation in the BSAI. Since these fisheries are currently open, it is important to immediately inform the industry as to the revised allocations. Immediate notification is necessary to allow for the orderly conduct and efficient operation of this fishery, to allow the industry to plan for the fishing season, and to avoid potential disruption to the fishing fleet as well as processors. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of March 31, 2016.
The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.
This action is required by § 679.20 and is exempt from review under Executive Order 12866.
16 U.S.C. 1801
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for certain Airbus Model A330-200, -200 Freighter and -300 series airplanes, and Model A340-200 and -300 series airplanes. This proposed AD was prompted by reports of spurious terrain awareness warning system (TAWS) alerts during approach and takeoff for airplanes fitted with the terrain and traffic collision avoidance system with transponder (T3CAS) when the T3CAS is constantly powered “ON” for more than 149 hours. This proposed AD would require repetitive on-ground power cycle of the T3CAS. We are proposing this AD to prevent spurious TAWS alerts (Collision Prediction and Alerting (CPA), or missing legitimate CPA), which could increase flight crew workload during critical landing or takeoff phases, and possibly result in reduced control of the airplane.
We must receive comments on this proposed AD by May 27, 2016.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For service information identified in this NPRM, contact Airbus SAS, Airworthiness Office—EAL, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 45 80; email
You may examine the AD docket on the Internet at
Vladimir Ulyanov, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1138; fax 425-227-1149.
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2015-0125, dated July 1, 2015, corrected on July 3, 2015 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus Model A330-200, -200 Freighter and -300 series airplanes, and Model A340-200 and -300 series airplanes. The MCAI states:
Cases were reported of spurious Terrain Awareness Warning System (TAWS) alerts during approach and take off, with aeroplane fitted with the Terrain and Traffic Collision Avoidance System with Transponder (T3CAS). Investigations on the unit were launched with the manufacturer of the system (ACSS). The results of the laboratory investigation confirmed that an internal frozen Global Positioning System position anomaly occurs when the T3CAS is constantly powered `ON' for more than 149 hours. The origin for this defect was identified as a counter limitation related to a T3CAS internal software misbehaviour, not self-detected.
This condition, if not corrected, could lead to spurious TAWS alerts (Collision Prediction and Alerting (CPA), or missing legitimate CPA), which could increase flight crew workload during critical landing or take off phases, possibly resulting in reduced control of the aeroplane.
Prompted by these reports, Airbus issued Alert Operators Transmission (AOT) A34L003-13 to provide instructions to accomplish an on ground repetitive power cycle of the T3CAS before exceeding 120 hours of continuous power, and EASA issued AD 2014-0242 to require repetitive on ground power cycles of the T3CAS unit.
Since that [EASA] AD was issued, the AOT A34L003-13 revision 1 has been issued which extend[s] the applicability to A340 aeroplanes modified in-service in accordance with Airbus SB 34-4282 (T3CAS std 1.2 unit installation). It was also identified that [EASA] AD 2014-0242 does not refer to affected A330 in-service aeroplanes on which SB A330-34-3271 or SB A330-34-3286 or SB A330-34-3301 have been embodied.
For the reason described above, this [EASA] AD retains the same required actions as EASA AD 2014-0242, which is superseded, expands the Applicability of the [EASA] AD to include post SB A330-34-3271, post SB A330-34-3286 and post SB A330-34-3301 A330 aeroplanes, and post SB A340-34-4282 A340 aeroplanes.
You may examine the MCAI in the AD docket on the Internet at
Airbus has issued AOT A34L003-13, Revision 1, dated May 26, 2015. The service information describes procedures for an on-ground power cycle of the T3CAS. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.
We estimate that this proposed AD affects 3 airplanes of U.S. registry.
We also estimate that it would take about 1 work-hour per product to comply with the basic requirements of this proposed AD. The average labor rate is $85 per work-hour. Required parts would cost about $0 per product. Based on these figures, we estimate the cost of this proposed AD on U.S. operators to be $255, or $85 per product.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska; and
4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by May 27, 2016.
None.
This AD applies to the following Airbus airplanes, certificated in any category.
(1) Airbus Model A330-201, -202, -203, -223, -243, -223F, -243F, -301, -302, -303, -321, -322, -323, -341, -342, and -343 airplanes, all manufacturer serial numbers on which Airbus Modification 202097 (T3CAS standard 1.1) or Modification 202849 (T3CAS standard 1.2) has been embodied in production, or Airbus Service Bulletin A330-34-3271, Airbus Service Bulletin A330-34-3286, or Airbus Service Bulletin A330-34-3301 have been embodied in-service.
(2) Airbus Model A340-211, -212, -213, -311, -312, and -313 airplanes, all manufacturer serial numbers on which Airbus Service Bulletin A340-34-4282 (T3CAS standard 1.2) has been embodied in-service.
Air Transport Association (ATA) of America Code 34, Navigation.
This AD was prompted by reports of spurious terrain awareness warning system (TAWS) alerts during approach and take off for airplanes fitted with the terrain and traffic collision avoidance system with transponder (T3CAS) when the T3CAS is constantly powered “ON” for more than 149 hours. We are issuing this AD to prevent spurious TAWS alerts (Collison Prediction and Alerting (CPA), or missing legitimate CPA), which could increase flight crew workload during critical landing or take off phases, and possibly result in reduced control of the airplane.
Comply with this AD within the compliance times specified, unless already done.
For Model A330 and A340 airplanes equipped with a T3CAS unit having a part number specified in paragraphs (g)(1) or (g)(2) of this AD: Within 30 days after the effective date of this AD, or within 120 hours of continuous power of the T3CAS after installation of the T3CAS, as specified in any applicable service information in paragraph (h) of this AD, whichever occurs later, do an on-ground power cycle of the T3CAS, in accordance with the instructions of Airbus Alert Operators Transmission (AOT) A34L003-13, Revision 1, dated May 26, 2015. Thereafter, repeat the on-ground power cycle of the T3CAS, at intervals not to exceed 120 hours of continuous power of the T3CAS.
(1) Affected T3CAS Units are those having part number (P/N) 9005000-10101, Software Standard 1.1.
(2) Affected T3CAS Units are those having P/N 9005000-10202, Software Standard 1.2.
Paragraphs (h)(1) through (h)(4) of this AD identify the service information that was used to install the T3CAS, as specified in paragraph (g) of this AD.
(1) Airbus Service Bulletin A330-34-3271.
(2) Airbus Service Bulletin A330-34-3286.
(3) Airbus Service Bulletin A330-34-3301.
(4) Airbus Service Bulletin A340-34-4282.
As of the effective date of this AD, installation on an airplane of a T3CAS unit having a part number specified in paragraph (g) of this AD is acceptable, provided that, following installation, the T3CAS unit is power cycled on a recurrent basis, as required by paragraph (g) of this AD.
This paragraph provides credit for actions required by paragraph (g) of this AD, if those actions were performed before the effective date of this AD using Airbus AOT A34L003-13, dated November 25, 2013, which is not incorporated by reference in this AD.
The following provisions also apply to this AD:
(1)
(2)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2015-0125, dated July 1, 2015, corrected on July 3, 2015, for related information. This MCAI may be found in the AD docket on the Internet at
(2) For service information identified in this AD, contact Airbus SAS, Airworthiness Office—EAL, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 45 80; email
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for all Airbus Model A330-200 Freighter, -200, and -300 series airplanes. This proposed AD was prompted by a report of a manufacturing defect that affects the durability of affected parts in the cargo and cabin compartment. This proposed AD would require an inspection of affected structural parts in the cargo and cabin compartments to determine if proper heat-treatment has been done, and replacement if necessary. We are proposing this AD to prevent crack initiation and propagation, which could result in reduced structural integrity of the fuselage.
We must receive comments on this proposed AD by May 27, 2016.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For service information identified in this NPRM, contact Airbus SAS, Airworthiness Office-EAL, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone: +33 5 61 93 36 96; fax: +33 5 61 93 45 80; email:
You may examine the AD docket on the Internet at
Vladimir Ulyanov, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone: 425-227-1138; fax: 425-227-1149.
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
The European Aviation Safety Agency (EASA), which is the Technical Agent
Airbus quality controls identified that several structural parts, intended for cargo or cabin compartment installation, were manufactured from improperly heat-treated materials. Subsequent review identified that some of those parts were installed on airplanes manufactured between November 2011 and February 2013. From February 2013, Airbus implemented measures into manufacturing processes to ensure detection and to prevent installation of such non-conforming parts.
A detailed safety assessment was accomplished to identify the possible impact of affected parts on the airplane structure. The result of this structural analysis demonstrated the capability of the affected structure to sustain static limit loads, but failed to confirm that the affected structures met the certified fatigue life.
This condition, if not detected and corrected, could lead to crack initiation and propagation, possibly resulting in reduced structural integrity of the fuselage.
To address this potentially unsafe condition, Airbus issued [Mandatory] Service Bulletin (SB) SB A330-53-3227 and SB A330-53-3228 to provide inspection instructions for affected cargo and cabin structural parts respectively.
For the reasons described above, this [EASA] AD requires a one-time Special Detailed Inspection (SDI) [eddy current inspection] to measure the electrical conductivity of affected structural parts, to identify the presence or absence of heat treatment, and, depending on findings, corrective action [replacement].
You may examine the MCAI in the AD docket on the Internet at
Airbus has issued the following service information:
• Airbus Mandatory Service Bulletin A330-53-3227, dated August 18, 2015. The service information describes procedures to inspect affected structural parts in the cargo compartment to determine if proper heat-treatment has been done, and replacement of parts; and
• Airbus Mandatory Service Bulletin A330-53-3228, dated August 18, 2015. The service information describes procedures to inspect affected structural parts in the cabin compartment to determine if proper heat-treatment has been done, and replacement of parts.
This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.
Figure A-GFAAA, Sheet 01, “Inspection Flowchart,” of Airbus Mandatory Service Bulletin A330-53-3227, dated August 18, 2015; and Figure A-GFAAA, Sheet 01, “Inspection Flowchart” of Airbus Mandatory Service Bulletin A330-53-3228, dated August 18, 2015, note that if any other measured (conductivity) value is found, to check the non-destructive test (NDT) tool and perform a new measurement; and if that measured value is confirmed, contact Airbus for further instructions. This proposed AD would require that if a measured value is confirmed that is outside the measurements specified in the service information, a repair must be done using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or EASA; or Airbus's EASA Design Organization Approval (DOA).
We estimate that this proposed AD affects 20 airplanes of U.S. registry.
We also estimate that it will take about 11 work-hours per product to comply with the basic requirements of this proposed AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this proposed AD on U.S. operators to be $18,700, or $935 per product.
In addition, we estimate that any necessary follow-on actions would take about 45 work-hours for a cost of $3,825 per product. We have received no definitive data that would enable us to provide cost of the parts for the on-condition actions specified in this proposed AD. We have no way of determining the number of aircraft that might need this action.
According to the manufacturer, some of the costs of this proposed AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all costs in our cost estimate.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska; and
4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by May 27, 2016.
None.
This AD applies to Airbus Model A330-223F and -243F airplanes; A330-201, -202, -203, -223, and -243 airplanes; A330-301, -302, -303, -321, -322, -323, -341, -342, and -343 airplanes, certificated in any category, manufacturer serial numbers 1175, 1180, 1287 through 1475 inclusive, 1478, 1480, 1483, and 1506.
Air Transport Association (ATA) of America Code 53, Fuselage.
This AD was prompted by a report of a manufacturing defect (
Comply with this AD within the compliance times specified, unless already done.
Within 72 months since first flight of the airplane, do an eddy current inspection (
If, during the inspection required by paragraph (g) of this AD, an affected structural part in the cargo compartment is identified to have a measured value greater than 26 megasiemens per meter (MS/m) or greater than 44.8% International Annealed Copper Standard (IACS), before further flight, replace the affected structural part with a serviceable part, in accordance with the Accomplishment Instructions of Airbus Mandatory Service Bulletin A330-53-3227, dated August 18, 2015.
If, during the inspection required by paragraph (g) of this AD, an affected structural part in the cargo compartment is identified to have a measured value other than those specified in Figure A-GFAAA, Sheet 01, “Inspection Flowchart,” of Airbus Mandatory Service Bulletin A320-53-3227, dated August 18, 2015, before further flight, repair using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or the European Aviation Safety Agency (EASA); or Airbus's EASA Design Organization Approval (DOA).
Within 72 months since first flight of the airplane, do an eddy current inspection of affected structural parts in the cargo compartment to determine if proper heat treatment has been done as identified in, and in accordance with, the Accomplishment Instructions of Airbus Mandatory Service Bulletin A330-53-3228, dated August 18, 2015.
If, during the inspection required by paragraph (j) of this AD, an affected structural part in the cabin compartment is identified to have a measured value greater than 26 MS/m or greater than 44.8% IACS, before further flight, replace the affected structural part with a serviceable part, in accordance with the Accomplishment Instructions of Airbus Mandatory Service Bulletin A330-53-3228, dated August 18, 2015.
If, during the inspection required by paragraph (j) of this AD, an affected structural part in the cargo compartment is identified to have a measured value other than those specified in Figure A-GFAAA, Sheet 01, “Inspection Flowchart,” of Airbus Service Bulletin A320-53-3228, dated August 18, 2015, before further flight, repair using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or the European Aviation Safety Agency (EASA); or Airbus's EASA Design Organization Approval (DOA).
The following provisions also apply to this AD:
(1)
(2)
(3)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA AD 2015-0212, dated November 4, 2015, for related information. You may examine the MCAI on the Internet at
(2) For service information identified in this AD, contact Airbus SAS, Airworthiness Office-EAL, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone: +33 5 61 93 36 96; fax: +33 5 61 93 45 80; email:
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for certain Pacific Aerospace Limited Model 750XL (type certificate previously held by Pacific Aerospace Corporation Ltd.) airplanes that would supersede AD 2006-13-05. This proposed AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as some critical rivets on the wing not being fully age-hardened and being installed in specific locations where reduction in rivet strength reduces wing strength. We are issuing this proposed AD to require actions to address the unsafe condition on these products.
We must receive comments on this proposed AD by May 27, 2016.
You may send comments by any of the following methods:
•
•
•
•
For service information identified in this proposed AD, contact Pacific Aerospace Limited, Airport Road, Hamilton, Private Bag 3027, Hamilton 3240, New Zealand; telephone: +64 7 843 6144; facsimile: +64 7 843 6134; email:
You may examine the AD docket on the Internet at
Karl Schletzbaum, Aerospace Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone: (816) 329-4123; fax: (816) 329-4090; email:
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
On June 12, 2006, we issued AD 2006-13-05, Amendment 39-14658 (71 FR 35509, June 21, 2006) (“AD 2006-13-05”). That AD required actions intended to address an unsafe condition on certain Pacific Aerospace Corporation Ltd. Model 750XL airplanes and was based on mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country.
Since we issued AD 2006-13-05, additional airplanes have been identified that need to be added to the applicability of the AD.
The Civil Aviation Authority (CAA), which is the aviation authority for New Zealand, has issued AD No. DCA/750XL/7B, dated February 25, 2016 (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:
DCA/750XL/7B revised to introduce PACSB/XL/018 issue 4, dated 20 January 2016, which reduces the applicability to S/N 101 through to 131 with no change to the requirements. Aircraft with S/N 132 onwards have been modified in accordance with PACSB/XL/018 at manufacture, which is a terminating action for the requirements of this AD.
Pacific Aerospace Limited has issued Service Bulletin PACSB/XL/018, Issue 4, dated January 20, 2016. The service bulletin describes procedures for removing rivets (part number (P/N) MS20470 DD6) and installing bolts (P/N NAS 6203-7X or NAS 6203-6X), washers (P/N AN960-10), and nuts (P/N MS21044N3) in place of the rivets to restore airplane to full take-off weight of 7,500 pounds. The service bulletin is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with this State of Design Authority, they have notified us of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all information and determined the unsafe condition exists and is likely to exist or
We estimate that this proposed AD will affect 9 products of U.S. registry. We also estimate that it would take about 32 work-hours per product to comply with the replacement requirements of this proposed AD. The average labor rate is $85 per work-hour. Required parts would cost about $519 per product.
Based on these figures, we estimate the cost of this proposed AD on U.S. operators to be $29,151, or $3,239 per product.
AD 2006-13-05 affected 8 of the 9 U.S. registered airplanes reflected in the above cost information. This proposed AD would only increase the cost already required by AD 2006-13-05 by one additional airplane. The FAA has a report that the additional airplane is already in compliance, thus the proposed AD would impose no additional cost impact on U.S. operators.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by May 27, 2016.
This AD replaces AD 2006-13-05, Amendment 39-14658 (71 FR 35509, June 21, 2006) (“AD 2006-13-05”).
This AD applies to the following Pacific Aerospace Limited Model 750XL airplanes (type certificate previously held by Pacific Aerospace Corporation Ltd.), that are certificated in any category.
(1)
(2)
Air Transport Association of America (ATA) Code 57: Wings.
This AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as some critical rivets on the wing not being fully age-hardened and being installed in specific locations where reduction in rivet strength reduces wing strength. We are issuing this AD to add airplanes to the Applicability section, paragraph (c) of this AD, and to ensure wing ultimate load requirements are met. If wing ultimate load requirements are not met, wing failure could result with consequent loss of control.
Unless already done, do the following actions:
(1) Insert the following information into the Limitations section of the airplane flight manual (AFM) at the compliance time specified in paragraphs (f)(1)(i) and (f)(1)(ii) of this AD. You may do this by inserting a copy of this AD into the Limitations section of the AFM: “The maximum takeoff weight is reduced from 7,500 pounds to 7,125 pounds.” The owner/operator holding at least a private pilot certificate as authorized by section 43.7 of the Federal Aviation Regulations (14 CFR 43.7) may do the flight manual changes requirement of this AD. Make an entry in the aircraft records showing compliance with this portion of the AD following section 43.9 of the Federal Aviation Regulations (14 CFR 43.9).
(i)
(ii)
(2) Remove rivets, part number (P/N) MS20470 DD6, on the main spar web and replace with bolts, P/N NAS 6203-6X or -7X, as indicated for the position, assembled with washers, P/N AN960-10, and nut, P/N MS21044N3, at the compliance time specified in paragraphs (f)(2)(i) and (f)(2)(ii) of this AD.
(i)
(ii)
(3)
The following provisions also apply to this AD:
(1)
(2)
Refer to MCAI Civil Aviation Authority (CAA) AD No. DCA/750XL/7B, dated February 25, 2016, for related information. You may examine the MCAI on the Internet at
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for certain Bombardier, Inc. Model BD-700-1A10 and BD-700-1A11 airplanes. This proposed AD was prompted by a design review, which found that the burst pressure of the flexible hose used to vent oxygen from the high-pressure relief valve of the oxygen cylinder overboard is lower than the opening pressure of the high-pressure relief valve. This pressure difference could cause the flexible hose to burst before it is able to vent excess oxygen overboard. This proposed AD would require replacement of flexible relief hoses for the crew oxygen bottles with new metal design relief hoses. We are proposing this AD to prevent the accumulation of excess oxygen in an enclosed space, which could, if near a source of ignition, cause an uncontrolled oxygen-fed fire.
We must receive comments on this proposed AD by May 27, 2016.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For service information identified in this NPRM, contact Bombardier, Inc., 400 Côte-Vertu Road West, Dorval, Québec H4S 1Y9, Canada; telephone 514-855-5000; fax 514-855-7401; email
You may examine the AD docket on the Internet at
Fabio Buttitta, Aerospace Engineer, Airframe and Mechanical Systems Branch, ANE-171, FAA, New York Aircraft Certification Office (ACO), 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7303; fax 516-794-5531.
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian Airworthiness Directive CF-2015-25, dated September 10, 2015 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Bombardier, Inc. Model BD-700-1A10 and BD-700-1A11 airplanes. The MCAI states:
A design review found that the burst pressure of the flexible hose used to vent oxygen from the high-pressure relief valve of the oxygen cylinder overboard is lower than the opening pressure of the high-pressure relief valve. This could cause the flexible hose to burst before it is able to vent the excess oxygen overboard. If an ignition source is present, the accumulation of oxygen in an enclosed space may result in an uncontrolled oxygen-fed fire.
This [Canadian] AD mandates the replacement of the oxygen [flexible] hose assembly with a new design oxygen [metal] hose assembly.
You may examine the MCAI in the AD docket on the Internet at
Bombardier, Inc. has issued the following service information:
• Service Bulletin 700-35-013, Revision 01, dated July 22, 2015;
• Service Bulletin 700-35-5001, Revision 01, dated July 22, 2015;
• Service Bulletin 700-35-6001, Revision 01, dated July 22, 2015;
• Service Bulletin 700-1A11-35-012, Revision 01, dated July 22, 2015.
The service information describes procedures to replace the flexible oxygen hoses with metal hoses. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.
We estimate that this proposed AD affects 73 airplanes of U.S. registry.
We also estimate that it will take about 3 work-hours per product to comply with the basic requirements of this proposed AD. The average labor rate is $85 per work-hour. Required parts would cost about $14,483 per product. Based on these figures, we estimate the cost of this proposed AD on U.S. operators to be $1,075,874, or $14,738 per product.
According to the manufacturer, some of the costs of this proposed AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all costs in our cost estimate.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska; and
4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by May 27, 2016.
None.
This AD applies to Bombardier, Inc. Model BD-700-1A10 and BD-700-1A11 airplanes, certificated in any category, having serial numbers (S/Ns) 9002 through 9704 inclusive and 9998.
Air Transport Association (ATA) of America Code 35, Oxygen.
This AD was prompted by a design review, which found that the burst pressure of the flexible hose used to vent oxygen from the high-pressure relief valve of the oxygen cylinder overboard is lower than the opening pressure of the high-pressure relief valve. This pressure difference could cause the flexible hose to burst before it is able to vent excess oxygen overboard. We are issuing this AD to prevent the accumulation of excess oxygen in an enclosed space, which could, if near a source of ignition, cause an uncontrolled oxygen-fed fire.
Comply with this AD within the compliance times specified, unless already done.
Within 2,500 flight hours or 42 months, whichever occurs first, after the effective date of this AD, incorporate Bombardier Modsum R700T400542 by replacing the oxygen flexible relief hoses for the crew oxygen bottles with new metal design hoses, in accordance with the Accomplishment Instructions of the applicable service information specified in paragraphs (g)(1) through (g)(4) of this AD. Airplanes with serial numbers listed in table 1 of paragraph 1, “Planning information,” of the service information specified in paragraphs (g)(2) and (g)(4) of this AD have incorporated Modsum R700T400542 and meet the requirements of this paragraph.
(1) For Model BD-700-1A10 airplanes having S/Ns 9002 through 9312 inclusive, 9314 through 9380 inclusive, and 9384 through 9429 inclusive: Bombardier Service Bulletin 700-35-013, Revision 01, dated July 22, 2015.
(2) For Model BD-700-1A10 airplanes having S/Ns 9313, 9381, and 9432 through 9704 inclusive: Bombardier Service Bulletin 700-35-6001, Revision 01, dated July 22, 2015.
(3) For Model BD-700-1A11 airplanes having S/Ns 9127 through 9383 inclusive, 9389 through 9400 inclusive, 9404 through 9431 inclusive, and 9998: Bombardier Service Bulletin 700-1A11-35-012, Revision 01, dated July 22, 2015.
(4) For Model BD-700-1A11 airplanes having S/Ns 9386, 9401, and 9445 through
As of the effective date of this AD, no person may install oxygen hoses in the low pressure/high pressure discharge system with part numbers listed in the “Used Part No.” column of Section 3.A, “Kit,” of the applicable service information specified in paragraphs (g)(1) through (g)(4) of this AD.
This paragraph provides credit for actions required by paragraph (g) of this AD, if those actions were performed before the effective date of this AD using the applicable service information identified in paragraphs (i)(1) through (i)(4) of this AD, which are not incorporated by reference in this AD.
(1) Bombardier Service Bulletin 700-35-013, dated February 20, 2015;
(2) Bombardier Service Bulletin 700-35-5001, dated February 20, 2015;
(3) Bombardier Service Bulletin 700-35-6001, dated February 20, 2015; and
(4) Bombardier Service Bulletin 700-1A11-35-012, dated February 20, 2015.
The following provisions also apply to this AD:
(1)
(2)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) Canadian Airworthiness Directive CF-2015-25, dated September 10, 2015, for related information. This MCAI may be found in the AD docket on the Internet at
(2) For service information identified in this AD, contact Bombardier, Inc., 400 Côte-Vertu Road West, Dorval, Québec H4S 1Y9, Canada; telephone 514-855-5000; fax 514-855-7401; email
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for Airbus Helicopters Model AS355NP helicopters with certain fire extinguishing systems. This proposed AD would require removing and installing the fire extinguishing system so that each squib on the engine compartment fire extinguisher is controlled by a matching control button. This proposed AD is prompted by the discovery that the left-hand discharge system of the fire extinguishing system was incorrectly connected to the right-hand engine compartment and the right-hand discharge system was incorrectly connected to the left-hand engine compartment. The proposed actions would correct the connections and would prevent the fire extinguishing system discharging to the wrong engine compartment, failure of the fire extinguishing system to control a fire, and subsequent loss of control of the helicopter.
We must receive comments on this proposed AD by June 13, 2016.
You may send comments by any of the following methods:
•
•
•
•
You may examine the AD docket on the Internet at
For service information identified in this proposed rule, contact Airbus Helicopters, 2701 N. Forum Drive, Grand Prairie, TX 75052; telephone (972) 641-0000 or (800) 232-0323; fax (972) 641-3775; or at
You may review the referenced service information at the FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy, Room 6N-321, Fort Worth, TX 76177.
George Schwab, Aviation Safety Engineer, Safety Management Group, Rotorcraft Directorate, FAA, 10101 Hillwood Pkwy, Fort Worth, TX 76177; telephone (817) 222-5110; email
We invite you to participate in this rulemaking by submitting written comments, data, or views. We also invite comments relating to the economic, environmental, energy, or federalism impacts that might result from adopting the proposals in this document. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should send only one copy of written comments, or if comments are filed electronically, commenters should submit only one time.
We will file in the docket all comments that we receive, as well as a report summarizing each substantive public contact with FAA personnel concerning this proposed rulemaking. Before acting on this proposal, we will consider all comments we receive on or before the closing date for comments. We will consider comments filed after the comment period has closed if it is possible to do so without incurring expense or delay. We may change this proposal in light of the comments we receive.
EASA, which is the Technical Agent for the Member States of the European Union, issued EASA Emergency AD No. 2011-0192-E, dated October 4, 2011, to correct an unsafe condition for Eurocopter (now Airbus Helicopters) Model AS355NP helicopters equipped with an Arrius 1A1 engine fire extinguishing system through production modification OP-3931. EASA advises that during an inspection of the engine fire extinguishing system on an AS355NP helicopter, the left hand (LH) fire extinguisher discharge system was found connected to the right hand (RH) engine compartment and the RH discharge system was connected to the LH engine compartment. An investigation showed that this erroneous installation was inherent in Eurocopter production modification OP-3931. According to EASA, this condition, if not detected and corrected, could lead to the discharge of the fire extinguisher in the wrong engine compartment in the event of a fire. Pending the development of a modified extinguishing system, EASA Emergency AD No. 2011-0192-E required installing a placard warning the flight crew of the erroneous installation until the squibs on each fire extinguisher are exchanged.
After EASA issued Emergency AD No. 2011-0192-E, Airbus Helicopters developed a permanent modification of the discharge system to reconfigure the position of the squibs on each fire extinguisher to line up with the control buttons. EASA subsequently issued superseding EASA AD No. 2015-0181, dated August 31, 2015, to retain the requirements of its previous Emergency AD and require the modification of the engine fire extinguishing discharge system within 12 months.
These helicopters have been approved by the aviation authority of France and are approved for operation in the United States. Pursuant to our bilateral agreement with France, EASA, its technical representative, has notified us of the unsafe condition described in its AD. We are proposing this AD because we evaluated all known relevant information and determined that an unsafe condition is likely to exist or develop on other products of the same type design.
We reviewed Airbus Helicopters Alert Service Bulletin No. AS355-26.00.10, Revision 0, dated July 2, 2015 (ASB AS355-26.00.10). ASB AS355-26.00.10 provides procedures for removing the fire extinguishing system and re-installing it in a configuration where the squibs match the positioning of the fire extinguisher discharge heads. ASB AS355-26.00.10 also specifies removing any previously-affixed placard on the instrument panel and installing new discharge system pipes. Helicopters with modification 07-3990 installed have already complied with ASB AS355-26.00.10.
This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
We also reviewed Eurocopter Emergency Alert Service Bulletin No. 26.00.09, Revision 0, dated September 15, 2011 (EASB 26.00.09), issued prior to the permanent modification developed by Airbus Helicopters. EASB 26.00.09 provided procedures for interchanging the squibs on each fire extinguisher. Until this was accomplished, EASB 26.00.09 specified affixing a label on the instrument panel to make the flight crew aware of the crossed connection.
This proposed AD would require within 600 hours time-in-service or at the next annual inspection, whichever occurs first, removing and correctly installing the fire extinguishing system, and removing any placards on the instrument panel if installed.
The EASA AD requires installing a placard on the instrument panel to warn the flight crew of the erroneous installation until the squibs on each fire extinguisher are exchanged, and then, within 12 months, removing and re-installing the fire extinguishing system to position the squibs in line with the control buttons. This proposed AD would not require installation of the placards or the temporary exchange of the squibs. Also, this proposed AD would require removing and re-installing the fire extinguisher system within 600 hours TIS or at the next annual inspection, whichever occurs first.
We estimate that this proposed AD would affect 2 helicopters of U.S. Registry and that labor costs average $85 per work hour. We expect that removing and installing the fire extinguishing system would require 24 work hours and required parts would cost $6,367. Based on these estimates, we expect a total cost of $8,407 per helicopter and $16,814 for the U.S. fleet.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed, I certify this proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction; and
4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities
We prepared an economic evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD applies to Airbus Helicopters Model AS355NP helicopters, certificated in any category, with an Arrius 1A1 fire extinguishing system installed.
This AD defines the unsafe condition as an incorrectly connected fire extinguishing discharge system. This condition could result in the fire extinguishing system discharging to the wrong engine compartment, failure of the fire extinguishing system to contain a fire, and loss of control of the helicopter.
We must receive comments by June 13, 2016.
You are responsible for performing each action required by this AD within the specified compliance time unless it has already been accomplished prior to that time.
Within 600 hours time-in-service or at the next annual inspection, whichever occurs first, remove and install the fire extinguishing system, and remove any placards on the instrument panel if installed, in accordance with the Accomplishment Instructions, paragraph 3.B. and 3.B.1 through 3.B.2, of Airbus Helicopters Alert Service Bulletin No. AS355-26.00.10, Revision 0, dated July 2, 2015.
(1) The Manager, Safety Management Group, FAA, may approve AMOCs for this AD. Send your proposal to: George Schwab, Aviation Safety Engineer, Safety Management Group, Rotorcraft Directorate, FAA, 10101 Hillwood Pkwy, Fort Worth, TX 76177; telephone (817) 222-5110; email
(2) For operations conducted under a 14 CFR part 119 operating certificate or under 14 CFR part 91, subpart K, we suggest that you notify your principal inspector, or lacking a principal inspector, the manager of the local flight standards district office or certificate holding district office before operating any aircraft complying with this AD through an AMOC.
(1) Eurocopter Emergency Alert Service Bulletin No. 26.00.09, Revision 0, dated September 15, 2011, which is not incorporated by reference, contains additional information about the subject of this AD. For service information identified in this AD, contact Airbus Helicopters, 2701 N. Forum Drive, Grand Prairie, TX 75052; telephone (972) 641-0000 or (800) 232-0323; fax (972) 641-3775; or at
(2) The subject of this AD is addressed in European Aviation Safety Agency (EASA) AD No. 2015-0181, dated August 31, 2015. You may view the EASA AD on the Internet at
Joint Aircraft Service Component (JASC) Code: 2620, Extinguishing System.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for certain Bombardier, Inc. Model DHC-8-102, -103, and -106 airplanes, and Model DHC-8-200 and -300 series airplanes. This proposed AD was prompted by a report of heat damage found on a nacelle firewall after an unsuccessful engine ground start and several events of heat damage found on direct current starter/generator terminal block assemblies. This proposed AD would require an inspection for damage on the nacelle firewalls and the terminal block assemblies and to make sure the insulating sleeves are installed and have no damage, and corrective action if necessary. We are proposing this AD to prevent arcing between the firewall and terminal blocks that are missing insulating sleeves on the conductive bushings, which could, in combination with a fuel or hydraulic fluid leak, be an ignition source for a fire.
We must receive comments on this proposed AD by May 27, 2016.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For service information identified in this NPRM, contact Bombardier, Inc., Q-Series Technical Help Desk, 123 Garratt Boulevard, Toronto, Ontario M3K 1Y5, Canada; telephone 416-375-4000; fax 416-375-4539; email
You may examine the AD docket on the Internet at
Assata Dessaline, Aerospace Engineer, Avionics and Flight Test Branch, ANE-172, FAA, New York Aircraft Certification Office, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7301; fax 516-794-5531.
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian Airworthiness Directive CF-2014-03R1, dated July 24, 2014 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Bombardier, Inc. Model DHC-8-102, -103, and -106 airplanes, and Model DHC-8-200 and -300 series airplanes. The MCAI states:
There has been one in-service report of heat damage on a nacelle firewall found after an unsuccessful engine ground start. There have also been several reports of heat damage found on Direct Current Starter/Generator terminal block assemblies, part number (P/N) 82450075-001.
The investigation determined that in all cases, the heat damage was caused by arcing between the firewall and terminal blocks with missing insulating sleeves on the conductive bushings. The insulating sleeves may have been inadvertently omitted during the incorporation of Modsum 8/1926, or during the installation of terminal blocks P/N 82450075-001.
Arcing with the firewall becomes an ignition source, creating a potential fire hazard when combined with a fuel or hydraulic fluid leak.
The original issue of this [Canadian] AD mandated the [detailed visual] inspection [for damage to the nacelle firewalls and to make sure the insulating sleeves are installed and have no damage] and rectification [corrective actions such as installing or replacing insulating sleeves, or replacing a terminal block], as required, of the nacelle firewall and terminal block assembly P/N 82450075-001 installed with Modsum 8/1926.
Revision 1 of this [Canadian] AD is issued to revise the Applicability to ensure that the terminal blocks have the insulating sleeves installed.
You may examine the MCAI in the AD docket on the Internet at
Bombardier has issued Service Bulletin 8-24-92, Revision A, dated April 11, 2014. This service information describes procedures for an inspection for damage on the nacelle firewalls and the terminal block assemblies and to make sure the insulating sleeves are installed and have no damage, and corrective action if necessary. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.
We estimate that this proposed AD affects 75 airplanes of U.S. registry.
We also estimate that it would take about 2 work-hours per product to comply with the basic requirements of this proposed AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this proposed AD on U.S. operators to be $12,750, or $170 per product.
In addition, we estimate that any necessary follow-on actions would take about 1 work-hour and require parts costing $551, for a cost of $636 per product. We have no way of determining the number of aircraft that might need these actions.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska; and
4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by May 27, 2016.
None.
This AD applies to Bombardier, Inc. airplanes identified in paragraphs (c)(1), (c)(2), and (c)(3) of this AD, certificated in any category, serial numbers 003 through 672 inclusive, on which terminal block part number 82450075-001 is installed.
(1) Model DHC-8-102, -103, and -106 airplanes.
(2) Model DHC-8-201 and -202 airplanes.
(3) Model DHC-8-301, -311, and -315 airplanes.
Air Transport Association (ATA) of America Code 24, Electrical Power.
This AD was prompted by a report of one event of heat damage found on a nacelle firewall after an unsuccessful engine ground start and several events of heat damage found on direct current starter/generator terminal block assemblies. We are issuing this AD to prevent arcing between the firewall and terminal blocks that are missing insulating sleeves on the conductive bushings, which could, in combination with a fuel or hydraulic fluid leak, be an ignition source for a fire.
Comply with this AD within the compliance times specified, unless already done.
Within 2,500 flight cycles or 14 months after the effective date of this AD, whichever occurs first, perform a detailed visual inspection of the right-hand side and left-hand side nacelle firewalls and terminal block assemblies, as defined in Bombardier Service Bulletin 8-24-92, Revision A, dated April 11, 2014, in accordance with the Accomplishment Instructions of Bombardier Service Bulletin 8-24-92, Revision A, dated April 11, 2014.
(1) If the inspection finds no damage on the engine firewalls and the terminal blocks, and that the insulating sleeves are installed on both terminal blocks, no further action is required by this AD.
(2) If the inspection finds that no insulating sleeves are installed, or the existing sleeves are damaged, and there is no damage to the nacelle firewall and terminal block, before further flight, install the replacement insulating sleeves, in accordance with the Accomplishment Instructions of Bombardier Service Bulletin 8-24-92, Revision A, dated April 11, 2014.
(3) If the inspection finds that no insulating sleeves are installed, or any existing sleeve is damaged, and there is no damage to the nacelle firewall, but there is damage to the terminal block, before further flight, replace the terminal block assembly (which includes insulating sleeves), in accordance with the Accomplishment Instructions of Bombardier Service Bulletin 8-24-92, Revision A, dated April 11, 2014.
(4) If the inspection finds that no insulating sleeves are installed and there is damage to the nacelle firewall and the terminal block, repair the damage using a method approved by the Manager, New York Aircraft Certification Office (ACO), ANE-170, Engine and Propeller Directorate, FAA; or Transport Canada Civil Aviation (TCCA); or Bombardier, Inc.'s TCCA Design Approval Organization (DAO).
This paragraph provides credit for actions required by paragraph (g) of this AD, if those actions were performed before the effective date of this AD using Bombardier Service Bulletin 8-24-92, dated September 25, 2013, which is not incorporated by reference in this AD.
The following provisions also apply to this AD:
(1)
(2)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) Canadian Airworthiness Directive CF-2014-03R1, dated July 24, 2014, for related information. This MCAI may be found in the AD docket on the Internet at
(2) For service information identified in this AD, contact Bombardier, Inc., Q-Series Technical Help Desk, 123 Garratt Boulevard, Toronto, Ontario M3K 1Y5, Canada; telephone 416-375-4000; fax 416-375-4539; email
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for all The Boeing Company Model 737-600, -700, -700C, -800, and -900 series airplanes. This proposed AD was prompted by reports of paint deterioration on the surface of the main landing gear (MLG) and the early onset of corrosion in the trunnion bore of the MLG outer cylinder. This proposed AD would require identifying affected parts, repetitive external surface detailed inspection for damage of affected parts, and related investigative and corrective actions if necessary. For certain airplanes, this AD also would require a detailed inspection and bushing replacement of the trunnion bore, and related investigative and corrective action if necessary. We are proposing this AD to prevent stress corrosion cracking of the external surfaces of the MLG, which could result in a fracture of the MLG and consequent MLG collapse.
We must receive comments on this proposed AD by May 27, 2016.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For service information identified in this NPRM, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-5000, extension 1; fax 206-766-5680; Internet
You may examine the AD docket on the Internet at
Alan Pohl, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6450; fax: 425-917-6590; email:
We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the
We will post all comments we receive, without change, to
We received reports from several operators of paint deterioration on the surface of the MLG and early onset of corrosion in the trunnion bore of the MLG outer cylinder. A maintenance repair and overhaul (MRO) facility observed forward trunnion bore corrosion on a right MLG while installing new bushings. Another MRO disclosed that between 2007 and 2010, the primer used on the landing gear components did not comply with Boeing Material Specification (BMS) 10-79. Also, paint chip and trunnion bore analysis showed that unqualified primer was used; primer application was up to 5 times too thick while enamel was too thin; there was early deterioration of the fillet seal at the trunnion bore; and the trunnion bushing installation process, which may have damaged the finish on the bore, did not follow the standard overhaul practices manual. This condition, if not corrected, could result in a fracture of the MLG and consequent MLG collapse.
We reviewed Boeing Special Attention Service Bulletin 737-32-1486, dated November 6, 2014, as revised by Boeing Special Attention Service Bulletin 737-32-1486, Revision 1, dated April 1, 2015. The service information describes procedures for identifying affected parts, repetitive external surface detailed inspection for damage of affected parts, and related investigative and corrective actions if necessary. For certain airplanes, this AD also would require a detailed inspection and bushing replacement of the trunnion bore, and related investigative and corrective action if necessary. The service information also describes procedures for certain airplanes that include a detailed inspection of the trunnion bore, and corrective actions. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
We are proposing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of these same type designs.
This proposed AD would require accomplishing the actions specified in the service information described previously, except as discussed under “Differences Between this Proposed AD and the Service Information.”
The phrase “corrective actions” is used in this proposed AD. “Corrective actions” correct or address any condition found. Corrective actions in an AD could include, for example, repairs.
The phrase “related investigative actions” is used in this proposed AD. “Related investigative actions” are follow-on actions that (1) are related to the primary action, and (2) further investigate the nature of any condition found. Related investigative actions in an AD could include, for example, inspections.
Boeing Special Attention Service Bulletin 737-32-1486, dated November 6, 2014, as revised by Boeing Special Attention Service Bulletin 737-32-1486, Revision 1, dated April 1, 2015, specifies to contact the manufacturer for instructions on how to repair certain conditions, but this proposed AD would require repairing those conditions in one of the following ways:
• In accordance with a method that we approve; or
• Using data that meet the certification basis of the airplane, and that have been approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) whom we have authorized to make those findings.
While the effectivity of Boeing Special Attention Service Bulletin 737-32-1486, dated November 6, 2014, as revised by Boeing Special Attention Service Bulletin 737-32-1486, Revision 1, dated April 1, 2015, is limited to those airplanes that are listed, the applicability of this AD affects all The Boeing Company Model 737-600, -700, -700C, -800, and -900 series airplanes.
An MLG overhauled by SAFRAN Messier-Bugatti-Dowty outside of the Boeing Exchange program from June 1, 2009, to July 31, 2013, would also be affected by this proposed AD.
We estimate that this proposed AD affects 33 airplanes of U.S. registry.
We estimate the following costs to comply with this proposed AD:
We estimate the following costs to do any necessary replacements that would be required based on the results of the proposed inspection. We have no way of determining the number of aircraft that might need this replacement.
We have received no definitive data that would enable us to provide cost estimates for certain on-condition actions (MLG external surface repair, MLG component replacement, outer cylinder repair, and MLG replacement) specified in this proposed AD.
According to the manufacturer, some of the costs of this proposed AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all costs in our cost estimate.
The previous info is based on known airplanes. However, the MLG may have been overhauled outside of the Boeing Exchange Program as specified in the Clarification of Affected MLGs section of this proposed AD.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by May 27, 2016.
None.
This AD applies to all The Boeing Company Model 737-600, -700, -700C, -800, and -900 series airplanes, certificated in any category.
Air Transport Association (ATA) of America Code 32, Landing Gear.
This AD was prompted by reports of paint deterioration on the surface of the main
Comply with this AD within the compliance times specified, unless already done.
At the applicable time specified in table 1 of paragraph 1.E., “Compliance,” of Boeing Special Attention Service Bulletin 737-32-1486, dated November 6, 2014, as revised by Boeing Special Attention Service Bulletin 737-32-1486, Revision 1, dated April 1, 2015, except as required by paragraph (k)(1) of this AD: Do the actions specified in paragraphs (g)(1) and (g)(2) of this AD in order to identify affected parts.
(1) Inspect the MLG to determine if it has any component installation or side strut assembly having a part number and serial number listed in Appendix D of Boeing Special Attention Service Bulletin 737-32-1486, dated November 6, 2014, as revised by Boeing Special Attention Service Bulletin 737-32-1486, Revision 1, dated April 1, 2015; except that the “Variable Number” column of Appendix D is to be disregarded in determining affected part and serial numbers. A MLG that has any MLG component installation or side strut assembly having a part number and serial number listed in Appendix D of Boeing Special Attention Service Bulletin 737-32-1486, dated November 6, 2014, as revised by Boeing Special Attention Service Bulletin 737-32-1486, Revision 1, dated April 1, 2015, is an affected part. A review of airplane maintenance records is acceptable in lieu of this inspection if the part number and serial number of the MLG component installation and side strut assembly can be conclusively identified from that review.
(2) Do a records review to determine if the MLG has been overhauled by SAFRAN Messier-Bugatti-Dowty outside of the Boeing Exchange program from June 1, 2009 to July 31, 2013. If the MLG has been overhauled by SAFRAN Messier-Bugatti-Dowty outside of the Boeing Exchange program from June 1, 2009 to July 31, 2013, that MLG is an affected part. If the records review cannot conclusively determine that an overhauled MLG was overhauled by an MRO other than SAFRAN Messier-Bugatti-Dowty, or if the records review cannot conclusively determine that an MLG overhauled by SAFRAN Messier-Bugatti-Dowty was part of the Boeing Exchange program from June 1, 2009 to July 31, 2013; that MLG is an affected part.
If any affected part is identified during the inspection or records review required by paragraph (g) of this AD: At the applicable time specified in table 3 of paragraph 1.E., “Compliance,” of Boeing Special Attention Service Bulletin 737-32-1486, dated November 6, 2014, as revised by Boeing Special Attention Service Bulletin 737-32-1486, Revision 1, dated April 1, 2015, except as required by paragraph (k)(1) of this AD: Do detailed inspections of the external surfaces of the MLG, and do all applicable related investigative and corrective actions, in accordance with Parts 1, 3, and 4 of the Accomplishment Instructions of Boeing Special Attention Service Bulletin 737-32-1486, dated November 6, 2014, as revised by Boeing Special Attention Service Bulletin 737-32-1486, Revision 1, dated April 1, 2015, except as required by paragraph (k)(2) of this AD. Repeat the inspections thereafter at the applicable time specified in table 3 of paragraph 1.E., “Compliance,” of Boeing Special Attention Service Bulletin 737-32-1486, dated November 6, 2014, as revised by Boeing Special Attention Service Bulletin 737-32-1486, Revision 1, dated April 1, 2015. All applicable related investigative and corrective actions must be done before further flight.
For airplanes that are identified as Groups 1 and 2, Configuration 1, in Boeing Special Attention Service Bulletin 737-32-1486, dated November 6, 2014, as revised by Boeing Special Attention Service Bulletin 737-32-1486, Revision 1, dated April 1, 2015, and that have an affected part identified during the inspection or records review required by paragraph (g) of this AD: At the applicable time specified in table 4 of Paragraph 1.E, “Compliance,” of Boeing Special Attention Service Bulletin 737-32-1486, dated November 6, 2014, as revised by Boeing Special Attention Service Bulletin 737-32-1486, Revision 1, dated April 1, 2015, except as required by paragraph (k)(1) of this AD, do a detailed inspection and bushing replacement of the MLG trunnion bore, and do all applicable related investigative and corrective actions, in accordance with Parts 2, 5, and 6 of the Accomplishment Instructions of Boeing Special Attention Service Bulletin 737-32-1486, dated November 6, 2014, as revised by Boeing Special Attention Service Bulletin 737-32-1486, Revision 1, dated April 1, 2015, except as required by paragraph (k)(2) of this AD.
(1) MLG replacement in accordance with Part 8 of the Accomplishment Instructions of Boeing Special Attention Service Bulletin 737-32-1486, dated November 6, 2014, as revised by Boeing Special Attention Service Bulletin 737-32-1486, Revision 1, dated April 1, 2015, terminates the requirements of paragraphs (g), (h), and (i) of this AD for that MLG only.
(2) MLG component replacement in accordance with Part 4 of the Accomplishment Instructions of Boeing Special Attention Service Bulletin 737-32-1486, dated November 6, 2014, as revised by Boeing Special Attention Service Bulletin 737-32-1486, Revision 1, dated April 1, 2015, terminates the requirements of paragraph (h) of this AD for that component only.
(3) MLG outer cylinder replacement in accordance with Part 7 of the Accomplishment Instructions of Boeing Special Attention Service Bulletin 737-32-1486, dated November 6, 2014, as revised by Boeing Special Attention Service Bulletin 737-32-1486, Revision 1, dated April 1, 2015, terminates the requirements of paragraph (i) of this AD for that component only.
(1) Where paragraph 1.E., “Compliance,” of Boeing Special Attention Service Bulletin 737-32-1486, dated November 6, 2014, as revised by Boeing Special Attention Service Bulletin 737-32-1486, Revision 1, dated April 1, 2015, specifies a compliance time “after the original issue date of this service bulletin,” this AD requires compliance within the specified compliance time after the effective date of this AD.
(2) Although Boeing Special Attention Service Bulletin 737-32-1486, dated November 6, 2014, as revised by Boeing Special Attention Service Bulletin 737-32-1486, Revision 1, dated April 1, 2015, specifies to contact Boeing for repair instructions, and specifies that action as “RC” (Required for Compliance), this AD requires repair before further flight using a method approved in accordance with the procedures specified in paragraph (m) of this AD.
As of the effective date of this AD, no person may install the following on any airplane identified in paragraph (c) of this AD, unless the MLG has been overhauled using a method approved in accordance with the procedures specified in paragraph (m) of this AD:
(1) An MLG having a part number and serial number identified in Appendix D to Boeing Special Attention Service Bulletin 737-32-1486, dated November 6, 2014, as revised by Boeing Special Attention Service Bulletin 737-32-1486, Revision 1, dated April 1, 2015.
(2) An MLG that was overhauled from June 1, 2009, to July 31, 2013, by SAFRAN Messier-Bugatti-Dowty.
(1) The Manager, Seattle Aircraft Certification Office (ACO), FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the ACO, send it to the attention of the person identified in paragraph (n)(1) of this AD. Information may be emailed to:
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
(3) An AMOC that provides an acceptable level of safety may be used for any repair, modification, or alteration required by this AD if it is approved by the Boeing
(4) Except as required by paragraph (k)(2) of this AD: For service information that contains steps that are labeled as RC, the provisions of paragraphs (m)(4)(i) and (m)(4)(ii) of this AD apply.
(i) The steps labeled as RC, including substeps under an RC step and any figures identified in an RC step, must be done to comply with the AD. An AMOC is required for any deviations to RC steps, including substeps and identified figures.
(ii) Steps not labeled as RC may be deviated from using accepted methods in accordance with the operator's maintenance or inspection program without obtaining approval of an AMOC, provided the RC steps, including substeps and identified figures, can still be done as specified, and the airplane can be put back in an airworthy condition.
(1) For more information about this AD, contact Alan Pohl, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle ACO, 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6450; fax: 425-917-6590; email:
(2) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-5000, extension 1; fax 206-766-5680; Internet
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to supersede Airworthiness Directive (AD) 2008-15-06, which applies to certain Textron Aviation Inc. Models 175 and 175A airplanes (type certificate previously held by Cessna Aircraft Company). AD 2008-15-06 currently requires checking the airplane logbook to determine if the original engine mounting brackets have been replaced. If the original engine mounting brackets are still installed, the AD requires repetitively inspecting those brackets for cracks and replacing any cracked engine mounting bracket until all four original engine mounting brackets are replaced. Replacing all four original engine mounting brackets terminates the actions required in AD 2008-15-06. Since we issued AD 2008-15-06, we have determined that the applicability needs to be changed to add a serial number and take one out. This proposed AD would retain the actions required in AD 2008-15-06 and would change the Applicability section. We are proposing this AD to correct the unsafe condition on these products.
We must receive comments on this proposed AD by May 27, 2016.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For service information identified in this NPRM, contact Cessna Aircraft Company, Product Support, P.O. Box 7706, Wichita, Kansas 67277; telephone: (316) 517-5800; fax: (316) 942-9006; Internet:
You may examine the AD docket on the Internet at
Gary Park, Aerospace Engineer, Wichita Aircraft Certification Office, 1801 Airport Road, Room 100, Wichita, Kansas 67209; telephone: (316) 946-4123; fax: (316) 946-4107, email:
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
On July 15, 2008, we issued AD 2008-15-06, Amendment 39-15618 (73 FR 43845, July 29, 2008), (“AD 2008-15-06”), for certain Textron Aviation Inc. Models 175 and 175A airplanes (type certificate previously held by Cessna Aircraft Company). AD 2008-15-06 requires you to check the airplane logbook to determine if the original engine mounting brackets have been replaced. If the original engine mounting brackets are still installed, this AD requires you to repetitively inspect those brackets for cracks and replace any cracked engine mounting bracket. After replacing all four original engine mounting brackets, no further action will be required by this AD. AD 2008-15-06 resulted from a report of the engine detaching from the firewall on a Cessna Model 175 airplane during landing. We issued AD 2008-15-06 to detect and correct cracks in the engine
Since we issued AD 2008-15-06, we have determined that the applicability for Model 175A airplanes needs to be changed. We have determined that a serial number has been inadvertently included in the applicability and a serial number has been inadvertently omitted from the applicability.
We reviewed Cessna Single Engine Service Bulletin SEB07-2, Revision 2, dated June 18, 2007. The service information describes procedures for inspecting the upper and lower engine mounting brackets on both the left and right sides for cracks and replacing cracked engine mounting brackets. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
We are proposing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.
This proposed AD would retain the requirements of AD 2008-15-06 and would add a serial number to the applicability and take one out.
We estimate that this AD would affect 1,218 airplanes in the U.S. registry.
We estimate the following costs to do each proposed inspection:
We estimate the following costs to do any necessary proposed replacements:
There is no estimated cost of compliance difference between this proposed AD and AD 2008-15-06 since there is no change in the number of affected airplanes or in the proposed actions. The cost impact on the public would be in the removal of serial number 691 and the addition of serial number 619.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We have determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that the proposed regulation:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
The FAA must receive comments on this AD action by May 27, 2016.
This AD replaces AD 2008-15-06, Amendment 39-15618 (73 FR 43845, July 29, 2008) (“AD 2008-15-06”).
This AD applies to the following Textron Aviation Inc. airplane models and serial
(1) Airplanes previously affected by AD 2008-15-06
(2) New airplane affected by this AD:
Joint Aircraft System Component (JASC)/Air Transport Association (ATA) of America Code 71, Power Plant.
This AD was prompted by the determination that an airplane needs to be added to the Applicability section and an airplane needs to be removed from the Applicability section. We are issuing this AD to detect and correct cracks in the engine mounting brackets, which could result in failure of the engine mounting bracket. This failure could lead to the engine detaching from the firewall.
Comply with this AD within the compliance times specified, unless already done.
(1) Check the airplane logbook to determine if all four of the original engine mounting brackets have been replaced. Do the logbook check at the following compliance time, as applicable. The owner/operator holding at least a private pilot certificate as authorized by section 43.7 may do this action.
(i)
(ii)
(2) If you can positively determine that all four of the original engine mounting brackets have been replaced, no further action is required. Make an entry into the aircraft logbook showing compliance with this portion of the AD in accordance with 14 CFR 43.9. The owner/operator holding at least a private pilot certificate as authorized by section 43.7 may do this action.
(3) If you cannot positively determine that all four of the original engine mounting brackets have been replaced, inspect each of the upper and lower engine mounting brackets on both the left and right sides for cracks following Cessna Single Engine Service Bulletin SEB07-2, Revision 2, dated June 18, 2007. Do the inspections at the following compliance times, as applicable.
(i)
(ii)
To terminate the repetitive inspections required in paragraphs (g)(3)(i) and (g)(3)(ii) of this AD, you may replace all four original engine mounting brackets following Cessna Single Engine Service Bulletin SEB07-2, Revision 2, dated June 18, 2007, at the following compliance times, as applicable.
(1)
(2)
(1) The Manager, Wichita Aircraft Certification Office (ACO), FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the ACO, send it to the attention of the person identified in paragraph (l) of this AD.
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
(3) AMOCs approved for AD 2008-15-06 are approved as AMOCs for the corresponding provisions of this AD.
(1) For more information about this AD, contact Gary Park, Aerospace Engineer, Wichita ACO, 1801 Airport Road, Room 100, Wichita, Kansas 67209; telephone: (316) 946-4123; fax: (316) 946-4107, email:
(2) For service information identified in this AD, contact Cessna Aircraft Company, Product Support, P.O. Box 7706, Wichita, Kansas 67277; telephone: (316) 517-5800; fax: (316) 942-9006; Internet:
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for certain Bombardier, Inc. Model CL-600-2C10 (Regional Jet Series 700, 701, & 702), Model CL-600-2D15 (Regional Jet Series 705), Model CL-600-2D24 (Regional Jet Series 900), and Model CL-600-2E25 (Regional Jet Series 1000) airplanes. This proposed AD was prompted by reports of corrosion found on the slat and flap torque tubes in the
We must receive comments on this proposed AD by May 27, 2016.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For service information identified in this NPRM, contact Bombardier, Inc., 400 Côte-Vertu Road West, Dorval, Québec H4S 1Y9, Canada; telephone: 514-855-5000; fax: 514-855-7401; email:
You may examine the AD docket on the Internet at
Cesar Gomez, Aerospace Engineer, Airframe and Mechanical Systems Branch, ANE-171, FAA, New York Aircraft Certification Office (ACO), 1600 Stewart Avenue, Suite 410, Westbury, New York 11590; telephone: 516-228-7318; fax: 516-794-5531.
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian AD CF-2016-03R1, dated February 18, 2016 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Bombardier, Inc. Model CL-600-2C10 (Regional Jet Series 700, 701, & 702), Model CL-600-2D15 (Regional Jet Series 705), Model CL-600-2D24 (Regional Jet Series 900), and Model CL-600-2E25 (Regional Jet Series 1000) airplanes. The MCAI states:
There have been a number of reports of corrosion found on the torque tubes in the slat and flap control system. Investigation revealed that the current design of the flap and slat torque tubes do not have proper corrosion protection and are not entirely sealed which leads to moisture ingress and internal corrosion. A corroded tube may rupture resulting in an inoperative slat or flap system, or in a worst case scenario, could result in reduced controllability of the aeroplane. This [Canadian] AD mandates the replacement of affected slat and flap system torque tubes with [new or] modified torque tubes.
This [Canadian] AD was revised to add the statement that accomplishment of the initial Service Bulletin (SB) 670BA-27-067, dated 15 January 2015 also meets the requirements of this AD and to correct the editorial error for the release date of SB 670BA-27-067, Revision A.
You may examine the MCAI in the AD docket on the Internet at
We reviewed Bombardier Service Bulletin 670BA-27-067, Revision A, dated February 23, 2015. This service information describes procedures for replacement of the slat and flap torque tubes in the slat and flap control system. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of these same type designs.
We estimate that this proposed AD affects 509 airplanes of U.S. registry.
We estimate the following costs to comply with this proposed AD:
According to the parts manufacturer, some of the costs of this proposed AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska; and
4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by May 27, 2016.
None.
This AD applies to the airplanes, certificated in any category, identified in paragraphs (c)(1), (c)(2), (c)(3), and (c)(4) of this AD.
(1) Bombardier, Inc. Model CL-600-2C10 (Regional Jet Series 700, 701, & 702) airplanes, serial numbers 10002 through 10342 inclusive.
(2) Bombardier, Inc. Model CL-600-2D15 (Regional Jet Series 705) airplanes, serial numbers 15001 through 15361 inclusive.
(3) Bombardier, Inc. Model CL-600-2D24 (Regional Jet Series 900) airplanes, serial numbers 15001 through 15361 inclusive.
(4) Bombardier, Inc. Model CL-600-2E25 (Regional Jet Series 1000) airplanes, serial numbers 19001 through 19041 inclusive.
Air Transport Association (ATA) of America Code 27, Flight controls.
This AD was prompted by reports of corrosion found on the slat and flap torque tubes in the slat and flap control system. We are issuing this AD to prevent rupture of a corroded slat or flap torque tube. This condition could result in an inoperative slat or flap system and consequent reduced controllability of the airplane.
Comply with this AD within the compliance times specified, unless already done.
Within the compliance times specified in paragraph (g)(1), (g)(2), or (g)(3) of this AD, as applicable: Replace the slat and flap torque tubes in the slat and flap control system with new or modified slat and flap torque tubes, in accordance with the Accomplishment Instructions of Bombardier Service Bulletin 670BA-27-067, Revision A, dated February 23, 2015.
(1) For airplanes that have accumulated 28,000 total flight hours or less as of the effective date of this AD, or with 137 months or less since the date of issuance of the original Canadian certificate of airworthiness or date of issuance of the original Canadian export certificate of airworthiness as of the effective date of this AD: Before the accumulation of 34,000 total flight hours or within 167 months since the date of issuance of the original Canadian certificate of airworthiness or date of issuance of the original Canadian export certificate of airworthiness, whichever occurs first.
(2) For airplanes that have accumulated more than 28,000 total flight hours but not more than 36,000 total flight hours as of the effective date of this AD, and with more than 137 months but not more than 176 months since the date of issuance of the original Canadian certificate of airworthiness or date of issuance of the original Canadian export certificate of airworthiness as of the effective date of this AD: At the earlier of the times specified in paragraphs (g)(2)(i) and (g)(2)(ii) of this AD.
(i) Within 6,000 flight hours or 30 months, whichever occurs first, after the effective date of this AD.
(ii) Before the accumulation of 38,000 total flight hours, or within 186 months since the date of issuance of the original Canadian certificate of airworthiness or date of issuance of the original Canadian export certificate of airworthiness, whichever occurs first.
(3) For airplanes that have accumulated more than 36,000 total flight hours as of the effective date of this AD, or with more than 176 months since the date of issuance of the original Canadian certificate of airworthiness or date of issuance of the original Canadian export certificate of airworthiness as of the effective date of this AD: Within 2,000 flight hours or 10 months, whichever occurs first, after the effective date of this AD.
This paragraph provides credit for actions required by paragraph (g) of this AD, if those actions were performed before the effective date of this AD using Bombardier Service Bulletin 670BA-27-067, dated January 15, 2015, which is not incorporated by reference in this AD.
The following provisions also apply to this AD:
(1)
(2)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) Canadian AD CF-2016-03R1, dated February 18, 2016, for related information. This MCAI may be found in the AD docket on the Internet at
(2) For service information identified in this AD, contact Bombardier, Inc., 400 Côte-Vertu Road West, Dorval, Québec H4S 1Y9, Canada; telephone: 514-855-5000; fax: 514-855-7401; email:
Postal Regulatory Commission.
Proposed rulemaking.
The Commission is proposing rules which amend existing rules related to the Mail Classification Schedule and its associated product lists. The proposed rules revise some existing rules in order to better conform with current Commission practices related to the Mail Classification Schedule. The Commission invites public comment on the proposed rules.
David A. Trissell, General Counsel, at 202-789-6820.
This rulemaking is initiated by the Postal Regulatory Commission (Commission) to fulfill its responsibilities under the Postal Accountability and Enhancement Act (PAEA), Public Law 109-435, 120 Stat. 3198 (2006). The proposed rules amend existing rules concerning the Mail Classification Schedule (MCS) and the associated market dominant and competitive product lists. The proposals amend existing rules to conform to the current practice of publishing the MCS on the Commission's Web site at
The proposed rules replace existing 39 CFR part 3020, subpart A in its entirety. Conforming changes also are proposed for 39 CFR part 3020, subparts B, C, and D. The proposed text for these rules appears after the signature of this Order.
On October 29, 2007, the Commission issued Order No. 43, which in part established rules concerning the MCS, and the market dominant and competitive product lists.
The Commission, in Docket No. RM2007-1, also began the process of developing a comprehensive MCS.
When an initial proposed MCS was complete, the Commission initiated Docket No. RM2011-8 to incorporate it into the CFR.
From an administrative perspective, the rulemaking also required the Commission to develop internal procedures for implementing the proposed rules. This included procedures for publishing timely updates to the MCS and the associated product lists appearing in the CFR. Because of the continuous flow of Postal Service proposals to add or modify products, the Commission recognized that keeping the CFR-published MCS and the associated product lists current would require updates on a weekly, if not daily, basis. With the procedures envisioned and the anticipated frequency of updates, the Commission concluded that it would incur prohibitive publication costs and challenging resource burdens.
In the interim, the Postal Service and the Commission each maintained versions of the MCS. The Postal Service used its version when presenting price and classification proposals to the Commission for evaluation. This required the Commission to first resolve any differences between the Commission's version of the MCS and the Postal Service's version of the MCS before considering the Postal Service's proposals.
On April 1, 2013, the Commission published its version of the MCS to the Commission's Web site.
The Commission developed internal procedures for updating the draft MCS appearing on its Web site on approximately a monthly basis. The Commission displays all changes in redline, as had been requested by the Postal Service. The redline changes are incorporated, and a new baseline MCS created, at the conclusion of major price or classification proceedings. All prior versions of the MCS are archived and available on the Web site for reference.
The Commission also developed internal procedures for publishing product list changes in the
The instant rulemaking proposes to codify the current practice, as described in the above procedures. The MCS appearing on the Web site has proven effective in documenting current prices and classifications and in facilitating communications of the Postal Service's proposed price and classification changes to the Commission. The procedures for noticing product list changes in the
The effect of the rulemaking is to make the version of the MCS appearing on the Commission's Web site the authoritative and most up to date comprehensive source for price and classification information for Postal Service products.
The Commission's existing rules concerning the MCS, which include the associated market dominant and the competitive product lists, are codified at 39 CFR part 3020, subpart A—Mail Classification Schedule. An abridged version of the MCS (which only includes the market dominant and competitive product lists) is codified at 39 CFR part 3020, Appendix A to subpart A—Mail Classification Schedule.
This rulemaking codifies current practice. The product lists and the MCS will be treated as separate items. Only the product lists are noticed in the
The title of subpart A is changed from “Mail Classification Schedule” to “Product Lists and Mail Classification Schedule.” The addition of “Product Lists” to the title more accurately describes the content of subpart A.
The existing § 3020.1, “Applicability,” specifies that the market dominant and competitive product lists are to be included as part of the MCS. The proposed § 3020.1 describes the product lists and the MCS as separate items.
Proposed § 3020.1(a) clarifies that it is the Commission's responsibility to establish and maintain lists of Postal Service products and a MCS.
Proposed § 3020.1(b) replaces existing § 3020.1(a). Both specify that the starting point for the product lists are the market dominant products identified in 39 U.S.C. 3621(a) and the competitive products identified in 39 U.S.C. 3631(a). Proposed § 3020.1(b) expands upon this requirement by including products within the product lists identified as market tests pursuant to 39 U.S.C. 3641 and nonpostal pursuant to 39 U.S.C. 404(e). This flows from the requirement for the Postal Service to properly categorize market tests as either market dominant or competitive (39 U.S.C. 3641(b)(2)) and the Commission to properly categorize nonpostal services as either market dominant or competitive (39 U.S.C. 404(e)(5)).
Proposed § 3020.1(c) states the purpose of the MCS as providing current price and classification information applicable to the products appearing on the market dominant and competitive product lists.
Proposed § 3020.1(d) modifies the material previously included in existing § 3020.1(b) by addressing the product lists and the MCS as two separate items. The proposed section provides that either item may be modified subject to the procedures in 39 CFR part 3020.
Proposed § 3020.2 directs that the market dominant and competitive product lists shall be published in the
Proposed § 3020.3 explains how product lists are modified and how the public is notified of such changes. This section replaces and expands upon the material previously appearing in existing § 3020.14. Generally, § 3020.3 implements the publication requirement appearing in 39 U.S.C. 3642(d)(2), which requires
Proposed § 3020.3(a) explains that the requirement to publish notice of a product list change is triggered by a Commission final order that directs such changes.
The current practice of the Commission is to accumulate all final orders involving changes to product lists and to file a product list update with the
The Commission's position is that Commission orders issued within its jurisdiction are binding upon the Postal Service when issued, unless challenged pursuant to 39 U.S.C. 3663. Accordingly, § 3020.3(c) specifies that changes to product lists are effective upon issuance of the final order, and not upon publication in the
Proposed § 3020.3(d) specifies the content of the
Since April 1, 2013, the MCS has been available on the Commission's Web site at
Proposed § 3020.5 explains that modifications to the MCS are triggered by Commission final orders directing such changes.
The current practice of the Commission is to accumulate all final orders involving changes to the MCS and to update it on a monthly basis. Proposed § 3020.5(b) sets a maximum 3-month deadline for filing the quarterly update. This essentially provides a maximum of 2 months from the quarterly accumulation cutoff date to process and post a revised MCS to the Web site.
The Commission's position is that its orders are binding upon the Postal Service when issued, unless challenged pursuant to 39 U.S.C. 3663. Accordingly, § 3020.3(c) specifies that changes to the MCS are effective upon issuance of the final order, and not once the MCS is actually modified, which generally occurs at a later date.
The titles to 39 CFR part 3020, subparts B, C, and D and §§ 3020.30, 3020.50, and 3020.70 refer to the product lists as being within the MCS. Conforming changes are proposed to remove this reference.
Pursuant to 39 U.S.C. 505, Kenneth E. Richardson is appointed to serve as an officer of the Commission (Public Representative) to represent the interests of the general public in this docket.
The Commission invites public comment on the proposed rules. Comments by interested persons are due 30 days after publication in the
1. Docket No. RM2016-8 is established for the purpose of receiving comments on the Commission's proposed rules.
2. The Commission proposes to amend its rules as described below. The proposed amendments involve amending 39 CFR part 3020, subpart A—Mail Classification Schedule, and conforming amendments to subparts B, C, and D.
3. Pursuant to 39 U.S.C. 505, the Commission appoints Kenneth E. Richardson to serve as an officer of the Commission (Public Representative) to represent the interests of the general public in this proceeding.
4. Interested persons may submit comments no later than 30 days after the date of publication of this Order in the
5. The Secretary shall arrange for publication of this Order in the
By the Commission.
Administrative practice and procedure.
For the reasons discussed in the preamble, the Commission proposes to amend chapter III of title 39 of the Code of Federal Regulations as follows:
39 U.S.C. 503; 3622; 3631; 3642; 3682.
(a) The rules in this part require the Postal Regulatory Commission to establish and maintain lists of Postal Service products and a Mail Classification Schedule.
(b) The product lists shall categorize postal products as either market dominant or competitive. As established, the market dominant and competitive product lists—shall be consistent with the market dominant products identified in 39 U.S.C. 3621(a) and the competitive products identified in 39 U.S.C. 3631(a). The market dominant and competitive product lists shall also include products identified as market tests pursuant to 39 U.S.C. 3641 and nonpostal pursuant to 39 U.S.C. 404(e).
(c) The Mail Classification Schedule shall provide current price and classification information applicable to the products appearing on the market dominant and competitive product lists.
(d) Once established, the product lists and the Mail Classification Schedule may be modified subject to the procedures specified in this part.
(a)
(b)
(a) Whenever the Postal Regulatory Commission issues a final order that modifies the list of products in the market dominant category or the competitive category, it shall cause notice of such change to be published in the
(b) Notice shall be submitted to the
(c) Modifications pending publication in the
(d) The
(i) Identify modifications to the current list of market dominant products and the current list of competitive products; and
(ii) Indicate how and when the previous product lists have been modified.
(a) The Postal Regulatory Commission shall publish a Mail Classification Schedule (including both current and previous versions) on its Web site at
(b) The Mail Classification Schedule shall include, but shall not be limited to: (1) Front matter, including:
(i) A cover page identifying the title of the document as the Mail Classification Schedule, the source of the document as the Postal Regulatory Commission (including Commission seal), and the publication date;
(ii) A table of contents;
(iii) A table specifying the revision history of the Mail Classification Schedule; and
(iv) A table identifying Postal Service trademarks; and
(2) Information concerning market dominant products, including:
(i) A copy of the Market Dominant Product List;
(ii) Descriptions of each market dominant product organized by the class of product, including:
(A) Where applicable, the general characteristics, size and weight limitations, minimum volume requirements, price categories, and available optional features of each market dominant product;
(B) A schedule listing the rates and fees for each market dominant product;
(C) Where applicable, the identification of a product as a special classification within the meaning of 39 U.S.C. 3622(c)(10) for market dominant products;
(D) Where applicable, the identification of a product as an experimental product undergoing a market test; and
(E) Where applicable, the identification of a product as a nonpostal product; and
(3) Information concerning competitive products, including:
(i) A copy of the competitive product list; and
(ii) Descriptions of each competitive product, including:
(A) Where applicable, the general characteristics, size and weight limitations, minimum volume requirements, price categories, and available optional features of each competitive product;
(B) A schedule listing the current rates and fees for each competitive product of general applicability;
(C) The identification of each product not of general applicability within the meaning of 39 U.S.C. 3632(b)(3) for competitive products;
(D) Where applicable, the identification of a product as an experimental product undergoing a market test; and
(E) Where applicable, the identification of a product as a nonpostal product; and
(4) A glossary of terms and conditions; and
(5) A list of country codes for international mail prices.
(a) Whenever the Postal Regulatory Commission issues a final order that modifies the Mail Classification Schedule, it shall update the Mail Classification Schedule appearing on its Web site at
(b) Modification to the Mail Classification Schedule shall be incorporated within 3 months of the issue date of the final order.
(c) Modifications pending incorporation into the Mail Classification Schedule are effective immediately upon written direction from the Postal Regulatory Commission.
The Postal Service, by filing a request with the Commission, may propose a modification to the market dominant product list or the competitive product list. For purposes of this part, modification shall be defined as adding a product to a list, removing a product from a list, or moving a product from one list to the other list.
Users of the mail, by filing a request with the Commission, may propose a modification to the market dominant product list or the competitive product list. For purposes of this part, modification shall be defined as adding a product to a list, removing a product from a list, or transferring a product from one list to the other list.
The Commission, of its own initiative, may propose a modification to the market dominant product list or the competitive product list. For purposes of this part, modification shall be defined as adding a product to a list, removing a product from a list, or transferring a product from one list to the other list.
Federal Communications Commission.
Proposed rule.
In this document, the Federal Communications Commission (Commission) proposes targeted rule changes to our existing accounting and affiliate transaction rules to eliminate inefficiencies and provide guidance to rate-of-return carriers regarding our expectations for appropriate expenditures.
Comments are due on or before May 12, 2016 and reply comments are due on or before June 13, 2016. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this document, you should advise the contact listed below as soon as possible.
You may submit comments, identified by either WC Docket No. 10-90, WC Docket No. 14-58 or CC Docket No. 01-92, by any of the following methods:
•
•
•
For detailed instructions for submitting comments and additional information on the rulemaking process, see the
Alexander Minard, Wireline Competition Bureau, or Suzanne Yelen, Wireline Competition Bureau, (202) 418-7400 or TTY: (202) 418-0484.
This is a synopsis of the Commission's Further Notice of Proposed Rulemaking (FNPRM) in WC Docket Nos. 10-90, 14-58 and CC Docket No. 01-92; FCC 16-33, adopted on March 23, 2016 and released on March 30, 2016. 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 St. SW., Washington, DC 20554 or at the following Internet address:
1. With this Further Notice of Proposed Rulemaking (FNPRM) and concurrently adopted Report and Order, Order, Order on Reconsideration, the Commission adopts significant reforms to place the universal service program on solid footing for the next decade to “preserve and advance” voice and broadband service in areas served by rate-of-return carriers. In 2011, the Commission unanimously adopted transformational reforms to modernize universal service for the 21st century, creating programs to support explicitly broadband-capable networks. In this Report and Order, Order, Order on Reconsideration, and FNPRM, the Commission takes necessary and crucial steps to reform our rate-of-return universal service mechanisms to fulfill our statutory mandate of ensuring that all consumers “have access to . . . advanced telecommunications and information services.” In particular, after extensive coordination and engagement with carriers and their associations, the Commission modernizes the rate-of-return program to support the types of broadband offerings that consumers increasingly demand, efficiently target support to areas that need it the most, and establish concrete deployment obligations to ensure demonstrable progress in connecting unserved consumers. This will provide the certainty and stability that carriers seek in order to invest for the future in the years to come. The Commission welcomes ongoing input and partnership as they move forward to implementing these reforms.
2. Rate-of-return carriers play a vital role in the high-cost universal service program. Many of them have made great strides in deploying 21st century networks in their service territories, in spite of the technological and marketplace challenges to serving some of the most rural and remote areas of the country. At the same time, millions of rural Americans remain unserved. In 2011, the Commission unanimously concluded that extending broadband service to those communities that lacked any service was one of core objectives of reform. At that time, it identified a rural-rural divide, observing that “some parts of rural America are connected to state-of-the art broadband, while other parts of rural America have no broadband access.” The Commission focuses now on the rural divide that exists within areas served by rate-of-return carriers. According to December 2014 Form 477 data, an estimated 20 percent of the housing units in areas served by rate-of-return carriers lack access to 10 Mbps downstream/1 Mbps upstream (10/1 Mbps) terrestrial fixed broadband service. It is time to close the gap, and take action to bring service to the consumers served by rate-of-return carriers that lack access to broadband. The Commission needs to modernize comprehensively the rate-of-return universal service program in order to benefit rural consumers throughout the country.
3. For years, the Commission has worked with active engagement from a wide range of interested stakeholders to develop new rules to support broadband-capable networks. One shortcoming of the current high-cost rules identified by rate-of-return carriers is that support is not provided if consumers choose to drop voice service, often referred to as “stand-alone broadband” or “broadband-only” lines. In the
4. In the FNPRM, the Commission proposes targeted rule changes to our existing accounting and affiliate transaction rules to eliminate inefficiencies and provide guidance to rate-of-return carriers regarding our expectations for appropriate expenditures. Consumers are harmed when “universal service provides more support than necessary to achieve our goals.” The statute requires that universal service funds be used for their intended purposes—maintaining and upgrading supported facilities and services. The Commission proposes to eliminate a number of expenses from inclusion in a rate-of-return carrier's revenue requirement and calculations of high-cost support. The Commission also seeks comment on establishing measures governing prudent or reasonable expense levels for certain expense categories. The FNPRM further seeks comment on ways in which the cost allocation procedures between regulated and non-regulated activities and the affiliate transaction rules can be improved to reduce the potential for a carrier to shift costs from non-regulated to regulated services or to the regulated affiliate.
5. Second, the Commission seeks comment in the FNPRM on additional options for disaggregating support for those discrete areas that are served by an unsubsidized competitor and other issues associated with implementation of the competitive overlap rule.
6. Third, the FNPRM seeks comment on proposals to adopt a mechanism to provide additional support to unserved Tribal lands. The Commission has long recognized the distinct challenges in bringing communications service to Tribal lands.
7. Fourth, the FNPRM seeks comment on other measures that the Commission could take within the existing budget to encourage further broadband deployment by rate-of-return carriers.
8. Lastly, the FNPRM seeks comment on additional proposals to modify or potentially eliminate certain eligible telecommunications carriers' (ETC) certifications and reporting obligations
9. The actions the Commission takes today, combined with the rate-of-return reforms undertaken in the past two years, will allow us to continue to advance the goal of ensuring deployment of advanced telecommunications and information services networks throughout “all regions of the nation.” Importantly, they build on proposals from and collaboration with the carriers and their associations. Through the coordinated reforms the Commission takes today, they will provide rate-of-return carriers with equitable and sustainable support for investment in the deployment and operation of 21st century broadband networks throughout the country, providing stability for the future. Achieving universal access to broadband will not occur overnight, but today marks another step on the path toward that goal.
10. With this Notice, the Commission commences a review of the extent to which certain investments and expenses incurred by a regulated local exchange carrier may be included in its rate base and revenue requirement for ratemaking and universal service fund (USF) purposes. The Commission's rules provide that local exchange carriers may not include expenses in their revenue requirement unless such expenses are “recognized by the Commission as necessary to the provision” of interstate telecommunications services. Similarly, high-cost support provided to an ETC must be used “only for the provision, maintenance, and upgrading of facilities and services for which the support is intended.”
11. The Commission has not comprehensively reviewed the continued reasonableness of its existing rules regarding permissible investments and expenses for local exchange carriers since the passage of the Telecommunications Act of 1996. Market and regulatory conditions have changed substantially since that time. Notably, regulated telecommunications carriers have expanded into the provision of retail broadband services, either directly or through affiliated entities. Regulated carriers also increasingly face competition, for both voice and broadband services, in portions of their incumbent territory from other facilities-based providers, such as cable and wireless providers. These changing conditions may impact the types of costs carriers attempt to include in their revenue requirement and the ways in which carriers allocate costs between regulated and non-regulated services and affiliates.
12. Moreover, with steady demands on the high-cost program and a shrinking contribution base, it is more important than ever that these limited funds be used solely for their intended purposes. Likewise, amidst challenging economic conditions, it simply is not right to expect consumers across the country, including those in rural areas, to reimburse rate-of-return carriers—through the regulated rates for interstate service—for excessive or otherwise inappropriate expenses.
13. While the Commission believes that most rate-of-return carriers properly record their costs and seek support only for the intended purposes, through audits, inquiries and other investigations, the Commission has recently been made aware of alleged abuses by rate-of-return carriers of the used and useful principles and its cost allocation rules. These situations involve rate-of-return carriers, for example, including questionable expenses in their revenue requirement, using support for purposes unrelated to the provision of services, and misallocating expenses among affiliates, or between regulated and non-regulated activities. Against that backdrop, the Commission concludes it is time to reevaluate the types of expenses that should be permitted—both in a carrier's revenue requirement and for recovery through high-cost support. Looking into the expenses permitted and the allocation of those expenses will help ensure that carriers are only recovering costs that are used and useful and prudently incurred, and in the case of high cost support, only costs that are necessary to the provision of interstate telecommunications services.
14. The Commission begins our reevaluation of a rate-of-return carrier's ability to include certain types of expenses in their revenue requirement and high-cost support with consideration of the appropriate standard to be applied. As noted above, the Commission has used different terms in different situations—“used and useful,” “prudent expenditure,” and “necessary to the provision of.” The Commission believes that these terms should be read consistently to describe those expenses that a carrier may appropriately include in its interstate rate base, interstate revenue requirement, and cost studies used to calculate high-cost support. Thus, they should reflect a business operation that is run efficiently to provide telecommunications services. The costs should include amounts of long-term investment and current expenditures that a business would reasonably incur to provide telecommunications services, taking into account current and reasonably forecasted operating conditions and business levels. The Commission invites parties to comment on these standards and whether they should be viewed as applying a consistent standard to regulated, tariffed services and to expenditures that are recovered through high-cost support. To the extent that a party believes different standards should be applied, it should specify the situations in which such differences should apply, what the differences are, and how they should be treated within the accounting and cost allocation processes of the Commission. As parties respond to the issues raised below, they should consider the application of the standards in their comments.
15. The Commission recently indicated that ETCs may not recover certain types of expenses through high-cost support. Those expenses include the following: Personal travel; entertainment; alcohol; food, including but not limited to meals to celebrate personal events, such as weddings, births, or retirements; political contributions; charitable donations; scholarships; penalties or fines for statutory or regulatory violations; penalties or fees for any late payments on debt, loans, or other payments; membership fees and dues in clubs and organizations; sponsorships of conferences or community events; gifts to employees; and, personal expenses of employees, board members, family members of employees and board members, contractors, or any other individuals affiliated with the ETC, including but not limited to personal expenses for housing, such as rent or mortgages.
16. The Commission seeks comment on explicitly prohibiting the inclusion of any of these expenses in a carrier's interstate revenue requirement, which would supersede any existing rules or precedent that might otherwise suggest these are legitimate expenditures. The Commission tentatively concludes that these expenditures are unnecessary to the provision of regulated interstate services and thus are not appropriately included in a rate-of-return carrier's interstate revenue requirement, just as they are not appropriately included in
17. In addition to the expenses identified in the
18. The Commission invites parties to comment on whether there is any reason that these expense categories should not be completely excluded from a carrier's revenue requirement or its high-cost support. Parties making an argument for inclusion of these expenses in a carrier's revenue requirement should explain clearly why such expenses are necessary to the provision of a supported service or to the provision of a regulated interstate telecommunications service. The Commission invites parties to indicate whether there is a definable subset of expenses within any of the categories that should not be excluded from a carrier's interstate revenue requirement or high-cost support. Parties believing that to be the case should provide examples of such expenses, the reason they are necessary, as well as specific language that would allow the Commission to distinguish these expenses from those that are appropriately excluded.
19. The Commission also invites parties to identify additional expenses that should be excluded from either a carrier's interstate revenue requirement, from calculations of high-cost support, or both. Parties identifying additional expenses to be excluded should address the reasons they are unnecessary to the provision of telecommunications service or to the provision of supported services. Parties seeking additional exclusions should also provide language that would allow the Commission to exclude such items if it elects to do so. With respect to ensuring the appropriate use of high-cost funds for certain expenses, our proposals apply to both price cap and rate-of-return carriers. Our proposals concerning permitted expenses for the revenue requirement would primarily apply to rate-of-return carriers, but they would also apply to price cap carriers in limited circumstances.
20. In addition to these categories, the Commission has seen instances in which “companies maintain comparatively high compensation portfolios for their executives.” The Commission expressed concern that these and other expenses were not reasonable and necessary given a number of considerations. The Commission seeks comment on how to address potential concerns regarding such expenses for executives, those with close relationships to those executives, and a carrier's other employees and contractors.
21. The Commission is also aware of at least one instance in which costly benefits were sought to be provided to board members. Are there circumstances under which compensation for board members, including fees per-meeting, for special duties assumed, and for travel and per diem expenses should be deemed unreasonable? If so, on what basis? Is additional evaluation warranted where board members have a close relationship to someone in the company?
22. The Commission seeks comment on whether the costs that may be included in a carrier's revenue requirement for buildings purchased or rented by regulated telecommunications carriers should be limited. For example, in cases where excessive square footage of office or warehouse space is purchased by a regulated carrier in order to earn a rate of return on that space, should part of the price paid for the building be excluded from the revenue requirement? How should “excessive” be defined for this purpose? Are there objective metrics available on the square footage of office space per employee that is reasonable, or on the square footage of warehouse space that a carrier should reasonably require given the number of loops the carrier provides and the density of its service area? Are there objective metrics on the price per square foot that should be paid for office or warehouse space in specific locations?
23. Section 32.2002 provides that plant held for future use must be utilized within two years. This plant is included in the carrier's rate base. The Commission is concerned that carriers may have incentives to place excess capacity in the interstate regulated rate base that will not be used in the foreseeable future, with ratepayers bearing the cost. The Commission reminds carriers that the benefit from a used and useful investment must be realized within a reasonable amount of time. Thus, the Commission invites parties to comment on whether they should adopt a rule that would prohibit a regulated carrier from leasing capacity from its unregulated affiliate that is not presently utilized in the provision of voice or broadband services. Alternatively, could this concern be addressed by defining more precisely what constitutes reasonable projections of use and/or requiring that such capacity be used within a shorter timeframe than two years? Parties are invited to address the types of uses that should be considered to meet the requirement that excess capacity be used in the foreseeable future.
24. As explained above, carriers record their financial transactions in the USOA books of account as they occur. These amounts then flow through the allocation procedures in Parts 64, 36, and 69 with the implied assumption that the recorded amounts are reasonable, and thus prudently incurred. While the used and useful and prudent expenditure standards apply to all investments and expenses of the carrier, the principles considered under
25. The Commission notes that transactions between non-affiliated parties that are negotiated at arm's length are generally presumed to produce commercially reasonable prices. Affiliate transactions, however, are not negotiated at arm's length and thus, may result in unreasonable prices absent standards governing how those transactions should be priced; that is why the Commission adopted rules for the pricing of affiliate transactions decades ago. The Commission now invites parties to comment on whether there are circumstances surrounding transactions between non-affiliated parties that might raise concerns about whether the resulting prices are reasonable. For example, would a close family relationship or cross-participation on boards of directors be situations that warrant more scrutiny of the price? The Commission invites parties to discuss these examples and to identify other examples that might raise concerns. Parties are invited to discuss whether presumptions concerning what would be a prudent expenditure could be employed to ensure that prices are reasonable.
26. The Commission's rules require a carrier in specified situations to record the purchase of a good or service from an affiliate at fair market value. The Commission invites parties to comment on whether the affiliate transaction standard should also be applied to goods and services acquired from non-affiliated entities. If not, parties should propose an alternative standard and explain why it is a preferable approach. The Commission also invites parties to comment on the factors that should be considered in determining whether a transaction is a prudent expenditure or is a reasonable market price in evaluating prices in situations identified as warranting a closer look. Are there circumstances where a prudent expenditure might be something other than the absolute lowest identified price? Parties are invited to identify other metrics beside cost and reliability that are relevant in determining whether an investment or expense is prudent for the purposes of our rules. Finally, are there specific circumstances under which a carrier should be required to make a good faith determination of fair market value for a good or service obtained from a non-affiliate, prior to incurring such expenses, for instance when the total aggregate annual value of the good(s) or service(s) reaches or exceeds a specified threshold for purchases from a non-affiliate, as is done under section 32.27(b)(3) and (c)(3) for affiliates?
27. Finally, the Commission invites parties to comment on the best manner of implementing any decision to exclude the expenses identified in this section. Specifically, parties should address whether it would be sufficient to adopt an order simply identifying and defining which costs are not allowed, as has generally been the process in the past, or whether some rule revisions are necessary. If rule revisions are thought necessary, parties should address where in the process they can best be implemented. Part 32 excludes certain investments and expenses as non-regulated, while Part 64 allocates investments and expenses used to provide both regulated and non-regulated activities that are recorded in the regulated accounts of Part 32 between regulated and non-regulated activities. In addition, for purposes of determining whether a carrier's realized rate-of-return exceeds the maximum allowable rate of return, Part 65 specifies the determination of earnings and rate base. Parties are encouraged to address whether some cost disallowances would be better achieved through revisions to the Part 32 rules, while other cost disallowances could best be addressed through revisions to other rules in Parts 64, 65, 69, or some combination of these rules. The Commission is providing state commissions with notice of this in compliance with the requirements of section 220(i) of the Act in the event they decide to make some revisions to Part 32. In other words, is it better to first enumerate which expenses should be excluded from the revenue requirement as not used and useful in the provision of regulated services and then proceed with allocating costs, or is it better to rely on the cost allocation procedures in Part 64 to exclude such expenses? One of the goals of the USOA at the time it was adopted was that it remain stable over time. How should this be factored into the decision of where to make certain disallowances? Parties are invited to submit proposed language to accomplish the approach they recommend. Lastly, the Commission invites parties to comment on whether they should require rate-of-return carriers to identify their cost consultants, if any, in their FCC Form 481s.
28. Rate-of-return carriers are subject to the Commission's longstanding Part 64 rules regarding the allocation of costs between regulated and non-regulated activities and to the affiliate transaction rules in Part 32. Under these rules, carriers currently apply broad principles in making such allocations, and the lack of specificity in the rules gives carriers a degree of discretion in making these allocation decisions. Therefore, there is an incentive to interpret the allocation rules in order to allocate as many costs as possible to their regulated activities, both to justify a higher interstate revenue requirement and to receive additional high-cost support. For instance, marketing costs could be recorded solely as regulated expenses, even though those marketing activities are designed to increase subscribership of retail broadband,
29. As noted, the Commission's existing cost allocation rules relating to regulated versus non-regulated activities generally provide that costs shall be directly assigned to either regulated or non-regulated activities where possible, and common costs are to be allocated according to a hierarchy of principles. To the extent costs cannot be allocated on direct or indirect cost causation principles, they are allocated based on a ratio of all expenses directly assigned or attributed to regulated and non-regulated activities. In certain cases, the affiliate transaction rule requires fully distributed costs to be used to determine the charge to the affiliate or the carrier.
30. The Commission seeks comment on adopting new rules to improve the process of allocating costs among regulated and non-regulated services and between affiliates. The Commission also seeks a better understanding of how to detect cases of misallocation. Our goal is to reduce the potential ability of carriers to include expenses associated with non-regulated services in their regulated revenue requirements, and to preclude carriers from artificially inflating their high-cost support through such actions. To this end, the Commission seeks comment on
31. The Commission is concerned about the potential for carriers to provide shared operational services to their affiliates under fully-distributed cost (FDC) allocation procedures that do not include all of the associated costs. The affiliate transaction rules employ a higher of cost or market standard when applicable, or a FDC standard to ensure that all costs of services provided by a regulated telecommunications company are recovered from its affiliates. The general nature of the FDC allocation guidelines, however, allows carriers significant discretion in performing the FDC cost study. This discretion allows carriers to exclude expenses associated with providing shared functions to their non-regulated affiliates, especially to those affiliates that then sell retail broadband services to end users on an unregulated basis, thus recovering these costs from rate payers. The Commission seeks comment on clarifying or adopting new rules to ensure the proper application of the affiliate transaction rules in light of provision of retail broadband by affiliates in certain telecommunications markets.
32. Our accounting and high-cost universal service support rules rely on proper allocation of costs to work as intended. The Commission seeks comment on specific instances in which additional rules or further clarification could minimize potential misallocations and thereby protect ratepayers of regulated services. Are there other methods that would help ensure proper allocation of costs between regulated and non-regulated services?
33. The Commission is also concerned that problems similar to those associated with regulated versus non-regulated allocations may arise in the application of the FDC process in connection with affiliate transactions. Section 32.27 of the Commission's rules requires an incumbent LEC to record assets or services received from its affiliated entities at the lesser of FDC or fair market value when no tariff rate, prevailing price, or publicly filed agreement exists. FDC may be over-inclusive, however, if it includes investment and expenses of the affiliate that would not properly be included in a carrier's revenue requirement or calculations for high-cost support. While the used and useful and prudent expenditure standards apply to costs included in affiliate transactions, the Commission seeks comment on whether they should adopt a rule that explicitly prohibits carriers from including in the FDC of an affiliate any costs that are disallowed from the regulated rate base or revenue requirement, or considered not to be used and useful or prudent expenditures. Without such a rule, carriers could shift costs to an affiliate and then effectively recover those disallowed costs through payments to the affiliate. The Commission invites parties to comment on how such an approach could be implemented, and whether there are circumstances under which these costs of affiliates should be properly included in the regulated rate base or costs used to calculate high-cost support.
34. The Commission seeks comment on whether additional data would assist in enforcement of the Commission's accounting and cost allocation rules, while minimizing ETC reporting burden.
35. Finally, the Commission seeks comment on the most effective way to ensure compliance with the proposed rules for universal service support and tariffing purposes. Rate-of-return affiliates of price cap carriers would be subject to any revised rules in establishing their tariffed rates for interstate services. In addition, if a price cap carrier is required to make a cost-based showing in the future, any expense rules adopted in this proceeding would apply to such showings. The Commission invites parties to comment on whether they should require carriers to certify that they have not included any prohibited expenses in their cost submissions used to calculate high-cost support. If so, is there a current certification that can be modified to encompass this aspect, or is a new rule necessary? Because audit findings can be used to recover overpayments of high-cost support, the Commission also invites parties to comment on how the Commission should implement any requirements it may adopt. Are there other proposals or considerations that the Commission should consider to ensure compliance with any revised requirements?
36. Ensuring compliance with any revised investment, expense, or cost allocation rules in the tariffing context raises different challenges. Rate-of-return carrier tariffs must be filed in advance of their effective date, and pursuant to section 204 of the Act, the Commission, during the notice period, may suspend the effectiveness of a tariff and initiate an investigation to determine whether the tariff is just and reasonable. Section 204(a)(3) provides that local exchange carrier tariffs that take effect on 7-days notice after filing (when rates are reduced) or 15-days notice (for any other change) after filing are “deemed lawful” unless rejected or suspended and investigated by the Commission. If a tariff investigation has not been completed within five months of the tariff's specified effective date, the proposed tariff goes into effect subject to the results of the investigation. At the conclusion of the investigation, the Commission may prescribe rates prospectively and order refunds as necessary for any period in which the tariff was in effect. With these constraints on timing and prohibition on retroactive relief, the Commission invites parties to comment on steps the Commission could take to ensure that carriers follow these requirements. As a starting point, the Commission proposes to require a certification and seek comment on what it should entail. The Commission also invites parties to comment on what sanctions should be used to give some meaning to the certifications.
37. The Commission invites parties to comment on whether, and if so, when an exception to the “deemed lawful” provision of section 204 of the Act would apply where a carrier violated these rules. The Commission notes that in
38. The vast majority of rate-of-return carriers are members of the NECA pool, and their costs are combined to establish pool rates. The Commission invites parties to comment on NECA's role in enforcing these rules. Should carriers be barred from pool participation if determined to be including expenses prohibited by Commission rules? How should the magnitude of the violation be determined? What percent level of prohibited cost inclusion should be required before immediate expulsion from pool participation is deemed necessary? Are there any other metrics that should be considered in making this determination? Should carrier violations for inclusion of prohibited expenses have a “repeated occurrences” component, or should one time inclusion of a certain percentage of prohibited expenses impact pool participation?
39. In section II.B of the concurrently adopted Report and Order, the Commission concludes that CAF BLS should not be provided in areas served by a qualifying unsubsidized competitor. The Commission adopts several methods of disaggregating Connect America Fund Broadband Loop Support (CAF BLS) for areas found to be competitively service, and allow carriers to select which method will be used. USTelecom and NTCA propose that in addition to the methods they specifically presented, carriers should also have the option of disaggregating support based on a “method approved by the Commission.” Here, the Commission invites commenters to propose other methods of disaggregation of support that can be implemented with minimal administrative burden for affected carriers and USAC. The Commission seeks to avoid complex allocations of the cost of facilities that that serve both competitive and non-competitive areas, which could be burdensome for rate-of-return carriers to implement.
40. The Commission also invites parties to comment on how the non-supported amount is to be recovered by the carrier, assuming such expenses remain regulated expenses for ratemaking purposes. At the outset, the Commission notes that rate-of-return carriers currently receive compensation for interstate loop costs through a combination of end-user charges,
41. First, the Commission could treat the non-supported expenses as being outside the tariffed regulated revenue requirement and allow carriers to assess a detariffed regulated rate to recover those non-supported costs. This would remove those costs from the NECA pooling process. The Commission invites parties to comment on whether the detariffed rates would be outside the prohibition on tariffing deaveraged rates in a study area, or whether a new rule should be adopted. The Commission invites parties to comment on this alternative. Does it present any opportunities for carriers to game the tariffing process?
42. A second option would be to raise the SLC caps for a particular study area to permit the recovery of the amounts not supported by the high-cost program. The Commission invites parties to comment on this alternative, including whether any SLC increases should be allowed only in the competitive area or should apply to the entire study area. In the former case, a modification of the rule prohibiting deaveraging within the study area would need to be made. Parties should particularly address the effects of deaveraging on the NECA pooling and tariffing processes. The Commission also invites parties to comment on the effects of deaveraging on carriers' billing and operation support systems. Are there other alternatives that the Commission should consider for recovery of the non-supported investment and associated expenses?
43.
44. The Commission recognizes the distinct challenges in bringing communications services to Tribal lands and seek comment on how best to achieve broadband deployment on Tribal lands commensurate with that in other areas. However, the Commission has acknowledged that there are areas throughout the United States that are expensive to serve and that face challenges in demographics, weather, and geography.
45. NTTA proposes that a TBF be applied to any non-model-based rate-of-return mechanism that the Commission adopts. In light of the other changes adopted today, including measures to provide a larger capital investment allowance for carriers that are below average in terms of broadband deployment, and defined deployment obligations for all rate-of-return carriers, is there a need for a separate mechanism for Tribal lands? The Commission seeks comment on whether a multiplier applied to the revised ICLS (
46. If the Commission determines that a multiplier of support amounts under CAF BLS is an appropriate mechanism, what factor is appropriate? NTTA provides little support of why 1.25x is the appropriate factor to ensure broadband deployment on Tribal lands, other than pointing to the 25 percent
47. The Commission also seeks comment on how best to target Tribal land-specific support to Tribal lands most in need of broadband deployment. NTTA recommends offering TBF support to all rate-of-return carriers serving Tribal lands and limiting the applicability of the TBF to specific census blocks that include Tribal lands. As noted above, broadband deployment differs substantially among Tribal lands. In light of this, should all Tribal lands be eligible for additional support, or only those with lower levels of deployment? Above, the Commission adopts a mechanism to allow a larger allowable loop expenditure for carriers below the average and to limit the allowable loop expenditure for those above the average. The Commission notes that the weighted average nationwide for rate-of-return carrier deployment of 10/1 Mbps service is currently 68 percent. Should Tribal-specific support only be provided to those rate-of-return carriers that are serving Tribal lands that report broadband deployment lower than the weighted average, based on Form 477 data? If so, should eligibility for Tribal-specific support be determined annually or on a less frequent basis? Should it be provided for a specified period of time, and if so, what is the appropriate time period?
48. If a rate-of-return carrier's study area is mostly non-Tribal, should that carrier be eligible to receive additional Tribal-specific support? Should there be some threshold percentage, for example 50 percent, of a carrier's service area is on Tribal lands in order to qualify for additional Tribal-specific support? The Commission also seeks comment on the appropriate data source to use to determine whether a census block contains Tribal lands. For example, should the Commission utilize maps and data distributed by the U.S. Census Bureau, or would maps and data provided by the Bureau of Indian Affairs be more appropriate? What other sources of data might the Commission use? The Commission notes that the Commission is currently engaged in consultation with the Tribal Nations of Oklahoma on the operational functionality and use of the Oklahoma Historical Map at the local and individual Tribal Nation level as part of the Lifeline rulemaking proceeding. The Commission seeks comment on how this process may affect our determination of which census blocks would be eligible for Tribal-specific support.
49. In addition, the Commission seeks comment on what specific broadband deployment obligations should be established, if they were to adopt a mechanism to provide additional support on Tribal lands that lag behind. NTTA supports tying build-out obligations to additional support, and proposes specific build-out obligations tied to a sliding scale based on current broadband deployment levels to “meaningfully improve broadband connectivity on Tribal lands . . . particularly in areas that are unserved today.” For instance, it proposes that recipients of TBF that currently have deployed 10/1 Mbps to less than 10 percent of their locations be required to provide 4/1 Mbps service to at least 25 percent of their locations within three years, and 10/1 Mbps to at least 10 percent of locations, within three years; for those that already have deployed 10/1 Mbps to at least 10 percent but not 25 percent of their locations, they would be required to offer 4/1 Mbps service to 50 percent of their locations and 10/1 Mbps service to 25 percent of locations within three years. If the Commission were to adopt some form of additional Tribal-specific support, how should these proposals be harmonized with the mandatory deployment obligations they adopt above for all rate-of-return carriers?
50. NTTA recommends that participation in the TBF be voluntary. The Commission seeks comment on whether carriers should have the option to decline Tribal-specific support if the Commission determines that the provision of additional support to Tribal lands is necessary to close the broadband deployment gap in such areas. NTTA suggests that if acceptance of Tribal-specific support is conditioned on build-out obligations, such support presents a “unique opportunity to promote greater deployment of broadband to Tribal lands.” Should participation in such a program be mandatory?
51. In the
52. Finally, the Commission asks whether carriers that serve Tribal lands, in whole or in part, should not be subject to the measures to limit operating expenses and the overall budget control mechanism concurrently adopted in the Report and Order. Parties have noted, for instance, that Tribal lands may pose unique challenges for obtaining permitting and other authorizations. If the Commission were to exempt such providers from those opex and overall budget limitations, how should they determine the providers subject to such limitations? For instance, to be eligible for such an exemption, should 50 percent or more of the carrier's study area be Tribal lands? What would the budgetary impact be on other rate-of-return carriers that remain on legacy support mechanisms if the Commission were to adopt such exemptions?
53. Some companies have informed us they have been unable to extend broadband despite their sincere desire to do so due to lack of access to capital. Some companies have seen declining support under the existing legacy mechanisms, and others are not eligible for high cost loop support (HCLS) support due to the prior “race to the top” that the Commission took steps to address in December 2014.
54. In the
55. The Commission intends to monitor the impact of these reforms over time. The Commission are optimistic that together, these two paths will provide sufficient options for carriers to make a business case to extend broadband service where it is lacking, while minimizing disruption for those carriers that prefer to remain under the reformed legacy mechanisms. The Commission invites commenters to submit into the record any other proposals or ideas for steps the Commission should take to provide appropriate incentives for broadband deployment to unserved areas working within the framework of the existing budget for rate-of-return areas.
56. As the Commission evaluates ways to improve the overall framework governing rate-of-return carriers, they also believe it is appropriate to ensure that the administration of the current rate-of-return system, a function largely performed by NECA, is as efficient as possible to ensure that the costs of administration, ultimately borne by consumers, are reasonable. The role of NECA has changed over the last few decades due to a number of factors, including market changes, significant regulatory reforms, and the creation of USAC as the Administrator for the federal universal service mechanisms. The Commission asks parties to address whether and how the Commission should amend subpart G of Part 69 to reflect these changes. The Commission also seeks comment on whether they should adopt rule changes to facilitate transparency into and evaluation of whether NECA's functions are accomplished in an efficient, cost effective, and neutral manner.
57. In addition to the modifications to ETC annual reporting obligations adopted above, the Commission seeks comment on certain, narrowly-tailored reporting changes to improve the Commission's ability to protect against waste, fraud, and abuse. The Commission also seeks comment on additional ways to lessen regulatory reporting burdens on ETCs, particularly those that are small businesses.
58. Here, the Commission seeks comment on whether to modify or eliminate five sets of requirements: specifically, the requirements by ETCs to provide outage information, unfulfilled service requests, the number of complaints per 1,000 subscribers for both voice and broadband service, pricing for both voice and broadband, and certification that it is complying with applicable service quality standards. What are the regulatory costs associated with requiring such information to be included in the annual Form 481, particularly for those categories of information that may be collected in some fashion through other means (the Commission's outage reporting system and consumer complaint system)? In the case of outage reporting, the Commission notes that all carriers are under a separate obligation to report outages under part 4 of our rules. Are the ETC-specific rules therefore duplicative, and can other means of collection be improved?
59. To the extent commenters believe such information should continue to be collected from ETCs, the Commission asks for specific suggestions on how to modify these requirements so that the information is more useful to analyze, both on an individual ETC and aggregate basis.
60. The underlying purpose of the unfulfilled service request reporting rule was to monitor rate-of-return carriers' progress in deploying broadband pursuant to the reasonable request standard. The Commission has concerns, however, that the rule, as implemented, is not adequately advancing that purpose. Similarly, the Commission has found the information regarding complaints to be of limited value, in large part because it is not clear that ETCs are reporting such information in a consistent fashion. If the Commission were to retain some form of reporting requirements for complaints and unfulfilled requests, should they implement more specific standardized instructions regarding the reporting of complaints and unfulfilled requests so that the information can be analyzed and aggregated in a more useful fashion? For the reporting of pricing information, would it be less burdensome if ETCs were to report only the price offering that meets or exceeds our minimum requirements, and not the full range of service offerings?
61. The Commission also seeks comment on whether, in light of our experience with the reporting requirements to date, they should modify or eliminate the requirement that an ETC certify it is complying with applicable service quality standards and consumer protection rules. Absent greater specificity, affected ETCs may not know what standards and rules are “applicable.” Should the Commission clarify that the obligation applies only to legally binding rules and/or voluntary guidelines with which the ETC has agreed to comply? If so, how should the ETC report its compliance? Are other clarifications or modifications to the rule appropriate?
62. Above the Commission directs USAC to establish an online tool to permit access to all information submitted by ETCs, including Form 481 data. USAC shall ensure that state regulators, and Tribal governments where applicable, will have access full Form 481 data filings, including any data marked confidential. In light of that change, the Commission proposes to eliminate ETCs' requirement to file a duplicate copy of Form 481 with states and/or Tribal governments. Instead, they would make a single filing with USAC, and both the Commission and other regulators would obtain the information through online access. The Commission tentatively concludes that centralizing all filing requirements with USAC would be beneficial for states and Tribal governments as it would reduce the need to sort through, in some cases, dozens of paper documents containing the same information that would be available more readily through an online tool. Interested parties have suggested that the Commission should reduce or eliminate duplicate filings of the same information. Having one place for ETCs to file their annual reports, instead of three or more, may reduce the filing burden on ETCs. The Commission seeks comment on this tentative conclusion.
63. Lastly, the Commission seeks comment on modifying or eliminating any other reporting requirements applicable to all ETCs that have broadband obligations as a condition of receiving high-cost support in order to further improve the alignment of carriers' obligations with our ability to monitor them through our reporting requirements.
64. This document contains new information collection requirements subject to the PRA. It will be submitted to the Office of Management and Budget (OMB) for review under section 3507(d) of the PRA. OMB, the general public, and other Federal agencies are invited to comment on the new information collection requirements contained in this proceeding. In addition, the Commission notes that pursuant to the Small Business Paperwork Relief Act of 2002, the Commission previously
65. As required by the Regulatory Flexibility Act of 1980, as amended (RFA), the Commission has prepared this Initial Regulatory Flexibility Analysis (IRFA) of the possible significant economic impact on a substantial number of small entities from the policies and rules proposed in this Further Notice of Proposed Rulemaking. The Commission requests written public comment on this IRFA. Comments must be identified as responses to the IRFA and must be filed by the deadlines for comments on the Further Notice provided on Further Notice of Proposed Rulemaking and the concurrently adopted Report and Order, Order and Order on Reconsideration. The Commission will send a copy of the Further Notice, including this IRFA, to the Chief Counsel for Advocacy of the Small Business Administration (SBA). In addition, the Further Notice and IRFA (or summaries thereof) will be published in the
66. In the Further Notice, the Commission commences a review of the extent to which certain investments and expenses incurred by a rate-of-return regulated local exchange carrier may be included in its rate base and revenue requirement for ratemaking and USF purposes. The Commission notes that there may be very limited circumstances where our proposed reforms would impact price cap regulated carriers' use of high-cost USF support. The Commission has not comprehensively reviewed the continued reasonableness of its existing rules regarding permissible investments and expenses for regulated local exchange carriers since the passage of the Telecommunications Act of 1996. Market and regulatory conditions have changed substantially since that time. Regulated telecommunications carriers have expanded into the provision of retail broadband services, either directly or through affiliated entities. Regulated carriers also increasingly face competition, for both voice and broadband services, in portions of their incumbent territory from other facilities-based providers, such as cable and wireless providers. These changing conditions may affect the incentives regarding the types of costs carriers attempt to include in their revenue requirement and the ways in which carriers allocate costs between regulated and non-regulated services and affiliates.
67. Through audits, inquiries, and other investigations, the Commission has recently become aware of alleged abuses by rate-of-return carriers of the used and useful principles and its cost allocation rules. The Commission therefore concluded that it is time to reevaluate the types of expenses that should be permitted—both in a carrier's revenue requirement and for recovery through high-cost support. Looking into the expenses permitted and the allocation of those expenses will help ensure that carriers are only recovering costs that are used and useful and prudently incurred, and in the case of high cost support, only costs that are necessary to the provision of interstate telecommunications services.
68. In the concurrently adopted Order, the Commission determined that universal service support should be targeted more specifically to those areas where support is most needed to ensure consumers are served with voice and broadband service. Therefore, the Commission adopted a process for identifying those areas served by an unsubsidized competitor and several methods of disaggregating support to those areas. However, the Commission seeks comment on other methods for disaggregating support that would be minimally burdensome on carriers and how the non-supported amount should be recovered.
69. The Commission recognizes that Tribal lands may need additional financial support to ensure the availability of broadband in these areas. Therefore, the Further Notice seeks comment on whether a separate mechanism is needed to support broadband in Tribal lands and, if so, how such a mechanism should be structured.
70. Some companies have informed the Commission that they are unable to extend broadband due to a lack of access to capital. Other carriers have seen declining support or are ineligible for certain types of support, such as HCLS. In the concurrently adopted Order, the Commission has adopted reforms to its high-cost universal service support to support broadband deployment. The Further Notice seeks comment on other proposals to expand broadband services in those areas served by rate-of-return carriers and any changes needed to make the administration of federal universal service programs more efficient.
71. The Commission also seeks to modify its ETC annual reporting obligations to improve the Commission's ability to protect against waste, fraud, and abuse. The Further Notice seeks comment on how best to make the information collected more useful while minimizing the burdens on those carriers subject to these reporting requirements.
72. The Further Notice begins by reevaluating a rate-of-return carrier's ability to include certain types of expenses in its revenue requirement and high-cost support with consideration of the appropriate standard to be applied. The Commission believes that the terms “used and useful,” “prudent expenditure,” and “necessary to the provision of” should be read consistently to describe those expenses that a carrier may appropriately include in its interstate rate base, interstate revenue requirement, and cost studies used to calculate high-cost support. The costs should include amounts of long-term investment and current expenditures that a business would reasonably incur to provide telecommunications services, taking into account current and reasonably forecasted operating conditions and business levels. Accordingly, the Commission seeks comment on a variety of expenses, and whether such expenses should be included when making these calculations.
73. Rate-of-return carriers are subject to the Commission's longstanding Part 64 rules regarding the allocation of costs between regulated and non-regulated activities and to the affiliate transaction rules in Part 32. Under these rules, carriers currently apply broad principles in making such allocations, and the lack of specificity in the rules gives carriers a degree of discretion in making these allocation decisions. Carriers have an incentive to interpret the allocation rules in order to allocate as many costs as possible to their regulated activities, both to justify a higher interstate revenue requirement and to receive additional high-cost support. Given the lack of specific guidance, the additional costs associated with the provision of retail broadband services, and the incentive to allocate costs to regulated activities, the Commission concludes that it is time to revisit the allocation
74. Additionally, the Commission seeks comment on the most effective way to ensure compliance with the proposed rules for universal service support and tariffing purposes. For example, the Commission seeks comment on what, if any, certification or reporting requirements should be implemented.
75. In the Further Notice, the Commission seeks comment on alternative methods of reducing support for areas served by an unsubsidized competitor. In the concurrently adopted Order, the Commission adopts several methods of disaggregating CAF BLS for areas found to be competitively served and allow carriers to select which method will be used. However, the Commission invites commenters to propose other methods of disaggregation of support that can be implemented with minimal administrative burden for affected carriers and USAC. The Commission seeks to avoid complex allocations of the cost of facilities that serve both competitive and non-competitive areas, which could be burdensome for rate-of-return carriers to implement.
76. The Commission also invites parties to comment on how the non-supported amount is to be recovered by the carrier, assuming such expenses remain regulated expenses for ratemaking purposes. The Commission notes that rate-of-return carriers currently receive compensation for interstate loop costs through a combination of end-user charges,
77. In the Further Notice, the Commission seeks comment on a proposal to adopt a mechanism to provide additional support to unserved Tribal lands, and alternative approaches. The Commission has observed that communities on Tribal lands have historically had less access to telecommunications services than any other segment of the population, and that greater financial support therefore may be needed in order to ensure the availability of broadband on Tribal lands. Therefore, the Commission seeks comment on adopting rules to increase support to rate-of-return carriers for census blocks that include Tribal lands and are unserved with broadband meeting the Commission's current requirements. The Commission also recognizes that broadband deployment differs substantially among Tribal lands. To assist small rate-of-return carriers that serve Tribal areas with minimal infrastructure build out, the Commission also seeks comment on how best to target Tribal land-specific support to Tribal areas most in need of broadband deployment.
78. Additionally, in the Further Notice, the Commission invites commenters to submit into the record any other proposals or ideas for steps the Commission should take to provide appropriate incentives for broadband deployment to unserved areas working within the framework of the existing budget for rate-of-return areas. Some companies have indicated they have been unable to extend broadband despite their sincere desire to do so due to lack of access to capital, while other companies have seen declining support under the existing legacy mechanisms. Dome carriers are not eligible for HCLS support due to the prior “race to the top” that the Commission took steps to address in December 2014. The Commission expects our reforms to the existing ICLS mechanism and addition of a voluntary path to the model will provide options for carriers to extend broadband where it is lacking. While the Commission intends to monitor the impact of these reforms over time, they invite commenters to submit into the record any other proposals or ideas for steps the Commission should take to provide appropriate incentives for broadband deployment to unserved areas while minimizing disruption for those carriers that prefer to remain under the reformed legacy mechanisms.
79. Lastly, with respect to ETC reporting requirements, the Commission seeks comment on additional ways to lessen regulatory reporting burdens on ETCs, particularly those that are small businesses. In the concurrently adopted Order, the Commission updates our annual reporting requirements for rate-of-return ETCs as a necessary component of our ongoing efforts to update the support mechanisms for such ETCs to reflect our dual objectives of supporting existing voice and broadband service, while extending broadband to those areas of the country where it is lacking. To further lessen the regulatory burden on ETCs, many of whom are small rate-of-return carriers, and to improve on the Commission's ability to protect against waste, fraud, and abuse, the Commission seeks comment on certain, narrowly-tailored reporting changes. Specifically, the Commission seeks comment on whether to modify or eliminate five sets of requirements: the requirements to provide outage information, unfulfilled service requests, the number of complaints per 1,000 subscribers for both voice and broadband service, pricing for both voice and broadband, and certification of compliance with applicable service quality standards.
80. The legal basis for any action that may be taken pursuant to the Notice is contained in sections 1, 2, 4(i), 5, 10, 201-206, 214, 218-220, 251, 252, 254, 256, 303(r), 332, 403, and 405 of the Communications Act of 1934, as amended, and section 706 of the Telecommunications Act of 1996, 47 U.S.C. 151, 152, 154(i), 155, 201-206, 214, 218-220, 251, 252, 254, 256, 303(r), 332, 403, 405, 1302, and sections 1.1, 1.3, 1.421, 1.427, and 1.429 of the Commission's rules, 47 CFR 1.1, 1.3, 1.421, 1.427, and 1.429.
81. 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-
82. Our proposed action, if implemented, may, over time, affect small entities that are not easily categorized at present. The Commission therefore describes here, at the outset, three comprehensive, statutory small entity size standards. First, nationwide, there are a total of approximately 28.2 million small businesses, according to the SBA, which represents 99.7% of all businesses in the United States. In addition, 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 2007, there were approximately 1,621,215 small organizations. Finally, the term “small governmental jurisdiction” is defined generally as “governments of cities, towns, townships, villages, school districts, or special districts, with a population of less than fifty thousand.” Census Bureau data for 2011 indicate that there were 90,056 local governmental jurisdictions in the United States. The Commission estimates that, of this total, as many as 89,327 entities may qualify as “small governmental jurisdictions.” Thus, the Commission estimates that most governmental jurisdictions are small.
83. The rules adopted in the concurrently adopted Order apply to broadband Internet access service providers. The Economic Census places these firms, whose services might include Voice over Internet Protocol (VoIP), in either of two categories, depending on whether the service is provided over the provider's own telecommunications facilities (
84. The broadband Internet access service provider industry has changed since this definition was introduced in 2007. The data cited above may therefore include entities that no longer provide broadband Internet access service, and may exclude entities that now provide such service. To ensure that this FRFA describes the universe of small entities that our action might affect, the Commission discusses in turn several different types of entities that might be providing broadband Internet access service. The Commission notes that, although they have no specific information on the number of small entities that provide broadband Internet access service over unlicensed spectrum, they include these entities in our Final Regulatory Flexibility Analysis.
85.
86.
87. The Commission has included small incumbent LECs in this present RFA analysis. As noted above, a “small business” under the RFA is one that,
88.
89.
90.
91.
92.
93.
94.
95. The broadband Internet access service provider category covered by the concurrently adopted Order may cover multiple wireless firms and categories of regulated wireless services. Thus, to the extent the wireless services listed below are used by wireless firms for broadband Internet access service, the proposed actions may have an impact on those small businesses as set forth above and further below. In addition, for those services subject to auctions, the Commission notes that, as a general matter, the number of winning bidders that claim to qualify as small businesses at the close of an auction does not necessarily represent the number of small businesses currently in service. Also, the Commission does not generally track subsequent business size unless, in the context of assignments and transfers or reportable eligibility events, unjust enrichment issues are implicated.
96.
97.
98.
99.
100.
101.
102.
103. On January 26, 2001, the Commission completed the auction of 422 C and F Block Broadband PCS licenses in Auction No. 35. Of the 35 winning bidders in that auction, 29 claimed small business status. Subsequent events concerning Auction 35, including judicial and agency determinations, resulted in a total of 163 C and F Block licenses being available for grant. On February 15, 2005, the Commission completed an auction of 242 C-, D-, E-, and F-Block licenses in Auction No. 58. Of the 24 winning bidders in that auction, 16 claimed small business status and won 156 licenses. On May 21, 2007, the Commission completed an auction of 33 licenses in the A, C, and F Blocks in Auction No. 71. Of the 12 winning bidders in that auction, five claimed small business status and won 18 licenses. On August 20, 2008, the Commission completed the auction of 20 C-, D-, E-, and F-Block Broadband PCS licenses in Auction No. 78. Of the eight winning bidders for Broadband PCS licenses in that auction, six claimed small business status and won 14 licenses.
104.
105. The auction of the 1,053 800 MHz SMR geographic area licenses for the General Category channels began on August 16, 2000, and was completed on September 1, 2000. Eleven bidders won 108 geographic area licenses for the General Category channels in the 800 MHz SMR band and qualified as small businesses under the $15 million size standard. In an auction completed on December 5, 2000, a total of 2,800 Economic Area licenses in the lower 80 channels of the 800 MHz SMR service were awarded. Of the 22 winning bidders, 19 claimed small business status and won 129 licenses. Thus, combining all four auctions, 41 winning bidders for geographic licenses in the 800 MHz SMR band claimed status as small businesses.
106. In addition, there are numerous incumbent site-by-site SMR licenses and licensees with extended implementation authorizations in the 800 and 900 MHz bands. The Commission does not know how many firms provide 800 MHz or 900 MHz geographic area SMR service pursuant to extended implementation
107.
108. In 2007, the Commission reexamined its rules governing the 700 MHz band in the
109.
110.
111.
112.
113. As of March 2010, there were 424,162 PLMR licensees operating 921,909 transmitters in the PLMR bands below 512 MHz. The Commission notes that any entity engaged in a commercial activity is eligible to hold a PLMR license, and that any revised rules in this context could therefore potentially impact small entities covering a great variety of industries.
114.
115.
116.
117.
118.
119.
120.
121.
122.
123. In 2009, the Commission conducted Auction 86, the sale of 78 licenses in the BRS areas. The Commission offered three levels of bidding credits: (i) A bidder with attributed average annual gross revenues that exceed $15 million and do not exceed $40 million for the preceding three years (small business) received a 15 percent discount on its winning bid; (ii) a bidder with attributed average annual gross revenues that exceed $3 million and do not exceed $15 million for the preceding three years (very small business) received a 25 percent discount on its winning bid; and (iii) a bidder with attributed average annual gross revenues that do not exceed $3 million for the preceding three years (entrepreneur) received a 35 percent discount on its winning bid. Auction 86 concluded in 2009 with the sale of 61 licenses. Of the ten winning bidders, two bidders that claimed small business status won 4 licenses; one bidder that claimed very small business status won three licenses; and two bidders that claimed entrepreneur status won six licenses.
124. In addition, the SBA's Cable Television Distribution Services small business size standard is applicable to EBS. There are presently 2,436 EBS licensees. All but 100 of these licenses are held by educational institutions. Educational institutions are included in this analysis as small entities. Thus, the Commission estimates that at least 2,336 licensees are small businesses. Since 2007, Cable Television Distribution Services have been defined within the broad economic census category of Wired Telecommunications Carriers; that category is defined as follows: “This industry comprises establishments primarily engaged in operating and/or providing access to transmission facilities and infrastructure that they own and/or lease for the transmission of voice, data, text, sound, and video using wired telecommunications networks. Transmission facilities may be based on a single technology or a combination of technologies.” The SBA has developed a small business size standard for this category, which is: all such firms having 1,500 or fewer employees. To gauge small business prevalence for these cable services the Commission must, however, use the most current census data that are based on the previous category of Cable and Other Program Distribution and its associated size standard; that size standard was: all such firms having $13.5 million or less in annual receipts. According to Census Bureau data for 2007, there were a total of 996 firms in this category that operated for the entire year. Of this total, 948 firms had annual receipts of under $10 million, and 48 firms had receipts of $10 million or more but less than $25 million. Thus, the majority of these firms can be considered small.
125.
126.
127.
128.
129.
130. The category of Satellite Telecommunications “comprises establishments primarily engaged in providing telecommunications services to other establishments in the telecommunications and broadcasting industries by forwarding and receiving communications signals via a system of satellites or reselling satellite telecommunications.” For this category, Census Bureau data for 2007 show that there were a total of 570 firms that operated for the entire year. Of this total, 530 firms had annual receipts of under $30 million, and 40 firms had receipts of over $30 million. Consequently, the Commission estimates that the majority of Satellite Telecommunications firms are small entities that might be affected by our action.
131. The second category of Other Telecommunications comprises,
132. Because section 706 requires us to monitor the deployment of broadband using any technology, the Commission anticipates that some broadband service providers may not provide telephone service. Accordingly, the Commission describes below other types of firms that may provide broadband services, including cable companies, MDS providers, and utilities, among others.
133.
134.
135.
136. The open video system (“OVS”) framework was established in 1996, and is one of four statutorily recognized options for the provision of video programming services by local exchange carriers. The OVS framework provides opportunities for the distribution of video programming other than through cable systems. Because OVS operators provide subscription services, OVS falls within the SBA small business size standard covering cable services, which is “Wired Telecommunications Carriers.” The SBA has developed a small business size standard for this category, which is: all such firms having 1,500 or fewer employees. According to Census Bureau data for 2007, there were a total of 955 firms in this previous category that operated for the entire year. Of this total, 939 firms had employment of 999 or fewer employees, and 16 firms had employment of 1,000 employees or more. Thus, under this second size standard, most cable systems are small and may be affected by rules adopted pursuant to the concurrently adopted Order. In addition, the Commission notes that they have certified some OVS operators, with some now providing service. Broadband service providers (“BSPs”) are currently the only significant holders of OVS certifications or local OVS franchises. The Commission does not have financial or employment information regarding the entities authorized to provide OVS, some of which may not yet be operational. Thus, again, at least some of the OVS operators may qualify as small entities.
137.
138.
139.
140.
141.
142. Additionally, the Commission asks how the non-supported amount is to be recovered by the carrier, assuming such expenses remain regulated expenses for ratemaking purposes. Specifically, the Commission invites parties to comment on two approaches for recovery of those amounts. First, the Commission could treat the non-supported expenses as being outside the tariffed regulated revenue requirement and allow carriers to assess a detariffed regulated rate to recover those non-supported costs. This would remove those costs from the NECA pooling process. The Commission invites parties to comment on whether the detariffed rates would be outside the prohibition on tariffing deaveraged rates in a study area, or whether a new rule should be adopted. A second option would be to raise the SLC caps for a particular study area to permit the recovery of the amounts not supported by the high-cost program. The Commission invites parties to comment on this alternative, including whether any SLC increases should be allowed only in the competitive area or should apply to the entire study area. Either of these alternatives would create new compliance requirements that could create administrative burdens for small rate-of-return carriers.
143.
144.
145.
146. The RFA requires an agency to describe any significant alternatives that it has considered in reaching its proposed approach, which may include (among others) the following four alternatives: (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 or reporting requirements under the rule for small entities; (3) the use of performance, rather than design, standards; and (4) an exemption from coverage of the rule, or any part thereof, for small entities. The Commission expects to consider all of these factors when they have received substantive comment from the public and potentially affected entities.
147. With respect to the costs of implementing the proposals to restrict permitted expenses, the Commission seeks comment on the least costly means of implementing any revisions, which would minimize burdens on carriers. The Commission notes that many of the proposals with respect to cost allocation would most likely change the way cost allocation is completed, but would not necessarily be any more burdensome. The proposal of identifying cost consultants would add a minimal burden on small entities if adopted because carriers should typically utilize cost consultants to submit information to NECA for purposes of pooling.
148. In discussing potential compliance procedures, the Commission asks whether there is a current certification that can be modified to encompass a certification that only permitted expenses are included. This methodology seeks to reduce the burden on smaller entities by making a small change instead of creating a new, more involved compliance mechanism.
149. In the concurrently adopted Order, the Commission adopts several methods of disaggregating CAF BLS for areas found to be competitively served and allow carriers to select which method will be used. However, in seeking comment on other methods of disaggregation of support that can be implemented with minimal administrative burden for affected carriers and USAC, the Commission takes further steps to reduce administrative and resource burdens on small rate-of-return carriers. The Commission seeks to avoid complex allocations of the cost of facilities that that serve both competitive and non-competitive areas, which could be burdensome for rate-of-return carriers to implement.
150. The Commission also invites parties to comment on how the non-supported amount is to be recovered by the carrier, assuming such expenses remain regulated expenses for ratemaking purposes. The Commission invites parties to comment on the two approaches for recovery of those amounts. The Commission seeks to minimize administrative burden under any approach.
151. The Commission also invites commenters to submit into the record any other proposals or ideas for steps the Commission should take to provide appropriate incentives for broadband deployment to unserved areas working within the framework of the existing budget for rate-of-return areas. The Commission is cognizant of the many compliance burdens small rate-of-return carriers face and seeks to minimize these burdens overall with this line of questioning.
152. In the concurrently adopted Order, the Commission updates our annual reporting requirements for rate-
153. More generally, the Commission expects to consider the economic impact on small entities, as identified in comments filed in response to the Notice and this IRFA, in reaching its final conclusions and taking action in this proceeding. The proposals and questions laid out in the Further Notice were designed to ensure the Commission has a complete understanding of the benefits and potential burdens associated with the different actions and methods.
154. None.
155. The Commission will send a copy of the concurrently adopted Report and Order to Congress and the Government Accountability Office pursuant to the Congressional Review Act,
156.
157.
• Electronic Filers: Comments may be filed electronically using the Internet by accessing the ECFS:
• Paper Filers: Parties who choose to file by paper must file an original and one copy of each filing. If more than one docket or rulemaking number appears in the caption of this proceeding, filers must submit two additional copies for each additional docket or rulemaking number.
Filings can be sent by hand or messenger delivery, by commercial overnight courier, or by first-class or overnight U.S. Postal Service mail. All filings must be addressed to the Commission's Secretary, Office of the Secretary, Federal Communications Commission.
• All hand-delivered or messenger-delivered paper filings for the Commission's Secretary must be delivered to FCC Headquarters at 445 12th St. SW., Room TW-A325, Washington, DC 20554. The filing hours are 8:00 a.m. to 7:00 p.m. All hand deliveries must be held together with rubber bands or fasteners. Any envelopes and boxes must be disposed of
• Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9300 East Hampton Drive, Capitol Heights, MD 20743.
• U.S. Postal Service first-class, Express, and Priority mail must be addressed to 445 12th Street SW., Washington, DC 20554.
158.
159. Comments and reply comments must include a short and concise summary of the substantive arguments raised in the pleading. Comments and reply comments must also comply with section 1.49 and all other applicable sections of the Commission's rules. The Commission directs all interested parties to include the name of the filing party and the date of the filing on each page of their comments and reply comments. All parties are encouraged to utilize a table of contents, regardless of the length of their submission. The Commission also strongly encourages parties to track the organization set forth in the FNPRM in order to facilitate our internal review process.
160.
161. Accordingly, IT IS ORDERED, pursuant to the authority contained in sections 1, 2, 4(i), 5, 10, 201-206, 214, 218-220, 251, 252, 254, 256, 303(r), 332, 403, and 405 of the Communications Act of 1934, as amended, and section 706 of the Telecommunications Act of 1996, 47 U.S.C. 151, 152, 154(i), 155, 201-206, 214, 218-220, 251, 252, 254, 256, 303(r), 332, 403, 405, 1302, and sections 1.1, 1.3, 1.421, 1.427, and 1.429 of the Commission's rules, 47 CFR 1.1, 1.3, 1.421, 1.427, and 1.429, that this Further Notice of Proposed Rulemaking
162. IT IS FURTHER ORDERED that, pursuant to the authority contained in sections 1, 2, 4(i), 5, 10, 201-206, 214, 218-220, 251, 252, 254, 256, 303(r), 332, 403, and 405 of the Communications Act of 1934, as amended, and section 706 of the Telecommunications Act of 1996, 47 U.S.C. 151, 152, 154(i), 155, 201-206, 214, 218-220, 251, 252, 254, 256, 303(r), 332, 403, 405, 1302, and sections 1.1, 1.3, 1.421, 1.427, and 1.429 of the Commission's rules, 47 CFR 1.1, 1.3, 1.421, 1.427, and 1.429, NOTICE IS HEREBY GIVEN of the proposals and tentative conclusions described in this Further Notice of Proposed Rulemaking.
163. IT IS FURTHER ORDERED that the Commission SHALL SEND a copy of this Further Notice of Proposed Rulemaking and the concurrently adopted Report and Order, Order and Order on Reconsideration to Congress and the Government Accountability Office pursuant to the Congressional Review Act,
164. IT IS FURTHER ORDERED, that the Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, SHALL SEND a copy of this Further Notice of Proposed Rulemaking and the concurrently adopted Report and Order, Order and Order on Reconsideration, including the Initial Regulatory Flexibility Analysis and the Final Regulatory Flexibility Analysis, to the Chief Counsel for Advocacy of the Small Business Administration.
Administrative practice and procedure, Communications common carriers, Reporting and recordkeeping requirements, Telephone.
For the reasons discussed in the preamble, the Federal Communications Commission proposes to amend 47 CFR part 65 as follows:
47 U.S.C. 151, 154, 201, 202, 203, 204, 205, 218, 219, 220, 403.
(d) Except for the allowance for funds used during construction and interest related to customer deposits, the amounts recorded as nonoperating income and expenses and taxes (Account 7300 and 7400) and interest and related items (Account 7500) and extraordinary items (Account 7600) shall not be included unless this Commission specifically determines that particular items recorded in those accounts shall be included.
(e) For purposes of determining whether an expense is recognized by the Commission as “necessary to the provision of these services” under paragraph (a) of this section, the expense must be used and useful and a prudent expenditure. The Commission specifically provides that the following expenses are not necessary to the provision of interstate telecommunications services regulated by the Commission:
(1) Personal travel; gifts to employees; childcare; housing allowances or other forms of mortgage or rent assistance for employees; personal expenses of employees, board members, family members of employees and board members, contractors, or any other individuals affiliated with the incumbent LEC, including but not limited to personal expenses for housing, such as rent or mortgages; personal use of company-owned housing, buildings, or facilities used for entertainment purposes by employees, board members, family members of employees and board members, contractors, or any other individuals affiliated with the incumbent local exchange carrier;
(2) Entertainment; artwork and other objects which possess aesthetic value; tangible property not logically related or necessary to the offering of voice or broadband services;
(3) Aircraft, watercraft, and other motor vehicles designed for off-road use, except insofar as necessary to access inhabited portions of the study area not reachable by motor vehicles travelling on roads; any vehicles provided to employees, board members, family members of employees and board members, contractors, or any other individuals affiliated with the incumbent local exchange carrier for personal use;
(4) Cafeterias and dining facilities; alcohol and food, including but not limited to meals to celebrate personal events, such as weddings, births, or retirements, except that a reasonable amount for food shall be allowed for work-related travel;
(5) Political contributions; charitable donations; scholarships; membership fees and dues in clubs and organizations; sponsorships of conferences or community events; and
(6) Penalties or fines for statutory or regulatory violations; penalties or fees for any late payments on debt, loans, or other payments.
(d) The following assets shall also be deducted from the interstate rate base:
(1) Artwork and other objects which possess aesthetic value;
(2) Tangible property not logically related or necessary to the offering of voice or broadband services;
(3) Personal residences and property used for entertainment purposes;
(4) Aircraft, watercraft, and other motor vehicles designed for off-road use, except insofar as necessary to access inhabited portions of the study area not reachable by motor vehicles travelling on roads;
(5) Any vehicles provided to employees, board members, family members of employees and board members, contractors, or any other individuals affiliated with the incumbent local exchange carrier for personal use; and
(6) Cafeterias and dining facilities.
The Department of Agriculture has submitted the following information collection requirement(s) to Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are requested regarding (1) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information to be collected; (4) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Comments regarding this information collection received by May 12, 2016 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725 17th Street NW., Washington, DC 20502. Commenters are encouraged to submit their comments to OMB via email to:
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
April 20, 2016, 1:00 p.m. EDT
U.S. Chemical Safety Board, 1750 Pennsylvania Ave. NW., Suite 910, Washington, DC 20006.
Open to the public.
The Chemical Safety and Hazard Investigation Board (CSB) will convene a public meeting on April 20, 2016, starting at 1:00 p.m. EDT in Washington, DC, at the CSB offices located at 1750 Pennsylvania Avenue NW., Suite 910. The Board will discuss the status of open investigations; an update on audits from the Office of the Inspector General; financial and organizational updates; a review of the agency's action plan; and a calendared notation item related to recommendations 2001-01-H-R9 and 2001-01-H-R10 from the 2002 study on Improving Reactive Hazard Management. An opportunity for public comment will be provided.
The meeting is free and open to the public. If you require a translator or interpreter, please notify the individual listed below as the “Contact Person for Further Information,” at least three business days prior to the meeting.
A conference call line will be provided for those who cannot attend in person. Please use the following dial-in number to join the conference: 1-(888) 466-9863, passcode 6069134#.
The CSB is an independent federal agency charged with investigating accidents and hazards that result, or may result, in the catastrophic release of extremely hazardous substances. The agency's Board Members are appointed by the President and confirmed by the Senate. CSB investigations look into all aspects of chemical accidents and hazards, including physical causes such as equipment failure as well as inadequacies in regulations, industry standards, and safety management systems.
The time provided for public statements will depend upon the number of people who wish to speak. Speakers should assume that their
Hillary Cohen, Communication Manager, at
United States Commission on Civil Rights.
Notice of Commission business meeting.
Friday, April 15, 2016, at 10:00 a.m. EST.
Gerson Gomez, Media Advisor at telephone: (202) 376-8371, TTY: (202) 376-8116 or email:
This business meeting is open to the public. If you would like to listen to the business meeting, please contact the above for the call-in information.
The Information Systems Technical Advisory Committee (ISTAC) will meet on April 27 and 28, 2016, 9:00 a.m., in the Herbert C. Hoover Building, Room 3884, 14th Street between Constitution and Pennsylvania Avenues NW., Washington, DC. The Committee advises the Office of the Assistant Secretary for Export Administration on technical questions that affect the level of export controls applicable to information systems equipment and technology.
6. Discussion of matters determined to be exempt from the provisions relating to public meetings found in 5 U.S.C. app. 2 sections 10(a)(1) and 10(a)(3).
The open session will be accessible via teleconference to 20 participants on a first come, first serve basis. To join the conference, submit inquiries to Ms. Yvette Springer at
A limited number of seats will be available for the public session. Reservations are not accepted. To the extent time permits, members of the public may present oral statements to the Committee. The public may submit written statements at any time before or after the meeting. However, to facilitate distribution of public presentation materials to Committee members, the Committee suggests that public presentation materials or comments be forwarded before the meeting to Ms. Springer.
The Assistant Secretary for Administration, with the concurrence of the delegate of the General Counsel, formally determined on January 7, 2016, pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. app. 2 section (10)(d)), that the portion of the meeting concerning trade secrets and commercial or financial information deemed privileged or confidential as described in 5 U.S.C. 552b(c)(4) and the portion of the meeting concerning matters the disclosure of which would be likely to frustrate significantly implementation of an agency action as described in 5 U.S.C. 552b(c)(9)(B) shall be exempt from the provisions relating to public meetings found in 5 U.S.C. app. 2 sections 10(a)(1) and 10(a)(3). The remaining portions of the meeting will be open to the public.
For more information, call Yvette Springer at (202) 482-2813.
The Materials Technical Advisory Committee will meet on May 5, 2016, 10:00 a.m., Herbert C. Hoover Building, Room 3884, 14th Street between Constitution & Pennsylvania Avenues NW., Washington, DC. The Committee advises the Office of the Assistant Secretary for Export Administration with respect to technical questions that affect the level of export controls applicable to materials and related technology.
1. Opening remarks and Introductions.
2. Remarks from the Bureau of Industry and Security senior management.
3. Report by regime representatives.
4. Report by working groups (Composite Working Group, Biological Working Group, Pump and Valves Working Group, and the Chemicals Working Group).
5. Public Comments and New Business.
6. Discussion of matters determined to be exempt from the provisions relating to public meetings found in 5 U.S.C. app. 2 §§ 10(a)(1) and 10(a)(3).
A limited number of seats will be available during the public session of the meeting. Reservations are not accepted. To the extent time permits, members of the public may present oral statements to the Committee. Written statements may be submitted at any time before or after the meeting. However, to facilitate distribution of public presentation materials to Committee members, the materials should be forwarded prior to the meeting to Ms. Springer via email.
The Assistant Secretary for Administration, with the concurrence of the delegate of the General Counsel, formally determined on November 5, 2015, pursuant to Section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. app. 2 § 10(d)), that the portion of the meeting dealing with pre-decisional changes to the Commerce Control List and the U.S. export control policies shall be exempt from the provisions relating to public meetings found in 5 U.S.C. app. 2 §§ 10(a)(1) and 10(a)(3). The remaining portions of the meeting will be open to the public.
For more information, call Yvette Springer at (202) 482-2813.
The Sensors and Instrumentation Technical Advisory Committee (SITAC) will meet on April 26, 2016, 9:30 a.m., in the Herbert C. Hoover Building, Room 3884, 14th Street between Constitution and Pennsylvania Avenues NW., Washington, DC. The Committee advises the Office of the Assistant Secretary for Export Administration on technical questions that affect the level of export controls applicable to sensors and instrumentation equipment and technology.
1. Welcome and Introductions.
2. Remarks from the Bureau of Industry and Security Management.
3. Industry Presentations.
4. New Business.
5. Discussion of matters determined to be exempt from the provisions relating to public meetings found in 5 U.S.C. app. 2 §§ 10(a)(1) and 10(a)(3).
The open session will be accessible via teleconference to 20 participants on a first come, first serve basis. To join the conference, submit inquiries to Ms. Yvette Springer at
A limited number of seats will be available during the public session of the meeting. Reservations are not accepted. To the extent that time permits, members of the public may present oral statements to the Committee. The public may submit written statements at any time before or after the meeting. However, to facilitate distribution of public presentation materials to the Committee members, the Committee suggests that the materials be forwarded before the meeting to Ms. Springer.
The Assistant Secretary for Administration, with the concurrence of the General Counsel, formally determined on November 5, 2015 pursuant to Section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. app. 2 § 10(d), that the portion of this meeting dealing with pre-decisional changes to the Commerce Control List and U.S. export control policies shall be exempt from the provisions relating to public meetings found in 5 U.S.C. app. 2 §§ 10(a)(1) and 10(a)(3). The remaining portions of the meeting will be open to the public.
For more information contact Yvette Springer on (202) 482-2813.
The Transportation and Related Equipment Technical Advisory Committee will meet on May 4, 2016, 9:30 a.m., in the Herbert C. Hoover Building, Room 3884, 14th Street between Constitution & Pennsylvania Avenues NW., Washington, DC. The Committee advises the Office of the Assistant Secretary for Export Administration with respect to technical questions that affect the level of export controls applicable to transportation and related equipment or technology.
1. Welcome and Introductions.
2. Status reports by working group chairs.
3. Public comments and Proposals.
4. Discussion of matters determined to be exempt from the provisions relating to public meetings found in 5 U.S.C. app. 2 sections 10(a)(1) and 10(a)(3).
The open session will be accessible via teleconference to 20 participants on a first come, first serve basis. To join the conference, submit inquiries to Ms. Yvette Springer at
A limited number of seats will be available during the public session of the meeting. Reservations are not accepted. To the extent time permits, members of the public may present oral statements to the Committee. The public may submit written statements at any time before or after the meeting. However, to facilitate distribution of public presentation materials to Committee members, the Committee suggests that presenters forward the public presentation materials prior to the meeting to Ms. Springer via email.
The Assistant Secretary for Administration, with the concurrence of the delegate of the General Counsel, formally determined on November 5,
For more information, call Yvette Springer at (202) 482·2813.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (the Department) is conducting an administrative review of the antidumping duty order on polyethylene retail carrier bags (PRCBs) from Thailand. The period of review (POR) is August 1, 2014, through July 31, 2015. We preliminarily find that subject merchandise has been sold at less than normal value by K. International Packaging Co., Ltd. (K. International Packaging).
Andre Gziryan, AD/CVD Operations, Office I, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-2201.
The merchandise subject to this order is polyethylene retail carrier bags, which are currently classified under subheading 3923.21.0085 of the Harmonized Tariff Schedule of the United States (HTSUS). While the HTSUS subheadings are provided for convenience and customs purposes, the written description is dispositive. A full description of the scope of the order is contained in the Preliminary Decision Memorandum.
As explained in the memorandum from the Acting Assistant Secretary for Enforcement and Compliance, the Department has exercised its discretion to toll all administrative deadlines due to the recent closure of the Federal Government. All deadlines in this segment of the proceeding have been extended by four business days. The revised deadline for the preliminary results of this review is now May 6, 2016.
We have relied on total facts available with respect to K. International Packaging, the sole company subject to this review. Because this company did not act to the best of its ability to respond to the Department's requests for information, we have drawn an adverse inference in selecting from among the facts otherwise available.
As a result of our review, we preliminarily determine that a weighted-average dumping margin of 122.88 percent exists for K. International Packaging Co., Ltd. on PRCBs from Thailand for the period August 1, 2014, through July 31, 2015.
Pursuant to 19 CFR 351.309(c), interested parties may submit case briefs not later than 30 days after the date of publication of this notice. Rebuttal briefs, limited to issues raised in the case briefs, may be filed not later than five days after the date for filing case briefs.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, must submit a written request to the Assistant Secretary for Enforcement and Compliance, filed electronically
Upon issuance of the final results, the Department shall determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries covered by this review. For the final results, if we continue to rely on total adverse facts available to establish K. International Packaging's weighted-average dumping margin, we will instruct CBP to apply an
We intend to issue liquidation instructions to CBP 15 days after
The following deposit requirements will be effective upon publication of the notice of final results of administrative review for all shipments of PRCBs from Thailand entered, or withdrawn from warehouse, for consumption on or after the date of publication, as provided by section 751(a)(2) of the Act: (1) The cash deposit rate for the reviewed company will be the rate established in the final results of this review; (2) for previously reviewed or investigated companies not listed above, the cash deposit rate will continue to be the company-specific rate published for the most recent period; (3) if the exporter is not a firm covered in this review, a prior review, or the less-than-fair-value investigation but the manufacturer is, the cash deposit rate will be the rate established for the most recent period for the manufacturer of the merchandise; (4) if neither the exporter nor the manufacturer has its own rate, the cash deposit rate will be 4.69 percent.
This notice also serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Department's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of doubled antidumping duties.
These preliminary results of administrative review are issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
On March 30, 2016, the United States Court of International Trade (CIT) sustained the Department of Commerce's (Department's) final results of redetermination,
Patricia M. Tran, AD/CVD Operations, Office III, Enforcement and Compliance, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone (202) 482-1503.
In the
In its final results of redetermination pursuant to
On March 30, 2016, the CIT sustained the Department's final results of redetermination pursuant to remand.
In its decision in
Because there is now a final court decision with respect to the
Since the
This notice is issued and published in accordance with sections 516A(e)(l), 75l(a)(l), and 777(i)(l) of the Act.
Notice of issuance of an amended Export Trade Certificate of Review to the Northwest Fruit Exporters of Washington (“NFE”), Application No. (84-26A12).
The Secretary of Commerce, through the Office of Trade and Economic Analysis (“OTEA”), issued an amended Export Trade Certificate of Review to NFE of California on March 21, 2016.
Joseph E. Flynn, Director, Office of Trade and Economic Analysis, International Trade Administration, by telephone at (202) 482-5131 (this is not a toll-free number) or email at
Title III of the Export Trading Company Act of 1982 (15 U.S.C. 4001-21) authorizes the Secretary of Commerce to issue Export Trade Certificates of Review. An Export Trade Certificate of Review protects the holder and the members identified in the Certificate from State and Federal government antitrust actions and from private treble damage antitrust actions for the export conduct specified in the Certificate and carried out in compliance with its terms and conditions. The regulations implementing title III are found at 15 CFR part 325 (2016).
OTEA is issuing this notice pursuant to 15 CFR 325.6(b), which requires the Secretary of Commerce to publish a summary of the certification in the
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Stephanie Moore, AD/CVD Operations, Office III, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Ave. NW., Washington, DC 20230, telephone: (202) 482-3692.
Section 702 of the Trade Agreements Act of 1979 (as amended) (the Act) requires the Department of Commerce (the Department) to determine, in consultation with the Secretary of Agriculture, whether any foreign government is providing a subsidy with respect to any article of cheese subject to an in-quota rate of duty, as defined in section 702(h) of the Act, and to publish quarterly updates to the type and amount of those subsidies. We hereby provide the Department's quarterly update of subsidies on articles of cheese that were imported during the periods October 1, 2015, through December 31, 2015.
The Department has developed, in consultation with the Secretary of Agriculture, information on subsidies, as defined in section 702(h) of the Act, being provided either directly or indirectly by foreign governments on articles of cheese subject to an in-quota rate of duty. The appendix to this notice lists the country, the subsidy program or programs, and the gross and net amounts of each subsidy for which information is currently available. The Department will incorporate additional programs which are found to constitute subsidies, and additional information
The Department encourages any person having information on foreign government subsidy programs which benefit articles of cheese subject to an in-quota rate of duty to submit such information in writing to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, 14th Street and Constitution Ave. NW., Washington, DC 20230.
This determination and notice are in accordance with section 702(a) of the Act.
The Board of Directors of the Corporation for National and Community Service gives notice of the following meeting:
Friday, April 22, 2016, 11:00 a.m.-12:15 p.m. (ET).
Corporation for National and Community Service, 250 E Street SW., Suite 4026, Washington, DC 20525 (Please go to the first floor lobby reception area for escort).
This meeting is available to the public through the following toll-free call-in number: 888-390-3401 conference call access code number 2572123. 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 CNCS 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. Replays are generally available one hour after a call ends. The toll-free phone number for the replay is 866-479-2459. TTY: 800-833-3722. The end replay date is May 6, 2016 at 10:59 p.m. (CT).
Open.
Members of the public who would like to comment on the business of the Board may do so in writing or in person. Individuals may submit written comments to
The Corporation for National and Community Service provides reasonable accommodations to individuals with disabilities where appropriate. Anyone who needs an interpreter or other accommodation should notify David Premo at
Dave Premo, Program Support Specialist, Corporation for National and Community Service, 250 E Street SW., Washington, DC 20525. Phone: 202-606-6717. Fax: 202-606-3460. TTY: 800-833-3722. Email:
Department of the Air Force, Air Force Research Laboratory Information Directorate, Rome, New York, DOD.
Notice of intent to issue an exclusive patent license.
Pursuant to the provisions of part 404 of Title 37, Code of Federal Regulations, which implements Public Law 96-517, as amended, the Department of the Air Force announces its intention to grant The Curators of the University of Missouri, a public corporation of Missouri having a place of business at the Office of Technology Management and Industry Relations, 1601 S. Providence Road, #124, Columbia, Missouri 65211, an exclusive license in any right, title and interest the United States Air Force has in: In U.S. Patent No. 14/795,953 entitled “SYSTEM AND METHOD FOR STATIC AND MOVING OBJECT DETECTION”, filed July 10, 2015.
An exclusive license for this patent will be granted unless a written objection is received within fifteen (15) days from the date of publication of this Notice.
Office of Elementary and Secondary Education, Department of Education.
Notice.
Notice inviting applications for new awards for fiscal year (FY) 2016.
Catalog of Federal Domestic Assistance (CFDA) Number: 84.330B.
The Elementary and Secondary Education Act of 1965 (ESEA), as amended by the No Child Left Behind Act of 2001 (NCLB) (20 U.S.C. 6531-6537).
On December 10, 2015, the President signed into law the Every Student Succeeds Act (ESSA), Public Law 114-95, which reauthorized the ESEA, as amended by NCLB. Under section 5(c) of the ESSA, APTF Program grants awarded in FY 2016 and earlier years will operate in accordance with the requirements of the ESEA, as amended by NCLB.
The regulations in 34 CFR part 79 apply to all applicants except federally recognized Indian tribes.
The Department is not bound by any estimates in this notice.
1.
For the purposes of this program, the Bureau of Indian Education in the U.S. Department of the Interior is treated as an SEA.
2.a.
b.
1.
To obtain a copy via the Internet, use the following address:
To obtain a copy from the program office, contact: Francisco Ramirez, U.S. Department of Education, 400 Maryland Avenue SW., Room 3E310, Washington, DC 20202-6200. Telephone: (202) 260-1541 or by email:
If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.
Individuals with disabilities can obtain a copy of the application package in an accessible format (
2.
3.
Applications Available: April 12, 2016.
Applications for grants under this competition must be submitted electronically using the Grants.gov Apply site (Grants.gov). For information (including dates and times) about how to submit your application electronically, or in paper format by mail or hand delivery if you qualify for an exception to the electronic submission requirement, please refer to
We do not consider an application that does not comply with the deadline requirements.
Individuals with disabilities who need an accommodation or auxiliary aid in connection with the application process should contact the person listed under
4.
5.
6.
a. Have a Data Universal Numbering System (DUNS) number and a Taxpayer Identification Number (TIN);
b. Register both your DUNS number and TIN with the System for Award Management (SAM) (formerly the Central Contractor Registry), the Government's primary registrant database;
c. Provide your DUNS number and TIN on your application; and
d. Maintain an active SAM registration with current information while your application is under review by the Department and, if you are awarded a grant, during the project period.
You can obtain a DUNS number from Dun and Bradstreet at the following Web site:
If you are a corporate entity, agency, institution, or organization, you can obtain a TIN from the Internal Revenue Service. If you are an individual, you can obtain a TIN from the Internal Revenue Service or the Social Security Administration. If you need a new TIN, please allow two to five weeks for your TIN to become active.
The SAM registration process can take approximately seven business days, but may take upwards of several weeks, depending on the completeness and accuracy of the data you enter into the SAM database. Thus, if you think you might want to apply for Federal financial assistance under a program administered by the Department, please allow sufficient time to obtain and register your DUNS number and TIN. We strongly recommend that you register early.
Once your SAM registration is active, it may be 24 to 48 hours before you can access the information in, and submit an application through, Grants.gov.
If you are currently registered with SAM, you may not need to make any changes. However, please make certain that the TIN associated with your DUNS number is correct. Also note that you will need to update your registration annually. This may take three or more business days.
Information about SAM is available at
In addition, if you are submitting your application via Grants.gov, you must (1) be designated by your organization as an Authorized Organization Representative (AOR); and (2) register yourself with Grants.gov as an AOR. Details on these steps are outlined at the following Grants.gov Web page:
7.
Applications for grants under the APTF Program, CFDA number 84.330B, must be submitted electronically using the Governmentwide Grants.gov Apply site at
We will reject your application if you submit it in paper format unless, as described elsewhere in this section, you qualify for one of the exceptions to the electronic submission requirement
You may access the electronic grant application for the APTF Program at
Please note the following:
• When you enter the Grants.gov site, you will find information about submitting an application electronically through the site, as well as the hours of operation.
• Applications received by Grants.gov are date and time stamped. Your application must be fully uploaded and submitted and must be date and time stamped by the Grants.gov system no later than 4:30:00 p.m., Washington, DC time, on the application deadline date. Except as otherwise noted in this section, we will not accept your application if it is received—that is, date and time stamped by the Grants.gov system—after 4:30:00 p.m., Washington, DC time, on the application deadline date. We do not consider an application that does not comply with the deadline requirements. When we retrieve your application from Grants.gov, we will notify you if we are rejecting your application because it was date and time stamped by the Grants.gov system after 4:30:00 p.m., Washington, DC time, on the application deadline date.
• The amount of time it can take to upload an application will vary depending on a variety of factors, including the size of the application and the speed of your Internet connection. Therefore, we strongly recommend that you do not wait until the application deadline date to begin the submission process through Grants.gov.
• You should review and follow the Education Submission Procedures for submitting an application through Grants.gov that are included in the application package for this competition to ensure that you submit your application in a timely manner to the Grants.gov system. You can also find the Education Submission Procedures pertaining to Grants.gov under News and Events on the Department's G5 system home page at
• You will not receive additional point value because you submit your application in electronic format, nor will we penalize you if you qualify for an exception to the electronic submission requirement, as described elsewhere in this section, and submit your application in paper format.
• You must submit all documents electronically, including all information you typically provide on the following forms: The Application for Federal Assistance (SF 424), the Department of Education Supplemental Information for SF 424, Budget Information—Non-Construction Programs (ED 524), and all necessary assurances and certifications.
• You must upload any narrative sections and all other attachments to your application as files in a read-only, non-modifiable Portable Document Format (PDF). Do not upload an interactive or fillable PDF file. If you upload a file type other than a read-only, non-modifiable PDF (
• Your electronic application must comply with any page-limit requirements described in this notice.
• After you electronically submit your application, you will receive from Grants.gov an automatic notification of receipt that contains a Grants.gov tracking number. This notification indicates receipt by Grants.gov only, not receipt by the Department. Grants.gov will also notify you automatically by email if your application met all the Grants.gov validation requirements or if there were any errors (such as submission of your application by someone other than a registered Authorized Organization Representative, or inclusion of an attachment with a file name that contains special characters). You will be given an opportunity to correct any errors and resubmit, but you must still meet the deadline for submission of applications.
Once your application is successfully validated by Grants.gov, the Department will retrieve your application from Grants.gov and send you an email with a unique PR/Award number for your application.
These emails do not mean that your application is without any disqualifying errors. While your application may have been successfully validated by Grants.gov, it must also meet the Department's application requirements as specified in this notice and in the application instructions. Disqualifying errors could include, for instance, failure to upload attachments in a read-only, non-modifiable PDF; failure to submit a required part of the application; or failure to meet applicant eligibility requirements. It is your responsibility to ensure that your submitted application has met all of the Department's requirements.
• We may request that you provide us original signatures on forms at a later date.
If you are prevented from electronically submitting your application on the application deadline date because of technical problems with the Grants.gov system, we will grant you an extension until 4:30:00 p.m., Washington, DC time, the following business day to enable you to transmit your application electronically or by hand delivery. You also may mail your application by following the mailing instructions described elsewhere in this notice.
If you submit an application after 4:30:00 p.m., Washington, DC time, on the application deadline date, please contact the person listed under
The extensions to which we refer in this section apply only to the unavailability of, or technical problems with, the Grants.gov system. We will not grant you an extension if you failed to fully register to submit your application to Grants.gov before the application deadline date and time or if the technical problem you experienced is unrelated to the Grants.gov system.
• You do not have access to the Internet; or
• You do not have the capacity to upload large documents to the Grants.gov system;
and
• No later than two weeks before the application deadline date (14 calendar days or, if the fourteenth calendar day before the application deadline date falls on a Federal holiday, the next business day following the Federal holiday), you mail or fax a written statement to the Department, explaining which of the two grounds for an exception prevents you from using the Internet to submit your application.
If you mail your written statement to the Department, it must be postmarked no later than two weeks before the application deadline date. If you fax your written statement to the Department, we must receive the faxed statement no later than two weeks before the application deadline date.
Address and mail or fax your statement to: Francisco Ramirez, U.S. Department of Education, 400 Maryland Avenue SW., Room 3E310, Washington, DC 20202-6200. FAX: (202) 260-8969.
Your paper application must be submitted in accordance with the mail or hand-delivery instructions described in this notice.
If you qualify for an exception to the electronic submission requirement, you may mail (through the U.S. Postal Service or a commercial carrier) your application to the Department. You must mail the original and two copies of your application, on or before the application deadline date, to the Department at the following address: U.S. Department of Education, Application Control Center, Attention: (CFDA Number 84.330B), LBJ Basement Level 1, 400 Maryland Avenue SW., Washington, DC 20202-4260.
You must show proof of mailing consisting of one of the following:
(1) A legibly dated U.S. Postal Service postmark.
(2) A legible mail receipt with the date of mailing stamped by the U.S. Postal Service.
(3) A dated shipping label, invoice, or receipt from a commercial carrier.
(4) Any other proof of mailing acceptable to the Secretary of the U.S. Department of Education.
If you mail your application through the U.S. Postal Service, we do not accept either of the following as proof of mailing:
(1) A private metered postmark.
(2) A mail receipt that is not dated by the U.S. Postal Service.
The U.S. Postal Service does not uniformly provide a dated postmark. Before relying on this method, you should check with your local post office.
We will not consider applications postmarked after the application deadline date.
If you qualify for an exception to the electronic submission requirement, you (or a courier service) may deliver your paper application to the Department by hand. You must deliver the original and two copies of your application by hand, on or before the application deadline date, to the Department at the following address: U.S. Department of Education, Application Control Center, Attention: (CFDA Number 84.330B), 550 12th Street SW., Room 7039, Potomac Center Plaza, Washington, DC 20202-4260.
The Application Control Center accepts hand deliveries daily between 8:00 a.m. and 4:30:00 p.m., Washington, DC time, except Saturdays, Sundays, and Federal holidays.
If you mail or hand deliver your application to the Department—
(1) You must indicate on the envelope and—if not provided by the Department—in Item 11 of the SF 424 the CFDA number, including suffix letter, if any, of the competition under which you are submitting your application; and
(2) The Application Control Center will mail to you a notification of receipt of your grant application. If you do not receive this notification within 15 business days from the application deadline date, you should call the U.S. Department of Education Application Control Center at (202) 245-6288.
1.
Under section 1707(1) of the ESEA, as amended by NCLB, “advanced placement test” means an advanced placement test administered by the College Board or approved by the Secretary. For FY 2016, advanced placement tests administered by the College Board include Advanced Placement (AP) Seminar and AP Research under the College Board's new AP Capstone program. In addition, for FY 2016, the Secretary approves the following advanced placement tests:
(a) Diploma Programme tests administered by the International Baccalaureate Organization (IBO);
(b) Advanced Subsidiary (AS) Level tests administered by Cambridge International Examinations, including Global Perspectives and Research Test; and
(c) Advanced (A) Level tests administered by Cambridge International Examinations; including Global Perspectives and Research Test.
For FY 2016, the Department expects to award approximately $28,483,000 in new grants under this program. Based on the anticipated number of applications and other available information (including any expected fee reductions for low-income students), the Department expects this amount to be sufficient to pay all but $15 of the cost of each advanced placement exam taken by low-income students.
Accordingly, SEAs may use APTF Program funds to cover a portion of the cost of each approved advanced placement exam taken by low-income students in school year 2015-16, as follows: (a) Up to $38 for each AP test administered by the College Board that is not an AP Seminar or AP Research exam under the College Board's AP Capstone program; (b) up to $85 for each AP Seminar test administered by the College Board under its AP Capstone program; (c) up to $85 for each AP Research test administered by the College Board under its AP Capstone program; (d) up to $98 for each Diploma Programme test administered by the IBO; (e) up to $69.10 for each AS Level test administered by Cambridge International Examinations that is not a Global Perspectives and Research exam; (f) up to $112.90 for each A Level test administered by Cambridge International Examinations that is not a Global Perspectives and Research exam; (g) up to $134.73 for each AS Level Global Perspectives and Research test administered by Cambridge International Examinations; and (h) up to $226.50 for each A Level Global Perspectives and Research test administered by Cambridge International Examinations.
APTF Program funds may not be used to pay registration fees on behalf of low-income students. Therefore, advanced placement test registration fees, including the student registration fees charged by the IBO, are not allowable costs under this program.
Further information and instructions on how to request funds for school year 2015-16 are included in the application package for this competition.
Also, in determining whether to approve an application for a new award (including the amount of the award) from an applicant with a current grant under this program, the Department will consider the amount of any unexpended funds under the existing grant and the applicant's use of funds under previous APTF Program grant awards.
We remind potential applicants that in reviewing applications in any discretionary grant competition, the Secretary may consider, under 34 CFR 75.217(d)(3), the past performance of the applicant in carrying out a previous award, such as the applicant's use of funds, achievement of project objectives, and compliance with grant conditions. The Secretary may also consider whether the applicant failed to submit a timely performance report or submitted a report of unacceptable quality.
In addition, in making a competitive grant award, the Secretary also requires various assurances, including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department of Education (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).
2.
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
3.
(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
(c) Under 34 CFR 75.250(b), the Secretary may provide a grantee with additional funding for data collection analysis and reporting. In this case the Secretary establishes a data collection period.
4.
Francisco Ramirez, U.S. Department of Education, 400 Maryland Avenue SW., Room 3E310, Washington, DC 20202-6200. Telephone: (202) 260-1541 or by email:
If you use a TDD or a TTY, call the FRS, toll free, at 1-800-877-8339.
You may also access documents of the Department published in the
Office of Elementary and Secondary Education (OESE), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501
Interested persons are invited to submit comments on or before May 12, 2016.
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 John Cheek, 202-401-0274.
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.
This data collection serves three purposes: First, data from three sources (grantees, project participants, and employers) are necessary to assess the performance of the IEPD program on its Government Performance Results Act (GPRA) measures. Second, data from all three sources are necessary to determine if IEPD participants are fulfilling the terms of their service/cash payback requirements. Finally, budget and project-specific performance data are collected from IEPD grantees for project-monitoring and compliance information. The forms and protocols contained in this package include the Grantee Reporting Form, the Participant Training Information and Employment Reporting Form, and the Employment Verification Form.
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written PRA comments should be submitted on or before June 13, 2016. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to Nicole Ongele, FCC, via email to
For additional information about the information collection, contact Nicole Ongele at (202) 418-2991.
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written PRA comments should be submitted on or before June 13, 2016. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to Cathy Williams, FCC, via email
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
These streamlined carrier change rules balance the protection of consumers' interests with ensuring that the Commission's rules do not unnecessarily inhibit routine business transactions.
The Federal Deposit Insurance Corporation (FDIC), as Receiver for 10494 Syringa Bank, Boise, Idaho (Receiver) has been authorized to take all actions necessary to terminate the receivership estate of Syringa Bank (Receivership Estate); the Receiver has made all dividend distributions required by law.
The Receiver has further irrevocably authorized and appointed FDIC-Corporate as its attorney-in-fact to execute and file any and all documents that may be required to be executed by the Receiver which FDIC-Corporate, in its sole discretion, deems necessary; including but not limited to releases, discharges, satisfactions, endorsements, assignments and deeds.
Effective April 1, 2016, the Receivership Estate has been terminated, the Receiver discharged, and the Receivership Estate has ceased to exist as a legal entity.
The Federal Deposit Insurance Corporation (FDIC), as Receiver for 10169 St. Stephen State Bank, St. Stephen, Minnesota (Receiver) has been authorized to take all actions necessary to terminate the receivership estate of St. Stephen State Bank (Receivership Estate); the Receiver has made all dividend distributions required by law.
The Receiver has further irrevocably authorized and appointed FDIC-Corporate as its attorney-in-fact to execute and file any and all documents that may be required to be executed by the Receiver which FDIC-Corporate, in its sole discretion, deems necessary; including but not limited to releases, discharges, satisfactions, endorsements, assignments and deeds.
Effective April 01, 2016, the Receivership Estate has been terminated, the Receiver discharged, and the Receivership Estate has ceased to exist as a legal entity.
The Federal Deposit Insurance Corporation (FDIC), as Receiver for 10468 Westside Community Bank, University Place, Washington (Receiver) has been authorized to take all actions necessary to terminate the receivership estate of Westside Community Bank (Receivership Estate); the Receiver has made all dividend distributions required by law.
The Receiver has further irrevocably authorized and appointed FDIC-Corporate as its attorney-in-fact to execute and file any and all documents that may be required to be executed by the Receiver which FDIC-Corporate, in its sole discretion, deems necessary; including but not limited to releases, discharges, satisfactions, endorsements, assignments and deeds.
Effective April 1, 2016, the Receivership Estate has been terminated, the Receiver discharged, and the Receivership Estate has ceased to exist as a legal entity.
Federal Election Commission.
Thursday, April 14, 2016 at 10:00 a.m.
999 E Street NW., Washington, DC (ninth floor).
This meeting will be open to the public.
Individuals who plan to attend and require special assistance, such as sign language interpretation or other reasonable accommodations, should contact Shawn Woodhead Werth, Secretary and Clerk, at (202) 694-1040, at least 72 hours prior to the meeting date.
Judith Ingram, Press Officer, Telephone: (202) 694-1220.
The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).
The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than April 27, 2016.
A. Federal Reserve Bank of Dallas (Robert L. Triplett III, Senior Vice President) 2200 North Pearl Street, Dallas, Texas 75201-2272:
1.
The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.
Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than May 6, 2016.
A. Federal Reserve Bank of Dallas (Robert L. Triplett III, Senior Vice President) 2200 North Pearl Street, Dallas, Texas 75201-2272:
1.
Federal Trade Commission.
Notice and request for comment.
In compliance with the Paperwork Reduction Act (PRA) of 1995, the FTC is seeking public comments on its request to OMB for a three-year extension of the current PRA clearance for the information collection requirements contained in the Mail, Internet, or Telephone Order Merchandise Rule (MITOR). This clearance expires on April 30, 2016.
Comments must be received by May 12, 2016.
Interested parties may file a comment online or on paper, by following the instructions in the Request for Comment part of the
Requests for additional information or copies of the proposed information requirements should be addressed to Jock Chung, Attorney, Division of Enforcement, Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue NW., Washington, DC 20580, (202) 326-2984.
The notice provisions in the Rule require a merchant who is unable to ship within the promised shipment time or 30 days to notify the consumer of a revised date and his or her right to cancel the order and obtain a prompt refund. Delays beyond the revised shipment date also trigger a notification requirement to consumers. When the
On January 19, 2016, the Commission sought comment on the information collection requirements in MTOR. See 81 FR 2860. The Commission received two comments but neither one addressed the issues raised by the public comment request. As required by OMB regulations, 5 CFR part 1320, the FTC is providing this second opportunity for public comment.
Third Party Disclosure: [(33,267 established businesses × 50 hours) + (1,263 new entrants × 230 hours) = 1,953,840 hours.
You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before May 12, 2016. Write “Mail, Internet, or Telephone Order Merchandise Trade Regulation Rule: FTC File No. R511929” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the public Commission Web site, at
Because your comment will be made public, you are solely responsible for making sure that your comment does not include any sensitive personal information, such as anyone's Social Security number, date of birth, driver's license number or other state identification number or foreign country equivalent, passport number, financial account number, or credit or debit card number. You are also solely responsible for making sure that your comment does not include any sensitive health information, like medical records or other individually identifiable health information. In addition, do not include any “[t]rade secret or any commercial or financial information which is . . . privileged or confidential,” as discussed in Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2). In particular, do not include competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names.
If you want the Commission to give your comment confidential treatment, you must file it in paper form, with a request for confidential treatment, and you are required to follow the procedure explained in FTC Rule 4.9(c), 16 CFR 4.9(c). Your comment will be kept confidential only if the FTC General Counsel grants your request in accordance with the law and the public interest.
Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comment online, or to send it to the Commission by courier or overnight service. To make sure that the Commission considers your online comment, you must file it at
If you file your comment on paper, write “Mail, Internet, or Telephone Order Merchandise Trade Regulation Rule: FTC File No. R511929” on your comment and on the envelope, and mail or deliver it to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610 (Annex J), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex J), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service.
The FTC Act and other laws that the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. The Commission will consider all timely and responsive public comments that it receives on or before May 12, 2016. You can find more information, including routine uses permitted by the Privacy Act, in the Commission's privacy policy, at
Comments on the information collection requirements subject to review under the PRA should also be submitted to OMB. If sent by U.S. mail, address comments to: Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for the Federal Trade Commission, New Executive Office Building, Docket Library, Room 10102, 725 17th Street NW., Washington, DC 20503. Comments sent to OMB by U.S. postal mail, however, are subject to delays due to heightened security precautions. Thus, comments instead should be sent by facsimile to (202) 395-5167.
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (DHHS).
This notice announces the Centers for Disease Control and Prevention's (CDC) intent to fund the Puerto Rico Department of Health with Prevention and Public Health Funds (PPHF).
PPHF 2016: Epidemiology and Laboratory Capacity Program—Emergency Funding for Puerto Rico Department of Health, Zika virus Outbreak for Infectious Diseases (ELC)—financed solely by Prevention and Public Health Funds.
FOA Number: CDC-RFA-CK14-140103CONTPPHF2016.
The U.S. Centers for Disease Control and Prevention (CDC) is providing $3,700,000 in urgent funding through the Epidemiology and Laboratory Capacity for Infectious Diseases (ELC) Cooperative Agreement to the Puerto Rico Department of Health (PRDOH) to combat the current outbreak of Zika virus.
Puerto Rico is experiencing an approximate doubling of confirmed Zika
Grantees awarded a grant, cooperative agreement, or contract from such funds with a value of $25,000 or more shall produce reports on a semi-annual basis with a reporting cycle of January 1-June 30 and July 1-December 31; and email such reports to the CDC Web site (template and point of contact to be provided after award) no later than 20 calendar days after the end of each reporting period (
Effective date is April 12, 2016.
Alvin Shultz, MSPH, Division of Preparedness and Emerging Infectious, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, 1600 Clifton Road NE., Atlanta, GA 30333, Phone: 404-639-7028, E-Mail:
Alvin Shultz, MSPH, Division of Preparedness and Emerging Infectious, National Center for Emerging and Zoonotic Infectious, Diseases Centers for Disease Control and Prevention, 1600 Clifton Road NE., Atlanta, GA 30333. Phone: 404-639-7028. E-Mail:
The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies.
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to
NCHS Vital Statistics Training Application (OMB Control No. 0920-0217, exp. 5/31/2016)—Revision—National Center for Health Statistics NCHS), Centers for Disease Control and Prevention (CDC).
In the United States, legal authority for the registration of vital events,
NCHS assists in achieving the comparability needed for combining data from all States into national statistics, by conducting a training program for State and local vital statistics staff to assist in developing expertise in all aspects of vital registration and vital statistics. The training offered under this program includes courses for registration staff, statisticians, and coding specialists, all designed to bring about a high degree of uniformity and quality in the data provided by the States. This training program is authorized by 42 U.S.C. 242b, section 304(a).
NCHS notifies State and local vital registration officials, as well as Canadian counterparts, about upcoming training. Individual candidates for training then submit an application form including name, address, occupation, and other relevant information.
In this revision, the application for the Vital Statistics Training is being updated to capture additional logistical information. The proposed changes include the addition of two questions (1) to identify the training personnel as either State or locally-based and (2) to
NCHS is requesting a three-year OMB clearance to collect the necessary information using these training application forms. The total estimated annualized burden hours are 30. There is no cost to respondents other than their time.
Notice.
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the
Comments on the collection(s) of information must be received by the OMB desk officer by May 12, 2016.
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' Web site address at
2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to
3. Call the Reports Clearance Office at (410) 786-1326.
Reports Clearance Office at (410) 786-1326.
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the
1.
The State must conduct RetroDUR which provides for the ongoing periodic examination of claims data and other records in order to identify patterns of fraud, abuse, inappropriate or medically unnecessary care. Patterns or trends of drug therapy problems are identified and reviewed to determine the need for intervention activity with pharmacists and/or physicians. States may conduct interventions via telephone, correspondence, or face-to-face contact.
Annual reports are submitted to CMS for the purposes of monitoring compliance and evaluating the progress of States' DUR programs. The information submitted by States is
2.
The form provides specific data regarding claims and provides a mechanism for States to request Child Care grant awards and to certify the availability of State matching funds. Failure to collect this data would seriously compromise ACF's ability to monitor Child Care and Development Fund expenditures. This information is also used to estimate outlays and may be used to prepare ACF budget submissions to Congress.
ACF has not made substantive revisions to the reporting form itself, but has revised the accompanying instructions to provide more detailed guidance to assist grantees with completing the form.
In compliance with the requirements of Section 506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. 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, 370 L'Enfant Promenade SW., Washington, DC 20447, Attn: ACF 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.
There is little consensus on how HMRE programs should address IPV or TDV in their programs. To date, no IPV or TDV screening tools have been empirically tested among HMRE program participants. The objective of the proposed data collection is to test and validate IPV and TDV screening instruments among HMRE program participants. Findings from this data collection will be used to develop practical, responsive guidance on IPV and TDV screening and surrounding protocols for HMRE programs.
Data collection will entail testing eight screening instruments: Six closed-ended screening instruments (three for IPV, three for TDV), and two open-ended instruments (one for IPV, one for TDV). It is anticipated that each participant will engage in four rounds of data collection, one round for each IPV or TDV instrument, at least two weeks apart. Data collection is expected to occur from Winter 2016/2017 through Spring 2017.
In compliance with the requirements of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. 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.
Administration for Children and Families, Department of Health and Human Services.
Comment request; correction.
The Administration for Children and Families published a document in the
Paula Bendl Smith, 202-401-5616.
(1) In the
(2) In the
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) has determined the regulatory review period for ADEMPAS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Anyone with knowledge that any of the dates as published (in the
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, 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
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human drug product ADEMPAS (riociguat). ADEMPAS is indicated for treatment of adults with persistent/recurrent Chronic Thromboembolic
FDA has determined that the applicable regulatory review period for ADEMPAS is 2,394 days. Of this time, 2,151 days occurred during the testing phase of the regulatory review period, while 243 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,317 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and ask for a redetermination (see
Submit petitions electronically to
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 May 12, 2016.
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
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
We conduct research and educational and public information programs relating to food safety and nutrition issued in our broad statutory authority, set forth in section 1003(b)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 393(b)(2)), to protect the public health by ensuring that foods are “safe, wholesome, sanitary, and properly labeled,” and in section 1003(d)(2)(C) of the FD&C Act (21 U.S.C. 393(d)(2)(C)), to conduct research relating to foods, drugs, cosmetics, devices and tobacco products.
Our current food safety education and outreach programs and materials generally are developed and provided for the English-speaking population in the United States (U.S.) (Ref. 1). To better protect public health and to help consumers practice safe food handling, we need empirical data on how different population groups understand, perceive and practice food safety and food handling. An emerging and important demographic trend in the United States is the increase in Hispanics. Recent estimates suggest that Hispanics (defined as those who identify themselves as of Hispanic or Latino origin) are the largest and fastest growing minority group in the nation; the proportion of the U.S. population that was Hispanic was 14 percent in 2005 and is projected to increase to 29 percent in 2050 (Ref. 2).
Data from the Centers for Disease Control and Prevention (CDC) indicate that, in the past two decades, Hispanics were one of the population groups that often experienced higher incidence rates (per 100,000 population) of bacterial causes of foodborne illness than Caucasians (Ref. 3). These bacterial causes include
FDA needs an understanding of how different population groups perceive and behave in terms of food safety and food handling to inform development of possible measures that we may take to better protect public health and to help consumers practice safe food handling. FDA is aware of no consumer research on a nationwide level on how different population groups understand, perceive and practice food safety and food handling. This study is intended to provide initial answers to research questions such as whether and how much Spanish-dominant Hispanics, English-dominant Hispanics, and English-speaking non-Hispanics differ in their knowledge, attitude, and behavior toward food safety and food handling and the role that demographic and other factors may play in any differences.
The proposed study will use a Web-based instrument to collect information from 3,000 adult members in online consumer panels maintained by a contractor. The study plans to randomly select 1,000 panel members in each of three groups: Spanish-dominant Hispanics, English-dominant Hispanics, and English-speaking non-Hispanics. Both English and Spanish questionnaires will be used, as appropriate. The study plans to include topics such as: (1) Food safety knowledge and attitude; and (2) food handling and consumption practice. To help us understand the data, the study will also collect information on respondents' background, including, but not limited to, health status and demographic characteristics, such as age, gender, education, and income, and degree of acculturation among Hispanic respondents using a measure developed by Marin et al. (Ref. 6).
The study is part of our continuing effort to protect the public health. We will not use the results of the study to develop population estimates. We plan to use the results of the study to develop follow-up quantitative and qualitative research to gauge the prevalence and extent of differences in food safety knowledge and behaviors between the three mentioned population groups. We plan to use the results of the follow-up research to help inform the design of effective education and outreach initiatives aimed at helping reduce the risk of foodborne illness for the general U.S. population as well as Hispanics.
In the
FDA estimates the burden of this collection of information as follows:
We base our estimates on prior experience with research that is similar to this proposed study. We will use a cognitive interview screener with 72 individuals to recruit prospective interview participants. We estimate that it will take a screener respondent approximately 5 minutes (0.083 hours) to complete the cognitive interview screener, for a total of 5.976 hours, rounded to 6 hours. We will conduct cognitive interviews with nine participants. We estimate that it will take a participant approximately 90 minutes to complete the interview, for a total of 13.5 hours, rounded to 14 hours. We also plan to conduct a pretest to identify and resolve potential survey administration problems. We will send a pretest invitation to 1,440 prospective pretest participants and estimate that it will take a respondent approximately 2 minutes (0.033 hours) to complete the invitation, for a total of 47.52 hours, rounded to 48 hours. We will administer the pretest with 180 participants and estimate that it will take a participant 15 minutes (0.25 hours) to complete the pretest, for a total of 45 hours. We will send a study invitation to 24,000 prospective participants and estimate that it will take a respondent approximately 2 minutes (0.033 hours) to complete the invitation, for a total of 792 hours. We will administer the study with 3,000 participants and estimate that it will take a participant 15 minutes (0.25 hours) to complete the study, for a total of 750 hours. The total estimated burden for all the study activities is 1,655 hours; this estimate is 9 hours higher than that shown in the 60-day notice due to revised hours for cognitive interviews, from 30 minutes (0.5 hours) to 90 minutes (1.5 hours) each interview.
1. U.S. Food and Drug Administration. “Foodborne Illness & Contaminants.” June 9, 2014. (
2. Passel, J.S. and C. D'Vera. “U.S. Population Projections: 2005-2050.” Pew
3. Quinlan, J.J. “Foodborne Illness Incidence Rates and Food Safety Risks for Populations of Low Socioeconomic Status and Minority Race/Ethnicity: A Review of the Literature.”
4. Taylor, P., M.H. Lopez, J. Martínez and G.Velasco. “Language Use Among Latinos.” Pew Research Center. April 4, 2012. (
5. Henley, S.C., S.E. Stein and J.J. Quinlan. “Identification of Unique Food Handling Practices That Could Represent Food Safety Risks for Minority Consumers.”
6. Marin, G., F. Sabogal, B.V. Marin,
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) is withdrawing approval of a new drug application (NDA) for LUVERIS (lutropin alpha for injection) held by EMD Serono, One Technology Place, Rockland, MA 02370. EMD Serono has voluntarily requested that approval of this application be withdrawn, thereby waiving its opportunity for a hearing.
Effective April 12, 2016.
Emily Helms Williams, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6280, Silver Spring, MD 20993-0002, 301-796-3381.
FDA approved LUVERIS (lutropin alpha for injection) on October 8, 2004, under the Agency's accelerated approval regulations, 21 CFR part 314, subpart H. LUVERIS is indicated for concomitant administration with GONAL-F (follitropin alfa for injection) for stimulation of follicular development in infertile hypogonadotropic hypogonadal women with profound luteinizing hormone deficiency. In a letter dated April 30, 2012, EMD Serono requested that FDA withdraw approval of NDA 021322 for LUVERIS under § 314.150(c). In that letter, EMD Serono noted that, as had been previously discussed with the Agency, it was not feasible to complete a trial that the company had agreed to at the time of approval under subpart H. By letter dated December 8, 2014, FDA notified EMD Serono that, when studies that are required as a condition of approval under the Agency's accelerated approval regulations are not completed, the approval of an application is withdrawn according to the procedures set forth in §§ 314.530 and 314.150(d) rather than under § 314.150(c). FDA requested that EMD Serono submit a new withdrawal request under § 314.150(d).
Following additional correspondence, by letter dated July 23, 2015, EMD Serono requested that FDA withdraw approval of NDA 021322 for LUVERIS under § 314.150(d) because a postmarketing study that was required as a condition of approval under subpart H was not completed. Because that study was required to verify and describe the clinical benefit of the drug product, the clinical benefit of LUVERIS has not been confirmed, and it has not been established to be safe and effective. In its July 23, 2015, letter, EMD Serono waived any opportunity for a hearing otherwise provided under §§ 314.150 and 314.530. FDA responded by letter dated September 2, 2015, acknowledging EMD Serono's request that FDA withdraw approval of LUVERIS under § 314.150(d). FDA also acknowledged that EMD Serono waived its opportunity for a hearing.
Therefore, under section 505(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(e)) and § 314.150(d), and under authority delegated by the Commissioner to the Director, Center for Drug Evaluation and Research, approval of NDA 021322, and all amendments and supplements thereto, is withdrawn (see DATES). Distribution of this product in interstate commerce without an approved application is illegal and subject to regulatory action (see sections 505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and 331(d)).
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 May 12, 2016.
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
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
FDA's investigational device regulations are intended to encourage the development of new, useful devices in a manner that is consistent with public health, safety, and compliant with ethical standards. Investigators should have freedom to pursue the least burdensome means of accomplishing this goal. However, to ensure that the balance is maintained between product
Under FDA regulations, clinical investigations using human specimens conducted in support of premarket submissions to FDA are considered human subject investigations (see 21 CFR 812.3(p)). Many investigational device studies are exempt from most provisions of part 812, Investigational Device Exemptions, under 21 CFR 812.2(c)(3), but FDA's regulations for the protection of human subjects (21 CFR parts 50 and 56) apply to all clinical investigations that are regulated by FDA (see 21 CFR 50.1, 21 CFR 56.101, 21 U.S.C. 360j(g)(3)(A), and 21 U.S.C. 360j(g)(3)(D)).
FDA regulations do not contain exceptions from the requirements of informed consent on the grounds that the specimens are not identifiable or that they are remnants of human specimens collected for routine clinical care or analysis that would otherwise have been discarded. Nor do FDA regulations allow IRBs to decide whether or not to waive informed consent for research involving leftover or unidentifiable specimens.
In a level 1 guidance document, entitled “Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable,” issued under the Good Guidances Practices regulation, 21 CFR 10.115, FDA outlines the circumstances in which it intends to exercise enforcement discretion as to the informed consent regulations for clinical investigators, sponsors, and IRBs.
The recommendations of the guidance impose a minimal burden on industry. FDA estimates that 700 studies will be affected annually. Each study will result in one annual record, estimated to take 4 hours to complete. This results in a total recordkeeping burden of 2,800 hours (700 × 4 = 2,800).
In the
FDA estimates the burden of this collection of information as follows:
Food and Drug Administration, HHS.
Notice of opportunity for hearing.
The Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), is proposing to withdraw approval of all new animal drug applications (NADAs) providing for use of carbadox in medicated swine feed. This action is based on CVM's determination that the use of carbadox under the approved conditions of use results in residues of carcinogenic concern in the edible tissues of the treated swine.
Phibro Animal Health Corp. may submit a request for a hearing by May 12, 2016. Submit all data and analysis upon which the request for a hearing relies by July 11, 2016.
The request for a hearing may be submitted by Phibro Animal Health Corp. by either of the following methods:
•
•
Because your request for a hearing will be made public, you are solely responsible for ensuring that your request does not include any confidential information that you may not wish to be publicly posted, such as confidential business information,
Phibro Animal Health Corp. may submit all data and analysis upon which the request for a hearing relies in the same manner as the request for a hearing except as follows:
• Confidential Submissions—To submit any data and analyses with confidential information that you do not wish to be made publicly available, submit your data and analyses only as a written/paper submission. You should submit two copies total of all data and analysis. 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 any decisions on this matter. The second copy, which will have the claimed confidential
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 Division of Dockets Management, 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
Vernon Toelle, Center for Veterinary Medicine (HFV-230), 7519 Standish Pl., Rockville, MD 20855, 240-276-9200.
Carbadox, a quinoxaline derivative, is a synthetic organic acid antimicrobial. Currently, there are three approved NADAs for use of carbadox in medicated swine feed, either by itself or in combination with other approved new animal drugs. Phibro Animal Health Corp. (Phibro), 65 Challenger Rd., Ridgefield Park, NJ 07660, is currently the sponsor of all three approved NADAs.
Carbadox is marketed as a Type A medicated article used to manufacture complete Type C medicated feeds that are administered ad libitum to swine. Carbadox is indicated for the control of dysentery and bacterial enteritis, and for growth promotion. A tolerance of 30 parts per billion (ppb)
The following three NADAs are approved for the use of carbadox:
NADA 041-061, originally approved in 1972 (37 FR 20683, October 3, 1972), provides for the use of MECADOX 10 (carbadox) Type A medicated article to manufacture single-ingredient Type C medicated swine feeds for the following conditions of use:
• Carbadox at 10 to 25 grams per ton (g/ton) of feed for increased rate of weight gain and improved feed efficiency; and
• Carbadox at 50 g/ton of feed for control of swine dysentery (vibrionic dysentery, bloody scours, or hemorrhagic dysentery); for control of bacterial swine enteritis (salmonellosis or necrotic enteritis caused by
Currently, the withdrawal period for these uses of carbadox is 42 days (§ 558.115(d)(1)(ii) and (d)(2)(ii) (21 CFR 558.115(d)(1)(ii) and (d)(2)(ii))).
NADA 092-955, originally approved in 1975 (40 FR 45164, October 1, 1975), provides for the use of MECADOX 10 (carbadox) Type A medicated article with BANMINTH (pyrantel tartrate) Type A medicated article to manufacture two-way, combination drug Type C medicated swine feeds for the following conditions of use:
• Carbadox at 50 g/ton of feed plus pyrantel tartrate at 96 g/ton of feed for control of swine dysentery (vibrionic dysentery, bloody scours, or hemorrhagic dysentery); for control of bacterial swine enteritis (salmonellosis or necrotic enteritis caused by
The withdrawal period for the use of this drug combination is 70 days (§ 558.115(d)(3)(ii)).
NADA 141-211, originally approved in 2004 (69 FR 51173, August 18, 2004), provides for the use of MECADOX 10 (carbadox) Type A medicated article with TERRAMYCIN 50, TERRAMYCIN 100, or TERRAMYCIN 200 (oxytetracycline) Type A medicated articles to manufacture two-way, combination drug Type C medicated swine feeds for the following conditions of use:
• Carbadox at 10 to 25 g/ton of feed plus oxytetracycline at levels in feed to deliver 10 mg carbadox per pound of body weight for treatment of bacterial enteritis caused by
The withdrawal period for the use of this animal drug combination is 42 days (§ 558.115(d)(4)(ii)).
CVM is providing notice of an opportunity for a hearing (NOOH) on a proposal to withdraw approval of the NADAs providing for use of carbadox in medicated swine feeds. New evidence regarding carcinogenic residues in edible tissues of swine treated with carbadox raises serious questions about the human food safety of the drug. Grounds for withdrawing carbadox are twofold. First, new evidence demonstrates that the Delaney Clause in section 512(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360b), which requires that no residue of a carcinogenic drug can be found in any edible portion of the animal after slaughter, applies because the Diethylstilbestrol (DES) Proviso exception is no longer met (see, Section III.C). Second, new evidence demonstrates that carbadox is not shown to be safe under the General Safety Clause (section 512(e)(1)(B) of the FD&C Act).
During the review of a supplemental application to NADA 041-061 approved in January 1998, CVM made the following conclusions about the drug: (1) The parent compound carbadox is rapidly metabolized and carcinogenic residues of the drug are not identifiable in any edible tissues beyond 72 hours post dosing; (2) remaining unextracted residues of carbadox are noncarcinogenic residues related to the noncarcinogenic metabolite QCA; and (3) QCA is a reliable marker residue for carbadox and its metabolites (Ref. 1).
Since the evaluation of information submitted by the sponsor in that supplemental application, CVM has become aware of new information that calls into question the basis for its previous conclusions. As described more fully in Section V., this includes new residue depletion data presented to the Joint FAO/WHO Expert Committee on Food Additives (JECFA)
Continued approval of carbadox would expose humans to concentrations of total residues of carcinogenic concern that are approximately 30 times higher (for the approved 42-day withdrawal period) or 11 times higher (for the approved 70-day withdrawal period) than the 0.915 ppb concentration of total residues of carcinogenic concern in liver that would be considered safe (Ref. 3 at p. 17, Table 8). Moreover, the sponsor has not identified an appropriate marker and analytical method to assure that residues of carcinogenic concern are below the level at which the residues present in the total human diet present no significant increase in the risk of cancer to people (the S
In addition to the new information presented to JECFA (Ref. 2), publications by Boison, et al., in 2009 (Ref. 4) and Baars, et al., in 1990 (Ref. 5) that were recently provided to CVM by the sponsor call into question the previous conclusion that QCA is an appropriate marker and that all residues of carcinogenic concern deplete within 72 hours after dosing.
The new evidence from the 2003 JECFA report (Ref. 2) in conjunction with the publications by Boison, et al., in 2009 (Ref. 4) and Baars, et al., in 1991 (Ref. 6), erode the scientific justification for, and validity of, conclusions previously made about the drug in 1998. Based on this new information, evaluated together with the information available at the time of the approvals, CVM has determined that the drug is not shown to be safe under the General Safety Clause and that the Delaney Clause applies to the drug, because the DES Proviso exception is no longer met. Therefore, CVM proposes to withdraw approval of all NADAs for new animal drugs containing carbadox.
Carbadox, for each of its uses in swine, is a new animal drug as defined in section 201(v) of the FD&C Act (21 U.S.C. 321(v)). As such, under sections 301, 501, 512, 571, and 572 of the FD&C Act (21 U.S.C. 331, 351, 360b, 360ccc, 360ccc-1), the drug cannot be legally introduced or delivered for introduction into interstate commerce in the absence of an NADA approval, a conditional approval, or an animal drug indexing. The requirements for approval of an NADA are set out in section 512(d)(2)(A) of the FD&C Act. Section 512(b)(1)(A) of the FD&C Act requires that a new animal drug must be shown to be safe and effective for its intended uses. Section 201(u) of the FD&C Act provides that “safe” as used in section 512 of the FD&C Act “has reference to the health of man or animal.” The determination of safety requires CVM to consider, among other relevant factors, “the probable consumption of such drug and any substance formed in or on food because of the use of such drug . . .” (section 512(d)(2)(A) of the FD&C Act). Accordingly, CVM must consider not only safety of the new animal drug to the target animal, but also the safety to humans of substances formed in or on food as a result of the use of the new animal drug.
“Safe,” in the context of human food safety, means a “reasonable certainty of no harm.” The definition is derived from language in H. Rep. No. 85-2284, at 4-5 (1958), defining the term “safe” as it appears in section 409 of the FD&C Act, which governs food additives (21 U.S.C. 348). Until passage of the Animal Drug Amendments of 1968 (Pub. L. 90-399) (the 1968 amendments), substances formed in or on food due to the use of animal drugs in food-producing animals were regulated under the food additive provisions in section 409 of the FD&C Act. The 1968 amendments consolidated all of the existing statutory authorities related to animal drugs into section 512 of the FD&C Act, and the legislative history shows that the consolidation in no way changed the authorities with respect to the regulation of new animal drugs (S. Rep. No. 90-1308, at 1 (1968)). During the new animal drug application review process, CVM has consistently applied the “reasonable certainty of no harm” standard in determining the safety of substances formed in or on food as a result of the use of a new animal drug in a food-producing animal.
In order to determine whether a new animal drug meets this standard, section 512(b)(1)(G)-(H) of the FD&C Act requires that whenever a drug may result in residues of the drug or its metabolites in food, an application must include not only full reports of investigations to show that the use of the drug is safe, but also a description of practicable methods for monitoring food to assure that there are no unsafe residues in human food attributable to the drug use, and a demonstration that the conditions of use are adequate to assure there are no unsafe residues.
In sum, under section 512(d)(2) of the FD&C Act, the Agency is required, in the evaluation of the supporting safety data, among other things, to consider:
• The probable consumption of such drug and of any substance formed in or on food because of the use of such drug (
• The cumulative effect on man or animal of such drug, taking into account any chemically or pharmacologically related substance,
• Safety factors which, in the opinion of experts qualified by scientific training and experience to evaluate the safety of such drugs, are appropriate for the use of animal experimentation data (
When establishing the human food safety of a noncarcinogenic new animal drug used in food-producing animals, CVM establishes a no observed effect level (NOEL) for the residues of that drug in edible tissues—namely, the highest dose of the drug that does not produce the most sensitive treatment-related toxic endpoint in test animals (Ref. 7). From the NOEL, CVM uses safety factors to calculate an acceptable daily intake, and consumption factors to calculate the safe concentration of residues in a particular edible tissue (Ref. 7 at p. 15; section 512(b)(1)(H) of the FD&C Act).
Carbadox is both a genotoxic
Section 512(e)(1)(B) of the FD&C Act provides grounds for withdrawal of approval of an NADA if new evidence not contained in an approved application or not available to the Secretary of Health and Human Services until after such application was approved, or tests by new methods, or tests by methods not deemed reasonably applicable when such application was approved, evaluated together with the evidence available to the Secretary when the application was approved, shows that such drug is not shown to be safe for use under the conditions of use upon the basis of which the application was approved or that subparagraph (I) of paragraph (1) of subsection (d) applies to such drug. The Secretary of Health and Human Services has delegated this authority to the Commissioner of Food and Drugs. See FDA Staff Manual Guide 1410.10 (April 11, 2014).
In other words, grounds for withdrawal exist where new evidence shows either that the Delaney Clause applies to the drug (“subparagraph (I) of paragraph (1) of subsection (d)”) or that the drug is not shown to be safe under the approved conditions of use (the General Safety Clause). As explained further, new evidence demonstrates that carbadox meets both grounds for withdrawal.
In a proceeding to withdraw the approval of an NADA, the sponsor has the burden of proof to demonstrate that the product is safe and therefore that the NADA approval should remain in effect (21 CFR 12.87(d): (“At a hearing involving issuing, amending, or revoking a regulation or order relating to the safety or effectiveness of a drug . . . the participant who is contending that the product is safe or effective or both and who is . . . contesting withdrawal of approval has the burden of proof in establishing safety or effectiveness or both and thus the right to approval.”); (
In the Hess & Clark case we held that the “new evidence” requirement of the safety clause “plainly places on the [CVM] an initial burden to adduce the ‘new evidence’ and what that evidence ‘shows’. Only when the [CVM] has met this initial burden of coming forward with the new evidence is there a burden on the manufacturer to show that the drug is safe.”
To meet its initial burden of proof to withdraw approval of a new animal drug that is “not shown to be safe,” CVM must provide “a reasonable basis from which serious questions about the ultimate safety of [the drug] and the residues that may result from its use may be inferred.”
Section 512(e)(1)(B) of the FD&C Act provides grounds for withdrawal of approval of an NADA if new evidence, tests by new methods, or tests by methods not deemed reasonably applicable when such application was approved, evaluated together with the evidence available when the application was approved shows that the Delaney Clause, section 512(d)(1)(I) of the FD&C Act, applies to the drug. Under the Delaney Clause, the Secretary may not approve a new animal drug application if “such drug induces cancer when ingested by man or animal or, after tests which are appropriate for the evaluation of the safety of such drug, induces cancer in man or animal” (section 512 (d)(1)(I) of the FD&C Act). An exception to this general rule, referred to as the DES Proviso, allows for the approval of a carcinogenic new animal drug where FDA finds that, under the approved conditions of use: (1) The drug will not adversely affect the animals treated with the drug and (2) no residues of the drug will be found by an approved regulatory method in any edible tissues of or in any foods yielded by the animal (section 512(d)(1)(I)(i)-(ii) of the FD&C Act).
FDA has issued implementing regulations that set the requirements for demonstrating that no residues of the drug will be found by an approved regulatory method in any edible tissues of or in any foods yielded from the animal (21 CFR part 500, subpart E). These regulations, referred to as the sensitivity of the method regulations (SOM regulations), describe how FDA determines whether the regulatory method proposed by a sponsor to detect no residues of the carcinogenic drug is sufficiently sensitive to ensure that residues of carcinogenic concern in edible tissues will not exceed concentrations that represent no significant increase in the risk of cancer to humans.
Pursuant to these regulations, CVM determines for each drug and each drug metabolite (on the basis of the results of chronic bioassays and other information) whether the drug or any of its metabolites should be regulated as a carcinogen (§ 500.84(a)). For the drug and each metabolite determined to be carcinogenic, CVM calculates, based upon submitted assays, the concentration of the test compound in the total diet of the test animal that corresponds to a maximum lifetime risk of cancer in the test animal of 1 in 1 million (§ 500.84(c)(1)). CVM designates the lowest value thus calculated as the S
Because the total diet is not derived only from food-producing animals, the SOM regulations make adjustments for human food intake of edible tissues, and determine the concentration of residues of carcinogenic concern in a specific edible tissue that corresponds to no significant increase in the risk of cancer to the human consumer. CVM assumes for purposes of these regulations that this value will correspond to the concentration of residues in a specific edible tissue that corresponds to a maximum lifetime risk of cancer in test animals of 1 in 1 million. This value is termed the S
Based upon residue depletion data submitted by a sponsor, CVM selects a target tissue (the edible tissue selected to monitor for residues in the target animals) and a marker residue (a residue whose concentration is in a known relationship to the concentration of the residues of carcinogenic concern in the last tissue to deplete to the S
A sponsor must submit a regulatory method that is able to detect the marker residue at or below the R
As stated above, pursuant to section 512(e)(1)(B) of the FD&C Act, the Secretary shall, after due notice and an opportunity for a hearing, withdraw approval of an NADA if the Secretary finds that new evidence, tests by new methods, or tests by methods not deemed reasonably applicable when such application was approved, evaluated together with the evidence available when the application was approved shows that the Delaney Clause applies to the drug. Evidence that the Delaney Clause applies to a drug exists where the drug has previously been determined to be a carcinogen and the new evidence shows CVM's prior establishment of an analytical method and residue tolerance under the DES proviso exception to the Delaney Clause is inadequate. An analytical method is inadequate where new evidence demonstrates that the method does not accurately detect the marker residue or where new evidence demonstrates that not all residues of carcinogenic concern have depleted at the approved tolerance level of the marker residue (
In establishing that grounds for withdrawal of approval exist under this clause, CVM carries an initial burden to demonstrate that the new animal drug and/or any of its metabolites induces cancer when ingested by man or animals.
In this case, CVM had previously determined, in the approval and supplemental approvals of new animal drugs containing carbadox, that carbadox and its metabolites, including DCBX, induce cancer in animals, but that the drug could be approved under the DES Proviso exception to the Delaney Clause.
In the case of an approved NADA for a carcinogenic compound, if FDA determines based on new information that the approved analytical method for detecting residues is inadequate . . . FDA could withdraw the approval on the basis of the Delaney Clause. Faced with evidence that an approved method was inadequate, FDA could not make a finding that “no residue” of the sponsored compound would be found in the edible products of treated animals. The DES Proviso cannot begin to operate without that finding, and, accordingly, the Delaney Clause would preclude continued approval.
In this case, new evidence raises serious questions both about the acceptability of the current method in determining levels of known carcinogenic residues of carbadox, and, further, demonstrates that previously unidentified carcinogenic metabolites exist that are entirely unaccounted for in current approved testing methodology. Because the current analytic method is inadequate to identify the level of known carcinogens and does not identify the residue level of unidentified metabolites of carcinogenic concern, the current method and tolerance are inadequate to satisfy the DES Proviso.
The General Safety Clause in section 512(e) of the FD&C Act provides grounds for withdrawal of approval of an NADA if new evidence, tests by new methods, or tests by methods not deemed reasonably applicable when such application was approved, evaluated together with the evidence available when the application was approved shows that the drug is “not shown to be safe for use under the conditions of use upon the basis of which the application was approved” (section 512(e)(1)(B) of the FD&C Act). CVM has the initial burden to present new evidence that raises serious questions about the safety of the drug. Only upon that showing is there a burden on the manufacturer to demonstrate that the drug is safe.
When evaluating a drug for withdrawal under the General Safety Clause, for CVM to satisfy its initial burden that new evidence raises serious human food safety questions, it must demonstrate a relationship between the drug residues found in edible tissues and risk to human health.
[Without using] the Delaney Clause, it is not enough for the Commissioner merely to show that animal carcasses contain residues and that [the drug] is a carcinogen. Instead, the FDA must show that two different issues are resolved in its favor before it can shift to petitioners the burden of showing safety: (1) whether the detected residues are related to the use of [the drug]; (2) if so, whether the residues, because of their composition, and in the amounts present in the tissue, present some potential hazard to the public health.
Applying this test, the D.C. Circuit Court of Appeals has held that new evidence of drug residues in edible tissues in conjunction with evidence that any drug residues of the drug in question present safety concerns is sufficient to satisfy CVM's burden of raising serious questions regarding the safety of the drug.
Applying the
Carbadox is a carcinogen and was approved as a new animal drug pursuant to the DES Proviso exception to the Delaney Clause. At the time of the initial approval of carbadox in 1972, CVM (then the Bureau of Veterinary Medicine) recognized that carbadox is a carcinogen and therefore required that no residues of carbadox or its metabolite QCA be found in uncooked edible tissues of swine at the time of slaughter, as determined by the approved method of analysis.
In this initial approval, based upon the submission of studies showing the depletion of carbadox residues in edible tissues, CVM determined that “[a]ll tissues except the liver [were] free of all residues” of unchanged carbadox at 24 hours after withdrawal of treatment and that unchanged carbadox “ha[d] disappeared from the liver after 24 hours” (Ref. 8). CVM also determined from submitted studies that the carcinogenic parent drug was undetectable in liver at 24 hours (Id.). CVM further determined that a “restriction of use in the labeling provides a withdrawal period long enough [70 days] to assure no hazard to humans consuming residues in meat. In proper use there would be virtually no residues” of carbadox in tissues at slaughter (Ref. 9). The conclusions CVM made in 1972 regarding the rapid depletion of carcinogenic residues were later independently corroborated by a 1990 evaluation of carbadox by JECFA (Ref. 10 at p. 30).
Labeled use restrictions, as the drug was approved in 1972, included an upper weight limit of 75 pounds body weight and a prohibition on mixing into complete feeds containing less than 15 percent crude protein, thus limiting the drug's use to young pigs. These use restrictions provided assurances that the 70-day withdrawal period would likely be followed in practice (Ref. 11).
Similarly in 1975, FDA approved NADA 092-955 for the use of carbadox with pyrantel tartrate in Type C medicated swine feed (40 FR 45164, October 1, 1975). At that time, CVM reviewed drug residue studies of carbadox and pyrantel tartrate used in combination. The studies showed that, at 45 and 60 days withdrawal, concentrations of residues of carbadox in all tissues tested were undetectable using the previously approved analytical method with a 30 ppb limit of detection (Ref. 12 at p. 2).
On May 9, 1986, the Center for Science in the Public Interest submitted a citizen petition requesting that FDA withdraw approval of new animal drug applications for ipronidazole, dimetridazole, and carbadox (Ref. 13). The petition asserted that FDA must withdraw the approval of carbadox because carbadox and its metabolites DCBX and hydrazine were found to be carcinogenic, and the approved test method for carbadox residues is “unsuitable” (Ref. 13 at p. 20). The asserted unsuitability of the approved test method was based upon the fact that only a small portion of total residues had been positively identified and that the analytical method for carbadox residues was not sensitive enough to ensure that all residues had depleted.
FDA responded to the 1986 citizen petition in 1995 after a review of new residue depletion data submitted by (the then sponsor) Pfizer as well as data previously submitted to the Agency as part of the carbadox NADAs. Based upon this review, FDA denied the petition as it related to carbadox because it determined that “if used according to label directions, residues of carbadox remaining in edible tissues of swine do not pose a human food safety risk to consumers” (Ref. 14 at p. 2). FDA based this safety determination on the following findings:
1. At 70 days withdrawal, the drug-related residue in swine liver measured 13 ppb. 2. Ten percent of the drug-related residue was extractable and identified to be a noncarcinogenic metabolite, quinoxaline-2-carboxylic acid. 3. The remaining 90% of the drug-related residue was unextractable or bound residues. 4. The bound residues were related to quinoxaline-2-carbodoxaldehyde and quinoxaline-2-carboxylic acid, both of which are of no carcinogenic concern. (Ref. 14 at p. 1).
In 1998, FDA approved two supplemental applications to NADA 041-061. The first supplement, approved in January 1998, assigned the noncarcinogenic metabolite QCA as the marker residue and set a tolerance of 30 ppb QCA in swine liver (Ref. 1).
Toxicology studies, including carcinogenicity bioassays with carbadox, DCBX (a primary metabolite of carbadox), and hydrazine were submitted as part of that supplemental application (Ref. 1 at pp. 1-5). The studies demonstrated the carcinogenicity of carbadox, DCBX, and hydrazine, and indicated that DCBX was the most potent of the three carcinogenic compounds (id.). Consequently, based on DCBX, CVM calculated an S
The SOM regulations, as they existed in 1998, directed CVM to establish an R
At the time it approved the supplement in January 1998, CVM said:
The sponsor and academic researchers have conducted numerous studies evaluating the fate of carbadox in animals. These residue depletion data are summarized in FAO Food and Nutrition Paper 41/3 (Food and Agriculture Organization (FAO) of the United Nations, 1991) and show that carbadox, desoxycarbadox and hydrazine do not persist in edible tissue as detectable residues beyond 72 hours. The agency's evaluation of these data, and the new information provided by the sponsor, demonstrate that following administration, parent carbadox is rapidly metabolized; that the metabolism of carbadox is similar among species; that the
CVM established a tolerance of 30 ppb for residues of QCA in liver, the tissue in which residues persist for the longest time. CVM concluded that the concentration of residues of carcinogenic concern in edible tissues was below the S
Under FDA's operational definition of “no residue,” a residue of carcinogenic concern, so long as it does not exceed the S
From these data, FDA has selected liver as the target tissue and quinoxaline-2-carboxylic acid (QCA) as the marker residue. FDA has determined that when QCA, the marker, is at or below 30 ppb in the target tissue, liver, that no residue of carcinogenic concern, above the S
The sponsor has submitted a regulatory method capable of measuring QCA at and below 30 ppb in the target tissue. (Ref. 1 at p. 14).
As part of their application supporting the January 1998 supplemental approval, the sponsor submitted a regulatory method for residues of QCA in swine liver. The regulatory method relies on a gas chromatograph assay with electron capture detection and has a limit of quantification of 5 ppb (Ref. 1 at p. 13), a 6-fold improvement of the sensitivity from the previously approved regulatory method (Ref 1.)
In October 1998, FDA approved an additional supplement to NADA 041-061 changing the withdrawal period for carbadox medicated feeds from 70 days to 42 days. The supplement was approved based upon the previous approval of a tolerance of 30 ppb for QCA and a residue depletion study that showed that residues of QCA in liver depleted below 30 ppb by 42 days (Ref. 16).
To summarize, in 1998, when FDA approved supplements to NADA 041-061 establishing a drug tolerance and shortening the withdrawal period, the evidence before CVM indicated:
• A 0.915 ppb concentration of total residues of carcinogenic concern in liver is the concentration that represents no significant increase in the risk of cancer to people—total residues of carcinogenic concern in liver above 0.915 ppb under the drug's approved conditions of use are unsafe. Such residues would preclude continued approval because the drug would not be shown to be safe and because the exception to the Delaney Clause would not apply (Ref. 1 at pp. 8-9, 10, 14).
• The parent compound carbadox is rapidly metabolized and carcinogenic residues of the drug are not identifiable in any edible tissues beyond 72 hours post dosing (Ref. 1 at p. 9).
• Remaining unextracted residues of carbadox are noncarcinogenic residues related to the noncarcinogenic metabolite QCA (Ref. 1 at pp. 9, 14).
• QCA is a reliable marker residue for carbadox and its metabolites; that is, measuring QCA residues in swine liver is a valid method for demonstrating the absence of residues of carcinogenic concern in edible tissues (id.).
Based upon these conclusions, CVM found that under the conditions of use the drug did not result in unsafe residues of carcinogenic concern in edible tissues and that the use of carbadox, as approved in the NADA supplements, satisfied the DES Proviso exception to the Delaney Clause prohibition on carcinogenic animal drugs (id.).
In 2004, FDA approved a combination drug medicated feed containing carbadox and oxytetracycline under NADA 141-211 (Ref. 17). In accordance with section 512(d)(4)(A) of the FD&C Act, approval of a combination new animal drug, where the underlying new animal drugs have previously been separately approved for particular uses and conditions of use for which they are intended for use in the combination, will not be refused on human food safety grounds unless the application fails to establish that: (1) None of the animal drugs used in combination, at the longest withdrawal period for any of the drugs in the combination, exceeds its established tolerance or (2) none of the drugs in the combination interferes with the method of analysis for any of the other drugs in the combination (section 512(d)(4)(A)(i)-(ii) of the FD&C Act). In other words, in order to approve a combination new animal drug for a drug product that contains two previously approved new animal drugs, no new information needs to be supplied to establish the safety of either drug. Instead, the application need only demonstrate that use of the drugs in combination will not result in violative
Both carbadox and oxytetracycline had been previously and separately approved by FDA for the same conditions of use proposed for their use in combination.
The sponsor further provided data demonstrating noninterference of oxytetracycline with the method of analysis of QCA in liver (id.). Having made the required human food safety demonstrations for combination animal drugs, there was no basis to refuse approval of the product on human food safety grounds. The combination new animal drug was subsequently approved (id.).
Three sources provide new information regarding carcinogenic residues in edible tissues: Data submitted to the 2003 JECFA and the subsequent JECFA report (Ref. 2) and two publications in the peer-reviewed literature (Refs. 4 and 6).
JECFA is an internationally recognized expert body, providing the scientific evaluations that become the basis for international food standards established by the Codex Alimentarius Commission and supporting international treaties such as the Sanitary Phytosanitary Agreement. JECFA experts are chosen based on expertise, reputation, assurance of lack of conflict of interest, and familiarity with the subject of that particular evaluation.
In addition, pursuant to section 512(
In 2003, at the request of the Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF), JECFA reevaluated the recommended Maximum Residue Limits (MRLs) for carbadox that were based upon a 1990 JECFA evaluation of the new animal drug (Ref. 2). CCRVDF, which includes CVM as a participant, determines priorities for the consideration of residues of veterinary drugs in foods and recommends MRLs for veterinary drugs to the Codex Alimentarius Commission of the Food and Agriculture Organization and the World Health Organization of the United Nations. The Codex Alimentarius Commission develops harmonized international food standards, guidelines, and codes of practice to protect the health of the consumers and ensure fair practices in food trade (see footnote 2).
Based on studies submitted to JECFA that showed the persistence of genotoxic, carcinogenic residues, JECFA could not determine an amount of residues of carbadox in human food that would have no adverse health effects in consumers. JECFA recommended that the Codex MRLs be withdrawn. CCRVDF concurred with JECFA's recommendation and proposed to the Commission that the MRLs be withdrawn. The Commission subsequently agreed and withdrew the Codex MRLs for carbadox (Ref. 18 at p. 120).
As part of the JECFA reevaluation process, Phibro presented two new residue studies to JECFA in 2003. Only one of these studies involved measurement of the depletion of carcinogenic metabolites of carbadox in edible tissues. In that study, animals were fed for 14 days at the approved dose of 55 ppm carbadox in feed (Ref. 2 at pp. 6-10). Animals were euthanized at various time points between 0 hours and 15 days post treatment, and samples of swine muscle, liver, skin, and fat were collected (Ref. 2 at pp. 7-8, Table 5).
Prior to analysis for residues, some of the tissue samples were exposed to human digestive enzymes
Residues of carbadox, DCBX, and QCA were measured by liquid chromatography-atmospheric pressure chemical ionization tandem mass spectrometry (LC/APCI-MS/MS). The tissue samples that were not incubated with enzymes were extracted with acetonitrile prior to analysis. The tissue samples that were incubated with enzymes were extracted with ethyl acetate prior to analysis. Supernatants of the enzyme digestion were analyzed directly without extraction. The limits of quantification for LC/APCI-MS/MS were 0.050 ppb for carbadox residues and 0.030 ppb for DCBX residues (id.). The detection capabilities of this methodology were greatly enhanced compared to the previous method for carbadox and DCBX (
The study presented to JECFA showed that residue concentrations of carbadox and DCBX were higher and persisted for a longer period post dosing in liver than in the other sampled tissues. In liver without treatment with simulated digestive fluids, carbadox was detectable (0.050 ppb) as long as 48 hours post dosing and DCBX was detectable (0.138 ppb) at the last sampling time point, which was 15 days post treatment (Ref. 2 at pp. 7-8, Table 5). Treatment of tissues with simulated digestive fluids resulted in measurement of significantly higher concentrations of DCBX. “Pretreatment of the samples with digestive fluids increased the amounts of carcinogenic residues found in all tissues. In liver the concentration of . . .[DCBX] increased by more than fourfold when the samples were treated with intestinal fluid, and large quantities were present 15 days after withdrawal . . .” (Ref. 2 at p. 17).
In particular, the study showed that concentrations of approximately 35 ppb of DCBX at 0 hours post dosing and approximately 2.7 ppb of DCBX at 15 days post dosing were measured in liver treated with pancreatin (Ref. 2 at p. 8, Table 5). The significantly increased residues found in liver after treatment with intestinal enzymes show that enzymatic treatment was able to release carcinogenic residues that were not extractable by organic solvents, such as those used in tissue residue studies to support the original and supplemental approval of NADAs for use of carbadox.
JECFA evaluated the percent recoveries of the analytes. Percent recovery is a measurement of accuracy of the analytical procedure and expresses the closeness of agreement between the true value of the analyte concentration and the mean value obtained by applying the analytical procedure (Ref. 21). JECFA reported that when carbadox, DCBX, and QCA were incubated for 4 hours with digestive enzymes, carbadox and DCBX were unstable (percent recovery decreased) in the samples treated with pepsin, but were stable in pancreatin (Ref. 2 at p. 16). JECFA also reported that the recoveries of the analytes from the liver samples were generally variable and decreased to low levels when digestive enzymes were used prior to extraction (Ref. 2 at pp. 17-18).
After evaluating the residue study, JECFA concluded that the poor recoveries obtained with the enzyme experiments “showed that the true concentrations of the carcinogenic metabolites in tissues cannot yet be estimated with certainty, since an unknown portion of the releasable residue [of carbadox and DCBX] is destroyed during incubation [of liver tissues] with the [digestive] enzymes” (Ref. 2 at p. 18). JECFA therefore concluded that the measured values of DCBX and carbadox “represent[ed] a lower estimate of the total present in the tissue” (id.).
Presented with data demonstrating both the depletion of QCA and depletion of the carcinogenic residue DCBX, JECFA established a relationship between the concentrations of QCA and DCBX in liver (Ref. 2 at p. 14). The statistical analysis of the data showed a linear relationship between the logarithms of the concentrations of QCA and DCBX (Ref. 2 at pp. 14, 18). This relationship allowed JECFA to use regression analysis to assess the concentrations of DCBX when QCA depleted to 30 ppb in liver (the Codex MRL and FDA approved tolerance for carbadox). JECFA determined that “[a]t the MRL [of 30 ppb] for QCA in liver, the average concentrations of the carcinogenic residue desoxy-carbadox in liver estimated by regression analysis were about 4 [ppb]” (Ref. 2 at pp. 14, 16-17). JECFA recognized that “tolerance limits for the concentration of desoxycarbadox were several times higher owing to the wide variation of the data” and thereby concluded that “QCA is not a suitable marker for monitoring carcinogenic metabolites of carbadox in liver . . . and QCA does not ensure the absence of carcinogenic residues” (Ref. 2 at p. 17).
In contrast to the previous findings of JECFA, these new data show that carcinogenic residues, in particular DCBX, are present in edible tissues for a significant time during the depletion of parent carbadox (Ref. 2 at p. 18). Moreover, the study shows that treatment with simulated digestive enzymes releases higher levels of the carcinogenic residues DCBX than were recovered using organic extractions in the study. These higher concentrations provide evidence that the carbadox residues that were not extractable or identified in previous studies submitted to the Agency could include carcinogenic residues of carbadox that are releasable with enzymatic treatment of tissues. This evidence calls into question the Agency's previous conclusions that all unextracted and unidentified residues were noncarcinogenic residues related to QCA.
After reviewing the new residue data, and considering the previously evaluated genotoxicity and carcinogenicity data, JECFA recommended withdrawal of the previously established Codex MRLs (Ref. 2 at p. 18). Codex subsequently agreed and withdrew the MRLs for carbadox (Ref. 18 at p. 120).
In summary, the studies considered by JECFA during its 2003 review of the drug indicated that:
• Residues of the carcinogenic metabolite of carbadox, DCBX, were measured in edible tissues for 15 days, which was the last sampling time point. DCBX was measured in swine liver after treatment with simulated digestive enzymes at concentrations as high as 2.69 ppb at 15 days post treatment (Ref. 2 at p. 8, Table 5).
• Analysis of measured concentrations of QCA and DCBX in liver indicated that approximately 4 ppb of DCBX would be present in the liver of treated animals when QCA reached the Codex MRL and the FDA tolerance of 30 ppb in liver (Ref. 2 at pp. 14, 17). This concentration of DCBX alone is more than 4 times higher than the concentration of total residues of carcinogenic concern in liver that would present no significant increase in the risk of cancer to people.
• Residues of carbadox previously unextracted from edible tissues could be released by gastric and intestinal fluids that mimic the human digestive process (Ref. 2 at p. 16). The enzymatic treatment used in the study significantly increased the recoveries of concentrations of DCBX and carbadox from edible tissues, thereby indicating that some portion of the previously unextracted and unidentified total residues is composed of carcinogenic compounds.
Following the reports of the 2003 JECFA reevaluation of carbadox, CVM requested that Phibro also provide the carcinogenic residue depletion study to CVM. In 2005, in response to CVM's request for information, Phibro submitted a summary of the carcinogenic residue depletion study previously provided to JECFA. Upon review of the summary data, CVM asked Phibro to submit existing studies or provide new and complete studies that address the relationship of QCA at 30 ppb and carbadox and DCBX residues, and about the use of QCA as the marker residue for surveillance purposes. In 2006, CVM asked for and received from Phibro a timeline for submission of complete information that addresses concerns about the relationship of QCA at 30 ppb and carbadox and DCBX residues, and about the use of QCA as the marker residue for surveillance purposes. Between 2006 and 2011, interactions between CVM and Phibro continued, with protocols submitted and reviewed, method validation reports submitted and reviewed, informal communications by email, and informal discussions by telephone. The focus of the interactions was development and validation of methods to measure QCA and DCBX in a tissue residue depletion study. Despite the continued interaction between Phibro and CVM, Phibro has not submitted the requested information.
In 2011, pursuant to section 512(
In response to the 2011 FDA order, Phibro provided CVM with the full study report and appendices, previously provided to JECFA in 2003.
CVM has independently evaluated the data from the Phibro study of depletion of carcinogenic residues reviewed by JECFA in 2003, and in particular has reviewed the JECFA conclusion that when QCA reaches 30 ppb in liver, residues of DCBX in liver are “estimated by regression analysis to be about 4 [ppb]” (Ref. 2 at p. 18). CVM's statistical analysis of the residue concentrations of DCBX in liver treated with pancreatin (a simulated intestinal fluid) shows that concentrations of DCBX in liver, when QCA reaches the 30 ppb approved tolerance, would average 4 ppb and, based on the data in the JECFA report, could reasonably range from 1.4 ppb to 11 ppb, using a 95 percent prediction range. Based upon this analysis, DCBX alone—leaving aside additional, unidentified residues of carcinogenic concern—significantly exceeds the approved S
In addition, a 2009 publication calls into question conclusions made by CVM when it approved the NADAs and supplemental NADAs for carbadox (Ref. 4). Boison,
Boison,
In 2012, in response to FDA's 2011 order under section 512(
CVM's prior conclusion that QCA is a reliable marker residue for carbadox and its metabolites was predicated on several underlying conclusions (Ref. 1 at pp. 13-14). These underlying conclusions are reviewed below in light of the new evidence presented above.
1. Previous Conclusion 1: The residue data show that carbadox, DCBX, and hydrazine do not persist in edible tissues as detectable residues beyond 72 hours.
Since the time CVM made this previous conclusion, we have become aware of information that undermines the previous conclusion that carbadox and its carcinogenic metabolites do not persist in edible tissues beyond 72 hours. JECFA, in 2003, reviewed a study detecting DCBX in livers of swine up to 15 days after cessation of carbadox exposure. The study JECFA reviewed was limited to 15 days. The data presented to JECFA in 2003 provide new scientific evidence that DCBX persists in edible tissues of swine as a detectable residue beyond 72 hours (Ref. 2).
Further, Baars, et al., 1991, reports detecting DCBX in liver up to Day 14 after cessation of exposure to carbadox using an analytical method with a detection limit of 1 ppb (Ref. 6). Baars, et al., 1991, provides new scientific evidence that DCBX persists as a detectable residue in edible tissues of swine for greater than 72 hours.
Scientific evidence from JECFA's 2003 evaluation of submitted information and Baars, et al., 1991, demonstrate that DCBX, one residue of carcinogenic concern for carbadox, persists in edible tissues of swine beyond 72 hours. All of this evidence was first received by CVM after the 1998 approval of the supplemental application to NADA 041-061. Based on this new scientific evidence, the previous conclusion that DCBX does not persist in edible tissues of swine as a detectable residue beyond 72 hours is no longer justified.
2. Previous Conclusion 2: The unextracted residues are related to a noncarcinogenic compound, QCA, and extractable QCA is the only residue detectable in the edible tissues of swine 72 hours post dosing.
At the time of the 1998 supplemental approval, CVM concluded that that unextracted residues were related to the noncarcinogenic compound, QCA, and that extractable QCA was the only residue detectable in the edible tissues after 72 hours post dosing. However, CVM is now aware of reports of extraction of residues being enhanced by pepsin or pancreatin digestion prior to organic extraction, making non-QCA residues previously thought to be unextractable currently extractable (Ref. 2). JECFA reports that some residues of carbadox previously identified as unextractable can now be extracted (id.). DCBX was found in the newly extractable residues. This scientific evidence demonstrates that some residues previously found to be unextractable are extractable and that the unextractable residues are not all related to QCA.
As discussed above, residues of DCBX, a residue of carcinogenic concern, have been detected in edible tissues longer than 72 hours post dosing
3. Previous Conclusion 3: No residue of carcinogenic concern even below the S
Boison, et al., 2009, reports a method capable of detecting DCBX at 0.05 ppb, which is below the 0.061 ppb S
4. Previous Conclusion 4: QCA is a reliable marker residue for carbadox and its metabolites.
In light of the new evidence presented above, the conclusion that QCA is a reliable marker residue for carbadox and its metabolites is no longer justified because: (1) Previous conclusions made by the Agency are no longer scientifically justified and (2) the relationship of QCA to a carbadox residue of carcinogenic concern, DCBX, in the last tissue to deplete to its S
CVM reevaluated the existing carbadox residue data as a result of discussions that took place during meetings in 2011 with Phibro about the composition of total residues of carbadox (Refs. 3 and 22). CVM also reexamined the residue data submitted in support of the 1998 NADA supplements in light of the new understanding from the 2003 JECFA report that carcinogenic residues of carbadox persisted in edible tissues for 15 days, which was the last sampling time point, and that the previously unextractable residues are not necessarily noncarcinogenic residues related to QCA (Ref. 2).
Using data in the FOI Summary for the January 30, 1998, supplemental approval, CVM reviewed information on total residue concentrations (measured from total radioactivity present in tissue from swine administered the radiolabeled drug), as well as the percent of total residues represented by QCA—the only noncarcinogenic metabolite of carbadox identified and quantified in the total residues of carbadox (Ref. 1). CVM used the total residue data and the percent of total residues represented by QCA to calculate the total residue of carcinogenic concern present in liver. Under the SOM regulations, “residues of carcinogenic concern” in edible tissues are total residues of a carcinogenic drug minus identified residues that are judged by CVM to be noncarcinogenic (§ 500.82(b)). CVM previously excluded the unextracted portions of total residues from carcinogenic concern because it believed they were noncarcinogenic, QCA-related residues. The data presented to JECFA in 2003 now refute that conclusion, and CVM has no information, from Phibro or otherwise, that identifies or measures noncarcinogenic residues other than QCA in total residues of carbadox at the withdrawal period. As such, CVM now identifies the total residue of carcinogenic concern by subtracting QCA (identified residues that are confirmed to be noncarcinogenic) from total residues of carbadox. Determining the concentration of residues of carcinogenic concern present in the liver allowed CVM to compare that value with the S
CVM reviewed data regarding concentrations of total residues in swine tissues following 5 days of feeding
Table 1 presents total carbadox residues and total carbadox residues minus the noncarcinogenic QCA. Column 1 lists the sampling time point when swine were slaughtered following administration of the last dose of carbadox. Column 2 presents mean total residues measured in livers collected from swine slaughtered at each time point. Column 3 lists the mean QCA percentage of total residues at each time point. Column 4 lists the calculated mean total residues of carcinogenic concern based on a subtraction of QCA from the mean total residue values in Column 2.
FDA first approved the use of carbadox in 1972 prior to the issuance of the Agency's SOM regulations. CVM did not make a calculation comparing total residues less QCA to the S
The individual data shown as mean values in Table 1 were used to predict total residues of carcinogenic concern at the approved 42-day withdrawal period for carbadox in NADAs 041-061 and 141-211, and the approved 70-day withdrawal period for carbadox in NADA 092-955. CVM analyzed the data using the logarithm of the dependent variable (carbadox-equivalents in liver). The logarithmic transformation or “exponential model” is consistent with the published JECFA analyses of carbadox and commonly observed elimination behavior of pharmaceuticals (Ref. 22). Using this modeling procedure, the total residues of carcinogenic concern at 42 days are estimated to be 27 ppb with a 95 percent prediction interval of 9 ppb to 80 ppb (Ref. 3 at p. 17, Table 8). These predictions can be compared with the S
Approval of a carcinogenic new animal drug under the DES Proviso to the Delaney Clause requires development of a sufficiently sensitive regulatory method that detects no residues of carcinogenic concern in the edible tissues of food-producing animals from the use of the animal drug. New evidence raises serious questions about whether the currently approved tolerance for uses of carbadox is adequate under the SOM regulations, and raises serious questions about the continued approval of the compound under the DES Proviso exception to the Delaney Clause due to the lack of a sufficiently sensitive regulatory method.
Carbadox is currently approved based upon CVM's previous conclusion that unextractable residues were QCA related and noncarcinogenic. Given this conclusion and the fact that no residues of carcinogenic compounds were detectable by any method beyond 72 hours, CVM determined that QCA was an acceptable marker residue and established the tolerance at 30 ppb. New evidence presented to JECFA in 2003 undermines the conclusion that all unextractable residues at the withdrawal period are QCA related. As a result, under FDA's SOM regulations, all unextractable residues except for measured residues of QCA must be considered residues of carcinogenic concern (§ 500.82(b)). Under CVM's analysis (Table 1), concentrations of total residues of carcinogenic concern in liver are approximately 30 times higher than the S
The new evidence indicates that QCA is not an appropriate marker residue for residues of carcinogenic concern and that QCA at 30 ppb in swine liver is not an appropriate tolerance. The new evidence also shows that the approved regulatory method for all approved carbadox NADAs is inadequate under the SOM regulations (part 500, subpart E). The inadequacy of the regulatory method is a basis for withdrawal of approval of all carbadox NADAs under section 512(e)(1)(B) of the FD&C Act.
Similarly, these findings demonstrate that carbadox is no longer shown to be safe under the General Safety Clause because residues of carcinogenic concern remain in swine tissue well past the established withdrawal period. Under the General Safety Clause, drug residues must be determined to be safe based on all available evidence. Where a drug is a known mutagenic carcinogen and new evidence shows that unidentified residues of carcinogenic concern are present at the established withdrawal time, the drug is no longer shown to be safe.
As stated previously, the new evidence presented to JECFA undermines the previously held conclusion that all unextracted residues are QCA related and noncarcinogenic. Because carbadox is a mutagenic carcinogen, all otherwise unidentified
New evidence regarding carcinogenic residues in edible tissues of swine treated with carbadox raises serious questions about the human food safety of the drug. Therefore, CVM is proposing to withdraw approval of the three NADAs that provide for use of carbadox in swine feed because new evidence demonstrates that the drug no longer meets the DES Proviso exception to the Delaney Clause and because new evidence demonstrates that carbadox is not shown to be safe under the General Safety Clause.
Therefore, notice is given to Phibro Animal Health Corp., 65 Challenger Rd., Ridgefield Park, NJ 07660, and to all other interested persons, that the Director of CVM proposes to issue an order under section 512(e) of the FD&C Act withdrawing approval of all NADAs providing for use of carbadox in medicated swine feed.
In accordance with section 512 of the FD&C Act and part 514 (21 CFR part 514) and under the authority delegated to the Director of CVM, Phibro Animal Health Corp., the sponsor, is hereby given an opportunity for hearing to show why approval of NADAs 041-061, 092-955, and 141-211 should not be withdrawn.
If the sponsor, Phibro Animal Health Corp., wishes to request a hearing the sponsor must file: (1) On or before [
The failure of a holder of an approval to file timely a written appearance and request for hearing as required by § 514.200 constitutes an election not to avail himself or herself of the opportunity for a hearing and a waiver of any contentions concerning the legal status of any such drug product, and the Director of CVM will summarily enter a final order withdrawing the approvals. Any new animal drug product marketed without an approved NADA is subject to regulatory action at any time.
A request for a hearing may not rest upon mere allegations of denials, but must set forth specific facts showing that there is a genuine and substantial issue of fact that requires a hearing. If it conclusively appears from the face of the data, information, and factual analyses in the request for hearing that there is no genuine and substantial issue of fact that precludes the withdrawal of approval of the applications, or when a request for hearing is not made in the required format or with the required analyses, the Commissioner of Food and Drugs will enter summary judgment against the person who requests a hearing, making findings and conclusions, and denying a hearing.
If a hearing is requested and is justified by the sponsor's response to this NOOH, the issues will be defined, a presiding officer will be assigned, and a written notice of the time and place at which the hearing will commence will be issued as soon as practicable.
This notice is issued under section 512 of the FD&C Act and under the authority delegated to the Director of CVM.
The Agency has determined under 21 CFR 25.33(g) that this action is of a type that does not individually or cumulatively have a significant impact on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
The collections of information requirements for this document are covered under OMB control numbers 0910-0032 and 0910-0184.
The following references have been placed on display in the Division of Dockets Management (see
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) has determined the regulatory review period for APOQUEL and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that animal drug product.
Anyone with knowledge that any of the dates as published (in the
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, 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
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: A testing phase and an approval phase. For animal drug products, the testing phase begins on the earlier date when either a major environmental effects test was initiated for the drug or when an exemption under section 512(j) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360b(j)) became effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the animal drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for an animal drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(4)(B).
FDA has approved for marketing the animal drug product APOQUEL (oclacitinib). APOQUEL is indicated for control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. Subsequent to this approval, the USPTO received a patent term restoration application for APOQUEL (U.S. Patent No. 6,890,929) from Pfizer Inc., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated May 11, 2015, FDA advised the USPTO that this animal drug product had undergone a regulatory review period and that the approval of APOQUEL represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for APOQUEL is 2,226 days. Of this time, 2,172 days occurred during the testing phase of the regulatory review period, while 54 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,139 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) has determined the regulatory review period for APTIOM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Anyone with knowledge that any of the dates as published (in the
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, 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
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human drug product APTIOM (eslicarbazepine acetate). APTIOM is indicated as an adjunctive treatment of partial-onset seizures. Subsequent to this approval, the USPTO received a patent term restoration application for APTIOM (U.S. Patent No. 5,753,646) from BIAL-PORTELA & CA, S.A., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated March 19, 2015, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of APTIOM represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for APTIOM is 2,517 days. Of this time, 832 days occurred during the testing phase of the regulatory review period, while 1,685 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,826 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and ask for a redetermination (see DATES). Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must be timely (see DATES) and contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a guidance for industry entitled “Safety Considerations for Product Design to Minimize Medication Errors.” The guidance is intended for sponsors of investigational new drug applications (INDs); applicants of new drug applications (NDAs), biologics licensing applications (BLAs), and abbreviated new drug applications (ANDAs); and manufacturers of prescription drugs marketed without an approved application or over-the-counter (OTC) monograph drugs. This guidance provides sponsors, applicants, and manufacturers with a set of principles to consider while developing drug products using a systems approach to minimize medication errors relating to product design and container closure design. The recommendations in this guidance document are intended to provide best practices on how to improve the drug product and container closure design for all prescription and nonprescription drug products. This guidance also provides examples of product designs that resulted in postmarketing error.
Submit either electronic or written comments on Agency guidances at any time.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, 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
Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Irene Z. Chan, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4420, Silver Spring, MD 20993-0002, 301-796-3962.
FDA is announcing the availability of a guidance for industry entitled “Safety Considerations for Product Design to Minimize Medication Errors.” The guidance is intended for sponsors of INDs; applicants of NDAs, BLAs, and ANDAs; and manufacturers of prescription drugs marketed without an approved application or OTC monograph drugs. This guidance provides sponsors, applicants, and manufacturers with a set of principles to consider while developing drug products using a systems approach to minimize medication errors relating to product design and container closure design. The recommendations in this guidance document are intended to provide best practices on how to improve the drug product and container closure design for all prescription and nonprescription drug products. The guidance also provides examples of product designs that resulted in postmarketing error.
This guidance document, which focuses on minimizing risks associated with the design of the drug product and its container closure system, is the first in a series of three planned guidances to minimize or eliminate hazards contributing to medication errors. The second guidance focuses on minimizing risks with the design of drug product container labels and carton labeling. The third guidance focuses on minimizing risks when developing and selecting proposed proprietary names for drugs.
In the
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency's current thinking on addressing safety achieved through drug product design to minimize medication errors. 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.
Interested persons may submit either electronic comments regarding this document to
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 21 CFR part 312 have been approved under OMB control number 0910-0014. The collections of information in 21 CFR part 314 have been approved under OMB control number 0910-0001. The collections of information in 21 CFR part 601 have been approved under OMB control number 0910-0338.
You may obtain the document at
Food and Drug Administration, HHS.
Notice of availability; correction.
The Food and Drug Administration (FDA) is correcting a notice that appeared in the
Lisa Granger, Office of Policy, Planning, Legislation, and Analysis, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3330, Silver Spring, MD 20993-0002, 301-796-9115.
In FR Doc. 2016-04893, appearing on page 11808 in the
1. On page 11808, in the third column, the docket number is corrected to read “FDA-2016-D-0768”.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the
Submit either electronic or written comments on the collection of information by June 13, 2016.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, 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
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
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 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.
In the United States, Federal and State Government Agencies ensure the safety of animal feed. FDA is responsible for ensuring that all food and feed moving in interstate commerce, except those
The FDA Food Safety Modernization Act passed on January 4, 2011, calls for enhanced partnerships and provides a legal mandate for developing an Integrated Food Safety System (IFSS). FDA is committed to implementing an IFSS thereby optimizing coordination of food and feed safety efforts with Federal, State, local, tribal, and territorial regulatory and public health agencies. Model standards provide a consistent, underlying foundation that is critical for uniformity across State and Federal Agencies to ensure credibility of food and feed programs within the IFSS.
The AFRPS provide a uniform and consistent approach to feed regulation in the United States. Implementation of the draft feed program standards is voluntary. States implementing the standards will identify and maintain program improvements that will strengthen the safety and integrity of the U.S. animal feed supply.
The feed standards are the framework that each State should use to design, manage, and improve its feed program. The standards include the following: (1) Regulatory foundation; (2) training; (3) inspection program; (4) auditing; (5) feed-related illness or death and emergency response; (6) enforcement program; (7) outreach activities; (8) budget and planning; (9) assessment and improvement; (10) laboratory services; and (11) sampling program.
Each standard has a purpose statement, requirement summary, description of program elements, projected outcomes, and a list of required documentation. When a State program voluntarily agrees to implement the feed standards, it must fully implement and maintain the individual program elements and documentation requirements in each standard in order to fully implement the standard.
The feed standards package includes forms, worksheets, and templates to help the State program assess and meet the program elements in the standard. State programs are not obligated to use the forms, worksheets, and templates provided with the feed standards. Other manual or automated forms, worksheets, and templates may be used as long as the pertinent data elements are present. Records and other documents specified in the feed standards must be maintained in good order by the State program and must be available to verify the implementation of each standard. The feed standards are not intended to address the performance appraisal processes that a State agency may use to evaluate individual employee performance.
In the first year of implementation, the State program uses the self-assessment worksheets to determine if the requirements for each standard are fully met, partially met, or not met. The self-assessments are used to develop an improvement plan for fully implementing the requirements of the 11 standards. Second and third-year assessments will provide progress evaluation.
Although FDA plans to provide financial support to State programs that implement the feed standards, funding opportunities are contingent upon the availability of funds. Funding opportunities may be only available to State feed regulatory programs that currently have an FDA feed inspection contract. State programs receiving financial support to implement the feed standards will be audited by FDA.
Persons with access to the Internet may submit requests for a single copy of the current feed standards from
FDA estimates the burden of this collection of information as follows:
The burden has been calculated to 3,000 hours per respondent. This burden was determined by capturing the average amount of time for each respondent to assess the current state of the program and work toward implementation of each of the 11 standards contained in AFRPS. FDA recognizes that full use and implementation of the feed standards by State feed programs will occur over many years and the number of years to fully implement the feed standards will vary among States.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) has determined the regulatory review period for
Anyone with knowledge that any of the dates as published (see the
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, 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.”
Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at
• 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
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human biologic product GAZYVA (obinutuzumab). GAZYVA is indicated, in addition with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia. Subsequent to this approval, the U.S. Patent and Trademark Office (USPTO) received patent term restoration applications for GAZYVA (U.S. Patent Nos. 6,602,684; 7,517,670; and 8,021,856) from Genentech, Inc., and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated May 11, 2015, FDA advised the USPTO that this human biological product had undergone a
FDA has determined that the applicable regulatory review period for GAZYVA is 1,698 days. Of this time, 1,504 days occurred during the testing phase of the regulatory review period, while 194 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 929, 946, or 484 days, respectively, of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and ask for a redetermination (see
Submit petitions electronically to
The Stakeholder Listening Session will help the HHS Office of Global Affairs prepare the U.S. delegation for the World Health Assembly by taking full advantage of the knowledge, ideas, feedback, and suggestions from all communities interested in and affected by agenda items to be discussed at the 69th World Health Assembly. Your input will contribute to U.S. positions as we negotiate with our international colleagues at the World Health Assembly these important health topics.
The listening session will be organized by agenda item, and participation is welcome from all individuals, particularly members of stakeholder communities, including:
• Public health and advocacy groups;
• State, local, and Tribal groups;
• Private industry;
• Minority health organizations; and
• Academic and scientific organizations.
All agenda items to be discussed at the 69th World Health Assembly can be found at this Web site:
Written comments are welcome and encouraged, even if you are planning on attending in person. Please send these to the email address:
We look forward to hearing your comments relative to the 69th World Health Assembly agenda items.
Office of Disease Prevention and Health Promotion, Office of the Assistant Secretary for Health, Office of the Secretary, U.S. Department of Health and Human Services.
Notice; correction.
The U.S. Department of Health and Human Services published a notice in the
Emmeline Ochiai, email address:
In the
Department of Health and Human Services (HHS), Office of the Secretary.
Notice, correction.
This document corrects one technical error that appeared in the final guidance published in the
This correction is effective on April 12, 2016.
Copy of the final guidance may be obtained at
For additional information, please contact: Sally Phillips, RN, Ph.D., Deputy Assistant Secretary, Office of Policy and Planning, Office of the Assistant Secretary for Preparedness and Response, 200 Independence SW., Washington, DC 20004.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), 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.
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(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the National Advisory Board on Medical Rehabilitation Research.
The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.
Information is also available on the Institute's/Center's home page:
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the Fogarty International Center Advisory Board. The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable materials, and personal information concerning individuals associated with the grant applications the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit.
Information is also available on the Institute's/Center's home page:
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the
To obtain a copy of the data collection plans and instruments or request more information on the proposed project contact: Dale Sandler, Ph.D., Chief, Epidemiology Branch, National Institute of Environmental Health Sciences, NIH, 111 T.W. Alexander Drive, P.O. Box 12233, MD A3-05, Research Triangle Park, NC 27709, or call non-toll-free number 919-541-4668, or email your request, including your address to:
OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 11,440.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Notice of availability; request for comments.
We, the U.S. Fish and Wildlife Service (Service), have received an application from Diversified Pacific (applicant), to amend a 5-year incidental take permit (permit). The application includes the applicant's revised habitat conservation plan (HCP), as required by the Endangered Species Act of 1973, as amended (Act). If approved, the amended permit would authorize incidental take of the endangered San Bernardino Merriam's kangaroo rat (SBKR) in the course of routine construction activities associated with the development of residential houses in the City of Redlands. We invite public comment on the application for a permit amendment and the revised HCP, and on our preliminary determination that the revised HCP continues to qualify as “low-effect” for a categorical exclusion under the National Environmental Policy Act. To make this determination we used our low-effect screening form.
To ensure consideration, please send your written comments by May 12, 2016.
You may request a copy of the amended permit application, the low-effect screening form, and/or the revised HCP by email, telephone, fax, or U.S. mail (see below). These documents are also available for public inspection by appointment during normal business hours at the office below. Please send your requests or comments by any one of the following methods, and specify “Diversified Pacific Low-Effect HCP” in your request or comment.
•
•
•
•
•
Karin Cleary-Rose, Inland Division Chief, Palm Springs Fish and Wildlife Office; telephone 760-332-2070 extension 206. If you use a telecommunications device for the deaf (TDD), please call the Federal Information Relay Service (FIRS) at 800-877-8339.
The Service issued an incidental take permit under section 10(a)(1)(B) of the Act to the applicant, Diversified Pacific, on August 21, 2015. The permit authorizes the applicant to take SBKR as a result of permanent impacts to 7.7 acres of habitat that the species uses for breeding, feeding, and sheltering. Take of SBKR is incidental to the applicant's activities associated with the construction of residential houses in the City of Redlands, San Bernardino County, California. The site is located southwest and southeast of the intersection of Pioneer Avenue and Judson Street in the City of Redlands, San Bernardino County, California. The proposed project site is surrounded by residential development and a mix of active and abandoned citrus orchards. An active municipal airport is located approximately 0.25 mile northeast of the project site.
The original permit required the applicant to mitigate impacts to the
The applicant requests a permit amendment to expand the SBKR translocation program permitted in the HCP to allow for additional capture and translocation of SBKR from the project site to a Service-approved receiver site as described in the revised HCP. Upon inspection of the remaining undeveloped areas within the permit area, the SBKR biologist determined that 9.7 acres may still be occupied, for a total of 14.1 acres of occupied SBKR habitat. To minimize impacts associated with the expanded translocation program, the applicant will provide funding for the perpetual management and monitoring of 7.3 acres of additional occupied high-quality SBKR habitat in the City of Redlands, owned and conserved by the Redlands Land Conservancy into perpetuity as part of the revised HCP. This increase in the SBKR population across a larger portion of the permit area was unexpected given the overall poor quality of the conditions onsite and the limited number of SBKR previously trapped. The abnormally wet 2015 summer season allowed for increased seed production of summer annual plants. In turn, the SBKR on the project site experienced high reproductive success, which led to an expansion of distribution of SBKR on the site. Because the project site is within an urban matrix and physically isolated from other areas that support SBKR, the project site still does not provide long-term conservation value for the species. Pursuant to the terms of the original permit, the applicant prepared a management plan for and provided financial assurances for long-term funding of the management of 20.9 acres of high-value SBKR conservation land at the Redlands Conservancy Conservation Area. Under the permit amendment, the applicant would fund an endowment account for management of an additional 7.3 acres of Conservancy lands, for a total of 28.2 acres of Conservancy lands with high-value SBKR land protected and managed in perpetuity.
We published a final rule to list SBKR as endangered on September 24, 1998 (63 FR 51005). The rule became effective September 24, 1998. Final designation of critical habitat was published on April 23, 2002 (67 FR 19812). A 5-year review of the species was published on May 21, 2010 (75 FR 28636).
Section 9 of the Act (16 U.S.C. 1531-1544
Regulations governing incidental take permits for threatened and endangered species are at 50 CFR 17.32 and 17.22, respectively. In addition to meeting other criteria, activities covered by an incidental take permit must not jeopardize the continued existence in the wild of federally listed wildlife or plants.
The applicant requests an amendment to the 5-year permit under section 10(a)(1)(B) of the Act to allow for expanded translocation of SBKR from the project site to high-quality habitat receiver sites. Upon issuance of the current permit, and as a condition of construction within the project area, the SBKR biologist trapped 4.4 acres of the estimated 7.7 acres of occupied habitat and discontinued trapping as the maximum take of SBKR had occurred. Upon further inspection, the SBKR biologist determined that 9.7 acres of undeveloped portions of the project area remained occupied by SBKR, for a total of 14.1 acres of occupied SBKR habitat.
We think that the abnormally wet 2015 summer season allowed for increased seed production of summer annual plants. In turn, the SBKR on the project site experienced high reproductive success and recruitment of juveniles, which increased the total numbers of individuals on the site and led to an expansion of distribution of SBKR on the site. Because the project site is within an urban matrix and physically isolated from other areas that support SBKR, we still believe that the project site does not provide long-term conservation value for the species.
If we approve the permit, the applicant would translocate all remaining SBKR to other Service-approved receiver sites from the remaining undeveloped portion of property as identified in the revised HCP. Translocation of SBKR from the project site is a requirement under the current permit as mitigation for impacts to SBKR, and it is recognized that moving the species off of the project site, which provides no connectivity to other SBKR populations, to approved receiver sites is a conservation benefit to the species. To mitigate take of SBKR at the project site, the applicant proposes the following mitigation strategy:
1. All SBKR captured prior to ground disturbance on the project site will be translocated to one or more Service-approved receiver sites in the Santa Ana River Watershed. These animals will be monitored for 5 years, including annual reporting.
2. The applicant will provide funding for the perpetual management and monitoring of 7.3 acres of additional high-quality occupied SBKR habitat in the City of Redlands, owned and conserved by the Redlands Land Conservancy into perpetuity as part of the revised HCP. In total for both the original HCP and the revised HCP, the applicant will fund the perpetual management and monitoring of 28.2 acres of SBKR habitat.
In the revised HCP, the applicant considers alternatives to the taking of SBKR under the proposed action. Our proposed action is to issue an amended permit to the applicant, who would implement the revised HCP. If we approve the amended permit, additional take of SBKR would be authorized for
We invite comments on our preliminary determination that our proposed action, based on the applicant's proposed activities to expand SBKR translocation minimization and mitigation measures, would have a minor or negligible effect on SBKR, and that the revised HCP qualifies as “low effect” as defined by our
We base our determination that this HCP qualifies as a low-effect plan on the following three criteria:
1. Implementation of the HCP would result in minor or negligible effects on federally listed, proposed, and candidate species and their habitats;
2. Implementation of the HCP would result in minor or negligible effects on other environmental values or resources; and
3. Impacts of the HCP, considered together with the impacts of other past, present, and reasonably foreseeable similarly situated projects, would not result, over time, in cumulative effects to environmental values or resources that would be considered significant.
As more fully explained in our associated low-effect screening form, the applicant's revised HCP qualifies as a low-effect HCP for the following reasons:
1. The project is small in size and the loss of this habitat would not jeopardize the continued existence of the SBKR.
2. The project site is not in designated critical habitat for the SBKR.
3. The translocation of additional SBKR off of the project site to conserved receiver sites would increase the local genetic diversity of SBKR at multiple locations in the Santa Ana River watershed, contributing to species recovery.
Therefore, our proposed issuance of the requested incidental take permit qualifies as a categorical exclusion under the National Environmental Policy Act, as provided by Department of the Interior implementing regulations in part 46 of title 43 of the Code of Federal Regulations (43 CFR 46.205, 46.210, and 46.215). Based on our review of public comments we receive in response to this notice, we may revise this preliminary determination.
The Service invites the public to comment on the application to amend the permit, including the revised HCP, during the public comment period. Copies of the documents will be available during a 30-day public comment period (see
We will evaluate the revised HCP and comments we receive to determine whether the application for a permit amendment meets the requirements and issuance criteria under section 10(a) of the Act (16 U.S.C. 1531
Fish and Wildlife Service, Interior.
Notice of availability; receipt of application and request for comment.
We, the U.S. Fish and Wildlife Service (Service), have received an application from the Las Vegas Valley Water District (applicant) for an enhancement of survival permit under the Endangered Species Act of 1973, as amended (Act). The permit application includes a proposed safe harbor agreement (SHA) between the applicant and the Service. The SHA provides for voluntary activities that will contribute to the recovery of the Pahrump poolfish. We have made a preliminary determination that the proposed SHA and permit application are eligible for categorical exclusion under the National Environmental Policy Act of 1969 (NEPA).
Written comments must be received on or before May 12, 2016.
Comments should be addressed to Michael J. Senn, Field Supervisor, by U.S. mail at Southern Nevada Fish and Wildlife Office, 4701 North Torrey Pines Drive, Las Vegas, NV 89130; or by fax to 702-515-5231 (see Public Review and Comment under
James Harter, Fish Biologist, at the Southern Nevada Fish and Wildlife Office address, or by telephone at 702-515-5230.
We have received an application from the Las Vegas Valley Water District (applicant) for an enhancement of survival permit under the Endangered Species Act of 1973, as amended (Act; 16 U.S.C. 1531
We have made a preliminary determination that the proposed SHA and permit application are eligible for categorical exclusion under the National Environmental Policy Act of 1969 (NEPA). The basis for this determination is contained in an environmental Action Statement, which is also available for public review.
The primary objective of this SHA is to encourage voluntary creation and maintenance of habitat to benefit the Pahrump poolfish by assuring the property owners that they will not be subjected to increased property use restrictions as a result of their efforts to establish a population of a listed species on their property, to increase the distribution and number of refugia within the range of the listed species. Application requirements and issuance criteria for enhancement of survival permits through SHAs are found in 50 CFR 17.22 and 17.32(c). As long as the enrolled landowner allows the agreed-upon conservation measures to be completed on their property and maintains their baseline responsibilities, they may make any other lawful use of the property during the permit term, even if such use results in the take of individual Pahrump poolfish or harm to their habitat as described in the SHA.
The landowner has suitable habitat for the establishment of a refugium that will contribute to the conservation of the species. The applicant has provided a SHA to the Service that includes: (1) A map of the property and its legal description; (2) a description of existing biological community, including nonnative aquatic species and sensitive or protected species; (3) the portion of the property to be enrolled and its acreage; (4) a description of the habitat types that occur on the property to be enrolled, including a description of the ponds and other aquatic habitats; and (5) current land use practices and existing developments, and the characteristics of water supplies to aquatic habitats.
The applicant, as the permittee, will be responsible for annual monitoring and reporting related to implementation of the SHA and fulfillment of their provisions. As specified in the SHA, the applicant will issue yearly reports to the Service related to implementation of the program.
Therefore, we have made a preliminary determination that our proposed issuance of the requested permit qualifies as a categorical exclusion under the National Environmental Policy Act, as provided by Department of the Interior implementing regulations in part 46 of title 43 of the Code of Federal Regulations (43 CFR 46.205, 46.210, and 46.215), based on the following criteria: (1) Implementation of the SHA would result in minor or negligible effects on federally listed, proposed, and candidate species and their habitats; (2) implementation of the SHA would result in minor or negligible effects on other environmental values or resources; and (3) impacts of the SHA, considered together with impacts of other past, present, and reasonably foreseeable similarly situated projects, would not result, over time, in cumulative effects to environmental values or resources that would be considered significant. This is more fully explained in our environmental action statement.
Based upon this preliminary determination, we do not intend to prepare further NEPA documentation. We will consider public comments in making our final determination on whether to prepare such additional documentation.
Individuals wishing copies of the permit application, the environmental action statement, or copies of the full text of the SHA, including a map of the proposed permit area, references, and legal descriptions of the proposed permit area, should contact the office and personnel listed 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—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.
We will evaluate the permit application, the SHA, and comments submitted thereon to determine whether the application meets the requirements of section 10(a) of the Act and NEPA regulations. If the requirements are met, the Service will sign the proposed SHA and issue an enhancement of survival permit under section 10(a)(1)(A) of the Act to the applicant for take of the Pahrump poolfish incidental to otherwise lawful activities of the project. We will not make a final decision until after the end of the 30-day comment period, and we will fully consider all comments received during the comment period.
We provide this notice under section 10(c) of the Act (16 U.S.C. 1531
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled
Lisa R. Barton, Secretary to the Commission, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2000. The public version of the complaint can be accessed on the Commission's Electronic Document Information System (EDIS) at EDIS,
General information concerning the Commission may also be obtained by accessing its Internet server at United States International Trade Commission
The Commission has received a complaint and a submission pursuant to section 210.8(b) of the Commission's Rules of Practice and Procedure filed on behalf of Creative Technology Ltd. and Creative Labs, Inc. on March 24, 2016. The complaint alleges violations of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain portable electronic devices and components thereof. The complaint names as respondents ZTE Corporation of China; ZTE (USA) Inc. of Richardson, TX; Sony Corporation of Japan; Sony Mobile Communications, Inc. of Japan; Sony Mobile Communications AB of Sweden; Sony Mobile Communications (USA), Inc. of Atlanta, GA; Samsung Electronics Co., Ltd. of Korea; Samsung Electronics America, Inc. of Ridgefield Park, NJ; Samsung Telecommunications America, LLC of Richardson, TX; LG Electronics, Inc. of Korea; LG Electronics U.S.A., Inc. of Englewood Cliffs, NJ; LG Electronics Mobilecomm U.S.A., Inc. of San Diego, CA; Lenovo Group Ltd. of China; Lenovo (United States) Inc. of Morrisville, NC; Motorola Mobility LLC of Chicago, IL; HTC Corporation of Taiwan; HTC America, Inc. of Bellevue, WA; Blackberry Ltd. of Canada; and Blackberry Corporation of Irving, TX. The complainant requests that the Commission issue a limited exclusion order and cease and desist orders, and impose a bond upon respondents' alleged infringing articles during the 60-day Presidential review period pursuant to 19 U.S.C. 1337(j).
Proposed respondents, other interested parties, and members of the public are invited to file comments, not to exceed five (5) pages in length, inclusive of attachments, on any public interest issues raised by the complaint or section 210.8(b) filing. Comments should address whether issuance of the relief specifically requested by the complainant in this investigation would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.
In particular, the Commission is interested in comments that:
(i) Explain how the articles potentially subject to the requested remedial orders are used in the United States;
(ii) identify any public health, safety, or welfare concerns in the United States relating to the requested remedial orders;
(iii) identify like or directly competitive articles that complainant, its licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded;
(iv) indicate whether complainant, complainant's licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to the requested exclusion order and/or a cease and desist order within a commercially reasonable time; and
(v) explain how the requested remedial orders would impact United States consumers.
Written submissions must be filed no later than by close of business, eight calendar days after the date of publication of this notice in the
Persons filing written submissions must file the original document electronically on or before the deadlines stated above and submit 8 true paper copies to the Office of the Secretary by noon the next day pursuant to section 210.4(f) of the Commission's Rules of Practice and Procedure (19 CFR 210.4(f)). Submissions should refer to the docket number (“Docket No. 3130”) in a prominent place on the cover page and/or the first page. (
Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment.
This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of sections 201.10 and 210.8(c) of the Commission's Rules of Practice and Procedure (19 CFR 201.10, 210.8(c)).
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled
Lisa R. Barton, Secretary to the Commission, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2000. The public version of the complaint can be accessed on the Commission's Electronic Document Information System (EDIS) at EDIS,
General information concerning the Commission may also be obtained by accessing its Internet server at United States International Trade Commission
The Commission has received a complaint and a submission pursuant to section 210.8(b) of the Commission's Rules of Practice and Procedure filed on behalf of Rovi Corporation and Rovi Guides, Inc. on April 6, 2016. The complaint alleges violations of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain digital video receivers and hardware and software components thereof. The complaint names as respondents: Comcast Corporation, Philadelphia, PA; Comcast Cable Communications, LLC, Philadelphia, PA; Comcast Cable Communications Management, LLC, Philadelphia, PA; Comcast Business Communications, LLC, Philadelphia, PA; Comcast Holdings Corporation, Philadelphia, PA; Comcast Shared Services, LLC, Chicago, IL; Humax Co., Ltd., South Korea; Humax USA, Inc., Irvine, CA; Technicolor SA, France; Technicolor USA, Inc., Indianapolis, IN; Technicolor Connected Home USA LLC, Indianapolis, IN; Pace Ltd., England; Pace Americas, LLC, Boca Raton, FL; Arris International plc, Suwanee, GA; Arris Group Inc., Suwanee, GA; Arris Technology, Inc., Horsham, PA; Arris Enterprises Inc., Suwanee, GA; and Arris Solutions, Inc., Suwanee, GA. The complainant requests that the Commission issue a limited exclusion order, cease and desist orders, and impose a bond upon respondents' alleged infringing articles during the 60-day Presidential review period pursuant to 19 U.S.C. 1337(j).
Proposed respondents, other interested parties, and members of the public are invited to file comments, not to exceed five (5) pages in length, inclusive of attachments, on any public interest issues raised by the complaint or section 210.8(b) filing. Comments should address whether issuance of the relief specifically requested by the complainant in this investigation would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.
In particular, the Commission is interested in comments that:
(i) Explain how the articles potentially subject to the requested remedial orders are used in the United States;
(ii) identify any public health, safety, or welfare concerns in the United States relating to the requested remedial orders;
(iii) identify like or directly competitive articles that complainant, its licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded;
(iv) indicate whether complainant, complainant's licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to the requested exclusion order and/or a cease and desist order within a commercially reasonable time; and
(v) explain how the requested remedial orders would impact United States consumers.
Written submissions must be filed no later than by close of business, eight calendar days after the date of publication of this notice in the
Persons filing written submissions must file the original document electronically on or before the deadlines stated above and submit 8 true paper copies to the Office of the Secretary by noon the next day pursuant to section 210.4(f) of the Commission's Rules of Practice and Procedure (19 CFR 210.4(f)). Submissions should refer to the docket number (“Docket No. 3135”) in a prominent place on the cover page and/or the first page. (
Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment.
This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of sections 201.10 and 210.8(c) of the Commission's Rules of Practice and Procedure (19 CFR 201.10, 210.8(c)).
By order of the Commission.
On the basis of the record
The Commission, pursuant to section 735(b) of the Tariff Act of 1930 (19 U.S.C. 1673d(b)), instituted this investigation effective February 19, 2015, following receipt of a petition filed with the Commission and Commerce by Felman Production LLC, Letart, West Virginia. The Commission scheduled the final phase of the investigation following notification of a preliminary determination by Commerce that imports of silicomanganese from Australia were being sold at LTFV within the meaning of section 733(b) of the Act (19 U.S.C.
The Commission made this determination pursuant to section 735(b) of the Tariff Act of 1930 (19 U.S.C. 1673d(b)). It completed and filed its determination in this investigation on April 6, 2016. The views of the Commission are contained in USITC Publication 4600 (April 2016), entitled
By order of the Commission.
United States International Trade Commission.
Notice of investigation and scheduling of a public hearing.
Following receipt of a request dated February 24, 2016 from the U.S. House of Representatives, Committee on Ways and Means (Committee) under section 332(g) of the Tariff Act of 1930 (19 U.S.C. 1332(g)), the U.S. International Trade Commission (Commission) instituted investigation No. 332-557:
September 5, 2016: Deadline for filing requests to appear at the public hearing.
September 12, 2016: Deadline for filing pre-hearing briefs and statements.
September 29, 2016: Public hearing.
October 7, 2016: Deadline for filing post-hearing briefs and submissions.
February 21, 2017: Deadline for filing all other written statements.
June 26, 2017: Transmittal of Commission report to the Committee.
All Commission offices, including the Commission's hearing rooms, are located in the United States International Trade Commission Building, 500 E Street SW., Washington, DC. All written submissions should be addressed to the Secretary, United States International Trade Commission, 500 E Street SW., Washington, DC 20436. The public record for this investigation may be viewed on the Commission's electronic docket (EDIS) at
Project Leader Karl Tsuji (202-205-3434 or
• An overview of the aluminum industry in the United States and other major global producing and exporting countries, including production, production capacity, capacity utilization, employment, wages, inventories, supply chains, domestic demand, and exports;
• Information on recent trade trends and developments in the global market for aluminum, including U.S. and other major foreign producer imports and exports, and trade flows through third countries for further processing and subsequent exports;
• A comparison of the competitive strengths and weaknesses of aluminum production and exports in the United States and other major producing and exporting countries, including such factors as producer revenue and production costs, industry structure, input prices and availability, energy costs and sources, production technology, product innovation, exchange rates, and pricing, as well as government policies and programs that directly or indirectly affect aluminum production and exporting in these countries;
• In countries where unwrought aluminum capacity has significantly increased, identify factors driving those capacity and related production changes; and
• A qualitative and, to the extent possible, quantitative assessment of the impact of government policies and programs in major foreign aluminum producing and exporting countries on their aluminum production, exports, consumption, and domestic prices, as well as on the U.S. aluminum industry and on aluminum markets worldwide.
The Committee asked that the Commission transmit its report not later than 16 months after receipt of the request, and the Commission will transmit its report by June 26, 2017. The Committee also stated that it intends to make the Commission's report available to the public in its entirety and asked that the report not include any confidential business information.
As requested by the Committee, the Commission will not include any confidential business information in the report that it sends to the Committee or makes available to the public. However, all information, including confidential business information, submitted in this investigation may be disclosed to and used: (i) By the Commission, its employees and Offices, and contract personnel (a) for developing or maintaining the records of this or a related proceeding, or (b) in internal investigations, audits, reviews, and evaluations relating to the programs, personnel, and operations of the Commission including under 5 U.S.C. Appendix 3; or (ii) by U.S. government employees and contract personnel for cybersecurity purposes. The Commission will not otherwise disclose any confidential business information in a manner that would reveal the operations of the firm supplying the information.
By order of the Commission.
Notice is hereby given, pursuant to the provisions of the Government in the Sunshine Act, that the Operations and Regulations Committee (Committee) of the Board of Directors for the Legal Services Corporation (LSC) will hold a Rulemaking Workshop (Workshop) to solicit public input on revisions to LSC's Cost Standards and Procedures and the Property Acquisition and Management Manual (PAMM).
Wednesday, April 20, 2016, 1:30-4:30 p.m. EDT.
F. William McCalpin Conference Center, Legal Services Corporation Headquarters, 3333 K Street NW., 3rd Floor, Washington DC 20007.
LSC encourages observation of and participation in the Workshop by interested individuals and organizations. The Workshop will be entirely open to public observation and will include opportunities for individuals who are not members of the panel to participate in person or via telephone. Persons interested in speaking during the public comment period are encouraged to pre-register by submitting a request in writing prior to close of business on Monday, April 18, 2016, to Stefanie K. Davis, Assistant General Counsel, at
• Call toll-free number: 1-872-240-3212;
• When prompted, enter the following numeric pass code: 925-917-349.
• When connected to the call, please immediately “MUTE” your telephone.
Members of the public are asked to keep their telephones muted to eliminate background noises. To avoid disrupting the meeting, please refrain from placing the call on hold if doing so will trigger recorded music or other sound. The Workshop moderator will solicit public comment as provided in the following Workshop Agenda.
Open.
1. Introductory remarks.
• Charles N.W. Keckler, Chair, Operations and Regulations Committee
2. Panelist introductions (including a description of the program's funding composition and brief overview of the areas in which each panelist sees the most differences between the requirements imposed by LSC and other funders).
• Steve Pelletier, Northwest Justice Project
• George Elliott, Legal Aid of Northwest Texas
• Steve Ogilvie, Inland Counties Legal Services
• AnnaMarie Johnson, Nevada Legal Services
• Shamim Huq, Legal Aid Society of Northeastern New York
• Patrick McClintock, Iowa Legal Aid Foundation
• Jon Asher, Colorado Legal Services
• Michael Maher, Legal Action of Wisconsin
• Robin Murphy, National Legal Aid and Defender Association
3. Discussion of other funders' prior approval requirements for purchases of personal and real property.
4. Discussion of disposition of personal and real property acquired with non-LSC funds.
5. Discussion of approval requirements imposed by other funders for procurement of services.
6. Discussion of other funders' requirements governing intellectual property created using various funding sources.
7. Discussion of potential conflicts with other funders' requirements regarding leases of personal property.
8. Public comment.
9. Closing remarks.
• Charles N.W. Keckler, Chair, Operations and Regulations Committee
Stefanie Davis, Assistant General Counsel, at (202) 295-1563. Questions may be sent by electronic mail to
LSC complies with the Americans with Disabilities Act and Section 504 of the 1973 Rehabilitation Act. Upon request, meeting notices and materials will be made available in alternative formats to accommodate individuals with disabilities. Individuals who need other accommodations due to disability in order to attend the meeting in person or telephonically should contact Stefanie Davis, at (202) 295-1563 or
Institute of Museum and Library Services, National Foundation on the Arts and the Humanities.
Submission for OMB Review, Comment Request.
The Institute of Museum and Library Service (“IMLS”) 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 (44 U.S.C. 3501
A copy of the proposed information collection request can be obtained by contacting the individual listed below in the
Written comments must be submitted to the office listed in the CONTACT section below on or before May 10, 2016.
OMB is particularly interested in comments that help the agency 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,
For a copy of the documents contact: Kim A. Miller, Management Analyst, Office of Impact Assessment and Learning, Institute of Museum and Library Services, 955 L'Enfant Plaza North SW., Suite 4000, Washington, DC 20024-2135. Ms. Miller can be reached by Telephone: 202-653-4762, Fax: 202-653-4601, or by email at
The Institute of Museum and Library Services (IMLS) is an independent Federal grant-making agency and is the primary source of federal support for the Nation's 123,000 libraries and 35,000 museums. IMLS provides a variety of grant programs to assist the Nation's museums and libraries in improving their operations and enhancing their services to the public. The IMLS Grants to States program is the largest source of federal funding support for library services in the United States. Using a population-based formula, more than $150 million is distributed among the State Library Administrative Agencies.
Nuclear Regulatory Commission.
Biweekly notice.
Pursuant to Section 189a.(2) of the Atomic Energy Act of 1954, as amended (the Act), the U.S. Nuclear Regulatory Commission (NRC) is publishing this regular biweekly notice. The Act requires the Commission to publish notice of any amendments
This biweekly notice includes all notices of amendments issued, or proposed to be issued, from March 15, 2016, to March 28, 2016. The last biweekly notice was published on March 29, 2016.
Comments must be filed by May 12, 2016. A request for a hearing must be filed by June 13, 2016.
You may submit comments by any of the following methods (unless this document describes a different method for submitting comments on a specific subject):
•
•
For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the
Lynn Ronewicz, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-1927, email:
Please refer to Docket ID NRC-2016-0073 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:
•
•
•
Please include Docket ID NRC-2016-0073, facility name, unit number(s), application date, and subject in your comment submission.
The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC posts all comment submissions at
If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment submissions into ADAMS.
The Commission has made a proposed determination that the following amendment requests involve no significant hazards consideration. Under the Commission's regulations in § 50.92 of title 10 of the
The Commission is seeking public comments on this proposed determination. Any comments received within 30 days after the date of publication of this notice will be considered in making any final determination.
Normally, the Commission will not issue the amendment until the expiration of 60 days after the date of publication of this notice. The Commission may issue the license amendment before expiration of the 60-day period provided that its final determination is that the amendment involves no significant hazards consideration. In addition, the Commission may issue the amendment prior to the expiration of the 30-day comment period should circumstances change during the 30-day comment period such that failure to act in a timely way would result, for example in derating or shutdown of the facility. Should the Commission take action prior to the expiration of either the comment period or the notice period, it will publish in the
Within 60 days after the date of publication of this notice, any person(s) whose interest may be affected by this action may file a request for a hearing and a petition to intervene with respect to issuance of the amendment to the subject facility operating license or combined license. Requests for a hearing and a petition for leave to intervene shall be filed in accordance with the Commission's “Agency Rules of Practice and Procedure” in 10 CFR part 2. Interested person(s) should consult a current copy of 10 CFR 2.309, which is available at the NRC's PDR, located at One White Flint North, Room O1-F21, 11555 Rockville Pike (first floor), Rockville, Maryland 20852. The NRC's regulations are accessible electronically from the NRC Library on the NRC's Web site at
As required by 10 CFR 2.309, a petition for leave to intervene shall set forth with particularity the interest of the petitioner in the proceeding, and how that interest may be affected by the results of the proceeding. The petition should specifically explain the reasons why intervention should be permitted with particular reference to the following general requirements: (1) The name, address, and telephone number of the requestor or petitioner; (2) the nature of the requestor's/petitioner's right under the Act to be made a party to the proceeding; (3) the nature and extent of the requestor's/petitioner's property, financial, or other interest in the proceeding; and (4) the possible effect of any decision or order which may be entered in the proceeding on the requestor's/petitioner's interest. The petition must also set forth the specific contentions which the requestor/petitioner seeks to have litigated at the proceeding.
Each contention must consist of a specific statement of the issue of law or fact to be raised or controverted. In addition, the requestor/petitioner shall provide a brief explanation of the bases for the contention and a concise statement of the alleged facts or expert opinion which support the contention and on which the requestor/petitioner intends to rely in proving the contention at the hearing. The requestor/petitioner must also provide references to those specific sources and documents of which the petitioner is aware and on which the requestor/petitioner intends to rely to establish those facts or expert opinion. The petition must include sufficient information to show that a genuine dispute exists with the applicant on a material issue of law or fact. Contentions shall be limited to matters within the scope of the amendment under consideration. The contention must be one which, if proven, would entitle the requestor/petitioner to relief. A requestor/petitioner who fails to satisfy these requirements with respect to at least one contention will not be permitted to participate as a party.
Those permitted to intervene become parties to the proceeding, subject to any limitations in the order granting leave to intervene, and have the opportunity to participate fully in the conduct of the hearing with respect to resolution of that person's admitted contentions, including the opportunity to present evidence and to submit a cross-examination plan for cross-examination of witnesses, consistent with NRC regulations, policies and procedures.
Petitions for leave to intervene must be filed no later than 60 days from the date of publication of this notice. Requests for hearing, petitions for leave to intervene, and motions for leave to file new or amended contentions that are filed after the 60-day deadline will not be entertained absent a determination by the presiding officer that the filing demonstrates good cause by satisfying the three factors in 10 CFR 2.309(c)(1)(i) through (iii).
If a hearing is requested, and the Commission has not made a final determination on the issue of no significant hazards consideration, the Commission will make a final determination on the issue of no significant hazards consideration. The final determination will serve to decide when the hearing is held. If the final determination is that the amendment request involves no significant hazards consideration, the Commission may issue the amendment and make it immediately effective, notwithstanding the request for a hearing. Any hearing held would take place after issuance of the amendment. If the final determination is that the amendment request involves a significant hazards consideration, then any hearing held would take place before the issuance of any amendment unless the Commission finds an imminent danger to the health or safety of the public, in which case it will issue an appropriate order or rule under 10 CFR part 2.
A State, local governmental body, Federally-recognized Indian Tribe, or agency thereof, may submit a petition to the Commission to participate as a party under 10 CFR 2.309(h)(1). The petition should state the nature and extent of the petitioner's interest in the proceeding. The petition should be submitted to the Commission by June 13, 2016. The petition must be filed in accordance with the filing instructions in the “Electronic Submissions (E-Filing)” section of this document, and should meet the requirements for petitions for leave to intervene set forth in this section, except that under § 2.309(h)(2) a State, local governmental body, or Federally-recognized Indian Tribe, or agency thereof does not need to address the standing requirements in 10 CFR 2.309(d) if the facility is located within its boundaries. A State, local governmental body, Federally-recognized Indian Tribe, or agency thereof may also have the opportunity to participate under 10 CFR 2.315(c).
If a hearing is granted, any person who does not wish, or is not qualified, to become a party to the proceeding may, in the discretion of the presiding officer, be permitted to make a limited appearance pursuant to the provisions of 10 CFR 2.315(a). A person making a limited appearance may make an oral or written statement of position on the issues, but may not otherwise participate in the proceeding. A limited appearance may be made at any session of the hearing or at any prehearing conference, subject to the limits and conditions as may be imposed by the presiding officer. Persons desiring to make a limited appearance are requested to inform the Secretary of the Commission by June 13, 2016.
All documents filed in NRC adjudicatory proceedings, including a request for hearing, a petition for leave to intervene, any motion or other document filed in the proceeding prior to the submission of a request for hearing or petition to intervene, and documents filed by interested governmental entities participating under 10 CFR 2.315(c), must be filed in accordance with the NRC's E-Filing rule (72 FR 49139; August 28, 2007). The E-Filing process requires participants to submit and serve all adjudicatory documents over the internet, or in some cases to mail copies on electronic storage media. Participants may not submit paper copies of their filings unless they seek an exemption in accordance with the procedures described below.
To comply with the procedural requirements of E-Filing, at least 10 days prior to the filing deadline, the participant should contact the Office of the Secretary by email at
Information about applying for a digital ID certificate is available on the NRC's public Web site at
If a participant is electronically submitting a document to the NRC in accordance with the E-Filing rule, the participant must file the document using the NRC's online, Web-based submission form. In order to serve documents through the Electronic Information Exchange System, users will be required to install a Web browser plug-in from the NRC's Web site. Further information on the Web-based submission form, including the installation of the Web browser plug-in, is available on the NRC's public Web site at
Once a participant has obtained a digital ID certificate and a docket has been created, the participant can then submit a request for hearing or petition for leave to intervene. Submissions should be in Portable Document Format (PDF) in accordance with NRC guidance available on the NRC's public Web site at
A person filing electronically using the NRC's adjudicatory E-Filing system may seek assistance by contacting the NRC Meta System Help Desk through the “Contact Us” link located on the NRC's public Web site at
Participants who believe that they have a good cause for not submitting documents electronically must file an exemption request, in accordance with 10 CFR 2.302(g), with their initial paper filing requesting authorization to continue to submit documents in paper format. Such filings must be submitted by: (1) First class mail addressed to the Office of the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemaking and Adjudications Staff; or (2) courier, express mail, or expedited delivery service to the Office of the Secretary, Sixteenth Floor, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852, Attention: Rulemaking and Adjudications Staff. Participants filing a document in this manner are responsible for serving the document on all other participants. Filing is considered complete by first-class mail as of the time of deposit in the mail, or by courier, express mail, or expedited delivery service upon depositing the document with the provider of the service. A presiding officer, having granted an exemption request from using E-Filing, may require a participant or party to use E-Filing if the presiding officer subsequently determines that the reason for granting the exemption from use of E-Filing no longer exists.
Documents submitted in adjudicatory proceedings will appear in the NRC's electronic hearing docket which is available to the public at
Petitions for leave to intervene must be filed no later than 60 days from the date of publication of this notice. Requests for hearing, petitions for leave to intervene, and motions for leave to file new or amended contentions that are filed after the 60-day deadline will not be entertained absent a determination by the presiding officer that the filing demonstrates good cause by satisfying the three factors in 10 CFR 2.309(c)(1)(i) through (iii).
For further details with respect to these license amendment applications, see the application for amendment which is available for public inspection in ADAMS and at the NRC's PDR. For additional direction on accessing information related to this document, see the “Obtaining Information and Submitting Comments” section of this document.
1 Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
The proposed changes do not involve a significant increase in the probability of any accident previously evaluated because no accident initiators or assumptions are affected. The proposed conversion and name change is administrative in nature and has no direct effect on any plant system, plant
2. Does the proposed change create the possibility of a new or different kind of accident from any previously evaluated?
Response: No.
The proposed changes do not create the possibility of a new or different kind of accident from any previously evaluated because the proposed name change is administrative in nature and does not involve new failure mechanisms, malfunctions, or accident initiators. The proposed changes have no direct effect on any plant system, plant personnel qualifications, or operation and maintenance of BSEP, RNP, and HNP.
3. Does the proposed change involve a significant reduction in a margin of safety?
Response: No.
The proposed changes will not involve a significant reduction in the margin of safety because the proposed changes do not involve changes to the initial conditions contributing to accident severity or consequences, or reduce response or mitigation capabilities. The proposed name change is administrative in nature and has no direct effect on any plant system, plant personnel qualifications, or operation and maintenance of BSEP, RNP, and HNP.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
The proposed amendment incorporates NEI topical report 94-01, Revision 3-A, into TS 5.5.13 as the basis for the RBS containment leakage rate testing program, which would allow for extensions to the frequencies of the Type A and Type C Tests. The proposed amendment also requests an extension to the Drywell Bypass Test frequency. The proposed changes do not involve any physical changes to the plant or any changes in the normal operation or control of the plant. In its license amendment request, the licensee identified the loss-of-coolant accident (LOCA) inside containment and the fuel handling accident (FHA) as the previously evaluated accidents in the Updated Safety Analysis Report that could potentially be impacted by the change. Changing the frequency of containment leakage rate testing has no impact upon the likelihood of a LOCA or of an FHA. Therefore, the probability of occurrence of an accident previously evaluated is not significantly increased by the proposed amendment.
The guidelines in NEI 94-01, Revision 3-A, provide a framework for a licensee's containment leakage rate testing program, the purpose of which is to ensure that the primary containment limits the uncontrolled release of radioactivity to the environment during a design-basis accident. As part of its amendment request, the licensee evaluated the potential consequences of extending the test intervals and determined that the change in risk was estimated to be acceptably small and within the guidelines, as published in Regulatory Guide 1.174. The proposed amendment does not change the overall containment leakage rate limit specified by the TSs. Therefore, it is concluded that the proposed amendment does not significantly increase the consequences of an accident previously evaluated.
Based on the above discussion, the proposed amendment does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No.
The proposed changes do not involve any physical changes to the plant or any changes in the normal operation or control of the plant. The proposed changes do not create any new accident precursors or initiators, and do not change any existing accident precursors or initiators, as described in the RBS safety analyses.
Therefore, the proposed amendment does not create the possibility of a new or different kind of accident from any previously evaluated.
3. Does the proposed amendment involve a significant reduction in a margin of safety?
Response: No.
The proposed amendment adopts the NRC-accepted guidelines of NEI 94-01, Revision 3-A, for the development of the RBS performance-based leakage rate testing program, to allow for frequency extensions for the Type A and Type C Tests. The proposed amendment also requests an extension to the Drywell Bypass Test frequency. The proposed changes do not alter the manner in which safety limits, limiting safety system setpoints, or limiting conditions for operation are determined. The specific requirements and conditions of the containment leakage rate testing program, as defined in the TSs, ensure that the primary containment will continue to provide a leaktight barrier to the uncontrolled release of radioactivity to the environment during a design-basis accident. The proposed amendment does not change the overall containment leakage rate limit specified by the TSs. Additionally, the proposed amendment does not include any changes to the Containment Inservice Inspection Plan at RBS, which serves to provide a high degree of assurance that the containment will not degrade in a manner that is not detectable by the Type A Test.
Based on the above discussion, the proposed amendment does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on its review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
The proposed training requirements change has no effect on normal plant operation or on any accident initiator. The change affects the response to radiological emergencies addressed in the SEP [site emergency plan]. The ability of the emergency response organization to respond adequately to radiological emergencies has been evaluated. Changes in the training provided to the on-shift organization, such as the reassignment of key on-shift emergency personnel to perform related RP [radiation protection] functions, provide assurance of an effective emergency response without competing or conflicting duties. An analysis was also performed on the effect of the proposed change on the timeliness of performing major tasks for the major functional areas of the SEP. The analysis concluded that the reduction in training requirements for the “on-shift” Chemistry Technician to support the initial RP support tasks does not affect the ability to perform the required RP Technician or Chemistry Technician tasks.
Therefore, the change in ERO staff training does not increase the probability or consequences of an accident previously evaluated.
2. Does the proposed change create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No.
The proposed change affects the training requirements for the “on-shift” Chemistry Technician and for supplementing onsite personnel in response to a radiological emergency. It has been evaluated and determined not to significantly affect the ability to perform required or related functions. It has no effect on the plant design or on the normal operation of the plant and does not affect how the plant is physically operated under emergency conditions. The reduction in ERO training requirements for the “on shift” Chemistry Technician in the SEP does not affect the plant operating procedures which are performed by plant staff during all plant conditions.
No new or different accidents are postulated to occur and there are no changes in any of the accidents previously evaluated.
3. Does the proposed change involve a significant reduction in a margin of safety?
Response: No.
The proposed change does not affect plant design or method of operation. 10 CFR 50.47(b) and 10 CFR 50 Appendix E establish emergency planning standards and requirements that require adequate staffing, satisfactory performance of key functional areas and critical tasks, and timely augmentation of the response capability. Since the SEP was originally developed, there have been improvements in the technology used to support the SEP functions and in the capabilities of onsite personnel. A functional analysis was performed on the effect of the proposed change on the timeliness of performing major tasks for the functional areas of the SEP. The analysis concluded that a reduction in training requirements for the “on-shift” Chemistry Technician would not significantly affect the ability to perform the required SEP tasks. Thus, the proposed change has been determined not to adversely affect the ability to meet the emergency planning standards as described in 10 CFR 50.47(b) and requirements in 10 CFR 50 Appendix E.
The proposed ERO staff training change does not involve a reduction in any margin of safety. The proposed change is consistent with the original and current ERO staffing levels implemented at PNPS.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed amendment involve a significant increase in the probability or consequences of any accident previously evaluated?
Response: No.
The proposed LAR [license amendment request] is purely an administrative change; therefore, the probability of any accident previously evaluated is not significantly increased. The systems and components required by the TS [technical specifications] for which SR 3.5.2.10 is applicable, continue to be operable and capable of performing any mitigation function assumed in the accident analysis. As a result, the consequences of any accident previously evaluated are not significantly increased.
Therefore, the proposed change does not involve a significant increase in the probability or consequences of an[y] accident previously evaluated.
2. Does the proposed amendment create the possibility of a new or different kind of accident from any [accident] previously evaluated?
Response: No.
The proposed LAR is purely an administrative change. The proposed change to add SR 3.5.2.10 to the list of applicable surveillances in SR 3.5.3.1 does not create a new or different kind of accident [than] previously evaluated.
The change does not involve a physical alteration of the plant (
Therefore, the proposed change does not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. Does the proposed amendment involve a significant reduction in a margin of safety?
Response: No.
The proposed LAR is purely an administrative change to add SR 3.5.2.10 to the list of applicable surveillances in SR 3.5.3.1.
The design, operation, testing methods, and acceptance criteria for systems, structures, and components (SSCs), specified in applicable codes and standards (or alternatives approved for use by the NRC) will continue to be met as described in the plant licensing basis (including the Final Safety Analysis Report and Bases to TS). Similarly, there is no impact to safety analysis acceptance criteria as described in the plant licensing basis.
Therefore, the proposed change does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
The proposed change results in additional heat added to Secondary Containment and the resultant increase in the time to achieve and maintain the required negative pressure in Secondary Containment following a LOCA. Neither the additional heat load from DCS [dry-cask storage] activities, nor the resultant increase in the time to achieve and maintain the required negative pressure in Secondary Containment affect any initiator or precursor of any accident previously evaluated. Therefore, the proposed change does not involve a significant increase in the probability of an accident previously evaluated.
The proposed change results in an increase in the post-LOCA radiological dose to a Control Room occupant. However, the resultant post-LOCA Control Room dose remains within the regulatory limits of 10 CFR 50.67 and GDC [General Design Criterion] 19. Therefore, the proposed change does not involve a significant increase in the consequences of an accident previously evaluated.
In summary, the proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed change create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No.
The proposed change does not alter the design function or operation of Secondary Containment or the Standby Gas Treatment system [SGTS], or the ability of each to perform its design function. EGC has evaluated the post-LOCA pressure response of Secondary Containment assuming the higher heat load, utilizing the design basis short-term pressure response analysis. The results of this analysis validated that SGTS will achieve and maintain the required negative pressure in Secondary Containment within the specified timeframe. The proposed change does not alter the safety limits, or safety analysis associated with the operation of the plant. Accordingly, the change does not introduce any new accident initiators. Rather, this proposed change is the result of an evaluation of the Control Room doses following the most limiting LOCA that can occur at CPS. The proposed change does not introduce any new modes of plant operation. As a result, no new failure modes are introduced.
Therefore, the proposed change does not create the possibility of a new or different kind of accident from any previously evaluated.
3. Does the proposed change involve a significant reduction in a margin of safety?
Response: No.
The revised post-LOCA dose consequences to a Control Room occupant were calculated in accordance with the requirements of 10 CFR 50.67, Regulatory Guide 1.183, and SRP [Standard Review Plan] 15.0.1 and are consistent with the post-LOCA dose calculations approved by the NRC in Amendment No. 167 to the CPS Facility Operating License NPF-62.
The margin of safety is considered to be that provided by meeting the applicable regulatory limits. The additional heat load that is added to Secondary Containment during DCS activities, leading to an increase in Secondary Containment drawdown time results in an increase in Control Room dose following the LOCA design basis accident. However, since the Control Room dose following the design basis accident remains within the regulatory limits, there is not a significant reduction in a margin of safety.
Therefore, operation of CPS in accordance with the proposed change will not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
Operation of DBNPS in accordance with the proposed amendment does not increase the probability or consequences of accidents previously evaluated. The Updated Final Safety Analysis Report (UFSAR) documents the analyses of design basis accidents (DBAs) at DBNPS. The proposed amendment does not affect accident initiators, nor does it alter design assumptions, conditions, or configurations of the facility that would increase the probability of accidents previously evaluated. Further, the changes to be made for fire hazard protection and mitigation do not adversely affect the ability of SSCs [structures, systems, and components] to perform their design functions for accident mitigation, nor do they affect the postulated initiators or assumed failure modes for accidents described and evaluated in the UFSAR. SSCs required to shut down the reactor safely and to maintain it in a safe and stable condition will remain capable of performing their design functions.
The purpose of the proposed amendment is to permit DBNPS to adopt a new fire protection licensing basis, which complies with the requirements of 10 CFR 50.48(a) and 10 CFR 50.48(c) and the guidance in [Regulatory Guide] RG 1.205, Revision 1. The NRC considers that NFPA 805 provides an acceptable methodology and performance criteria for licensees to identify fire protection requirements that are an acceptable alternative to the 10 CFR 50, Appendix R required fire protection features (69 FR 33536, June 16, 2004). Engineering analyses, which may include engineering evaluations, probabilistic safety assessments, and fire modeling calculations, have been performed to demonstrate that the
NFPA 805, taken as a whole, provides an acceptable alternative for satisfying General Design Criterion 3 (GDC 3) of Appendix A to 10 CFR 50, meets the underlying intent of the NRC's existing fire protection regulations and guidance, and provides for DID [defense-in-depth]. The goals, performance objectives, and performance criteria specified in Chapter 1 of the standard ensure that, if there are any increases in CDF [core damage frequency] or risk, the increase will be small and consistent with the intent of the Commission's Safety Goal Policy.
Based on this, the implementation of the proposed amendment does not increase the probability of any accident previously evaluated. Equipment required to mitigate an accident remains capable of performing the assumed function(s). The proposed amendment will not affect the source term, containment isolation, or radiological release assumptions used in evaluating the radiological consequences of any accident previously evaluated. The applicable radiological dose criteria will continue to be met. Therefore, the consequences of any accident previously evaluated are not significantly increased with the implementation of the proposed amendment.
2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No.
Operation of DBNPS in accordance with the proposed amendment does not create the possibility of a new or different kind of accident from any accident previously evaluated. The proposed change does not alter the requirements or functions for systems required during accident conditions. Implementation of the new fire protection licensing basis that complies with the requirements of 10 CFR 50.48(a) and 10 CFR 50.58(c) and the guidance in RG 1.205, Revision 1, will not result in new or different accidents.
The proposed amendment does not adversely affect accident initiators or alter design assumptions, conditions, or configurations of the facility. The proposed amendment does not adversely affect the ability of SSCs to perform their design function. SSCs required to maintain the plant in a safe and stable condition remain capable of performing their design functions.
The proposed amendment does not introduce new or different accident initiators, nor does it alter design assumptions, conditions, or configurations of the facility. The proposed amendment does not adversely affect the ability of SSCs to perform their design function. SSCs required to safely shutdown the reactor and maintain it in a safe and stable condition remain capable of performing their design functions.
The purpose of the proposed amendment is to permit DBNPS to adopt a new fire protection licensing basis that complies with the requirements of 10 CFR 50.48(a) and 10 CFR 50.48(c) and the guidance in Regulatory Guide 1.205, Revision 1. The NRC considers that NFPA 805 provides an acceptable methodology and appropriate performance criteria for licensees to identify fire protection systems and features that are an acceptable alternative to the 10 CFR 50, Appendix R required fire protection features (69 FR [
The requirements of NFPA 805 address only fire protection and the impacts of fire on the plant that have previously been evaluated. Based on this, implementation of the proposed amendment would not create the possibility of a new or different kind of accident from any kind of accident previously evaluated. No new accident scenarios, transient precursors, failure mechanisms, or limiting single failures will be introduced as a result of this amendment. There will be no adverse effect or challenges imposed on any safety-related system as a result of this amendment. Therefore, the possibility of a new or different kind of accident from any kind of accident previously evaluated is not created with the implementation of this amendment.
3. Does the proposed amendment involve a significant reduction in a margin of safety?
Response: No.
Operation of DBNPS in accordance with the proposed amendment does not involve a significant reduction in the margin of safety. The proposed amendment does not alter the manner in that safety limits, limiting safety system settings or limiting conditions for operation are determined. The safety analysis acceptance criteria are not affected by this change. The proposed amendment does not adversely affect existing plant safety margins or the reliability of equipment assumed to mitigate accidents in the UFSAR. The proposed amendment does not adversely affect the ability of SSCs to perform their design function. SSCs required to safely shut down the reactor and to maintain it in a safe and stable condition remain capable of performing their design functions.
The purpose of the proposed amendment is to permit FENOC to adopt a new fire protection licensing basis which complies with the requirements in 10 CFR 50.48(a) and 10 CFR 50.48(c) and the guidance in RG 1.205, Revision 1. The NRC considers that NFPA 805 provides an acceptable methodology and performance criteria for licensees to identify fire protection systems and features that are an acceptable alternative to the 10 CFR 50 Appendix R required fire protection features (69 FR 33536, June 16, 2004). Engineering analyses, which may include engineering evaluations, probabilistic safety assessments, and fire modeling calculations, have been performed to demonstrate that the performance-based requirements of NFPA 805 do not result in a significant reduction in the margin of safety.
The proposed changes are evaluated to ensure that risk and safety margins are kept within acceptable limits. Therefore, the transition to NFPA 805 does not involve a significant reduction in the margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
The proposed change revises the definition of SDM. SDM is not an initiator to any accident previously evaluated. Accordingly, the proposed change to the definition of SDM has no effect on the probability of any
Therefore, the proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed change create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No.
The proposed change revises the definition of SDM. The change does not involve a physical alteration of the plant (
Therefore, the proposed change does not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. Does the proposed change involve a significant reduction in a margin of safety?
Response: No.
The proposed change revises the definition of SDM. The proposed change does not alter the manner in which safety limits, limiting safety system settings or limiting conditions for operation are determined. The proposed change ensures that the SDM assumed in determining safety limits, limiting safety system settings or limiting conditions for operation is correct for all Boiling Water Reactor fuel types at all times during the fuel cycle.
Therefore, the proposed change does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
The overall protection system performance will remain within the bounds of the previously performed accident analyses since no hardware changes are proposed. The same reactor trip system (RTS) and engineered safety feature actuation system (ESFAS) instrumentation will continue to be used. The protection systems will continue to function in a manner consistent with the plant design basis. These changes to the Technical Specifications do not result in a condition where the design, material, and construction standards that were applicable prior to the change are altered.
The proposed changes will not modify any system interfaces. The proposed changes will not affect the probability of any event initiators. There will be no degradation in the performance of or an increase in the number of challenges imposed on safety-related equipment assumed to function during an accident situation. There will be no change to normal plant operating parameters or accident mitigation performance. The proposed changes will not alter any assumptions or change any mitigation actions in the radiological consequence evaluations in the Final Safety Analysis Report (FSAR).
The determination that the results of the proposed changes are acceptable was established in the NRC Safety Evaluation prepared for WCAP-1 5376-P-A (issued by letter dated December 20, 2002 [ML023540534]). Implementation of the proposed changes will result in an insignificant risk impact. Applicability of these conclusions has been verified through plant-specific reviews and implementation of the generic analysis results in accordance with the NRC Safety Evaluation conditions.
The proposed changes to the Completion Times, bypass test times, and Surveillance Frequencies reduce the potential for inadvertent reactor trips and spurious engineered safety feature (ESF) actuations, and therefore do not increase the probability of any accident previously evaluated. The proposed changes do not change the response of the plant to any accidents and have an insignificant impact on the reliability of the RTS and ESFAS signals. The RTS and ESFAS instrumentation will remain highly reliable and the proposed changes will not result in a significant increase in the risk of plant operation. This is demonstrated by showing that the impact on plant safety as measured by the increase in core damage frequency (CDF) is less than 1.0E-06 per year and the increase in large early release frequency (LERF) is less than 1.0E-07 per year. In addition, for the Completion Time changes, the incremental conditional core damage probabilities (ICCDP) and incremental conditional large early release probabilities (ICLERP) are less than 5.0E-07 and 5.0E-08, respectively. These changes meet the acceptance criteria in Regulatory Guides 1.174 and 1.177. Therefore, since the RTS and ESFAS instrumentation will continue to perform their functions with high reliability as originally assumed, and the risk impact as measured by the ΔCDF, ΔLERF, ICCDP, and ICLERP risk metrics is within the acceptance criteria of existing regulatory guidance, there will not be a significant increase in the consequences of any accidents.
The proposed changes do not adversely affect accident initiators or precursors nor alter the design assumptions, conditions, or configuration of the facility or the manner in which the plant is operated and maintained. The proposed changes do not alter or prevent the ability of structures, systems, and components (SSCs) from performing their intended function to mitigate the consequences of an initiating event within the assumed acceptance limits. The proposed changes do not affect the source term, containment isolation, or radiological release assumptions used in evaluating the radiological consequences of an accident previously evaluated. The proposed changes are consistent with safety analysis assumptions and resultant consequences.
Therefore, the proposed changes do not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed change create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No.
There are no hardware changes nor are there any changes in the method by which any safety-related plant system performs its safety function. The proposed changes will not affect the normal method of plant operation. No performance requirements will be affected or eliminated.
The proposed changes will not result in physical alteration to any plant system nor will there be any change in the method by which any safety-related plant system performs its safety function. The proposed changes do not include any changes to the instrumentation setpoints or changes to the accident analysis assumptions.
No new accident scenarios, transient precursors, failure mechanisms, or limiting
Therefore, the proposed changes do not create the possibility of a new or different kind of accident from any previously evaluated.
3. Does the proposed change involve a significant reduction in a margin of safety?
Response: No.
The proposed changes do not affect the acceptance criteria for any analyzed event nor is there a change to any Safety Analysis Limit (SAL). There will be no effect on the manner in which safety limits, limiting safety system settings, or limiting conditions for operation are determined nor will there be any effect on those plant systems necessary to assure the accomplishment of protection functions.
The redundancy of RTS and ESFAS is maintained, and diversity with regard to the signals that provide reactor trip and ESF actuation is also maintained. All signals credited as primary or secondary, and all operator actions credited in the accident analyses will remain the same. The proposed changes will not result in plant operation in a configuration outside the design basis. The calculated impact on risk is insignificant and meets the acceptance criteria contained in Regulatory Guides 1.174 and 1.177. Although there was no attempt to quantify any positive human factors benefit due to increased Completion Times and bypass test times, it is expected that there would be a net benefit due to a reduced potential for spurious reactor trips and actuations associated with testing.
Implementation of the proposed changes is expected to result in an overall improvement in safety, as follows:
(a) Reduced testing should result in fewer inadvertent reactor trips, less frequent actuation of ESFAS components, less frequent distraction of operations personnel without significantly affecting RTS and ESFAS reliability.
(b) The Completion Time extensions for the reactor trip breakers should provide additional time to complete test and maintenance activities while at power, potentially reducing the number of forced outages related to compliance with reactor trip breaker Completion Times, and provide consistency with the Completion Times for the logic trains.
Therefore, the proposed changes do not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
WCAP-16096 (Common Q Software Program Manual) was updated to Revision 4 to reference later NRC endorsed regulatory guides and standards and update the requirements for the software design and development processes for the Common Q portion of the AP1000 Protection and Safety Monitoring System (PMS). WCAP-16097 (Common Q Topical Report) was updated to Revision 3 to describe new Common Q components and standards currently used for the AP1000 PMS implementation of the Common Q platform. These two WCAPs have been reviewed and approved by the NRC in Safety Evaluations dated February 7, 2013. WCAP-15927 was updated to reference the newest revisions of WCAP-16096 and WCAP-16097 and for editorial corrections. The proposed activity adopts the updated versions as incorporated by reference documents into the UFSAR. Other proposed document changes support the implementation of the updated versions of WCAP-16096, WCAP-16097, and WCAP-15927.
The Common Q platform is an acceptable platform for nuclear safety-related applications. The Common Q system meets the requirements of 10 CFR part 50, Appendix A, General Design Criteria (Criteria 1, 2, 4, 13, 19, 20, 21, 22, 23, 24, and 25), the Institute of Electrical and Electronics Engineers Standard 603-1991 for the design of safety-related reactor protection systems, engineered safety features systems and other plant systems, and the guidelines of Regulatory Guide 1.152 and supporting industry standards for the design of digital systems.
Because the Common Q platform and the PMS implementation of the Common Q platform meet the criteria in the applicable General Design Criteria, the revisions to these documents do not affect the prevention and mitigation of abnormal events, such as accidents, anticipated operational occurrences, earthquakes, floods and turbine missiles, or their safety or design analyses as described in the licensing basis. The incorporation of the updated documents does not adversely affect the interface with any structure, system, or component accident initiator or initiating sequence of events. Thus, the probabilities of the accidents previously evaluated in the UFSAR are not affected.
Therefore, the proposed amendment does not involve an increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No.
The proposed changes to adopt the updated WCAP-16096, WCAP-16097, and WCAP-15927 into the UFSAR do not adversely affect the design or operation of safety-related equipment or equipment whose failure could initiate an accident beyond what is already described in the licensing basis. These changes do not adversely affect fission product barriers. No safety analysis or design basis acceptance limit/criterion is challenged or exceeded by the requested change.
Therefore, this activity does not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. Does the proposed amendment involve a significant reduction in a margin of safety?
Response: No.
The proposed changes to adopt the updated WCAP-16096, WCAP-16097, and WCAP-15927 into the UFSAR do not adversely affect the design, construction, or operation of any plant SSCs, including any equipment whose failure could initiate an accident or a failure of a fission product barrier. No analysis is adversely affected by the proposed changes. Furthermore, no system function, design function, or equipment qualification will be adversely affected by the changes.
Therefore, the proposed change does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed amendment involve a significant increase in the probability or consequence of an accident previously evaluated?
Response: No.
The proposed change adds new Condition A to Technical Specification (TS) 3.7.8, Essential Raw Cooling Water (ERCW) System for Sequoyah Nuclear Plant (SQN) Units 1 and 2. The proposed change will extend the allowed completion time to restore ERCW System train to OPERABLE status from 72 hours to 7 days for planned maintenance when the opposite unit is defueled or in mode 6 following defueled with refueling water cavity level ≥ [greater than or equal to] 23 ft. above top of reactor vessel flange and UHS [ultimate heat sink] Temperature is ≤ [less than or equal to 79 degrees F. This change does not result in any physical changes to plant safety-related structures, systems, or components (SSCs). The UHS and associated ERCW system function is to remove plant system heat loads during normal and accident conditions. As such, the UHS and ERCW system are not design basis accident initiators, but instead perform accident mitigation functions by serving as the heat sink for safety-related equipment to ensure the conditions and assumptions credited in the accident analyses are preserved. During operation under the proposed change with one ERCW train inoperable, the other ERCW train will continue to perform the design function of the ERCW system. Therefore, the proposed change does not involve a significant increase in the probability of an accident previously evaluated.
Accordingly, as demonstrated by TVA design heat transfer and flow modeling calculations, operation with one ERCW System inoperable for 7 days for planned maintenance when the opposite unit is defueled or in mode 6 following defueled with refueling water cavity level ≥ 23 ft. above top of reactor vessel flange, the fuel cladding, Reactor Coolant System (RCS) pressure boundary, and containment integrity limits are not challenged during worst-case post-accident conditions. Accordingly, the conclusions of the accident analyses will remain as previously evaluated such that there will be no significant increase in the post-accident dose consequences.
Therefore, the proposed change does not involve a significant increase in the probability or consequence of an accident previously evaluated.
2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No.
The proposed change does not involve any physical changes to plant safety related SSCs or alter the modes of plant operation in a manner that is outside the bounds of the current UHS and ERCW system design heat transfer and flow modeling analyses. The proposed change to add new Condition A to TS 3.7.8, ERCW System, which would extend the allowed completion time to restore ERCW System train to OPERABLE status from 72 hours to 7 days for planned maintenance when the opposite unit is defueled or in mode 6 following defueled with refueling water cavity level ≥ 23 ft. above top of reactor vessel flange. Thus, although the specified ERCW system alignments result in reduced heat transfer flow capability, the plant's overall ability to reject heat to the UHS during normal operation, normal shutdown, and hypothetical worst-case accident conditions will not be significantly affected by this proposed change. Because the safety and design requirements continue to be met and the integrity of the RCS pressure boundary is not challenged, no new credible failure mechanisms, malfunctions, or accident initiators are created, and there will be no effect on the accident mitigating systems in a manner that would significantly degrade the plant's response to an accident.
Therefore, the proposed change does not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. Does the proposed amendment involve a significant reduction in a margin of safety?
Response: No.
The proposed change to add new Condition A to TS 3.7.8, ERCW System, which would extend the allowed completion time to restore ERCW System train to OPERABLE status from 72 hours to 7 days for planned maintenance when the opposite unit is defueled or in mode 6 following defueled with refueling water cavity level ≥ 23 ft. above top of reactor vessel flange. As demonstrated by TVA design basis heat transfer and flow modeling calculations, the design limits for fuel cladding, RCS pressure boundary, and containment integrity are not exceeded under both normal and post-accident conditions. As required, these calculations include evaluation of the worst-case combination of meteorology and operational parameters, and establish adequate margins to account for measurement and instrument uncertainties. While operating margins have been reduced by the proposed change in order to support necessary maintenance activities, the current limiting design basis accidents remain applicable and the analyses conclusions remain bounding such that the accident safety margins are maintained. Accordingly, the proposed change will not significantly degrade the margin of safety of any SSCs that rely on the UHS and ERCW system for heat removal to perform their safety related functions.
Therefore, the proposed change does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
The proposed change would allow the use of Optimized ZIRLO
Therefore, the proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed change create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No.
Use of Optimized ZIRLO
Therefore, the proposed change does not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. Does the proposed change involve a significant reduction in a margin of safety?
Response: No.
The proposed change will not involve a significant reduction in the margin of safety because it has been demonstrated that the material properties of the Optimized ZIRLO
Therefore, the proposed change does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
During the period since publication of the last biweekly notice, the Commission has issued the following amendments. The Commission has determined for each of these amendments that the application complies with the standards and requirements of the Atomic Energy Act of 1954, as amended (the Act), and the Commission's rules and regulations. The Commission has made appropriate findings as required by the Act and the Commission's rules and regulations in 10 CFR chapter I, which are set forth in the license amendment.
A notice of consideration of issuance of amendment to facility operating license or combined license, as applicable, proposed no significant hazards consideration determination, and opportunity for a hearing in connection with these actions, was published in the
Unless otherwise indicated, the Commission has determined that these amendments satisfy the criteria for categorical exclusion in accordance with 10 CFR 51.22. Therefore, pursuant to 10 CFR 51.22(b), no environmental impact statement or environmental assessment need be prepared for these amendments. If the Commission has prepared an environmental assessment under the special circumstances provision in 10 CFR 51.22(b) and has made a determination based on that assessment, it is so indicated.
For further details with respect to the action see (1) the applications for amendment, (2) the amendment, and (3) the Commission's related letter, Safety Evaluation and/or Environmental Assessment as indicated. All of these items can be accessed as described in the “Obtaining Information and Submitting Comments” section of this document.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated March 16, 2016.
No significant hazards consideration comments received: No.
The Commission's related evaluation of this amendment is contained in the Safety Evaluation dated March 14, 2016.
No significant hazards consideration comments received: No.
The Commission's related evaluation of the amendments is contained in a safety evaluation dated March 17, 2016.
No significant hazards consideration comments received: No.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated March 15, 2016.
No significant hazards consideration comments received: No.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated March 21, 2016.
No significant hazards consideration comments received: Yes.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated July 17, 2015.
No significant hazards consideration comments received: No.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated September 23, 2015.
No significant hazards consideration comments received: No.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated November 12, 2015.
No significant hazards consideration comments received: No.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated February 29, 2016.
No significant hazards consideration comments received: No.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated March 21, 2016.
No significant hazards consideration comments received: No.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated March 23, 2016.
No significant hazards consideration comments received: No.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated March 28, 2016.
No significant hazards consideration comments received: No.
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Draft technical report; public meeting and request for comment.
The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment draft technical report, “State-of-the-Art Reactor Consequence Analyses (SOARCA): Sequoyah Integrated Deterministic and Uncertainty Analysis.” A public meeting related to the issuance of this draft technical report will be held on April 20, 2016. The purpose of the meeting is to present information on the pilot study for potential severe reactor accident progression and resulting offsite radiological health consequences.
Submit comments by May 12, 2016. Comments received after this date will be considered if it is practical to do so, but the Commission is able to ensure consideration only for comments received before this date.
You may submit comments by any of the following methods (unless this document describes a different method for submitting comments on a specific subject):
•
•
For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the
Salman Haq, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-1799; email:
Please refer to Docket ID NRC-2016-0074 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:
•
•
•
Please include Docket ID NRC-2016-0074 in your comment submission.
The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at
If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.
The Sequoyah SOARCA project considered a select set of potential severe reactor accidents at the Sequoyah power plant. The project combined up-to-date information about the plant's layout and operations with local population data and emergency preparedness plans. This information was then analyzed using state-of-the-art computer codes that incorporate decades of research into severe reactor accidents.
The public meeting will be held on April 20, 2016, from 6:30 p.m. to 8:00 p.m. at the Sequoyah Nuclear Plant Training Center, 2600 Igou Ferry Road, Soddy-Daisy, Tennessee 37379. The SOARCA team will hold an informal poster session, then present the project's approach and findings, answer questions, and take comments on the draft report. The meeting agenda will be published on the NRC's Public Meeting Schedule Web site,
For the Nuclear Regulatory Commission.
April 11, 18, 25, May 2, 9, 16, 2016.
Commissioners' Conference Room, 11555 Rockville Pike, Rockville, Maryland.
Public and Closed.
There are no meetings scheduled for the week of April 11, 2016.
This meeting will be webcast live at the Web address—
There are no meetings scheduled for the week of April 25, 2016.
There are no meetings scheduled for the week of May 2, 2016.
There are no meetings scheduled for the week of May 9, 2016.
This meeting will be webcast live at the Web address—
The schedule for Commission meetings is subject to change on short notice. For more information or to verify the status of meetings, contact Denise McGovern at 301-415-0681 or via email at
The NRC Commission Meeting Schedule can be found on the Internet at:
The NRC provides reasonable accommodation to individuals with disabilities where appropriate. If you need a reasonable accommodation to participate in these public meetings, or need this meeting notice or the transcript or other information from the public meetings in another format (
Members of the public may request to receive this information electronically. If you would like to be added to the distribution, please contact the Nuclear Regulatory Commission, Office of the Secretary, Washington, DC 20555 (301-415-1969), or email
Securities and Exchange Commission (the “Commission”).
Notice of application for an order under section 6(c) of the Investment Company Act of 1940 (“Act”) for an exemption from all provisions of the Act.
Secretary, U.S. Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090. Applicant, Meclis-i Mebusan Caddesi No. 81 34427 Fındıklı, Istanbul, Turkey.
Elizabeth G. Miller, Senior Counsel, at (202) 551-8707, or Holly Hunter-Ceci, Branch Chief, at (202) 551-6825 (Division of Investment Management, Chief Counsel's Office).
The following is a summary of the application. The complete application may be obtained via the Commission's Web site by searching for the file number, or applicant using the Company name box, at
1. Applicant is a banking institution organized as a public joint stock company of unlimited duration under the laws of Turkey. Applicant was established on May 31, 1950 as a “Development and Investment Bank” in accordance with Turkish Banking Law, No. 5411. As mandated by Turkish law, Applicant's principal activity is promotion of Turkish economic development through providing long-term funding for domestic and international investment by Turkish companies, primarily through loans denominated in foreign currencies. The Applicant's mandate as a “Development and Investment Bank” is to extend medium- to long-term financing to business enterprises, to assist domestic and foreign capital owners to finance the development of new businesses in Turkey, and to contribute to improvements in Turkish capital markets. A majority of Applicant's assets, together with its consolidated financial subsidiaries (the “Group”), currently consist of loans and leasing receivables net of allowance for possible losses and a securities portfolio (of which 91.7% constituted Turkish government securities). Since such securities and loans could be considered “investment securities” within the meaning of section 3(a)(1)(C) of the Act, Applicant may be considered an investment company, and it requests an exemption from all provisions of the Act.
2. As a Turkish development and industrial bank, Applicant (i) supports private sector, productive investments in the Turkish industrial and service sectors; (ii) assists with the financing and development of new businesses in Turkey; and (iii) contributes to the improvement of Turkish capital markets. Applicant may engage,
3. As of December 31, 2015, Applicant is privately controlled, with 50.3% of its shares held directly or indirectly by Türkiye İş Bankası A.Ş. Group and 8.4% by Türkiye Vakıflar Bankası T.A.O. As of the same date, 39.3% of Applicant's shares were publicly traded on the Borsa İstanbul A.Ş. (“BIST”) (of which 59.3% were held by foreign investors), with the remaining shares owned by various other institutional investors. A significant portion of the Group's obligations is subject to a guarantee by the Turkish Treasury.
4. Applicant is subject to a regulatory regime substantially equivalent to that of commercial banks in Turkey, including oversight and supervision by the Turkish Banking Regulation and Supervision Agency (the “BRSA”), the Central Bank of Turkey (the “Central Bank”), the Capital Markets Board of Turkey, the BIST, the Turkish Banks Association, and the Financial Crimes Investigation Board, including a full range of banking, competition, antitrust, anti-money laundering, sanctions and other laws and regulations designed to maintain the safety and financial soundness of Turkish banks, ensure their compliance with economic and other obligations, and limit their exposure to risk. Applicant is subject to extensive oversight, supervision, and regulation by the Turkish government on the same terms as other large commercial banks, including in accordance with the Basel III framework and international capital and liquidity standards. The Turkish Treasury guarantees a significant portion of Applicant's long-term funding from development financial institutions and appoints a representative to Applicant's Board of Directors. Applicant's Board of Directors and management have implemented comprehensive policies and procedures governing Applicant's banking operations.
5. As described more fully in the application, while Applicant performs many of the same functions as Turkish commercial banks and is subject to extensive supervision and regulation by the Turkish government, Applicant is prohibited from accepting deposits from the public. The scope of Applicant's operations is more limited than that of Turkish commercial banks owing to its specific objectives as a development and investment bank.
6. Development financial institutions (“DFIs”) are Applicant's primary source of funding; however, as DFI funding is typically received in the form of “tied loans” limited to a specific purpose or sector within Turkey, Applicant plans to offer and sell debt securities to supplement its funding base. Accordingly, Applicant proposes to issue and sell its debt securities in the United States from time to time, including under its Global Medium Term Note Program. Applicant intends to use the proceeds of any such sale of securities as an additional source of funding for its general purposes and in connection with its development and investment banking mandate. The proceeds of any such sale of debt securities will be used by Applicant as an additional source of funding for its general corporate purposes and in connection with its development and investment banking mandate. Specifically, Applicant intends to use any such debt security funding to extend loans to public-private partnerships and other socially responsible investment projects, including health, education, and renewable energy projects, that are ineligible for DFI tied loan funding.
1. Section 3(a)(1)(C) of the Act defines an “investment company” to include any issuer engaged in the business of investing, reinvesting, owning, holding or trading in securities, and that owns or proposes to acquire investment securities having a value exceeding 40% of the issuer's total assets. Section 3(a)(2) of the Act defines “investment securities” to include all securities except Government securities, securities issued by employees' securities companies, and securities issued by majority-owned subsidiaries of the owner which (a) are not investment companies, and (b) are not relying on the exclusions from the definition of investment company in section 3(c)(1) or 3(c)(7) of the Act.
2. Applicant states that as of December 31, 2015, the Group had total assets of TL21.4 billion, of which loans and leasing receivables net of allowance for possible losses accounted for 63.8% and the Group's securities portfolio for 18.0% (of which 91.7% constituted Turkish government securities). Such loans and securities could be construed as “investment securities” within the meaning of Section 3(a)(1)(C) of the Act, thus potentially rendering Applicant a
3. Section 6(c) of the Act provides, in relevant part, that the Commission, by order upon application, may conditionally or unconditionally exempt any person, security, or transaction from any provision of the Act, if and to the extent necessary or appropriate in the public interest and consistent with the protection of investors and the purposes fairly intended by the policy and provisions of the Act.
4. Rule 3a-6 under the Act excludes foreign banks from the definition of an investment company under the Act. A “foreign bank” is defined in the rule to include a banking institution “engaged substantially in commercial banking activity” which in turn is defined to include “extending commercial and other types of credit, and accepting demand and other types of deposits.” Applicant represents that it is the functional equivalent of a “foreign bank” insofar as it (i) offers financial services and issues financial products similar to those offered and issued by other Turkish commercial banks and (ii) is subject to extensive oversight, supervision, and regulation as a bank by the Turkish government. However, by Turkish law, Applicant is prohibited from accepting deposits. Therefore, Applicant states that there is uncertainty as to whether the Rule 3a-6 exemption would be deemed to apply.
5. Applicant also believes that the rationale of Congress and the Commission in promulgating rules under the Act in exempting foreign financial institutions applies to Applicant. Applicant represents that it is subject to extensive oversight, supervision and regulation by the Turkish Government to an equivalent extent as applies to Turkish commercial banks. Applicant further represents that it is subject to a more direct form of government oversight and supervision than commercial banks in Turkey owing to representation of the Turkish Treasury on the Applicant's board of Directors and the Turkish government's guarantee of certain of the Group's liabilities. Applicant also represents that the Turkish government guarantees a significant portion of the Group's obligation and the Turkish Treasury appoints a representative to Applicant's Board of Directors. Accordingly, Applicant represents that its operations do not lend themselves to the abuses against which the Act is directed, and states that it believes it satisfies the standards for relief under section 6(c) of the Act.
Applicant agrees that the order granting the requested relief will be subject to the following conditions:
1. In connection with any offering by Applicant of its debt securities in the United States, Applicant will appoint an agent in the United States to accept service of process in any suit, action, or proceeding brought with respect to such debt securities instituted in any state or federal court in the Borough of Manhattan, The City of New York, New York. Applicant will expressly submit to the jurisdiction of New York State and U.S. federal courts sitting in the Borough of Manhattan, The City of New York, New York, with respect to any such suit, action, or proceeding. Applicant also will waive the defense of
2. Applicant undertakes to provide to any person to which it offers its debt securities in the United States disclosure documents that are at least so comprehensive in their description of Applicant and its business as those which may be used by comparable U.S. issuers in similar U.S. offerings of such securities and that contain the latest available audited annual financial statements (and, if available, reviewed interim financial statements) of the Group. Applicant further undertakes to ensure that any underwriter or dealer through whom it makes such offers will provide such disclosure documents to each person to whom such offers are made prior to any sale of securities to such offeree. Such documents will be updated promptly to reflect any material change in the Group's financial status and shall be at least as comprehensive as offering memoranda customarily used in similar offerings in the United States. Any offering of Applicant's securities in
3. Applicant shall rely upon the order so long as (i) its activities conform in all material respects to the activities described in this Application and (ii) Applicant continues to be regulated by the BRSA, the Central Bank, or other applicable Turkish regulatory authorities as a development and investment bank as described in the application.
For the Commission, by the Division of Investment Management, pursuant to delegated authority.
It appears to the Securities and Exchange Commission that there is a lack of current and accurate information concerning the securities of Royale Globe Holding Inc. because of questions regarding the accuracy of publicly available information about the company's operations and securities ownership, including details about its affiliation with Maxim Capital Limited, a purported investment company operating under the name Maxim Trader. Royale Globe Holding Inc. is delinquent in its periodic filings with the Commission, having not filed any periodic reports since it filed its Form 10-Q for the period ended July 31, 2015. Royale Globe Holding Inc. (CIK No. 0001383145), is a Nevada corporation with its principal place of business listed as Kuala Lumpur, Malaysia with stock quoted on OTC Link (previously, “Pink Sheets”) operated by OTC Markets Group, Inc. under the ticker symbol ROGP.
The Commission is of the opinion that the public interest and the protection of investors require a suspension of trading in the securities of the above-listed company.
By the Commission.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to establish fees for options that overlie a reduced value of the FTSE 100 Index and the FTSE China 50 Index. The text of the proposed rule change is available on the Exchange's Web site (
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to amend its Fees Schedule, effective March 29, 2016. Specifically, commencing March 29, 2016, the Exchange will list new options on two FTSE Russell indexes. More specifically, the Exchange proposes to establish fees for options that overlie a reduced value of the FTSE 100 Index (“UKXM”) and the China 50 Index “(FXTM”).
By way of background, a specific set of proprietary products are commonly included or excluded from a variety of programs, qualification calculations and transaction fees. In lieu of listing out these products in various sections of the Fees Schedule, the Exchange uses the term “Underlying Symbol List A” to represent these products. Currently, Underlying Symbol List A is defined in Footnote 34 and represents the following proprietary products: OEX, XEO, RUT, RLG, RLV, RUI, SPX (including SPXw), SPXpm, SRO, VIX, VOLATILITY INDEXES and binary options. The Exchange notes that the reason the products in Underlying Symbol List A are often collectively included or excluded from certain programs, qualification calculations and transactions fees is because the Exchange has expended considerable resources developing and maintaining its proprietary, exclusively-listed products. Similar to the products currently represented by “Underlying Symbol List A,” UKXM and FXTM are not listed on any other exchange. As such, the Exchange proposes to exclude or include UKXM and FXTM in the same programs as the other products in Underlying Symbol List A, as well as add UKXM and FXTM to the definition of Underlying Symbol List A in Footnote 34. Specifically, like the other products in Underlying Symbol List A, the Exchange proposes to except UKXM and FXTM from the Liquidity Provider Sliding Scale, the Volume Incentive Program (VIP), the Marketing Fee, the Clearing Trading Permit Holder Fee Cap (“Fee Cap”) and [sic] exemption from fees for facilitation orders, and the Order Router Subsidy (ORS) and Complex Order Router Subsidy (CORS) Programs. Like all other products in Underlying Symbol List A (with the exception of SROs), the Exchange proposes to apply to UKXM and FXTM
The Exchange next proposes to establish transaction fees for UKXM and FXTM. Particularly, the Exchange proposes to assess the same fees for UKXM and FXTM as apply to RUT, RUI, RLV and RLG options. Transaction fees for UKXM and FXTM options will be as follows (all listed rates are per contract):
The Exchange also proposes to apply to UKXM and FXTM, like RUI, RLV, and RLG, and RUT, the Floor Brokerage Fee of $0.04 per contract ($0.02 per contract for crossed orders). The Exchange also proposes to apply to UKXM and FXTM the CFLEX Surcharge Fee of $0.10 per contract for all UKXM and FXTM orders executed electronically on CFLEX, capped at $250 per trade (
The Exchange currently assesses an Index License Surcharge for RUT of $0.45 per contract for all non-customer orders. Because the fees associated with the license for UKXM and FXTM are lower than the license fees for RUT, the Exchange proposes to assess a Surcharge of $0.10 per contract in order to recoup the costs associated with the UKXM and FXTM license.
In order to promote and encourage trading of UKXM and FXTM, the Exchange proposes to waive all transaction fees (including the Floor Brokerage Fee, Index License Surcharge and CFLEX Surcharge Fee) for UKXM and FXTM transactions through September 30, 2016. In order to promote and encourage trading of RUI, RLV and RLG, the Exchange also proposes to extend the waiver of transaction fees (including the Floor Brokerage Fee, Index License Surcharge and CFLEX Surcharge Fee) for RUI, RLV and RLG. The Exchange proposes to amend Footnote 40 to the Fees Schedule to make clear that transaction fees for RUI, RLV, RLG, UKXM and FXTM will be waived through September 30, 2016.
The Exchange is also offering a compensation plan to the Designated Primary Market-Maker(s) (“DPM(s)”) appointed in FXTM or UKXM to offset the initial DPM costs. The Exchange proposes to add Footnote 43 to the Fees Schedule that provides that DPM(s) appointed for an entire month in either FXTM or UKXM will receive a payment of $5,000 per class per month through December 31, 2016. Because FXTM and UKXM are scheduled to be listed on March 29, 2016, the appointed DPM(s) will not have an appointment in FXTM or UKXM for the entire month of March; thus, the DPM(s) will not receive compensation for March 2016. The DPM(s) appointed for the entire month of April, May, etc. will receive compensation of $5,000 for each entire month the DPM is appointed in FXTM or UKXM through December 31, 2016.
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.
Particularly, the Exchange believes it is reasonable to charge different fee amounts to different user types in the manner proposed because the proposed fees are consistent with the price differentiation that exists today for other index products, including RUT, RUI, RLV, and RLG. The Exchange also believes that the proposed fee amounts for UKXM and FXTM orders are reasonable because the proposed fee amounts are the same already assessed for similar products (
The Exchange believes that it is equitable and not unfairly discriminatory to assess lower fees to Customers as compared to other market participants because Customer order flow enhances liquidity on the Exchange for the benefit of all market participants. Specifically, customer liquidity benefits all market participants by providing more trading opportunities, which attracts Market-Makers. An increase in the activity of these market participants in turn facilitates tighter spreads, which may cause an additional corresponding increase in order flow from other market participants. The fees offered to customers are intended to attract more customer trading volume to the Exchange. Moreover, the options industry has a long history of providing preferential pricing to Customers, and the Exchange's current Fees Schedule currently does so in many places, as do
The Exchange believes that it is equitable and not unfairly discriminatory to, [sic] assess lower fees to Market-Makers as compared to other market participants other than Customers because Market-Makers, unlike other market participants, take on a number of obligations, including quoting obligations, that other market participants do not have. Further, these lower fees offered to Market-Makers are intended to incent Market-Makers to quote and trade more on the Exchange, thereby providing more trading opportunities for all market participants. Additionally, the proposed fee for Market-Makers will be applied equally to all Market-Makers (meaning that all Market-Makers will be assessed the same amount). This concept also applies to orders from all other origins. It should also be noted that all fee amounts described herein are intended to attract greater order flow to the Exchange in UKXM and FXTM which should therefore serve to benefit all Exchange market participants. Similarly, it is equitable and not unfairly discriminatory to assess lower fees to Clearing Trading Permit Holder Proprietary orders than those of other market participants (except Customers and Market-Makers) because Clearing Trading Permit Holders also have a number of obligations (such as membership with the Options Clearing Corporation), significant regulatory burdens, and financial obligations, that other market participants do not need to take on. The Exchange also notes that the UKXM and FXTM fee amounts for each separate type of market participant will be assessed equally to all such market participants (
The Exchange believes the proposed AIM transaction fees for Brokers Dealers, Non-Trading Permit Holder Market-Makers, Professionals/Voluntary Professionals, JBOs and Customers are reasonable because the amounts are still lower than assessed for AIM transactions in other proprietary products.
Assessing the Floor Brokerage Fee of $0.04 per contract for non-crossed orders and $0.02 per contract for crossed orders to Floor Brokers (and not other market participants) trading UKXM and FXTM orders is equitable and not unfairly discriminatory because only Floor Brokers are statutorily capable of representing orders in the trading crowd, for which they charge a commission. Moreover, this fee is already assessed, in the same amounts, to the other products in Underlying Symbol List A, including RUT, RUI, RLV, and RLG.
The Exchange believes that assessing an Index License Surcharge Fee of $0.10 per contract to UKXM and FXTM transactions is reasonable because the Surcharge helps recoup some of the costs associated with the license for UKXM and FXTM options. Additionally, the Exchange notes that the Surcharge amount is the same as, and in some cases lower than, the amount assessed as an Index License Surcharge to other index products. The proposed Surcharge is also equitable and not unfairly discriminatory because the amount will be assessed to all market participants to whom the Surcharge applies. Not applying the UKXM and FXTM Index License Surcharge Fee to Customer orders is equitable and not unfairly discriminatory because this is designed to attract Customer UKXM and FXTM orders, which increases liquidity and provides greater trading opportunities to all market participants. Additionally, it is equitable and not unfairly discriminatory to assess a lower License Index Surcharge amount to UKXM and FXTM transactions as compared to RUT transactions because the costs of the license associated with RUT is greater.
Similarly, the Exchange believes assessing a CFLEX Surcharge Fee of $0.10 per contract for all UKXM and FXTM orders executed electronically on CFLEX and capping it at $250 (
Excepting UKXM and FXTM from the Liquidity Provider Sliding Scale, VIP, the Marketing Fee, the Fee Cap, and [sic] the exemption from fees for facilitation orders and the ORS and CORS Programs is reasonable because other Underlying Symbol List A products (
The Exchange believes it is reasonable, equitable and not unfairly discriminatory to waive all transaction fees, including the Floor Brokerage fee, the License Index Surcharge and CFLEX Surcharge Fee because it promotes and encourages trading of these new products and applies to all Trading Permit Holders (“TPHs”).
Applying to UKXM and FXTM to the CBOE Proprietary Products Sliding Scale is reasonable because it also applies to other Underlying Symbol List A products. This is equitable and not unfairly discriminatory for the same reason; it seems equitable to apply to UKXM and FXTM the same items on the Fees Schedule that apply to Underlying Symbol List A options classes (
The Exchange believes it's reasonable, equitable and not unfairly discriminatory to continue to include UKXM and FXTM in the calculation of the qualifying volume for the Floor Broker Trading Permit Fees rebate because the Exchange wishes to support and encourage open-outcry trading of UKXM and FXTM, which allows for price improvement and has a number of positive impacts on the market system.
Finally, the Exchange believes that it is equitable and not unfairly discriminatory to compensate DPM(s) that are appointed for an entire month in either FXTM or UKXM. DPM(s) incur costs when receiving an appointment, and in the case of FXTM and UKXM, the Exchange believes it is appropriate to provide compensation to the DPM(s) to offset those costs.
The Exchange does not believe that the proposed rule changes will impose any burden on competition that are not necessary or appropriate in furtherance of the purposes of the Act. The Exchange does not believe that the proposed rule change will impose any burden on intramarket competition that is not necessary or appropriate in furtherance of the purposes of the Act because, while different fees are
The Exchange does not believe that the proposed rule changes will impose any burden on intermarket competition that is not necessary or appropriate in furtherance of the purposes of the Act because UKXM and FXTM will be exclusively listed on CBOE. To the extent that the proposed changes make CBOE a more attractive marketplace for market participants at other exchanges, such market participants are welcome to become CBOE market participants.
The Exchange neither solicited nor received comments on the proposed rule change.
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 20549-1090.
All submissions should refer to File Number
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice is hereby given, pursuant to the provisions of the Government in the Sunshine Act, Public Law 94-409, that the Securities and Exchange Commission will hold a Closed Meeting on Thursday, April 14, 2016 at 1:00 p.m.
Commissioners, Counsel to the Commissioners, the Secretary to the Commission, and recording secretaries will attend the Closed Meeting. Certain staff members who have an interest in the matters also may be present.
The General Counsel of the Commission, or her designee, has certified that, in her opinion, one or more of the exemptions set forth in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR 200.402(a)(3), (5), (7), 9(ii) and (10), permit consideration of the scheduled matter at the Closed Meeting.
Chair White, as duty officer, voted to consider the items listed for the Closed Meeting in closed session.
The subject matter of the Closed Meeting will be:
Institution and settlement of injunctive actions;
Institution and settlement of administrative proceedings;
Resolution of litigation claims; and
Other matters relating to enforcement proceedings.
At times, changes in Commission priorities require alterations in the scheduling of meeting items.
For further information and to ascertain what, if any, matters have been added, deleted or postponed, please contact the Office of the Secretary at (202) 551-5400.
Pursuant to Section 19(b)(1)
The Exchange proposes to (1) amending Section 4.01(a) of the NYSE Arca's Bylaws and NYSE Arca Rule 3.3 to establish a Committee for Review as a sub-committee of the Regulatory Oversight Committee (“ROC”), deleting NYSE Arca Rule 3.2(b)(3) governing the OTP Advisory Committee and NYSE Arca Equities Rule 3.2(b)(3) governing the Member Advisory Committee, both of whose functions will be assumed by the Committee for Review, and making conforming changes to NYSE Arca Rules 2.4, 10.3, 10.6, 10.8, 10.11, 10.12, 10.14 and NYSE Arca Equities Rules 2.3, 3.3, 5.5, 10.3, 10.6, 10.8, 10.11, 10.12, and 10.13; and (2) deleting references to “NYSE Regulation, Inc.” and “NYSE Regulation” in NYSE Arca and NYSE Arca Equities Rule 0 and NYSE Arca Equities Rule 5.3(i)(1) and replacing a reference to the “NYSE Regulation, Inc. Chief Executive Officer” in NYSE Arca Equities Rules 2.100. This Amendment No. 1 to SR-NYSEArca-2016-11 amends and replaces the original filing in its entirety. The proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes the following changes to the Rules of NYSE Arca and NYSE Arca Equities:
• Amending Section 4.01(a) of the NYSE Arca's Bylaws and NYSE Arca Rule 3.3 to establish a Committee for Review (“CFR”) as a sub-committee of the ROC, deleting NYSE Arca Rule 3.2(b)(3) governing the OTP Advisory Committee and NYSE Arca Equities Rule 3.2(b)(3) governing the Member Advisory Committee, both of whose functions will be assumed by the CFR, and making conforming changes to NYSE Arca Rules 2.4, 10.3, 10.6, 10.8, 10.11, 10.12, 10.14 and NYSE Arca Equities Rules 2.3, 3.3, 5.5, 10.3, 10.6, 10.8, 10.11, 10.12, and 10.13;
• Deleting references to “NYSE Regulation, Inc.” and “NYSE Regulation”
• Replacing a reference to the “NYSE Regulation, Inc. Chief Executive Officer” in NYSE Arca Equities Rule 2.100.
NYSE Arca, a registered securities exchange, operates a marketplace for trading options and, through its wholly-owned subsidiary NYSE Arca Equities, a marketplace for trading equities.
The Exchange's disciplinary jurisdiction extends to Options Trading Permit (“OTP”) Holders, OTP Firms and associated persons of an OTP Firm or OTP Holder alleged to have violated or aided and abetted a violation of any provision of the Exchange Act or the rules and regulations thereunder, any provision of the Exchange's Bylaws or Rules or any commentary thereof, any resolution of the Board of Directors of the Exchange regulating the conduct of business on the Exchange, or Exchange policy or procedure.
Under current NYSE Arca Rules 3.3 and 10.8, an appeal of matters subject to the applicable provisions of NYSE Arca Rules 3.2(b)(1)(C) or 10, including a Conduct Panel decision pursuant to Rule 10.7 or summary determination pursuant to Rule 10.4(c), may be
NYSE Arca Equities' disciplinary jurisdiction extends to any ETP Holder or associated person of an ETP Holder alleged to have violated or aided and abetted a violation of any provision of the Exchange Act or the rules and regulations thereunder, any provision of NYSE Arca Equities' Bylaws or Rules or any commentary thereof, any resolution of the Board of Directors of NYSE Arca Equities regulating the conduct of NYSE Arca Equities, or NYSE Arca Equities policy or procedure.
Under current NYSE Arca Equities Rules 3.3 and 10.8, an appeal of matters subject to the applicable provisions of NYSE Arca Equities Rules 3.2(b)(1)(C), 5 or 10 may be reviewed by the NYSE Arca Equities Board Appeals Committee (“NYSE Arca Equities BAC”).
In 2015, the Board established a ROC as a committee of the SRO Board.
By establishing a single CFR, the Exchange proposes to make its appellate process consistent with that of its affiliates NYSE and NYSE MKT LLC (“NYSE MKT”), both of which recently established a CFR as a subcommittee of the respective affiliate's ROC.
As proposed, the CFR would be composed of OTP Director(s) of NYSE Arca, ETP Director(s) of NYSE Arca Equities and the Public Directors of both markets
To effect these changes, the Exchange proposes amending Section 4.01(a) of the NYSE Arca's Bylaws and NYSE Arca Rule 3.3, deleting NYSE Arca Rule 3.2(b)(3) and NYSE Arca Equities Rule 3.2(b)(3), and make conforming changes to NYSE Arca Rules 2.4, 10.3, 10.6, 10.8, 10.11, 10.12, 10.14 and NYSE Arca Equities Rules 2.3, 3.3, 5.5, 10.3, 10.6, 10.8, 10.11, 10.12, and 10.13.
NYSE Arca Rule 3.1(a) provides the Board with authority to establish one or more committees consisting partly or entirely of directors of NYSE Arca. The Exchange proposes to amend NYSE Arca Rule 3.3 to provide for a CFR and delineate its composition and functions.
Proposed NYSE Arca Rule 3.3(a)(2)(A) would provide that the Board shall annually appoint a CFR as a sub-committee of the ROC.
Proposed NYSE Arca Rule 3.3(a)(2)(B) would provide that the CFR may appoint a CFR Appeals Panel made up of members of the CFR. Like the current requirements for the Appeals Panels of the NYSE Arca BAC, the proposed Rule would provide that the CFR Appeals Panel would be made up of no less than three but no more than five individuals. Proposed NYSE Arca Rule 3.3(a)(2)(B) would provide that a CFR Appeals Panel for NYSE Arca would, like current NYSE Arca BAC Appeals Panels provided for in NYSE Arca Rule 3.3(a)(1)(B), conduct reviews of matters subject to the applicable provisions of NYSE Arca Rule 3.2(b)(1)(C) or 10.
Proposed NYSE Arca Rule 3.3(a)(2)(B) would further provide that each CFR Appeals Panel would contain at least one Public Director and at least one Director that is an OTP Holder or Allied Person or Associated Person of an OTP Firm.
Finally, proposed NYSE Arca Rule 3.3(a)(2)(C) would retain the current provision governing the NYSE Arca BAC that, subject to Rule 10, decisions of the CFR would be subject to SRO Board review. Proposed subsection (a)(2)(C) would also provide, like the current provision governing the NYSE Arca BAC, that the decision of the Board shall constitute the final action of NYSE Arca, unless the Board remands the proceedings.
NYSE Arca also proposes to amend Article IV, Section 4.01(a) of its Bylaws governing board committees. Specifically, NYSE Arca proposes to replace references to the “Board Appeals Committee” with references to the “Committee for Review as a subcommittee of the Regulatory Oversight Committee” and “its subcommittee, the CFR.”
NYSE Arca proposes conforming amendments to NYSE Arca Rules 2.4, 10.3, 10.6, 10.8, 10.11, 10.12, 10.14 to replace references to the Board Appeals Committee with references to the “Committee for Review” or “CFR” and references to the Appeals Panel with references to the “CFR Appeals Panel.”
Similar conforming changes are proposed for NYSE Arca Equities. In particular, NYSE Arca Equities Rules 3.3, which mirrors NYSE Arca Rule 3.3, would be retitled “Committee for Review” and amended to provide that the SRO Board shall, on an annual basis, appoint the CFR as a sub-committee of the ROC. Proposed Rule 3.3(a)(1)(A) would provide that the CFR may, in turn, appoint a CFR Appeals Panel for NYSE Arca Equities market. Like the proposed CFR Appeals Panel for NYSE Arca, any CFR Appeals Panel appointed for NYSE Arca Equities would be made up of no less than three but no more than five individuals.
A CFR Appeals Panel reviewing matters related to the equities market would conduct reviews of matters subject to the applicable provisions of Rules 3.2(b)(1)(C), 5 or 10.
Outdated references to the NYSE Arca Board of Governors in NYSE Arca Equities Rules 3.3(a)(1)(B) would be replaced with references to the “NYSE Arca Board of Directors.” The current Rule would otherwise remain unchanged. The revised provision would thus provide that, subject to Rule 10, decisions of the CFR shall be subject to the review of the SRO Board and that the decision of the SRO Board would constitute the final action of NYSE Arca Equities, unless such SRO Board remands the proceedings.
Conforming amendments to NYSE Arca Equities Rules 2.3, 5.5, 10.3, 10.6, 10.8, 10.11,
The Exchange does not propose to retain the OTP Advisory Committee of NYSE Arca or the Member Advisory Committee of NYSE Arca Equities to act in an advisory capacity regarding disciplinary matters and trading rules for their respective marketplaces. Under NYSE Arca Rule 3.2(b)(3), which the Exchange proposes to delete, the OTP Advisory Committee is made up of OTP Holders and acts in an advisory capacity regarding rule changes related to disciplinary matters and trading rules. Under NYSE Arca Equities Rule 3.2(b)(3), which the Exchange also proposes to delete, the Member Advisory Committee is made up of ETP Holders and acts in an advisory capacity regarding rule changes related to disciplinary matters and off-board trading rules.
The Exchange proposes that the CFR would serve in the same advisory capacity as the current OTP Advisory and Member Advisory Committees. The Exchange notes that the same categories of permit holders as the advisory committees would be represented on the proposed CFR, whose mandate as set forth in proposed Rule 3.3(a)(2)(A) would include acting in an advisory capacity to the Board with respect to disciplinary matters, the listing and delisting of securities, regulatory programs, rulemaking and regulatory rules, including trading rules. The proposed CFR would therefore serve in the same advisory capacity as the OTP Advisory and Member Advisory Committees. The Exchange accordingly believes that retaining the OTP Advisory Committee or Member Advisory Committee would be redundant and unnecessary. The Exchange notes that the proposal is consistent with the structure recently approved for the NYSE, which abolished its advisory committees and transferred the functions to the newly created NYSE CFR, whose mandate includes acting in an advisory capacity to the Board with respect to disciplinary matters, the listing and delisting of securities, regulatory programs, rulemaking and regulatory rules, including trading rules. The Exchange's affiliate NYSE MKT has a similar structure in place.
In connection with the Exchange's termination of the intercompany RSA pursuant to which NYSE Regulation provided regulatory services to the Exchange,
In particular, NYSE Arca Rule 0 (Regulation of the Exchange, OTP Holders and OTP Firms) and NYSE Arca Equities Rule 0 (Regulation of the Exchange and Exchange Trading Permit Holders), which describes the regulatory services agreement between the NYSE and FINRA, would be amended to remove references to “NYSE Regulation, Inc., NYSE Regulation staff or departments”, retaining the existing reference in Rule 0 to Exchange staff, which reference would encompass the Exchange's regulatory staff.
Similarly, subdivision (i)(1) of NYSE Arca Equities Rule 5.3 (Financial Reports and Related Notices) would be amended to replace the reference to “NYSE Regulation” with “regulatory staff” to more particularly describe who an issuer should consult with under the Rule.
Finally, the Exchange proposes to amend NYSE Arca Equities Rule 2.100 to replace “NYSE Regulation, Inc. Chief Executive Officer” with “Chief Regulatory Officer.” NYSE Arca Equities Rule 2.100 currently provides that, for purposes of the rule,
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Exchange Act
The proposal to amend Section 4.01(a) of the NYSE Arca Bylaws and NYSE Arca and NYSE Arca Equities Rules 3.3 to establish a Committee for Review as a sub-committee of the recently approved ROC, and to delete NYSE Arca Rule 3.2(b)(3) governing the OTP Advisory Committee and NYSE Arca Equities Rule 3.2(b)(3) governing the Member Advisory Committee, both of whose functions will be assumed by the Committee for Review, complies with Section 6(b)(7) of the Exchange
Further, the Exchange believes that permitting the CFR to appoint CFR Appeals Panels composed of at least three and no more than five individuals to conduct reviews of matters decided by the EBCC and BCC for the options and equities marketplaces is consistent with Section 6(b)(7) of the Exchange Act. CFR Appeals Panels for NYSE Arca would contain at least one Public Director and at least one Director that is an OTP Holder or Allied Person or Associated Person of an OTP Firm, and CFR Appeals Panels for NYSE Arca Equities would contain at least one Public Director and at least one director that is an ETP Holder or Allied Person or Associated Person of an ETP Holder. The Exchange believes that the role of the CFR Appeals Panels, including that the CFR would retain authority to determine the disposition of appeals, would ensure that the Exchange's rules provide a fair procedure for the disciplining of members and persons associated with members. In addition, for the reasons stated below, the Exchange believes that participation on the proposed CFR and CFR Appeals Panels of permit holders and persons allied or associated with permit holders would be sufficient to provide for the fair representation of members in the administration of the affairs of the Exchange, including rulemaking and the disciplinary process, consistent with Section 6(b)(3) of the Exchange Act.
The Exchange believes that having the Exchange Board, rather than the board of directors of its subsidiary NYSE Arca Equities, appoint the members of the appeals panel for the equities marketplace complies with Section 6(b)(7) of the Exchange Act. The Exchange is the entity with ultimate legal responsibility for the regulation of its permit holders and markets. As noted, under the proposal, the CFR would consist of the OTP Director(s), the ETP Director(s) and the Public Directors, thereby ensuring that CFR Appeals Panels named for the equities marketplace would consist of at least one Public Director and at least one director that is an ETP Holder or Allied Person or Associated Person of an ETP Holder.
The Exchange believes that having the CFR serve in the advisory capacity of the OTP Advisory Committee and Member Advisory Committee for the Exchange's options and equities marketplaces, respectively, is consistent with and facilitates a governance and regulatory structure that furthers the objectives of Section 6(b)(5) of the Exchange Act.
The Exchange believes that deleting the reference to the “NYSE Regulation, Inc. Chief Executive Officer” in NYSE Arca Equities Rule 2.100 and replacing it with Chief Regulatory Officer, which is used throughout the Exchange's rules, removes impediments to and perfects a national market system because it would reduce potential confusion that may result from retaining different designations for the same individual in the Exchange's rulebook. Removing potentially confusing conflicting designations would also further the goal of transparency and add consistency to the Exchange's rules.
Finally, making conforming amendments to NYSE Arca Rules 2.4, 10.3, 10.6, 10.8, 10.11, 10.12, 10.14 and NYSE Arca Equities Rules 2.3, 5.5, 10.3, 10.6, 10.8, 10.11, 10.12, and 10.13 in connection with creation of the proposed CFR removes impediments to and perfects the mechanism of a free and open market by removing confusion that may result from having obsolete references in the Exchange's rulebook. Deleting references to “NYSE Regulation, Inc.” and “NYSE Regulation” in NYSE Arca and NYSE Arca Equities Rule 0 and NYSE Arca Equities Rule 5.3(i)(1) and references to the “NYSE Arca Board of Governors” in NYSE Arca Equities Rules 3.3, 10.3, 10.12 and 10.13 removes impediments to and perfects the mechanism of a free and open market by removing confusion that may result from having obsolete references in the Exchange's rulebook. The Exchange further believes that the proposal removes impediments to and perfects the mechanism of a free and open market by ensuring that persons subject to the Exchange's jurisdiction, regulators, and the investing public can more easily navigate and understand the Exchange's rulebook. The Exchange believes that eliminating obsolete references would not be inconsistent with the public interest and the protection of investors because investors will not be harmed and in fact would benefit from increased transparency, thereby reducing potential confusion. Removing such obsolete references will also further the goal of transparency and add clarity to the Exchange's rules.
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 Exchange Act. The proposed rule change is not intended to address competitive issues but rather is concerned solely with the administration and functioning of the Exchange and its board of directors.
No written comments were solicited or received with respect to the proposed rule change.
Within 45 days of the date of publication of this notice in the
(A) By order approve or disapprove the proposed rule change, or
(B) Institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule
• 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 February 2, 2016, EDGA Exchange, Inc. (the “Exchange” or “EDGA”) filed with the Securities and Exchange Commission (the “Commission”), pursuant to Section 19(b)(1)
The Exchange proposes to amend its rules to: (i) Create a new trading session, the Early Trading Session, which will run from 7:00 a.m. to 8:00 a.m. Eastern Time; and (ii) adopt three new TIF instructions.
The Exchange trading day is currently divided into three sessions: (i) The Pre-Opening Session which starts at 8:00 a.m. and ends at 9:30 a.m. Eastern Time; (ii) Regular Trading Hours which runs from 9:30 a.m. to 4:00 p.m. Eastern Time; and (iii) the Post-Closing Session, which runs from 4:00 p.m. to 8:00 p.m. Eastern Time. The Exchange proposes to amend its rules to create the Early Trading Session. Exchange Rule 1.5 would be amended to add a new term, “Early Trading Session,” under proposed paragraph (ii). “Early Trading Session” would be defined as “the time between 7:00 a.m. and 8:00 a.m. Eastern Time.”
The Exchange also proposes to amend Exchange Rule 11.1(a) to state that orders may be entered or executed on, or routed away from, the Exchange during the the Early Trading Session and to reflect the start time of the Early Trading Session as 7:00 a.m. Eastern Time. Other than the proposal to adopt an Early Trading Session, the Exchange does not propose to amend the substance or operation of Exchange Rule 11.1(a).
Users
As amended, Exchange Rule 11.1(a)(1) would state that orders entered between 6:00 a.m. and 7:00 a.m. Eastern Time, rather than 6:00 a.m. and 8:00 a.m. Eastern Time, would not be eligible for execution until the start of the Early Trading Session, Pre-Opening Session, or Regular Trading Hours, depending on the TIF selected by the User. Exchange Rule 11.1(a)(1) will also be amended to state that the Exchange will not accept the following orders prior to 7:00 a.m. Eastern Time, rather than 8:00 a.m.:
The Exchange also proposes to make the changes described below to Exchange Rules 3.21, 11.8, 11.10, 11.15, 14.1, 14.2 and 14.3 to reflect the adoption of the Early Trading Session:
• Exchange Rule 3.21, Customer Disclosures. Exchange Rule 3.21 prohibits Members from accepting an order from a customer for execution in the Pre-Opening or Post-Closing Session without disclosing to their customer that extended hours trading involves material trading risks, including the possibility of lower liquidity, high volatility, changing prices, unlinked markets, an exaggerated effect from news announcements, wider spreads and any other relevant risk. The Exchange proposes to amend Exchange Rule 3.21 to also require such disclosures for customer orders that are to be executed during the Early Trading Session.
• Exchange Rules 11.8(b), (c), (d), (e) and (g). The Exchange proposes to amend the description of Limit Orders under Exchange Rule 11.8(b), ISOs under Exchange Rule 11.8(c), MidPoint Peg Orders under Exchange Rule 11.8(d), MidPoint Discretionary Orders (“MDO”) under Rule 11.8(e), and Supplemental Peg Orders under Rule 11.8(g) to account for the Early Trading Session. Every order type that is currently available beginning at 8:00 a.m. will be available beginning at 7:00 a.m. for inclusion in the Early Trading Session. All other order types, and all order type behaviors, will otherwise remain unchanged. Therefore, each of the above rules for Limit Orders, ISOs, MidPoint Peg Orders, MDOs, and Supplemental Peg Orders would be amended to state that those order types are available during the Early Trading Session.
• Exchange Rules 11.8(a) and (f). Market Orders and Market Maker Peg Orders would not be eligible for execution during the Early Trading Session. Market Orders are only eligible for execution during the Regular Session.
• Exchange Rule 11.10, Order Execution and Routing. Exchange Rule 11.10(a)(2) discusses compliance with Regulation NMS and Trade Through Protections and states that the price of any execution occurring during the Pre-Opening Session or the Post-Closing Session must be equal to or better than the highest Protected Bid or lowest Protected Offer, unless the order is marked ISO or a Protected Bid is crossing a Protected Offer. The Exchange proposes to amend Exchange Rule 11.10(a)(2) to expand the rule's requirements to the Early Trading Session.
• Exchange Rule 11.15, Clearly Erroneous Executions. Exchange Rule 11.15 outlines under which conditions the Exchange may determine that an execution is clearly erroneous. The Exchange proposes to amend Exchange Rule 11.15 to include executions that occur during the Early Trading Session. Exchange Rule 11.15(c)(1) sets forth the numerical guidelines the Exchange is to follow when determining whether an execution was clearly erroneous during Regular Trading Hours or the Pre-Opening or Post-Closing Trading Session. Exchange Rule 11.15(c)(3) sets forth additional factors the Exchange may consider in determining whether a transaction is clearly erroneous. These factors include whether the transaction was executed during the Pre-Opening or Post-Closing Trading Sessions. The Exchange proposes to amend Exchange Rule 11.15(c)(1) and (3) to include executions occurring during the Early Trading Session.
• Exchange Rule 14.1, Unlisted Trading Privileges. The Exchange proposes to amend Exchange Rules 14.1(c)(2), and Interpretation and Policies .01(a) and (b) to account for the Early Trading Session. Specifically, the Exchange proposes to amend paragraph (c)(2) to state that an information circular distributed by the Exchange prior to the commencement of trading of a UTP Derivative Security
• Exchange Rule 14.2, Investment Company Units. The Exchange proposes to amend Exchange Rule 14.2(g) to state that transactions in Investment Company Units may occur during the Early Trading Session. Currently, such transactions may occur during Regular Trading Hours and the Pre-Opening and Post Closing Sessions.
• Exchange Rule 14.3, Trust Issued Receipts. The Exchange proposes to amend Exchange Rule 14.3(d) to state that transactions in Trust Issued Receipts may occur during the Early Trading Session. Currently, such transactions may occur during Regular Trading Hours and the Pre-Opening and Post-Closing Sessions.
The Exchange proposes to adopt three new TIF instructions under Exchange Rule 11.6(q).
Although the Exchange states that the proposal to adopt an Early Trading Session is in response to User requests for their orders to be eligible for execution starting at 7:00 a.m. Eastern Time, some Users have requested that their orders continue to not be eligible for execution until the start of the Pre-Opening Session at 8:00 a.m.
• Pre-Opening Session Plus (“PRE”). A limit order that is designated for execution during the Pre-Opening Session and Regular Trading Hours. Like the current Day TIF instruction,
• Pre-Opening Session `til Extended Day (“PTX”). A limit order that is designated for execution during the Pre-Opening Session, Regular Trading Hours, and the Post-Closing Session. Like the current GTX TIF instruction,
• Pre-Opening Session `til Day (“PTD”). A limit order that is designated for execution during the Pre-Opening Session, Regular Trading Hours, and the Post-Closing Session. Like the current GTD TIF instruction,
Under each proposed TIF instruction, Users may designate that their orders only be eligible for execution starting with the Pre-Opening Session. Users may continue to enter orders as early as 6:00 a.m., but orders with the proposed TIF instructions would not be eligible for execution until 8:00 a.m. Eastern Time, the start of the Pre-Opening Session.
The Exchange proposes to amend the following order types under Exchange Rule 11.8 to account for the three proposed TIF instructions:
• Market Orders. The proposed TIF instruction of PRE, PTX, and PTD would not be available for Market Orders. Under Exchange Rule 11.8(a)(2), a Market Order may only include a TIF instruction of IOC, RHO, FOK, or Day.
• Limit Orders. Exchange Rule 11.8(b)(2) describes the TIF instructions that may be attached to a Limit Order. The Exchange proposes to amend paragraph (b)(2) to add the TIF instructions of PRE, PTX, or PTD to the list of TIF instructions that a Limit Order may include.
• ISOs. Exchange Rule 11.8(c)(1) describes the TIF instructions that may be attached to an incoming ISO. The Exchange proposes to amend paragraph (c)(1) to state that an incoming ISO may have a TIF instruction of PRE, PTX, or PTD, in addition to Day, GTD, RHO, GTX, and IOC. Exchange Rule 11.8(c)(1) would be further amended to state that an incoming ISO with a Post Only and TIF instruction of PRE, PTX, or PTD, like those with an TIF instruction or GTD, GTX, or Day, will be cancelled without execution if, when entered, it is immediately marketable against an order with a Displayed instruction resting in the EDGA Book unless such order removes liquidity pursuant to Exchange Rule 11.6(n)(4).
• MidPoint Peg Orders. Exchange Rule 11.8(d)(1) describes the TIF instructions that may be attached to a MidPoint Peg Order. The Exchange proposes to amend paragraph (d)(1) to state that a MidPoint Peg Order may have a TIF instruction of PRE, PTX, or PTD, in addition to Day, FOK, IOC, RHO, GTX and GTD.
• MDO. Rule 11.8(e)(1) describes the TIF instructions that may be attached to an MDO. The Exchange proposes to amend paragraph (e)(1) to state that an MDO may have a TIF instruction of PRE, PTX, or PTD, in addition to Day, RHO, GTX and GTD.
• Market Maker Peg Orders. The proposed TIF instruction of PRE, PTX, and PTD would not be available to Market Maker Peg Orders. Under Exchange Rule 11.8(f)(4), a Market Maker Peg Order may only include a TIF instruction of Day, RHO, or GTD.
• Supplemental Peg. Exchange Rule 11.8(g)(1) describes the TIF instructions that may be attached to a Supplemental Peg Order. The Exchange proposes to amend paragraph (g)(1) to state that a Supplemental Peg Order may have a TIF instruction of PRE, PTX, or PTD, in addition to GTD, GTX, RHO and Day.
After careful consideration, the Commission finds that the proposed rule change, as modified by Amendment No. 1, is consistent with the requirements of the Act and the rules and regulations thereunder applicable to a national securities exchange.
The Exchange proposes to adopt an Early Trading Session and three new TIF instructions and to make related changes to its rules as discussed above.
The Commission notes that the Exchange has represented that it would subject orders that are eligible for execution as of the start of the Pre-Opening Session to all of the Exchange's standard regulatory checks, as it currently does with all orders upon entry.
The Commission further notes the Exchange's discussion of the best execution obligations of Members utilizing the proposed TIF instructions.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
The Exchange proposes to amend Rule 952NY (Opening Process) with respect to opening trading in an options series. The proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Exchange is proposing changes to Rule 952NY with respect to opening
Rule 952NY describes the process pursuant to which the System
Any orders in the System that are not executed in the Auction Process become eligible for the Core Trading Session immediately after the conclusion of the Auction Process. If the System does not open a series with an Auction Process, the System shall open the series for trading after receiving notification of an initial NBBO disseminated by OPRA for the series or on a Market Maker quote, provided that the bid-ask differential does not exceed the bid-ask differential specified under Rule 925NY(b)(5).
First, the Exchange proposes to change Rule 952NY(b) regarding how the System determines when to start the Auction Process. Current paragraph (b) of the Rule provides that “[a]fter the primary market for the underlying security disseminates the opening trade or the opening quote, the related option series will be opened automatically.” However, because it is possible that either an opening quote or opening trade alone may not accurately reflect the state of the market, the Exchange proposes to specify that an option series will be opened automatically, “once the primary market for the underlying security disseminates a quote and a trade that is at or within the quote.”
Next, the Exchange proposes to modify Rule 952NY(b)(E), which currently provides, in relevant part, that “[i]f the System does not open a series with an Auction Process, the System shall open the series for trading after receiving notification of an initial NBBO disseminated by OPRA for the series or on a Market Maker quote.”
In connection with the proposed changes to Rule 952NY(b), the Exchange likewise proposes to strike from Rule 952NY(c) reference to “the midpoint of the best quote bids and quote offers in the System Book” as it relates to the Exchange determining the opening price for options issues designated for trading on the System.
Finally, the Exchange proposes new paragraph (F) to Rule 952NY(c) to provide the Exchange with discretion to deviate from the standard Opening Process where it is necessary in the interests of a fair and orderly market.
The Exchange believes the proposed rule change is consistent with Section 6(b)
Specifically, the proposed change to Rule 952NY(b) would clarify that the Exchange would only open a series automatically after it receives a quote in the underlying security and a trade in that security at or between the disseminated quote—as opposed to automatically opening on either an opening quote or an opening trade alone per the current rule text, which may not always accurately reflect the state of the market. The Exchange believes this added transparency would promote just and equitable principles of trade and remove impediments to, and perfect the mechanism of, a free and open market and a national market system to the benefit of market participants. Further, the Exchange believes that waiting to open trading in an option series until there has been both a disseminated quote and trade in the underlying security would protect investors and the public interest because it would help to augment the Auction Process by ensuring that an underlying security has been opened pursuant to a robust price discovery process before opening the overlying options for trading. Moreover, this proposed change would promote just and equitable principles of trade to the benefit of investors and the public interest because it would provide market participants with greater certainty as to the true state of the market at the opening of the trading day and should lead to more accurate prices on the Exchange.
The Exchange also believes that specifying that, to open a series, the Exchange would require an initial uncrossed NBBO disseminated by OPRA would promote just and equitable principles of trade as the change is designed to protect investors and the public interest. The Exchange notes that OPRA disseminates to each exchange the NBBO as well as the top of book for each exchange, such that the Exchange's market maker quote would be disseminated back to the Exchange as the BBO—and could be, but is not necessarily, the NBBO. Because OPRA disseminates this information to all exchanges at the same time, the Exchange believes the proposal to open only after receiving an uncrossed NBBO from OPRA would eliminate any ambiguity as to the source of the information for each series and should lead to more accurate prices on the Exchange.
Similarly, the Exchange believes the conforming change to Rule 952NY(c), which strikes reference to quote bids and quote offers in the OX Book [sic] for purposes of determining an opening price, likewise would promote just and equitable principles of trade as it would add transparency and internal consistency to Exchange rules, which would make them easier for market participants to navigate.
Finally, the Exchange believes the proposal to permit the Exchange to open options trading when such opening is in the interests of a fair and orderly market (even if the conditions set forth in the rule are not met), is consistent with the protection of investors and the public interest because the proposed changes would allow the Exchange to open trading in options contracts in a fair and orderly manner. Specifically, the Exchange believes that the proposed changes would reduce potential delays in opening an option series that may prevent the Exchange from displaying and/or routing orders on its Consolidated Book and may also prevent the Exchange from disseminating a protected quote that draws trading interest from other options markets. Thus, the Exchange believes that the proposed changes would allow the Exchange to open options series faster and more efficiently, thereby reducing any delay in execution of orders on the Exchange that may be unnecessary and harmful to market participants. The Exchange also notes that this proposed rule change is based on the rules of other options exchanges.
The Exchange does not believe that the proposed rule change would impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The proposed change is not designed to address any competitive issue but rather to add specificity and transparency to Exchange rules, thereby reducing confusion and making the Exchange's rules easier to understand and navigate. The Exchange believes that the proposed rule change would serve to promote regulatory clarity and consistency, thereby reducing burdens on the marketplace and facilitating investor protection.
No written comments were solicited or received with respect to the proposed rule change.
Within 45 days of the date of publication of this notice in the
(A) By order approve or disapprove the proposed rule change, or
(B) institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act.
• 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 22, 2015, The NASDAQ Stock Market LLC (“Exchange” or “Nasdaq”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act” or Exchange Act”)
The Exchange proposes to list and trade the shares (“Shares”) of the Europe Fund, Asia Pacific Fund, Emerging Markets Fund, and Developed International Fund (individually, “Fund,” and collectively, “Funds”) under Nasdaq Rule 5735, which governs the listing and trading of Managed Fund Shares on the Exchange. Each Fund, which will be a series of First Trust Exchange-Traded Fund III (“Trust”), will be an actively managed exchange-traded fund (“ETF”). The Shares will be offered by the Trust,
First Trust Advisors L.P. will be the investment adviser (“Adviser”) to the
The Exchange has made the following representations and statements describing the Funds and the Funds' investment strategies, including the Funds' portfolio holdings and investment restrictions.
Each Fund's investment objective will be to provide capital appreciation. Under normal market conditions,
For each Fund, (a) “Principal Equity Securities” will consist of the following U.S. and non-U.S. exchange-listed securities: (i) Common stocks; (ii) common and preferred shares of real estate investment trusts (“REITs”); and (iii) American Depositary Receipts (“ADRs”), European Depositary Receipts (“EDRs”), and Global Depositary Receipts (“GDRs” and, together with ADRs and EDRs, collectively, “Depositary Receipts”),
(1) For the Europe Fund, Principal Fund Equity Securities will be Principal Equity Securities of European companies;
(2) for the Asia Pacific Fund, Principal Fund Equity Securities will be Principal Equity Securities of Asian Pacific companies;
(3) for the Emerging Markets Fund, Principal Fund Equity Securities will be Principal Equity Securities of emerging market companies;
(4) for the Developed International Fund, Principal Fund Equity Securities will be Principal Equity Securities of developed market companies.
In selecting securities for a Fund, the Sub-Adviser will score individual securities from a portfolio of eligible securities according to several core attributes, using multiple proprietary factors within each core attribute. The Sub-Adviser will then rank each qualifying security based on its core attribute score, and the highest scoring securities will be considered for inclusion in the Fund's portfolio. The Sub-Adviser will utilize its proprietary optimization process to maximize the percentage of high-scoring securities included in each Fund's portfolio.
In addition, for each Fund, by entering into Forward Contracts and currency spot transactions, the Sub-Adviser will deploy a dynamic currency hedge (hedging up to 100% of such Fund's foreign currency exposure) based on its proprietary hedging methodology. The Sub-Adviser's hedging methodology will be constructed from a combination of quantitative measures and qualitative measures. Each Fund will only enter into transactions in Forward Contracts with counterparties that the Adviser and/or the Sub-Adviser reasonably believe are capable of performing under the applicable Forward Contract.
According to the Exchange, each Fund may invest (in the aggregate) up to 20% of its net assets in the following securities and instruments.
Each Fund may invest in the following U.S. and non-U.S. exchange-listed securities (other than Principal Fund Equity Securities): (i) Common stocks; (ii) common and preferred shares of REITs; (iii) Depositary Receipts; and (iv) equity securities of business development companies (collectively, “Other Equity Securities”).
Each Fund may invest in short-term debt securities and other short-term debt instruments (described below), as well as cash equivalents, or it may hold cash. The percentage of each Fund invested in such holdings or held in cash will vary and will depend on several factors, including market conditions. Each Fund may invest in the following short-term debt instruments:
Each Fund may invest (but only up to 5% of its net assets) in exchange-listed equity index futures contracts.
According to the Exchange, under normal market conditions, each Fund will invest in at least 20 Equity Securities. Each Fund will satisfy the “ISG Criteria” (as described below) and/or the “Alternative Criteria” (as described below).
A Fund will satisfy the ISG Criteria if at least 90% of such Fund's net assets that are invested (in the aggregate) in Equity Securities will be invested in Equity Securities that trade in markets that are members of the Intermarket Surveillance Group (“ISG”)
A Fund will satisfy the Alternative Criteria if, under normal market conditions, its Equity Securities meet the following criteria at the time of purchase and on a continuous basis: (1) Non-U.S. Equity Securities
According to the Exchange, each Fund's transactions in Forward Contracts and exchange-listed equity index futures contracts will be consistent with its investment objective and the 1940 Act and will not be used to seek to achieve a multiple or inverse multiple of an index. Each Fund will comply with the regulatory requirements of the Commission with respect to coverage in connection with its transactions in Forward Contracts and exchange-listed equity index futures contracts. If the applicable guidelines prescribed under the 1940 Act so require, a Fund will earmark cash, U.S. government securities and/or other liquid assets permitted by the Commission in the amount prescribed.
Each Fund may hold up to an aggregate amount of 15% of its net assets in illiquid assets (calculated at the time of investment), deemed illiquid by the Adviser and/or the Sub-Adviser.
The Funds may not invest 25% or more of the value of their respective total assets in securities of issuers in any one industry. This restriction does not apply to (a) obligations issued or guaranteed by the U.S. government, its agencies or instrumentalities, or (b) securities of other investment companies.
Each Fund intends to qualify each year as a regulated investment company under Subchapter M of the Internal Revenue Code.
After careful review, the Commission finds that the Exchange's proposal is consistent with the Exchange Act and the rules and regulations thereunder
The Commission also finds that the proposal is consistent with Section 11A(a)(1)(C)(iii) of the Exchange Act,
Quotation and last-sale information for the Shares will be available via Nasdaq proprietary quote and trade services, as well as in accordance with the Unlisted Trading Privileges and the Consolidated Tape Association (“CTA”) plans for the Shares. On each business day, before commencement of trading in Shares in the Regular Market Session
In addition, the Intraday Indicative Value
Information regarding market price and trading volume of the Shares will be continually available on a real-time basis throughout the day on brokers' computer screens and other electronic services. Information regarding the previous day's closing price and trading volume information for the Shares will be published daily in the financial section of newspapers. Quotation and last-sale information for the Equity Securities (to the extent traded on a U.S. exchange) will be available from the exchanges on which they are traded as well as in accordance with any applicable CTA plans. Pricing information for Short-Term Debt Instruments, repurchase agreements, Forward Contracts, bank time deposits, certificates of deposit, and currency spot transactions will be available from major broker-dealer firms and/or major market data vendors and/or Pricing Services. Pricing information for exchange-listed equity index futures contracts and non-U.S. Equity Securities will be available from the applicable listing exchange and from major market data vendors. In addition, the Exchange notes that the Funds' Web site will include a form of the prospectus for the Funds and additional data relating to NAV and other applicable quantitative information.
The Commission also believes that the proposal to list and trade the Shares is reasonably designed to promote fair disclosure of information that may be necessary to price the Shares appropriately and to prevent trading when a reasonable degree of transparency cannot be assured. The Exchange states that it will obtain a representation from the issuer of the Shares that the NAV per Share will be calculated daily and that the NAV and the Disclosed Portfolio will be made available to all market participants at the same time. The Exchange also represents that it may consider all relevant factors in exercising its discretion to halt or suspend trading in the Shares of a Fund. The Exchange will halt trading in the Shares under the conditions specified in Nasdaq Rules 4120 and 4121, including the trading pauses under Nasdaq Rules 4120(a)(11) and (12). Trading may be halted because of market conditions or for reasons that, in the view of the Exchange, make
The Exchange states that it has a general policy prohibiting the distribution of material, non-public information by its employees. The Exchange further states that neither the Adviser nor the Sub-Adviser is a broker-dealer, but each is affiliated with a broker-dealer, and that the Adviser and Sub-Adviser has each implemented a fire wall with respect to its respective broker-dealer affiliate regarding access to information concerning the composition of, and changes to, each Fund's portfolio.
Nasdaq deems the Shares to be equity securities, thus rendering trading in the Shares subject to Nasdaq's existing rules governing the trading of equity securities. In support of this proposal, the Exchange represented that:
(1) The Shares will be subject to Nasdaq Rule 5735, which sets forth the initial and continued listing criteria applicable to Managed Fund Shares.
(2) Trading in the Shares will be subject to the existing trading surveillances, administered by both Nasdaq and FINRA on behalf of the Exchange, which are designed to detect violations of Exchange rules and applicable federal securities laws. The Exchange represents that these procedures are adequate to properly monitor Exchange trading of the Shares in all trading sessions and to deter and detect violations of Exchange rules and applicable federal securities laws.
(3) FINRA, on behalf of the Exchange, will communicate as needed regarding trading in the Shares and certain of the Equity Securities and exchange-listed equity index futures contracts held by the Funds with other markets and other entities that are members of ISG, and FINRA may obtain trading information regarding trading in the Shares and such securities and instruments held by the Funds from such markets and other entities. In addition, the Exchange may obtain information regarding trading in the Shares and certain of the Equity Securities and exchange-listed equity index futures contracts held by the Funds from markets and other entities that are members of ISG, which includes securities and futures exchanges, or with which the Exchange has in place a comprehensive surveillance sharing agreement. Moreover, FINRA, on behalf of the Exchange, will be able to access, as needed, trade information for certain fixed income securities held by the Funds reported to FINRA's Trade Reporting and Compliance Engine (“TRACE”).
(4) For each Fund, at least 90% of such Fund's net assets that are invested (in the aggregate) in exchange-listed equity index futures contracts will be invested in instruments that trade in markets that are members of ISG or are parties to a comprehensive surveillance sharing agreement with the Exchange.
(5) The Exchange has appropriate rules to facilitate transactions in the Shares during all trading sessions.
(6) Prior to the commencement of trading, the Exchange will inform its members in an Information Circular of the special characteristics and risks associated with trading the Shares. Specifically, the Information Circular for each Fund will discuss the following: (a) The procedures for purchases and redemptions of Shares in Creation Units (and that Shares are not individually redeemable); (b) Nasdaq Rule 2111A, which imposes suitability obligations on Nasdaq members with respect to recommending transactions in the Shares to customers; (c) how information regarding the Intraday Indicative Value and the Disclosed Portfolio is disseminated; (d) the risks involved in trading the Shares during the Pre-Market and Post-Market Sessions when an updated Intraday Indicative Value will not be calculated or publicly disseminated; (e) the requirement that members deliver a prospectus to investors purchasing newly issued Shares prior to or concurrently with the confirmation of a transaction; and (f) trading information.
(7) For initial and continued listing, the Funds must be in compliance with Rule 10A-3 under the Act.
(8) Each Fund may hold up to an aggregate amount of 15% of its net assets in illiquid assets.
(9) The Pricing Committee will be subject to procedures designed to prevent the use and dissemination of material non-public information regarding each Fund's portfolio.
(10) Each Fund will satisfy: (a) The ISG Criteria; and/or (b) the Alternative Criteria at the time of purchase and on a continuous basis.
(11) A minimum of 100,000 Shares will be outstanding at the commencement of trading on the Exchange.
The Exchange represents that all statements and representations made in the filing regarding (a) the description of the portfolios, (b) limitations on portfolio holdings or reference assets, or (c) the applicability of Exchange rules and surveillance procedures shall constitute continued listing requirements for listing the Shares on the Exchange. In addition, the issuer has represented to the Exchange that it will advise the Exchange of any failure by the Funds to comply with the continued listing requirements, and, pursuant to its obligations under Section 19(g)(1) of the Act, the Exchange will monitor for compliance with the continued listing requirements.
For the foregoing reasons, the Commission finds that the proposed rule change, as modified by Amendment Nos. 1, 2, and 3 thereto, is consistent with Section 6(b)(5) of the Act
It is therefore ordered, pursuant to Section 19(b)(2) of the Exchange Act,
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to delete two incorrect cross-references in Rule 1064, Crossing, Facilitation and Solicited Orders.
The text of the proposed rule change is detailed below: Proposed new language is in italics and proposed deletions are in brackets.
(a)-(c) No change.
(d) No change.
(i)-(ii) No change.
(iii) No change.
(A)-(F) No change.
(G) prior to entering tied hedge orders on behalf of customers, the member or member organization must deliver to the customer a written notification informing the customer that his order may be executed using the Exchange's tied hedge procedures. The written notification must disclose the terms and conditions contained [in this Commentary] herein and be in a form approved by the Exchange. A combination option and hedging position offered in reliance on this [Commentary .04] provision shall be referred to as a “tied hedge” order.
(H)-(I) No change.
(e) No change.
• • • Commentary: ------------------
.01-.02 No change.
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The purpose of the filing is to correct Rule 1064 by deleting two references to the “commentary” to the rule, which no longer exists. The Exchange recently deleted Commentary .04
The Exchange believes that its proposal is consistent with Section 6(b) of the Act
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. This minor correction does not impact competition.
No written comments were either solicited or received.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A)(iii) of the Act
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 February 2, 2016, EDGX Exchange, Inc. (the “Exchange” or “EDGX”) filed with the Securities and Exchange Commission (the “Commission”), pursuant to Section 19(b)(1)
The Exchange proposes to amend its rules to: (i) Create a new trading session, the Early Trading Session, which will run from 7:00 a.m. to 8:00 a.m. Eastern Time; and (ii) adopt three new TIF instructions.
The Exchange trading day is currently divided into three sessions: (i) The Pre-Opening Session which starts at 8:00 a.m. and ends at 9:30 a.m. Eastern Time; (ii) Regular Trading Hours which runs from 9:30 a.m. to 4:00 p.m. Eastern Time; and (iii) the Post-Closing Session, which runs from 4:00 p.m. to 8:00 p.m.
The Exchange also proposes to amend Exchange Rule 11.1(a) to state that orders may be entered or executed on, or routed away from, the Exchange during the the Early Trading Session and to reflect the start time of the Early Trading Session as 7:00 a.m. Eastern Time. Other than the proposal to adopt an Early Trading Session, the Exchange does not propose to amend the substance or operation of Exchange Rule 11.1(a).
Users
As amended, Exchange Rule 11.1(a)(1) would state that orders entered between 6:00 a.m. and 7:00 a.m. Eastern Time, rather than 6:00 a.m. and 8:00 a.m. Eastern Time, would not be eligible for execution until the start of the Early Trading Session, Pre-Opening Session, or Regular Trading Hours, depending on the TIF selected by the User. Exchange Rule 11.1(a)(1) will also be amended to state that the Exchange will not accept the following orders prior to 7:00 a.m. Eastern Time, rather than 8:00 a.m.: Orders with a Post Only instruction,
The Exchange also proposes to make the changes described below to Exchange Rules 3.21, 11.8, 11.10, 11.15, 14.1, 14.2 and 14.3 to reflect the adoption of the Early Trading Session:
• Exchange Rule 3.21, Customer Disclosures. Exchange Rule 3.21 prohibits Members from accepting an order from a customer for execution in the Pre-Opening or Post-Closing Session without disclosing to their customer that extended hours trading involves material trading risks, including the possibility of lower liquidity, high volatility, changing prices, unlinked markets, an exaggerated effect from news announcements, wider spreads and any other relevant risk. The Exchange proposes to amend Exchange Rule 3.21 to also require such disclosures for customer orders that are to be executed during the Early Trading Session.
• Exchange Rules 11.8(b), (c), (d), and (f). The Exchange proposes to amend the description of Limit Orders under Exchange Rule 11.8(b), ISOs under Exchange Rule 11.8(c), MidPoint Peg Orders under Exchange Rule 11.8(d), and Supplemental Peg Orders under Exchange Rule 11.8(f) to account for the Early Trading Session. Every order type that is currently available beginning at 8:00 a.m. will be available beginning at 7:00 a.m. for inclusion in the Early Trading Session. All other order types, and all order type behaviors, will otherwise remain unchanged. Therefore, each of the above rules for Limit Orders, ISOs, MidPoint Peg Orders, and Supplemental Peg Orders would be amended to state that those order types are available during the Early Trading Session.
• Exchange Rules 11.8(a) and (e). Market Orders and Market Maker Peg Orders would not be eligible for execution during the Early Trading Session. Market Orders are only eligible for execution during the Regular Session.
• Exchange Rule 11.10, Order Execution and Routing. Exchange Rule 11.10(a)(2) discusses compliance with Regulation NMS and Trade Through Protections and states that the price of any execution occurring during the Pre-Opening Session or the Post-Closing Session must be equal to or better than the highest Protected Bid or lowest Protected Offer, unless the order is marked ISO or a Protected Bid is crossing a Protected Offer. The Exchange proposes to amend Exchange Rule 11.10(a)(2) to expand the rule's requirements to the Early Trading Session.
• Exchange Rule 11.15, Clearly Erroneous Executions. Exchange Rule 11.15 outlines under which conditions the Exchange may determine that an execution is clearly erroneous. The Exchange proposes to amend Exchange Rule 11.15 to include executions that occur during the Early Trading Session.
• Exchange Rule 14.1, Unlisted Trading Privileges. The Exchange proposes to amend Exchange Rules 14.1(c)(2), and Interpretation and Policies .01(a) and (b) to account for the Early Trading Session. Specifically, the Exchange proposes to amend paragraph (c)(2) to state that an information circular distributed by the Exchange prior to the commencement of trading of a UTP Derivative Security
• Exchange Rule 14.2, Investment Company Units. The Exchange proposes to amend Exchange Rule 14.2(g) to state that transactions in Investment Company Units may occur during the Early Trading Session. Currently, such transactions may occur during Regular Trading Hours and the Pre-Opening and Post Closing Sessions.
• Exchange Rule 14.3, Trust Issued Receipts. The Exchange proposes to amend Exchange Rule 14.3(d) to state that transactions in Trust Issued Receipts may occur during the Early Trading Session. Currently, such transactions may occur during Regular Trading Hours and the Pre-Opening and Post-Closing Sessions.
The Exchange proposes to adopt three new TIF instructions under Exchange Rule 11.6(q).
Although the Exchange states that the proposal to adopt an Early Trading Session is in response to User requests for their orders to be eligible for execution starting at 7:00 a.m. Eastern Time, some Users have requested that their orders continue to not be eligible for execution until the start of the Pre-Opening Session at 8:00 a.m.
• Pre-Opening Session Plus (“PRE”). A limit order that is designated for execution during the Pre-Opening Session and Regular Trading Hours. Like the current Day TIF instruction,
• Pre-Opening Session `til Extended Day (“PTX”). A limit order that is designated for execution during the Pre-Opening Session, Regular Trading Hours, and the Post-Closing Session. Like the current GTX TIF instruction,
• Pre-Opening Session `til Day (“PTD”). A limit order that is designated for execution during the Pre-Opening Session, Regular Trading Hours, and the Post-Closing Session. Like the current GTD TIF instruction,
Under each proposed TIF instruction, Users may designate that their orders only be eligible for execution starting with the Pre-Opening Session. Users may continue to enter orders as early as 6:00 a.m., but orders with the proposed TIF instructions would not be eligible for execution until 8:00 a.m. Eastern Time, the start of the Pre-Opening Session.
The Exchange proposes to amend the following order types under Exchange Rule 11.8 to account for the three proposed TIF instructions:
• Market Orders. The proposed TIF instruction of PRE, PTX, and PTD would not be available for Market Orders. Under Exchange Rule 11.8(a)(2), a Market Order may only include a TIF instruction of IOC, RHO, FOK, or Day.
• Limit Orders. Exchange Rule 11.8(b)(2) describes the TIF instructions that may be attached to a Limit Order. The Exchange proposes to amend paragraph (b)(2) to add the TIF instructions of PRE, PTX, or PTD to the list of TIF instructions that a Limit Order may include.
• ISOs. Exchange Rule 11.8(c)(1) describes the TIF instructions that may be attached to an incoming ISO. The Exchange proposes to amend paragraph (c)(1) to state that an incoming ISO may have a TIF instruction of PRE, PTX, or PTD, in addition to Day, GTD, RHO, GTX, and IOC. Exchange Rule 11.8(c)(1) would be further amended to state that an incoming ISO with a Post Only and TIF instruction of PRE, PTX, or PTD, like those with an TIF instruction or GTD, GTX, or Day, will be cancelled without execution if, when entered, it is immediately marketable against an order with a Displayed instruction resting in the EDGX Book unless such order removes liquidity pursuant to Exchange Rule 11.6(n)(4).
• MidPoint Peg Orders. Exchange Rule 11.8(d)(1) describes the TIF instructions that may be attached to a MidPoint Peg Order. The Exchange proposes to amend paragraph (d)(1) to state that a MidPoint Peg Order may have a TIF instruction of PRE, PTX, or PTD, in addition to Day, FOK, IOC, RHO, GTX and GTD.
• Market Maker Peg Orders. The proposed TIF instruction of PRE, PTX, and PTD would not be available to Market Maker Peg Orders. Under Exchange Rule 11.8(e)(4), a Market Maker Peg Order may only include a TIF instruction of Day, RHO, or GTD.
• Supplemental Peg. Exchange Rule 11.8(f)(1) describes the TIF instructions that may be attached to a Supplemental Peg Order. The Exchange proposes to amend paragraph (f)(1) to state that a Supplemental Peg Order may have a TIF instruction of PRE, PTX, or PTD, in addition to GTD, GTX, RHO and Day.
After careful consideration, the Commission finds that the proposed rule change, as modified by Amendment No. 1, is consistent with the requirements of the Act and the rules and regulations thereunder applicable to a national securities exchange.
The Exchange proposes to adopt an Early Trading Session and three new TIF instructions and to make related changes to its rules as discussed above.
The Commission notes that the Exchange has represented that it would subject orders that are eligible for execution as of the start of the Pre-Opening Session to all of the Exchange's standard regulatory checks, as it currently does with all orders upon entry.
The Commission further notes the Exchange's discussion of the best execution obligations of Members utilizing the proposed TIF instructions.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice is hereby given, pursuant to the provisions of the Government in the Sunshine Act, Public Law 94-409, that the Securities and Exchange Commission Investor Advisory Committee will hold a meeting on Thursday, April 14, 2016, in Multi-Purpose Room LL-006 at the Commission's headquarters, 100 F Street NE., Washington, DC. The meeting will begin at 9:30 a.m. (ET) and will be open to the public. Seating will be on a first-come, first-served basis. Doors will open at 9:00 a.m. Visitors will be subject to security checks. The meeting will be webcast on the Commission's Web site at
On March 23, 2016, the Commission issued notice of the Committee meeting (Release No. 33-10058), indicating that the meeting is open to the public (except during that portion of the meeting reserved for an administrative work session during lunch), and inviting the public to submit written comments to the Committee. This Sunshine Act notice is being issued because a quorum of the Commission may attend the meeting.
The agenda for the meeting includes: Remarks from Commissioners; a discussion of a recommendation of the Investor as Purchaser subcommittee regarding mutual fund cost disclosure; an update from the Commission's Office of Compliance Inspections and Examinations; subcommittee reports; a discussion regarding cybersecurity and related investor protection concerns; reflections on the first full term of Investor Advisory Committee membership; and a nonpublic administrative work session during lunch.
For further information, please contact the Office of the Secretary at (202) 551-5400.
Pursuant to Section 19(b)(1)
The Exchange proposes to amend the Eighth Amended and Restated Operating Agreement of the Exchange (“Operating Agreement”) to (1) change the process for nominating non-affiliated directors; (2) remove a reference to an obsolete category of member; and (3) add references to Designated Market Makers. The proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes to amend the Operating Agreement to (1) change the process for nominating non-affiliated directors; (2) remove a reference to an obsolete category of member; and (3) add references to Designated Market Makers (“DMMs”).
Pursuant to the Operating Agreement, at least 20% of the Board of Directors of the Exchange (“Board”) is made up of “Non-Affiliated Directors” (commonly referred to as “fair representation directors”).
Currently, the nomination by the ICE NGC is the final step in the process for electing a Non-Affiliated Director. First, the DCRC recommends a candidate, whose name then is announced to the Exchange's Member Organizations. The Member Organizations may propose alternate candidates by petition. If there are no petition candidates, the DCRC recommends its candidate to the ICE NGC. If petition candidates are proposed, the ICE NGC makes the determination of whether the candidates are eligible, and then all of the eligible candidates are submitted to the Member Organizations for a vote. The DCRC recommends to the ICE NGC the candidate receiving the highest number of votes. The ICE NGC is obligated to designate the DCRC-recommended candidate as the nominee, and NYSE Group is obligated to elect him or her as a Non-Affiliated Director.
The Exchange believes obligating the ICE NGC to nominate the candidates for Non-Affiliated Directors based on the DCRC's unalterable recommendation is neither necessary nor meaningful. Pursuant to Section 2.03(a)(iii) the ICE NGC is obligated to designate whomever the DCRC recommends or, if there is a petition candidate, whomever emerges from the petition process. The ICE NGC does not have any discretion. Removing this unnecessary step would make the NYSE MKT process more efficient.
The Exchange believes that having the Exchange determine whether persons endorsed to be petition candidates are eligible also would be more efficient, as it would not require action from the ICE NGC, thereby removing the possibility
The Exchange believes that the proposed changes will make its process more consistent with the process by which its affiliate, NYSE Arca, Inc. (“NYSE Arca”), designates its fair representation directors, in which the ICE NGC plays no role.
Accordingly, the Exchange proposes to revise Section 2.03(a)(iii)-(v) of the Operating Agreement to amend the process for electing Non-Affiliated Directors. As proposed, the process would be as follows. First, as is currently the case, the DCRC would recommend a candidate, whose name would be announced to the Member Organizations, and the Member Organizations could propose alternate candidates by petition. Second, if there were no petition candidates, the DCRC would nominate the candidate it had previously recommended. If there were petition candidates, the Exchange would make the eligibility determination of petition candidates, all eligible candidates would be submitted to the Member Organizations for a vote, and the DCRC would nominate the candidate receiving the highest number of votes. Finally, NYSE Group would be obligated to elect the DCRC-nominated candidate as a Non-Affiliated Director.
The Exchange would make a conforming change to Section 2.03(h)(i) to state that the DCRC “will be responsible for nominating Non-Affiliate Director Candidates.” Currently, the provision states that the DCRC “will be responsible for recommending Non-Affiliated Director Candidates to the ICE NGC.”
As noted above, the Operating Agreement requires that the DCRC include representatives from each of four categories of Exchange members. The Exchange proposes to amend Section 2.03(h)(i) of the Operating Agreement to eliminate from the DCRC representatives of the fourth category, which relates to individuals who are “associated with a Member Organization and spend a majority of their time on the trading floor of the [Exchange] and have as a substantial part of their business the execution of transactions on the trading floor of the [Exchange] for their own account or the account of their Member Organization, but are not registered as a specialist.”
This fourth category describes a class of proprietary traders known as Registered Equity Market Makers (“REMM”) on the former American Stock Exchange LLC, a predecessor of the Exchange. REMMs were floor traders who engaged in on-floor proprietary trading, subject to certain requirements intended to have these members effectively function like market makers, pursuant to the exemption for market makers in Section 11(a)(1)(A) of the Exchange Act.
In 2008, the Exchange adopted rules, based on NYSE rules, that transformed specialists in the Exchange's equity market into DMMs.
Section 2.02 of the Operating Agreement provides that the Board has general supervision over Member Organizations and over approved persons in connection with their conduct with or affecting Member Organizations. Section 2.02 further provides that the Board “may disapprove of any member acting as a specialist or odd lot dealer”. The Exchange proposes to add “designated market maker (as defined in Rule 2 of the Company Rules) (`DMM')” after “specialist” in Section 2.02.
Section 2.03(h)(i) sets out the categories of individuals that shall be represented on the DCRC. The Exchange proposes to add “or DMM” to the references to “specialist” in categories (ii) and (iii), so that they reference both types of market makers. The changes would be consistent with the categories of members of the Committee for Review in Section 2.03(h)(iii), which refers to both DMMs and specialists.
Finally, the Exchange proposes to make technical and conforming changes to the recitals and signature page of the Operating Agreement.
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Exchange Act
The proposed change would remove the requirement that the ICE NGC nominate the candidates for Non-Affiliated Directors and have the DCRC nominate the candidates for Non-Affiliated Director directly. This proposed change would remove an unnecessary step in the process of nominating candidates for Non-Affiliated Directors and increase efficiency. In addition, the proposed change would remove the requirement that the ICE NGC make the determination whether persons endorsed to be petition candidates are eligible to be Non-Affiliated Directors, and have the Exchange make such determination instead. By not requiring action from the ICE NGC, the possibility of any resulting delay in the process is removed. For these reasons, the Exchange believes that the proposed rule change would contribute to the orderly operation of the Exchange and would enable the Exchange to be so organized as to have the capacity to carry out the purposes of the Exchange Act and comply and enforce compliance with the provisions of the Exchange Act by its members and persons associated with its members. The Exchange therefore believes that approval of the proposed is consistent with Section 6(b)(1) of the Act.
The Exchange believes that amending the Operating Agreement to remove the requirement that the DCRC include representatives from the fourth category of members would remove a reference to an obsolete category, thereby reducing potential confusion that may result from retaining obsolete references in the Exchange's Operating Agreement. The Exchange believes that eliminating such obsolete references would not be inconsistent with the public interest and the protection of investors because investors will not be harmed and in fact would benefit from increased transparency, thereby reducing potential confusion. Removing such obsolete references will also further the goal of transparency and add clarity to the Exchange's rules.
The Exchange believes that adding references to DMMs enables the Exchange to be so organized as to have the capacity to be able to carry out the purposes of the Exchange Act and to comply, and to enforce compliance by its exchange members and persons associated with its exchange members, with the provisions of the Exchange Act, the rules and regulations thereunder, and the rules of the Exchange. The proposed addition of a reference to DMMs in Section 2.02 will clarify that the Board has general supervision over all Member Organizations, including the ability to disapprove of any member acting as a DMM, as well as a specialist or odd lot dealer. The proposed addition of references to DMMs in Section 2.03(h)(i) further the goals of Section 6(b)(3) of ensuring fair representation of an exchange's members in the selection of its directors and administration of its affairs by including both types of market makers in the categories of individuals that shall be represented on the DCRC.
The Exchange also believes that this filing furthers the objectives of Section 6(b)(5) of the Exchange Act
The Exchange believes that having the DCRC nominate the candidates for Non-Affiliated Director would remove impediments to and perfect a national market system because the proposed rule change would remove an unnecessary step in the process for nominating candidates for Non-Affiliated Directors and would remove the ICE NGC from making the determination whether persons endorsed to be petition candidates are eligible to be Non-Affiliated Directors. By not requiring action from the ICE NGC, the possibility of any resulting delay in the process is removed. The Exchange believes that the proposed rule change is therefore consistent with and facilitates a governance and regulatory structure that furthers the objectives of Section 6(b)(5) of the Act.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Exchange Act. The proposed rule change is not intended to address competitive issues but rather is concerned solely with the administration and functioning of the Exchange and its board of directors.
No written comments were solicited or received with respect to the proposed rule change.
Within 45 days of the date of publication of this notice in the
(A) By order approve or disapprove the proposed rule change, or
(B) Institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
The Exchange proposes changes to Rule 6.64 (OX Opening Process) with respect to opening trading in an options series. The proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Exchange is proposing changes to Rule 6.64 with respect to opening trading in an option series as described below.
Rule 6.64 describes the process pursuant to which OX (“OX System”)
Any orders in the OX System that are not executed in the Auction Process become eligible for the Core Trading Session immediately after the conclusion of the Auction Process. If the OX System does not open a series with an Auction Process, the OX System shall open the series for trading after receiving notification of an initial NBBO disseminated by OPRA for the series or on a Market Maker quote, provided that the bid-ask differential does not exceed the bid-ask differential specified under Rule 6.37A(b)(4).
First, the Exchange proposes to change Rule 6.64(b) regarding how the OX System determines when to start the Auction Process. Current paragraph (b) of the Rule provides that “[a]fter the primary market for the underlying security disseminates the opening trade or the opening quote, the related option series will be opened automatically.” However, because it is possible that either an opening quote or opening trade alone may not accurately reflect the state of the market, the Exchange proposes to specify that an option series will be opened automatically, “once the primary market for the underlying security disseminates a quote and a trade that is at or within the quote.”
Next, the Exchange proposes to modify Rule 6.64(b)(E), which currently provides, in relevant part, that “[i]f the OX System does not open a series with an Auction Process, the OX System shall open the series for trading after receiving notification of an initial NBBO disseminated by OPRA for the series or on a Market Maker quote.”
In connection with the proposed changes to Rule 6.64(b), the Exchange likewise proposes to strike from Rule 6.64(c) reference to “the midpoint of the best quote bids and quote offers in the OX Book” as it relates to the Exchange determining the opening price for options issues designated for trading on the OX System.
Finally, the Exchange proposes new paragraph (F) to Rule 6.64(b) to provide the Exchange with discretion to deviate from the standard Opening Process where it is necessary in the interests of a fair and orderly market.
The Exchange believes the proposed rule change is consistent with Section 6(b)
Specifically, the proposed change to Rule 6.64(b) would clarify that the Exchange would only open a series automatically after it receives a quote in the underlying security and a trade in that security at or between the disseminated quote—as opposed to automatically opening on either an opening quote or an opening trade alone per the current rule text, which may not always accurately reflect the state of the market. The Exchange believes this added transparency would promote just and equitable principles of trade and remove impediments to, and perfect the mechanism of, a free and open market and a national market system to the benefit of market participants. Further, the Exchange believes that waiting to open trading in an option series until there has been both a disseminated quote and trade in the underlying security would protect investors and the public interest because it would help to augment the Auction Process by ensuring that an underlying security has been opened pursuant to a robust price discovery process before opening the overlying options for trading. Moreover, this proposed change would promote just and equitable principles of trade to the benefit of investors and the public interest because it would provide market participants with greater certainty as to the true state of the market at the opening of the trading day and should lead to more accurate prices on the Exchange.
The Exchange also believes that specifying that, to open a series, the Exchange would require an initial uncrossed NBBO disseminated by OPRA would promote just and equitable principles of trade as the change is designed to protect investors and the public interest. The Exchange notes that OPRA disseminates to each exchange the NBBO as well as the top of book for each exchange, such that the Exchange's market maker quote would be disseminated back to the Exchange as the BBO—and could be, but is not necessarily, the NBBO. Because OPRA disseminates this information to all
Similarly, the Exchange believes the conforming change to Rule 6.64(c), which strikes reference to quote bids and quote offers in the OX Book for purposes of determining an opening price, likewise would promote just and equitable principles of trade as it would add transparency and internal consistency to Exchange rules, which would make them easier for market participants to navigate.
Finally, the Exchange believes the proposal to permit the Exchange to open options trading when such opening is in the interests of a fair and orderly market (even if the conditions set forth in the rule are not met), is consistent with the protection of investors and the public interest because the proposed changes would allow the Exchange to open trading in options contracts in a fair and orderly manner. Specifically, the Exchange believes that the proposed changes would reduce potential delays in opening an option series that may prevent the Exchange from displaying and/or routing orders on its Consolidated Book and may also prevent the Exchange from disseminating a protected quote that draws trading interest from other options markets. Thus, the Exchange believes that the proposed changes would allow the Exchange to open options series faster and more efficiently, thereby reducing any delay in execution of orders on the Exchange that may be unnecessary and harmful to market participants. The Exchange also notes that this proposed rule change is based on the rules of other options exchanges.
The Exchange does not believe that the proposed rule change would impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The proposed change is not designed to address any competitive issue but rather to add specificity and transparency to Exchange rules, thereby reducing confusion and making the Exchange's rules easier to understand and navigate. The Exchange believes that the proposed rule change would serve to promote regulatory clarity and consistency, thereby reducing burdens on the marketplace and facilitating investor protection.
No written comments were solicited or received with respect to the proposed rule change.
Within 45 days of the date of publication of this notice in the
(A) By order approve or disapprove the proposed rule change, or
(B) Institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
U.S. Small Business Administration.
Amendment 2.
This is an amendment of the Presidential declaration of a major disaster for the State of Texas (FEMA-4266-DR), dated 03/19/2016.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416.
The notice of the President's major disaster
All other information in the original declaration remains unchanged.
U.S. Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the District of Columbia (FEMA-4260-DR), dated 04/01/2016.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416.
Notice is hereby given that as a result of the President's major disaster declaration on 04/01/2016, Private Non-Profit organizations that provide essential services of governmental nature may file disaster loan applications at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 14690B and for economic injury is 14691B
Small Business Administration.
30-Day notice.
The Small Business Administration (SBA) is publishing this notice to comply with requirements of the Paperwork Reduction Act (PRA) (44 U.S.C. Chapter 35), which requires agencies to submit proposed reporting and recordkeeping requirements to OMB for review and approval, and to publish a notice in the
Submit comments on or before May 12, 2016.
Comments should refer to the information collection by name and/or OMB Control Number and should be sent to:
Curtis Rich, Agency Clearance Officer, (202) 205-7030
Information collection is needed to ensure that Microloan Program activity meets the statutory goals of assisting mandated target market. The information is used by the reporting participants and the SBA to assist with portfolio management, risk management, loan servicing oversight and compliance, data management and understanding of short and long term trends and development of outcome measures.
SBA is requesting comments on (a) Whether the collection of information is necessary for the agency to properly perform its functions; (b) whether the burden estimates are accurate; (c) whether there are ways to minimize the burden, including through the use of automated techniques or other forms of information technology; and (d) whether there are ways to enhance the quality, utility, and clarity of the information.
U.S. Small Business Administration.
Amendment 1.
This is an amendment of the Presidential declaration of a major disaster for the State of Mississippi (FEMA-4268-DR), dated 03/25/2016.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
Alan Escobar, Office of Disaster
The notice of the Presidential disaster declaration for the State of MISSISSIPPI, dated 03/25/2016 is hereby amended to include the following areas as adversely affected by the disaster:
All other information in the original declaration remains unchanged.
Notice of request for emergency OMB approval and public comment.
The Department of State has submitted the information collection request described below to the Office of Management and Budget (OMB) for review and approval in accordance with the emergency review procedures of the Paperwork Reduction Act of 1995 (5 CFR 1320.13). The purpose of this notice is to allow for public comment from all interested individuals and organizations. Emergency review and approval of this collection has been requested from OMB by April 29, 2016. If granted, the emergency approval is only valid for 180 days. The Department plans to follow this emergency request with a submission for a 3 year approval through OMB's normal PRA clearance process (5 CFR 1320.10).
Direct any comments on this emergency request to both the Department of State Desk Officer in the Office of Information and Regulatory Affairs at the Office of Management and Budget (OMB) and to the Legislation and Regulation Division in the Department of State's Visa Office.
All public comments must be received by April 25, 2016. You may submit comments to OMB by the following methods:
•
•
You may submit comments to the Visa Office by the following methods:
•
•
Direct requests for additional information regarding the collection listed in this notice, including requests for copies of the proposed collection instrument and supporting documents, to Taylor Mauck, who may be reached at 202-485-7635 or at
•
•
•
•
•
•
•
•
•
•
•
•
We are soliciting public comments to permit the Department to:
• Evaluate whether the proposed information collection is necessary for the proper functions of the Department.
• Evaluate the accuracy of our estimate of the time and cost burden of this proposed collection, including the validity of the methodology and assumptions used.
• Enhance the quality, utility, and clarity of the information to be collected.
• Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.
Please note that comments submitted in response to this Notice are public record. Before including any detailed personal information, you should be aware that your comments as submitted, including your personal information, will be available for public review.
The Adoptive Family Relief Act (Pub. L. 114-70) amended section 221(c) of the Immigration and Nationality Act (INA), 8 U.S.C. 1201(c), to allow for the waiver or refund certain immigrant visa fees for a lawfully adopted child, or a child coming to the United States to be adopted by a United States citizen, subject to criteria prescribed by the Secretary of State. Over 350 American families have successfully adopted children from the Democratic Republic of the Congo. However, since September 25, 2013, they have not been able to bring their adoptive children home to the United States because the Democratic Republic of the Congo suspended the issuance of “exit permits” for these children. As the permit suspension drags on, however, American families are repeatedly paying visa renewal and related fees, while also continuing to be separated from their adopted children.
The waiver or refund provides support and relief to American families seeking to bring their adoptive children from the Democratic Republic of Congo to the United States, and would also provide relief to similarly situated adoptive families should barriers arise in other countries in the future. See 161 Cong. Rec. S2796-01.
This form will collect information to determine the extra fees these families have paid and refund them in accordance with the Adoptive Family Relief Act. This is an emergency collection in order to immediately alleviate the financial burden on families who need multiple visas and those families are still waiting for refunds.
The form DS-7781 will be hosted on the Department of State Web site to be
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 May 2, 2016.
Send comments identified by docket number FAA-2015-0060 using any of the following methods:
•
•
•
•
Dan Ngo (202) 267-4264 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 May 2, 2016.
Send comments identified by docket number FAA-2015-5644 using any of the following methods:
•
•
•
•
Dan Ngo, (202) 267-4264. 800 Independence Avenue SW., Washington, DC 20591.
This notice is published pursuant to 14 CFR 11.85.
Issued in Washington, DC.
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 May 2, 2016.
Send comments identified by docket number FAA-2015-4805 using any of the following methods:
•
•
•
•
Joshua Parker (202) 267-1538, Office of Rulemaking, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591.
This notice is published pursuant to 14 CFR 11.85.
Issued in Washington, DC.
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 May 2, 2016.
Send comments identified by docket number FAA-2015-0094 using any of the following methods:
•
•
•
•
Dan Ngo (202) 267-4264, 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 May 2, 2016.
Send comments identified by docket number FAA-2015-8680 using any of the following methods:
•
•
•
•
Dan Ngo, 202-267-4264, 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 May 2, 2016.
Send comments identified by docket number FAA-2015-0534 using any of the following methods:
•
•
•
•
Paul Pellicano, 404-474-5558, Atlanta Certification Office, Federal Aviation Administration, 1701 Columbia Avenue, College Park, GA 30337.
This notice is published pursuant to 14 CFR 11.85.
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of applications for exemptions; request for comments.
FMCSA announces receipt of applications from 11 individuals for exemption from the vision requirement in the Federal Motor Carrier Safety Regulations. They are unable to meet the vision requirement in one eye for various reasons. The exemptions will enable these individuals to operate commercial motor vehicles (CMVs) in interstate commerce without meeting the prescribed vision requirement in one eye. If granted, the exemptions would enable these individuals to qualify as drivers of commercial motor vehicles (CMVs) in interstate commerce.
Comments must be received on or before May 12, 2016. All comments will be investigated by FMCSA. The exemptions will be issued the day after the comment period closes.
You may submit comments bearing the Federal Docket Management System (FDMS) Docket No. FMCSA-2016-0025 using any of the following methods:
•
•
•
•
Christine A. Hydock, Chief, Medical Programs Division, (202) 366-4001,
Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption from the Federal Motor Carrier Safety Regulations for a 2-year period if it finds “such exemption would likely achieve a level of safety that is equivalent to or greater than the level that would be achieved absent such exemption.” FMCSA can renew exemptions at the end of each 2-year period. The 11 individuals listed in this notice have each requested such an exemption from the vision requirement in 49 CFR 391.41(b)(10), which applies to drivers of CMVs in interstate commerce. Accordingly, the Agency will evaluate the qualifications of each applicant to determine whether granting an exemption will achieve the required level of safety mandated by statute.
Mr. Arroyo, 46, has had corneal opacity in his right eye since childhood. The visual acuity in his right eye is no light perception, and in his left eye, 20/20. Following an examination in 2015, his optometrist stated, “He had no color defects and in my medical opinion he is able to safely operate a commercial vehicle based in [
Mr. Carey, 54, has had decreased vision in his right eye since 2011. The visual acuity in his right eye is 20/200, and in his left eye, 20/25. Following an examination in 2016, his optometrist stated, “In my medical opinion Ronald has sufficient vision to perform the driving tasks required to operate a commercial vehicle.” Mr. Carey reported that he has driven straight trucks for 2 years, accumulating 150,000 miles and tractor-trailer combinations for 27 years, accumulating 1.65 million miles. He holds a Class AM CDL from Pennsylvania. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Chernyy, 51, has complete loss of vision in his left eye due to a traumatic incident in 1986. The visual acuity in his right eye is 20/20, and in his left eye, no light perception. Following an examination in 2015, his optometrist stated, “This certifies in my medical opinion that Valentin Chernyy has sufficient vision in his right eye to perform the driving tasks required to operate a commercial vehicle.” Mr. Chernyy reported that he has driven straight trucks for 14 years, accumulating 980,000 miles. He holds a Class O operator's license from Nebraska. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Floyd, 56, has had optic atrophy in his right eye since 2012 due to a traumatic incident. The visual acuity in his right eye is no light perception, and in his left eye, 20/20. Following an examination in 2016, his optometrist
Ms. Gerez-Bentancourt, 39, has had amblyopia in her right eye since childhood. The visual acuity in her right eye is 20/200, and in her left eye, 20/25. Following an examination in 2015, her ophthalmologist stated, “She was diagnosed with Amblyopia of right eye . . . She is able to perform all driving tasks that [
Mr. Junod, 62, has had a macular scar in his right eye since childhood. The visual acuity in his right eye is 20/70, and in his left eye, 20/15. Following an examination in 2016, his ophthalmologist stated, “I certify that the visual deficiency of this gentleman is stable and that in my medical opinion, based on the eye exam and his driving record which he verbally gives [
Mr. Kerns, 22, has had amblyopia in his right eye since childhood. The visual acuity in his right eye is 20/200, and in his left eye, 20/20. Following an examination in 2016 his optometrist stated, “In my medical opinion, Roger W. Kerns III has sufficient vision to perform the driving tasks required to operate a commercial vehicle.” Mr. Kerns reported that he has driven straight trucks for 2 years, accumulating 1,000 miles and tractor-trailer combinations for 2 years, accumulating 200,000 miles. He holds a Class A CDL from Iowa. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Maxwell, 73, has had a pigment epithelia detachment in his left eye in 2000. The visual acuity in his right eye is 20/25, and in his left eye, 20/70. Following an examination in 2015, his ophthalmologist stated, “He has a history of an epiretinal membrane and pigment epithelial detachment of his left eye. He has been driving a commercial vehicle without difficulty for many years, and I feel that he can safely continue to do so without any concerns.” Mr. Maxwell reported that he has driven straight trucks for 2 years, accumulating 80,000 miles and tractor-trailer combinations for 40 years, accumulating 12 million miles. He holds a Class A CDL from Ohio. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Palmer, 46, has had amblyopia in his left eye since childhood. The visual acuity in his right eye is 20/20, and in his left eye, 20/300. Following an examination in 2015, his optometrist stated, “In my medical opinion, Scott Palmer has sufficient vision to perform the driving tasks required to operate a commercial vehicle.” Mr. Palmer reported that he has driven straight trucks for 20 years, accumulating 800,000 miles. He holds a Class B CDL from New York. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Roberts, 82, has had macular degeneration in his right eye since 2008. The visual acuity in his right eye is 20/200, and in his left eye, 20/25. Following an examination in 2015, his ophthalmologist stated, “The patient has been able to operate commercial vehicles safely for many years, including the last seven years after being treated for macular degeneration. There has been no worsening in that time, so I believe that patient can continue to operative [
Mr. Tipton, 61, has had macular atrophy in his left eye since childhood. The visual acuity in his right eye is 20/30, and in his left eye, 20/200. Following an examination in 2015, his optometrist stated, “In summery Mr. Tipton in my opinion is more than able to meet the requirements visually for operation of a commercial vehicle.” Mr. Tipton reported that he has driven tractor-trailer combinations for 15 years, accumulating 20,500 miles. He holds a Class A CDL from Illinois. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
FMCSA encourages you to participate by submitting comments and related materials.
If you submit a comment, please include the docket number for this notice, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online or by fax, mail, or hand delivery, 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 the Agency can contact you if it has questions regarding your submission.
To submit your comment online, go to
FMCSA will consider all comments and material received during the comment period. FMCSA may issue a final determination at any time after the close of the comment period.
To view comments, as well as documents mentioned in this preamble as being available in the docket, go to
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of applications for exemptions; request for comments.
FMCSA announces receipt of applications from 46 individuals for exemption from the prohibition against persons with insulin-treated diabetes mellitus (ITDM) operating commercial motor vehicles (CMVs) in interstate commerce. If granted, the exemptions would enable these individuals with ITDM to operate CMVs in interstate commerce.
Comments must be received on or before May 12, 2016.
You may submit comments bearing the Federal Docket Management System (FDMS) Docket No. FMCSA-2016-0035 using any of the following methods:
•
•
•
•
Christine A. Hydock, Chief, Medical Programs Division, (202) 366-4001,
Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption from the Federal Motor Carrier Safety Regulations for a 2-year period if it finds “such exemption would likely achieve a level of safety that is equivalent to or greater than the level that would be achieved absent such exemption.” The statute also allows the Agency to renew exemptions at the end of the 2-year period. The 46 individuals listed in this notice have recently requested such an exemption from the diabetes prohibition in 49 CFR 391.41(b) (3), which applies to drivers of CMVs in interstate commerce. Accordingly, the Agency will evaluate the qualifications of each applicant to determine whether granting the exemption will achieve the required level of safety mandated by statute.
Mr. Adams, 50, has had ITDM since 2009. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Adams understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Adams meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from South Carolina.
Mr. Beideck, 67, has had ITDM since 1985. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Beideck understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Beideck meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds an operator's license from Oregon.
Mr. Bizanos, 54, has had ITDM since 2012. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in
Mr. Bohnert, 82, has had ITDM since 2013. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Bohnert understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Bohnert meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Pennsylvania.
Mr. Boruszewski, 47, has had ITDM since 2015. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Boruszewski understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Boruszewski meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2016 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Illinois.
Mr. Braithwaite, 56, has had ITDM since 2015. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Braithwaite understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Braithwaite meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds an operator's license from Ohio.
Mr. Brown, 73, has had ITDM since 2010. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Brown understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Brown meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2015 and certified that he has stable nonproliferative diabetic retinopathy. He holds a Class A CDL from New York.
Mr. Church, 58, has had ITDM since 2015. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Church understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Church meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2016 and certified that he does not have diabetic retinopathy. He holds an operator's license from Indiana.
Mr. Conley, 49, has had ITDM since 2014. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Conley understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Conley meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2016 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Indiana.
Mr. Davis, 51, has had ITDM since 2012. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Davis understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Davis meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Virginia.
Mr. Dudzenski, 34, has had ITDM since 2015. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Dudzenski understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Dudzenski meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2016 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Pennsylvania.
Mr. Dutton, 56, has had ITDM since 2014. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Dutton understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Dutton meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2016 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from North Dakota.
Mr. Favier, 64, has had ITDM since 2012. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Favier understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Favier meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2016 and certified that he does not have diabetic retinopathy. He holds an operator's license from Connecticut.
Mr. Fiscus, 57, has had ITDM since 1990. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Fiscus understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Fiscus meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds an operator's license from Massachusetts.
Mr. Fleming, 56, has had ITDM since 2015. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Fleming understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Fleming meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2016 and certified that he has stable nonproliferative diabetic retinopathy. He holds a Class A CDL from Illinois.
Mr. Garza, 58, has had ITDM since 2015. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Garza understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Garza meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2016 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Illinois.
Mr. Gear, 54, has had ITDM since 2004. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Gear understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Gear meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2015 and certified that he has stable nonproliferative diabetic retinopathy. He holds a Class A CDL from Missouri.
Mr. Gelb, 55, has had ITDM since 2005. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Gelb understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Gelb meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class C CDL from Massachusetts.
Mr. Hartill, 64, has had ITDM since 2005. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Hartill understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Hartill meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Washington.
Mr. Himebauch, 55, has had ITDM since 2015. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Himebauch understands
Mr. Hofmann, 47, has had ITDM since 1988. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Hofmann understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Hofmann meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2015 and certified that he has stable nonproliferative diabetic retinopathy. He holds an operator's license from Illinois.
Mr. Ingham, 45, has had ITDM since 1989. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Ingham understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Ingham meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2016 and certified that he has stable nonproliferative diabetic retinopathy. He holds a Class A CDL from Washington.
Mr. Jensen, 52, has had ITDM since 2015. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Jensen understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Jensen meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2016 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from South Dakota.
Mr. Kaneps, 58, has had ITDM since 1965. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Kaneps understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Kaneps meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2016 and certified that he has stable proliferative diabetic retinopathy. He holds an operator's license from Colorado.
Mr. Laubauskas, 46, has had ITDM since 2003. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Laubauskas understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Laubauskas meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2016 and certified that he has stable nonproliferative diabetic retinopathy. He holds an operator's license from New Jersey.
Mr. Lillie, 47, has had ITDM since 1996. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Lillie understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Lillie meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class C CDL from Michigan.
Mr. Mahabee, 33, has had ITDM since 2001. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Mahabee understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Mahabee meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2016 and certified that he does not have diabetic retinopathy. He holds an operator's license from New York.
Mr. Maines, 26, has had ITDM since 1996. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Maines understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Maines meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy.
Mr. Marnell, 29, has had ITDM since 1996. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Marnell understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Marnell meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2016 and certified that he has stable nonproliferative diabetic retinopathy. He holds an operator's license from Iowa.
Mr. McCoy, 61, has had ITDM since 2006. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. McCoy understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. McCoy meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class B CDL from Texas.
Mr. Neset, 52, has had ITDM since 1998. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Neset understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Neset meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from North Dakota.
Mr. Newell, 55, has had ITDM since 2001. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Newell understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Newell meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a chauffer's license from Michigan.
Mr. Paytas, 22, has had ITDM since 1994. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Paytas understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Paytas meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds an operator's license from Utah.
Mr. Pisiakowski, 58, has had ITDM since 2010. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Pisiakowski understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Pisiakowski meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2016 and certified that he does not have diabetic retinopathy. He holds a Class B CDL from Connecticut.
Mr. Pratt, 46, has had ITDM since 2011. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Pratt understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Pratt meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Minnesota.
Mr. Rangel, 73, has had ITDM since 2015. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Rangel understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Rangel meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from California.
Mr. Roy, 31, has had ITDM since 2003. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist
Mr. Santopietro, 61, has had ITDM since 2011. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Santopietro understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Santopietro meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2016 and certified that he does not have diabetic retinopathy. He holds a Class B CDL from Connecticut.
Mr. Silver, 36, has had ITDM since 1998. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Silver understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Silver meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds an operator's license from Florida.
Mr. Simmons, 40, has had ITDM since 2013. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Simmons understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Simmons meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2016 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Washington.
Mr. Smith, 38, has had ITDM since 2002. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Smith understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Smith meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2016 and certified that he does not have diabetic retinopathy. He holds a Class B CDL from North Carolina.
Mr. Taylor, 60, has had ITDM since 2014. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Taylor understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Taylor meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2016 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Indiana.
Mr. Tompkins, 74, has had ITDM since 2014. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Tompkins understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Tompkins meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2016 and certified that he has stable nonproliferative diabetic retinopathy. He holds a Class B CDL from New York.
Mr. Tsimis, 43, has had ITDM since 2014. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Tsimis understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Tsimis meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2016 and certified that he does not have diabetic retinopathy. He holds a Class B CDL from New York.
Mr. Voudren, 56, has had ITDM since 1989. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Voudren understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Voudren meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2015 and certified that he has stable nonproliferative diabetic retinopathy. He holds an operator's license from Virginia.
Mr. Yamauchi, 43, has had ITDM since 2015. His endocrinologist examined him in 2016 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Yamauchi understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Yamauchi meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2016 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Minnesota.
In accordance with 49 U.S.C. 31136(e) and 31315, FMCSA requests public comment from all interested persons on the exemption petitions described in this notice. We will consider all comments received before the close of business on the closing date indicated in the date section of the notice.
FMCSA notes that section 4129 of the Safe, Accountable, Flexible and Efficient Transportation Equity Act: A Legacy for Users requires the Secretary to revise its diabetes exemption program established on September 3, 2003 (68 FR 52441).
Section 4129 requires: (1) Elimination of the requirement for 3 years of experience operating CMVs while being treated with insulin; and (2) establishment of a specified minimum period of insulin use to demonstrate stable control of diabetes before being allowed to operate a CMV.
In response to section 4129, FMCSA made immediate revisions to the diabetes exemption program established by the September 3, 2003 notice. FMCSA discontinued use of the 3-year driving experience and fulfilled the requirements of section 4129 while continuing to ensure that operation of CMVs by drivers with ITDM will achieve the requisite level of safety required of all exemptions granted under 49 U.S.C. 31136(e).
Section 4129(d) also directed FMCSA to ensure that drivers of CMVs with ITDM are not held to a higher standard than other drivers, with the exception of limited operating, monitoring and medical requirements that are deemed medically necessary.
The FMCSA concluded that all of the operating, monitoring and medical requirements set out in the September 3, 2003 notice, except as modified, were in compliance with section 4129(d). Therefore, all of the requirements set out in the September 3, 2003 notice, except as modified by the notice in the
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
We will consider all comments and material received during the comment period. FMCSA may issue a final determination at any time after the close of the comment period.
To view comments, as well as any documents mentioned in this preamble, go to
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of applications for exemptions; request for comments.
FMCSA announces receipt of applications from 25 individuals for exemption from the vision requirement in the Federal Motor Carrier Safety Regulations. They are unable to meet the vision requirement in one eye for various reasons. The exemptions will enable these individuals to operate commercial motor vehicles (CMVs) in interstate commerce without meeting the prescribed vision requirement in one eye. If granted, the exemptions would enable these individuals to qualify as drivers of commercial motor vehicles (CMVs) in interstate commerce.
Comments must be received on or before May 12, 2016. All comments will be investigated by FMCSA. The exemptions will be issued the day after the comment period closes.
You may submit comments bearing the Federal Docket Management System (FDMS) Docket No. FMCSA-2016-0024 using any of the following methods:
• Federal eRulemaking Portal: Go to
•
•
•
Christine A. Hydock, Chief, Medical Programs Division, (202) 366-4001,
Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption from the Federal Motor Carrier Safety Regulations for a 2-year period if it finds “such exemption would likely achieve a level of safety that is equivalent to or greater than the level that would be achieved absent such exemption.” FMCSA can renew exemptions at the end of each 2-year period. The 25 individuals listed in this notice have each requested such an exemption from the vision requirement in 49 CFR 391.41(b)(10), which applies to drivers of CMVs in interstate commerce. Accordingly, the Agency will evaluate the qualifications of each applicant to determine whether granting an exemption will achieve the required level of safety mandated by statute.
Mr. Ahne, 56, tore the iris in his right eye in childhood due to a traumatic incident. The visual acuity in his right eye is 20/400, and in his left eye, 20/20. Following an examination in 2015, his optometrist stated, “I believe that Mr. Ahne does have sufficient vision to drive a commercial vehical [
Mr. Bass, 56, has been blind in his right eye since 2008 due to a traumatic incident. The visual acuity in his right eye is hand motion, and in his left eye, 20/20. Following an examination in 2015, his optometrist stated, “In my medical opinion, Mr. Bass has sufficient vision to perform the driving tasks required to operate a commercial vehicle.” Mr. Bass reported that he has driven straight trucks for 20 years, accumulating 700,000 miles. He holds an operator's license from Kentucky. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Castonguay, 54, has had macular degeneration in his left eye since 2012. The visual acuity in his right eye is 20/20, and in his left eye, 20/100. Following an examination in 2016, his optometrist stated, “It is my opinion that Daniel Castonguay has stable vision at this time and has sufficient vision to drive a commercial vehicle as he has done for the last 22 years.” Mr. Castonguay reported that he has driven straight trucks for 5 years, accumulating 250,000 miles and tractor-trailer combinations for 25 years, accumulating 1.5 million miles. He holds a Class A CDL from Maine. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Crandall, 31, has refractive amblyopia in his right eye since childhood. The visual acuity in his right eye is 20/60, and in his left eye, 20/15. Following an examination in 2016, his optometrist stated, “It is my opinion that Mr. Crandal [
Mr. Curtis, 55, has had ischemic optic neuropathy in his left eye since birth. The visual acuity in his right eye is 20/20, and in his left eye, light perception. Following an examination in 2016, his optometrist stated, “He has sufficient vision to perform the driving tasks required to operate a commercial vehicle.” Mr. Curtis reported that he has driven straight trucks for 17 years, accumulating 70,000 miles and tractor-trailer combinations for 17 years, accumulating 1,000 miles. He holds a Class A CDL from New Mexico. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Dellinger, 60, had a branch retinal vein occlusion in his left eye in 2011. The visual acuity in his right eye is 20/20, and in his left eye, 20/200. Following an examination in 2015, his optometrist stated, “In my medical opinion, with his right eye correction to 20/20 and his full temporal peripheral fields, he has sufficient vision to perform the driving tasks required to operate a commercial vehicle.” Mr. Dellinger reported that he has driven straight trucks for 41 years, accumulating 410,000 miles and tractor-trailer combinations for 41 years, accumulating 123,000 miles. He holds an operator's license from North Carolina. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Dow, 51, has had amblyopia in his right eye since birth. The visual acuity in his right eye is 20/70, and in his left eye, 20/20. Following an examination in 2016, his optometrist stated, “In my opinion Mr. Dow has sufficient vision to perform the driving tasks required to operate a commercial vehicle.” Mr. Dow reported that he has driven straight trucks for 30 years, accumulating 1.05 million miles and tractor-trailer combinations for 30 years, accumulating 150,000 miles. He holds a Class A CDL from Vermont. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Filion, 68, is blind in his left eye due to a traumatic incident in 2011. The visual acuity in his right eye is 20/20, and in his left eye, no light perception. Following an examination in 2015, his optometrist stated, “If there is an allowance or waiver given for monocular status then Mr. Filion would meet requirements for commercial driving.” Mr. Filion reported that he has driven straight trucks for 25 years, accumulating 500,000 miles and tractor-trailer combinations for 8 years, accumulating 560,000 miles. He holds a Class A CDL from Vermont. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Floquet, 31, has had Morning Glory Syndrome in his left eye since birth. The visual acuity in his right eye is 20/20, and in his left eye, light perception. Following an examination in 2015, his optometrist stated, “Based on these tests, Louis has sufficient vison to perform the driving tasks required to operate a commercial vehicle.” Mr. Floquet reported that he has driven straight trucks for 15 years, accumulating 150,000 miles. He holds an operator's license from California. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Harrison, 67, has had a corneal scar in his left eye since childhood. The visual acuity in his right eye is 20/25, and in his left eye, 20/80. Following an examination in 2015, his ophthalmologist stated, “Left eye poor vision is long-standing, right eye meets standards . . . for CDL.” Mr. Harrison reported that he has driven straight trucks for 45 years, accumulating 450,000 miles. He holds a Class A CDL from New Jersey. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Joyner, 38, has had strabismic amblyopia in his left eye since childhood. The visual acuity in his right eye is 20/20, and in his left eye, 20/100. Following an examination in 2016, his optometrist stated, “I believe pt [
Mr. Kaley, 43, is blind in his left eye due to a traumatic incident in childhood. The visual acuity in his right eye is 20/20, and in his left eye, no light perception. Following an examination in 2015, his optometrist stated, “I see no reason that he should be denied a license as I believe that he has sufficient vision to operate a commercial vehicle.” Mr. Kaley reported that he has driven straight trucks for 25 years, accumulating 750,000 miles. He holds an operator's license from Pennsylvania. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Krysinski, 56, has had optic atrophy in his left eye since 2012. The visual acuity in his right eye is 20/20, and in his left eye, hand motion. Following an examination in 2015, his optometrist stated, “I believe he can continue to safely operate his commercial motor vehicle for interstate driving without any restrictions.” Mr. Krysinski reported that he has driven tractor-trailer combinations for 35 years, accumulating 2.3 million miles. He holds a Class A CDL from Minnesota. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Linde, 67, has had amblyopia in his left eye since childhood. The visual acuity in his right eye is 20/20, and in his left eye, 20/400. Following an examination in 2015, his optometrist stated, “In my professional opinion of his vision, Mr. Linde is qualified to perform all duties expected for operating a commercial vehicle.” Mr. Linde reported that he has driven tractor-trailer combinations for 21 years, accumulating 10,500 miles. He holds a Class A CDL from Iowa. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Martinez, 55, has had a choroidal macular scar in his left eye since 1985. The visual acuity in his right eye is 20/20, and in his left eye, counting fingers. Following an examination in 2015, his optometrist stated, “In my medical opinion, he has sufficient vision centrally OD and Peripherally [sic] OU to operate a commercial vehical [
Mr. Mason, 51, has been blind in his left eye due to a retinal detachment in 2003. The visual acuity in his right eye is 20/20, and in his left eye, no light perception. Following an examination in 2015, his optometrist stated, “Patient has sufficient visual acuity and VF [
Mr. Milliman, 63, has had an incomplete macular formation in his left eye since birth. The visual acuity in his right eye is 20/20, and in his left eye, 20/200. Following an examination in 2015, his optometrist stated, “It is my opinion that Mr. Milliman's exceptional vision in his right eye allows him to compensate for his lack of visual acuity in his left eye and leads me to believe he has sufficient vision to perform all commercial driving tasks.” Mr. Milliman reported that he has driven straight trucks for 24 years, accumulating 1.92 million miles and tractor-trailer combinations for 33 years, accumulating 3.47 million miles. He holds an operator's license from Illinois. His driving record for the last 3 years shows no crashes and 1 conviction for a moving violation in a CMV; he operated in an improper traffic lane.
Mr. Orloski, 69, has had amblyopia in his left eye since birth. The visual acuity in his right eye is 20/20, and in his left eye, 20/150. Following an examination in 2015, his optometrist stated, “Mr. Orloski's visual condition is stable. I find no medical reason to prevent Donald Orloski from safely operating a commercial vehicle.” Mr. Orloski reported that he has driven straight trucks for 37 years, accumulating 592,000 miles and tractor-trailer combinations for 37 years, accumulating 37,000 miles. He holds a Class A CDL from Pennsylvania. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Piroso, 60, has had amblyopia in his left eye since birth. The visual acuity in his right eye is 20/20, and in his left eye, 20/400. Following an examination in 2015, his ophthalmologist stated, “Alan Piroso has been driving for many years without a problem and I believe he should be able to renew his CDL license based on his eye examination.” Mr. Piroso reported that he has driven straight trucks for 31 years, accumulating 930,000 miles and tractor-trailer combinations for 6 years, accumulating 30,000 miles. He holds a Class AMC CDL from New Hampshire. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Ramirez, 31, has had exotropia with amblyopia in his left eye since childhood. The visual acuity in his right eye is 20/30, and in his left eye, 20/100. Following an examination in 2015, his optometrist stated, “I believe Mr. Ramirez should be considered for [sic] federal vision exemption to operate a CMV in interstate commerce.” Mr. Ramirez reported that he has driven straight trucks for 6 years, accumulating 600,000 miles and tractor-trailer combinations for 2 years, accumulating 120,000 miles. He holds a Class A CDL from Ohio. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Rowland, 35, has had amblyopia in his right eye since birth. The visual acuity in his right eye is hand motion, and in his left eye, 20/15. Following an examination in 2015, his ophthalmologist stated, “It is my opinion that Mr. Rowland is able to operate a commercial vehicle, as his vision has remained stable, and he has operate [sic] a commercial vehicle for the past several years.” Mr. Rowland reported that he has driven straight trucks for 17 years, accumulating 340,000 miles and tractor-trailer combinations for 2 years, accumulating 10,000 miles. He holds a Class A CDL from New York. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Smith, 36, has had amblyopia in his left eye since childhood. The visual acuity in his right eye is 20/20, and in his left eye, 20/400. Following an examination in 2015, his optometrist stated, “In my opinion, Colby has more than adequate vision to perform all driving tasks required to operate a commercial vehicle.” Mr. Smith reported that he has driven straight trucks for 10 years, accumulating 120,000 miles. He holds a Class D operator's license from Utah. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Warnecke, 55, has had amblyopia in his right eye since childhood. The visual acuity in his right eye is 20/200, and in his left eye, 20/20. Following an examination in 2015, his ophthalmologist stated, “I think that he does have sufficient vision to perform the driving tasks required to operate a commercial vehicle, according to their guidelines.” Mr. Warnecke reported that he has driven straight trucks for 35 years, accumulating 210,000 miles and tractor-trailer combinations for 35 years, accumulating 35,000 miles. He holds a Class A CDL from Ohio. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. West, 55, has had a macular scar in his right eye due to a retinal hemorrhage in 2004. The visual acuity in his right eye is 20/70, and in his left eye, 20/20. Following an examination in 2015, his optometrist stated, “I certify that Ed West has sufficient vision to perform the driving tasks required to operate a commercial vehicle.” Mr. West reported that he has driven straight trucks for 37 years, accumulating 185,000 miles and tractor-trailer combinations for 37 years, accumulating 185,000 miles. He holds a Class A CDL from Missouri. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
Mr. Wojtaszek, 62, has had amblyopia in his left eye since childhood. The visual acuity in his right eye is 20/20, and in his left eye, 20/200. Following an examination in 2015, his optometrist stated, “I hereby certify that in my medical opinion, this individual has sufficient vision to perform driving tasks required to operate a commercial vehicle.” Mr. Wojtaszek reported that he has driven straight trucks for 42 years, accumulating 84,000. He holds a Class C license from Pennsylvania. His driving record for the last 3 years shows no crashes and no convictions for moving violations in a CMV.
FMCSA encourages you to participate by submitting comments and related materials.
If you submit a comment, please include the docket number for this notice, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online or by fax, mail, or hand delivery, 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 the Agency can contact you if it has questions regarding your submission.
To submit your comment online, go to
FMCSA will consider all comments and material received during the comment period. FMCSA may issue a final determination at any time after the close of the comment period.
To view comments, as well as documents mentioned in this preamble as being available in the docket, go to
Federal Transit Administration (FTA), DOT.
Notice; correction.
On March 29, 2016, the Federal Transit Administration (FTA) published a Notice of Funding Opportunity (NOFO) in the
For the Bus Program, contact Sam Snead, FTA Office of Program Management, 202-366-1089, or
The FTA notice published in the
Therefore, FR Doc. 2016-07027 is corrected as follows:
1. On page 17560, in the 2nd column, subsection
The FTA requires that all capital procurements meet FTA's Buy America requirements, which require that all iron, steel, or manufactured products be produced in the U.S. These requirements help create and protect manufacturing jobs in the U.S. The Bus Program and Low-No Program will have a significant economic impact toward meeting the objectives of the Buy America law. The FAST Act amended the Buy America requirements to provide for a phased increase in the domestic content for rolling stock. For FY16 and FY17, the cost of components and subcomponents produced in the United States must be more than 60 percent of the cost of all components. For FY18 and FY19, the cost of components and subcomponents produced in the United States must be more than 65 percent of the cost of all components. For FY20 and beyond, the cost of components and subcomponents produced in the United States must be more than 70 percent of the cost of all components. There is no change to the requirement that final assembly of rolling stock must occur in the United States. FTA will be issuing guidance on the implementation of the phased increase in domestic content in the near future. Any proposal that will require a waiver must identify the items for which a waiver will be sought in the application. Applicants should not proceed with the expectation that waivers will be granted, nor should applicants assume that selection of a project under the Low-No Program that includes a partnership with a manufacturer, vendor, consultant, or other third party constitutes a waiver of the Buy America requirements for rolling stock applicable at the time the project is undertaken.
2. On page 17560, in the 2nd column, subsection
The FTA requires that its recipients receiving planning, capital and/or operating assistance that will award prime contracts exceeding $250,000 in FTA funds in a Federal fiscal year comply with the Disadvantaged Business Enterprise (DBE) program regulations at 49 CFR part 26. Applicants should expect to include any funds awarded, excluding those to be used for vehicle procurements, in setting their overall DBE goal. Note, however, that projects including vehicle procurements remain subject to the DBE program regulations. The rule requires that, prior to bidding on any FTA-assisted vehicle procurement, entities that manufacture vehicles, perform post-production alterations or retrofitting must submit a DBE Program plan and goal methodology to FTA. The FTA will then issue a transit vehicle manufacturer (TVM) concurrence/certification letter. Grant recipients must verify each entity's compliance with these requirements before accepting its bid. A list of compliant, certified TVMs is posted on FTA's Web page at
3. On page 17560, in the 3rd column, section G.
Federal Transit Administration (FTA), Department of Transportation (DOT).
Notice of Safety Advisory.
The Federal Transit Administration (FTA) issued Safety Advisory 16-1 regarding stop signal overruns on rail fixed guideway public transportation systems, and an accompanying letter to the State Safety Oversight (SSO) program managers and
The FTA is asking the directors of the SSO programs to submit the requested data and information by July 2016.
For program matters, Mr. Sam Shelton, Office of System Safety, telephone (202) 366-0815 or
Across the rail transit industry, many if not most operators keep a database on the number of instances in which their passenger or maintenance vehicles over run a stop signal. In some instances, State Safety Oversight Agencies (SSOAs) have identified stop signal overruns as event data a Rail Fixed Guideway Public Transportation System (RFGPTS) must record and report to the SSOA, as part of the hazard management process in the System Safety Program Plans required by the FTA rules at 49 CFR part 659. The FTA considers stop signal overruns to be significant events, creating safety risks, with potentially catastrophic consequences. The FTA now seeks to better understand the prevalence of stop signal overruns throughout the industry. The FTA issued Safety Advisory 16-1, “Stop Signal Overruns,” which is eliciting data and information on stop signal overruns at RFGPTSs that occurred during calendar year 2015.
Specifically, FTA is requesting that each SSOA provide FTA with; (1) the total number of stop signal overruns that occurred during 2015 at each RFGPTS within the SSOA's oversight; (2) each RFGPTS's definition of stop signal overrun; (3) each RFGPTS's definition of a stop signal/stop aspect (
Also, FTA is aware that a number of RFGPTSs keep data and information on stop signal overruns on their own volition, for the purpose of enhancing the safety of their operations, albeit they are not required to report that data and information to their SSOAs. The FTA seeks to develop as complete a database as practical, thus, FTA would appreciate these RFGPTSs submitting their data and information to their SSOAs, and in turn, the SSOAs providing that material to FTA. The cooperation of the entire rail transit industry would be very helpful in developing a better understanding of stop signal overruns, and in due course, a strategy for mitigating the safety risks created by stop signal overruns.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Denial of petition.
Mercedes-Benz USA LLC (MBUSA), on behalf of itself and its parent company Daimler AG (DAG), collectively referred to as “Mercedes” has determined that certain model year (MY) 2015 Mercedes-Benz C-Class (205 Platform) passenger cars do not fully comply with paragraph S10.18.4 of Federal Motor Vehicle Safety Standard (FMVSS) No. 108,
For further information on this decision contact Mike Cole, Office of Vehicle Safety Compliance, the National Highway Traffic Safety Administration (NHTSA), telephone (202) 366-2334, facsimile (202) 366-5930.
Notice of receipt of Mercedes' petition was published, with a 30-day public comment period, on April 16, 2015 in the
(A) Mercedes believes that new manufacturing methods, including the use of optical image processing to adjust the horizontal and the vertical illumination levels of headlamps in addition to the reduction in assembly tolerances for headlamp assemblies, has resulted in optimal headlamp adjustments on vehicles leaving their manufacturing plants. As a result, on-vehicle aiming devices are no longer common in the industry. Mercedes believes that this has led to the elimination of the need for horizontal headlamp adjustment on in-use
(B) Mercedes states that they have only received five customer complaints in the United States, relating to alleged headlamp mis-aiming in the subject vehicles. None of the complaints relate to horizontal mis-aiming of the headlamps. In all instances customers brought their vehicles in for service by Mercedes repair shops, who know how to perform a headlamp readjustment properly, without using the horizontal adjustment screw.
(C) Mercedes states that they provide service instructions to U.S. repair shops that horizontal headlamp adjustment is not permitted and do not even mention that a horizontal headlamp adjustment screw exists. Similarly, the vehicle owner's manual does not include information about performing headlamp illumination adjustment. Thus, since the horizontal headlamp screw's existence is not mentioned in any sales or service instructions or manuals, use of the screw by the customer or repair facilities would be extremely unlikely.
(D) Mercedes also states that even if the screw were to be used, such adjustment would result in only minimal differences in illumination levels compared to the original levels because it provides only a minimal range of adjustment. Mercedes elaborated by stating that when the horizontal adjustment screw is turned to the far left or far right end-position, only a few measuring points are slightly above or below the FMVSS No. 108 required levels. Specifically, when the horizontal adjustment screw is turned to the maximum left end-position (−2.8°), only 4 out of 24 measuring points are above (3) or under (1) the required illumination levels. And when the horizontal adjustment screw is turned to the maximum right end-position (+3.2°), only 2 out of 24 measuring points are under the required illumination levels. Thus, the difference between these worst-case levels and the required minimum or maximum levels are very small. According to Mercedes' headlamp development engineers, a difference of 300 cd [candela] is unlikely to be noticed by a driver and would not affect oncoming traffic or visibility in any material way. In addition, the subject headlamps rely on a reflection-based system which Mercedes' believes leads to less glare then projection-based system.
Mercedes has additionally informed NHTSA that it has corrected the subject noncompliance on vehicles in subsequent production and that all future vehicles will be in full compliance with FMVSS No. 108.
In summation, Mercedes believes that the described noncompliance of the subject vehicles is inconsequential to motor vehicle safety, and that its petition, to exempt from providing recall notification of noncompliance as required by 49 U.S.C. 30118 and remedying the noncompliance as required by 49 U.S.C. 30120 should be granted.
NHTSA has granted prior inconsequentiality petitions with similar arguments; however, the prior petitions also demonstrated that the horizontal aiming mechanisms were difficult to access (see Bentley Motors, Inc., 76 FR 4744, and General Motors, 71 FR 34415). That is not the case for the Mercedes petition. Because no mention was made of the accessibility of the horizontal aiming mechanism, a NHTSA representative inspected a 2015 Mercedes C-Class and found that a non-sealed horizontal aiming mechanism would be easily accessible, and would likely be the first adjustment screw used to alter the headlamp adjustment by someone unfamiliar with this headlamp design. This is because the horizontal aiming mechanism screw is in plain view, whereas, the required vertical aiming mechanism is out of sight and only accessible through a non-descript hole in the upper radiator support using a long tool.
Mercedes also argued that even if the horizontal aim were adjusted, it would result in only minimal differences in illumination levels that would be unlikely to be noticed by a driver or affect oncoming traffic in any material way. To substantiate its claim, Mercedes provided photometric test data at the extreme right and left adjustment of the horizontal aiming mechanism. (Mercedes did not provide any test data at intermediate locations of horizontal adjustment) When adjusted to the extreme left position, the initial measured intensity level was 1,035 candela at test point 1U-1.5L which is nearly 48% over the required maximum of 700 candela. Using a
49 U.S.C. 30118, 30120: delegations of authority at 49 CFR 1.95 and 501.8.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Grant of petition.
Continental Tire the Americas, LLC (CTA), has determined that certain Continental Tire brand T-type spare tires do not fully comply with paragraph S4.3(a) of Federal Motor Vehicle Safety Standard (FMVSS) No. 109,
For further information on this decision contact Abraham Diaz, Office of Vehicle Safety Compliance, the National Highway Traffic Safety Administration (NHTSA), telephone (202) 366-5310, facsimile (202) 366-5930.
Notice of receipt of the petition was published with a 30-day public comment period, on October 29, 2015 in the
S4.3
(a) One size designation, except that equivalent inch and metric size designations may be used; . . .
CTA also stated its belief that the omission of the tire size designation markings has no impact on the operational performance or durability of these tires or on the safety of vehicles on which these tires may be mounted and that the affected tires cannot be confused with normal P-metric or metric passenger tires for the following reasons:
1. Both sidewalls of the affected tires have permanently molded letters that are
2. Both sidewalls of the affected tires have permanently molded letters and numerals that are
3. The affected tires are intended as spare tires for the Chevy Impala, which is equipped with four ground tires of size P235[/]55R17 98W. The ground tires are significantly different in width (approximately four inches wider) and in diameter (approximately three inches larger) than the subject spare tires.
4. The affected tires also have a starting tread depth of only 3/32 inch, whereas a typical P-metric or metric passenger tire has a much deeper tread depth of approximately 10/32 inch.
CTA also noted that they are not aware of any crashes, injuries, customer complaints or field reports associated with this noncompliance.
In addition, CTA informed NHTSA that it has corrected the mold at the manufacturing plant so that no additional tires will be manufactured with the subject noncompliance and that all remaining CTA inventory of the subject tires in their possession have been scrapped.
CTA also made reference to inconsequential noncompliance petitions that NHTSA previously granted concerning noncompliances that CTA believes are similar to the subject noncompliance.
In summation, CTA believes that the described noncompliance of the subject tires is inconsequential to motor vehicle safety, and that its petition, to exempt CTA from providing recall notification of noncompliance as required by 49 U.S.C. 30118 and remedying the recall noncompliance as required by 49 U.S.C. 30120 should be granted.
NHTSA bases its decision on several points. First, CTS labeled the subject tires on both sidewalls with the words “TEMPORARY USE ONLY” and “INFLATE TO 420KPA (60PSI).” The maximum pressure labeled on the subject tires correlates with the pressure specified for all temporary use tires in the TRA's tire publication. Together, these additional labels provide the user with the same information intended by the missing labels, and by spelling out the word TEMPORARY, provides that information in clear format. All other sidewall labels and safety information are correct.
Next, NHTSA agrees that the subject tires would not be confused with non-temporary tires used on vehicles for which the tires are intended because of the differences in geometry of the two types of tires. CTA indicated that the subject tires are approximately four
Finally, neither CTA nor NHTSA are aware of any crashes, injuries, customer complaints or field reports associated with the omitted labeling.
NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and 30120(h)) that permit manufacturers to file petitions for a determination of inconsequentiality allow NHTSA to exempt manufacturers only from the duties found in sections 30118 and 30120, respectively, to notify owners, purchasers, and dealers of a defect or noncompliance and to remedy the defect or noncompliance. Therefore, this decision only applies to the subject tires that CTA no longer controlled at the time it determined that the noncompliance existed. However, the granting of this petition does not relieve equipment distributors and dealers of the prohibitions on the sale, offer for sale, or introduction or delivery for introduction into interstate commerce of the noncompliant tires under their control after CTA notified them that the subject noncompliance existed.
49 U.S.C. 30118, 30120: delegations of authority at 49 CFR 1.95 and 501.8.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Denial of petition.
Morgan 3 Wheeler Limited (Morgan) has determined that certain model year (MY) 2012 and 2013 Morgan model M3W three-wheeled motorcycles do not comply with all of the requirements of Federal Motor Vehicle Safety Standard (FMVSS) No. 108,
For further information on this decision contact Mike Cole, Office of Vehicle Safety Compliance, National Highway Traffic Safety Administration (NHTSA), telephone (202) 366-2334, facsimile (202) 366-5930.
Notice of receipt of the petition was published, with a 30-day public comment period, on December 9, 2013 in the
The second noncompliance concerns the lack of a required marking on the headlamps. Paragraph S6.5.1 of FMVSS No. 108 requires that the lens of each original equipment and replacement headlamp be marked with the symbol “DOT,” either horizontally or vertically, to indicate certification under 49 U.S.C. 30115.
Paragraph S7.9.6.2(b) (applies only to the subject vehicles manufactured before December 1, 2012).
If the system consists of two headlamps, each of which provides both an upper and lower beam, the headlamps shall be mounted either at the same height and symmetrically disposed about the vertical centerline or mounted on the vertical centerline. If the headlamps are horizontally disposed about the vertical centerline, the distance between the closest edges of their effective projected luminous lens areas shall not be greater than 200 mm (8 in.).
Paragraph S10.17.1.2.2 (applies only to the subject vehicles manufactured after December 1, 2012).
If the headlamps are horizontally disposed about the vertical centerline, the distance between the closest edges of their effective projected luminous lens areas must not be greater than 200 mm.
With respect to the headlamp spacing noncompliance, Morgan contends that
Morgan contends that the lens marking noncompliance is inconsequential to motor vehicle safety because the lamps meet the substantive requirements of FMVSS No. 108. Morgan also states that owners of Morgan vehicles almost exclusively go to Morgan dealers for replacement parts; the agency assumes that Morgan is implying that because the vehicle owner is likely to obtain a replacement part directly from a dealer, the owner can be confident that the headlamp complies with all applicable requirements, even though it lacks the proper “DOT” marking.
With respect to both noncompliances, Morgan asserts, based on its reading of previous inconsequentiality petition grants by NHTSA, that its noncompliances should be found to be inconsequential because the M3W is an exotic vehicle with no roof or doors, produced in very low numbers, driven a low number of miles, and likely to be operated on a limited basis, as opposed to an ordinary passenger automobile designed to be used as a family's primary passenger vehicle. Morgan also states that there have been no reports of any safety issues or injuries related to the subject noncompliances. NHTSA received one comment on Morgan's petition from Peter Larsen. Mr. Larsen makes several arguments in support of Morgan's petition. First, Mr. Larsen asserts that a NHTSA-published guidebook on motorcycle requirements does not contain the 200 mm spacing requirement. Second, Mr. Larsen argues that when NHTSA promulgated this requirement it did not contemplate three-wheeled vehicles with the frontal aspect of a small automobile, for which headlights spaced more than 200 mm apart help to indicate the size and shape of the vehicle. Accordingly, Mr. Larsen contends that the 200 mm requirement, as applied to the subject vehicles, is not in the interest of safety. Third, Mr. Larsen suggests that if the subject vehicles are remedied so that the dual headlights are replaced with a compliant center headlight, owners and dealers of the subject vehicles would likely remove the single center light and replace it with the dual, widely-spaced lights; and that a recall or design revision, Mr. Larsen asserts, would “criminalize” these actions. Finally, Mr. Larsen argues that many existing three-wheeled vehicles have similarly-spaced dual headlights, and it would be unjust to penalize Morgan's similar design. Mr. Larsen requests that NHTSA “properly amend” FMVSS No. 108.
Congress has, however, recognized that under some limited circumstances a noncompliance may be “inconsequential” to motor vehicle safety. Neither NHTSA's statute nor its regulations define “inconsequential.” NHTSA determines whether a particular noncompliance is inconsequential to motor vehicle safety based on the specific facts before the agency. The key issue in evaluating an inconsequentiality petition is whether the noncompliance is likely to increase the safety risk to individuals who experience the type of injurious event against which the standard was designed to protect.
NHTSA is not persuaded by the arguments of Morgan or Mr. Larsen regarding the noncompliance with the headlamp spacing requirement in S10.17.1.2.2. Morgan's assertion that the subject vehicles meet the “technical requirements” of FMVSS No. 108 is inaccurate because the distance requirement for headlamp configuration is clearly stated in the regulation as one of the requirements for compliance.
The agency is also not persuaded by Morgan and Mr. Larsen's arguments that the noncompliance not only does not increase the safety risk, but is, in fact, safety-enhancing, because the wider-spaced headlamps convey a more accurate impression of the vehicle's width to other motorists. An inconsequentiality petition is not the appropriate means to challenge the basis or appropriateness of a requirement specified in an FMVSS. The appropriate venue for such an argument is a petition for rulemaking to amend the current safety standard. Nevertheless, neither Morgan nor Mr. Larsen have offered persuasive evidence that either the standard or market conditions have changed to undermine the basis for the spacing limitation. The 200 mm maximum spacing requirement was added to the standard in 1998 in response to a petition for rulemaking. In the preamble to the final rule, NHTSA explained the rationale for the motorcycle headlight requirements: “[A]t the time that the motorcycle headlight requirements in Standard No. 108 were originally issued, the predominant concern was that the headlighting system clearly identify a motorcycle as such when the vehicle was being operated at night.”
Similarly, Mr. Larsen asserts that when NHTSA promulgated this headlamp spacing regulation it did not contemplate three-wheeled vehicles such as the subject vehicles, which, he states, display the frontal aspect of a small automobile. The initial Federal Motor Vehicle Safety Standards, published in 1967, defined a “motorcycle” as “a motor vehicle with motive power having a seat or saddle for the use of the rider and designed to travel on not more than three wheels in contact with the ground.”
Morgan also cites, in support of its petition, a prior agency decision granting a General Motors inconsequentiality petition.
Mr. Larsen also states that he developed a motorcycle on which the subject vehicle is based, and states that the headlamp location was configured as described in NHTSA's published guidebook entitled “Requirements of Motorcycle Manufacturers.” Mr. Larsen did not further identify this guide, but he appears to refer to the NHTSA guide entitled “Requirements for Motorcycle Manufacturers,” published in February 2000.
Mr. Larsen also suggests that if NHTSA were to deny Morgan's petition, it would “criminalize” owners and dealers of the subject vehicles (who, he asserts, will likely replace a single center light and replace it with dual, widely-spaced lights). This is incorrect. Today's denial requires Morgan to notify owners of the subject vehicles of the noncompliance and to remedy the noncompliance if and when a vehicle owner presents a vehicle for repair. Neither NHTSA's denial nor the recall and remedy requirements impose any obligations on vehicle owners. Today's denial simply ensures that vehicle owners will be notified of the noncompliance and will have the opportunity to have their vehicle remedied, if the vehicle owner so chooses.
Finally, the agency is not persuaded by Mr. Larsen's argument that it would be unjust to “suddenly penalize” and require Morgan to recall the subject vehicles because, he asserts, there are many three-wheeled vehicles with wide-spaced dual headlights similar to the subject vehicles. The spacing regulation at issue has been in effect since 1998. Moreover, it does not apply to all three-wheeled motorcycles currently on the road. It applies to vehicles manufactured or imported into the United States after the effective date of the 1998 final rule. Accordingly, it does not apply, for example, to vintage vehicles that were manufactured before the effective date of the final rule.
Regarding the “DOT” marking requirement, the agency is also not persuaded by Morgan's arguments. In the past, NHTSA has granted inconsequentiality petitions for lighting components that did not have certain required markings.
In addition to the arguments addressed above, the agency is also not persuaded by two additional arguments Morgan makes for why it believes NHTSA should grant the petition with respect to both noncompliances. First, Morgan argues that its petition should be granted because the subject vehicle is an exotic vehicle produced in very low numbers and likely to be operated on a limited basis, as opposed to a passenger automobile designed to be used as a family's primary passenger vehicle. In support of this argument, Morgan cites two previous agency decisions granting inconsequentiality petitions.
Second, Morgan states that there have been no reports of any safety issues or injuries related to the subject noncompliances. NHTSA does not consider the absence of complaints to show that the noncompliances are inconsequential to safety. The subject vehicle population is small, so the lack of reports or complaints may not be surprising. Further, vehicle lighting functions as a signal to other motorists and pedestrians; if other motorists found the noncompliant lighting confusing, it is unlikely that those motorists would have been able to identify the subject vehicle and make a complaint to either NHTSA or Morgan. Most importantly, the absence of a complaint does not mean there have not been any safety issues, nor does it mean that there will not be safety issues in the future.
Finally, the agency observes that although Morgan's Part 573 report and inconsequentiality petition only concern the headlamp spacing and headlamp marking noncompliances, the subject vehicles may also fail to comply with other applicable FMVSSs. For example, a motorcycle headlamp that incorporates a replaceable light source that does not comply with FMVSS No. 108, paragraph S11 (
49 U.S.C. 30118, 30120: delegations of authority at 49 CFR 1.95 and 501.8.
Office of the Comptroller of the Currency (OCC), Treasury.
Notice and request for comment.
The OCC, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995 (PRA).
In accordance with the requirements of the PRA, the OCC may not conduct or sponsor, and the respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number.
The OCC is soliciting comment concerning its information collection titled, “Notice Regarding Unauthorized Access to Customer Information.”
Comments must be submitted on or before June 13, 2016.
Because paper mail in the Washington, DC area and at the OCC is subject to delay, commenters are encouraged to submit comments by email, if possible. Comments may be sent to: Legislative and Regulatory Activities Division, Office of the Comptroller of the Currency, Attention: 1557-0227, 400 7th Street SW., Suite 3E-218, Mail Stop 9W-11, Washington, DC 20219. In addition, comments may be sent by fax to (571) 465-4326 or by electronic mail to
All comments received, including attachments and other supporting materials, are part of the public record and subject to public disclosure. Do not include any information in your comment or supporting materials that you consider confidential or inappropriate for public disclosure.
Shaquita Merritt, OCC Clearance Officer, (202) 649-5490 or, for persons who are deaf or hard of hearing, TTY, (202) 649-5597, Legislative and Regulatory Activities Division, Office of the Comptroller of the Currency, 400 7th Street SW., Suite 3E-218, Mail Stop 9W-11, Washington, DC 20219.
Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the OMB for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) to include agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. 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
The OCC is proposing to extend, with revision, the approval of the following information collection:
The Interagency Guidelines Establishing Information Security Standards, 12 CFR part 30, Appendix B and part 170, Appendix B (collectively, Security Guidelines), which implement section 501(b), require each entity supervised by the OCC (supervised institution) to consider and adopt a response program, as appropriate, that specifies actions to be taken when the supervised institution suspects or detects that unauthorized individuals have gained access to customer information.
The Interagency Guidance on Response Programs for Unauthorized Customer Information and Customer Notice (Breach Notice Guidance
(1) Assessing the nature and scope of an incident, and identifying what customer information systems and types of customer information have been accessed or misused;
(2) Notifying its primary Federal regulator as soon as possible when the supervised institution becomes aware of an incident involving unauthorized access to, or use of, sensitive customer information;
(3) Consistent with the OCC's Suspicious Activity Report regulations, notifying appropriate law enforcement authorities and filing a timely SAR in situations in which a Federal criminal violation requires immediate attention, such as when a reportable violation is ongoing;
(4) Taking appropriate steps to contain and control the incident in an effort to prevent further unauthorized access to, or use of, customer information, for example, by monitoring, freezing, or closing affected accounts, while preserving records and other evidence; and
(5) Notifying customers as warranted.
This collection of information covers the notice provisions in the Breach Notice Guidance.
Comments submitted in response to this notice will be summarized and included in the request for OMB approval. All comments will become a matter of public record. Comments are invited on:
(a) Whether the collection of information is necessary for the proper performance of the functions of the OCC, including whether the information has practical utility;
(b) The accuracy of the OCC's estimate of the burden of the information collection;
(c) Ways to enhance the quality, utility, and clarity of the information to be collected;
(d) Ways to minimize the burden of the collection on respondents, including through the use of automated collection techniques or other forms of information technology; and
(e) Estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information.
Veterans Health Administration, Department of Veterans Affairs.
Notice.
The Veterans Health Administration (VHA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
Written comments and recommendations on the proposed collection of information should be received on or before June 13, 2016.
Submit written comments on the collection of information through the Federal Docket Management System
Brian McCarthy at (202) 461-6345.
Under the PRA of 1995 (Pub. L. 104-13; 44 U.S.C. 3501-3521), Federal agencies must obtain approval from OMB for each collection of information they conduct or sponsor. This request for comment is being made pursuant to section 3506(c)(2)(A) of the PRA.
With respect to the following collection of information, VHA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of VHA's functions, including whether the information will have practical utility; (2) the accuracy of VHA'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 respondents, including through the use of automated collection techniques or the use of other forms of information technology.
For RIN 2900-AP09, the Notice of Proposed Rule Making (NPRM) package was not submitted to OMB for review at the time of publication of the NPRM.
1. VA Form 10-10d, Application for CHAMPVA Benefits, is used to determine eligibility of persons applying for healthcare benefits under the CHAMPVA program in accordance with 38 U.S.C. 501 and 1781.
2. VA Form 10-7959a, CHAMPVA Claim Form, is used to adjudicate claims for CHAMPVA benefits in accordance with 38 U.S.C. 501 and 1781, and 10 U.S.C. 1079 and 1086. This information is required for accurate adjudication and processing of beneficiary submitted claims. The claim form is also instrumental in the detection and prosecution of fraud. In addition, the claim form is the only mechanism to obtain, on an interim basis, other health insurance (OHI) information.
3. Except for Medicaid and health insurance policies that are purchased exclusively for the purpose of supplementing CHAMPVA benefits, CHAMPVA is always the secondary payer of healthcare benefits (38 U.S.C. 501 and 1781, and 10 U.S.C. 1086). VA Form 10-7959c, CHAMPVA—Other Health Insurance (OHI) Certification, is used to systematically obtain OHI information and to correctly coordinate benefits among all liable parties.
4. The Federal Medical Care Recovery Act (42 U.S.C. 2651-2653), mandates recovery of costs associated with healthcare services related to an injury/illness caused by a third party. VA Form 10-7959d, CHAMPVA Potential Liability Claim, provides basic information from which potential liability can be assessed. Additional authority includes 38 U.S.C. 501; 38 CFR 1.900
5. VA Form 10-7959e, VA Claim for Miscellaneous Expenses, information collection is needed to carry out the health care programs for certain children of Korea and/or Vietnam veterans authorized under 38 U.S.C., chapter 18, as amended by section 401, P.L. 106-419 and section 102, P.L. 108-183. VA's medical regulations 38 CFR part 17 (17.900 through 17.905) establish regulations regarding provision of health care for certain children of Korea and Vietnam veterans and women Vietnam veterans' children born with spina bifida and certain other covered birth defects. These regulations also specify the information to be included in requests for preauthorization and claims from approved health care providers.
6. Payment of Claims for Provision of Health Care for Certain Children of Korea and/or Vietnam Veterans (includes provider billing and VA Forms 10-7959e). This data collection is for the purpose of claiming payment/reimbursement of expenses related to spina bifida and certain covered birth defects. Beneficiaries utilize VA Form 10-7959e, VA Claim for Miscellaneous Expenses. Providers utilize provider generated billing statements and standard billing forms such as: Uniform Billing-Forms UB-04, and CMS 1500, Medicare Health Insurance Claims Form. VA would be unable to determine the correct amount to reimburse providers for their services or beneficiaries for covered expenses without the requested information. The information is instrumental in the timely and accurate processing of provider and beneficiary claims for reimbursement. The frequency of submissions is not determined by VA, but will determined by the provider or claimant and will be based on the volume of medical services and supplies provided to patients and claims for reimbursement are submitted individually or in batches.
7. Review and Appeal Process Regarding Provision of Health Care or Payment Relating to Provision of Health Care for Certain Children of Korea and/or Vietnam Veterans. The provisions of 38 CFR 17.904 establish a review process regarding disagreements by an eligible veteran's child or representative with a determination concerning provision of health care or a health care provider's disagreement with a determination regarding payment. The person or entity requesting reconsideration of such determination is required to submit such a request to the Chief Business Office Purchased Care (CBOPC) (Attention: Chief, Customer Service), in writing within one year of the date of initial determination. The request must state why the decision is in error and include any new and relevant information not previously considered. After reviewing the matter, a Customer Service Advisor issues a written determination to the person or entity seeking reconsideration. If such person or entity remains dissatisfied with the determination, the person or entity is permitted to submit within 90 days of the date of the decision a written request for review by the Director, CBOPC.
1. VA Form 10-10d—4,411 hours.
2. VA Form 10-7959a—37,336 hours.
3. VA Form 10-7959c—13,456 hours.
4. VA Form 10-7959d—467 hours.
5. VA Form 10-7959e—200 hours.
6. Payment (beneficially claims)—500 hours.
7. Review and Appeal Process—200 hours.
1. VA Form 10-10d—10 minutes.
2. VA Form 10-7959a—10 minutes.
3. VA Form 10-7959c—10 minutes.
4. VA Form 10-7959d—7 minutes.
5. VA Form 10-7959e—15 minutes.
6. Payment (beneficially claims)—10 minutes.
7. Review and Appeal Process—20 minutes.
1. VA Form 10-10d—26,468.
2. VA Form 10-7959a—224,018.
3. VA Form 10-7959c—80,733.
4. VA Form 10-7959d—4,000.
5. VA Form 10-7959e—800.
6. Payment (beneficially claims)—3,000.
7. Review and Appeal Process—600.
By direction of the Secretary.
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is finalizing a revision to the Federal implementation plan (FIP) addressing the requirement for best available retrofit technology (BART) for taconite plants in Minnesota and Michigan. In response to petitions for reconsideration, we are revising the nitrogen oxides (NO
This final rule is effective on May 12, 2016.
EPA has established a docket for this action under Docket ID No. EPA-R05-OAR-2015-0196. All documents in the docket are listed in the
Steven Rosenthal, Environmental Engineer, Attainment Planning & Maintenance Section, Air Programs Branch (AR-18J), U.S. 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 section is arranged as follows:
For the purpose of this document, we are giving meaning to certain words or initials as follows:
• The initials BACT mean or refer to Best Available Control Technology.
• The initials BART mean or refer to Best Available Retrofit Technology.
• The initials CAA mean or refer to the Clean Air Act.
• The initials CBI mean or refer to Confidential Business Information.
• The initials CEMS means or refers to continuous emission monitoring system.
• The initials CFD mean or refer to computational fluid dynamic.
• The words EPA, we, us, or our mean or refer to the United States Environmental Protection Agency.
• The initials FIP mean or refer to Federal Implementation Plan.
• The initials LNB mean or refer to low-NO
• The initials MACT mean or refer to Maximum Achievable Control Technology.
• The initials MCEA means or refers to the Minnesota Center for Environmental Advocacy.
• The initials MMBtu mean or refer to million British thermal units.
• The initials MW mean or refer to megawatts.
• The initials NAAQS mean or refer to National Ambient Air Quality Standards.
• The initials NESHAP mean or refer to National Emission Standards for Hazardous Air Pollutants.
• The initials NSPS mean or refer to Standards of Performance for New Stationary Sources.
• The initials NO
• The initials NPCA means or refers to the National Parks Conservation Association.
• The initials NTAA means or refers to the National Tribal Air Association.
• The initials PRB mean or refer to the Powder River Basin.
• The initials RHR mean or refer to the EPA's Regional Haze Rule.
• The initials RMB mean or refer to RMB Consulting and Research.
• The initials SCR mean or refer to Selective Catalytic Reduction.
• The initials SIP mean or refer to State Implementation Plan.
• The initials SO
• The initials UPL mean or refer to Upper Prediction Limit.
In section 169A of the 1977 Amendments to the CAA, Congress created a program for protecting visibility in the nation's national parks and wilderness areas. This section of the CAA establishes as a national goal the “prevention of any future, and the remedying of any existing, impairment of visibility in mandatory Class I Federal areas
Section 169A of the CAA directs states, or EPA if developing a FIP, to
On July 6, 2005, EPA published the
The process of establishing BART emission limitations includes identifying those sources that meet the definition of “BART-eligible source” set forth in 40 CFR 51.301,
States, or EPA if developing a FIP, must address all visibility-impairing pollutants emitted by a source in the BART determination process. The most significant visibility impairing pollutants are SO
A SIP or FIP addressing regional haze must include source-specific BART emission limits and compliance schedules for each source subject to BART. Once a state or EPA has made a BART determination, the BART controls must be installed and operated as expeditiously as practicable, but no later than five years after the date of the final SIP or FIP.
On February 6, 2013, EPA promulgated a FIP (78 FR 8706) that included BART limits for taconite furnaces subject to BART in Minnesota and Michigan. EPA took this action because Minnesota and Michigan had failed to meet a statutory deadline to submit their Regional Haze SIPs and subsequently failed to require BART at the taconite facilities. Cliffs, ArcelorMittal, and the State of Michigan petitioned the Eighth Circuit Court of Appeals for review of the FIP, and, on May 17, 2013, Cliffs and ArcelorMittal filed a joint motion for stay of the final rule, which was granted by the Eighth Circuit on June 14, 2013, and is still in effect.
EPA received petitions for reconsideration of the 2013 Taconite FIP from the National Mining Association on March 8, 2013, ArcelorMittal on March 22, 2013, the State of Michigan on April 1, 2013, Cliffs on April 3, 2013, Congressman Richard M. Nolan on April 8, 2013, the State of Minnesota on April 8, 2013, and United States Steel Corporation (U.S. Steel) on November 26, 2013.
In a related action, EPA published a final partial disapproval of the Michigan and Minnesota Regional Haze SIPs on September 30, 2013 (78 FR 59825), for failure to require BART for SO
EPA subsequently reached a settlement agreement with Cliffs, ArcelorMittal, and Michigan regarding issues raised by these parties in their petitions for review and reconsideration. Notice of the settlement was published in the
On October 22, 2015, EPA published a
EPA proposed to revise the NO
The public comment period on the proposal ended on December 23, 2015. EPA received comments from the National Park Service of the United
In a study conducted by Hatch for U.S. Steel, SCR with reheat was considered as a potential control option, but further discussion with potential vendors resulted in the determination that SCR with reheat is not a technically feasible control option for taconite indurating furnaces. One potential vendor, Mitsubishi Power Systems, cited temperature and layout as factors rendering SCR with reheat less than optimal for NO
EPA has committed to consider all relevant information obtained during tribal consultation to help ensure that EPA's actions do not conflict with treaty rights, to help ensure that EPA is fully informed when it seeks to implement its programs, and to further protect treaty rights and resources when it has discretion to do so. We have done so in this action. EPA consulted and coordinated with tribal officials and provided information on both the 2012 FIP proposal and the current taconite FIP proposal early in the process of developing this regulation in order to allow tribal governments to have meaningful and timely input. EPA provided information to tribes on the rationale for proposing this regulation in the absence of the states submitting plans, the potential health and environmental impacts associated with these facilities, and the emissions reductions to be gained from implementing this regulation. EPA also took into consideration the concerns and needs identified by tribal governments during this process. These consultation and education and outreach efforts began in August 2012 and continue through the present utilizing forums such as monthly tribe-EPA conference calls, presentations during annual meetings and conferences, and one-to-one discussions with EPA subject matter experts as requested.
EPA's revision of the FIP is expected to have significant environmental benefits relative to the SIPs submitted by Michigan and Minnesota. On-and off-reservation trust resources held by Minnesota tribes (and other tribes), as recognized in treaties and in
U.S. Steel submitted the following comments to ensure that EPA's approach to amending the original FIP is applied evenly and fairly and results in a consistent approach to BART for the taconite industry.
The proposal describes the process for establishing final emission limits to which the identified facilities shall become subject. As discussed in the proposal, the final limit must be based on the 95 percent upper predictive limit (UPL) using CEMS data compiled over an eight-month testing period. The UPL is a statistical technique that examines an existing set of data points and predicts the chances (
The settlement agreement and proposed FIP specified three equations for determining the UPL depending upon whether the data are normally distributed and, if so, whether the data are statistically independent or not statistically independent. In the proposal (the equation numbers have been changed in the final), Equation 1 applied to normally distributed, statistically independent data sets; Equation 3 applied to normally distributed, but not statistically independent data sets; and Equation 4, the non-parametric UPL equation, applied to data sets that do not conform to a specific distribution. EPA's statistical guidance for environmental applications, the ProUCL User Guide,
We are finalizing the non-parametric equation contained in the proposal with a clarification regarding the appropriate data set to be used. As stated above, the UPL equations are used to determine emission limits. To correctly calculate the UPL using the non-parametric equation, the data that is ranked from smallest to highest must be in the same form as the emission limit. The final emission limits are expressed in terms of 720-hour averages, so the ranked data set used in the non-parametric equation must be a set of 720-hour averages as well. Using data sets based upon an averaging time inconsistent with the form of the emission limit would be an improper use of the equation. For instance, calculating the 95 percent non-parametric limit using a data set of ranked one-hour values would establish the emission rate (based upon a one-hour average) that the source would be predicted to be below during 95 out of 100 one-hour averaging periods,
To reiterate, the purpose of a 95 percent UPL is to establish an emission rate that a source is predicted to be below during 95 out of 100 averaging periods. Importantly, however, this does not mean that the source would be expected to exceed its emission limit five percent of the time once the limit is in place. During the eight-month testing period, Cliffs and ArcelorMittal will operate their furnaces and the new control technologies in a manner that will not interfere with pellet quality. The furnace operators will be adjusting numerous variables to optimize control technology performance, which will result in higher emissions at times. These periods of higher emissions will factor into the UPL calculation. Once the eight-month testing period is over, however, the operators will have gained sufficient experience to run the furnaces and control technologies with fewer adjustments, meaning less emission variations and lower emissions overall. Using the 95 percent UPL ensures that the final emission limits will be consistent with the actual emission reduction capabilities of the BART controls, as required by 40 CFR 51.301, which defines BART as “the degree of reduction achievable.” We also note that the 720-hour averaging period for the final emission limits will provide considerable flexibility for the sources. The operators will be able to continually review CEMS data on an hourly basis and make any necessary adjustments over the remaining 719 hours to ensure compliance.
For the reasons stated in the proposed FIP revision and the response to comments, EPA is finalizing the new BART emission limits and related requirements for taconite furnaces as proposed, with two exceptions. First, EPA is revising the requirement to report CEMS and pellet quality data at the end of a period that did not fall within the preceding calendar quarter from within 7 days of the close of the period to within 30 days of the close of the period. This revision will allow the facilities sufficient time to complete the appropriate laboratory analyses and quality assurance for the data and will not significantly interfere with expeditiously setting the final limits. Second, EPA is replacing the incorrect equation for normally distributed but not statistically independent data with the non-parametric UPL equation, which is consistent with EPA guidance. A summary of our final decision is included in the table below.
Additional information about these statutes and Executive Orders can be found at
This action is exempt from review by the Office of Management and Budget (OMB) because it is a rule of particular applicability and only affects four facilities.
This action does not impose an information collection burden under the PRA. Because the FIP applies to just four facilities, the Paperwork Reduction Act does not apply.
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. In making this determination, the impact of concern is any significant adverse economic impact on small entities. An agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, has no net burden or otherwise has a positive economic effect on the small entities subject to the rule. EPA's rule adds additional controls to certain sources. The Regional Haze FIP revisions that EPA is promulgating here would impose Federal control requirements to meet the BART requirement for NO
This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments or the private sector.
This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.
This action does not have tribal implications as specified in Executive Order 13175. It will not have substantial direct effects on tribal governments. Thus, Executive Order 13175 does not apply to this rule. However, EPA did discuss this action on a number of occasions, including a June 28, 2015, conference call with the Michigan and Minnesota tribes.
This action is not subject to Executive Order 13045 because it is not economically significant as defined in Executive Order 12866, and because EPA does not believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. However, to the extent this rule will limit emissions of NO
This action is not subject to Executive Order 13211, because it is not a significant regulatory action under Executive Order 12866.
This rulemaking does not involve technical standards.
EPA believes the human health or environmental risk addressed by this action will not have potential disproportionately high and adverse human health or environmental effects on minority, low-income or indigenous populations. We have determined that this rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it increases the level of environmental protection for all affected populations without having any disproportionately high and adverse human health or environmental effects on any population, including any minority or low-income population.
This rule is exempt from the CRA because it is a rule of particular applicability.
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by June 13, 2016. 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, Nitrogen dioxide, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Regional haze, Volatile organic compounds.
For the reasons stated in the preamble, 40 CFR chapter I is amended as follows:
42 U.S.C. 7401
(k) Tilden Mining Company, or any subsequent owner/operator of the Tilden Mining Company facility in Ishpeming, Michigan, shall meet the following requirements:
(1)
(ii) Compliance with these emission limits shall be demonstrated with data collected by a continuous emissions monitoring system (CEMS) for NO
(iii) No later than 48 months from May 12, 2016, the owner or operator must submit to EPA a report, including any final report(s) completed by the selected NO
(iv) The NO
(v) Commencing on the earlier of: Six months from the installation of the NO
(vi) No later than 57 months after May 12, 2016, the owner or operator may submit to EPA a report to either confirm or modify the NO
(vii) EPA will take final agency action by publishing its final confirmation or modification of the NO
(viii) If the owner or operator submits a report proposing a single NO
(2)
(3) The owner or operator of the Tilden Grate Kiln Line 1 furnace shall meet an emission limit of 500 lbs SO
(4) Starting 26 months from May 12, 2016, records shall be kept for any day during which fuel oil is burned as fuel (either alone or blended with other fuels) in Grate Kiln Line 1. These records must include, at a minimum, the gallons of fuel oil burned per hour, the sulfur content of the fuel oil, and the SO
(5) Starting 26 months from May 12, 2016, the SO
(l)
(2) The owner or operator shall install, certify, calibrate, maintain, and operate a CEMS for SO
(3) The owner or operator shall install, certify, calibrate, maintain, and operate one or more continuous diluent monitor(s) (O
(4) For purposes of this section, all CEMS required by this section must meet the requirements of paragraphs (l)(4)(i) through (xiv) of this section.
(i) All CEMS must be installed, certified, calibrated, maintained, and operated in accordance with 40 CFR part 60, appendix B, Performance Specification 2 (PS-2) and appendix F, Procedure 1.
(ii) All CEMS associated with monitoring NO
(iii) The owner or operator must conduct a performance evaluation of each CEMS in accordance with 40 CFR part 60, appendix B, PS-2. The performance evaluations must be completed no later than 60 days after the respective CEMS installation.
(iv) The owner or operator of each CEMS must conduct periodic Quality Assurance, Quality Control (QA/QC) checks of each CEMS in accordance with 40 CFR part 60, appendix F, Procedure 1. The first CEMS accuracy test will be a relative accuracy test audit (RATA) and must be completed no later than 60 days after the respective CEMS installation.
(v) The owner or operator of each CEMS must furnish the Regional Administrator two, or upon request, more copies of a written report of the results of each performance evaluation and QA/QC check within 60 days of completion.
(vi) The owner or operator of each CEMS must check, record, and quantify the zero and span calibration drifts at least once daily (every 24 hours) in accordance with 40 CFR part 60, appendix F, Procedure 1, Section 4.
(vii) Except for CEMS breakdowns, repairs, calibration checks, and zero and span adjustments, all CEMS required by this section shall be in continuous operation during all periods of process operation of the indurating furnaces, including periods of process unit startup, shutdown, and malfunction.
(viii) All CEMS required by this section must meet the minimum data requirements at paragraphs (l)(4)(viii)(A) through (C) of this section.
(A) Complete a minimum of one cycle of operation (sampling, analyzing, and data recording) for each successive 15-minute quadrant of an hour.
(B) Sample, analyze, and record emissions data for all periods of process operation except as described in paragraph (l)(4)(viii)(C) of this section.
(C) When emission data from CEMS are not available due to continuous monitoring system breakdowns, repairs, calibration checks, or zero and span adjustments, emission data must be obtained using other monitoring systems or emission estimation methods approved by the EPA. The other monitoring systems or emission estimation methods to be used must be incorporated into the monitoring plan required by this section and provide information such that emissions data are available for a minimum of 18 hours in each 24-hour period and at least 22 out of 30 successive unit operating days.
(ix) Owners or operators of each CEMS required by this section must reduce all data to 1-hour averages. Hourly averages shall be computed using all valid data obtained within the hour but no less than one data point in each 15-minute quadrant of an hour. Notwithstanding this requirement, an hourly average may be computed from at least two data points separated by a minimum of 15 minutes (where the unit operates for more than one quadrant in an hour) if data are unavailable as a result of performance of calibration, quality assurance, preventive maintenance activities, or backups of data from data acquisition and handling systems and recertification events.
(x) The 30-day rolling average emission rate determined from data derived from the CEMS required by this section (in lbs/MMBTU or lbs/hr depending on the emission standard selected) must be calculated in accordance with paragraphs (l)(4)(x)(A) through (F) of this section.
(A) Sum the total pounds of the pollutant in question emitted from the unit during an operating day and the previous 29 operating days.
(B) Sum the total heat input to the unit (in MMBTU) or the total actual hours of operation (in hours) during an operating day and the previous 29 operating days.
(C) Divide the total number of pounds of the pollutant in question emitted during the 30 operating days by the total heat input (or actual hours of operation depending on the emission limit selected) during the 30 operating days.
(D) For purposes of this calculation, an operating day is any day during
(E) If the owner or operator of the CEMS required by this section uses an alternative method to determine 30-day rolling averages, that method must be described in detail in the monitoring plan required by this section. The alternative method will only be applicable if the final monitoring plan and the alternative method are approved by EPA.
(F) A new 30-day rolling average emission rate must be calculated for the period ending each new operating day.
(xi) The 720-hour rolling average emission rate determined from data derived from the CEMS required by this section (in lbs/MMBTU) must be calculated in accordance with paragraphs (l)(4)(xi)(A) through (C) of this section.
(A) Sum the total pounds of NO
(B) Sum the total heat input to the unit (in MMBTU) every hour and the previous (not necessarily consecutive) 719 hours for which that type of fuel (either natural gas or mixed coal and natural gas) was used.
(C) Divide the total number of pounds of NO
(xii) Data substitution must not be used for purposes of determining compliance under this regulation.
(xiii) All CEMS data shall be reduced and reported in units of the applicable standard.
(xiv) A Quality Control Program must be developed and implemented for all CEMS required by this section in accordance with 40 CFR part 60, appendix F, Procedure 1, Section 3. The program will include, at a minimum, written procedures and operations for calibration checks, calibration drift adjustments, preventative maintenance, data collection, recording and reporting, accuracy audits/procedures, periodic performance evaluations, and a corrective action program for malfunctioning CEMS.
(m)
(ii) Records required by this section must be kept for a minimum of five years following the date of creation.
(iii) Records must be kept on site for at least two years following the date of creation and may be kept offsite, but readily accessible, for the remaining three years.
(2) The owner or operator of the BART affected unit must maintain the records identified in paragraphs (m)(2)(i) through (xi) of this section.
(i) A copy of each notification and report developed for and submitted to comply with this section including all documentation supporting any initial notification or notification of compliance status submitted, according to the requirements of this section.
(ii) Records of the occurrence and duration of each startup, shutdown, and malfunction of the BART affected unit, air pollution control equipment, and CEMS required by this section.
(iii) Records of activities taken during each startup, shutdown, and malfunction of the BART affected unit, air pollution control equipment, and CEMS required by this section.
(iv) Records of the occurrence and duration of all major maintenance conducted on the BART affected unit, air pollution control equipment, and CEMS required by this section.
(v) Records of each excess emission report, including all documentation supporting the reports, dates and times when excess emissions occurred, investigations into the causes of excess emissions, actions taken to minimize or eliminate the excess emissions, and preventative measures to avoid the cause of excess emissions from occurring again.
(vi) Records of all CEMS data including, as a minimum, the date, location, and time of sampling or measurement, parameters sampled or measured, and results.
(vii) All records associated with quality assurance and quality control activities on each CEMS as well as other records required by 40 CFR part 60, appendix F, Procedure 1 including, but not limited to, the quality control program, audit results, and reports submitted as required by this section.
(viii) Records of the NO
(ix) Records of the SO
(x) Records associated with the CEMS unit including type of CEMS, CEMS model number, CEMS serial number, and initial certification of each CEMS conducted in accordance with 40 CFR part 60, appendix B, Performance Specification 2 must be kept for the life of the CEMS unit.
(xi) Records of all periods of fuel oil usage as required in paragraph (k)(4) of this section.
(n)
(2) The owner or operator of each BART affected unit identified in this section and CEMS required by this section must provide to the Regional Administrator the written notifications, reports, and plans identified at paragraphs (n)(2)(i) through (viii) of this section. If acceptable to both the Regional Administrator and the owner or operator of each BART affected unit identified in this section and CEMS required by this section the owner or operator may provide electronic notifications, reports, and plans.
(i) A notification of the date construction of control devices and installation of burners required by this section commences postmarked no later than 30 days after the commencement date.
(ii) A notification of the date the installation of each CEMS required by this section commences postmarked no later than 30 days after the commencement date.
(iii) A notification of the date the construction of control devices and installation of burners required by this section is complete postmarked no later than 30 days after the completion date.
(iv) A notification of the date the installation of each CEMS required by this section is complete postmarked no later than 30 days after the completion date.
(v) A notification of the date control devices and burners installed by this section startup postmarked no later than 30 days after the startup date.
(vi) A notification of the date CEMS required by this section postmarked no later than 30 days after the startup date.
(vii) A notification of the date upon which the initial CEMS performance evaluations are planned. This notification must be submitted at least 60 days before the performance evaluation is scheduled to begin.
(viii) A notification of initial compliance signed by the responsible official, who shall certify its accuracy, attesting to whether the source has complied with the requirements of this section, including, but not limited to, applicable emission standards, control device and burner installations, and CEMS installation and certification. This notification must be submitted before the close of business on the 60th calendar day following the completion of the compliance demonstration and must include, at a minimum, the information in paragraphs (n)(2)(viii)(A) through (F) of this section.
(A) The methods used to determine compliance.
(B) The results of any CEMS performance evaluations and other monitoring procedures or methods that were conducted.
(C) The methods that will be used for determining continuing compliance, including a description of monitoring and reporting requirements and test methods.
(D) The type and quantity of air pollutants emitted by the source, reported in units of the standard.
(E) A description of the air pollution control equipment and burners installed as required by this section for each emission point.
(F) A statement by the owner or operator as to whether the source has complied with the relevant standards and other requirements.
(3) The owner or operator must develop and implement a written startup, shutdown, and malfunction plan for NO
(4) The written reports of the results of each performance evaluation and QA/QC check in accordance with and as required in paragraph (l)(4)(v) of this section.
(5)
(i) The first compliance report must cover the period beginning on the compliance date that is specified for the affected source through June 30 or December 31, whichever date comes first after the compliance date that is specified for the affected source.
(ii) The first compliance report must be postmarked no later than 30 calendar days after the reporting period covered by that report (July 30 or January 30), whichever comes first.
(iii) Each subsequent compliance report must cover the semiannual reporting period from January 1 through June 30 or the semiannual reporting period from July 1 through December 31.
(iv) Each subsequent compliance report must be postmarked no later than 30 calendar days after the reporting period covered by that report (July 30 or January 30).
(6)
(i) Company name and address.
(ii) Statement by a responsible official, with the official's name, title, and signature, certifying the truth, accuracy, and completeness of the content of the report.
(iii) Date of report and beginning and ending dates of the reporting period.
(iv) Identification of the process unit, control devices, and CEMS covered by the compliance report.
(v) A record of each period of a startup, shutdown, or malfunction during the reporting period and a description of the actions the owner or operator took to minimize or eliminate emissions arising as a result of the startup, shutdown, or malfunction and whether those actions were or were not consistent with the source's startup, shutdown, and malfunction plan.
(vi) A statement identifying whether there were or were not any deviations from the requirements of this section during the reporting period. If there were deviations from the requirements of this section during the reporting period, then the compliance report must describe in detail the deviations which occurred, the causes of the deviations, actions taken to address the deviations, and procedures put in place to avoid such deviations in the future. If there were no deviations from the requirements of this section during the reporting period, then the compliance report must include a statement that there were no deviations. For purposes of this section, deviations include, but are not limited to, emissions in excess of applicable emission standards established by this section, failure to continuously operate an air pollution control device in accordance with operating requirements designed to assure compliance with emission standards, failure to continuously operate CEMS required by this section, and failure to maintain records or submit reports required by this section.
(7) Each owner or operator of a CEMS required by this section must submit quarterly excess emissions and monitoring system performance reports to the Regional Administrator for each pollutant monitored for each BART affected unit monitored. All reports must be postmarked by the 30th day following the end of each 3-month period of a calendar year (January-March, April-June, July-September, October-December) and must include, at a minimum, the requirements of paragraphs (n)(7)(i) through (xv) of this section.
(i) Company name and address.
(ii) Identification and description of the process unit being monitored.
(iii) The dates covered by the reporting period.
(iv) Total source operating hours for the reporting period.
(v) Monitor manufacturer, monitor model number, and monitor serial number.
(vi) Pollutant monitored.
(vii) Emission limitation for the monitored pollutant.
(viii) Date of latest CEMS certification or audit.
(ix) A description of any changes in continuous monitoring systems, processes, or controls since the last reporting period.
(x) A table summarizing the total duration of excess emissions, as defined in paragraphs (n)(7)(x)(A) through (B) of this section, for the reporting period broken down by the cause of those excess emissions (startup/shutdown, control equipment problems, process problems, other known causes, unknown causes), and the total percent of excess emissions (for all causes) for the reporting period calculated as described in paragraph (n)(7)(x)(C) of this section.
(A) For purposes of this section, an excess emission is defined as any 30-day or 720-hour rolling average period, including periods of startup, shutdown, and malfunction, during which the 30-day or 720-hour (as appropriate) rolling average emissions of either regulated pollutant (SO
(B)(
(
(C) For purposes of this section, the total percent of excess emissions will be determined by summing all periods of excess emissions (in days) for the reporting period, dividing that number by the total BART affected unit operating days for the reporting period, and then multiplying by 100 to get the total percent of excess emissions for the reporting period. An operating day, as defined previously, is any day during which fuel is fired in the BART affected unit for any period of time. Because of the possible overlap of 30-day rolling average excess emissions across quarters, there are some situations where the total percent of excess emissions could exceed 100 percent. This extreme situation would only result from serious excess emissions problems where excess emissions occur for nearly every day during a reporting period.
(xi) A table summarizing the total duration of monitor downtime, as defined in paragraph (n)(7)(xi)(A) of this section, for the reporting period broken down by the cause of the monitor downtime (monitor equipment malfunctions, non-monitor equipment malfunctions, quality assurance calibration, other known causes, unknown causes), and the total percent of monitor downtime (for all causes) for the reporting period calculated as described in paragraph (n)(7)(xi)(B) of this section.
(A) For purposes of this section, monitor downtime is defined as any period of time (in hours) during which the required monitoring system was not measuring emissions from the BART affected unit. This includes any period of CEMS QA/QC, daily zero and span checks, and similar activities.
(B) For purposes of this section, the total percent of monitor downtime will be determined by summing all periods of monitor downtime (in hours) for the reporting period, dividing that number by the total number of BART affected unit operating hours for the reporting period, and then multiplying by 100 to get the total percent of excess emissions for the reporting period.
(xii) A table which identifies each period of excess emissions for the reporting period and includes, at a minimum, the information in paragraphs (n)(7)(xii)(A) through (F) of this section.
(A) The date of each excess emission.
(B) The beginning and end time of each excess emission.
(C) The pollutant for which an excess emission occurred.
(D) The magnitude of the excess emission.
(E) The cause of the excess emission.
(F) The corrective action taken or preventative measures adopted to minimize or eliminate the excess emissions and prevent such excess emission from occurring again.
(xiii) A table which identifies each period of monitor downtime for the reporting period and includes, at a minimum, the information in paragraphs (n)(7)(xiii)(A) through (D) of this section.
(A) The date of each period of monitor downtime.
(B) The beginning and end time of each period of monitor downtime.
(C) The cause of the period of monitor downtime.
(D) The corrective action taken or preventative measures adopted for system repairs or adjustments to minimize or eliminate monitor downtime and prevent such downtime from occurring again.
(xiv) If there were no periods of excess emissions during the reporting period, then the excess emission report must include a statement which says there were no periods of excess emissions during this reporting period.
(xv) If there were no periods of monitor downtime, except for daily zero and span checks, during the reporting period, then the excess emission report must include a statement which says there were no periods of monitor downtime during this reporting period except for the daily zero and span checks.
(8) The owner or operator of each CEMS required by this section must develop and submit for review and approval by the Regional Administrator a site specific monitoring plan. The purpose of this monitoring plan is to establish procedures and practices which will be implemented by the owner or operator in its effort to comply with the monitoring, recordkeeping, and reporting requirements of this section. The monitoring plan must include, at a minimum, the information in paragraphs (n)(8)(i) through (x) of this section.
(i) Site specific information including the company name, address, and contact information.
(ii) The objectives of the monitoring program implemented and information
(iii) Information on any emission factors used in conjunction with the CEMS required by this section to calculate emission rates and a description of how those emission factors were determined.
(iv) A description of methods to be used to calculate emission rates when CEMS data are not available due to downtime associated with QA/QC events.
(v) A description of the QA/QC program to be implemented by the owner or operator of CEMS required by this section. This can be the QA/QC program developed in accordance with 40 CFR part 60, appendix F, Procedure 1, Section 3.
(vi) A list of spare parts for CEMS maintained on site for system maintenance and repairs.
(vii) A description of the procedures to be used to calculate 30-day rolling averages and 720-hour rolling averages and example calculations which show the algorithms used by the CEMS to calculate 30-day rolling averages and 720-hour rolling averages.
(viii) A sample of the document to be used for the quarterly excess emission reports required by this section.
(ix) A description of the procedures to be implemented to investigate root causes of excess emissions and monitor downtime and the proposed corrective actions to address potential root causes of excess emissions and monitor downtime.
(x) A description of the sampling and calculation methodology for determining the percent sulfur by weight as a monthly block average for coal used during that month.
(p)
(i) To determine if statistically independent, use the Rank von Neumann Test on p. 137 of data Quality Assessment: Statistical Methods for Practitioners EPA QA/G-9S.
(ii) Alternative to Rank von Neumann test to determine if data are dependent, data are dependent if t test value is greater than t critical value, where:
(iii) The Anderson-Darling normality test is used to establish whether the data are normally distributed. That is, a distribution is considered to be normally distributed when p > 0.05.
(2)
If
If
(b)
(1) * * *
(ii)
(
(
(
(
(
(
(B)
(
(
(
(
(
(
(C)
(
(
(
(
(
(
(iv)
(
(
(
(
(
(
(
(B)
(
(
(
(
(
(
(
(v)
(
(
(
(
(
(
(B) [Reserved]
(2) * * *
(iv) United Taconite: An aggregate emission limit of 529.0 lbs SO
(c)
(2) The owner or operator shall install, certify, calibrate, maintain, and operate CEMS for SO
(3) The owner or operator shall install, certify, calibrate, maintain, and operate one or more continuous diluent monitor(s) (O
(4) For purposes of this section, all CEMS required by this section must meet the requirements of paragraphs (c)(4)(i) through (xiv) of this section.
(i) All CEMS must be installed, certified, calibrated, maintained, and operated in accordance with 40 CFR part 60, appendix B, Performance Specification 2 (PS-2) and appendix F, Procedure 1.
(ii) CEMS must be installed and operational as follows:
(A) All CEMS associated with monitoring NO
(B) All CEMS associated with monitoring NO
(C) All CEMS associated with monitoring SO
(D) All CEMS associated with monitoring SO
(E) The operational status of the CEMS identified in paragraphs (c)(1) and (2) of this section shall be verified by, as a minimum, completion of the manufacturer's written requirements or recommendations for installation, operation, and calibration of the devices.
(iii) The owner or operator must conduct a performance evaluation of each CEMS in accordance with 40 CFR part 60, appendix B, PS-2. The performance evaluations must be completed no later than 60 days after the respective CEMS installation.
(iv) The owner or operator of each CEMS must conduct periodic Quality Assurance, Quality Control (QA/QC) checks of each CEMS in accordance with 40 CFR part 60, appendix F, Procedure 1. The first CEMS accuracy test will be a relative accuracy test audit (RATA) and must be completed no later than 60 days after the respective CEMS installation.
(v) The owner or operator of each CEMS must furnish the Regional Administrator two, or upon request, more copies of a written report of the results of each performance evaluation and QA/QC check within 60 days of completion.
(vi) The owner or operator of each CEMS must check, record, and quantify the zero and span calibration drifts at least once daily (every 24 hours) in accordance with 40 CFR part 60, appendix F, Procedure 1, Section 4.
(vii) Except for CEMS breakdowns, repairs, calibration checks, and zero and span adjustments, all CEMS required by this section shall be in continuous operation during all periods of BART affected process unit operation, including periods of process unit startup, shutdown, and malfunction.
(viii) All CEMS required by this section must meet the minimum data requirements at paragraphs (c)(4)(viii)(A) through (C) of this section.
(A) Complete a minimum of one cycle of operation (sampling, analyzing, and data recording) for each successive 15-minute quadrant of an hour.
(B) Sample, analyze, and record emissions data for all periods of process operation except as described in paragraph (c)(4)(viii)(C) of this section.
(C) When emission data from CEMS are not available due to continuous monitoring system breakdowns, repairs, calibration checks, or zero and span adjustments, emission data must be obtained using other monitoring systems or emission estimation methods approved by the EPA. The other monitoring systems or emission estimation methods to be used must be incorporated into the monitoring plan required by this section and provide information such that emissions data are available for a minimum of 18 hours in each 24-hour period and at least 22 out of 30 successive unit operating days.
(ix) Owners or operators of each CEMS required by this section must reduce all data to 1-hour averages. Hourly averages shall be computed using all valid data obtained within the hour but no less than one data point in each 15-minute quadrant of an hour. Notwithstanding this requirement, an hourly average may be computed from at least two data points separated by a minimum of 15 minutes (where the unit operates for more than one quadrant in an hour) if data are unavailable as a result of performance of calibration, quality assurance, preventive maintenance activities, or backups of data from data acquisition and handling systems and recertification events.
(x) The 30-day rolling average emission rate determined from data derived from the CEMS required by this section (in lbs/MMBTU or lbs/hr depending on the emission standard selected) must be calculated in accordance with paragraphs (c)(4)(x)(A) through (F) of this section.
(A) Sum the total pounds of the pollutant in question emitted from the unit during an operating day and the previous 29 operating days.
(B) Sum the total heat input to the unit (in MMBTU) or the total actual hours of operation (in hours) during an operating day and the previous 29 operating days.
(C) Divide the total number of pounds of the pollutant in question emitted during the 30 operating days by the total heat input (or actual hours of operation depending on the emission limit selected) during the 30 operating days.
(D) For purposes of this calculation, an operating day is any day during which fuel is combusted in the BART affected unit regardless of whether pellets are produced. Actual hours of operation are the total hours a unit is firing fuel regardless of whether a complete 24-hour operational cycle occurs (
(E) If the owner or operator of the CEMS required by this section uses an alternative method to determine 30-day rolling averages, that method must be described in detail in the monitoring plan required by this section. The alternative method will only be applicable if the final monitoring plan and the alternative method are approved by EPA.
(F) A new 30-day rolling average emission rate must be calculated for each new operating day.
(xi) The 720-hour rolling average emission rate determined from data derived from the CEMS required by this section (in lbs/MMBTU) must be calculated in accordance with (c)(4)(xi)(A) through (C).
(A) Sum the total pounds of NO
(B) Sum the total heat input to the unit (in MMBTU) every hour and the previous (not necessarily consecutive) 719 hours for which that type of fuel (either natural gas or mixed coal and natural gas) was used.
(C) Divide the total number of pounds of NO
(xii) Data substitution must not be used for purposes of determining compliance under this section.
(xiii) All CEMS data shall be reduced and reported in units of the applicable standard.
(xiv) A Quality Control Program must be developed and implemented for all CEMS required by this section in accordance with 40 CFR part 60, appendix F, Procedure 1, Section 3. The program will include, at a minimum, written procedures and operations for calibration checks, calibration drift adjustments, preventative maintenance, data collection, recording and reporting, accuracy audits/procedures, periodic performance evaluations, and a corrective action program for malfunctioning CEMS.
(d)
(ii) Records required by this section must be kept for a minimum of five years following the date of creation.
(iii) Records must be kept on site for at least two years following the date of creation and may be kept offsite, but readily accessible, for the remaining three years.
(2) The owner or operator of the BART affected units must maintain the records at paragraphs (d)(2)(i) through (xi) of this section.
(i) A copy of each notification and report developed for and submitted to comply with this section including all documentation supporting any initial notification or notification of compliance status submitted according to the requirements of this section.
(ii) Records of the occurrence and duration of startup, shutdown, and malfunction of the BART affected units, air pollution control equipment, and CEMS required by this section.
(iii) Records of activities taken during each startup, shutdown, and malfunction of the BART affected unit, air pollution control equipment, and CEMS required by this section.
(iv) Records of the occurrence and duration of all major maintenance conducted on the BART affected units, air pollution control equipment, and CEMS required by this section.
(v) Records of each excess emission report, including all documentation supporting the reports, dates and times when excess emissions occurred, investigations into the causes of excess emissions, actions taken to minimize or eliminate the excess emissions, and preventative measures to avoid the cause of excess emissions from occurring again.
(vi) Records of all CEMS data including, as a minimum, the date, location, and time of sampling or measurement, parameters sampled or measured, and results.
(vii) All records associated with quality assurance and quality control activities on each CEMS as well as other records required by 40 CFR part 60, appendix F, Procedure 1 including, but not limited to, the quality control program, audit results, and reports submitted as required by this section.
(viii) Records of the NO
(ix) Records of the SO
(x) Records associated with the CEMS unit including type of CEMS, CEMS model number, CEMS serial number, and initial certification of each CEMS conducted in accordance with 40 CFR part 60, appendix B, Performance Specification 2 must be kept for the life of the CEMS unit.
(xi) Records of all periods of fuel oil usage as required at paragraph (b)(2)(vii) of this section.
(e)
(2) The owner or operator of each BART affected unit identified in this section and CEMS required by this section must provide to the Regional Administrator the written notifications, reports and plans identified at paragraphs (e)(2)(i) through (viii) of this section. If acceptable to both the Regional Administrator and the owner or operator of each BART affected unit identified in this section and CEMS required by this section the owner or operator may provide electronic notifications, reports, and plans.
(i) A notification of the date construction of control devices and installation of burners required by this section commences postmarked no later than 30 days after the commencement date.
(ii) A notification of the date the installation of each CEMS required by this section commences postmarked no later than 30 days after the commencement date.
(iii) A notification of the date the construction of control devices and installation of burners required by this
(iv) A notification of the date the installation of each CEMS required by this section is complete postmarked no later than 30 days after the completion date.
(v) A notification of the date control devices and burners installed by this section startup postmarked no later than 30 days after the startup date.
(vi) A notification of the date CEMS required by this section startup postmarked no later than 30 days after the startup date.
(vii) A notification of the date upon which the initial CEMS performance evaluations are planned. This notification must be submitted at least 60 days before the performance evaluation is scheduled to begin.
(viii) A notification of initial compliance, signed by the responsible official who shall certify its accuracy, attesting to whether the source has complied with the requirements of this section, including, but not limited to, applicable emission standards, control device and burner installations, CEMS installation and certification. This notification must be submitted before the close of business on the 60th calendar day following the completion of the compliance demonstration and must include, at a minimum, the information at paragraphs (e)(2)(viii)(A) through (F) of this section.
(A) The methods used to determine compliance.
(B) The results of any CEMS performance evaluations, and other monitoring procedures or methods that were conducted.
(C) The methods that will be used for determining continuing compliance, including a description of monitoring and reporting requirements and test methods.
(D) The type and quantity of air pollutants emitted by the source, reported in units of the standard.
(E) A description of the air pollution control equipment and burners installed as required by this section, for each emission point.
(F) A statement by the owner or operator as to whether the source has complied with the relevant standards and other requirements.
(3) The owner or operator must develop and implement a written startup, shutdown, and malfunction plan for NO
(4) The written reports of the results of each performance evaluation and QA/QC check in accordance with and as required by paragraph (c)(4)(v) of this section.
(5)
(i) The first compliance report must cover the period beginning on the compliance date that is specified for the affected source through June 30 or December 31, whichever date comes first after the compliance date that is specified for the affected source.
(ii) The first compliance report must be postmarked no later than 30 calendar days after the reporting period covered by that report (July 30 or January 30), whichever comes first.
(iii) Each subsequent compliance report must cover the semiannual reporting period from January 1 through June 30 or the semiannual reporting period from July 1 through December 31.
(iv) Each subsequent compliance report must be postmarked no later than 30 calendar days after the reporting period covered by that report (July 30 or January 30).
(6)
(i) Company name and address.
(ii) Statement by a responsible official, with the official's name, title, and signature, certifying the truth, accuracy, and completeness of the content of the report.
(iii) Date of report and beginning and ending dates of the reporting period.
(iv) Identification of the process unit, control devices, and CEMS covered by the compliance report.
(v) A record of each period of startup, shutdown, or malfunction during the reporting period and a description of the actions the owner or operator took to minimize or eliminate emissions arising as a result of the startup, shutdown or malfunction and whether those actions were or were not consistent with the source's startup, shutdown, and malfunction plan.
(vi) A statement identifying whether there were or were not any deviations from the requirements of this section during the reporting period. If there were deviations from the requirements of this section during the reporting period, then the compliance report must describe in detail the deviations which occurred, the causes of the deviations, actions taken to address the deviations, and procedures put in place to avoid such deviations in the future. If there were no deviations from the requirements of this section during the reporting period, then the compliance report must include a statement that there were no deviations. For purposes of this section, deviations include, but are not limited to, emissions in excess of applicable emission standards established by this section, failure to continuously operate an air pollution control device in accordance with operating requirements designed to assure compliance with emission standards, failure to continuously operate CEMS required by this section, and failure to maintain records or submit reports required by this section.
(7) Each owner or operator of a CEMS required by this section must submit quarterly excess emissions and monitoring system performance reports for each pollutant monitored for each BART affected unit monitored. All reports must be postmarked by the 30th day following the end of each three-month period of a calendar year (January-March, April-June, July-September, October-December) and must include, at a minimum, the requirements at paragraphs (e)(7)(i) through (xv) of this section.
(i) Company name and address.
(ii) Identification and description of the process unit being monitored.
(iii) The dates covered by the reporting period.
(iv) Total source operating hours for the reporting period.
(v) Monitor manufacturer, monitor model number, and monitor serial number.
(vi) Pollutant monitored.
(vii) Emission limitation for the monitored pollutant.
(viii) Date of latest CEMS certification or audit.
(ix) A description of any changes in continuous monitoring systems, processes, or controls since the last reporting period.
(x) A table summarizing the total duration of excess emissions, as defined at paragraphs (e)(7)(x)(A) through (B) of this section, for the reporting period broken down by the cause of those excess emissions (startup/shutdown, control equipment problems, process problems, other known causes, unknown causes), and the total percent of excess emissions (for all causes) for the reporting period calculated as described at paragraph (e)(7)(x)(C) of this section.
(A) For purposes of this section, an excess emission is defined as any 30-day or 720-hour rolling average period, including periods of startup, shutdown, and malfunction, during which the 30-day or 720-hour (as appropriate) rolling average emissions of either regulated pollutant (SO
(B)(
(
(C) For purposes of this section, the total percent of excess emissions will be determined by summing all periods of excess emissions (in days) for the reporting period, dividing that number by the total BART affected unit operating days for the reporting period, and then multiplying by 100 to get the total percent of excess emissions for the reporting period. An operating day, as defined previously, is any day during which fuel is fired in the BART affected unit for any period of time. Because of the possible overlap of 30-day rolling average excess emissions across quarters, there are some situations where the total percent of excess emissions could exceed 100 percent. This extreme situation would only result from serious excess emissions problems where excess emissions occur for nearly every day during a reporting period.
(xi) A table summarizing the total duration of monitor downtime, as defined at paragraph (e)(7)(xi)(A) of this section, for the reporting period broken down by the cause of the monitor downtime (monitor equipment malfunctions, non-monitor equipment malfunctions, quality assurance calibration, other known causes, unknown causes), and the total percent of monitor downtime (for all causes) for the reporting period calculated as described at paragraph (e)(7)(xi)(B) of this section.
(A) For purposes of this section, monitor downtime is defined as any period of time (in hours) during which the required monitoring system was not measuring emissions from the BART affected unit. This includes any period of CEMS QA/QC, daily zero and span checks, and similar activities.
(B) For purposes of this section, the total percent of monitor downtime will be determined by summing all periods of monitor downtime (in hours) for the reporting period, dividing that number by the total number of BART affected unit operating hours for the reporting period, and then multiplying by 100 to get the total percent of excess emissions for the reporting period.
(xii) A table which identifies each period of excess emissions for the reporting period and includes, at a minimum, the information in paragraphs (e)(7)(xii)(A) through (F) of this section.
(A) The date of each excess emission.
(B) The beginning and end time of each excess emission.
(C) The pollutant for which an excess emission occurred.
(D) The magnitude of the excess emission.
(E) The cause of the excess emission.
(F) The corrective action taken or preventative measures adopted to minimize or eliminate the excess emissions and prevent such excess emission from occurring again.
(xiii) A table which identifies each period of monitor downtime for the reporting period and includes, at a minimum, the information in paragraphs (e)(7)(xiii)(A) through (D) of this section.
(A) The date of each period of monitor downtime.
(B) The beginning and end time of each period of monitor downtime.
(C) The cause of the period of monitor downtime.
(D) The corrective action taken or preventative measures adopted for system repairs or adjustments to minimize or eliminate monitor downtime and prevent such downtime from occurring again.
(xiv) If there were no periods of excess emissions during the reporting period, then the excess emission report must include a statement which says there were no periods of excess emissions during this reporting period.
(xv) If there were no periods of monitor downtime, except for daily zero and span checks, during the reporting period, then the excess emission report must include a statement which says there were no periods of monitor downtime during this reporting period except for the daily zero and span checks.
(8) The owner or operator of each CEMS required by this section must develop and submit for review and approval by the Regional Administrator a site specific monitoring plan. The purpose of this monitoring plan is to establish procedures and practices which will be implemented by the owner or operator in its effort to comply with the monitoring, recordkeeping, and reporting requirements of this section. The monitoring plan must include, at a minimum, the information at paragraphs (e)(8)(i) through (x) of this section.
(i) Site specific information including the company name, address, and contact information.
(ii) The objectives of the monitoring program implemented and information describing how those objectives will be met.
(iii) Information on any emission factors used in conjunction with the
(iv) A description of methods to be used to calculate emission rates when CEMS data are not available due to downtime associated with QA/QC events.
(v) A description of the QA/QC program to be implemented by the owner or operator of CEMS required by this section. This can be the QA/QC program developed in accordance with 40 CFR part 60, appendix F, Procedure 1, Section 3.
(vi) A list of spare parts for CEMS maintained on site for system maintenance and repairs.
(vii) A description of the procedures to be used to calculate 30-day rolling averages and 720-hour rolling averages and example calculations which show the algorithms used by the CEMS to calculate 30-day rolling averages and 720-hour rolling averages.
(viii) A sample of the document to be used for the quarterly excess emission reports required by this section.
(ix) A description of the procedures to be implemented to investigate root causes of excess emissions and monitor downtime and the proposed corrective actions to address potential root causes of excess emissions and monitor downtime.
(x) A description of the sampling and calculation methodology for determining the percent sulfur by weight as a monthly block average for coal used during that month.
(f)
(i) To determine if statistically independent, use the Rank von Neumann Test on p. 137 of data Quality Assessment: Statistical Methods for Practitioners EPA QA/G-9S.
(ii) Alternative to Rank von Neumann test to determine if data are dependent, data are dependent if t test value is greater than t critical value, where:
(iii) The Anderson-Darling normality test is used to establish whether the data are normally distributed. That is, a distribution is considered to be normally distributed when p > 0.05.
(2)
If
If
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR