Page Range | 71325-71570 | |
FR Document |
Page and Subject | |
---|---|
81 FR 71384 - Federal Acquisition Regulation; Unique Identification of Entities Receiving Federal Awards | |
81 FR 71501 - Sunshine Act Meeting | |
81 FR 71544 - Sunshine Act Meeting | |
81 FR 71515 - National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting | |
81 FR 71517 - Center for Scientific Review; Notice of Closed Meetings | |
81 FR 71356 - Special Conditions: Learjet Model 45 Series Airplanes; Aircraft Electronic System Security Protection From Unauthorized External Access | |
81 FR 71357 - Special Conditions: Learjet Model 45 Series Airplanes; Isolation or Security Protection of the Aircraft Control Domain and the Airline Information Services Domain From the Passenger Services Domain | |
81 FR 71505 - Agency Forms Undergoing Paperwork Reduction Act Review | |
81 FR 71357 - Special Conditions: Embraer S.A., Model ERJ 190-300 Series Airplanes; Electrical/Electronic Equipment Bay Fire Detection and Smoke Penetration | |
81 FR 71480 - Small Diameter Graphite Electrodes From the People's Republic of China: Amended Final Results of Antidumping Duty Administrative Review; 2014-2015 | |
81 FR 71492 - Applications for New Awards; Upward Bound Program | |
81 FR 71482 - Certain Steel Nails From the United Arab Emirates: Final Results of Antidumping Duty Administrative Review; 2014-2015 | |
81 FR 71523 - Statutorily Mandated Designation of Difficult Development Areas and Qualified Census Tracts for 2017 | |
81 FR 71427 - User Fees for Installment Agreements; Hearing Cancellation | |
81 FR 71503 - Agency Information Collection Activities; Proposed Collection; Comment Request for a Modified OGE Form 278e Executive Branch Personnel Public Financial Disclosure Report | |
81 FR 71410 - Coastal Migratory Pelagic Resources of the Gulf of Mexico and South Atlantic; 2016-2017 Commercial Accountability Measures and Closure for King Mackerel in Western Zone of the Gulf of Mexico | |
81 FR 71356 - Federal Agricultural Mortgage Corporation Governance; Standards of Conduct; Risk Management; and Disclosure and Reporting | |
81 FR 71538 - Statistical Policy Directive No. 4 Addendum: Release and Dissemination of Statistical Products Produced by Federal Statistical Agencies and Recognized Statistical Units | |
81 FR 71381 - Safety Zones; Fireworks Events in Captain of the Port New York Zone | |
81 FR 71520 - Agency Information Collection Activities: Application for Suspension of Deportation or Special Rule Cancellation of Removal (Pursuant to Section 203 of Public Law 105-100, NACARA), Form I-881; Extension, Without Change, of a Currently Approved Collection | |
81 FR 71521 - Agency Information Collection Activities: Application To Adjust Status From Temporary to Permanent Resident, Form I-698; Extension, Without Change, of a Currently Approved Collection | |
81 FR 71528 - Proposed New Information Collection: OMB Control Number 1094-ONEW, Indian Water Rights Settlements: Economic Analysis | |
81 FR 71522 - Agency Information Collection Activities: Application for Waiver of Grounds of Inadmissibility, Form I-601; Revision of a Currently Approved Collection | |
81 FR 71491 - Proposed Collection; Comment Request | |
81 FR 71508 - Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds | |
81 FR 71506 - Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Drug User Fee Act Waivers and Reductions | |
81 FR 71504 - World Trade Center Health Program Scientific/Technical Advisory Committee (WTCHP STAC or Advisory Committee), National Institute for Occupational Safety and Health (NIOSH) | |
81 FR 71498 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Federal Direct Loan Program Regulations for Forbearance and Loan Rehabilitation | |
81 FR 71511 - Abbreviated New Drug Application Submissions-Prior Approval Supplements Under Generic Drug User Fee Amendments; Guidance for Industry; Availability | |
81 FR 71490 - Proposed Collection; Comment Request | |
81 FR 71542 - Agency Information Collection Activities: Proposed Collection; Comment Request; Member Inspection of Credit Union Books, Records, and Minutes | |
81 FR 71365 - Cuba: Revisions to License Exceptions | |
81 FR 71563 - Notice of Intent To Solicit Comments and Conduct a Public Scoping Meeting on a Global Water Strategy | |
81 FR 71372 - Cuban Assets Control Regulations | |
81 FR 71562 - Culturally Significant Objects Imported for Exhibition Determinations: “Doris Salcedo: The Materiality of Mourning” Exhibition | |
81 FR 71562 - Industry Advisory Group: Notice of Open Meeting | |
81 FR 71499 - Kenai Hydro, LLC; Notice of Technical Meeting | |
81 FR 71498 - Consolidated Hydro New Hampshire, LLC; Notice of Intent To File License Application, Filing of Pre-Application Document, Approving Use of the Traditional Licensing Process | |
81 FR 71499 - Texas Eastern Transmission, LP; Notice of Application | |
81 FR 71415 - Electronic Submission of Labeling for Certain Home-Use Medical Devices | |
81 FR 71489 - Submission for OMB Review; Comment Request | |
81 FR 71502 - Formations of, Acquisitions by, and Mergers of Bank Holding Companies | |
81 FR 71501 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company | |
81 FR 71348 - Regulatory Capital Rules, Liquidity Coverage Ratio: Revisions to the Definition of Qualifying Master Netting Agreement and Related Definitions | |
81 FR 71563 - InterVISTAS Study | |
81 FR 71542 - Submission for OMB Review; Comment Request | |
81 FR 71382 - Extension of the Presumptive Period for Compensation for Gulf War Veterans | |
81 FR 71531 - Action Subject to Intergovernmental Review | |
81 FR 71477 - Designation for the Olympia, WA Area | |
81 FR 71535 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Certification on Agency Letterhead Authorizing Purchase of Firearm for Official Duties of Law Enforcement Officer | |
81 FR 71536 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Approval of an Existing Collection in Use Without an OMB Control Number Credit Card Payment Form (1-786) | |
81 FR 71537 - Agency Information Collection Activities; Proposed eCollection eComments Requested; United States Victims of State Sponsored Terrorism Fund Application Form | |
81 FR 71543 - Advisory Committee on Reactor Safeguards; Procedures for Meetings | |
81 FR 71502 - Notice of Senior Executive Performance Review Board Appointments | |
81 FR 71475 - Angeles National Forest, California, Cattle Canyon Improvements Project | |
81 FR 71477 - Proposed Posting and Posting of Stockyards | |
81 FR 71510 - Substitutability of Generic Drugs: Perceptions and Reality; Public Workshop | |
81 FR 71513 - Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Type A Medicated Articles | |
81 FR 71370 - Medical Devices; Cardiovascular Devices; Classification of the Apical Closure Device | |
81 FR 71566 - Pipeline Safety: General Policy Statement; Civil Penalties | |
81 FR 71471 - Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Reef Fish Fishery of the Gulf of Mexico; Yellowtail Snapper Management Measures | |
81 FR 71480 - Submission for OMB Review; Comment Request | |
81 FR 71500 - Combined Notice of Filings #1 | |
81 FR 71531 - Certain Marine Sonar Imaging Devices, Including Downscan and Sidescan Devices, Products Containing the Same, and Components Thereof; Notice of Institution of Formal Enforcement Proceeding | |
81 FR 71534 - Certain Lithium Metal Oxide Cathode Materials, Lithium-Ion Batteries for Power Tool Products Containing Same, and Power Tool Products With Lithium-Ion Batteries Containing Same; Commission's Procedure for a Public Hearing on the Issues of Laches, Contributory Infringement, and the Public Interest | |
81 FR 71533 - Stainless Steel Sheet and Strip From Japan, Korea, and Taiwan; Notice of Commission Determination To Conduct Full Five-Year Reviews | |
81 FR 71532 - The Economic Effects of Significant U.S. Import Restraints; Ninth Update; Special Topic: The Effects of Tariffs and of Customs and Border Procedures on Global Supply Chains | |
81 FR 71562 - Investment Company Act of 1940 | |
81 FR 71545 - Self-Regulatory Organizations; Fixed Income Clearing Corporation; Order Approving Proposed Rule Change To Describe the Blackout Period Exposure Charge That May Be Imposed on GCF Repo Participants | |
81 FR 71559 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Amending Its Rules To Remove Definitions and Trading Rules That Are No Longer Operative After the Completed Full Migration of All Symbols to the Pillar Trading Platform | |
81 FR 71556 - Self-Regulatory Organizations; NASDAQ PHLX LLC; Notice of Filing of Proposed Rule Change To Amend the Pricing Schedule at Section IV, Part B titled “Flex Transaction Fees” | |
81 FR 71548 - Self-Regulatory Organizations; The Nasdaq Stock Market LLC; Notice of Filing of Proposed Rule Change To Amend the Continued Listing Requirements for Exchange-Traded Products | |
81 FR 71549 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of Proposed Rule Change To List and Trade Exchange-Traded Managed Funds | |
81 FR 71558 - Submission for OMB Review; Comment Request | |
81 FR 71545 - Senior Executive Service Performance Board | |
81 FR 71412 - Filing of Complaints of Prohibited Personnel Practices or other Prohibited Activities and Filing Disclosures of Information; Correction | |
81 FR 71484 - Magnuson-Stevens Fishery Conservation and Management Act; General Provisions for Domestic Fisheries; Application for Exempted Fishing Permit | |
81 FR 71484 - Marine Fisheries Advisory Committee Meeting | |
81 FR 71515 - Advisory Council on Alzheimer's Research, Care, and Services; Meeting | |
81 FR 71427 - International Mailing Services: Proposed Price Changes | |
81 FR 71564 - Qualification of Drivers; Exemption Applications; Epilepsy and Seizure Disorders | |
81 FR 71564 - Petition for Exemption; Summary of Petition Received; 501ZD | |
81 FR 71501 - Notice of Termination; 10270 Williamsburg First National Bank, Kingstree, South Carolina | |
81 FR 71543 - Membership of National Science Foundation's Senior Executive Service Performance Review Board | |
81 FR 71412 - Rotorcraft Pilot Compartment View | |
81 FR 71519 - Notice of Revocation of Customs Brokers' Licenses | |
81 FR 71516 - Office of the Secretary; Notice of Meeting | |
81 FR 71519 - National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting | |
81 FR 71519 - National Institute on Aging; Notice of Closed Meeting | |
81 FR 71516 - National Institute on Aging; Notice of Closed Meeting | |
81 FR 71515 - National Cancer Institute; Notice of Closed Meetings | |
81 FR 71518 - Center for Scientific Review; Notice of Closed Meetings | |
81 FR 71518 - Center for Scientific Review; Amended Notice of Meeting | |
81 FR 71511 - Issuance of Priority Review Voucher; Rare Pediatric Disease Product | |
81 FR 71529 - Notice of Proposed Classification of Public Lands and Minerals for State Indemnity Selection, Montana | |
81 FR 71479 - Notice of Public Meeting of the Tennessee Advisory Committee | |
81 FR 71479 - Notice of Public Meeting of the South Carolina Advisory Committee | |
81 FR 71479 - Notice of Public Meeting of the Kansas Advisory Committee to discuss completion of a Committee Study on Voting Rights, and To Discuss Other Civil Rights Issues in the State for Future Inquiry | |
81 FR 71502 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company | |
81 FR 71457 - Endangered and Threatened Wildlife and Plants; Review of Foreign Species That Are Candidates for Listing as Endangered or Threatened; Annual Notification of Findings on Resubmitted Petitions; Annual Description of Progress on Listing Actions | |
81 FR 71444 - Air Plan Approval; Ohio; Redesignation of the Cleveland Area to Attainment of the 2008 Ozone Standard | |
81 FR 71485 - Notice of Roundtables and Request for Comments Related to Patent Subject Matter Eligibility | |
81 FR 71367 - Unsuccessful Work Attempts and Expedited Reinstatement Eligibility | |
81 FR 71325 - Energy Conservation Program: Energy Conservation Standards for Direct Heating Equipment | |
81 FR 71475 - Notice of Public Information Collection Requirements Submitted to OMB for Review | |
81 FR 71386 - Endangered and Threatened Wildlife and Plants; Reclassifying the Columbia River Distinct Population Segment of the Columbian White-Tailed Deer as Threatened With a Rule Under Section 4(d) of the Act | |
81 FR 71570 - Departmental Offices; Debt Management Advisory Committee Meeting | |
81 FR 71428 - New Mailing Standards for Domestic Mailing Services Products | |
81 FR 71378 - Privacy Act of 1974; Implementation | |
81 FR 71331 - Procedures for Determining Eligibility for Access to Classified Matter or Special Nuclear Material | |
81 FR 71360 - Cancellation of Standard Instrument Approach Procedures as Part of the National Procedures Assessment (NPA) Initiative | |
81 FR 71384 - Update of Department of Transportation Regulations; Termination of the Department of Transportation Board of Contract Appeals |
Forest Service
Grain Inspection, Packers and Stockyards Administration
Industry and Security Bureau
International Trade Administration
National Oceanic and Atmospheric Administration
Patent and Trademark Office
Army Department
Federal Energy Regulatory Commission
Centers for Disease Control and Prevention
Food and Drug Administration
National Institutes of Health
Coast Guard
U.S. Citizenship and Immigration Services
U.S. Customs and Border Protection
Fish and Wildlife Service
Land Management Bureau
Surface Mining Reclamation and Enforcement Office
Alcohol, Tobacco, Firearms, and Explosives Bureau
Federal Aviation Administration
Federal Motor Carrier Safety Administration
Pipeline and Hazardous Materials Safety Administration
Foreign Assets Control Office
Internal Revenue Service
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Office of Energy Efficiency and Renewable Energy, Department of Energy.
Final determination.
The Energy Policy and Conservation Act of 1975 (EPCA), as amended, prescribes energy conservation standards for various consumer products and certain commercial and industrial equipment, including direct heating equipment. EPCA also requires the U.S. Department of Energy (DOE) to periodically determine whether more-stringent standards would be technologically feasible and economically justified, and would save a significant amount of energy. In this final determination, DOE is finalizing its determination that more-stringent energy conservation standards for direct heating equipment are not economically justified and is therefore not amending its energy conservation standards.
The effective date of this rule is December 16, 2016.
The docket for this rulemaking, which includes
A link to the docket Web page can be found at
For further information on how to review the docket, contact the Appliance and Equipment Standards Program Staff at (202) 586-6636 or by email:
John Cymbalsky, U.S. Department of Energy, Office of Energy Efficiency and Renewable Energy, Building Technologies Office, EE-5B, 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone: (202) 287-1692. Email:
Ms. Sarah Butler, U.S. Department of Energy, Office of the General Counsel, GC-33, 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone: (202) 586-1777. Email:
DOE has determined that energy conservation standards should not be amended for direct heating equipment (DHE). DOE has concluded that the DHE market characteristics are largely similar to those analyzed in the previous rulemaking and the technologies available for improving DHE energy efficiency have not advanced significantly since the previous rulemaking analyses
Title III, Part B
Pursuant to the requirements set forth under EPCA, any new or amended standard for a covered product must be designed to achieve the maximum improvement in energy efficiency that is technologically feasible and economically justified. (42 U.S.C. 6295(o)(2)(A)) Furthermore, DOE may not adopt any standard that would not result in the significant conservation of energy. (42 U.S.C. 6295(o)(3)(B)) Moreover, DOE may not prescribe a standard: (1) For certain products, including DHE, if no test procedure has been established for the product,
(1) The economic impact of the standard on manufacturers and consumers of the products subject to the standard;
(2) The savings in operating costs throughout the estimated average life of the covered products in the type (or class) compared to any increase in the price, initial charges, or maintenance expenses for the covered products that are likely to result from the standard;
(3) The total projected amount of energy (or as applicable, water) savings likely to result directly from the standard;
(4) Any lessening of the utility or the performance of the covered products likely to result from the standard;
(5) The impact of any lessening of competition, as determined in writing by the Attorney General, that is likely to result from the standard;
(6) The need for national energy and water conservation; and
(7) Other factors the Secretary of Energy (Secretary) considers relevant.
Further, EPCA, as codified, establishes a rebuttable presumption that a standard is economically justified if the Secretary finds that the additional cost to the consumer of purchasing a product complying with an energy conservation standard level will be less than three times the value of the energy savings during the first year that the consumer will receive as a result of the standard, as calculated under the applicable test procedure. (42 U.S.C. 6295(o)(2)(B)(iii))
EPCA, as codified, also contains what is known as an “anti-backsliding” provision, which prevents the Secretary from prescribing any amended standard that either increases the maximum allowable energy use or decreases the minimum required energy efficiency of a covered product. (42 U.S.C. 6295(o)(1)) Also, the Secretary may not prescribe an amended or new standard if interested persons have established by a preponderance of the evidence that the standard is likely to result in the unavailability in the United States in any covered product type (or class) of performance characteristics (including reliability), features, sizes, capacities, and volumes that are substantially the same as those generally available in the United States. (42 U.S.C. 6295(o)(4))
Federal energy conservation requirements generally supersede State laws or regulations concerning energy conservation testing, labeling, and standards. (42 U.S.C. 6297(a)-(c)) DOE may, however, grant waivers of Federal preemption for particular State laws or regulations, in accordance with the procedures and other provisions set forth under 42 U.S.C. 6297(d)).
Finally, any final rule for new or amended energy conservation standards promulgated after July 1, 2010, is required to address standby mode and off mode energy use. (42 U.S.C. 6295(gg)(3)) Specifically, when DOE adopts a standard for a covered product after that date, it must, if justified by the criteria for adoption of standards under EPCA (42 U.S.C. 6295(o)), incorporate standby mode and off mode energy use into a single standard, or, if that is not feasible, adopt a separate standard for such energy use for that product. (42 U.S.C. 6295(gg)(3)(A)-(B)) DOE's current test procedures for vented home heating equipment address standby mode fossil-fuel energy use only.
In the April 2010 Final Rule, DOE prescribed the current energy conservation standards for DHE manufactured on and after April 16, 2013. 75 FR 20112. These standards are set forth in DOE's regulations at 10 CFR 430.32(i)(2) and are shown in Table I-1.
EPCA, as codified, initially set forth energy conservation standards for certain DHE product classes that are the subject of this document and directed DOE to conduct two subsequent rulemakings to determine whether the existing standards should be amended. (42 U.S.C. 6295(e)(3) and (4)) The first of these two rulemakings included both DHE and pool heaters and concluded with the April 2010 Final Rule (codified at 10 CFR 430.32(i) and (k)). 75 FR 20112. With respect to DHE, the first rulemaking amended the energy conservation standards for vented home heating equipment, a subset of DHE, and consolidated some of the product classes from the previous standards established by EPCA. Compliance with the amended standards was required beginning on April 16, 2013.
This rulemaking satisfies the statutory requirement under EPCA to (1) conduct a second round of review of the DHE
Subsequently, on April 11, 2016, DOE published in the
In the most recent DOE rulemaking for DHE energy conservation standards, DOE initially proposed standards for vented home heating products in a NOPR published on December 11, 2009 (“December 2009 NOPR”) that represented a six AFUE percentage point (weighted-average across all product classes) increase over the standards established by EPCA and codified at 42 U.S.C. 6295(e)(3). 74 FR 65852 (December 11, 2009). In response to the December 2009 NOPR several commenters presented the following concerns:
• Shipments of DHE were low, therefore energy savings potential was low;
• Low shipments would make it difficult to recoup manufacturers' expenditures related to complying with amended standards;
• Product offerings may be reduced;
• Manufacturers may leave the market entirely; and
• Employment in the industry may be negatively impacted due to reduced product lines and/or insufficient return on investment required to meet amended standards.
In the April 2010 Final Rule, DOE also found that:
• The industry had gone through considerable consolidation, with three businesses controlling the vast majority of the market;
• Consolidation was driven by the decrease in shipments;
• Product lines were predominantly maintained to provide replacements, not new construction; and
• Small business manufacturers could be disproportionately disadvantaged by a more stringent standard due to low shipment volumes and a high ratio of anticipated investment costs to annual earnings.
DOE ultimately rejected TSL 3 and all higher TSLs in the April 2010 Final Rule on the grounds that capital conversion costs would lead to a large reduction in INPV and that small businesses would be disproportionately impacted. DOE also noted that the life-cycle cost (LCC) and payback period analyses (PBP) for TSL 4 and higher suggested that benefits to consumers were outweighed by initial costs. 75 FR 20112, 20215-20218 (April 16, 2010). DOE, therefore, adopted standards at TSL 2 for vented home heating equipment. Compliance with the adopted standards (codified at 10 CFR 430.32(i)(2)) was required for all vented home heating equipment manufactured on or after April 16, 2013.
In the April 2016 NOPD DOE found that few changes to the industry and product offerings had occurred since the April 2010 Final Rule and therefore the conclusions presented in that final rule were still valid. First, DOE conducted a review of the current DHE market, including product literature and product listings in the DOE Compliance Certification Management System (CCMS) database and Air-Conditioning, Heating, and Refrigeration Institute (AHRI) product directory.
Second, DOE examined available technologies used to improve the efficiency of DHE. DOE contractors analyzed current products through product teardowns and engaged in manufacturer interviews to obtain further information in support of its analysis. In response to the March 2015 RFI, AHRI commented that the current energy conservation standards are close to if not at the maximum technology level for most product classes of DHE. (Docket EERE-2015-BT-STD-0003: AHRI, No. 7 at p. 4) During confidential manufacturer interviews, DOE received similar feedback regarding the small potential for improving efficiency over current standards for most product classes. Moreover, manufacturers suggested that because these units are primarily sold as replacement units, new designs or prototypes are generally not being pursued. DOE noted in the April 2016 NOPD that the same technology options (namely improved heat exchanger, induced draft, electronic ignition, and a two-speed blower for wall fan-type furnaces) were considered as part of the previous DHE rulemaking analysis, and agreed that the technology options available for DHE likely have limited potential for achieving energy savings.
In addition to these technology options, DOE also noted that a condensing fan-type wall furnace with two input capacities (17,500 Btu/h with a 90.2% AFUE rating, and 35,000 Btu/h with a 91.8% AFUE rating) had become available since the last rulemaking. DOE must set amended standards that result in the maximum improvement in energy efficiency that is technologically feasible (42 U.S.C.
Finally, DOE acknowledged in the April 2016 NOPD that the DHE industry had seen further consolidation, with the total number of manufacturers declining from six to four. Furthermore, according to manufacturers,
In light of these considerations, DOE proposed in the April 2016 NOPD not to amend its energy conservation standards for DHE. DOE tentatively concluded that amended standards for DHE could not be economically justified based on low and declining shipments, lack of cost-effective technology options, and the potential for severe impacts on small businesses.
In response to the April 2016 NOPD, DOE received five comment submissions from Tyler McAnelly (individual), the American Public Gas Association (APGA), the Association of Home Appliance Manufacturers (AHAM), the California Investor Owned Utilities (CA IOUs), and the Air-conditioning, Heating, and Refrigeration Institute (AHRI).
APGA, AHAM, and AHRI supported DOE's tentative determination that amended standards for DHE would not be economically justified. (APGA, No. 4 at p. 1-2; AHAM, No. 5 at p. 2; AHRI, No. 7 at p. 1-2) APGA reiterated that because the market is small, any increase in the standard would result in significant impacts on manufacturers. (APGA, No. 4 at p. 1) AHRI agreed that model offerings had been reduced and suggested that this was a result of the last rulemaking. (AHRI, No. 7 at p. 1) They agreed with DOE's determination that an amended standard set at a condensing efficiency level for fan-type wall furnaces would severely impact manufacturers. (AHRI, No. 7 at p. 1) They also presented their estimates of the percent change in total shipments for the years 2010-2015 compared with the total shipments over the period 2001-2006, estimating that wall furnace shipments were 21% less, direct vent wall furnace (a form of wall furnace) shipments were 31% less, and room heater shipments were 44% less. (AHRI, No. 7 at p. 2)
McAnelly suggested that amended standards for DHE may be technologically feasible, may save a significant amount of energy such that DOE should not wait until such standards are economically justified, and that therefore DOE should consider adopting amended standards for DHE. (McAnelly, No. 3 at p. 1) In response, DOE notes that it is required by statute (42 U.S.C. 6295(o)(2)(A)) to establish energy conservation standards that are both technologically feasible and economically justified, and therefore cannot legally amend standards that cannot be shown to be economically justified based on the seven criteria found at 42 U.S.C. 6295(o)(2)(B).
In response to the April 2016 NOPD, the CA IOUs urged DOE to consider energy conservation standards for portable electric heaters (a form of unvented home heating equipment). They cited reports indicating both a growing market, the overall energy use for these products, and the prevalence of thermostats and their potential to save energy. They also suggested that DOE modify the test procedure for unvented home heating equipment in order to reflect energy savings due to control features like thermostats, occupancy sensors, automatic shut-off, and network capabilities. (CA IOUs, No. 6 at p. 1-2)
The DOE test procedure for unvented home heating equipment (appendix G), includes a calculation of annual energy consumption based on a single assignment of active mode hours for unvented heaters that are used as the primary heating source for the home. For unvented heaters that are not used as the primary heating source for the home, there are no provisions for calculating either the energy efficiency or annual energy consumption. Pursuant to 42 U.S.C. 6295(o)(3) DOE is prohibited from prescribing a new or amended standard for a covered consumer product if a test procedure has not been prescribed for that consumer product. As such, DOE cannot consider standards for these products at this time. DOE may consider amending the test procedures and establishing standards for unvented home heating equipment in the future.
DOE did not receive any comments or data suggesting that DOE's initial analysis of the DHE market in the April 2016 NOPD was inaccurate. Therefore, due to the lack of advancement in the DHE industry since the April 2010 Final Rule in terms of product offerings, available technology options and associated costs, and declining shipment volumes, DOE continues to believe that amending the DHE energy conservation standards would impose a substantial burden on manufacturers of DHE, particularly to small manufacturers. DOE rejected higher TSLs during the previous DHE rulemaking due to significant impacts on industry profitability, risks of accelerated industry consolidation, and the likelihood that small manufacturers would experience disproportionate impacts that could lead them to
As discussed in section I.A, EPCA requires DOE to incorporate standby mode and off mode energy use into a single amended or new standard (if feasible) or prescribe a separate standard for standby mode and off mode energy consumption in any final rule establishing or revising a standard for a covered product, adopted after July 1, 2010. (42 U.S.C. 6295(gg)(3)(A)-(B)) Because DOE is not amending standards for DHE in this rule, DOE is not required to adopt amended standards that include standby and off mode energy use. DOE notes that fossil fuel energy use in standby mode and off mode is already included in the AFUE metric, and DOE anticipates that electric standby and off mode energy use is small in comparison to fossil fuel energy use.
This final determination is not subject to review under Executive Order (E.O.) 12866, “Regulatory Planning and Review.” 58 FR 51735 (October 4, 1993).
The Regulatory Flexibility Act (5 U.S.C. 601
DOE reviewed this final determination under the provisions of the Regulatory Flexibility Act and the policies and procedures published on February 19, 2003. In this final determination, DOE finds that amended energy conservation standards for DHE would not be economically justified at any level above the current standard level because benefits of more stringent standards would not outweigh the burdens. This determination does not establish amended energy conservation standards for DHE. On the basis of the foregoing, DOE certifies that this determination will not have a significant economic impact on a substantial number of small entities. Accordingly, DOE has not prepared an FRFA for this final determination. DOE will transmit this certification and supporting statement of factual basis to the Chief Counsel for Advocacy of the Small Business Administration for review under 5 U.S.C. 605(b).
This final determination, which determines that amended energy conservation standards for DHE would not be economically justified at any level above the current standard level because benefits of more stringent standards would not outweigh the burdens, and imposes no new information or record keeping requirements. Accordingly, the Office of Management and Budget (OMB) clearance is not required under the Paperwork Reduction Act. (44 U.S.C. 3501
In this final determination, DOE determines that amended energy conservation standards for DHE would not be economically justified at any level above the current standard level because benefits of more stringent standards would not outweigh the burdens. DOE has determined that review under the National Environmental Policy Act of 1969 (NEPA), Public Law 91-190, codified at 42 U.S.C. 4321
Executive Order 13132, “Federalism,” 64 FR 43255 (August 10, 1999), imposes certain requirements on Federal agencies formulating and implementing policies or regulations that preempt State law or that have Federalism implications. The Executive Order requires agencies to examine the constitutional and statutory authority supporting any action that would limit the policymaking discretion of the States and to carefully assess the necessity for such actions. The Executive Order also requires agencies to have an accountable process to ensure meaningful and timely input by State and local officials in the development of regulatory policies that have Federalism implications. On March 14, 2000, DOE published a statement of policy describing the intergovernmental consultation process it will follow in the development of such regulations. 65 FR 13735. As this final determination determines that amended standards are not likely to be warranted for DHE, there is no impact on the policymaking discretion of the states. Therefore, no action is required by Executive Order 13132.
With respect to the review of existing regulations and the promulgation of new regulations, section 3(a) of Executive Order 12988, “Civil Justice Reform,” imposes on Federal agencies the general duty to adhere to the following requirements: (1) Eliminate drafting errors and ambiguity; (2) write regulations to minimize litigation; (3) provide a clear legal standard for affected conduct rather than a general standard; and (4) promote simplification and burden reduction. 61 FR 4729 (Feb. 7, 1996). Regarding the review required by section 3(a), section 3(b) of Executive Order 12988 specifically requires that Executive agencies make every reasonable effort to ensure that the regulation: (1) Clearly specifies the preemptive effect, if any; (2) clearly specifies any effect on existing Federal law or regulation; (3) provides a clear legal standard for affected conduct while promoting simplification and burden reduction; (4) specifies the retroactive effect, if any; (5) adequately defines key terms; and (6) addresses other important issues affecting clarity and general draftsmanship under any guidelines issued by the Attorney General. Section 3(c) of Executive Order 12988 requires Executive agencies to review regulations in light of applicable standards in section 3(a) and section 3(b) to determine whether they are met or it is unreasonable to meet one or more of them. DOE has completed the required review and determined that, to the extent permitted by law, this proposed determination meets the
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) requires each Federal agency to assess the effects of Federal regulatory actions on State, local, and Tribal governments and the private sector. Public Law 104-4, sec. 201 (codified at 2 U.S.C. 1531). For a proposed regulatory action likely to result in a rule that may cause the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector of $100 million or more in any one year (adjusted annually for inflation), section 202 of UMRA requires a Federal agency to publish a written statement that estimates the resulting costs, benefits, and other effects on the national economy. (2 U.S.C. 1532(a), (b)) The UMRA also requires a Federal agency to develop an effective process to permit timely input by elected officers of State, local, and Tribal governments on a proposed “significant intergovernmental mandate,” and requires an agency plan for giving notice and opportunity for timely input to potentially affected small governments before establishing any requirements that might significantly or uniquely affect them. On March 18, 1997, DOE published a statement of policy on its process for intergovernmental consultation under UMRA. 62 FR 12820. DOE's policy statement is also available at
Section 654 of the Treasury and General Government Appropriations Act, 1999 (Pub. L. 105-277) requires Federal agencies to issue a Family Policymaking Assessment for any rule that may affect family well-being. This final determination will not have any impact on the autonomy or integrity of the family as an institution. Accordingly, DOE has concluded that it is not necessary to prepare a Family Policymaking Assessment.
Pursuant to Executive Order 12630, “Governmental Actions and Interference with Constitutionally Protected Property Rights,” 53 FR 8859 (March 15, 1988), DOE has determined that this final determination will not result in any takings that might require compensation under the Fifth Amendment to the U.S. Constitution.
Section 515 of the Treasury and General Government Appropriations Act, 2001 (44 U.S.C. 3516 note) provides for Federal agencies to review most disseminations of information to the public under information quality guidelines established by each agency pursuant to general guidelines issued by OMB. OMB's guidelines were published at 67 FR 8452 (Feb. 22, 2002), and DOE's guidelines were published at 67 FR 62446 (Oct. 7, 2002). DOE has reviewed this final determination under the OMB and DOE guidelines and has concluded that it is consistent with applicable policies in those guidelines.
Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use,” 66 FR 28355 (May 22, 2001), requires Federal agencies to prepare and submit to OIRA at OMB, a Statement of Energy Effects for any proposed significant energy action. A “significant energy action” is defined as any action by an agency that promulgates or is expected to lead to promulgation of a final rule, and that: (1) Is a significant regulatory action under Executive Order 12866, or any successor order; and (2) is likely to have a significant adverse effect on the supply, distribution, or use of energy, or (3) is designated by the Administrator of OIRA as a significant energy action. For any proposed significant energy action, the agency must give a detailed statement of any adverse effects on energy supply, distribution, or use should the proposal be implemented, and of reasonable alternatives to the action and their expected benefits on energy supply, distribution, and use.
Because this final determination determines that amended standards for DHE are not warranted, it is not a significant energy action, nor has it been designated as such by the Administrator at OIRA. Accordingly, DOE has not prepared a Statement of Energy Effects.
On December 16, 2004, OMB, in consultation with the Office of Science and Technology Policy (OSTP), issued its Final Information Quality Bulletin for Peer Review (the Bulletin). 70 FR 2664 (Jan. 14, 2005). The Bulletin establishes that certain scientific information shall be peer reviewed by qualified specialists before it is disseminated by the Federal Government, including influential scientific information related to agency regulatory actions. The purpose of the bulletin is to enhance the quality and credibility of the Government's scientific information. Under the Bulletin, the energy conservation standards rulemaking analyses are “influential scientific information,” which the Bulletin defines as “scientific information the agency reasonably can determine will have, or does have, a clear and substantial impact on important public policies or private sector decisions.” Id. at FR 2667.
In response to OMB's Bulletin, DOE conducted formal in-progress peer reviews of the energy conservation standards development process and analyses and has prepared a Peer Review Report pertaining to the energy conservation standards rulemaking analyses. Generation of this report involved a rigorous, formal, and documented evaluation using objective criteria and qualified and independent reviewers to make a judgment as to the technical/scientific/business merit, the actual or anticipated results, and the productivity and management effectiveness of programs and/or projects. The “Energy Conservation Standards Rulemaking Peer Review Report” dated February 2007 has been disseminated and is available at the following Web site:
The Secretary of Energy has approved publication of this final determination.
Administrative practice and procedure, Confidential business information, Energy conservation, Household appliances, Imports, Incorporation by reference, Intergovernmental relations, Small businesses.
Department of Energy.
Final rule.
The Department of Energy (DOE) is amending its regulations which set forth the policies and procedures for resolving questions concerning eligibility for DOE access authorization. The revisions update and provide added clarity throughout the regulations, and streamline the process for resolving access authorization eligibility determinations. Additionally, DOE is updating references to DOE Offices and officials to reflect the current DOE organizational structure.
This rule is effective November 16, 2016.
Mark R. Pekrul, Office of Departmental Personnel Security, (202) 586-4097,
The Department of Energy is publishing this final rule in order to update and clarify DOE's policies and procedures for the denial and revocation of access authorizations.
10 CFR part 710 had not been substantively updated since 2001 (66 FR 47062, Sept. 11, 2001). Since that time, as the Department has gained operational experience under the existing rule, revisions to update and clarify provisions in the rule became appropriate. On April 19, 2016, DOE issued a notice of proposed rulemaking (NOPR) to propose the updating of part 710 (81 FR 22920). The NOPR proposed amending the existing rule to: (1) Accord primacy to the national Adjudicative Standards when determining eligibility for access authorization; (2) clarify that DOE can, in exigent circumstances, suspend an access authorization without recourse to certain administrative procedures; (3) permit individuals subject to criminal proceedings to suspend access authorization revocation proceedings under this part, subject to certain conditions; (4) limit the ability of the Appeal Panel to consider new evidence on appeal of a decision by the Department's Office of Hearings and Appeals or the Manager to deny or revoke access authorization; (5) introduce a one-year waiting period before an individual, previously the subject of denial or revocation of access authorization, may be reconsidered for access authorization; (6) add to part 710 the requirements of Presidential Policy Directive 19, which provides appeal rights to the Department's Office of Inspector General under certain circumstances; (7) revise, delete, and add definitions for certain terms used in the regulation; and (8) update references to DOE Offices and officials to reflect the current DOE organizational structure.
As described below, DOE makes only a few minor changes to the existing rule that are different than those proposed in the NOPR. Details of those change to the existing rule are summarized in Section II. DOE's responses to public comments received on the NOPR are discussed in Section III.
Laws, regulations and directives which may apply to part 710 include, but are not limited to: The Atomic Energy Act of 1954; Executive Order 13467 (73 FR 38103, June 30, 2008; Executive Order 12968 (60 FR 40245, August 2, 1995, as amended); Executive Order 13526 (75 FR 707, January 5, 2010); Executive Order 10865 (25 FR 1583, February 24, 1960, as amended); Executive Order 10450 (18 FR 2489, April 27, 1954, as amended); Presidential Policy Directive 19 (October 10, 2012).
DOE published a NOPR on April 19, 2016 (81 FR 22920), inviting public comments on proposed regulatory changes in the NOPR. In response to the publication of the NOPR, DOE received the following comments:
1. A commenter indicated that the need for the rule is not clearly addressed and that it seems the new rule will slow down rather than streamline the process.
2. Another commenter expressed concern with the proposed changes to §§ 710.29 and 710.30 of the previous rule that would limit the introduction of new evidence on appeal. The commenter notes that the changes would not allow for an individual to show continued rehabilitation after the closing of the administrative record. DOE acknowledges that the changes to §§ 710.29 and 710.30 would mean that an individual would not be able to show continued rehabilitation after the closing of the administrative record. However, the DOE does not believe the Appeal Panel is the appropriate venue for the consideration of new evidence, including evidence that may demonstrate continued rehabilitation or reformation. The introduction of new information should be limited to the administrative review hearing where an Administrative Judge can assign proper weight to new information by questioning the individual and other witnesses about the evidence and consulting with the DOE psychologist or psychiatrist, as appropriate, about the relevance and significance of the information. These changes would be consistent with the policies governing the introduction of new evidence during the appeal process at other federal agencies. For example, the Defense Office of Hearings and Appeals (DOHA) makes industrial security clearance determinations for contractor employees of Department of Defense organizations and approximately 20 other federal agencies and organizations. The Appeal Board that decides appeals from decisions issued by DOHA is prohibited from receiving or considering new evidence. Response: Not accepted.
In addition to the foregoing comments, DOE has determined that, for purposes of clarity and consistency with the previous rule, the term “appeal” as used in §§ 710.9(e) and 710.21(c)(2) to refer to a federal employee's right to request further review by the Office of the Inspector General (OIG) should be replaced with “request for review” or “review” since the term “appeal” does
DOE amends 10 CFR part 710 as follows:
The title of this part is revised to delete the words “CRITERIA AND” to reflect the proposed deletion of the criteria in current § 710.8, and because the term “Procedures” adequately describes the content of the rule. Additionally, the heading, Subpart A, “General Criteria and Procedures for Determining Eligibility for Access to Classified Matter and Special Nuclear Material,” is deleted. Previously, the entire body of this rule was denominated as Subpart A to Part 710. In this revision, each existing undesignated subpart heading is designated as an individual subpart, in accordance with the U.S. Government Printing Office's Document Drafting Handbook.
1. The current heading “GENERAL PROVISIONS” located above current § 710.1 is revised to add “SUBPART A —” at the beginning.
2. Section 710.1 “Purpose” deletes references to the specific types of individuals to which this part applies since this information is set forth in § 710.2; and updates the applicable legal authorities.
3. Section 710.2 “Scope” clarifies that determining eligibility for an individual's access authorization requires application of the national Adjudicative Guidelines, and reference to “criteria” is deleted.
4. Section 710.3 “Reference” deletes the reference to the Atomic Energy Act and replaces it with a reference to the Adjudicative Guidelines.
5. Section 710.4 “Policy” replaces the phrase “criteria for determining eligibility for access authorization and” with “procedures” in paragraph (a) to reflect the deletion of the criteria in current § 710.8. Previous § 710.4(c) is renumbered § 710.32(b)(1). Previous § 710.4(d) is renumbered § 710.32(b)(2). Previous paragraphs (e) and (f) are deleted since the situations addressed in those paragraphs are already covered in the rule. Previous paragraph (g) is renumbered § 710.32(c).
6. In § 710.5 “Definitions” a number of new or revised definitions are added. In addition, the terms contained in this section have been re-ordered so that they are listed in alphabetical order; previous § 710.5(b) would be deleted as unnecessary.
The term “DOE Counsel” is amended to delete the requirement that such an individual be subject to a favorably adjudicated background investigation. Instead, the requirement that such an individual must hold a DOE Q access authorization, the grant of which is predicated on a favorably adjudicated background investigation, is added.
The term “Administrative Judge” is amended in the same fashion and for the same reasons as the definition of “DOE Counsel,” and also to delete the requirement that this person be a “senior management official.”
The term “Director” is added and defined as the Director, Office of Departmental Personnel Security, to reflect organizational changes within the DOE's personnel security program.
The terms “Local Director of Security” and “Manager” are revised to reflect organizational changes throughout DOE.
The term “national security information” is deleted as it does not appear anywhere in this rule.
7. The previous heading “CRITERIA AND PROCEDURES FOR DETERMINING ELIGIBILITY FOR ACCESS TO CLASSIFIED MATTER OR SPECIAL NUCLEAR MATERIAL” located above previous § 710.6 is revised to add “SUBPART B—” at the beginning, and to delete “CRITERIA AND” to reflect the deletion of the criteria in proposed § 710.8.
8. Section 710.6 “Cooperation by the individual.”
(1) Paragraph (a)(1) revises the language for clarity but does not change it substantively.
(2) Paragraph (a)(2) updates the reference to polygraph examinations to be consistent with the intent of 10 CFR part 709, and updates terms as in paragraph (a)(1), described above.
(3) Paragraph (b) reflects current DOE organizational structures.
(4) Paragraph (c) clarifies the process by which an individual could appeal decisions taken by DOE under proposed paragraphs (a)(1) and (a)(2).
9. The previous § 710.7 “Application of the criteria” removes references to the criteria and clarifies that all determinations of eligibility for access authorization at DOE will be made in accordance with the national Adjudicative Guidelines. DOE has for several decades utilized the criteria previously in § 710.8 to determine eligibility for access authorization. When the national Adjudicative Guidelines were introduced in 1997, DOE began using them in conjunction with the criteria previously in § 710.8. This revision makes all access authorization determinations in reliance solely on the Adjudicative Guidelines. The previous title “Application of the criteria” is revised to replace “criteria” with “Adjudicative Guidelines.” Additionally, the previous § 710.9(a) is renumbered § 710.7(d) to clearly indicate how information obtained by DOE may be considered derogatory under the Adjudicative Guidelines and used to determine access authorization eligibility. The last sentence of the previous § 710.7(a) is moved to the beginning of § 710.7(d) where it more logically fits.
10. Previous § 710.8 “Criteria” is removed in its entirety, since exclusive reliance on the national Adjudicative Guidelines for making access authorization eligibility determinations renders this section unnecessary.
11. The previous § 710.9 “Action on derogatory information” is renumbered § 710.8.
(1) Previous paragraph (a) is moved to § 710.7(d) as indicated in the discussion of § 710.7.
(2) Paragraph (a)—previously paragraph (b)—removes the specific reference to a DOE mental evaluation as an example of actions that can be taken to resolve derogatory information. Since a mental evaluation is just one of many actions DOE can take to resolve derogatory information, DOE is deleting the example to avoid any misperception that DOE is limited to this action.
(3) Previous paragraph (e) is renumbered as paragraph (d) and is revised to reflect changes in the DOE organizational structure.
12. Previous § 710.10 “Suspension of access authorization” is renumbered § 710.9.
(1) Paragraph (b) clarifies that the Department can take immediate action to suspend an individual's access authorization, without taking actions to investigate derogatory information, when there are immediate threats to the national security or to the safety and security of a DOE facility or employee. An individual whose access authorization has been suspended under these circumstances is entitled to due process protections as set forth in part 710 before the Department makes a final decision on the individual's eligibility for access authorization.
(2) Previous paragraph (b) is renumbered as paragraph (c). Paragraph (c) clarifies the responsibilities of the Manager upon the recommendation of a Local Director of Security that an individual's access authorization should be suspended.
(3) Paragraph (e) is added to reflect the requirements of Presidential Policy Directive 19, and provides that a Federal employee who believes action to
13. The previous heading, “ADMINISTRATIVE REVIEW,” located above previous § 710.20, is predesignated as Subpart C by adding, “SUBPART C—” at the beginning.
14. 710.20 “Purpose of administrative review” remains unchanged except for an editorial revision clarifying that the procedures in proposed Subpart C “govern” and not just “establish methods for” the conduct of administrative review proceedings under this part.
15. Section 710.21 “Notice to the individual”
(1) Paragraph (b)(7) clarifies that the Administrative Judge has the option of conducting administrative review hearings via video teleconferencing. The use of video teleconferencing for this purpose has been piloted with successful results. Additionally, paragraph (b)(7) includes information previously contained in § 710.34, “Attorney representation,” which is deleted. The previous § 710.34 addressed the responsibility of the individual to provide DOE with notice of representation by an attorney, so the substance of § 710.34 fits better in paragraph (b)(7) since it already addresses the individual's right to attorney representation.
(2) Paragraph (b)(8) clarifies that in the event that an individual fails to file a timely written request for a hearing before an Administrative Judge, the Manager shall issue a final decision to revoke or deny an individual's access authorization.
(3) Previous paragraphs (c)(1) and (c)(3) are renumbered as paragraphs (b)(10) and (b)(11), respectively, for better flow.
(4) Paragraphs (b)(12)(i) through (iii) address the rights of individuals who, at the time they receive a notification letter pursuant to § 710.21, are the subject of criminal proceedings for a felony offense or for an offense which is punishable by more than a year in prison. The addition clarifies that individuals in that situation have the right to decide whether to continue with or withdraw from the Administrative Review process. Under the previous rule, the discretion to continue with the Administrative Review process resided with DOE. Under the revision, the individual concerned decides to either (1) proceed with Administrative Review, requiring him/her to participate fully in the process, or (2) withdraw from the Administrative Review process, resulting in the administrative withdrawal of the individual's access authorization. Once the individual's criminal law matter concludes, a request for access authorization could be resubmitted.
(5) Paragraph (c)(2), embodying the requirements of Presidential Policy Directive 19, is added providing that a Federal employee who believes action to deny or revoke access authorization under the Administrative Review process was taken as retaliation for having made a protected disclosure of information may submit a request for review of the decision to the Department's Office of the Inspector General.
16. Section 710.22 “Initial Decision Process” clarifies, in paragraph (c)(4), that if the individual does not exercise his/her right to appeal the initial decision of a Manager to deny or revoke access authorization within 30 calendar days of that decision, the Manager's initial decision would become final action not subject to further review or appeal.
17. Section 710.25 “Appointment of Administrative Judge; prehearing conference; commencement of hearings” clarifies the authority of the Administrative Judge to conduct hearings via video teleconferencing and shorten the time limit for the Administrative Judge to commence a hearing, from 90 days to 60 days from the date the individual's request for hearing is received by the Office of Hearings and Appeals. This change reflects the DOE Office of Hearings and Appeals' current internal procedures for commencing a hearing.
18. Section 710.26(d) was proposed to be amended to delete “if possible” after “All witnesses shall be subject to cross-examination,” and add “except as provided in § 710.26(l)” in its place. Upon review, the reference to § 710.26(l) is not necessary, so this change is not being made in the revised rule.
19. Section 710.27 “Administrative Judge's decision” indicates that the Administrative Judge shall render a decision as to the granting or restoring of an individual's access authorization within 30 calendar days from the date of receipt of the hearing transcript. This change reflects the DOE Office of Hearings and Appeals' current internal procedures for issuing a decision.
20. Section 710.28 “Action on the Administrative Judge's decision” clarifies that an Administrative Judge's decision shall constitute final action not subject to review or further appeal if a written request for a review of the decision by the Appeal Panel is not filed within a timely manner with the Director. Additionally, paragraph (c) addresses the process by which the Department may appeal a decision by the Administrative Judge to grant or to continue an individual's access authorization, to comport with the process in previous paragraph (b) which addresses how the individual may appeal a decision by the Administrative Judge to deny or revoke access authorization.
21. Section 710.29 “Final appeal process” reflects, in paragraph (e), that an appeal decision would be based solely upon information in the administrative record at the time of the Manager's decision or the Administrative Judge's initial decision. Consequently, previous paragraphs (h), (i) and (j) are deleted in their entirety. Paragraphs (a) through (d) are revised to reflect the current Departmental organization and to more clearly describe the process by which an Appeal Panel is convened. Paragraph (f) is revised to clarify that the Appeal Panel's decision is not subject to further review or appeal.
22. Previous § 710.30 “New evidence” is deleted to reflect that an appeal decision is based solely upon information in the administrative record at the time of the Manager's decision or the Administrative Judge's initial decision.
23. Section 710.30 “Action by the Secretary,” previously § 710.31 and renumbered § 710.30 in the revised rule, states that the Secretary's responsibilities could be delegated in accordance with Executive Orders 12968 and 10865. Also, references to previous § 710.29(h) and (i) are deleted since those sections are deleted.
24. Section 710.31 “Reconsideration of Access Eligibility.” This section, renumbered from § 710.32, provides for a minimum of one year between a final decision to deny or revoke access authorization and the time when an individual may apply for reconsideration. Previously, part 710 contained no time limit and many individuals sought reconsideration within days of receiving a final decision denying or revoking the individual's access authorization. Further, individuals had been permitted to file a request for reconsideration repeatedly, even after previous reconsideration requests have been denied. A one-year time limit conveys clear expectations to the individual as to when a reconsideration request could be accepted and would reduce the undue burden on the Department of considering multiple close-in-time appeals. In addition, paragraph (d) more
25. The previous heading, “TERMINATIONS,” located above previous § 710.33 is predesignated as Subpart D by adding, “SUBPART D—” at the beginning.
26. Section 710.32 “Terminations.” This section, is renumbered from § 710.33. Section 710.32(a), previously § 710.33, clarifies that if the procedures of this part are terminated after an unfavorable initial agency decision has been rendered, any subsequent requests for access authorization for an individual would be processed as a review of the decision by the Appeal Panel, unless a minimum of one year has elapsed. Section 710.32(b)(1), previously § 710.4(c), indicates that the type of criminal proceedings for which DOE may take action to terminate processing an access authorization application include felony offenses and offenses punishable by one year of imprisonment or longer. Previously, this threshold was six months; this change to one year is consistent with the one-year time frame in § 710.21. Section 710.32(b)(2) and § 710.32(c), are renumbered from previous § 710.4(d) and (g), respectively.
27. Previous § 710.34 “Notice to individual” is deleted. The substance of previous § 710.34 is added to § 710.21.
28. Section 710.33 “Time frames,” previously § 710.35, is renumbered as § 710.33.
29. Section 710.34 “Acting Officials,” previously § 710.36, reflects organizational changes within the Department and permits the Deputy Associate Under Secretary for Environment, Health, Safety and Security greater flexibility to delegate his/her responsibilities under part 710. Previously, these responsibilities could only be exercised by persons in security-related Senior Executive Service positions. The change permits the Deputy Associate Under Secretary for Environment, Health, Safety and Security to delegate his/her authorities under part 710 to persons in senior security-related positions. It is expected that only persons in GS-15 or Senior Executive Service positions would meet this requirement. This change enhances the Department's ability to effectively manage the Administrative Review process prescribed by part 710.
The national Adjudicative Guidelines are Appendix A.
This final rule has been determined not to be a “significant regulatory action” under Executive Order 12866, “Regulatory Planning and Review,” 58 FR 51735 (October 4, 1993). Accordingly, this rule is not subject to review under the Executive Order by the Office of Information and Regulatory Affairs within the Office of Management and Budget.
DOE has also reviewed the regulation pursuant to Executive Order 13563, issued on January 18, 2011 (76 FR 3281 (Jan. 21, 2011)). Executive Order 13563 is supplemental to and explicitly reaffirms the principles, structures, and definitions governing regulatory review established in Executive Order 12866. To the extent permitted by law, agencies are required by Executive Order 13563 to: (1) Propose or adopt a regulation only upon a reasoned determination that its benefits justify its costs (recognizing that some benefits and costs are difficult to quantify); (2) tailor regulations to impose the least burden on society, consistent with obtaining regulatory objectives, taking into account, among other things, and to the extent practicable, the costs of cumulative regulations; (3) select, in choosing among alternative regulatory approaches, those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity); (4) to the extent feasible, specify performance objectives, rather than specifying the behavior or manner of compliance that regulated entities must adopt; and (5) identify and assess available alternatives to direct regulation, including providing economic incentives to encourage the desired behavior, such as user fees or marketable permits, or providing information upon which choices can be made by the public.
DOE emphasizes as well that Executive Order 13563 requires agencies to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible. In its guidance, the Office of Information and Regulatory Affairs has emphasized that such techniques may include identifying changing future compliance costs that might result from technological innovation or anticipated behavioral changes. DOE believes that this rule is consistent with these principles, including the requirement that, to the extent permitted by law, agencies adopt a regulation only upon a reasoned determination that its benefits justify its costs and, in choosing among alternative regulatory approaches, those approaches maximize net benefits.
With respect to the review of existing regulations and the promulgation of new regulations, section 3(a) of Executive Order 12988, “Civil Justice Reform,” 61 FR 4729 (February 7, 1996), imposes on Executive agencies the general duty to adhere to the following requirements: (1) Eliminate drafting errors and ambiguity; (2) write regulations to minimize litigation; and (3) provide a clear legal standard for affected conduct rather than a general standard and promote simplification and burden reduction.
With regard to the review required by section 3(a), section 3(b) of Executive Order 12988 specifically requires that Executive agencies make every reasonable effort to ensure that the regulation: (1) Clearly specifies the preemptive effect, if any; (2) clearly specifies any effect on existing Federal law or regulation; (3) provides a clear legal standard for affected conduct while promoting simplification and burden reduction; (4) specifies the retroactive effect, if any; (5) adequately defines key terms; and (6) addresses other important issues affecting clarity and general draftsmanship under any guidelines issued by the Attorney General. Section 3(c) of Executive Order 12988 requires Executive agencies to review regulations in light of applicable standards in section 3(a) and section 3(b) to determine whether they are met or it is unreasonable to meet one or more of them. DOE has completed the required review and determined that, to the extent permitted by law, this regulation meets the relevant standards of Executive Order 12988.
The Regulatory Flexibility Act (5 U.S.C. 601
This rule amends procedures that apply to the determination of eligibility of individuals for access to classified information and access to special nuclear material. The rule applies to individuals, and would not apply to “small entities,” as that term is defined in the Regulatory Flexibility Act. As a result, the rule does not have a significant economic impact on a substantial number of small entities.
Accordingly, DOE certifies that the rule will not have a significant economic impact on a substantial number of small entities, and, therefore, no regulatory flexibility analysis is required.
This rule does not impose a collection of information requirement subject to the Paperwork Reduction Act, 44 U.S.C. 3501
DOE has concluded that promulgation of this rule falls into a class of actions which would not individually or cumulatively have significant impact on the human environment, as determined by DOE's regulations (10 CFR part 1021, subpart D) implementing the National Environmental Policy Act (NEPA) of 1969 (42 U.S.C. 4321
Executive Order 13132, 64 FR 43255 (August 4, 1999), imposes certain requirements on agencies formulating and implementing policies or regulations that preempt State law or that have federalism implications. Agencies are required to examine the constitutional and statutory authority supporting any action that would limit the policymaking discretion of the States and carefully assess the necessity for such actions. DOE has examined this rule and has determined that it does not preempt State law and does 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. No further action is required by Executive Order 13132.
The Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) generally requires a Federal agency to perform a detailed assessment of costs and benefits of any rule imposing a Federal Mandate with costs to State, local or tribal governments, or to the private sector, of $100 million or more. This rulemaking does not impose a Federal mandate on State, local or tribal governments or on the private sector.
Section 654 of the Treasury and General Government Appropriations Act, 1999 (Pub. L. 105-277), requires Federal agencies to issue a Family Policymaking Assessment for any rule or policy that may affect family well being. This rule, has no impact on family well-being. Accordingly, DOE has concluded that it is not necessary to prepare a Family Policymaking Assessment.
Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use,” 66 FR 28355 (May 22, 2001), requires Federal agencies to prepare and submit to the Office of Information and Regulatory Affairs (OIRA), Office of Management and Budget, a Statement of Energy Effects for any significant energy action. A “significant energy action” is defined as any action by an agency that promulgates or is expected to lead to promulgation of a final rule, and that: (1) Is a significant regulatory action under Executive Order 12866, or any successor order; and (2) is likely to have a significant adverse effect on the supply, distribution, or use of energy, or (3) is designated by the Administrator of OIRA as a significant energy action. For any proposed significant energy action, the agency must give a detailed statement of any adverse effects on energy supply, distribution or use should the proposal be implemented, and of reasonable alternatives to the action and their expected benefits on energy supply, distribution and use. This rule is not a significant energy action. Accordingly, DOE has not prepared a Statement of Energy Effects.
The Treasury and General Government Appropriations Act, 2001 (44 U.S.C. 3516, note) provides for agencies to review most disseminations of information to the public under implementing guidelines established by each agency pursuant to general guidelines issued by OMB. OMB's guidelines were published at 67 FR 8452 (February 22, 2002), and DOE's guidelines were published at 67 FR 62446 (October 7, 2002). DOE has reviewed this rule under the OMB and DOE guidelines and has concluded that it is consistent with applicable policies in those guidelines.
The Office of the Secretary of Energy has approved issuance of this rule.
As required by 5 U.S.C. 801, DOE will report to Congress on the promulgation of this rule prior to its effective date. The report will state that it has been determined that the rule is not a “major rule” as defined by 5 U.S.C. 804(2).
Administrative practice and procedure, Classified information, Government contracts, Government employees, Nuclear energy.
42 U.S.C. 2165, 2201, 5815, 7101,
(a) This part establishes the procedures for determining the eligibility of individuals described in § 710.2 for access to classified matter or special nuclear material, pursuant to the Atomic Energy Act of 1954, or for access to national security information in accordance with Executive Order 13526 (Classified National Security Information).
(b) This part implements: Executive Order 12968, 60 FR 40245 (August 2, 1995), as amended; Executive Order 13526, 75 FR 707 (January 5, 2010); Executive Order 10865, 25 FR 1583 (February 24, 1960), as amended; Executive Order 10450, 18 FR 2489 (April 27, 1954), as amended; and the Adjudicative Guidelines for Determining Eligibility for Access to Classified Information approved by the President (the “Adjudicative Guidelines”; see Appendix A of this part).
The procedures outlined in this rule require the application of the Adjudicative Guidelines (see § 710.7) in determining eligibility for access authorization for:
(a) Employees (including consultants) of, and applicants for employment with, contractors and agents of the DOE;
(b) Access permittees of the DOE and their employees (including consultants) and applicants for employment;
(c) Employees (including consultants) of, and applicants for employment with, the DOE; and
(d) Other persons designated by the Secretary of Energy.
The Adjudicative Guidelines are set forth in Appendix A to this part.
(a) It is the policy of DOE to provide for the security of its programs in a manner consistent with traditional American concepts of justice and fairness. To this end, the Secretary has established procedures that will afford those individuals described in § 710.2 the opportunity for administrative review of questions concerning their eligibility for access authorization.
(b) It is also the policy of DOE that none of the procedures established for determining eligibility for access authorization shall be used for an improper purpose, including any attempt to coerce, restrain, threaten, intimidate, or retaliate against individuals for exercising their rights under any statute, regulation or DOE directive. Any DOE officer or employee violating, or causing the violation of this policy, shall be subject to appropriate disciplinary action.
(a) As used in this part:
(b) [Reserved]
(a)(1) It is the responsibility of the individual to provide full, frank, and truthful answers to DOE's relevant and material questions, and when requested, to furnish or authorize others to furnish information that the DOE deems pertinent to the individual's eligibility for access authorization. This obligation to cooperate applies when completing security forms, during the course of a personnel security background investigation or reinvestigation, and at any stage of DOE's processing of the individual's access authorization request, including but not limited to, personnel security interviews, DOE-sponsored mental health evaluations, and other authorized DOE investigative activities under this part. The individual may elect not to cooperate; however, such refusal may prevent DOE from reaching an affirmative finding required for granting or continuing
(2) It is the responsibility of an individual subject to 10 CFR 709.3(d) to consent to and take a polygraph examination required by part 709. A refusal to consent to or take such an examination may prevent DOE from reaching an affirmative finding required for continuing access authorization. In this event, any access authorization then in effect may be administratively withdrawn.
(b) If the individual believes that the provisions of paragraph (a) of this section have been inappropriately applied, the individual may file a written appeal of the action with the Director within 30 calendar days of the date the individual was notified of the action.
(c) Upon receipt of the written appeal, the Director shall conduct an inquiry as to the circumstances involved in the action and shall, within 30 calendar days of receipt of the written appeal, notify the individual, in writing, of his/her decision. If the Director determines that the action was inappropriate, the Director shall notify the Manager that access authorization must be reinstated or, for applicants, that the individual must continue to be processed for access authorization. If the Director determines the action was appropriate, the Director shall notify the individual of this fact in writing. The Director's decision is final and not subject to further review or appeal.
(a) The decision on an access authorization request is a comprehensive, common-sense judgment, made after consideration of all relevant information, favorable and unfavorable, as to whether the granting or continuation of access authorization will not endanger the common defense and security and is clearly consistent with the national interest. Any doubt as to an individual's access authorization eligibility shall be resolved in favor of the national security.
(b) All such determinations shall be based upon application of the Adjudicative Guidelines, or any successor national standard issued under the authority of the President.
(c) Each Adjudicative Guideline sets forth a series of concerns that may create a doubt regarding an individual's eligibility for access authorization. In resolving these concerns, all DOE officials involved in the decision-making process shall consider: The nature, extent, and seriousness of the conduct; the circumstances surrounding the conduct, to include knowledgeable participation; the frequency and recency of the conduct; the age and maturity of the individual at the time of the conduct; the voluntariness of participation; the absence or presence of rehabilitation or reformation and other pertinent behavioral changes; the motivation for the conduct; the potential for pressure, coercion, exploitation, or duress; the likelihood of continuation or recurrence; and other relevant and material factors.
(d) If the reports of investigation of an individual or other reliable information tend to establish the validity and significance of one or more areas of concern as set forth in the Adjudicative Guidelines, such information shall be regarded as derogatory and create a question as to the individual's access authorization eligibility. Absent any derogatory information, a favorable determination will be made as to access authorization eligibility.
(a) If a question arises as to the individual's access authorization eligibility, the Local Director of Security shall authorize the conduct of an interview with the individual, or other appropriate actions and, on the basis of the results of such interview or actions, may authorize the granting of the individual's access authorization. If, in the opinion of the Local Director of Security, the question as to the individual's access authorization eligibility has not been favorably resolved, the Local Director of Security shall submit the matter to the Manager with a recommendation that authority be obtained to process the individual's case under administrative review procedures set forth in this part.
(b) If the Manager agrees that unresolved derogatory information is present and that appropriate attempts to resolve such derogatory information have been unsuccessful, the Manager shall notify the Director of the proposal to conduct an administrative review proceeding, accompanied by an explanation of the security concerns and a duplicate Personnel Security File. If the Manager believes that the derogatory information has been favorably resolved, the Manager shall direct that access authorization be granted for the individual. The Manager may also direct the Local Director of Security to obtain additional information prior to deciding whether to grant the individual access authorization or to submit a request for authority to conduct an administrative review proceeding. A decision in the matter shall be rendered by the Manager within 10 calendar days of its receipt.
(c) Upon receipt of the Manager's notification, the Director shall review the matter and confer with the Manager on:
(1) The institution of administrative review proceedings set forth in §§ 710.20 through 710.30;
(2) The granting of access authorization; or
(3) Other actions as the Director deems appropriate.
(d) The Director shall act pursuant to one of these options within 30 calendar days of receipt of the Manager's notification unless an extension is granted by the Deputy Associate Under Secretary for Environment, Health, Safety and Security.
(a) If derogatory information is received, the Local Director of Security shall authorize action(s), to be taken on an expedited basis, to resolve the question pursuant to § 710.8(a). If the question as to the individual's continued access authorization eligibility is not resolved in favor of the individual, the Local Director of Security shall submit the matter to the Manager with the recommendation that the individual's access authorization be suspended pending the final determination resulting from the procedures set forth in this part.
(b) If the information received is determined to represent an immediate threat to national security or to the safety or security of a DOE facility or employee, or is determined to be so serious in nature that action(s) to resolve the matter as set forth in § 710.8(b) are not practical or advisable, the Local Director of Security shall immediately submit the matter to the Manager with a recommendation that the individual's access authorization be suspended pending the final determination resulting from the procedures set forth in this part. The Manager shall either authorize the immediate suspension of access authorization, or shall direct the Local Director of Security to take action(s) as set forth in § 710.8(b), in an expedited manner, to resolve the matter.
(c) The Manager shall, within two working days of receipt of the recommendation from the Local Director of Security to suspend the individual's DOE access authorization:
(1) Approve the suspension of access authorization; or
(2) Direct the continuation of access authorization, or
(3) Take or direct other such action(s) as the Manager deems appropriate.
(d) Upon suspension of an individual's access authorization pursuant to paragraph (c)(1) of this section, the individual, the individual's employer, any other DOE office or program having an access authorization interest in the individual, and, if known, any other government agency where the individual holds an access authorization, security clearance, or access approval, or to which the DOE has certified the individual's DOE access authorization, shall be notified immediately in writing. The appropriate DOE database for tracking access authorizations and related actions shall also be updated. Notification to the individual shall reflect, in general terms, the reason(s) why the suspension has been affected. Pending final determination of the individual's eligibility for access authorization from the operation of the procedures set forth in this part, the individual shall not be afforded access to classified matter, special nuclear material, or unescorted access to security areas that require the individual to possess a DOE access authorization.
(e) Written notification to the individual shall include, if the individual is a Federal employee, notification that if the individual believes that the action to suspend his/her access authorization was taken as retaliation against the individual for having made a protected disclosure, as defined in Presidential Policy Directive 19,
(f) Following the decision to suspend an individual's DOE access authorization pursuant to paragraph (c)(1) of this section, the Manager shall immediately notify the Director in writing of the action and the reason(s) therefor. In addition, the Manager, within 10 calendar days of the date of suspension (unless an extension of time is approved by the Director), shall notify the Director in writing of his/her proposal to conduct an administrative review proceeding, accompanied by an explanation of its basis and a duplicate Personnel Security File.
(g) Upon receipt of the Manager's notification, the Director shall review the matter and confer with the Manager on:
(1) The institution of administrative review procedures set forth in §§ 710.20 through 710.30; or
(2) The reinstatement of access authorization; or
(3) Other actions as the Director deems appropriate.
(h) The Director shall act pursuant to one of these options within 30 calendar days of the receipt of the Manager's notification unless an extension is granted by the Deputy Associate Under Secretary for Environment, Health, Safety and Security.
These procedures govern the conduct of the administrative review of questions concerning an individual's eligibility for access authorization when it is determined that such questions cannot be favorably resolved by interview or other action.
(a) Unless an extension is authorized in writing by the Director, within 30 calendar days of receipt of authority to institute administrative review procedures, the Manager shall prepare and deliver to the individual a notification letter approved by the local Office of Chief Counsel, or the Office of the General Counsel for Headquarters cases. Where practicable, the letter shall be delivered to the individual in person.
(b) The letter shall state:
(1) That reliable information in the possession of DOE has created a substantial doubt concerning the individual's eligibility for access authorization.
(2) The information which creates a substantial doubt regarding the individual's access authorization eligibility (which shall be as comprehensive and detailed as the national security permits) and why that information creates such doubt.
(3) That the individual has the option to have the substantial doubt regarding eligibility for access authorization resolved in one of two ways:
(i) By the Manager, without a hearing, on the basis of the existing information in the case; or
(ii) By personal appearance before an Administrative Judge (a “hearing”).
(4) That, if the individual desires a hearing, the individual must, within 20 calendar days of the date of receipt of the notification letter, make a written request for a hearing to the Manager from whom the letter was received.
(5) That the individual may also file with the Manager the individual's written answer to the reported information which raises the question of the individual's eligibility for access authorization, and that, if the individual requests a hearing without filing a written answer, the request shall be deemed a general denial of all of the reported information.
(6) That, if the individual so requests, a hearing shall be scheduled before an Administrative Judge, with due regard for the convenience and necessity of the parties or their representatives, for the purpose of affording the individual an opportunity of supporting his eligibility for access authorization. The Administrative Judge shall decide whether the hearing will be conducted via video teleconferencing.
(7) That, if a hearing is requested, the individual will have the right to appear personally before an Administrative Judge or, at the discretion of the Administrative Judge, via video teleconferencing; to present evidence in his/her own behalf, through witnesses, or by documents, or both; and, subject to the limitations set forth in § 710.26(g), to be present during the entire hearing and be accompanied, represented, and advised by counsel or other representative of the individual's choosing and at the individual's own expense at every stage of the proceedings. Such representative or counsel, if applicable, shall be identified in writing to the Administrative Judge and DOE Counsel and authorized by the individual to receive all correspondence, transcripts and other documents pertaining to the proceedings under this part.
(8) That the individual's failure to file a timely written request for a hearing before an Administrative Judge in accordance with paragraph (b)(4) of this section, unless time deadlines are extended for good cause, shall be considered as a relinquishment by the individual of the right to a hearing provided in this part, and that in such event a final decision to deny or revoke the individual's access authorization shall be made by the Manager.
(9) That in any proceedings under this subpart DOE Counsel will participate on behalf of and representing DOE and that any statements made by the individual to DOE Counsel may be used in subsequent proceedings;
(10) The individual's access authorization status until further notice;
(11) The name and telephone number of the designated DOE official to contact for any further information desired concerning the proceedings, including an explanation of the individual's rights under the Freedom of Information Act and Privacy Act;
(12) If applicable, that if the individual is currently the subject of criminal charges for a felony offense or an offense punishable by imprisonment of one year or more, the individual must elect either to continue with the Administrative Review process and have the substantial doubt regarding eligibility for access authorization resolved by the Manager or by a hearing, or to withdraw from the Administrative Review process.
(i) If the individual elects to continue with the Administrative Review process a determination as to the individual's access authorization shall be made by the Manager or by an Administrative Judge via a hearing. The individual will be expected to participate fully in the process. Any refusal to cooperate, answer all questions, or provide requested information may prevent DOE from reaching an affirmative finding required for granting or continuing access authorization.
(ii) If the individual elects to withdraw from the Administrative Review process, the individual's access authorization shall be administratively withdrawn. Such action shall be taken in accordance with applicable procedures set forth in pertinent Departmental directives. Any future requests for access authorization for the individual must be accompanied by documentary evidence of resolution of the criminal charges.
(iii) The individual must, within 20 calendar days of receipt of the notification letter, indicate in writing his/her decision to continue or to withdraw from the Administrative Review process. Such notification must be made to the Manager from whom the notification letter was received.
(c) The notification letter referenced in paragraph (b) of this section shall also:
(1) Include a copy of this part, and
(2) For Federal employees only, indicate that if the individual believes that the action to process the individual under this part was taken as retaliation against the individual for having made a protected disclosure, as defined in Presidential Policy Directive 19,
(a) The Manager shall make an initial decision as to the individual's access authorization eligibility based on the existing information in the case if:
(1) The individual fails to respond to the notification letter by filing a timely written request for a hearing before an Administrative Judge or fails to respond to the notification letter after requesting an extension of time to do so;
(2) The individual's response to the notification letter does not request a hearing before an Administrative Judge; or
(3) The Administrative Judge refers the individual's case to the Manager in accordance with § 710.25(e) or § 710.26(b).
(b) Unless an extension of time is granted by the Director, the Manager's initial decision as to the individual's access authorization eligibility shall be made within 15 calendar days of the date of receipt of the information in paragraph (a) of this section. The Manager shall either grant or deny, or reinstate or revoke, the individual's access authorization.
(c) A letter reflecting the Manager's initial decision shall be signed by the Manager and delivered to the individual within 15 calendar days of the date of the Manager's decision unless an extension of time is granted by the Director. If the Manager's initial decision is unfavorable to the individual, the individual shall be advised:
(1) Of the Manager's unfavorable decision and the reason(s) therefor;
(2) That within 30 calendar days from the date of receipt of the letter, the individual may file a written request for a review of the Manager's initial decision, through the Director, to the DOE Headquarters Appeal Panel (Appeal Panel);
(3) That the Director may, for good cause shown, at the written request of the individual, extend the time for filing a written request for a review of the case by the Appeal Panel; and
(4) That if the written request for a review of the Manager's initial decision by the Appeal Panel is not filed within 30 calendar days of the individual's receipt of the Manager's letter, the Manager's initial decision in the case shall be final and not subject to further review or appeal.
The Manager may, for good cause shown, at the written request of the individual, extend the time for filing a written request for a hearing, and/or the time for filing a written answer to the matters contained in the notification letter. The Manager shall notify the Director, in writing, when such extensions have been approved.
(a) Upon receipt from the individual of a written request for a hearing, a DOE attorney shall forthwith be assigned by the Manager to act as DOE Counsel.
(b) DOE Counsel is authorized to consult directly with the individual if he/she is not represented by counsel, or with the individual's counsel or other representative if so represented, to clarify issues and reach stipulations with respect to testimony and contents of documents and physical evidence. Such stipulations shall be binding upon the individual and the DOE Counsel for the purposes of this part.
(a) Upon receipt of a request for a hearing, the Manager shall in a timely manner transmit that request to the Office of Hearings and Appeals, and identify the DOE Counsel. The Manager shall at the same time transmit a copy of the notification letter and the individual's response to the Office of Hearings and Appeals.
(b) Upon receipt of the hearing request from the Manager, the Director, Office of Hearings and Appeals, shall appoint, as soon as practicable, an Administrative Judge.
(c) Immediately upon appointment, the Administrative Judge shall notify the individual and DOE Counsel of his/her identity and the address to which all further correspondence should be sent.
(d) The Administrative Judge shall have all powers necessary to regulate the conduct of proceedings under this part, including, but not limited to, establishing a list of persons to receive service of papers, issuing subpoenas for witnesses to attend the hearing or for the production of specific documents or physical evidence, administering oaths and affirmations, ruling upon motions, receiving evidence, regulating the course of the hearing, disposing of procedural requests or similar matters, and taking other actions consistent with the regulations in this part. Requests for subpoenas shall be liberally granted except where the Administrative Judge finds that the issuance of subpoenas would result in evidence or testimony that is repetitious, incompetent, irrelevant, or immaterial to the issues in the case. The Administrative Judge may take sworn testimony, sequester witnesses, and control the dissemination or reproduction of any
(e) The Administrative Judge shall determine the day, time, and place for the hearing and shall decide whether the hearing will be conducted via video teleconferencing. Hearings will normally be held at or near the relevant DOE facility, unless the Administrative Judge determines that another location would be more appropriate. Normally the location for the hearing will be selected for the convenience of all participants. In the event the individual fails to appear at the time and place specified, without good cause shown, the record in the case shall be closed and returned to the Manager, who shall then make an initial determination regarding the eligibility of the individual for DOE access authorization in accordance with § 710.22(a)(3).
(f) At least 7 calendar days prior to the date scheduled for the hearing, the Administrative Judge shall convene a prehearing conference for the purpose of discussing stipulations and exhibits, identifying witnesses, and disposing of other appropriate matters. The conference will usually be conducted by telephone.
(g) Hearings shall commence within 60 calendar days from the date the individual's request for a hearing is received by the Office of Hearings and Appeals. Any extension of the hearing date past 60 calendar days from the date the request for a hearing is received by the Office of Hearings and Appeals shall be decided by the Director, Office of Hearings and Appeals.
(a) In all hearings conducted under this part, the individual shall have the right to be represented by a person of his/her own choosing, at the individual's own expense. The individual is responsible for producing witnesses in his/her own behalf, including requesting the issuance of subpoenas, if necessary, or presenting testimonial, documentary, or physical evidence before the Administrative Judge to support the individual's defense to the derogatory information contained in the notification letter. With the exception of procedural or scheduling matters, the Administrative Judge is prohibited from initiating or otherwise engaging in
(b) Unless the Administrative Judge finds good cause for deferring issuance of a decision, in the event that the individual unduly delays the hearing, such as by failure to meet deadlines set by the Administrative Judge, the record shall be closed, and an initial decision shall be made by the Manager on the basis of the record in the case per § 710.22(a)(3).
(c) Hearings shall be open only to DOE Counsel, duly authorized representatives of DOE, the individual and the individual's counsel or other representatives, and such other persons as may be authorized by the Administrative Judge. Unless otherwise ordered by the Administrative Judge, witnesses shall testify in the presence of the individual but not in the presence of other witnesses.
(d) DOE Counsel shall assist the Administrative Judge in establishing a complete administrative hearing record in the proceeding and bringing out a full and true disclosure of all facts, both favorable and unfavorable, having a bearing on the issues before the Administrative Judge. The individual shall be afforded the opportunity of presenting testimonial, documentary, and physical evidence, including testimony by the individual in the individual's own behalf. The proponent of a witness shall conduct the direct examination of that witness. All witnesses shall be subject to cross-examination, if possible. Whenever reasonably possible, testimony shall be given in person.
(e) The Administrative Judge may ask the witnesses any questions which the Administrative Judge deems appropriate to assure the fullest possible disclosure of relevant and material facts.
(f) During the course of the hearing, the Administrative Judge shall rule on all objections raised.
(g) In the event it appears during the course of the hearing that classified matter may be disclosed, it shall be the duty of the Administrative Judge to assure that disclosure is not made to persons who are not authorized to receive it, and take other appropriate measures.
(h) Formal rules of evidence shall not apply, but the Federal Rules of Evidence may be used as a guide for procedures and principles designed to assure production of the most probative evidence available. The Administrative Judge shall admit into evidence any matters, either oral or written, which are material, relevant, and competent in determining issues involved, including the testimony of responsible persons concerning the integrity of the individual. In making such determinations, the utmost latitude shall be permitted with respect to relevancy, materiality, and competency. The Administrative Judge may also exclude evidence which is incompetent, immaterial, irrelevant, or unduly repetitious. Every reasonable effort shall be made to obtain the best evidence available. Subject to §§ 710.26(l), 710.26(m), 710.26(n) and 710.26(o), hearsay evidence may, at the discretion of the Administrative Judge and for good cause show, be admitted without strict adherence to technical rules of admissibility and shall be accorded such weight as the Administrative Judge deems appropriate.
(i) Testimony of the individual and witnesses shall be given under oath or affirmation. Attention of the individual and each witness shall be directed to 18 U.S.C. 1001 and 18 U.S.C. 1621.
(j) The Administrative Judge shall endeavor to obtain all the facts that are reasonably available in order to arrive at a decision. If, prior to or during the proceedings, in the opinion of the Administrative Judge, the derogatory information in the notification letter is not sufficient to address all matters into which inquiry should be directed, the Administrative Judge may recommend to the Manager concerned that, in order to give more adequate notice to the individual, the notification letter should be amended. Any amendment shall be made with the concurrence of the local Office of Chief Counsel or the Office of the General Counsel in Headquarters cases. If, in the opinion of the Administrative Judge, the circumstances of such amendment may involve undue hardship to the individual because of limited time to respond to the new derogatory information in the notification letter, an appropriate adjournment shall be granted upon the request of the individual.
(k) A written or oral statement of a person relating to the characterization in the notification letter of any organization or person other than the individual may be received and considered by the Administrative Judge without affording the individual an opportunity to cross-examine the person making the statement on matters relating to the characterization of such organization or person, provided the individual is given notice that such a statement has been received and may be considered by the Administrative Judge, and is informed of the contents of the statement, provided such notice is not prohibited by paragraph (g) of this section.
(l) Any oral or written statement adverse to the individual relating to a controverted issue may be received and
(1) The head of the agency supplying the statement certifies that the person who furnished the information is a confidential informant who has been engaged in obtaining intelligence information for the Government and that disclosure of the informant's identity would be substantially harmful to the national interest;
(2) The Secretary or the Secretary's special designee for that particular purpose has preliminarily determined, after considering information furnished by the investigative agency as to the reliability of the person and the accuracy of the statement concerned, that:
(i) The statement concerned appears to be reliable and material; and
(ii) Failure of the Administrative Judge to receive and consider such statement would, in view of the access sought to classified matter or special nuclear material, be substantially harmful to the national security and that the person who furnished the information cannot appear to testify:
(A) Due to death, severe illness, or similar cause, in which case the identity of the person and the information to be considered shall be made available to the individual, or
(B) Due to some other specified cause determined by the Secretary to be good and sufficient.
(m) Whenever procedures under paragraph (l) of this section are used:
(1) The individual shall be given a summary or description of the information which shall be as comprehensive and detailed as the national interest permits, and
(2) Appropriate consideration shall be accorded to the fact that the individual did not have an opportunity to cross-examine such person(s).
(n) Records compiled in the regular course of business, or other evidence other than investigative reports obtained by DOE, may be received and considered by the Administrative Judge subject to rebuttal without authenticating witnesses, provided that such information has been furnished to DOE by an investigative agency pursuant to its responsibilities in connection with assisting the Secretary to safeguard classified matter or special nuclear material.
(o) Records compiled in the regular course of business, or other evidence other than investigative reports, relating to a controverted issue which, because they are classified, may not be inspected by the individual, may be received and considered by the Administrative Judge, provided that:
(1) The Secretary or the Secretary's special designee for that particular purpose has made a preliminary determination that such evidence appears to be material;
(2) The Secretary or the Secretary's special designee for that particular purpose has made a determination that failure to receive and consider such evidence would, in view of the access sought to classified matter or special nuclear material, be substantially harmful to the national security; and
(3) To the extent that national security permits, a summary or description of such evidence is made available to the individual. In every such case, information as to the authenticity and accuracy of such evidence furnished by the investigative agency shall be considered.
(p) The Administrative Judge may request the Local Director of Security to arrange for additional investigation on any points which are material to the deliberations of the Administrative Judge and which the Administrative Judge believes need further investigation or clarification. In this event, the Administrative Judge shall set forth in writing those issues upon which more evidence is requested, identifying where possible persons or sources from which the evidence should be sought. The Local Director of Security shall make every effort through appropriate sources to obtain additional information upon the matters indicated by the Administrative Judge.
(q) A written transcript of the entire hearing shall be made and, except for portions containing classified matter, a copy of such transcript shall be furnished to the individual without cost.
(r) Whenever information is made a part of the record under the exceptions authorized by paragraphs (l) or (o) of this section, the record shall contain certificates evidencing that the determinations required therein have been made.
(a) The Administrative Judge shall carefully consider the entire record of the proceeding and shall render a decision, within 30 calendar days of the receipt of the hearing transcript, as to whether granting or restoring the individual's access authorization would not endanger the common defense and security and would be clearly consistent with the national interest. In resolving a question concerning the eligibility of an individual for access authorization under these procedures, the Administrative Judge shall consider the factors stated in § 710.7(c) to determine whether the findings will be favorable or unfavorable.
(b) In reaching the findings, the Administrative Judge shall consider the demeanor of the witnesses who have testified at the hearing, the probability or likelihood of the truth of their testimony, their credibility, and the authenticity and accuracy of documentary evidence, or lack of evidence on any material points in issue. If the individual is, or may be, handicapped by the non-disclosure to the individual of undisclosed information or by lack of opportunity to cross-examine confidential informants, the Administrative Judge shall take that fact into consideration. The possible adverse impact of the loss of the individual's access authorization upon the DOE program in which the individual works shall not be considered by the Administrative Judge.
(c) The Administrative Judge shall make specific findings based upon the record as to the validity of each instance of derogatory information contained in the notification letter and the significance which the Administrative Judge attaches to it. These findings shall be supported fully by a statement of reasons which constitute the basis for such findings.
(d) The Administrative Judge's decision shall be based on the Administrative Judge's findings of fact. If, after considering all of the factors set forth in § 710.7(c) in light of the Adjudicative Guidelines, the Administrative Judge is of the opinion that it will not endanger the common defense and security and will be clearly consistent with the national interest to grant or reinstate access authorization for the individual, the Administrative Judge shall render a favorable decision; otherwise, the Administrative Judge shall render an unfavorable decision. Within 15 calendar days of the Administrative Judge's written decision, the Administrative Judge shall provide copies of the decision and the administrative record to the Manager and the Director.
(a) Within 10 calendar days of receipt of the decision and the administrative record, unless an extension of time is granted by the Director, the Manager shall:
(1) Notify the individual in writing of the Administrative Judge's decision;
(2) Advise the individual in writing of the appeal procedures available to the individual in paragraph (b) of this
(3) Advise the individual in writing of the appeal procedures available to the Manager and the Director in paragraph (c) of this section if the decision is favorable to the individual; and
(4) Provide the individual and/or his/her counsel or other representative a copy of the Administrative Judge's decision and the administrative record.
(b) If the Administrative Judge's decision is unfavorable to the individual:
(1) The individual may file with the Director a written request for further review of the decision by the Appeal Panel along with a statement required by paragraph (e) of this section within 30 calendar days of the individual's receipt of the Manager's notice;
(2) The Director may, for good cause shown, extend the time for filing a request for further review of the decision by the Appeal Panel at the written request of the individual, provided the request for an extension of time is filed by the individual within 30 calendar days of receipt of the Manager's notice;
(3) The Administrative Judge's decision shall be final and not subject to review or appeal if the individual does not:
(i) File a written request for a review of the decision by the Appeal Panel or for an extension of time to file a written request for review of the decision by the Appeal Panel in accordance with paragraphs (b)(1) or (b)(2) of this section, or
(ii) File a written request for review of the decision by the Appeal Panel after having been granted an extension of time to do so.
(c) If the Administrative Judge's decision is favorable to the individual:
(1) The Manager, with the concurrence of the Director, shall grant or reinstate the individual's access authorization within 30 calendar days of the Administrative Judge's decision becoming final, or
(2) The Manager or the Director may file a written request with the Deputy Associate Under Secretary for Environment, Health, Safety and Security for review of the decision by the Appeal Panel, along with statement required by paragraph (e) of this section, within 30 calendar days of the individual's receipt of the Manager's notice.
(3) The Deputy Associate Under Secretary for Environment, Health, Safety and Security may, for good cause shown, extend the time for filing a request for review of the decision by the Appeal Panel at the request of the Manager or Director, provided the request for an extension of time is filed by the Manager or Director within 30 calendar days of the receipt of the Manager's notice;
(4) The Administrative Judge's decision shall constitute final action, and not be subject to review or appeal, if the Manager or Director does not:
(i) File a written request for review of the decision by the Appeal Panel or for an extension of time to file a written request for review of the decision by the Appeal Panel in accordance with paragraphs (c)(2) or (c)(3) of this section, or
(ii) File a written request for a review of the decision by the Appeal Panel after having been granted an extension of time to do so.
(d) A copy of any request for review of the individual's case by the Appeal Panel filed by the Manager or the Director shall be provided to the individual by the Manager.
(e) The party filing a request for review by the Appeal Panel shall include with the request a statement identifying the issues upon which the appeal is based. A copy of the request and statement shall be served on the other party, who may file a response with the Appeal Panel within 20 calendar days of receipt of the statement.
(a) The Appeal Panel shall be convened by the Deputy Associate Under Secretary for Environment, Health, Safety and Security to review and render a final decision in access authorization eligibility cases referred by the individual, the Manager, or the Director in accordance with §§ 710.22 or 710.28.
(b) The Appeal Panel shall consist of three members, each of whom shall be a DOE Headquarters employee, a United States citizen, and hold a DOE Q access authorization. The Deputy Associate Under Secretary for Environment, Health, Safety and Security shall serve as a permanent member of the Appeal Panel and as the Appeal Panel Chair. The second member of the Appeal Panel shall be a DOE attorney designated by the General Counsel. The head of the DOE Headquarters element which has cognizance over the individual whose access authorization eligibility is being considered may designate an employee to act as the third member on the Appeal Panel; otherwise, the third member shall be designated by the Chair. Only one member of the Appeal Panel shall be from the security field.
(c) In filing a written request for a review by the Appeal Panel in accordance with §§ 710.22 and 710.28, the individual, or his/her counsel or other representative, shall identify the issues upon which the appeal is based. The written request, and any response, shall be made a part of the administrative record. The Director shall provide staff support to the Appeal Panel as requested by the Chair.
(d) Within 15 calendar days of the receipt of the request for review of a case by the Appeal Panel, the Chair shall arrange for the Appeal Panel members to convene and review the administrative record or provide a copy of the administrative record to the Appeal Panel members for their independent review.
(e) The Appeal Panel shall consider only that evidence and information in the administrative record at the time of the Manager's or the Administrative Judge's initial decision.
(f) Within 45 calendar days of receipt of the administrative record, the Appeal Panel shall render a final decision in the case. If a majority of the Appeal Panel members determine that it will not endanger the common defense and security and will be clearly consistent with the national interest, the Chair shall grant or reinstate the individual's access authorization; otherwise, the Chair shall deny or revoke the individual's access authorization. The Appeal Panel's written decision shall be made a part of the administrative record and is not subject to further review or appeal.
(g) The Chair, through the Director, shall inform the individual in writing, as well as the individual's counsel or other representative, of the Appeal Panel's final decision. A copy of the correspondence shall also be provided to the other panel members and the Manager.
(a) Whenever an individual has not been afforded an opportunity to cross-examine witnesses who have furnished information adverse to the individual under the provisions of §§ 710.26(l) or (o), the Secretary may issue a final decision to deny or revoke access authorization for the individual after personally reviewing the administrative record and any additional material provided by the Chair. The Secretary's authority may, in accordance with applicable provisions of Executive Order 12968, be delegated to the Deputy Secretary where the effected individual is a Federal employee. The Secretary's authority, in accordance with applicable provisions of Executive Order 10865, may not be delegated where the effected individual is a contractor employee.
(b) Whenever the Secretary issues a final decision as to an individual's access authorization eligibility, the individual and other concerned parties shall be notified in writing by the Chair of that decision and of the Secretary's findings with respect to each instance of derogatory information contained in the notification letter and each substantial issue identified in the statement in support of the request for review to the extent allowed by the national security.
(c) Nothing contained in these procedures shall be deemed to limit or affect the responsibility and powers of the Secretary to issue subpoenas or to deny or revoke access to classified matter or special nuclear material.
(a) If, pursuant to the procedures set forth in §§ 710.20 through 710.30, the Manager, Administrative Judge, Appeal Panel, or the Secretary has made a decision granting or reinstating an individual's access authorization, eligibility shall be reconsidered as a new administrative review under the procedures set forth in this part when previously unconsidered derogatory information is identified, or the individual violates a commitment upon which the DOE previously relied to favorably resolve an issue of access authorization eligibility.
(b) If, pursuant to the procedures set forth in §§ 710.20 through 710.31, the Manager, Administrative Judge, Appeal Panel, or the Secretary has made a decision denying or revoking the individual's access authorization, eligibility may be reconsidered only when the individual so requests in writing, when there is a bona fide offer of employment requiring access authorization, and when there is either material and relevant new evidence which the individual and the individual's representatives were without fault in failing to present earlier, or convincing evidence of rehabilitation or reformation.
(1) A request for reconsideration shall be accepted when a minimum of one year has elapsed since the date of the Manager's, Administrative Judge's, Appeal Panel's or Secretary's final decision, or of a previous denial of reconsideration. Requests must be submitted in writing to the Deputy Associate Under Secretary for Environment, Health, Safety and Security, and must include an affidavit setting forth in detail the new evidence or evidence of rehabilitation or reformation.
(2) If the Deputy Associate Under Secretary for Environment, Health, Safety and Security approves the request for reconsideration of an individual's access authorization eligibility, he/she shall so notify the individual, and shall direct the Manager to take appropriate actions to determine whether the individual is eligible for access authorization.
(3) If the Deputy Associate Under Secretary for Environment, Health, Safety and Security denies the request for reconsideration of an individual's access authorization eligibility, he/she shall so notify the individual in writing. Such a denial is final and not subject to review or appeal.
(4) If, pursuant to the provisions of § 710.31(2), the Manager determines the individual is eligible for access authorization, the Manager shall grant access authorization.
(5) If, pursuant to the provisions of § 710.31(2), the Manager determines the individual remains ineligible for access authorization, the Manager shall so notify the Director in writing. If the Director concurs, the Director shall notify the individual in writing. This decision is final and not subject to review or appeal. If the Director does not concur, the Director shall confer with the Manager on further actions.
(6) Determinations as to eligibility for access authorization pursuant to paragraphs (f) or (g) of this section may be based solely upon the mitigation of derogatory information which was relied upon in a final decision to deny or to revoke access authorization. If, pursuant to the procedures set forth in paragraph (d) of this section, previously unconsidered derogatory information is identified, a determination as to eligibility for access authorization must be subject to a new Administrative Review proceeding.
(a) If the individual is no longer an applicant for access authorization or no longer requires access authorization, the procedures of this part shall be terminated without a final decision as to the individual's access authorization eligibility, unless a final decision has been rendered prior to the DOE being notified of the change in the individual's pending access authorization status. Where the procedures of this part have been terminated pursuant to this paragraph after an unfavorable initial agency decision as to the individual's access authorization eligibility has been rendered, any subsequent request for access authorization for the individual will be processed as a request for a review of the initial agency decision by the Appeal Panel and a final agency decision will be rendered pursuant to § 710.29, unless a minimum of one year has elapsed since the date of the initial agency decision.
(b) With regard to applicants (individuals for whom DOE has not yet approved access authorization), DOE may administratively terminate processing an application for access authorization under the following circumstances:
(1) If the applicant is currently the subject of criminal proceedings for a felony offense or an offense that is punishable by a term of imprisonment of one year or longer, or is awaiting or serving a form of probation, suspended or deferred sentencing, or parole. Once all judicial proceedings on the criminal charges have been finally resolved, and the term (if any) of imprisonment, probation, or parole has been completed, DOE processing of a request for access authorization shall resume upon receipt by DOE of a written request therefor, provided that the individual has a bona fide offer of employment requiring access authorization.
(2) If sufficient information about the individual's background cannot be obtained to meet the investigative scope and extent requirements for the access authorization requested.
(c) If an individual believes that the provisions of paragraph (b) of this section have been inappropriately applied, a written appeal may be filed with the Director within 30 calendar days of the date the individual was notified of the action. The Director shall act on the written appeal as described in § 710.6(c).
Statements of time established for processing aspects of a case under this part are the agency's desired time frames in implementing the procedures set forth in this part. However, failure to meet the time frames shall have no impact upon the final disposition of an access authorization by a Manager, Administrative Judge, the Appeal Panel, or the Secretary, and shall confer no procedural or substantive rights upon an individual whose access authorization eligibility is being considered.
Except for the Secretary, the responsibilities and authorities conferred in this part may be exercised by persons who have been designated in writing as acting for, or in the temporary capacity of, the following DOE positions: The Local Director of Security; the Manager; the Director, or the General Counsel. The responsibilities and authorities of the Deputy Associate Under Secretary for Environment, Health, Safety and Security may be exercised by persons in senior security-related positions within the Office of Environment, Health, Safety and Security who have been designated in writing as acting for, or in the temporary capacity of, the Deputy Associate Under Secretary for Environment, Health, Safety and Security, with the approval of the Associate Under Secretary for Environment, Health, Safety and Security.
1.
Decisions regarding eligibility for access to classified information take into account factors that could cause a conflict of interest and place a person in the position of having to choose between his or her commitment to the United States, including the commitment to protect classified information, and any other compelling loyalty. Access decisions also take into account a person's reliability, trustworthiness and ability to protect classified information. No coercive policing could replace the self-discipline and integrity of the person entrusted with the nation's secrets as the most effective means of protecting them. When a person's life history shows evidence of unreliability or untrustworthiness, questions arise whether the person can be relied on and trusted to exercise the responsibility necessary for working in a secure environment where protecting classified information is paramount.
2.
(a) The adjudicative process is an examination of a sufficient period of a person's life to make an affirmative determination that the person is an acceptable security risk. Eligibility for access to classified information is predicated upon the individual meeting these personnel security guidelines. The adjudication process is the careful weighing of a number of variables known as the whole-person concept. Available, reliable information about the person, past and present, favorable and unfavorable, should be considered in reaching a determination. In evaluating the relevance of an individual's conduct, the adjudicator should consider the following factors:
(1) The nature, extent, and seriousness of the conduct;
(2) The circumstances surrounding the conduct, to include knowledgeable participation;
(3) The frequency and recency of the conduct;
(4) The individual's age and maturity at the time of the conduct;
(5) The extent to which participation is voluntary;
(6) The presence or absence of rehabilitation and other permanent behavioral changes;
(7) The motivation for the conduct;
(8) The potential for pressure, coercion, exploitation, or duress; and
(9) The likelihood of continuation or recurrence.
(b) Each case must be judged on its own merits, and final determination remains the responsibility of the specific department or agency. Any doubt concerning personnel being considered for access to classified information will be resolved in favor of the national security.
(c) The ability to develop specific thresholds for action under these guidelines is limited by the nature and complexity of human behavior. The ultimate determination of whether the granting or continuing of eligibility for a security clearance is clearly consistent with the interests of national security must be an overall common sense judgment based upon careful consideration of the following guidelines, each of which is to be evaluated in the context of the whole person.
(1) Guideline A: Allegiance to the United States;
(2) Guideline B: Foreign Influence;
(3) Guideline C: Foreign Preference;
(4) Guideline D: Sexual Behavior;
(5) Guideline E: Personal Conduct;
(6) Guideline F: Financial Considerations;
(7) Guideline G: Alcohol Consumption;
(8) Guideline H: Drug Involvement;
(9) Guideline I: Psychological Conditions;
(10) Guideline J: Criminal Conduct;
(11) Guideline K: Handling Protected Information;
(12) Guideline L: Outside Activities;
(13) Guideline M: Use of Information Technology Systems.
(d) Although adverse information concerning a single criterion may not be sufficient for an unfavorable determination, the individual may be disqualified if available information reflects a recent or recurring pattern of questionable judgment, irresponsibility, or emotionally unstable behavior. Notwithstanding the whole-person concept, pursuit of further investigation may be terminated by an appropriate adjudicative agency in the face of reliable, significant, disqualifying, adverse information.
(e) When information of security concern becomes known about an individual who is currently eligible for access to classified information, the adjudicator should consider whether the person:
(1) Voluntarily reported the information;
(2) Was truthful and complete in responding to questions;
(3) Sought assistance and followed professional guidance, where appropriate;
(4) Resolved or appears likely to favorably resolve the security concern:
(5) Has demonstrated positive changes in behavior and employment;
(6) Should have his or her access temporarily suspended pending final adjudication of the information.
(f) If after evaluating information of security concern, the adjudicator decides that the information is not serious enough to warrant a recommendation of disapproval or revocation of the security clearance, it may be appropriate to recommend approval with a warning that future incidents of a similar nature may result in revocation of access.
3.
4.
(a) Involvement in, support of, training to commit, or advocacy of any act of sabotage, espionage, treason, terrorism, or sedition against the United States of America;
(b) Association or sympathy with persons who are attempting to commit, or who are committing, any of the above acts;
(c) Association or sympathy with persons or organizations that advocate, threaten, or use force or violence, or use any other illegal or unconstitutional means, in an effort to:
(1) Overthrow or influence the government of the United States or any state or local government;
(2) Prevent Federal, state, or local government personnel from performing their official duties;
(3) Gain retribution for perceived wrongs caused by the Federal, state, or local government;
(4) Prevent others from exercising their rights under the Constitution or laws of the United States or of any state.
5.
(a) The individual was unaware of the unlawful aims of the individual or organization and severed ties upon learning of these;
(b) The individual's involvement was only with the lawful or humanitarian aspects of such an organization;
(c) Involvement in the above activities occurred for only a short period of time and
(d) The involvement or association with such activities occurred under such unusual circumstances, or so much times has elapsed, that it is unlikely to recur and does not cast doubt on the individual's current reliability, trustworthiness, or loyalty.
6.
7.
(a) Contact with a foreign family member, business or professional associate, friend, or other person who is a citizen of or resident in a foreign country if that contact creates a heightened risk of foreign exploitation, inducement, manipulation, pressure, or coercion;
(b) Connections to a foreign person, group, government, or country that create a potential conflict of interest between the individual's obligation to protect sensitive information or technology and the individual's desire to help a foreign person, group, or country by providing that information;
(c) Counterintelligence information, that may be classified, indicates that the individual's access to protected information may involve unacceptable risk to national security;
(d) Sharing living quarters with a person or persons, regardless of citizenship status, if that relationship creates a heightened risk of foreign inducement, manipulation, pressure, or coercion;
(e) A substantial business, financial, or property interest in a foreign country, or in any foreign-owned or foreign-operated business, which could subject the individual to heightened risk of foreign influence or exploitation;
(f) Failure to report, when required, association with a foreign national;
(g) Unauthorized association with a suspected or known agent, associate, or employee of a foreign intelligence service;
(h) Indications that representatives or nationals from a foreign country are acting to increase the vulnerability of the individual to possible future exploitation, inducement, manipulation, pressure, or coercion;
(i) Conduct, especially while traveling outside the U.S., which may make the individual vulnerable to exploitation, pressure, or coercion by a foreign person, group, government, or country.
8.
(a) The nature of the relationships with foreign persons, the country in which these persons are located, or the positions or activities of those persons in that country are such that it is unlikely the individual will be placed in a position of having to choose between the interests of a foreign individual, group, organization, or government and the interests of the U.S.;
(b) There is no conflict of interest, either because the individual's sense of loyalty or obligation to the foreign person, group, government, or country is so minimal, or the individual has such deep and longstanding relationships and loyalties in the U.S., that the individual can be expected to resolve any conflict of interest in favor of the U.S. interest;
(c) Contact or communication with foreign citizens is so casual and infrequent that there is little likelihood that it could create a risk for foreign influence or exploitation;
(d) The foreign contacts and activities are on U.S. Government business or are approved by the cognizant security authority;
(e) The individual has promptly complied with existing agency requirements regarding the reporting of contacts, requests, or threats from persons, groups, or organizations from a foreign country;
(f) The value or routine nature of the foreign business, financial, or property interests is such that they are unlikely to result in a conflict and could not be used effectively to influence, manipulate, or pressure the individual.
9.
10.
(a) Exercise of any right, privilege or obligation of foreign citizenship after becoming a U.S. citizen or through the foreign citizenship of a family member. This includes but is not limited to:
(1) Possession of a current foreign passport;
(2) Military service or a willingness to bear arms for a foreign country;
(3) Accepting educational, medical, retirement, social welfare, or other such benefits from a foreign country;
(4) Residence in a foreign country to meet citizenship requirements;
(5) Using foreign citizenship to protect financial or business interests in another country;
(6) Seeking or holding political office in a foreign country;
(7) Voting in a foreign election;
(b) Action to acquire or obtain recognition of a foreign citizenship by an American citizen;
(c) Performing or attempting to perform duties, or otherwise acting, so as to serve the interests of a foreign person, group, organization, or government in conflict with the national security interest;
(d) Any statement or action that shows allegiance to a country other than the United States: for example, declaration of intent to renounce United States citizenship; renunciation of United States citizenship.
11.
(a) Dual citizenship is based solely on parents' citizenship or birth in a foreign country;
(b) The individual has expressed a willingness to renounce dual citizenship;
(c) Exercise of the rights, privileges, or obligations of foreign citizenship occurred before the individual became a U.S. citizen or when the individual was a minor;
(d) Use of a foreign passport is approved by the cognizant security authority;
(e) The passport has been destroyed, surrendered to the cognizant security authority, or otherwise invalidated;
(f) The vote in a foreign election was encouraged by the United States Government.
12.
13.
(a) Sexual behavior of a criminal nature, whether or not the individual has been prosecuted;
(b) A pattern of compulsive, self-destructive, or high-risk sexual behavior that the person is unable to stop or that may be symptomatic of a personality disorder;
(c) Sexual behavior that causes an individual to be vulnerable to coercion, exploitation, or duress;
(d) Sexual behavior of a public nature and/or that which reflects lack of discretion or judgment.
14.
(a) The behavior occurred prior to or during adolescence and there is no evidence of subsequent conduct of a similar nature;
(b) The sexual behavior happened so long ago, so infrequently, or under such unusual circumstances, that it is unlikely to recur and does not cast doubt on the individual's current reliability, trustworthiness, or good judgment;
(c) The behavior no longer serves as a basis for coercion, exploitation, or duress;
(d) The sexual behavior is strictly private, consensual, and discreet.
15.
(a) Refusal, or failure without reasonable cause, to undergo or cooperate with security processing, including but not limited to meeting with a security investigator for subject interview, completing security forms or releases, and cooperation with medical or psychological evaluation;
(b) Refusal to provide full, frank and truthful answers to lawful questions of investigators, security officials, or other official representatives in connection with a personnel security or trustworthiness determination.
16.
(a) Deliberate omission, concealment, or falsification of relevant facts from any personnel security questionnaire, personal history statement, or similar form used to conduct investigations, determine employment qualifications, award benefits or status, determine security clearance eligibility or trustworthiness, or award fiduciary responsibilities;
(b) Deliberately providing false or misleading information concerning relevant facts to an employer, investigator, security official, competent medical authority, or other official government representative;
(c) Credible adverse information in several adjudicative issue areas that is not sufficient for an adverse determination under any other single guideline, but which, when considered as a whole, supports a whole-person assessment of questionable judgment, untrustworthiness, unreliability, lack of candor, unwillingness to comply with rules and regulations, or other characteristics indicating that the person may not properly safeguard protected information;
(d) Credible adverse information that is not explicitly covered under any other guideline and may not be sufficient by itself for an adverse determination, but which, when combined with all available information supports a whole-person assessment of questionable judgment, untrustworthiness, unreliability, lack of candor, unwillingness to comply with rules and regulations, or other characteristics indicating that the person may not properly safeguard protected information. This includes but is not limited to consideration of:
(1) Untrustworthy or unreliable behavior to include breach of client confidentiality, release of proprietary information, unauthorized release of sensitive corporate or other government protected information;
(2) Disruptive, violent, or other inappropriate behavior in the workplace;
(3) A pattern of dishonesty or rule violations;
(4) Evidence of significant misuse of Government or other employer's time or resources;
(e) Personal conduct or concealment of information about one's conduct, that creates a vulnerability to exploitation, manipulation, or duress, such as:
(1) Engaging in activities which, if known, may affect the person's personal, professional, or community standing, or
(2) While in another country, engaging in any activity that is illegal in that country or that is legal in that country but illegal in the United States and may serve as a basis for exploitation or pressure by the foreign security or intelligence service or other group;
(f) Violation of a written or recorded commitment made by the individual to the employer as a condition of employment;
(g) Association with persons involved in criminal activity.
17.
(a) The individual made prompt, good-faith efforts to correct the omission, concealment, or falsification before being confronted with the facts;
(b) The refusal or failure to cooperate, omission, or concealment was caused or significantly contributed to by improper or inadequate advice of authorized personnel or legal counsel advising or instructing the individual specifically concerning the security clearance process. Upon being made aware of the requirement to cooperate or provide the information, the individual cooperated fully and truthfully;
(c) The offense is so minor, or so much time has passed, or the behavior is so infrequent, or it happened under such unique circumstances that it is unlikely to recur and does not cast doubt on the individual's reliability, trustworthiness, or good judgment;
(d) The individual has acknowledged the behavior and obtained counseling to change the behavior or taken other positive steps to alleviate the stressors, circumstances, or factors that caused untrustworthy, unreliable, or other inappropriate behavior, and such behavior is unlikely to recur;
(e) The individual has taken positive steps to reduce or eliminate vulnerability to exploitation, manipulation, or duress;
(f) Association with persons involved in criminal activities has ceased or occurs under circumstances that do not cast doubt upon the individual's reliability, trustworthiness, judgment, or willingness to comply with rules and regulations.
18.
19.
(a) Inability or unwillingness to satisfy debts;
(b) Indebtedness caused by frivolous or irresponsible spending and the absence of any evidence of willingness or intent to pay the debt or establish a realistic plan to pay the debt.
(c) A history of not meeting financial obligations;
(d) Deceptive or illegal financial practices such as embezzlement, employee theft, check fraud, income tax evasion, expense account fraud, filing deceptive loan statements, and other intentional financial breaches of trust;
(e) Consistent spending beyond one's means, which may be indicated by excessive indebtedness, significant negative cash flow, high debt-to-income ratio, and/or other financial analysis;
(f) Financial problems that are linked to drug abuse, alcoholism, gambling problems, or other issues of security concern.
(g) Failure to file annual Federal, state, or local income tax returns as required or the fraudulent filing of the same;
(h) Unexplained affluence, as shown by a lifestyle or standard of living, increase in net worth, or money transfers that cannot be explained by subject's known legal sources of income;
(i) Compulsive or addictive gambling as indicated by an unsuccessful attempt to stop gambling, “chasing losses” (
20.
(a) The behavior happened so long ago, was so infrequent, or occurred under such circumstances that it is unlikely to recur and does not cast doubt on the individual's current reliability, trustworthiness, or good judgment;
(b) The conditions that resulted in the financial problem were largely beyond the person's control (
(c) The person has received or is receiving counseling for the problem and/or there are clear indications that the problem is being resolved or is under control;
(d) The individual initiated a good-faith effort to repay overdue creditors or otherwise resolve debts;
(e) The individual has a reasonable basis to dispute the legitimacy of the past-due debt which is the cause of the problem and provides documented proof to substantiate the basis of the dispute or provides evidence of actions to resolve the issue;
(f) The affluence resulted from a legal source of income.
21.
22.
(a) Alcohol-related incidents away from work, such as driving while under the influence, fighting, child or spouse abuse, disturbing the peace, or other incidents of concern, regardless of whether the individual is diagnosed as an alcohol abuser or alcohol dependent;
(b) Alcohol-related incidents at work, such as reporting for work or duty in an intoxicated or impaired condition, or drinking on the job, regardless of whether the individual is diagnosed as an alcohol abuser or alcohol dependent;
(c) Habitual or binge consumption of alcohol to the point of impaired judgment, regardless of whether the individual is diagnosed as an alcohol abuser or alcohol dependent;
(d) Diagnosis by a duly qualified medical professional (
(e) Evaluation of alcohol abuse or alcohol dependence by a licensed clinical social worker who is a staff member of a recognized alcohol treatment program;
(f) Relapse after diagnosis of alcohol abuse or dependence and completion of an alcohol rehabilitation program;
(g) Failure to follow any court order regarding alcohol education, evaluation, treatment, or abstinence.
23.
(a) So much time has passed, or the behavior was so infrequent, or it happened under such unusual circumstances that it is unlikely to recur or does not cast doubt on the individual's current reliability, trustworthiness, or good judgment;
(b) The individual acknowledges his or her alcoholism or issues of alcohol abuse, provides evidence of actions taken to overcome this problem, and has established a pattern of abstinence (if alcohol dependent) or responsible use (if an alcohol abuser);
(c) The individual is a current employee who is participating in a counseling or treatment program, has no history of previous treatment and relapse, and is making satisfactory progress;
(d) The individual has successfully completed inpatient or outpatient counseling or rehabilitation along with any required aftercare, has demonstrated a clear and established pattern of modified consumption or abstinence in accordance with treatment recommendations, such as participation in meetings of Alcoholics Anonymous or a similar organization and has received a favorable prognosis by a duly qualified medical professional or a licensed clinical social worker who is a staff member of a recognized alcohol treatment program.
24.
(a) Drugs are defined as mood and behavior altering substances, and include:
(1) Drugs, materials, and other chemical compounds identified and listed in the Controlled Substances Act of 1970, as amended (
(2) Inhalants and other similar substances
(b) Drug abuse is the illegal use of a drug or use of a legal drug in a manner that deviates from approved medical direction.
25.
(a) Any drug abuse (see above definition);
(b) Testing positive for illegal drug use;
(c) Illegal drug possession, including cultivation, processing, manufacture, purchase, sale, or distribution; or possession of drug paraphernalia;
(d) Diagnosis by a duly qualified medical professional (
(e) Evaluation of drug abuse or drug dependence by a licensed clinical social worker who is a staff member of a recognized drug treatment program;
(f) Failure to successfully complete a drug treatment program prescribed by a duly qualified medical professional;
(g) Any illegal drug use after being granted a security clearance;
(h) Expressed intent to continue illegal drug use, or failure to clearly and convincingly commit to discontinue drug use.
26.
(a) The behavior happened so long ago, was so infrequent, or happened under such circumstances that it is unlikely to recur or does not cast doubt on the individual's current reliability, trustworthiness, or good judgment;
(b) A demonstrated intent not to abuse any drugs in the future, such as:
(1) Dissociation from drug-using associates and contacts;
(2) Changing or avoiding the environment where drugs were used;
(3) An appropriate period of abstinence;
(4) A signed statement of intent with automatic revocation of clearance for any violation;
(c) Abuse of prescription drugs was after a severe or prolonged illness during which these drugs were prescribed, and abuse has since ended;
(d) Satisfactory completion of a prescribed drug treatment program, including but not limited to rehabilitation and aftercare requirements, without recurrence of abuse, and a favorable prognosis by a duly qualified medical professional.
27.
28.
(a) Behavior that casts doubt on an individual's judgment, reliability, or trustworthiness that is not covered under any other guideline, including but not limited to emotionally unstable, irresponsible, dysfunctional, violent, paranoid, or bizarre behavior;
(b) An opinion by a duly qualified mental health professional that the individual has a condition not covered under any other guideline that may impair judgment, reliability, or trustworthiness;
(c) The individual has failed to follow treatment advice related to a diagnosed emotional, mental, or personality condition,
29.
(a) The identified condition is readily controllable with treatment, and the individual has demonstrated ongoing and consistent compliance with the treatment plan;
(b) The individual has voluntarily entered a counseling or treatment program for a condition that is amenable to treatment, and the individual is currently receiving counseling or treatment with a favorable prognosis by a duly qualified mental health professional;
(c) Recent opinion by a duly qualified mental health professional employed by, or acceptable to and approved by the U.S. Government that an individual's previous condition is under control or in remission, and has a low probability of recurrence or exacerbation;
(d) The past emotional instability was a temporary condition (
(e) There is no indication of a current problem.
30.
31.
(a) A single serious crime or multiple lesser offenses;
(b) Discharge or dismissal from the Armed Forces under dishonorable conditions;
(c) Allegation or admission of criminal conduct, regardless of whether the person was formally charged, formally prosecuted or convicted;
(d) Individual is currently on parole or probation;
(e) Violation of parole or probation, or failure to complete a court-mandated rehabilitation program.
32.
(a) So much time has elapsed since the criminal behavior happened, or it happened under such unusual circumstances that it is unlikely to recur or does not cast doubt on the individual's reliability, trustworthiness, or good judgment;
(b) The person was pressured or coerced into committing the act and those pressures are no longer present in the person's life;
(c) Evidence that the person did not commit the offense;
(d) There is evidence of successful rehabilitation; including but not limited to the passage of time without recurrence of criminal activity, remorse or restitution, job training or higher education, good employment record, or constructive community involvement.
33.
34.
(a) Deliberate or negligent disclosure of classified or other protected information to unauthorized persons, including but not limited to personal or business contacts, to the media, or to persons present at seminars, meetings, or conferences;
(b) Collecting or storing classified or other protected information in any unauthorized location;
(c) Loading, drafting, editing, modifying, storing, transmitting, or otherwise handling classified reports, data, or other information on any unapproved equipment including but not limited to any typewriter, word processor, or computer hardware, software, drive, system, gameboard, handheld, “palm” or pocket device or other adjunct equipment;
(d) Inappropriate efforts to obtain or view classified or other protected information outside one's need to know;
(e) Copying classified or other protected information in a manner designed to conceal or remove classification or other document control markings;
(f) Viewing or downloading information from a secure system when the information is beyond the individual's need to know;
(g) Any failure to comply with rules for the protection of classified or other sensitive information;
(h) Negligence or lax security habits that persist despite counseling by management;
(i) Failure to comply with rules or regulations that results in damage to the National Security, regardless of whether it was deliberate or negligent.
35.
(a) So much time has elapsed since the behavior, or it happened so infrequently or under such unusual circumstances that it is unlikely to recur or does not cast doubt on the individual's current reliability, trustworthiness, or good judgment;
(b) The individual responded favorably to counseling or remedial security training and now demonstrates a positive attitude toward the discharge of security responsibilities;
(c) The security violations were due to improper or inadequate training.
36.
37.
(a) Any employment or service, whether compensated or volunteer, with:
(1) The government of a foreign country;
(2) Any foreign national, organization, or other entity;
(3) A representative of any foreign interest;
(4) Any foreign, domestic, or international organization or person engaged in analysis, discussion, or publication of material on intelligence, defense, foreign affairs, or protected technology;
(b) Failure to report or fully disclose an outside activity when this is required.
38.
(a) Evaluation of the outside employment or activity by the appropriate security or counterintelligence office indicates that it does not pose a conflict with an individual's security responsibilities or with the national security interests of the United States;
(b) The individual terminates the employment or discontinued the activity upon being notified that it was in conflict with his or her security responsibilities.
39.
40.
(a) Illegal or unauthorized entry into any information technology system or component thereof;
(b) Illegal or unauthorized modification, destruction, manipulation or denial of access to information, software, firmware, or hardware in an information technology system;
(c) Use of any information technology system to gain unauthorized access to another system or to a compartmented area within the same system;
(d) Downloading, storing, or transmitting classified information on or to any unauthorized software, hardware, or information technology system;
(e) Unauthorized use of a government or other information technology system;
(f) Introduction, removal, or duplication of hardware, firmware, software, or media to or from any information technology system without authorization, when prohibited by rules, procedures, guidelines or regulations.
(g) Negligence or lax security habits in handling information technology that persist despite counseling by management;
(h) Any misuse of information technology, whether deliberate or negligent, that results in damage to the national security.
41.
(a) So much time has elapsed since the behavior happened, or it happened under such unusual circumstances, that it is unlikely to recur or does not cast doubt on the individual's reliability, trustworthiness, or good judgment;
(b) The misuse was minor and done only in the interest of organizational efficiency and effectiveness, such as letting another person use one's password or computer when no other timely alternative was readily available;
(c) The conduct was unintentional or inadvertent and was followed by a prompt, good-faith effort to correct the situation and by notification of supervisor.
Federal Deposit Insurance Corporation (FDIC).
Final rule.
The FDIC is adopting a final rule that amends the definition of “qualifying master netting agreement” under the regulatory capital rules and the liquidity coverage ratio rule. In this final rule, the FDIC also is amending the definitions of “collateral agreement,” “eligible margin loan,” and “repo-style transaction” under the regulatory capital rules. These amendments are designed to ensure that the regulatory capital and liquidity treatment of certain financial contracts generally would not be affected by implementation of special resolution regimes in non-U.S. jurisdictions that are substantially similar to the U.S. resolution framework or by changes to the International Swaps and Derivative Association (ISDA) Master Agreement that provide for contractual submission to such regimes. The Office of the Comptroller of the Currency (OCC) and the Board of
The final rule is effective October 17, 2016.
Ryan Billingsley, Acting Associate Director,
The regulatory capital rules of the Federal Reserve, the OCC, and the FDIC (collectively, the agencies) permit a banking organization to measure exposure from certain types of financial contracts on a net basis, provided that the contracts are subject to a “qualifying master netting agreement” that provides for certain rights upon a counterparty default.
The agencies' current definition of “qualifying master netting agreement” recognizes that default rights may be stayed if the financial company is in receivership, conservatorship, or resolution under Title II of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act),
Regarding non-U.S. special resolution regimes that provide a limited stay of termination rights and other remedies in financial contracts, in 2014, the European Union (EU) finalized the Bank Recovery and Resolution Directive (BRRD), which prescribes aspects of a special resolution regime that EU member nations should implement. For the BRRD to be fully implemented, each member nation of the EU must transpose the BRRD requirements into local law. The implementation of the BRRD by EU member nations was permitted as early as January 1, 2015, and the transposition process is largely complete.
Regarding contractual amendments between counterparties to OTC derivatives, various U.S. banking organizations have adhered to the 2015 Universal ISDA Resolution Stay Protocol (ISDA Protocol),
In addition, the ISDA Protocol provides for limited stays of termination rights and other remedies for cross-defaults resulting from affiliate insolvency proceedings under a limited number of U.S. insolvency regimes. ISDA Master Agreements
A master netting agreement under which default rights may be stayed under the BRRD or that incorporates the ISDA Protocol would no longer qualify as a qualifying master netting agreement under the FDIC's current regulatory capital and liquidity rules. This would result in considerably higher capital and liquidity requirements.
The FDIC issued in the
Under this final rule, the FDIC permits an otherwise qualifying master netting agreement to qualify for favored netting treatment under the FDIC's regulatory capital and liquidity rules if (i) default rights under the agreement may be stayed under a qualifying non-U.S. special resolution regime or (ii) the agreement incorporates a qualifying special resolution regime by contract. Through these revisions, the final rule maintains the existing treatment for these contracts for purposes of the regulatory capital and liquidity rules, while recognizing the recent changes instituted by the BRRD and the ISDA Protocol.
The final rule also revises certain other definitions of the regulatory capital rules to make various conforming changes designed to ensure that a banking organization may continue to recognize the risk mitigating effects of financial collateral
It is common market practice for bilateral derivatives and certain other types of financial contracts entered into by large banking organizations to permit a non-defaulting counterparty to exercise early termination rights and other contractual remedies upon a counterparty (or a related entity) experiencing an event of default. These contractual provisions are generally recognized as a credit risk mitigant because the provisions allow a non-defaulting party the uninterrupted right to close-out, net, and liquidate any collateral securing its claim under the contract upon a counterparty's default.
However, as the failure of Lehman Brothers demonstrated, the uninterrupted exercise of such rights by counterparties of a globally active financial company with a significant derivatives portfolio could impede the orderly resolution of the financial company and pose risks to financial stability. The United States has enacted laws that impose a limited stay on the exercise of early termination rights and other remedies with regard to qualified financial contracts (such as OTC derivatives, securities financing transactions, and margin loans) with insured depository institutions in resolution under the FDI Act and, in 2010, with financial companies in resolution under Title II of the Dodd-Frank Act.
In recognition of the issues faced in the financial crisis concerning resolution of globally-active financial companies, the EU issued the BRRD on April 15, 2014, which requires EU member states to implement a resolution mechanism by December 31, 2014, in order to increase the likelihood for successful national or cross-border resolutions of a financial company organized in the EU.
ISDA launched the ISDA Protocol on November 12, 2015, which provides a mechanism for parties to transactions under ISDA Master Agreements (and securities financing transactions documented under industry standard documentation for such transactions) to amend those agreements to stay certain early termination rights and other remedies provided under the agreement. As of July 14, 2016, 217 parties, including several of the largest U.S. banking organizations,
The contractual amendments effectuated pursuant to the ISDA Protocol would apply the provisions of Title II of the Dodd-Frank Act and the FDI Act concerning limited stays of termination rights and other remedies in qualified financial contracts to ISDA Master Agreements between adhering counterparties, including adhering counterparties that are not otherwise subject to U.S. law. The amendments also would apply substantially similar provisions of certain non-U.S. laws, to ISDA Master Agreements between adhering counterparties that are not otherwise subject to such laws.
As noted above, the agencies' regulatory capital rules permit a banking organization to measure exposure from certain types of financial contracts on a net basis, provided that the contracts are subject to a qualifying master netting agreement or other agreement that contains specific provisions. Specifically, under the current regulatory capital rules, a banking organization with multiple OTC derivatives that are subject to a qualifying master netting agreement would be able to calculate a net exposure amount by netting the sum of all positive and negative fair values of the individual OTC derivative contracts subject to the qualifying master netting agreement and calculating a risk-weighted asset amount based on the net exposure amount. For purposes of the current supplementary leverage ratio (as applied only to advanced approaches banking organizations), a banking organization that has one or more OTC derivatives with the same counterparty that are subject to a qualifying master netting agreement would be permitted to not include in total leverage exposure cash variation margin received from such counterparty that has offset the mark-to-fair value of the derivative asset, or cash collateral that is posted to such counterparty that has reduced the banking organization's on-balance sheet assets.
In addition, for risk-based capital purposes, a banking organization with a securities financing transaction that meets the definition of a repo-style transaction with financial collateral, a margin loan that meets the definition of an eligible margin loan with financial collateral, or an OTC derivative contract collateralized with financial collateral may determine a net exposure amount to its counterparty according to section 37 or section 132 of the regulatory capital rules. A banking organization with multiple repo-style transactions or eligible margin loans with a counterparty that are subject to a qualifying master netting agreement may net the exposure amounts of the individual transactions under that agreement. In addition, for purposes of the supplementary leverage ratio, an advanced approaches banking organization with multiple repo-style transactions with the same counterparty that are subject to a qualifying master netting agreement would be permitted to net for purposes of calculating the counterparty credit risk component of its total leverage exposure. In general, recognition of netting results in a lower
The agencies also use the concept of a qualifying master netting agreement in the LCR rule.
The final rule amends the definitions of “collateral agreement, “eligible margin loan,” “qualifying master netting agreement,” and “repo-style transaction” in the FDIC's regulatory capital rules and “qualifying master netting agreement” in the FDIC's LCR rules to ensure that the regulatory capital and liquidity treatment of OTC derivatives, repo-style transactions, eligible margin loans, and other collateralized transactions would be unaffected by the adoption of various foreign special resolution regimes and the ISDA Protocol. In particular, the final rule amends these definitions to provide that a relevant netting agreement or collateral agreement may provide for a limited stay or avoidance of rights where the agreement is subject by its terms to, or incorporates, certain resolution regimes applicable to financial companies, including Title II of the Dodd-Frank Act, the FDI Act, or any similar foreign resolution regime that are jointly determined by the agencies to be substantially similar to Title II of the Dodd-Frank Act or the FDI Act.
In determining whether the laws of foreign jurisdictions are “similar” to the FDI Act and Title II of the Dodd-Frank Act, the FDIC, jointly with the OCC and FRB, intends to consider all aspects of U.S. law, including all aspects of stays provided thereunder.
This final rule allows for the continuation of the existing netting treatment for these contracts for purposes of the regulatory capital and liquidity rules. Implementation of consistent, national resolution regimes on a global basis furthers the orderly resolution of internationally active financial companies, and enhances financial stability. In addition, the development of the ISDA Protocol furthers the principles of Title II of the Dodd-Frank Act and the FDI Act (in instances where a counterparty is a U.S. entity or its subsidiary) to counterparties who are not otherwise subject to U.S. law.
In addition to giving contractual effect to limited stays of termination rights under special resolution regimes on a cross-border basis, the ISDA Protocol also provides for limited stay of termination rights for cross-defaults resulting from affiliate insolvency proceedings under a limited number of U.S. general insolvency regimes, including the U.S. bankruptcy code. This provision takes effect upon the effective date of implementing regulations in the United States. To the extent the agencies implement regulations to give effect to these provisions of the ISDA Protocol, the FDIC will consider further amending the definition of “qualifying master netting agreement” in the regulatory capital and liquidity rules and the definition of “collateral agreement”, “repo-style transaction” and “eligible margin loan” in the regulatory capital rules.
The qualified master netting agreement definition in the FDIC's capital and liquidity rules also relates to the eligible master netting agreement definition in the swap margin rules issued by the adopting agencies in November 2015.
The swap margin rule's definition of “eligible master netting agreement” is substantively the same as the definition of “qualified master netting agreement” as amended by this final rule.
The FDIC received three comments on the January 2015 NPR. One comment was generally supportive of the proposed rule in the January 2015 NPR as a necessary technical amendment that would promote the objective of establishing effective resolution regimes for globally active financial companies. That commenter also recommended that the FDIC revisit in the near term the broader policy questions surrounding the impact of close-out netting on systemic risk mitigation, and evaluate how well the regulatory capital and liquidity coverage ratio rules reflect the risks associated with netted financial contracts.
Two of the commenters
The narrow purpose of amending the definition of “qualifying master netting agreement” in the proposed rule and this final rule is to maintain the regulatory capital and liquidity treatment of certain financial contracts as unaffected by the ISDA Master Agreement and stays by non-U.S. resolution authorities. The FDIC has considered the comments for purposes of the final rule, and has determined that the commenters raise an issue that is beyond that limited purpose.
This final rule is effective upon publication in the
Section 302 of the Riegle Community Development and Regulatory Improvement Act
The Administrative Procedure Act (“APA”) requires that a final rule be published in the
The final rule is intended to prevent any change in the treatment of QFCs under capital and liquidity rules that may result from the establishment of non-U.S. special resolution regimes or by contract. As stated above, the final rule maintains the existing treatment for these contracts for purposes of the regulatory capital and liquidity rules, while recognizing the recent changes instituted by the BRRD and the ISDA Protocol. Implementation of consistent, national resolution regimes on a global basis furthers the orderly resolution of internationally active financial companies, and enhances financial stability. In addition, the development of the ISDA Protocol furthers the principles of Title II of the Dodd-Frank Act and the FDI Act (in instances where a counterparty is a U.S. entity or its subsidiary) to counterparties who are not otherwise subject to U.S. law.
This final rule will benefit FDIC-supervised institutions that adhere to the ISDA Protocol by allowing for the continuation of the existing netting treatment for these contracts for purposes of the regulatory capital and liquidity rules. Absent the final rule, such FDIC-supervised institutions would be unable to include a master netting agreement under which default rights may be stayed under the BRRD or that incorporates the ISDA Protocol as a qualifying master netting agreement under the FDIC's current regulatory capital and liquidity regulations, and would be required to hold more capital and liquid assets as a result.
The final rule may result in administrative costs associated with changing the legal language that govern QFCs for a small number of entities. These costs are likely to be very small relative to the increase in capital and liquidity requirements likely to result if capital and liquidity requirements for QFCs had to be calculated on a gross basis. Any administrative costs associated with the proposed rule are likely to be very low given that similar legal structures already exist in the ISDA Protocol. The FDIC estimates that six FDIC-supervised institutions will be directly affected by this rule. Therefore, any administrative costs for FDIC-supervised institutions is likely to be low and the volume of costs for all FDIC-supervised institutions is likely to have no significant impact on financial institutions or the economy.
The Office of Management and Budget has determined that the final rule is not a “major rule” within the meaning of the Small Business Regulatory Enforcement Fairness Act of 1996 (Title II, Pub. L. 104-121).
The Regulatory Flexibility Act, 5 U.S.C. 601
Under regulations issued by the Small Business Administration, a small entity includes a depository institution, bank
The final rule is expected only to apply to banking organizations that adhere to the ISDA Protocol or engage in a substantial amount of cross-border derivatives transactions. Small entities generally would not fall into this category. Accordingly, the FDIC believes that this final rule would not have a significant economic impact on small banking organizations supervised by the FDIC and therefore believes that there are no significant alternatives to the issuance of this final rule that would reduce the economic impact on small banking organizations supervised by the FDIC. Pursuant to section 605(b) of the RFA, the FDIC certifies that the Final Rule will not have a significant economic impact on a substantial number of small entities.
In accordance with the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521) (PRA), the FDIC may not conduct or sponsor, and a 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 FDIC has reviewed this final rule and determined that it does not create any new, or revise any existing, collection of information pursuant to the PRA. Consequently, no information has been submitted to the Office on Management and Budget for review.
The FDIC has determined that the final rule will not affect family well-being within the meaning of section 654 of the Treasury and General Government Appropriations Act, enacted as part of the Omnibus Consolidated and Emergency Supplemental Appropriations Act of 1999 (Pub. L. 105-277, 112 Stat. 2681).
Section 722 of the Gramm-Leach-Bliley Act, Public Law 106-102, 113 Stat. 1338, 1471 (Nov. 12, 1999), requires the Federal banking agencies to use plain language in all proposed and final rules published after January 1, 2000. The FDIC invited comments on how to make this rule easier to understand. No comments addressing this issue were received.
Administrative practice and procedure; Banks, banking; Capital adequacy; Reporting and recordkeeping requirements; Savings associations; State non-member banks.
Administrative practice and procedure; Banks, banking; Federal Deposit Insurance Corporation, FDIC; Liquidity; Reporting and recordkeeping requirements.
For the reasons set forth in the supplementary information, the Federal Deposit Insurance Corporation amends 12 CFR Chapter III, parts 324 and 329 to read as follows:
12 U.S.C. 1815(a), 1815(b), 1816, 1818(a), 1818(b), 1818(c), 1818(t), 1819(Tenth), 1828(c), 1828(d), 1828(i), 1828(n), 1828(o), 1831o, 1835, 3907, 3909, 4808; 5371; 5412; Pub. L. 102-233, 105 Stat. 1761, 1789, 1790 (12 U.S.C. 1831n note); Pub. L. 102-242, 105 Stat. 2236, 2355, as amended by Pub. L. 103-325, 108 Stat. 2160, 2233 (12 U.S.C. 1828 note); Pub. L. 102-242, 105 Stat. 2236, 2386, as amended by Pub. L. 102-550, 106 Stat. 3672, 4089 (12 U.S.C. 1828 note); Pub. L. 111-203, 124 Stat. 1376, 1887 (15 U.S.C. 78o-7 note).
(1) In receivership, conservatorship, or resolution under the Federal Deposit Insurance Act, Title II of the Dodd-Frank Act, or under any similar insolvency law applicable to GSEs, or laws of foreign jurisdictions that are substantially similar
(2) Where the agreement is subject by its terms to any of the laws referenced in paragraph (1) of this definition.
(1) An extension of credit where:
(i) The extension of credit is collateralized exclusively by liquid and readily marketable debt or equity securities, or gold;
(ii) The collateral is marked to fair value daily, and the transaction is subject to daily margin maintenance requirements; and
(iii) The extension of credit is conducted under an agreement that provides the FDIC-supervised institution the right to accelerate and terminate the extension of credit and to liquidate or set-off collateral promptly upon an event of default, including upon an event of receivership, insolvency, liquidation, conservatorship, or similar proceeding, of the counterparty, provided that, in any such case, any exercise of rights under the agreement will not be stayed or avoided under applicable law in the relevant jurisdictions, other than in receivership, conservatorship, or resolution under the Federal Deposit Insurance Act, Title II of the Dodd-Frank Act, or under any similar insolvency law applicable to GSEs,
(2) In order to recognize an exposure as an eligible margin loan for purposes of this subpart, an FDIC-supervised institution must comply with the requirements of § 324.3(b) with respect to that exposure.
(1) The agreement creates a single legal obligation for all individual transactions covered by the agreement upon an event of default following any stay permitted by paragraph (2) of this definition, including upon an event of receivership, insolvency, conservatorship, liquidation, or similar proceeding, of the counterparty;
(2) The agreement provides the FDIC-supervised institution the right to accelerate, terminate, and close-out on a net basis all transactions under the agreement and to liquidate or set-off collateral promptly upon an event of default, including upon an event of receivership, conservatorship, insolvency, liquidation, or similar proceeding, of the counterparty, provided that, in any such case, any exercise of rights under the agreement will not be stayed or avoided under applicable law in the relevant jurisdictions, other than:
(i) In receivership, conservatorship, or resolution under the Federal Deposit Insurance Act, Title II of the Dodd-Frank Act, or under any similar insolvency law applicable to GSEs, or laws of foreign jurisdictions that are substantially similar
(ii) Where the agreement is subject by its terms to, or incorporates, any of the laws referenced in paragraph (2)(i) of this definition;
(3) The agreement does not contain a walkaway clause (that is, a provision that permits a non-defaulting counterparty to make a lower payment than it otherwise would make under the agreement, or no payment at all, to a defaulter or the estate of a defaulter, even if the defaulter or the estate of the defaulter is a net creditor under the agreement); and
(4) In order to recognize an agreement as a qualifying master netting agreement for purposes of this subpart, an FDIC-supervised institution must comply with the requirements of § 324.3(d) of this chapter with respect to that agreement.
(1) The transaction is based solely on liquid and readily marketable securities, cash, or gold;
(2) The transaction is marked-to-fair value daily and subject to daily margin maintenance requirements;
(3)(i) The transaction is a “securities contract” or “repurchase agreement” under section 555 or 559, respectively, of the Bankruptcy Code (11 U.S.C. 555 or 559), a qualified financial contract under section 11(e)(8) of the Federal Deposit Insurance Act, or a netting contract between or among financial institutions under sections 401-407 of the Federal Deposit Insurance Corporation Improvement Act or the Federal Reserve's Regulation EE (12 CFR part 231); or
(ii) If the transaction does not meet the criteria set forth in paragraph (3)(i) of this definition, then either:
(A) The transaction is executed under an agreement that provides the FDIC-supervised institution the right to accelerate, terminate, and close-out the transaction on a net basis and to liquidate or set-off collateral promptly upon an event of default, including upon an event of receivership, insolvency, liquidation, or similar proceeding, of the counterparty, provided that, in any such case, any exercise of rights under the agreement will not be stayed or avoided under applicable law in the relevant jurisdictions, other than in receivership, conservatorship, or resolution under the Federal Deposit Insurance Act, Title II of the Dodd-Frank Act, or under any similar insolvency law applicable to GSEs, or laws of foreign jurisdictions that are substantially similar
(B) The transaction is:
(4) In order to recognize an exposure as a repo-style transaction for purposes of this subpart, an FDIC-supervised institution must comply with the requirements of § 324.3(e) with respect to that exposure.
12 U.S.C. 1815, 1816, 1818, 1819, 1828, 1831p-1, 5412.
(1) The agreement creates a single legal obligation for all individual transactions covered by the agreement upon an event of default following any stay permitted by paragraph (2) of this definition, including upon an event of receivership, insolvency, conservatorship, liquidation, or similar proceeding, of the counterparty;
(2) The agreement provides the FDIC-supervised institution the right to accelerate, terminate, and close-out on a net basis all transactions under the agreement and to liquidate or set-off collateral promptly upon an event of default, including upon an event of receivership, conservatorship, insolvency, liquidation, or similar proceeding, of the counterparty, provided that, in any such case, any exercise of rights under the agreement will not be stayed or avoided under applicable law in the relevant jurisdictions, other than:
(i) In receivership, conservatorship, or resolution under the Federal Deposit Insurance Act, Title II of the Dodd-Frank Act, or under any similar insolvency law applicable to GSEs, or laws of foreign jurisdictions that are substantially similar
(ii) Where the agreement is subject by its terms to, or incorporates, any of the laws referenced in paragraph (2)(i) of this definition;
(3) The agreement does not contain a walkaway clause (that is, a provision that permits a non-defaulting counterparty to make a lower payment than it otherwise would make under the agreement, or no payment at all, to a defaulter or the estate of a defaulter, even if the defaulter or the estate of the defaulter is a net creditor under the agreement); and
(4) In order to recognize an agreement as a qualifying master netting agreement for purposes of this subpart, an FDIC-supervised institution must comply with the requirements of § 329.4(a) with respect to that agreement.
By order of the Board of directors of the Federal Deposit Insurance Corporation.
Farm Credit Administration.
Notice of effective date.
The Farm Credit Administration (FCA, we, Agency or our) amended our regulations to related to the Federal Agricultural Mortgage Corporation's (Farmer Mac or Corporation) risk governance and making enhancements to existing disclosure and reporting requirements. The risk governance regulations require the Corporation to establish and maintain a board-level risk management committee and a risk officer, as well as risk management policies and internal controls. The changes to disclosure and reporting requirements remove repetitive reporting and allow for electronic filing of reports. We also finalized rules on the examination and enforcement authorities held by the FCA Office of Secondary Market Oversight over the Corporation. In accordance with the law, the effective date of the rule is no earlier than 30 days from the date of publication in the
The Farm Credit Administration amended our regulations related to the Federal Agricultural Mortgage Corporation's (Farmer Mac or Corporation) risk governance and making enhancements to existing disclosure and reporting requirements. The risk governance regulations require the Corporation to establish and maintain a board-level risk management committee and a risk officer, as well as risk management policies and internal controls. The changes to disclosure and reporting requirements remove repetitive reporting and allow for electronic filing of reports. We also finalized rules on the examination and enforcement authorities held by the FCA Office of Secondary Market Oversight over the Corporation. In accordance with 12 U.S.C. 2252, the effective date of the final rule is no earlier than 30 days from the date of publication in the
Federal Aviation Administration (FAA), DOT.
Final special conditions; request for comments; correction.
The FAA is correcting a final special conditions; request for comments document published in the
This correction is effective on October 17, 2016.
Varun Khanna, FAA, Airplane and Flight Crew Interface Branch, ANM-111, Transport Airplane Directorate, Aircraft Certification Service, 1601 Lind Avenue SW., Renton, WA 98055-4056; telephone (425) 227-1298; facsimile (425) 227-1149.
On October 31, 2013 (78 FR 65153), the FAA published a final special conditions, request for comments document entitled “Special Conditions: Learjet Model 45 Series Airplanes; Aircraft Electronic System Security Protection from Unauthorized External Access.” The document issued special conditions pertaining to aircraft electronic system security protection from unauthorized external access for the Learjet Model 45 series airplanes.
However, the final special conditions; request for comments, document was published with an incorrect special conditions number. The correct special conditions number for this document is “25-501-SC.”
Also, there was a typographical error in one of the headings paragraphs of the document. The correct heading should read “
Since no part of the regulatory information in the special conditions has been changed, the special conditions are not being republished.
In Final special conditions; request for comments document [FR Doc. 2013-25846, Filed 10-30-13; 8:45 a.m.] and published in the
1. On page 65153, in the first column, correct the 4th headings paragraph, from “[Docket No. FAA-2013-0920, Special Conditions No. 25-13-12-SC]” to read as “[Docket No. FAA-2013-0920, Special Conditions No. 25-501-SC].”
2. On page 63153, in the first column, correct the 7th headings paragraph, from “
Federal Aviation Administration (FAA), DOT.
Final special conditions; request for comments; correction.
The FAA is correcting a final special conditions; request for comments document published in the
This correction is effective on October 17, 2016.
Varun Khanna, FAA, Airplane and Flight Crew Interface Branch, ANM-111, Transport Airplane Directorate, Aircraft Certification Service, 1601 Lind Avenue SW., Renton, WA 98055-4056; telephone (425) 227-1298; facsimile (425) 227-1149.
On October 31, 2013 (78 FR 65155), the FAA published a final special conditions, request for comments document entitled “Special Conditions: Learjet Model 45 Series Airplanes; Isolation or Security Protection of the Aircraft Control Domain and the Airline Information Services Domain from the Passenger Services Domain.” The document issued special conditions pertaining to isolation or security protection of the aircraft control domain and the airline information services domain from the passenger services domain for the Learjet Model 45 series airplanes.
However, the special conditions; request for comments document was published with an incorrect special conditions number. The correct special conditions number for this document is “25-502-SC.”
Also, there was a typographical error in one of the headings paragraphs in the document. The correct heading should read “
Since no part of the regulatory information in the special conditions has been changed, the special conditions are not being republished.
In Final special conditions; request for comments document [FR Doc. 2013-25851, Filed 10-30-13; 8:45 a.m.] and published on October 31, 2013 (78 FR 65155), make the following corrections:
1. On page 65155, in the first column, correct the 4th headings paragraph, from “[Docket No. FAA-2013-0919, Special Conditions No. 25-13-11-SC]” to read as “[Docket No. FAA-2013-0919, Special Conditions No. 25-502-SC].”
2. On page 65155, in the first column, correct the 7th headings paragraph, from “
Federal Aviation Administration (FAA), DOT.
Final special conditions; request for comments.
These special conditions are issued for the Embraer S.A. Model ERJ 190-300 series airplanes. These airplanes will have novel or unusual design features when compared to the
This action is effective on Embraer S.A. on October 17, 2016. We must receive your comments by December 1, 2016.
Send comments identified by docket number FAA-2016-9282 using any of the following methods:
•
•
•
•
Stephen Happenny, FAA, Propulsion and Mechanical Systems Branch, ANM-112, Transport Airplane Directorate, Aircraft Certification Service, 1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone 425-227-2147; facsimile 425-227-1149.
The FAA has determined that notice of, and opportunity for prior public comment on, these special conditions is impracticable because these procedures would significantly delay issuance of the design approval and thus delivery of the affected airplane.
In addition, the substance of these special conditions has been subject to the public comment process in several prior instances with no substantive comments received. The FAA therefore finds that good cause exists for making these special conditions effective upon publication in the
The FAA is requesting comments to allow interested persons to submit views that may not have been submitted in response to the prior opportunities for comment described above. We invite interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data.
We will consider all comments we receive by the closing date for comments. We may change these special conditions based on the comments we receive.
On September 13, 2013, Embraer S.A. applied for an amendment to Type Certificate (TC) No. A57NM to include the new Model ERJ 190-300 series airplanes. The ERJ 190-300, which is a derivative of the ERJ 190-100 STD currently approved under TC No. A57NM, is a 97 to 114-passenger transport category airplane with two Pratt & Whitney Model PW1900G engines, a new wing design with a high aspect ratio and raked wingtip, and a new electrical distribution system.
The ERJ 190-300 will have electrical/electronic equipment bays distributed throughout the airplane, with three of them in the pressurized area. The applicable airworthiness requirements of Title 14, Code of Federal Aviation (14 CFR) 25.831 and 25.869 do not contain adequate or appropriate safety standards regarding smoke or fire detection and protection against the penetration of hazardous quantities of smoke into occupied areas of the airplane for this type of airplane configuration.
Under the provisions of 14 CFR 21.101, Embraer S.A. must show that the ERJ 190-300 meets the applicable provisions of the regulations listed in TC No. A57NM or the applicable regulations in effect on the date of application for the change, except for earlier amendments as agreed upon by the FAA. Embraer S.A. must show that the ERJ 190-300 meets the applicable provisions of 14 CFR part 25, as amended by Amendments 25-1 through 25-137.
If the Administrator finds that the applicable airworthiness regulations (
Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same novel or unusual design features, or should any other model already included on the same type certificate be modified to incorporate the same novel or unusual design features, these special conditions would also apply to the other model under § 21.101.
In addition to the applicable airworthiness regulations and special conditions, the ERJ 190-300 must comply with the fuel vent and exhaust emission requirements of 14 CFR part 34 and the noise-certification requirements of 14 CFR part 36.
The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type certification basis under § 21.101.
The ERJ 190-300 will incorporate the following novel or unusual design features: Electrical/electronic equipment bays that are distributed throughout the airplane. There are three electrical bays in the pressurized area—forward, center, and aft. The forward bay is located below the flight deck; the center bay is in the center fuselage below the
Traditionally, airplanes certified under part 25 have had one or two electrical equipment bays located in the lower lobe adjacent to pressure regulator and outflow valves or vents. If a fire occurs in an electrical/electronic equipment bay, any smoke is drawn toward the outflow valves or vents and discharged from the airplane without entering occupied areas. On these airplanes, the procedure for flight crew determination of whether the source of the smoke is in the electrical/electronic equipment bay has relied on trial and error. However, many factors, including the airflow pattern, potential leak paths, and location of outflow and regulator valves, can make it difficult to identify the smoke source, especially during system and flight transients, such as climbing, descending, or other changes that would affect the internal flow path. Also, if smoke penetrates occupied areas, the flight crew would have less information with which to determine whether the source of the smoke is in an electrical/electronic equipment bay.
The FAA has accepted this trial and error approach for airplanes with no more than two electrical/electronic equipment bays, both located in the lower lobe. However, for airplanes with three or more equipment bays, the additional time it could take the flightcrew to determine the source of smoke would also allow the fire additional time to spread and generate significant amounts of smoke and damage.
Section 25.857 requires that cargo compartments have means to prevent hazardous quantities of smoke or fire extinguishing agent from penetrating into occupied areas of the airplane. However, the regulatory requirements do not address the following:
• Preventing hazardous quantities of smoke or extinguishing agent originating from the electrical/electronic equipment bays from penetrating into occupied areas of the airplane; or
• Installing smoke or fire detectors in electrical/electronic equipment bays.
The FAA determined that airplanes with electrical/electronic equipment bay configurations like that of the ERJ 190-300 need a means to detect smoke or fire in each electrical/electronic equipment bay located in the pressurized cabin to ensure that the flightcrew can make an informed decision as to the source of smoke and shut down the specific electrical/electronic equipment where smoke or fire is present. If the electrical/electronic equipment cannot be completely shut down due to conflict with other safety requirements, Embraer must conduct an analysis to:
• Show the criteria for shutting down the specific electrical/electronic equipment in the electrical/electronic equipment bay that can be shut down; and
• For the remaining electrical/electronic equipment, demonstrate that there are safety precautions incorporated against fire propagation, such as thermal protection, fire containment, or other means, as addressed in advisory circular AC 25-16, “Electrical Fault and Fire Prevention and Protection,” dated April 5, 1991.
The purpose of the smoke/fire detection systems is to accomplish one or more of the following: Automatically shut off power to the affected equipment; reconfigure the environmental control systems, if necessary, to control any smoke resulting from a fire or overheat condition; or alert the crew to the existence of the fire.
These alternate criteria that the FAA has developed to certify airplane designs that incorporate distributed electrical/electronic equipment bays are based on existing smoke/fire detection and smoke penetration guidance and acceptable past practices. Sections 25.831(b), (c), and (d), and 25.869 provide the general requirements that apply to electrical/electronic equipment smoke penetration and evacuation. Flight tests are conducted to demonstrate compliance; however, the amount of smoke generated and flight test conditions have been highly variable.
The special conditions below require a smoke or fire detection system in each electrical/electronic equipment bay located in the pressurized compartment. They also include requirements to prevent propagation of hazardous quantities of smoke or fire extinguishing agent throughout the passenger cabin.
These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
As discussed above, these special conditions are applicable to the ERJ 190-300 series airplanes. Should Embraer S.A. apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, these special conditions would apply to that model as well.
This action affects only certain novel or unusual design features on one model series of airplanes. It is not a rule of general applicability.
Aircraft, Aviation safety, Reporting and recordkeeping requirements.
The authority citation for these special conditions is as follows:
49 U.S.C. 106(g), 40113, 44701, 44702, 44704.
Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for the Embraer S.A. Model ERJ 190-300 series airplanes.
Design Requirements for Smoke Detection and Smoke Penetration in Distributed Electrical/Electronic Equipment Bays.
1. Requirements to prevent propagation of smoke from entering the passenger cabin and cockpit:
a. To prevent such propagation, means to prevent hazardous quantities of smoke originating from the electrical/electronic equipment bays from incapacitating passengers and crew must be demonstrated. Flight tests must be part of such demonstration and shall cover all dispatchable system configurations.
b. A small quantity of smoke may enter an occupied area only if the design meets all of the following conditions:
i. The smoke enters occupied areas during system transients
ii. Penetration of the small quantity of smoke is a dynamic event, characterized by either dissipation or mobility. Dissipation is rapid dilution of the smoke by ventilation air, and mobility is rapid movement of the smoke into and out of the occupied area. In no case should there be formation of a light haze indicative of stagnant airflow, as this
iii. The smoke from a smoke source below the main deck must not rise above armrest height on the main deck.
iv. The smoke from a source in the main deck must dissipate rapidly via dilution with fresh air and be evacuated from the airplane. A procedure must be included in the Airplane Flight Manual (AFM) to evacuate smoke from the occupied areas of the airplane. In order to demonstrate that the quantity of smoke is small, a flight test must be conducted that simulates the emergency procedures used in the event of a fire/smoke during flight, including the use of V
2. Requirement for smoke or fire detection in electrical/electronic equipment bays:
A smoke or fire detection system compliant with 14 CFR 25.858 and 25.855 must be provided for each electrical/electronic equipment bay in the pressurized cabin. Each system must provide a visual indication to the flight deck within one minute after the start of a fire. Airplane flight tests must be conducted to show compliance with these requirements, and the performance of the detectors must be shown in accordance with AC 25-9A, “Smoke Detection, Penetration, and Evacuation Tests and Related Flight Manual Emergency Procedures,” or other means acceptable to the FAA.
3. Requirement for AFM procedures safety evaluation:
It shall be demonstrated by means of flight tests that, in the event of smoke/fire detection in the electrical/electronic equipment bays, the AFM procedures for shutting down any or all of the electrical/electronic equipment do not compromise the safe operation of the airplane.
In case a procedure requests only part of the equipment to be shut down, the remaining equipment shall be incorporated with safety features against fire propagation.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule.
The FAA is issuing a final rule that removes certain redundant or underutilized ground-based nondirectional radio beacon (NDB) and VHF omnidirectional range (VOR) Standard Instrument Approach Procedures (SIAPs). On April 13, 2015, the FAA published a notice of proposed rulemaking to remove 736 SIAPs. This final rule addresses 125 of the 198 procedures for which comments were received.
This rule is effective at 0901 UTC on November 10, 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
Dana Mitchell, Aeronautical Information Services, AJV-5, Federal Aviation Administration, Air Traffic Organization, 1305 East-West Highway, Room 5257, Silver Spring, MD 20910; Telephone (301) 427-4897; Email
The FAA's authority to issue rules on aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart i, Section 40103, sovereignty and use of airspace, and Subpart iii, Section 44701, general requirements. Under these sections, the FAA is charged with prescribing regulations to regulate the safe and efficient use of the navigable airspace; to govern the flight, navigation, protection, and identification of aircraft for the protection of persons and property on the ground, and for the efficient use of the navigable airspace (49 U.S.C. 40103(b)), and to promote safe flight of civil aircraft in air commerce by prescribing regulations and minimum standards for other practices, methods, and procedures necessary for safety in air commerce and national security (49 U.S.C. 44701(a)(5)). This action is within the scope of that authority.
SIAPs are promulgated by rulemaking procedures and are incorporated by reference into 14 CFR 97.20.
On June 27, 2014, the FAA published criteria for determining whether to retain existing SIAPs (79 FR 36576). Removing identified ground-based NDB and VOR SIAPs is an integral part of right-sizing the quantity and type of procedures in the National Airspace System (NAS). As new technology facilitates the introduction of area navigation (RNAV) instrument approach procedures, the number of procedures available in the NAS has nearly doubled over the past decade. The complexity and cost of maintaining the existing ground based navigational infrastructure while expanding RNAV capability is not sustainable.
On April 13, 2015, the FAA published a notice of proposed rulemaking (NPRM) proposing to remove certain SIAPs (80 FR 19577). The NPRM included a list of 736 procedures that were identified for cancellation and the comment period closed on May 28, 2015. The FAA received comments on 198 of those procedures. Of those 198 procedures, 125 are being addressed in this final rule. The remaining 73 require additional evaluation and will be addressed in a subsequent
It should be noted that NPA Instrument Flight Procedure (IFP) cancellation activities, and associated criteria, do not supersede similar activities being performed under the FAA's Very-High Frequency Omni-Directional Range Minimum Operational Network (
The following 8 SIAPs were proposed for cancellation in the NPRM: VOR/DME RWY 25, Alaska (GAL); VOR RWY 18, AL (DCU); VOR RWY 18, Illinois
Prior to the comment review process, because of the possibility of SIAP inventory changes, all procedures were again reviewed for compliance with the initial cancellation criteria as stated in the notice of policy published June 27, 2014. The following 2 procedures did not meet the stated criteria and, therefore, will remain in effect and are not included in this final rule; however the FAA may reevaluate these procedures at a later date.
The following 2 procedures have been requested by the FAA's Very-High Frequency Omni-Directional Range Minimum Operational Network (VOR MON) Program to remain in effect and are not included in this final rule; however the FAA may reevaluate these procedures at a later date.
The following 18 procedures have been requested by the Department of Defense to remain in effect and are not included in this final rule; however the FAA may reevaluate these procedures at a later date.
Numerous comments mentioned the need for a VOR or NDB procedure as a “backup” in case a localizer-based procedure became unusable for any reason. The FAA determined that, in the case of an airport having a single instrument approach procedure using a localizer NavAid, or multiple instrument approach procedures using a single localizer NavAid, that a VOR or NDB procedure would be retained at that airport in case the localizer NavAid became unusable. Due to this determination, the following 25 procedures will remain in effect and are not included in this final rule; however, the FAA may reevaluate these procedures at a later date.
Numerous comments mentioned the need for a VOR and/or NDB procedures for IFR training and/or proficiency. To address that concern, each procedure that received a comment(s) pertaining to IFR training and/or proficiency was reviewed in the following manner: If there was not a similar type (
The following instrument flight procedures received comments that were not substantive enough to warrant retention in the National Airspace System IFP inventory. Some comments were general in nature, expressing opposition to the cost of equipping their aircraft with GPS equipment, while others expressed opposition to the decommissioning of NavAids, which is unrelated to this final rule. Numerous comments pertained to the cancellation of multiple procedures at each airport, but those comments became insubstantial once another procedure at the same airport was retained, as in the instances mentioned previously in this final rule. Cancellation of the following 59 procedures is in accordance with the criteria stated in the notice of policy published June 27, 2014, as well as the criteria established for the provision for IFR training/proficiency as stated earlier in this final rule.
SIAPs and associated supporting data adopted or removed by the FAA are documented on FAA Forms 8260-3, 8260-4, and 8260-5, which are incorporated by reference under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR part 97. The FAA has determined that the 59 procedures listed above should be removed consistent with FAA policy on maintaining instrument approach procedures in the NAS.
The FAA has determined that this final rule only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979) and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
An electronic copy of rulemaking documents may be obtained from the Internet by—
1. Searching the Federal eRulemaking Portal (
2. Visiting the FAA's Regulations and Policies Web page at
3. Accessing the Government Publishing Office's Web page at
Copies may also be obtained by sending a request to the Federal Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence Avenue SW., Washington, DC 20591, or by calling (202) 267-9677. Persons requesting additional information must identify the docket or amendment number of this rulemaking.
All documents the FAA considered in developing this rule, including technical reports, may be accessed from the Internet through the Federal eRulemaking Portal referenced in item (1) above.
Comments received may be viewed by going to
The Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996 requires FAA to comply with small entity requests for information or advice about compliance with statutes and regulations within its jurisdiction. A small entity with questions regarding this document, may contact its local FAA official, or the person listed under the
Air traffic control, Airports, Incorporation by reference, Navigation (air).
Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) is amended by removing Standard Instrument Approach Procedures and/or Takeoff Minimums and Obstacle Departure Procedures effective at 0901 UTC on the dates specified, as follows:
49 U.S.C. 106(f), 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, and 44721-44722.
Bureau of Industry and Security, Commerce.
Final rule.
This rule amends a license exception to allow cargo aboard aircraft to transit Cuba when that cargo is bound for destinations other than Cuba. This rule also authorizes export and reexport of certain items sold directly to individuals in Cuba under a license exception. Finally, this rule revises the lists of ineligible Cuban officials for purposes of certain license exceptions. BIS is publishing this rule to further implement the administration's policy of increasing engagement and commerce that benefits the Cuban people.
Effective: October 17, 2016.
Foreign Policy Division, Bureau of Industry and Security, Phone: (202) 482-4252.
On December 17, 2014, the President announced a new approach in U.S. policy toward Cuba. This approach recognized that increased engagement and commerce benefits the American and Cuban people, and sought to make the lives of ordinary Cubans easier and more prosperous. In furtherance of that policy, and in coordination with the Department of the Treasury's Office of Foreign Assets Control (OFAC), the Bureau of Industry and Security published five rules amending the Export Administration Regulation (EAR) between January 16, 2015, and March 16, 2016 (
Today, BIS is taking this action in coordination with OFAC, which is amending the Cuban Assets Control Regulations (CACR) (31 CFR part 515).
This rule continues the President's policy of increasing engagement and commerce between the United States and Cuba by making cargo transiting Cuba via aircraft on temporary sojourn eligible for License Exception Aircraft, Vessels and Spacecraft (AVS) (§ 740.15 of the EAR), placing it on par with such cargo aboard vessels on temporary sojourn to Cuba. This rule also makes a non-substantive clarifying edit in describing the limits that apply to the transiting cargo. Previously, one of those limits read: “The cargo . . . does not enter the Cuban economy. . . .” This rule revises that limit to read: “The cargo . . . is not removed from the aircraft or vessel for use in Cuba. . . .” BIS believes that the latter more clearly expresses the underlying concept,
In furtherance of the President's policy to support the Cuban people, this rule also makes exports or reexports of eligible items sold directly to eligible individuals in Cuba for their personal use or their immediate family's personal use eligible for License Exception SCP. To be eligible, the items must be designated as EAR99 or controlled on the Commerce Control List (CCL) (Supplement No. 1 to Part 774 of the EAR) only for anti-terrorism reasons. Additionally, the purchasers and end users must not be members of the Council of Ministers, flag officers of the Revolutionary Armed Forces, or members of the Politburo. This amendment to License Exception SCP facilitates direct sales to individuals in Cuba by online retailers and others that sell eligible consumer products directly to end users. This new provision of License Exception SCP complements existing authorizations in the EAR. License Exception SCP already authorizes the export or reexport to Cuba of certain items for use by the Cuban private sector. There is an existing case-by-case licensing policy for the export or reexport to Cuba of items that would meet the needs of the Cuban people, including items for wholesale and retail distribution for domestic consumption by the Cuban people. Additionally, certain donations to the Cuban people have been authorized pursuant to License Exceptions Gift Parcels and Humanitarian Donations (GFT) (§ 740.12 of the EAR), Consumer Communications
Finally, this rule revises the lists of Cuban government and Cuban Communist Party officials that are ineligible for provisions of three license exceptions: individual gift parcels (GFT, § 740.12(a) of the EAR), consumer communications devices (CCD, § 740.19 of the EAR), and software and commodities that will be used by the private sector or by individuals to improve the free flow of communications or support certain private sector activities in Cuba (SCP, § 740.21(d)(4) of the EAR). Under this rule, ineligible recipients are limited to members of the Council of Ministers, flag officers of the Revolutionary Armed Forces, and members of the Politburo. BIS is revising these lists to correspond to amendments that OFAC is making to its definitions of prohibited officials of the Government of Cuba and prohibited members of the Cuban Communist Party in §§ 515.337 and 515.338 of the CACR, respectively.
Although the Export Administration Act expired on August 20, 2001, the President, through Executive Order 13222 of August 17, 2001, 3 CFR, 2001 Comp., p. 783 (2002), as amended by Executive Order 13637 of March 8, 2013, 78 FR 16129 (March 13, 2013), and as extended by the Notice of August 4, 2016, 81 FR 52587 (August 8, 2016), has continued the Export Administration Regulations in effect under the International Emergency Economic Powers Act. BIS continues to carry out the provisions of the Export Administration Act, as appropriate and to the extent permitted by law, pursuant to Executive Order 13222 as amended by Executive Order 13637.
1. Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been designated a “significant regulatory action,” although not economically significant, under section 3(f) of Executive Order 12866. Accordingly, the rule has been reviewed by the Office of Management and Budget (OMB).
2. Notwithstanding any other provision of law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden, to Jasmeet K. Seehra, Office of Management and Budget, by email at
3. This rule does not contain policies with Federalism implications as that term is defined under Executive Order 13132.
4. The provisions of the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking and the opportunity for public participation, and a delay in effective date, are inapplicable because this regulation involves a military or foreign affairs function of the United States (
Administrative practice and procedure, Exports, Reporting and recordkeeping requirements.
Exports, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, 15 CFR Chapter VII, Subchapter C is amended as follows:
50 U.S.C. 4601
(a) * * *
(2) * * *
(v) * * *
(A) No gift parcel may be sent to any member of the Council of Ministers or flag officer of the Revolutionary Armed Forces.
(B) No gift parcel may be sent to any member of the Politburo.
This License Exception authorizes departure from the United States of foreign registry civil aircraft on temporary sojourn in the United States and of U.S. civil aircraft for temporary sojourn abroad; the export of equipment and spare parts for permanent use on a vessel or aircraft; exports to vessels or planes of U.S. or Canadian registry and U.S. or Canadian Airlines' installations or agents; the export or reexport of cargo that will transit Cuba on an aircraft or vessel on temporary sojourn; and the export of spacecraft and components for fundamental research. Generally, no License Exception symbol is necessary
(d) * * *
(6)
(i) Cargo vessels for hire for use in the transportation of items;
(ii) Passenger vessels for hire for use in the transportation of passengers and/or items; and
(iii) Recreational vessels that are used in connection with travel authorized by the Department of the Treasury, Office of Foreign Assets Control (OFAC).
Readers should also consult U.S. Coast Guard regulations at 33 CFR part 107 Subpart B—Unauthorized Entry into Cuban Territorial Waters.
(e)
(1) The aircraft or vessel is exported or reexported on temporary sojourn to Cuba pursuant to paragraph (a) or (d) of this section or a license from BIS; and
(2) The cargo departs with the aircraft or vessel at the end of its temporary sojourn to Cuba, is not removed from the aircraft or vessel for use in Cuba and is not transferred to another aircraft or vessel while in Cuba.
(c) * * *
(2) * * *
(i)
(ii)
The addition and revisions read as follows:
(b) * * *
(4) Items sold directly to individuals in Cuba for their personal use or their immediate family's personal use, other than officials identified in paragraphs (d)(4)(ii) or (iii) of this section.
(d) * * *
(4) * * *
(ii) Members of the Council of Ministers and flag officers of the Revolutionary Armed Forces; and
(iii) Members of the Politburo.
50 U.S.C. 4601
(a) * * *
(1) * * *
(x) Aircraft, vessels and spacecraft (AVS) for certain aircraft on temporary sojourn; equipment and spare parts for permanent use on a vessel or aircraft, and ship and plane stores; vessels on temporary sojourn; or cargo transiting Cuba on aircraft or vessels on temporary sojourn (
Social Security Administration.
Final rules.
These rules finalize the rules we proposed in our notice of proposed rulemaking (NPRM), published on May 11, 2016. In these rules, we remove some of the requirements for evaluation of an unsuccessful work attempt (UWA) that lasts between 3 and 6 months, allow previously entitled beneficiaries to apply for expedited reinstatement (EXR) in the same month they stop performing substantial gainful activity (SGA), and provide that provisional benefits will begin the month after the request for EXR if the beneficiary stops performing SGA in the month of the EXR request. These changes will simplify our policies and make them easier for the public to understand.
These final rules will be effective November 16, 2016, except for the amendments to §§ 404.1592c and 416.999a, which will be effective April 17, 2017.
Kristine Erwin-Tribbitt, Office of Retirement and Disability Policy, Office of Research, Demonstration, and Employment Support, Social Security Administration, 6401 Security Boulevard, Robert Ball Building 3-A-26, Baltimore, MD 21235-6401, (410) 965-3353. For information on eligibility or filing for benefits, call our national toll-free number, 1-800-772-1213 or TTY 1-800-325-0778, or visit our Internet site, Social Security Online, at
On May 11, 2016, we published an NPRM in the
The final rules at 20 CFR 404.1574(c), 404.1575(d), 416.974(c), and 416.975(d) remove the additional conditions that we used when we evaluated a work attempt in employment or self-employment that lasted between 3 and 6 months and use the current 3-month standard for all work attempts that are 6 months or less. Under these rules, ordinarily, work you have done will not
You can find additional information and discussion regarding these changes in the preamble to our proposed rule.
We received eight timely submitted comments that addressed issues within the scope of our proposed rules. Below, we present the views we received and address all of the relevant and significant issues raised by the commenters. We carefully considered their concerns, but did not make any changes to our rules because of the comments.
Of these eight comments, six were from disability advocacy organizations, all of whom supported our proposed rules. The organizations expressed that the proposed changes will have a positive impact on beneficiaries by supporting their attempts to work and helping them understand and use the rules. They asserted that this, in turn, would provide greater assurance to beneficiaries who want to attempt a return to work and would result in increased program participation.
To be entitled to disability benefits, an individual must be unable to engage in any SGA by reason of any medically determinable physical or mental impairment that can be expected to result in death, or has lasted or can be expected to last for a continuous period of not less than 12 months.
Because we are required to terminate benefits, we established EXR in order to facilitate benefit reinstatement to individuals whose benefits terminated as a result of SGA. Previously entitled individuals may request EXR within 60 months of their prior termination of benefits if their medical condition no longer permits them to perform SGA. To qualify for EXR, a previously entitled individual must be unable to perform SGA due to an impairment that is the same as, or related to, an impairment that was the basis for the previous entitlement.
To be eligible for disability benefits, an individual must be unable to engage in any SGA by reason of any medically determinable physical or mental impairment which can be expected to result in death or which has lasted or can be expected to last for a continuous period of not less than 12 months.
Disability claimants and beneficiaries may attempt to return to work and engage in SGA following a break in the continuity of their work. For SGA determination purposes, we may disregard work in employment or self-employment if a claimant or beneficiary, after working for a period of 6 months or less, stops working or reduces the amount of work so that the earnings fall below the SGA level because of the original impairment or the removal of special conditions that were essential to the performance of his or her work, and if there was a significant break in the continuity of work before this work attempt.
We consulted with the Office of Management and Budget (OMB) and determined that these rules do not meet the criteria for a significant regulatory action under Executive Order 12866, as supplemented by Executive Order 13563. Therefore, OMB has not reviewed them.
We certify that these rules will not have a significant economic impact on a substantial number of small entities because they affect individuals only. Therefore, a regulatory flexibility analysis is not required under the Regulatory Flexibility Act, as amended.
These rules do not create any new or affect any existing collections and, therefore, do not require Office of Management and Budget approval under the Paperwork Reduction Act.
Administrative practice and procedure, Blind, Disability benefits, Reporting and recordkeeping requirements, Social security, Vocational rehabilitation.
Administrative practice and procedure, Medicaid, Reporting and recordkeeping requirements,
For the reasons set out in the preamble, we amend 20 CFR part 404 subpart P and 20 CFR part 416 subpart I as set forth below:
Secs. 202, 205(a)-(b) and (d)-(h), 216(i), 221(a), (i), and (j), 222(c), 223, 225, and 702(a)(5) of the Social Security Act (42 U.S.C. 402, 405(a)-(b) and (d)-(h), 416(i), 421(a), (i), and (j), 422(c), 423, 425, and 902(a)(5)); sec. 211(b), Pub. L. 104-193, 110 Stat. 2105, 2189; sec. 202, Pub. L. 108-203, 118 Stat. 509 (42 U.S.C. 902 note).
(c) * * *
(1)
(3)
(d) * * *
(1)
(3)
(a) * * *
(4) * * *
(i) You are not able or become unable to do substantial gainful activity because of your medical condition as determined under paragraph (c) of this section;
(c) * * *
(2) You are not able or become unable to do substantial gainful activity in the month you file your request for reinstatement; and
(a) * * *
(1) We will pay you provisional benefits, and reinstate your Medicare if you are not already entitled to Medicare, beginning with the month you file your request for reinstatement under § 404.1592c(a) if you do not perform substantial gainful activity in that month. We will pay you provisional benefits, and reinstate your Medicare if you are not already entitled to Medicare, beginning with the month after you file your request for reinstatement under § 404.1592c(a) if you perform substantial gainful activity in the month in which you file your request for reinstatement.
Secs. 221(m), 702(a)(5), 1611, 1614, 1619, 1631(a), (c), (d)(1), and (p), and 1633 of the Social Security Act (42 U.S.C. 421(m), 902(a)(5), 1382, 1382c, 1382h, 1383(a), (c), (d)(1), and (p), and 1383b; secs. 4(c) and 5, 6(c)-(e), 14(a), and 15, Pub. L. 98-460, 98 Stat. 1794, 1801, 1802, and 1808 (42 U.S.C. 421 note, 423 note, and 1382h note).
(c) * * *
(3)
(d) * * *
(1)
(3)
(a) * * *
(4) * * *
(i) You are not able or become unable to do substantial gainful activity because of your medical condition as determined under paragraph (c) of this section.
(c) * * *
(2) You are not able or become unable to do substantial gainful activity in the month you file your request for reinstatement; and
Food and Drug Administration, HHS.
Final order.
The Food and Drug Administration (FDA) is classifying the apical closure device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the apical closure device's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
This order is effective October 17, 2016. The classification was applicable on July 27, 2016.
Jennifer Piselli, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 66, Rm. 1561, Silver Spring, MD, 20993-0002, 240-402-6646,
In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval unless and until the device is classified or reclassified into class I or II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i), to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
Section 513(f)(2) of the FD&C Act, as amended by section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144), provides two procedures by which a person may request FDA to classify a device under the criteria set forth in section 513(a)(1). Under the first procedure, the person submits a premarket notification under section 510(k) of the FD&C Act for a device that has not previously been classified and, within 30 days of receiving an order classifying the device into class III under section 513(f)(1) of the FD&C Act, the person requests a classification under section 513(f)(2). Under the second procedure, rather than first submitting a premarket notification under section 510(k) of the FD&C Act and then a request for classification under the first procedure, the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence and requests a classification under section 513(f)(2) of the FD&C Act. If the person submits a request to classify the device under this second procedure, FDA may decline to undertake the classification request if FDA identifies a legally marketed device that could provide a reasonable basis for review of substantial equivalence with the device or if FDA determines that the device submitted is not of “low-moderate risk” or that general controls would be inadequate to control the risks and special controls to mitigate the risks cannot be developed.
In response to a request to classify a device under either procedure provided by section 513(f)(2) of the FD&C Act, FDA shall classify the device by written order within 120 days. This classification will be the initial classification of the device.
On June 25, 2015, Micro Interventional Devices, Inc. submitted a request for classification of the Permaseal Device under section 513(f)(2) of the FD&C Act.
In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1). FDA classifies devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the request, FDA determined that the device can be classified into class II with the establishment of special controls. FDA believes these special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device.
Therefore, on July 27, 2016, FDA issued an order to the requestor classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 870.4510.
Following the effective date of this final classification order, any firm submitting a premarket notification (510(k)) for an apical closure device will need to comply with the special controls named in this final administrative order.
The device is assigned the generic name apical closure device, and it is identified as a prescription device consisting of a delivery system and implant component that is used for soft tissue approximation of cardiac apical tissue during transcatheter valve replacement procedures.
FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1:
FDA believes that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of the safety and effectiveness.
Apical closure devices are not safe for use except under the supervision of a practitioner licensed by law to direct the use of the device. As such, the device is a prescription device and must satisfy prescription labeling requirements (see 21 CFR 801.109
Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k), if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this type of device, FDA has determined that premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device. Therefore, this device type is not exempt from premarket notification requirements. Persons who intend to market this type of device must submit to FDA a premarket notification, prior to marketing the device, which contains information about the apical closure device they intend to market.
The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
This final administrative order establishes special controls that refer to previously approved collections of information found in other FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120, and the collections of information in 21 CFR part 801, regarding labeling have been approved under OMB control number 0910-0485.
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 870 is amended as follows:
21 U.S.C. 351, 360, 360c, 360e, 360j, 360
(a)
(b)
(1) The patient contacting materials must be evaluated to be biocompatible.
(2) Performance data must validate the sterility of the patient-contacting components of the device.
(3) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the labeled shelf life.
(4) Non-clinical performance testing data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Consistent and reliable implant deployment;
(ii) Assessment of implant pull-out force; and
(iii) Sheath size compatibility with implant.
(5) In vivo evaluation of the device must demonstrate device performance, including device operation resulting in closure of the myocardial wound.
(6) Labeling must include the following:
(i) Detailed information explaining how the device operates;
(ii) Sheath size that device can accommodate;
(iii) Identification of the minimum myocardial wall thickness to ensure optimal device function; and
(iv) A shelf life.
Office of Foreign Assets Control, Treasury.
Final rule.
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is amending the Cuban Assets Control Regulations to further implement elements of the policy announced by the President on December 17, 2014, to engage and empower the Cuban people. Among other things, these amendments authorize certain transactions related to Cuban-origin pharmaceuticals and joint medical research; add, expand, and clarify authorizations relating to trade and commerce; authorize certain civil aviation safety-related services; further facilitate authorized travel to Cuba; and expand the authorizations for grants and humanitarian-related services designed to directly benefit the Cuban people. These amendments also implement certain technical and conforming changes. OFAC is making these amendments in support of the process of normalizing bilateral relations with Cuba.
The Department of the Treasury's Office of Foreign Assets Control: Assistant Director for Licensing, tel.: 202-622-2480, Assistant Director for Regulatory Affairs, tel.: 202-622-4855, Assistant Director for Sanctions Compliance & Evaluation, tel.: 202-622-2490; or the Department of the Treasury's Office of the Chief Counsel (Foreign Assets Control), Office of the General Counsel, tel.: 202-622-2410.
This document and additional information concerning OFAC are available from OFAC's Web site (
The Department of the Treasury issued the Cuban Assets Control Regulations, 31 CFR part 515 (the “Regulations”), on July 8, 1963, under the Trading With the Enemy Act (50 U.S.C. 4301-4341). OFAC has amended the Regulations on numerous occasions.
Most recently, on January 16, June 15, and September 21, 2015, and January 27 and March 16, 2016, OFAC amended the Regulations, in coordinated actions with the Department of Commerce, to implement certain policy measures announced by the President on December 17, 2014, to further engage and empower the Cuban people. Today, OFAC and the Department of Commerce are taking additional coordinated actions in support of the President's Cuba policy.
OFAC is making additional amendments to the Regulations with respect to health, trade and commerce, civil aviation safety, travel and related transactions, humanitarian-related activities, and certain other activities, as set forth below.
In addition, revised section 515.547 authorizes persons subject to U.S. jurisdiction who are engaging in such authorized activities to open, maintain, and close bank accounts at Cuban financial institutions as long as such accounts are used solely for the authorized activities. The statement of licensing policy previously contained in section 515.547 for the importation of Cuban-origin commodities for bona-fide research purposes in sample quantities remains in effect for items that would not be authorized by the new general license in section 515.547(b).
OFAC is also making a technical correction to section 515.533(a) to remove references to “agricultural items” so that only “agricultural commodities,” as defined in 15 CFR part 772, are subject to the limitations on payment and financing terms required by the Trade Sanctions Reform and Export Enhancement Act of 2000, 22 U.S.C. 7207(b)(1). OFAC is making a conforming edit with respect to section 515.584(f) and also expanding that authorization to apply to any banking institution.
Finally, OFAC is adding a note to section 515.533(a) to clarify that this paragraph authorizes the importation into the United States of items from a third country for exportation to Cuba pursuant to a license or other authorization by the Department of Commerce. OFAC is making additional technical and conforming changes to remove certain obsolete language and consolidate all of the conditions applicable to this general license in a single paragraph.
OFAC is making several changes to rules related to the importation of Cuban-origin merchandise as accompanied baggage and certain travel-related authorizations.
Because the amendment of the Regulations involves a foreign affairs function, the provisions of Executive Order 12866 and the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, opportunity for public participation, and delay in effective date are inapplicable. Because no notice of proposed rulemaking is required for this rule, the Regulatory Flexibility Act (5 U.S.C. 601-612) does not apply.
The collections of information related to the Regulations are contained in 31 CFR part 501 (the “Reporting, Procedures and Penalties Regulations”) and section 515.572 of this part. Pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), those collections of information have been approved by the Office of Management and Budget under control numbers 1505-0164, 1505-0167, and 1505-0168. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid control number.
Administrative practice and procedure, Banking, Banks, Blocking of assets, Credit, Cuba, Financial transactions, Foreign trade, Reporting and recordkeeping requirements, Sanctions, Services, Travel restrictions.
For the reasons set forth in the preamble, the Department of the Treasury's Office of Foreign Assets Control amends 31 CFR part 515 as set forth below:
22 U.S.C. 2370(a), 6001-6010, 7201-7211; 31 U.S.C. 321(b); 50 U.S.C. 4301-4341; Pub. L. 101-410, 104 Stat. 890 (28 U.S.C. 2461 note); Pub. L. 104-114, 110 Stat. 785 (22 U.S.C. 6021-6091); Pub. L. 105-277, 112 Stat. 2681; Pub. L. 111-8, 123 Stat. 524; Pub. L. 111-117, 123 Stat. 3034; E.O. 9193, 7 FR 5205, 3 CFR, 1938-1943 Comp., p. 1174; E.O. 9989, 13 FR 4891, 3 CFR, 1943-1948 Comp., p. 748; Proc. 3447, 27 FR 1085, 3 CFR, 1959-1963 Comp., p. 157; E.O. 12854, 58 FR 36587, 3 CFR, 1993 Comp., p. 614.
For purposes of this part, the term
For purposes of this part, the term
* * * The prohibition set forth in § 515.201(b)(1) also prohibits payment for air travel by a person subject to U.S. jurisdiction to Cuba on a third-country carrier unless the travel is pursuant to an OFAC general or specific license.
(a) * * *
(4) * * *
See § 515.533(a)(4) for payment and financing terms for exportations or reexportations authorized pursuant to § 515.533.
(a) All transactions ordinarily incident to the exportation of items from the United States, or the reexportation of items from a third country, to any person within Cuba are authorized, provided that:
(1) The exportation or reexportation is licensed or otherwise authorized by the Department of Commerce under the provisions of the Export Administration Act of 1979, as amended (50 U.S.C. 4601-4623) (see the Export Administration Regulations, 15 CFR parts 730 through 774);
(2) The transaction is not a transaction between a U.S.-owned or -controlled firm in a third country and Cuba for the exportation to Cuba of commodities produced in a country other than the United States or Cuba;
(3) The transaction is not financed from any blocked account; and
(4) In the case of agricultural commodities, as that term is defined in 15 CFR part 772, only the following payment and financing terms are used:
(i) Payment of cash in advance. For the purposes of this section, the term “payment of cash in advance” shall mean payment before the transfer of title to, and control of, the exported items to the Cuban purchaser; or
(ii) Financing by a banking institution located in a third country provided the banking institution is not a designated national, a U.S. citizen, a U.S. permanent resident alien, or an entity organized under the laws of the United States or any jurisdiction within the United States (including any foreign branch of such an entity). Such financing may be confirmed or advised by a U.S. banking institution.
The transactions authorized by this paragraph include all transactions that are directly incident to the shipping of specific exports or reexports (
The limitation in paragraph (a)(4) applies only to payment and financing terms for exports or reexports of agricultural commodities and is required by the Trade Sanctions Reform and Export Enhancement Act of 2000, 22 U.S.C. 7207(b)(1). For other authorized exports and reexports, paragraph (a) does not restrict payment and financing terms. See § 515.584 for an authorization for banking institutions to provide financing for authorized exports and reexports of items other than agricultural commodities.
Transactions ordinarily incident to exportation from the United States authorized by this paragraph include the importation into the United States of items from a third country for exportation to Cuba pursuant to a license or other authorization by the Department of Commerce.
See § 515.534 for a general license authorizing certain contingent contracts, including contingent contracts for the sale of items that may be exported from the United States to Cuba or reexported from a third country to Cuba consistent with the export licensing policy of the Department of Commerce, where performance of such contingent contracts is expressly made contingent on prior authorization by the Department of Commerce.
(b)
(i) The items previously were exported or reexported to Cuba pursuant to paragraph (a) of this section or § 515.559; and
(ii) The items are being imported into the United States or a third country either:
(A) In order to service or repair the items before they are exported or reexported back to Cuba, or
(B) To return them to the United States or a third country.
This paragraph does not authorize the exportation or reexportation of any item to Cuba. The exportation or reexportation of serviced, repaired, or replacement items to Cuba must be separately authorized pursuant to paragraph (a) of this section or § 515.559, in addition to any Department of Commerce authorization that may be required.
(c)
(2) The travel-related transactions set forth in § 515.560(c) and such additional transactions as are directly incident to the facilitation of the temporary sojourn of aircraft and vessels as authorized by 15 CFR 740.15 (License Exception Aircraft, Vessels and Spacecraft) or pursuant to other authorization by the Department of Commerce for authorized travel between the United States and Cuba, including travel-related transactions by persons subject to U.S. jurisdiction who are required for normal operation and service aboard a vessel or aircraft, as well as persons subject to U.S. jurisdiction who are required to provide services to a vessel in port or aircraft on the ground, are authorized, provided that:
(i) Such travel-related transactions are limited to the duration and scope of their duties in relation to the particular authorized temporary sojourn; and
(ii) The aircraft or vessel must be transporting individuals whose travel between the United States and Cuba is authorized pursuant to any section of this part other than paragraph (c)(2) of this section.
(d)
(a) Persons subject to the jurisdiction of the United States are authorized to enter into, and to engage in all transactions ordinarily incident to the negotiation of and entry into, contingent contracts for transactions that are prohibited by this part, provided that:
(1) The performance of any such contingent contract is made expressly contingent on the prior authorization of the Office of Foreign Assets Control pursuant to this part or authorization no longer being required; and
(2) The performance of any such contingent contract that is subject to licensing requirements of another Federal agency is expressly made contingent upon the prior authorization of that agency or the removal of those licensing requirements.
(b) For purposes of this section, the term “contingent contracts” includes executory contracts, executory pro forma invoices, agreements in principle, executory offers capable of acceptance such as bids or proposals in response to public tenders, binding memoranda of understanding, or any other similar agreement.
This section does not authorize transactions related to travel to, from, or within Cuba. See § 515.533(c) for a general license authorizing travel-related and other transactions incident to the negotiation of contracts for the exportation or reexportation of certain items to Cuba, and § 515.564(a)(2) for a general license authorizing travel-related and other transactions incident to attending or organizing professional meetings in Cuba, which include professional meetings relating to the negotiation of contingent contracts authorized by this section.
(a) The purchase outside the United States for importation into the United States of nickel-bearing materials presumptively subject to § 515.204 and the importation of such merchandise into the United States are authorized if there is presented to the collector of
For an authorization of travel-related transactions that are directly incident to the conduct of market research, commercial marketing, sales or contract negotiation, accompanied delivery, installation, leasing, servicing, or repair in Cuba of items consistent with the export or reexport policy of the Department of Commerce, see § 515.533(c). For an authorization of travel-related transactions that are directly incident to participation in professional meetings, including where such meetings relate to telecommunications services or other activities authorized by paragraphs (b) through (e) of this section, see § 515.564(a).
(a) Persons subject to U.S. jurisdiction are authorized to engage in all transactions incident to joint medical research projects with Cuban nationals.
The export or reexport to Cuba of goods (including software) or technology subject to the Export Administration Regulations (15 CFR parts 730 through 774) may require separate authorization from the Department of Commerce.
This paragraph does not authorize transactions related to travel to, from, or within Cuba, nor does it authorize transactions related to travel to, from, or within the United States by Cuban nationals. See § 515.564(a) for a general license authorizing travel-related and other transactions incident to professional research and professional meetings in Cuba. See § 515.571 for a general license authorizing transactions incident to travel to, from, and within the United States by certain Cuban nationals.
This paragraph also does not authorize persons subject to U.S. jurisdiction to establish a business or physical presence in Cuba, to hire Cuban nationals, or to engage in any transactions prohibited by § 515.208.
(b) Persons subject to U.S. jurisdiction are authorized to engage in all transactions incident to obtaining approval from the U.S. Food and Drug Administration (FDA) of Cuban-origin pharmaceuticals, including discovery and development, pre-clinical research, clinical research, regulatory review, regulatory approval and licensing, regulatory post-market activities, and the importation into the United States of Cuban-origin pharmaceuticals.
(c) Persons subject to U.S. jurisdiction are authorized to engage in all transactions incident to the marketing, sale, or other distribution in the United States of FDA-approved Cuban-origin pharmaceuticals, including the importation into the United States of Cuban-origin pharmaceuticals.
(d)(1)
(2)
(e)
(2) Specific licenses may be issued for transactions related to medical research or pharmaceutical products not authorized by paragraphs (a) through (c) of this section.
Transactions authorized by this section may require separate authorizations or approvals by the FDA or other Federal agencies.
(a) Unless a vessel is otherwise engaging or has otherwise engaged in transactions that would prohibit entry pursuant to § 515.207, § 515.207 shall not apply to a vessel that is:
(1) Engaging or has engaged in trade with Cuba authorized pursuant to this part;
The authorization in this paragraph includes, for example, trade with Cuba authorized pursuant to § 515.533, § 515.559, or § 515.582, or by specific license.
(2) Engaging or has engaged in trade with Cuba that is exempt from the prohibitions of this part (see § 515.206);
(3) Engaging or has engaged in the exportation or reexportation to Cuba from a third country of agricultural commodities, medicine, or medical devices that, were they subject to the Export Administration Regulations (15 CFR parts 730 through 774) (EAR), would be designated as EAR99;
(4) A foreign vessel that has entered a port or place in Cuba while carrying students, faculty, and staff that are authorized to travel to Cuba pursuant to § 515.565(a); or
(5) Carrying or has carried persons between the United States and Cuba or within Cuba pursuant to the authorization in § 515.572(a)(2) or, in the case of a vessel used solely for personal travel (and not transporting passengers), pursuant to a license or other authorization issued by the Department of Commerce for the exportation or reexportation of the vessel to Cuba.
(b) Unless a vessel is otherwise engaging or has otherwise engaged in transactions that would prohibit entry pursuant to § 515.207, § 515.207(a) shall not apply to a foreign vessel that has engaged in the exportation to Cuba from a third country only of items that, were they subject to the EAR, would be designated as EAR99 or would be controlled on the Commerce Control List only for anti-terrorism reasons.
(d)
(c) * * *
(3)
(6) * * *
(ii)
The export or reexport to Cuba of goods (including software) or technology subject to the Export Administration Regulations (15 CFR parts 730 through 774) may require separate authorization from the Department of Commerce.
(a) * * *
(2)
(i) For a traveler attending a professional meeting or conference, the purpose of the meeting or conference directly relates to the traveler's profession, professional background, or area of expertise, including area of graduate-level full-time study;
(ii) For a traveler organizing a professional meeting or conference on behalf of an entity, either the traveler's profession must be related to the organization of professional meetings or conferences or the traveler must be an employee or contractor of an entity that is organizing the professional meeting or conference; and
(iii) The traveler's schedule of activities does not include free time or recreation in excess of that consistent with a full-time schedule of attendance at, or organization of, professional meetings or conferences.
Transactions incident to the organization of professional meetings or conferences include marketing related to such meetings or conferences in Cuba.
(a) * * *
(11) The organization of, and preparation for, activities described in paragraphs (a)(1) through (a)(10) of this section by employees or contractors of the sponsoring organization that is a person subject to U.S. jurisdiction;
See § 515.590(a) for an authorization for the provision of educational grants, scholarships, or awards to a Cuban national or in which Cuba or a Cuban national otherwise has an interest.
The importation of merchandise subject to the prohibitions in § 515.204, including Cuban-origin goods, brought into the United States as accompanied baggage by any person arriving in the United States other than a citizen or resident of the United States is hereby authorized, provided that such goods are not in commercial quantities and are not imported for resale.
(i)
(a) * * *
(5)
For provisions related to transactions ordinarily incident to the exportation or reexportation of items to Cuba, see §§ 515.533 and 515.559.
(b) * * *
(1) Persons subject to U.S. jurisdiction providing services authorized pursuant to paragraphs (a)(1) through (a)(4) of this section must retain for at least five years from the date of the transaction a certification from each customer indicating the section of this part that authorizes the person to travel or send remittances to Cuba. In the case of a customer traveling under a specific license, the specific license number or a copy of the license must be maintained on file with the person subject to U.S. jurisdiction providing services authorized pursuant to this section.
(a) * * *
See § 515.590(b) for an authorization for the provision of grants, scholarships, or awards related to humanitarian projects in or related to Cuba that are designed to directly benefit the Cuban people as set forth in paragraph (b).
(a) * * *
The export or reexport to Cuba of items subject to the
Persons subject to U.S. jurisdiction are authorized to sponsor, organize, or provide services in connection with, as well as participate in, conferences or other similar events in a third country that are attended by Cuban nationals.
The export or reexport to Cuba of technology subject to the Export Administration Regulations (15 CFR parts 730 through 774) may require separate authorization from the Department of Commerce.
(c)
(f) Any banking institution, as defined in § 515.314, that is a person subject to U.S. jurisdiction is authorized to provide financing for exports or reexports of items, other than agricultural commodities, authorized pursuant to § 515.533, including issuing, advising, negotiating, paying, or confirming letters of credit (including letters of credit issued by a financial institution that is a national of Cuba), accepting collateral for issuing or confirming letters of credit, and processing documentary collections.
(c) Individuals who are persons subject to U.S. jurisdiction who are present in a third country are authorized to purchase or acquire merchandise subject to the prohibitions in § 515.204, including Cuban-origin goods, and to receive or obtain services in which Cuba or a Cuban national has an interest that are ordinarily incident to travel and maintenance within that country.
(d) Individuals who are persons subject to U.S. jurisdiction are authorized to import into the United States as accompanied baggage merchandise subject to the prohibitions in § 515.204, including Cuban-origin goods, that is purchased or acquired in a third country, provided that the merchandise is imported for personal use only.
Except as provided in paragraphs (c) and (d) of this section, this section does not authorize any transactions prohibited by § 515.204.
The export or reexport to Cuba of goods (including software) or technology subject to the Export Administration Regulations (15 CFR parts 730 through 774) may require separate authorization from the Department of Commerce.
The provision of grants, scholarships, or awards relating to the following activities to a Cuban national or in which Cuba or a Cuban national otherwise has an interest is authorized:
(a) Educational activities;
(b) Humanitarian projects, as set forth in § 515.575(b);
(c) Scientific research; and
(d) Religious activities.
Persons subject to the jurisdiction of the United States are authorized to provide to Cuba or Cuban nationals services related to developing, repairing, maintaining, and enhancing Cuban infrastructure that directly benefit the Cuban people, provided that those services are consistent with the export or reexport licensing policy of the Department of Commerce. For the purposes of this section, infrastructure means systems and assets used to provide the Cuban people with goods and services produced or provided by the public transportation, water management, waste management, non-nuclear electricity generation, and electricity distribution sectors, as well as hospitals, public housing, and primary and secondary schools. This authorization includes projects related to the environmental protection of U.S., Cuban, and international air quality, waters, and coastlines.
For provisions related to transactions ordinarily incident to the exportation or reexportation of items to Cuba, see §§ 515.533 and 515.559. See § 746.2(b) of the Export Administration Regulations (15 CFR parts 730 through 774) for the Department of Commerce's Cuba licensing policy.
See § 515.564 for a general license authorizing travel-related and other transactions incident to professional research and professional meetings in Cuba, § 515.533(c) for a general license authorizing travel-related and other transactions relating to certain exports and reexports to Cuba, and § 515.575(a) for a general license authorizing transactions, including travel-related transactions, related to certain humanitarian projects.
Office of the Secretary of Defense, DoD.
Final rule.
The Office of the Secretary of Defense is exempting records maintained in DUSDI 01-DoD, “Department of Defense (DoD) Insider Threat Management and Analysis Center (DITMAC) and DoD Component Insider Threat Records System,” from subsections (c)(3) and (4); (d)(1), (2), (3), and (4); (e)(1), (2), (3), (4)(G), (H), and (I), (5), and (8); and (g) of the Privacy Act.
In addition, in the course of carrying out collections and analysis of information in connection with the operations of the DITMAC and DoD Component insider threat programs, exempt records received from other systems of records may become part of this system. To the extent that copies of exempt records from those other systems of records are maintained in this system, the Department also claims the same exemptions for the records from those other systems that are maintained in this system, as claimed
Cindy Allard, Chief, of the Defense Privacy, Civil Liberties, and Transparency Division, 703-571-0070.
The DITMAC was established by the Under Secretary of Defense for Intelligence in order to consolidate and analyze insider threat information reported by the DoD Component insider threat programs mandated by Presidential Executive Order 13587, issued October 7, 2011, which required Federal agencies to establish an insider threat detection and prevention program to ensure the security of classified networks and the responsible sharing and safeguarding of classified information consistent with appropriate protections for privacy and civil liberties. For purposes of this system of records, the term “insider threat” is defined in the Minimum Standards for Executive Branch Insider Threat Task Force based on direction provided in Section 6.3(b) of Executive Order 13587. The DITMAC helps prevent, deter, detect, and/or mitigate the potential threat that personnel, including DoD military personnel, civilian employees, and contractor personnel, who have or had been granted eligibility for access to classified information or eligibility to hold a sensitive position may harm the security of the United States. This threat can include damage to the United States through espionage, terrorism, unauthorized disclosure of national security information, or through the loss or degradation of departmental resources or capabilities.
The system of records will be used to analyze, monitor, and audit insider threat information for insider threat detection and mitigation within DoD on threats that persons who have or had been granted eligibility for access to classified information or eligibility to hold sensitive positions may pose to DoD and U.S. Government installations, facilities, personnel, missions, or resources. The system of records will support the DITMAC and DoD Component insider threat programs, enable the identification of systemic insider threat issues and challenges, and provide a basis for the development and recommendation of solutions to deter, detect, and/or mitigate potential insider threats. It will assist in identifying best practices among other Federal Government insider threat programs, through the use of existing DoD resources and functions and by leveraging existing authorities, policies, programs, systems, and architectures.
The Department of Defense published a proposed Privacy Act exemption rule for its Insider Threat Management and Analysis Center (DITMAC) and DoD Component Insider Threat Records Systems (hereafter Insider Threat) on May 19, 2016 (81 FR 31561). The Department of Defense received comments from seven submitters related to a proposed Federal Rulemaking (docket: DOD-2016-OS-0059, published May 19, 2016) relating to a Privacy Act exemption rule for the Department of Defense (DoD) Insider Threat Management and Analysis Center (DITMAC) and DoD Component Insider Threat Records System (hereafter Insider Threat). In addressing comments submitted to this proposed Privacy Act exemption rule, the Department notes that such rules do not mandate exemptions in every instance, and are not intended to apply to all records, but must be reviewed in each specific case.
Two commenters were opposed to the proposed exemption rule but did not provide specific concerns; an additional commenter provided a number of proposals for the Insider Threat program at large, as well as one addressing an access concern which is addressed in the access discussion.
The largest number of comments related to the proposed exemption from the access provisions of the Privacy Act (5 U.S.C. 552a(d)(1), (2), (3), and (4)). The Department notes that the specific exemptions upon which the access limitation is based are generally predicated on “the identity of a source who furnished information to the Government under an express promise that the identity of the source would be held in confidence” found in 5 U.S.C. 552a(k)(2), (5), and (7). One of these commenters raised concerns that the “largest and most common sources providing information to the DITMAC provide such information under a general promise of confidentiality.” It is not clear to the Department which sources the commenter believes are providing information under a general promise of confidentiality, but the language used in exemptions (k)(2), (5), and (7) requires an “express promise” (if promised after the Act took effect). This is normally done on a case-by-case basis. One commenter noted that “it is important to allow people as much access as possible to the data being collected about them, so that they can make informed decisions about what to do in the event of a data loss.” In response, the Department anticipates providing access rights, except in those specific cases where an exemption rule would appropriately apply. In view of the earlier discussion in this paragraph, DoD anticipates exercising access exemption rules as the exception rather than the norm.
Another commenter was also particularly concerned that “it would become entirely possible that qualified Soldiers might unknowingly become flagged as non-promotable for being a possible insider threat.” We note first that when exercising the (k)(7) exemption, the Department uses reasonable segregability to provide the maximum amount of the record to the subject while honoring the express promise of confidentiality to the source. Moreover, the Department notes that the Insider Threat system of records is not a source of information for the promotion selection process.
Several comments also addressed the proposed exemption from the amendment provisions of the Privacy Act. The Insider Threat Hubs will aggregate information from a number of sources, the first of which is the subject of the record. Since the subjects of Insider Threat records are cleared personnel, the most appropriate place for them to address a factual error is with the appropriate DoD source (
One commenter noted that the collections and proposed exemptions asserted by the Department of Defense were overly extensive and would diminish accountability:
DoD claims the authority to collect any information it wants without disclosing where it came from or even acknowledging its existence. The net result of these exemptions, coupled with DoD's proposal to collect and retain virtually unlimited information unrelated to any purpose Congress delegated to the agency, would be to diminish the legal accountability of the agency's information collection activities.
In response, disclosure could interfere with or reveal information relating to actual or potential criminal, civil, or administrative investigations or actions. DoD further notes that it identified the varied sources of Insider Threat information in the System of Records Notice and has asserted exemptions to protect from disclosure sources
The commenter claims that DoD “contemplates collecting information that will not be relevant or necessary to a specific investigation” and that “the inability to determine, in advance, whether information is accurate, relevant, timely, and complete precludes its agents from complying with the obligation to ensure that the information meets these criteria after it is stored.” In response, the Department notes that it is implementing an insider threat program required by Executive Order as well as by Public Law (
There were no comments related to the exemption of the access provisions through (k)(1), pertaining to classified information; (k)(4), applicable to records required by statute to be maintained and used solely as statistical records; or (k)(6), testing or examination material used solely to determine individual qualifications for appointment or promotion in the Federal service the disclosure of which would compromise the objectivity or fairness of the testing or examination process. The Department also asserted an access exemption under (j)(2), which addresses law enforcement activities, which did not receive comment.
DoD made no changes to the regulatory text of the rule based on public comments received.
It has been determined that this rule is not a significant rule. This rule does not (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 otherwise interfere with an action taken or planned by another Agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs, or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in these Executive orders.
It has been certified that this rule does not have a significant economic impact on a substantial number of small entities because it is concerned only with the administration of Privacy Act systems of records within DoD. A Regulatory Flexibility Analysis is not required.
It has been determined that this rule does not impose additional information collection requirements on the public under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
It has been determined that this rule does not involve a Federal mandate that may result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $100 million or more and that it will not significantly or uniquely affect small governments.
It has been determined that this rule does not have federalism implications. This rule does not have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government.
Privacy.
Accordingly, 32 CFR part 310 is amended as follows:
5 U.S.C. 552a.
(a) Use of
(b)
(2) Ensure promises of confidentiality are not automatically given but are used sparingly. Establish appropriate procedures and identify fully categories of individuals who may make such promises. Promises of confidentiality shall be made only when they are essential to obtain the information sought (see 5 CFR part 736).
(c)
(d)
(1)
Exemption: This system of records is exempted from subsections (c)(3) and (4); (d)(1), (2), (3) and (4); (e)(1), (2), (3), (4)(G)(H) and (I), (5) and (8); and (g) of the Privacy Act pursuant to 5 U.S.C. 552a(j)(2) and (k)(1), (2), (4), (5), (6), and (7).
(2) Records are only exempt from pertinent provisions of 5 U.S.C. 552a to
(3) Exemption from the particular subsections is justified for the following reasons:
(i)
(ii)
(iii)
(iv)
(v)
(vi)
(vii)
(viii)
(ix)
(x)
(xi)
(xii)
(4) In addition, in the course of carrying out analysis for insider threats, exempt records from other systems of records may in turn become part of the case records maintained in this system. To the extent that copies of exempt records from those other systems of records are maintained into this system, the DoD claims the same exemptions for the records from those other systems that are entered into this system, as claimed for the original primary system of which they are a part.
Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce various safety zones within the Captain of the Port New York Zone on the specified date and time. This action is necessary to ensure the safety of vessels and spectators from hazards associated with fireworks displays. During the enforcement period, no person or vessel may enter the safety zone without permission of the Captain of the Port (COTP).
The regulation for the safety zones described in 33 CFR 165.160 will be enforced on the date and time listed in the table below.
If you have questions on this notice, call or email Petty Officer First Class Ronald Sampert U.S. Coast Guard; telephone 718-354-4154, email
The Coast Guard will enforce the safety zones listed in 33 CFR 165.160 on the specified dates and times as indicated in Table 1 below. This regulation was published in the
Under the provisions of 33 CFR 165.160, vessels may not enter the safety zones unless given permission from the COTP or a designated representative. Spectator vessels may transit outside the safety zones but may not anchor, block, loiter in, or impede the transit of other vessels. The Coast Guard may be assisted by other Federal, State, or local law enforcement agencies in enforcing this regulation.
This notice is issued under authority of 33 CFR 165.160(a) and 5 U.S.C. 552 (a). In addition to this notice in the
If the COTP determines that a safety zone need not be enforced for the full duration stated in this notice, a Broadcast Notice to Mariners may be used to grant general permission to enter the safety zone.
Department of Veterans Affairs.
Interim final rule.
The Department of Veterans Affairs (VA) is issuing this interim final rule to amend its adjudication regulations regarding compensation for disabilities resulting from undiagnosed illnesses suffered by veterans who served in the Persian Gulf War. This amendment is necessary to extend the presumptive period for qualifying chronic disabilities resulting from undiagnosed illnesses that must become manifest to a compensable degree in order that entitlement for compensation be established. The intended effect of this amendment is to provide consistency in VA adjudication policy and preserve certain rights afforded to Persian Gulf War veterans and ensure fairness for current and future Persian Gulf War veterans.
Written comments may be submitted through
Stephanie Li, Chief, Regulations Staff (211D), Compensation Service, Veterans Benefits Administration, 810 Vermont Avenue NW., Washington, DC 20420, (202) 461-9700. (This is not a toll-free telephone number.)
In response to the needs and concerns of veterans who served in the Southwest Asia theater of operations during the Persian Gulf War, Congress enacted the Persian Gulf War Veterans' Benefits Act, Title I of the Veterans' Benefits Improvement Act of 1994, Public Law 103-446, which was codified in relevant part at 38 U.S.C. 1117. This law provided authority for the Secretary of Veterans Affairs (Secretary) to compensate eligible Gulf War veterans with a chronic disability resulting from undiagnosed illness. That illness must have become manifest either during active duty service in the Southwest Asia theater of operations during the Persian Gulf War, or disabling to a degree of ten percent or more during a period determined by the Secretary and prescribed by regulation. The Secretary would determine this period after reviewing any credible medical or scientific evidence, the historical treatment afforded disabilities for which VA had established such periods, and other pertinent circumstances regarding the experiences of veterans of the Persian Gulf War.
To implement 38 U.S.C. 1117, VA published a final rule to add 38 CFR 3.317, which established the framework for VA to pay compensation under the Persian Gulf War Veterans' Benefits Act. See 60 FR 6660-6666, Feb. 3, 1995. As part of that rulemaking, VA established a period of two years after Gulf War service in which VA would presume a medical relationship of an undiagnosed illness to that service. VA determined that there was little or no scientific or medical evidence at that time useful in determining an appropriate presumptive period for undiagnosed illnesses. Therefore, VA primarily based this two-year period on its history of establishing presumptive periods as well as the available facts regarding service in the Southwest Asia theater of operations during the Gulf War.
The lack of medical and scientific evidence about the nature and cause of the illnesses suffered by Gulf War veterans continued, as did the uncertainty of an appropriate presumptive period for undiagnosed illnesses. Accordingly, VA established December 31, 2001, as the date by which an undiagnosed illness must become manifest. See 62 FR 23138, Apr. 29, 1997. In 2001, VA again extended the period to December 31, 2006. See 66 FR 56614, Nov. 9, 2001.
In December 2001, section 202(a) of Public Law 107-103 amended 38 U.S.C. 1117 by revising the term “chronic disability” to include the following (or any combination thereof): (a) An undiagnosed illness; (b) a medically unexplained chronic multisymptom illness (such as chronic fatigue syndrome, fibromyalgia, and irritable bowel syndrome) that is defined by a cluster of signs and symptoms; or (c) any diagnosed illness that the Secretary determines warrants a presumption of service connection. The term “qualifying chronic disability” broadened the scope of those illnesses the Secretary may presume related to service. Under 38 U.S.C. 1117, a chronic disability must still occur during service in the Southwest Asia theater of operations during the Persian Gulf War, or to a degree of ten percent or more disabling during the prescribed presumptive period following such service. VA amended § 3.317 to reflect these changes. See 68 FR 34539, June 10, 2003.
As required by Public Law 105-368, the National Academy of Sciences (NAS) reviews, evaluates, and summarizes the scientific and medical literature for possible association between service in the Southwest Asia theater of operations and long-term adverse health effects. Following review of such NAS reports, VA determined that the evidence remained inconclusive
In a report published in 2010 titled
The scientific and medical literature surveyed by NAS in 2010 thus suggested that, while the prevalence of chronic multisymptom illness may decrease over time following deployment to the Gulf War, the prevalence remained significantly elevated among deployed veterans more than a decade after deployment. As military operations in the Southwest Asia theater of operations had not ended and scientific and medical evidence failed to identify the manifestation period for associated illnesses, VA again published a rule amending 38 CFR 3.317(b) to extend the presumptive period from December 31, 2011, to December 31, 2016. See 76 FR 81834, Dec. 29, 2011.
In a report published earlier this year, NAS continued to conclude that there is sufficient evidence of association between Gulf War deployment and the constellation of chronic symptoms known as Gulf War illness.
Currently, military operations in the Southwest Asia theater of operations continue. No end date for the Gulf War has been established by Congress or the President. See 38 U.S.C. 101(33). Because scientific uncertainty remains as to the cause and time of onset of illnesses suffered by Persian Gulf War veterans and current IOM research studies are incomplete, limiting entitlement to benefits payable under 38 U.S.C. 1117 due to the expiration of the presumptive period in 38 CFR 3.317(a)(1)(i) is premature. If extension of the current presumptive period is not implemented, servicemembers whose conditions manifest after December 31, 2016, would be substantially disadvantaged compared to servicemembers whose conditions manifested at an earlier date.
Therefore, VA is extending the presumptive period in 38 CFR 3.317(a)(1)(i) for qualifying chronic disabilities that become manifest to a degree of 10 percent or more through December 31, 2021 (a period of 5 years), to ensure those benefits established by Congress are fairly administered.
The Secretary of Veterans Affairs finds that there is good cause under the provisions of 5 U.S.C. 553(b)(B) and (d)(3) to publish this rule without prior opportunity for public comment and good cause to publish this rule with an immediate effective date. Absent extension of the sunset date in the current regulation, VA's authority to provide benefits in new claims for qualifying chronic disability in Gulf War veterans will lapse on December 31, 2016. A lapse of such authority would be contrary to the public interest because it would have a significant adverse impact on veterans with such disabilities. To avoid such impact, VA is issuing this rule as an interim final rule, effective upon date of publication. However, VA invites public comments on this interim final rule and will fully consider and address any comments received.
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
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 hereby certifies that this interim 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 interim final rule will directly affect only individuals and will not directly affect small entities. Therefore, pursuant to 5 U.S.C. 605(b), this rulemaking is exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604.
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 the 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 interim final rule will have no such effect on State, local, and tribal governments, or on the private sector.
This interim final rule contains no provisions constituting a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).
The Catalog of Federal Domestic Assistance program numbers and titles for this rule are: 64.104, Pension for Non-Service-Connected Disability for Veterans; 64.109, Veterans Compensation for Service-Connected Disability.
The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Gina S. Farrisee, Deputy Chief of Staff, Department of Veterans Affairs, approved this document on October 7, 2016, for publication.
Administrative practice and procedure, Disability benefits, Pensions, Veterans.
For the reasons set out in the preamble, VA amends 38 CFR part 3 as follows:
38 U.S.C. 501(a), unless otherwise noted.
(a) * * *
(1) * * *
(i) Became manifest either during active military, naval, or air service in the Southwest Asia theater of operations, or to a degree of 10 percent or more not later than December 31, 2021; and
In rule document 2016-23198 beginning on page 67736 in the issue of September 30, 2016, make the following correction:
Board of Contract Appeals, Office of the Secretary (OST), U.S. Department of Transportation (DOT).
Final rule.
The Department of Transportation is revising its regulations by removing chapter 63 of Title 48 of the Code of Federal Regulations (CFR) and amending 49 CFR part 6. These revisions result from our ongoing efforts to review and improve our regulations, and will harmonize the CFR with Departmental restructuring required by statutory changes.
This final rule is effective on October 17, 2016.
Jill Laptosky, Attorney, Office of
On December 9, 1999, the President signed the Motor Carrier Safety Improvement Act of 1999, Public Law 106-159, 113 Stat. 1748, removing regulatory authority over motor carriers from the Federal Highway Administration and vesting that authority in the newly created Federal Motor Carrier Safety Administration (FMCSA). Then, on November 25, 2002, the President signed the Homeland Security Act of 2002, Public Law 107-296, 116 Stat. 2135. In addition to creating the Department of Homeland Security (DHS), the Homeland Security Act reorganized certain agencies of the Federal executive branch; in particular, the Homeland Security Act transferred the United States Coast Guard (USCG) from DOT to the newly created DHS.
On January 6, 2006, the President signed the National Defense Authorization Act for FY 2006, Public Law 109-163 (the Act), establishing the Civilian Board of Contract Appeals (CBCA). Section 847 of the Act vests the CBCA with jurisdiction over claims that previously would have been filed before the boards of contract appeals of individual agencies. In light of this change, references to the now-defunct Department of Transportation Board of Contract Appeals are being removed from our regulations.
Prior to the modifications announced in this final rule, 49 CFR 6.5, concerning the applicability of the Equal Access to Justice Act in DOT proceedings, referred to the “agency board of contract appeals.” This regulatory language is being revised to reflect the statutory changes discussed above, as well as the updated DOT organizational structure.
DOT is publishing this final rule without notice and comment under the “good cause” exemption of the Administrative Procedure Act (5 U.S.C. 553). The good cause exemption allows agencies to dispense with notice and comment if those procedures are impracticable, unnecessary, or contrary to the public interest. We have determined that, given the obsolete nature of the regulations affected by this final rule, notice and comment are unnecessary. For these same reasons, we have determined that good cause exists for the final rule to become effective immediately.
Executive Orders 12866 and 13563 direct agencies to assess all the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). This final rule is not a significant regulatory action as defined by Executive Order 12866 and, therefore, is not subject to review by the Office of Information and Regulatory Affairs. As this rule removes and updates obsolete regulatory provisions, we expect there to be no costs related to the changes made in this rule.
This final rule will not have a substantial effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among various levels of government, within the meaning of Executive Order 13132.
This final rule will not result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $156 million or more in any one (1) year, and it will not significantly or uniquely affect small governments. Therefore, no actions are deemed necessary under the provisions of the Unfunded Reform Act of 1995.
Since notice and comment is not necessary for this rulemaking, the provisions of the Regulatory Flexibility Act (Pub. L. 96-354, 5 U.S.C. 601-612) do not apply.
This final rule does not contain information collection requirements subject to the Paperwork Reduction Act.
The agency has analyzed the environmental impacts of this proposed action pursuant to the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321
Administrative practice and procedure, Government procurement.
Claims, Equal access to justice, Lawyers.
For the reasons set forth in the preamble, in accordance with sec. 847 of Public Law 109-163, (119 Stat. 3391), OST amends 48 CFR by removing chapter 63 and, under the same authority, as well as the authority in sec. 1704 of Public Law 107-296 (116 Stat. 2314), OST amends 49 CFR part 6 as follows:
5 U.S.C. 504; 28 U.S.C. 2412.
(a) The Act applies to adversarial adjudications conducted by the
Issued under authority delegated in 49 CFR 1.27(c).
Fish and Wildlife Service, Interior.
Final rule.
We, the U.S. Fish and Wildlife Service (Service), determine threatened species status under the Endangered Species Act of 1973 (Act), as amended, for the Columbia River distinct population segment (DPS) of Columbian white-tailed deer (
This rule is effective November 16, 2016.
This final rule is available online at
Paul Henson, State Supervisor, telephone: 503-231-6179. Direct all questions or requests for additional information to: Columbian White-tailed Deer Information Request, U.S. Fish and Wildlife Service, Oregon Fish and Wildlife Office, 2600 SE. 98th Avenue, Portland, OR 97266. Individuals who are hearing impaired or speech impaired may call the Federal Relay Service at 800-877-8337 for TTY (telephone typewriter or teletypewriter) assistance 24 hours a day, 7 days a week.
This rule finalizes the reclassification of the Columbia River DPS of CWTD as a threatened species. It includes provisions under the authority of section 4(d) of the Act that are necessary and advisable for the conservation needs of the CWTD.
Under section 4(d) of the Act, the Secretary of the Interior has discretion to issue such regulations she deems necessary and advisable to provide for the conservation of the species. A 4(d) rule may include some or all of the prohibitions and authorizations set out in title 50 of the Code of Federal Regulations (CFR) at sections 17.31 and 17.32 (50 CFR 17.31 and 17.32), but also may be more or less restrictive than those general provisions. For the Columbia River DPS of CWTD, the Service has determined that a 4(d) rule is appropriate as a means to facilitate conservation of CWTD in the Columbia River DPS and expansion of the species' range by increasing flexibility in management activities for our State and Tribal partners and private landowners.
On March 11, 1967, the Secretary of the Interior identified the CWTD as an endangered species (32 FR 4001), under the authority of the Endangered Species Preservation Act of October 15, 1966 (80 Stat. 926; 16 U.S.C. 668aa(c)). On March 8, 1969, the Secretary of the Interior again identified the CWTD as an endangered species (34 FR 5034) under section 1(c) of the Endangered Species Preservation Act of 1966. On August 25, 1970, the Acting Secretary of the Interior proposed to list the CWTD as an endangered subspecies (35 FR 13519) under the authority of new regulations implementing the Endangered Species Conservation Act (ESCA) of 1969. On October 13, 1970, the Director of the Bureau of Sport Fisheries and Wildlife listed the CWTD as an endangered subspecies (35 FR 16047) under the authority of new regulations implementing the ESCA of 1969. Species listed as endangered under the ESCA of 1969 were automatically included in the List of Endangered and Threatened Wildlife when the Endangered Species Act (16 U.S.C. 1531
On October 21, 1976, the Service released the CWTD Recovery Plan. On June 14, 1983, the Service released the Revised Recovery Plan for CWTD. The revised plan addressed the two main populations of CWTD, Columbia River and Douglas County, separately. On July 24, 2003, the Service published a rule (68 FR 43647) that: (1) Recognized the Douglas County and Columbia River populations as DPSs under the Service's 1996 Policy Regarding the Recognition of Distinct Vertebrate Population Segments under the Act (see 61 FR 4722; February 7, 1996), and (2) removed the Douglas County population of CWTD from the List of Endangered and Threatened Wildlife. It was determined that recovery criteria for the Douglas County population had been met, as it achieved benchmarks in both population size and amount of secure habitat.
A 5-year status review of the Columbia River DPS was completed on November 5, 2013 (U.S. Fish and Wildlife Service 2013a). This review concluded that the CWTD's status had substantially improved since listing, that the DPS no longer met the definition of an endangered species under the Act, and recommended that the DPS be downlisted from endangered to threatened.
On October 8, 2015, we published a proposed rule (80 FR 60850) to downlist the Columbia River DPS of CWTD from endangered to threatened, with a 4(d) rule that is necessary and advisable to provide for the conservation of that DPS. We accepted public comments on the proposal for 60 days, ending December 7, 2015.
The CWTD is the westernmost representative of 38 subspecies of white-tailed deer in North and Central America (Gavin 1984, p. 6). It resembles other white-tailed deer subspecies, ranging in size from 39 to 45 kilograms (kg) (85 to 100 pounds (lb)) for females and 52 to 68 kg (115 to 150 lb) for males (Oregon Department of Fish and Wildlife 1995, p. 2). Although CWTD can live up to 20 years, their median lifespan ranges from 3 to 5 years for bucks and 5 to 9 years for does (Gavin 1984, p. 490; U.S. Fish and Wildlife Service, unpublished data). Breeding occurs from mid-September through late February, with a peak in November. Does reach sexual maturity by 6 months of age or when their weight reaches approximately 36 kg (80 lb); however, their maturation and fertility depends on the nutritional quality of available forage (Verme and Ullrey 1984, p. 96). Fawns are born in early summer after an approximately 200-day gestation period. In their first pregnancy, does usually give birth to a single fawn, although twins are common in later years if forage is abundant (Verme and Ullrey 1984, p. 96). On the JBHR Mainland Unit, Service biologists often observe fawns in pastures of tall, dense reed canary grass (
CWTD were formerly distributed throughout the bottomlands and prairie woodlands of the lower Columbia, Willamette, and Umpqua River basins in Oregon and southern Washington (Bailey 1936, p. 92; Verts and Carraway 1998, p. 479). The subspecies occupied a range of approximately 60,000 square kilometers (km
In the proposed rule that published on October 8, 2015 (80 FR 60850), we requested that all interested parties submit written comments on the proposal by December 7, 2015. We also contacted appropriate Federal and State agencies, scientific experts and organizations, and other interested parties and invited them to comment on the proposal. Newspaper notices inviting general public comments were published in the Oregonian, Columbian, Olympian, and Seattle Times newspapers. We did not receive any requests for a public hearing.
During the public comment period on the proposed rule, we received a total of 9 comment letters, including 3 from peer reviewers, addressing the proposed downlisting and proposed 4(d) rule. We received two duplicate comments in opposition to the proposed downlisting; however, no reasons specific to CWTD were given. The other seven comment letters either supported the proposed downlisting and proposed 4(d) rule or provided anecdotal evidence of increases in CWTD numbers. Within those 7 comment letters, we identified 15 substantive comments grouped into 6 categories: status of CWTD, population dynamics, threat assessment, surveys, calculated take, and habitat security. All substantive information provided during comment periods has either been incorporated directly into this final determination or is addressed below. All public and peer review comments are available at
In accordance with our policy, “Notice of Interagency Cooperative Policy for Peer Review in Endangered Species Act Activities,” published on July 1, 1994 (59 FR 34270), we solicited expert opinion of three knowledgeable individuals with scientific expertise that included familiarity with CWTD and its habitat, biological needs, and threats. We received responses from all three peer reviewers.
(1)
(2)
(3)
(4)
(5)
In this instance, a correlation coefficient is not an appropriate statistical analysis to accurately reflect population trends across the DPS for multiple reasons. First, the data used for the correlation were from 1984 to 2005, which eliminates 10 years of population data and eliminates the upward trend in the population in those 10 years. Second, the reviewer stated that the choice of the aforementioned dates was for the period in which there was data collected with a similar protocol in the same locations over time; however, from 1984 to 1996, only ground counts were conducted to obtain population data, but from 1996 to 2005, both FLIR and ground counts were used. Thus, the protocol was not similar throughout the time frame suggested for the correlation. Third, correlation is only applicable to linear relationships. A scatter plot of the population data portrays a quadratic relationship due to the negative trend through 2004, followed by the upward population trend observed from 2005 onward. Fourth, the overall population trend for the Columbia River DPS does appear to decline over time until 2004; however, closer examination revealed that the overall trend was strongly influenced by the decline at the JBHR Mainland Unit in the late 1980s. Although population estimates fluctuated, the population has been steadily increasing over time since 2004. We know that population numbers have been influenced by severe flooding in the late 1990s and early 2000s, and by the new subpopulation at Ridgefield NWR, which has been observed breeding and producing twins following translocations. Thus, we have biological evidence to support the positive population trend occurring since 2004.
(6)
(7)
Section 4(b)(5)(A)(ii) of the Act states that the Secretary shall give actual notice of the proposed regulation (including the complete text of the regulation) to the State agency in each State in which the species is believed to occur, and to each county or equivalent jurisdiction in which the species is believed to occur, and invite the comment of such agency and each such jurisdiction on the proposed regulation. We submitted the proposed rule (containing our proposed regulation language) to the States of Oregon and Washington and received formal comments from Oregon. We also notified Clatsop, Multnomah, and Columbia Counties in Oregon, and Cowlitz, Wahkiakum, Pacific, Skamania, and Clark Counties in Washington, when we published the proposed rulemaking. We did not receive any comments from the counties.
(8)
(9)
In response to comments, in the preamble of this final rule, we added an explanation of how viable population size using sex and age structure data was determined in the Revised Recovery Plan, greater detail regarding the Upper Estuary subpopulation, and clarification of surveys conducted to estimate population size. We also reorganized the information associated with downlisting criterion 2 (maintain three viable subpopulations, two of which are located on secure habitat) to clarify the interaction between population viability and secure habitat. In addition, we revised the section discussing climate change. Finally, we added survey data from 2015 that were unavailable when the proposed downlisting and proposed 4(d) rule published in the
In the Regulation Promulgation section of this final rule, we made minor changes to what we proposed for the 4(d) rule for clarity. Specifically, in the definition of CWTD, we include “individual specimens” to clarify the use of that term in the rule. Also, where we set forth the provisions concerning the take of problem CWTD, we specify that this is take “resulting in mortality.” Last, where we set forth reporting and disposal requirements, we now include a reference to requirements for Tribal employees, State and local law enforcement officers, and State-licensed wildlife rehabilitation facilities acting under 50 CFR 17.40(i)(6) of the rule.
Section 4(f) of the Act directs us to develop and implement recovery plans for the conservation and survival of endangered and threatened species unless we determine that such a plan will not promote the conservation of the species. Under section 4(f)(1)(B)(ii), recovery plans must, to the maximum extent practicable, include objective, measurable criteria which, when met, would result in a determination, in accordance with the provisions of section 4 of the Act, that the species be removed from the List of Endangered and Threatened Wildlife or the List of Endangered and Threatened Plants. However, revisions to the Lists of Endangered and Threatened Wildlife and Plants (adding, removing, or reclassifying a species) must be based on determinations made in accordance with sections 4(a)(1) and 4(b) of the Act. Section 4(a)(1) requires that the Secretary determine whether a species is endangered or threatened (or not) because of one or more of five threat factors. Section 4(b) of the Act requires that the determination be made “solely on the basis of the best scientific and commercial data available.” While recovery plans provide important guidance to the Service, States, and other partners on methods of minimizing threats to listed species and measurable objectives against which to measure progress towards recovery, they are not regulatory documents and cannot substitute for the determinations and promulgation of regulations required under section 4(a)(1) of the Act. A decision to revise the status of a species on, or to remove a species from, the Federal List of Endangered and Threatened Wildlife (50 CFR 17.11) is ultimately based on an analysis of the best scientific and commercial data then available to determine whether a species continues to meet the definition of an endangered species or a threatened species, regardless of whether that information differs from the recovery plan.
There are many paths to accomplishing recovery of a species, and recovery may be achieved without all criteria suggested in the recovery plan being fully met. For example, one or more criteria may be exceeded while other criteria may not yet be achieved or may never be achieved. In that instance, we may determine that the threats are minimized sufficiently and the species is robust enough to delist. In other cases, recovery opportunities may be discovered that were not known when the recovery plan was finalized. These opportunities may be used instead of methods identified in the recovery plan. Likewise, information on the species may be learned that was not known at the time the recovery plan was finalized. The new information may change the extent to which criteria need to be met for recognizing recovery of the species. Recovery of a species is a dynamic process requiring adaptive management that may, or may not, fully follow the guidance provided in a recovery plan.
For downlisting the Columbia River DPS from endangered to threatened, the Revised Recovery Plan for CWTD (U.S. Fish and Wildlife Service 1983) established the following criteria: (1) Maintain a minimum of at least 400 CWTD across the Columbia River DPS; and (2) maintain three viable subpopulations, two of which are located on secure habitat (U.S. Fish and Wildlife Service 1983, pp. 31-33). Viable is defined as a minimum November population of 50 individuals or more in a subpopulation. A minimum viable population size of 50 deer in each subpopulation and of 400 total deer in the DPS would theoretically cancel out any deleterious effects of inbreeding. To determine minimum population sizes, the Revised Recovery Plan used the formula F = 1/(2N
To determine the sex ratio and the percentage of breeding individuals, we used data from surveys of fawn to doe ratios that also included number of bucks seen during those surveys. We did not, however, have estimates of the age structure of the population. In white-tailed deer, age can be estimated based on tooth wear and replacement, the amount of cementum built up on the roots of the teeth, or physical characteristics. The first two techniques require the jaws of the deer, which require capturing or killing the deer; however, the latter technique, also known as aging on the hoof (AOTH), can be done in the field. In a recent study assessing the efficacy of AOTH by deer biologists, the overall accuracy of assigning white-tailed deer of known ages into the correct age category was 36 percent (Gee
In order to ensure viable subpopulations of at least 50 individuals, the Revised Recovery Plan determined that protection through securing habitat would be necessary. Secure habitat was defined as free from adverse human activities in the foreseeable future and relatively safe from natural phenomena that would destroy the habitat's value to CWTD (U.S. Fish and Wildlife Service 1983, p. 33). An example of a human activity that may cause adverse impacts to deer is large-scale commercial development. An example of natural phenomena that may destroy CWTD habitat is persistent flooding.
For delisting (
Forty-nine years have passed since the CWTD was federally listed as endangered, and the species is now more abundant and better distributed throughout the lower Columbia River Valley. The improvement is due in part to the maintenance and augmentation of existing subpopulations, and to the establishment of new subpopulations via successful translocations within the species' historical range. Many threats to the species have been substantially ameliorated, and CWTD have met all of the criteria for downlisting to threatened in the Revised Recovery Plan. A review of the species' current status relative to the downlisting criteria follows.
While the overall population trend for the Columbia River DPS appeared to decline over time along a similar trajectory as the JBHR Mainland Unit subpopulation until 2006, closer examination revealed that the overall trend was strongly influenced by the decline at the JBHR Mainland Unit in the late 1980s. Although population numbers fluctuated, the other subpopulations did not undergo a similar decline, and when the JBHR Mainland Unit is left out of the analysis, the overall Columbia River DPS population demonstrates a more positive trend exceeding the minimum population size of 400 individuals. Thus, downlisting criterion 1 has been met.
Apart from Wallace Island and the Westport Unit, most of the area where the Westport/Wallace Island subpopulation resides is owned and managed by one individual family. The family has managed the land for duck hunting for many years, implementing intensive predator control and maintaining levees as part of their land management activities. The Service suspects that CWTD reproduction in the Westport/Wallace Island subpopulation has benefited from this intensive predator control (Meyers 2013, pers. comm.). If the property owners alter the management regime or the property should change hands, the Westport/Wallace Island subpopulation could be negatively affected, particularly if the owners decide to remove the current levees, thereby inundating some of the CWTD habitat (Meyers 2013, pers. comm.). Because the stability of CWTD in this area appears to be so closely tied to one private landowner and their land management choices, there is less certainty as to the long-term security of this subpopulation and its associated habitat. As a result, although a small portion of the habitat for this subpopulation is protected for CWTD, the Service does not currently recognize Westport/Wallace Island as secure habitat. However, given that the area has supported a healthy subpopulation of CWTD for several decades, if the landowner were willing, then securing this property through purchase or conservation agreement would potentially increase recovery prospects for the Columbia River DPS.
To establish a new subpopulation in the Upper Estuary Islands, translocations of CWTD to Fisher/Hump and Lord/Walker Islands began in 2003, and a total of 66 deer (33 to each set of islands) have been relocated there to date (U.S. Fish and Wildlife Service 2013a, p. 23). In addition, 66 deer have been translocated to Crims Island through several translocation efforts (U.S. Fish and Wildlife Service 2013a, p. 21). At the time of the translocations, CWTD were not known to inhabit these islands, but habitat was available. The population goal for the five-island
The JBHR Mainland Unit subpopulation has fluctuated in numbers since regular surveys began, with a high of 500 CWTD in 1987 to a low of 51 deer in 1996 (after a catastrophic flood event). When the refuge was established, refuge biologists established a goal of approximately 125 deer for the JBHR Mainland Unit to balance the density of deer given the amount of available habitat (U.S. Fish and Wildlife Service 2010, p. 2:62).
Flooding on the JBHR Mainland Unit has occurred three times over the history of the refuge, in 1996, 2006 and 2009, resulting in short-term population declines after each flood. In March of 2011, a geotechnical assessment determined that the dike that protects the JBHR Mainland Unit from flooding by the Columbia River was at “imminent risk” of failure (U.S. Fish and Wildlife Service 2013b, p. 2) and a breach at that location would result in the flooding of the JBHR Mainland Unit at high tides. In response to this threat, the Service conducted an emergency translocation of 37 CWTD from the JBHR Mainland Unit to unoccupied but suitable habitat at Ridgefield NWR in early 2013 (U.S. Fish and Wildlife Service 2013c, p. 8). The U.S. Army Corps of Engineers subsequently constructed a set-back levee on the JBHR Mainland Unit to prevent flooding of the refuge and to restore salmonid habitat (U.S. Army Corps of Engineers 2013, p. 11). Though the set-back dike, completed in fall 2014, reduces available CWTD habitat on the JBHR Mainland Unit by approximately 28 ha (70 ac), or approximately 3.5 percent of the total 797 ha (1,970 ac), it will reduce the likelihood of future flooding. After the removal of 37 CWTD in 2013, the population of the JBHR Mainland Unit rebounded to an estimated 100 deer (2015). Although the current subpopulation count exceeds the criterion of 50 individuals described in the Revised Recovery Plan, we currently characterize the JBHR Mainland subpopulation as non-viable because in defining viability, the Revised Recovery Plan did not account for either the significant changes in the numbers of individuals within a donor subpopulation resulting from translocations or the impacts of significant land disturbances necessary to protect habitat. Therefore, we recognize that additional demographic monitoring is needed to more reliably demonstrate viability of the JBHR Mainland Unit subpopulation, given the removal of nearly half its numbers in 2013 (from 83 prior to translocations to 46 afterward) and the reduction in habitat from the construction of the setback dike.
Ridgefield NWR is the most recently established subpopulation of CWTD and it was created by translocating individual deer from the JBH Mainland, Puget Island, and Westport subpopulations to the refuge beginning in 2013. It is located in Clark County, Washington, approximately 108 km (67 mi) southeast of JBHR, and is comprised of 2,111 ha (5,218 ac) of marshes, grasslands, and woodlands with about 1,537 ha (3,800 ac) of upland terrestrial habitat. As part of the 2013 emergency translocation, the Service moved 37 deer from the JBHR Mainland Unit to the Ridgefield NWR (U.S. Fish and Wildlife Service 2013c, p. 8). Eleven of the deer suffered either capture-related mortality or post-release mortality within 2 months, potentially due to predation (U.S. Fish and Wildlife Service, unpublished data). In 2014, another 21 deer were translocated to Ridgefield NWR from Puget Island and Westport, and the current estimated population based on FLIR surveys is 100 deer (see Table 1, above). Although this subpopulation has exceeded the criterion of 50 individuals described in the Revised Recovery Plan, we currently characterize the Ridgefield NWR subpopulation as non-viable because in defining viability, the Revised Recovery Plan did not account for the complex suite of factors that determine the success or failure of translocations and the resulting establishment of a new subpopulation. While translocations may appear immediately successful, variation in both an animal's ability to adapt to a new environment and the habitat affect the ultimate success of translocations. This variation can include donor deer population genetics, animal condition, age and sex of translocated individuals, and quality of food sources (Foley
Puget Island is a mix of private and public land. The private land consists mainly of pasture for cattle and goats, residential lots, and hybrid cottonwood plantations that provide food and shelter for the deer. Farmers and ranchers on the island often implement predator (coyote,
Of the three viable subpopulations, only the Tenasillahe Island and Puget Island subpopulations are located on secure habitat. Page 37 of the Revised Recovery Plan states, “. . . protection and enhancement (of off-refuge CWTD habitat) can be secured through local land use planning, zoning, easement, leases, agreements, and/or memorand[a] of understanding” (U.S. Fish and Wildlife Service 1983, p. 37). In much of the 30 years following the development of the Revised Recovery Plan, the Service interpreted this to mean that the only ways to securing habitat in order to meet recovery criteria were the ones listed in the above citation. This led the Service to focus most CWTD recovery efforts on increasing and maintaining the subpopulations within the boundaries of the JBHR rather than working in areas that did not meet this narrow interpretation of “secure” habitat. These efforts resulted in some successful recovery projects such as growing and stabilizing the subpopulation on Tenasillahe Island, which is part of JBHR and currently one of the largest subpopulations in the Columbia River DPS. However, it also led the Service to put significant resources and time toward efforts that have shown less consistent success, such as establishing viable and stable herds on the Upper Estuary Islands. At present, a total of 314 deer have been translocated in an effort to move CWTD to “secure” habitats. As discussed earlier in this section, some translocations appear to have yielded success (Ridgefield NWR) and some failed to create viable and secure subpopulations (Cottonwood Island and the Upper Estuary Islands).
Two subpopulations, Puget Island and Westport/Wallace Island, have maintained relatively large and consistent numbers over the last 3 decades even though these areas are not under conservation ownership or agreement. The number of CWTD in these two areas clearly demonstrates a measure of security in the habitat regardless of the ownership of the land and may be related to the type of activity taking place in these areas.
The 30-year population trends from Puget Island and Westport/Wallace Island make it clear that CWTD can maintain secure and stable populations on suitable habitat that is not formally set aside by acquisition, conservation easement, or agreement. In light of this information, we have reevaluated the current status of CWTD and have determined that “secure” habitat includes locations that, regardless of ownership status, have supported viable subpopulations of CWTD for 20 or more years, and have no anticipated change to land management in the foreseeable future that would make the habitat less suitable to CWTD.
While Puget Island and Westport/Wallace Island had previously not been considered “secure” habitat, they have been supporting two of the largest and most stable subpopulations in the Columbia River DPS since listing. Although CWTD numbers at these 2 locations have fluctuated, the Westport/Wallace Island subpopulation had 150 deer in 1984 and 164 deer in 2010, and the Puget Island population had 170 deer in 1984 and 227 deer in 2014 (see Table 1, above). The Revised Recovery Plan identified Puget Island and the Westport area as suitable sources for CWTD translocations due in large part to their population stability. Subsequently, these two locations have been the donor source for numerous translocations over the last 30 years, including the removal of 23 deer from Puget Island and 10 deer from Westport as part of the 2013 and 2014 translocation efforts. Removal of CWTD from these two locations on multiple occasions for the purpose of translocation has not resulted in any significant decrease in donor population numbers.
Since the late 1980s, the total acreage of tree plantations on Puget Island decreased by roughly half (Stonex 2012, pers. comm.). However, a proportional decrease in the numbers of CWTD did not occur. Furthermore, though Puget Island has experienced changes in land use and increases in development over time, such as the break-up of large agricultural farms into smaller hobby farms, the changes have not inhibited the ability of CWTD to maintain a very stable population on the island. The Wahkiakum Comprehensive Plan (2006) anticipates that future development on Puget Island will continue to be tree farms, agricultural farms, and rural residential (both low density with 1- to 2-ha (2.5- to 5-ac) lots and medium density with 0.4- to 1-ha (1- to 2.5-ac) lots), with a goal of preserving the rural character of the area (Wahkiakum County 2006, p. 392). Puget Island's human population has grown at a nominal rate of 1 to 1.5 percent over the past 15 years; that past rate along with building permit growth over the last 5 years leads Wahkiakum County to project a population growth rate on the island of 1.5 percent through the 20-year “plan horizon” that extends through the year 2025 (Wahkiakum County 2006, p. 379). Because CWTD have demonstrated the ability to adapt to this type of development on the island, continued development of this type and at this low
In conclusion, there are currently three viable subpopulations of CWTD: Tenasillahe Island at 155 deer, Puget Island at 228 deer, and Westport/Wallace Island at 190 deer (see Table 1, above). Of those, we consider Tenasillahe Island and Puget Island to be located on secure habitat. Thus, the downlisting criterion to maintain three viable subpopulations, two of which are located on secure habitat, has been met. The Westport/Wallace Island subpopulation has shown consistent stability over the last 30 years, on par with Puget and Tenasillahe Islands, but its long-term security is less certain. While the secure JBHR Mainland Unit and Ridgefield NWR subpopulations have reached the criterion of 50 individuals described in the Revised Recovery Plan, we currently characterize them as non-viable because in defining viability, the Revised Recovery Plan did not account for either the significant changes in the numbers of individuals within a donor subpopulation resulting from translocations or the impacts of significant land disturbances necessary to protect habitat (
Section 4 of the Act and its implementing regulations (50 CFR part 424) set forth the procedures for listing species, reclassifying species, or removing species from listed status. “Species” is defined by the Act as including any species or subspecies of fish or wildlife or plants, and any distinct vertebrate population segment of vertebrate fish or wildlife that interbreeds when mature (16 U.S.C. 1532(16)). A species may be determined to be an endangered or threatened species because of any one or a combination of the five factors described in section 4(a)(1) of the Act: (A) The present or threatened destruction, modification, or curtailment of its habitat or range; (B) overutilization for commercial, recreational, scientific, or educational purposes; (C) disease or predation; (D) the inadequacy of existing regulatory mechanisms; or (E) other natural or manmade factors affecting its continued existence. We must consider these same five factors in reclassifying (in this case, downlisting) a species. We may reclassify a species from endangered to threatened (“downlist”) if the best available scientific and commercial data indicate that the species no longer meets the definition of endangered, but instead meets the definition of threatened because: (1) The species' status has improved to the point that it is not in danger of extinction at the present time throughout all or a significant portion of its range, but the species is not recovered (as is the case with the CWTD); or (2) the original scientific data used at the time the species was classified were in error.
Determining whether a species' status has improved to the point that it can be downlisted requires consideration of whether the species is endangered or threatened because of the same five categories of threats specified in section 4(a)(1) of the Act. For species that are already listed as endangered or threatened, this analysis of threats is an evaluation of both the threats currently facing the species and the threats that are reasonably likely to affect the species in the foreseeable future following the delisting or downlisting and the removal or reduction of the Act's protections.
A species is “endangered” for purposes of the Act if it is in danger of extinction throughout all or a significant portion of its range and is “threatened” if it is likely to become endangered within the foreseeable future throughout all or a significant portion of its range. The word “range” in the significant portion of its range (SPR) phrase refers to the general geographical area in which the species occurs at the time a status determination is made. For the purposes of this analysis, we evaluate whether the currently listed species, the Columbia River DPS of CWTD, continues to meet the definition of endangered.
In considering what factors might constitute threats, we must look beyond the exposure of the species to a particular factor to evaluate whether the species may respond to the factor in a way that causes actual impacts to the species. If there is exposure to a factor and the species responds negatively, the factor may be a threat, and during the five-factor analysis, we attempt to determine how significant a threat it is. The threat is significant if it drives or contributes to the risk of extinction of the species, such that the species warrants listing as endangered or threatened as those terms are defined by the Act. However, the identification of factors that could impact a species negatively may not be sufficient to compel a finding that the species warrants listing. The information must include evidence sufficient to suggest that the potential threat is likely to materialize and that it has the capacity (
In the following analysis, we evaluate the status of the Columbia River DPS of CWTD throughout its range as indicated by the five-factor analysis of threats currently affecting, or that are likely to affect, the species within the foreseeable future.
CWTD evolved as a prairie edge/woodland-associated species with historically viable populations that were not confined to river valleys (Bailey 1936, pp. 92-93). However, CWTD have been extirpated in all but two areas of their historical range: the Columbia River DPS area and the Douglas County DPS area. The remnant Columbia River DPS population was forced by anthropogenic factors (residential and commercial development, roads, agriculture, etc., causing fragmentation of natural habitats) into the lowland patches of forest and fields it now inhabits. While CWTD can adapt to scattered human development, the diffusion of urban, suburban, and agricultural areas now limit natural range expansion within the current subpopulations, and existing occupied areas support densities of CWTD indicative of low-quality habitats, particularly lower-lying and wetter habitat than where the species would typically be found.
Loss of habitat is suspected as a key factor in historical CWTD declines; 12,140 ha (30,000 ac) of habitat along the lower Columbia River were converted for residential and large-scale agricultural use from 1870 to 1970 (Northwest Power and Conservation Council 2004, p. B4:13). Over time, CWTD were forced into habitat that was fragmented, wetter, and in more lowland than what would be ideal for the species. The recovery of the Douglas County DPS reflects the availability of more favorable habitat (a mix of conifer and hardwood-dominated vegetation communities, including oak woodlands
Though limited access to high-quality upland habitat in the Columbia River DPS remains the most prominent hindrance to CWTD dispersal and recovery today, the majority of habitat loss and fragmentation has already occurred. The most dramatic land-use changes occurred during the era of hydroelectric and floodplain development in the Columbia River basin, beginning with the construction of the Willamette Falls Dam in 1888, and continuing through the 1970s (Northwest Power and Conservation Council 2013, p. 1). Compared to the magnitude of change that occurred in CWTD habitat through activities associated with these types of development (
Recovery efforts for CWTD have, in large part, focused on formally protecting land for the recovery of the species through acquisitions and agreements such as JBHR, Crims Island, Cottonwood Island, and Wallace Island, as well as restoration activities to increase the quality of existing available habitat. In addition, the Service has expanded CWTD distribution from approximately 8,093 ha (20,000 ac) to 24,281 ha (60,000 ac) through translocations, reducing the risk that a catastrophic event affecting any one subpopulation would lead to extinction. To date, the Service has worked to conserve 3,604 ha (8,918 ac) of habitat for the protection of CWTD (U.S. Fish and Wildlife Service 2013, p. 20). Habitat restoration and enhancement activities on JBHR have improved the quality of habitat since publication of the Revised Recovery Plan in 1983, and the Ridgefield NWR now has an active habitat enhancement program in place to support the translocated population of CWTD. These efforts have added to the available suitable habitat for the Columbia River DPS and helped offset some of the impacts of previous habitat loss.
Although much of the occupied habitat in the Columbia River DPS is fragmented, wetter than the species prefers, and vulnerable to flooding, many variables influence CWTD survival. A mosaic of ownerships and protection levels does not necessarily hinder the existence of CWTD when land use is compatible with the habitat needs of the deer. For example, on Puget Island, which is not formally set aside for the protection of CWTD, the fawn:doe (F:D) ratios are higher than on the protected JBHR Mainland Unit, and the area has supported a stable CWTD population without active management in the midst of continued small-scale development for several decades. Additionally, the Westport/Wallace Island subpopulation has long maintained stable numbers, even though most of the area is not managed for the protection of CWTD. The level of predation, level of disturbance, and condition of habitat all influence how CWTD can survive in noncontiguous habitats.
Flooding, from either anthropogenic or natural events, is a threat to CWTD habitat when browsing and fawning grounds become inundated for prolonged periods. CWTD habitat is susceptible to flooding because a large proportion of occupied CWTD habitat is land that was reclaimed from tidal inundation by construction of dikes and levees for agricultural use in the early 20th century (U.S. Fish and Wildlife Service 2010, p. 2:48). For example, in 1983, the population of CWTD at Karlson Island was estimated to be between 8 and 12 individuals. Since that time, however, the dike on the island has breached such that the island is now prone to sustained and frequent flooding events. CWTD have abandoned the island. On the JBHR Mainland Unit, three major storm-related floods occurred in 1996, 2006, and 2009. These flooding events were associated with a sudden drop in population numbers, followed by population recovery in the next few years.
In recent years, there has been interest in restoring the natural tidal regime to some of the land that was reclaimed from tidal inundation in the early 20th century, mainly for fish habitat enhancement. This restoration could reduce habitat for CWTD in certain areas where the majority of the subpopulation relies upon the reclaimed land. Since 2009, three new tide gates were installed on the JBHR Mainland Unit to improve fish passage and facilitate drainage in the event of large-scale flooding. When the setback levee on the refuge was completed in fall 2014, the original dike under Steamboat Slough Road was breached, and the estuarine buffer created now provides additional protection from flooding to the JBHR Mainland Unit. However, it has also resulted in the loss or degradation of about 28 ha (70 ac) of CWTD habitat, which amounts to approximately 3.5 percent of the total acreage of the JBHR Mainland Unit.
The persistence of invasive species, especially reed canary grass, has reduced forage quality over much of the CWTD's range, but it remains unclear how much this change in forage quality is affecting the overall status of CWTD. While CWTD will eat the grass, it is only palatable during early spring growth, or about 2 months in spring, and it is not a preferred forage species (U.S. Fish and Wildlife Service 2010, p. 3:12). Cattle grazing and mowing are used on JBHR lands to control the growth of reed canary grass along with tilling and planting of pasture grasses and forbs. This management entails a large effort that will likely be required in perpetuity unless other control options are discovered. Reed canary grass is often mechanically suppressed in agricultural and suburban landscapes, but remote areas, such as the upriver islands, experience little control. Reed canary grass thrives in wet soil and excludes the establishment of other grass or forb vegetation that is likely more palatable to CWTD. Increased groundwater due to sea-level rise or subsidence of diked lands may exacerbate this problem by extending the area impacted by reed canary grass. However, where groundwater levels rise high enough and are persistent, reed canary grass will be drowned and may be eradicated, although this rise in water level may also negatively affect CWTD. The total area occupied by reed canary grass in the future may therefore decrease, remain the same, or increase, depending on topography, land management, or both.
Competition with elk (
Our analyses under the Act include consideration of ongoing and projected
Environmental changes related to climate change will likely affect CWTD occupying low-lying habitat that is not adequately protected by well-maintained dikes. Furthermore, even in areas that have adequate dikes built, the integrity of those dikes could be at risk of failure due to the effects of climate change. Climatic models have projected significant sea-level rise over the next century (Mote
Maintaining the integrity of existing flood barriers that protect CWTD habitat will be important for recovery of the Columbia River DPS until greater numbers of CWTD can occupy upland habitat through additional translocations, and subsequent recruitment and natural range expansion. The JBHR Mainland Unit has experienced three major storm-related floods since 1996. While we do not have data to indicate that climate change is responsible for past storm-related flooding events, climate change could result in increased storm intensity and frequency, which would exacerbate the impacts of flooding. Flooding events have been associated with sudden drops in the CWTD population (see Table 1, above), which then slowly recovered. An increased rate of occurrence of these events, however, could permanently reduce the size of this subpopulation. To facilitate drainage in the event of large-scale flooding, three new tide gates have been installed on the JBHR Mainland Unit since 2009. Potentially, additional tide gates could be installed and dikes could be elevated to reduce the impact of flooding and sea-level rise on the JBHR Mainland Unit. A new, larger culvert under Highway 4 was also installed in 2015 allowing a tributary better flow from the Elochoman River to facilitate drainage and reduce the likelihood of flooding. Since Puget and Tenasillahe Islands lack stream input from the Elochoman River or other stream sources, the risk of flooding from storm events is low. Additionally, Puget Island and Tenasillahe Island are adequately protected from potential sea level rises due to the height of their levees and their location within the main stem of the Columbia River.
The National Wildlife Federation has employed a model to project changes in sea level in Puget Sound, Washington, and along areas of the Oregon and Washington coastline. The study projected an average rise of 0.28 meters (m) (0.92 feet (ft)) by 2050, and 0.69 m (2.26 ft) by 2100, in the Columbia River region (Glick
Due to the reasons listed above, we find the effects of climate change (specifically sea level rise and increased frequency and magnitude of storm events) to be a threat to CWTD in the foreseeable future. The indirect effects of climate change in the form of more frequent or more severe floods may be exacerbated by that threat. Because of the low-lying nature of some currently occupied CWTD habitat in the Columbia River DPS, the long-term stability of the subpopulations in those areas may rely on the availability of and access to upland habitat protected from the effects of projected sea-level rise. The Columbia River DPS would benefit from the identification of additional suitable high-quality upland habitat and the development of partnerships with State wildlife agencies to facilitate the translocation of CWTD to these areas, as well as securing land with existing stable subpopulations, such as the Westport area.
Habitat loss from fragmentation, flooding, and continued urban and suburban expansion remains a threat to CWTD persistence. Stable populations of the species do persist in habitat that was previously dismissed as inadequate for long-term survival such as the subpopulations on Puget Island, Washington, and in Westport, Oregon (Westport/Wallace Island subpopulation). Historical habitat loss was largely a result of development, and while this activity is still a limiting factor, we now understand that the type of development influences how CWTD respond. Areas such as Puget Island have been and are expected to continue experiencing the break-up of large agricultural farms into smaller hobby farms with a continued focus on low- to medium-density rural residential development. This type of change has not inhibited the ability of CWTD to maintain a stable population on Puget Island (about 2,023 ha (5,000 ac)). Therefore, this type of development is not expected to impact CWTD on Puget Island in the foreseeable future. In contrast, areas like Willow Grove will likely see a continued change from an agricultural to a suburban landscape; this type of development may have a negative impact on CWTD depending on the density of development.
The Service's recovery efforts involving habitat acquisition and restoration have led to a corresponding increase in the amount and quality of habitat specifically protected for the benefit of CWTD. Habitat enhancement efforts have been focused primarily on the JBHR Mainland Unit, Tenasillahe Island, and Crims Island where attention has been focused on increasing the quality of browse, forage, and cover. There is also a new habitat
The rise in sea level predicted by climate change models may threaten any low-lying habitat of the Columbia River DPS not adequately protected by dikes, and may also threaten the integrity of dikes providing flood control to certain subpopulations of CWTD. To minimize possible impacts from flooding, dikes and levees will need to be maintained and potentially rebuilt or improved over time. Although the effects of climate change do not constitute a threat to CWTD now, we do expect the effects to constitute a threat in the foreseeable future. Overall, although the threat of habitat loss and modification still remains, it is lower than when the species was listed and the Recovery Plan was developed; this is due to habitat acquisition and enhancement efforts, based on an overall better understanding of the influence of different types of development on CWTD populations.
Overutilization for commercial, scientific, or educational purposes would likely be a threat to CWTD without the continued protections of the Act. Although legal harvest of CWTD in the Columbia River DPS ceased when CWTD were federally listed as endangered, historical overharvest of CWTD in the late 1800s and early 1900s contributed to population decline. Early pioneers and explorers to western Oregon used CWTD as a food resource along main travel corridors, resulting in extirpation of CWTD in these locations (Crews 1939, p. 5).
As long as take prohibitions generally remain in place, poaching is not currently considered a threat. Just after the establishment of the JBHR, poaching was not uncommon given the JBHR's proximity to roads and easy accessibility. Public understanding and views of CWTD have gradually changed, however, and poaching is no longer considered a threat but could become a threat if regulations and enforcement are not maintained to protect CWTD from overutilization. This downlisting and associated 4(d) rule will not change this. There have been only a few cases of intentional shooting of CWTD through poaching in the 49 years since CWTD were first listed (Bergh 2014, pers. comm.). Although poaching cannot be completely ameliorated, this current level of poaching is not considered a threat to the DPS. If poaching levels change, however, then poaching could hinder CWTD population growth because of the DPS's small population size. Small populations face greater risks of extinction because genetic drift and demographic stochasticity (
The Revised Recovery Plan lists necrobacillosis (hoof rot) as a primary causal factor in CWTD mortality on the JBHR (U.S. Fish and Wildlife Service 1983, p. 13).
Deer hair loss syndrome (DHLS) was documented in black-tailed deer in northwestern Oregon from 2000 to 2004 (Biederbeck 2004, p. 4). DHLS results when a deer with an immune system weakened by internal parasites is plagued with ectoparasites such as deer lice (
DHLS is not thought to be highly contagious, nor is it considered to be a primary threat to CWTD survival, although it has been associated with deer mortality (Biederbeck 2002, p. 11; 2004, p. 7). Reports of DHLS among black-tailed deer in Washington have indicated significant mortality associated with the condition. In 2006, a high number of Yakima area mule deer (
Parasite loads were tested in 16 CWTD on the JBHR Mainland Unit and Tenasillahe Island in February of 1998 (Creekmore and Glaser 1999, p. 3). All CWTD tested via fecal samples showed
Coyote predation on CWTD has been a problem for the Columbia River DPS, but careful attention to predator control has demonstrated that predation can be managed. Since 1983, studies have been conducted to determine the primary factors affecting fawn survival throughout the range of the Columbia River DPS of CWTD (U.S. Fish and Wildlife Service, unpublished data), and coyote predation is thought to be the most significant impact on fawn recruitment. On the JBHR Mainland Unit, Clark
Between 1997 and 2008, 46 coyotes were removed from the JBHR Mainland Unit by the U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (U.S. Fish and Wildlife Service 2010, p. 4:62). Coyote removal appears to result in an increase in fawn survival, although this has not been analyzed statistically. In 1996, the estimated JBHR Mainland Unit fawn:doe (F:D) ratio was 15:100. The following year, after 9 coyotes were removed, the F:D ratio increased to 61:100 (U.S. Fish and Wildlife Service 2010, p. 4:54); however, this was the year following catastrophic flooding, so some F:D ratio improvement could be a result of post-flooding conditions. On Tenasillahe Island, the average F:D ratio between 2001 and 2003 was 6:100. No coyotes were removed during that time. Over the next 5 years (2004 to 2008), 31 coyotes were removed, and the F:D ratio improved and averaged 37:100. Clark
It is common for private landowners in the region to practice predator control on their property, but we do not know the extent of predator control occurring currently or the amount that is likely to occur in the future. On private lands with sheep and other livestock, we have no information that leads us to anticipate a decrease in the level of predator control in the foreseeable future (Meyers 2016, pers. comm.). Even with predation occurring on private lands, the populations of Puget Island and Westport still demonstrate a positive growth rate over time (see Table 1, above). Additionally, coyote control has been in practice on refuge lands for some time and will continue to be implemented on both the JBHR and Ridgefield NWR to support CWTD populations. While coyote control efforts in the Columbia River DPS have met with some success, there may be other factors, such as habitat enhancement, that are also influencing increased F:D ratios in certain CWTD subpopulations. Doe survival in the DPS depends heavily on the availability of nutritious forage rather than on predation pressure, although fawn predation within subpopulations is most likely influenced by coyote population cycles (Phillips 2009, p. 20). Furthermore, deer and elk populations can be depressed by the interplay between various factors such as habitat quality and predation pressure (Oregon Department of Fish and Wildlife 2013, p. 8).
The causes of mortality in ungulates are often divided into predation and food limitation (Linnell
Naturally occurring diseases such as hoof rot, DHLS, and parasite loads can often work through an ungulate population without necessarily reducing the overall population abundance. Although the relatively high parasite load in the Columbia River DPS of CWTD is compounded by the additional stressor of suboptimal forage and habitat quality for some subpopulations, the load itself has never been linked to mortality in the DPS. Disease in the Columbia River DPS of CWTD is not a threat now, and we have no evidence to suggest it may become a threat in the foreseeable future.
Predation in the Columbia River DPS of CWTD is not a threat now, and we have no reason to expect it to become a threat in the foreseeable future. Depredation of fawns by coyotes is common in the Columbia River DPS; however, many factors, such as food availability, work in conjunction with each other to determine the overall level of fawn recruitment. Coyote control is in practice on some private lands in the
Under this factor, we examine whether existing regulatory mechanisms adequately address the threats to the CWTD discussed under other factors. Section 4(b)(1)(A) of the Act requires the Service to take into account, “those efforts, if any, being made by any State or foreign nation, or any political subdivision of a State or foreign nation, to protect such species. . . .” In relation to Factor D under the Act, we interpret this language to require the Service to consider relevant Federal, State, and Tribal laws, regulations, and other such mechanisms that may minimize any of the threats we describe in threat analyses under the other four factors, or otherwise enhance conservation of the species. We give strongest weight to statutes and their implementing regulations and to management direction that stems from those laws and regulations. Examples are State governmental actions enforced under a State statute or constitution, or Federal action under statute.
The following section includes a discussion of State, local, or Federal laws, regulations, or treaties that apply to CWTD. It includes legislation for Federal land management agencies and State and Federal regulatory authorities affecting land use or other relevant management. Before CWTD was federally listed as endangered in 1967, the species had no regulatory protections. Existing laws were considered inadequate to protect the subspecies. The CWTD was not officially recognized by Oregon or Washington as needing any special protection or given any special consideration under other environmental laws when project impacts were reviewed.
Now the CWTD is designated as “State Endangered” by the WDFW. Although there is no State Endangered Species Act in Washington, the Washington Fish and Wildlife Commission has the authority to list species (Revised Code of Washington (RCW) 77.12.020), and they listed CWTD as endangered in 1980. State-listed species are protected from direct take, but their habitat is not protected (RCW 77.15.120). Under the Washington State Forest Practices Act, the Washington State Forest Practices Board has the authority to designate critical wildlife habitat for State-listed species affected by forest practices (Washington Administrative Code (WAC) 222-16-050, WAC 222-16-080), although there is no critical habitat designated for CWTD.
The WDFW's hunting regulations remind hunters that CWTD are listed as endangered by the State of Washington (Washington Department of Fish and Wildlife 2015, pp. 18, 20). This designation means it is illegal to hunt, possess, or control CWTD in Washington. There has been one documented case of an accidental shooting of CWTD by a black-tailed deer hunter due to misidentification, and a few cases of intentional shooting of CWTD through poaching in the 49 years since CWTD were first listed (Bergh 2014, pers. comm.). The State endangered designation protects individual CWTD from direct harm, but offers no protection to CWTD habitat.
The Washington State Legislature established the authority for Forest Practices Rules (FPR) in 1974. The Forest Practices Board established rules to implement the Forest Practices Act in 1976, and has amended the rules continuously over the last 30 years. The WDNR is responsible for implementing the FPR and is required to consult with the WDFW on matters relating to wildlife, including CWTD. The FPR do not specifically address CWTD, but they do address endangered and threatened species under their “Class IV-Special” rules (WAC 222-10-040). If a landowner's forestry-related action would “reasonably . . . be expected, directly or indirectly, to reduce appreciably the likelihood of the survival or recovery of a listed species in the wild by reducing the reproduction, numbers, or distribution of that species,” then the landowner would be required to comply with the State's Environmental Policy Act guidelines before the landowner could perform the action in question. The guidelines can require the landowner to employ mitigation measures, or they may place conditions on the action such that any potentially significant adverse impacts would be reduced. Compliance with the FPR does not substitute for or ensure compliance with the Federal Endangered Species Act. A permit system for the scientific taking of State-listed endangered and threatened wildlife species is managed by the WDFW.
Though CWTD (Columbia River DPS) are not listed as endangered or threatened by the State of Oregon, they are classified as a “protected mammal” by the State of Oregon because of their federally endangered designation, and this will not change upon CWTD being federally downlisted to threatened (Oregon Department of Fish and Wildlife 2012, p. 1). The CWTD is designated as “Sensitive-Vulnerable” by the Oregon Department of Fish and Wildlife (ODFW). The “Sensitive” species classification was created under Oregon's Sensitive Species Rule (Oregon Administrative Rules (OAR) 635-100-040) to address the need for a proactive species conservation approach. The Sensitive Species List is a nonregulatory tool that helps focus wildlife management and research activities, with the goal of preventing species from declining to the point of qualifying as “endangered” or “threatened” under the Oregon Endangered Species Act (Oregon Revised Statutes (ORS) 496.171, 496.172, 496.176, 496.182 and 496.192). Species designated as Sensitive-Vulnerable are those facing one or more threats to their populations, habitats, or both. Vulnerable species are not currently imperiled with extirpation from a specific geographic area or the State, but could become so with continued or increased threats to populations, habitats, or both. This designation encourages but does not require the implementation of any conservation actions for the species. The ODFW does not allow hunting of CWTD, except for controlled hunt of the federally delisted Douglas County DPS in areas near Roseburg, Oregon (Oregon Department of Fish and Wildlife 2015, p. 39). There have been no documented cases of accidental or intentional killing of CWTD in the Columbia River DPS in Oregon (Boechler 2014, pers. comm.).
The State may authorize a permit for the scientific taking of a federally endangered or threatened species for “activities associated with scientific resource management such as research, census, law enforcement, habitat acquisition and maintenance, propagation and transplantation.” An incidental taking permit or statement issued by a Federal agency for a species listed under the Federal Endangered Species Act “shall be recognized by the state as a waiver for any state protection measures or requirements otherwise applicable to the actions allowed under the federal permit” (ORS 96.172(4)).
The Oregon Forest Practices Act (ORS 527.610 to 527.992 and OAR chapter 629, divisions 600 to 665) lists
The Oregon Department of Forestry recently updated their Northwest Oregon Forest Plan (Oregon Department of Forestry 2010). There is no mention of CWTD in their Forest Plan, but they do manage for elk and black-tailed deer. Landowners and operators are advised that Federal law prohibits a person from taking certain endangered or threatened species that are protected under the Federal Endangered Species Act (OAR 629-605-0105).
The 4(d) rule we are making final in this rulemaking retains most take prohibitions, which will provide additional protections to CWTD that are not available under State laws. Other than the “take” that will be allowed for the specific activities outlined in the 4(d) rule, “take” of CWTD is prohibited on all lands without a permit or exemption from the Service. Furthermore, the National Wildlife Refuge System Improvement Act of 1997 (16 U.S.C. 668dd
The JBHR was established in Washington in 1971, specifically to protect and manage the endangered CWTD. Approximately one-third of the population of CWTD occurs on the JBHR in the JBHR Mainland Unit subpopulation and the Tenasillahe Island subpopulation. The JBHR's comprehensive conservation plan (CCP) includes goals for the following: (1) Protecting, maintaining, enhancing, and restoring habitats for CWTD; (2) contributing to the recovery of CWTD by maintaining minimum population sizes on JBHR properties; and (3) conducting survey and research activities, assessments, and studies to enhance species protection and recovery (U.S. Fish and Wildlife Service 2010a, pp. 2:48-76). The JBHR implements habitat improvement and enhancement actions on a regular basis as well as predator management. As of early 2013, the Ridgefield NWR is home to a new subpopulation of CWTD. The Ridgefield CCP states that current and proposed habitat management will support a mix of habitats suitable for CWTD (U.S. Fish and Wildlife Service 2010b, p. 48). Habitat conditions on Ridgefield NWR are favorable for CWTD, and both habitat enhancement and predator control are being implemented. Regular monitoring will occur to assess the viability of this subpopulation over time. Both JBHR and Ridgefield NWR must conduct consultations under section 7 of the Act for any refuge activity that may result in adverse effects to CWTD.
Although additional regulatory mechanisms have been developed for the Columbia River DPS since its listing under the Act and these mechanisms are working as designed and help to minimize threats, they do not fully ameliorate the threats to the species and its habitat. Without the continued protections of the Act, the existing regulatory mechanisms for the Columbia River DPS would be inadequate.
Hybridization with black-tailed deer was not considered a significant threat to the Columbia River DPS of CWTD at the time of the development of the Revised Recovery Plan (U.S. Fish and Wildlife 1983, p. 40). Later studies raised some concern over the presence of black-tailed deer genes in the isolated Columbia River DPS population. Gavin and May (1988, p. 1) found evidence of hybridization in 6 of 33 samples of CWTD on the JBHR Mainland Unit and surrounding area. A subsequent study revealed evidence of hybridization on Tenasillahe Island, but not within the JBHR Mainland Unit (Piaggio and Hopken 2009, p. 18). On Tenasillahe Island, 32 percent (8) of the 25 deer tested and identified as CWTD contained genes from black-tailed deer. Preliminary evidence shows no morphological differences in CWTD/black-tailed deer hybrids, suggesting molecular analysis may be the only analytic tool in tracking hybridization. These data suggest that these genes may have been due to a single hybridization event that is being carried through the Tenasillahe Island population (Piaggio and Hopken 2009, p. 18).
Translocation efforts have at times placed CWTD in areas that support black-tailed deer populations. While few black-tailed deer inhabit the JBHR Mainland Unit or Tenasillahe Island, the Upper Estuary Islands population may experience more interspecific interactions. Aerial FLIR survey results in 2006 detected 44 deer on the four-island complex of Fisher/Hump and Lord/Walker. Based upon the proportion of CWTD to black-tailed deer sightings using trail cameras on these islands, Service biologists estimated that, at most, 14 of those detected were CWTD (U.S. Fish and Wildlife Service 2007, p. 1). A study conducted in 2010 by the JBHR and the National Wildlife Research Center using fecal samples collected on Crims, Lord, and Walker Islands showed no hybridization in any of the samples collected, suggesting a low tendency to hybridize even in island situations (Piaggio and Hopken 2010, p. 14). The actual magnitude of hybridization has probably not changed since the listing of CWTD; however, there are not enough data available to confirm this assumption. Hybridization might affect the genetic viability of the Columbia River DPS, and additional research regarding hybridization could give broader insight to the implications and occurrence of this phenomenon, and how it may influence subspecies designation. Although a more complete data set would provide more conclusive information regarding hybridization in CWTD, based upon the minor level of detections of black-tailed deer genetic material and the complete lack of any evidence of hybridization on several islands, we find that hybridization is not a threat to the Columbia River DPS.
Because deer are highly mobile, collisions between CWTD and vehicles do occur, but the number of collisions in the Columbia River DPS has not prevented the DPS from increasing over time and meeting downlisting criteria. The frequency of collisions is dependent on the proximity of a subpopulation to roads with high traffic levels, and collisions with CWTD have been most frequent among deer that have been translocated to areas that are relatively close to high trafficked roads. In 2010, 7 of 15 deer translocated to Cottonwood Island, Washington, from Westport, Oregon swam off the island and were killed by collisions with vehicles on U.S. Highway 30 in Oregon, and on Interstate 5 in Washington (Cowlitz Indian Tribe 2010, p. 3). In 2013, 5 of 12 deer translocated to Cottonwood Island from Puget Island were killed by collisions with vehicles,
The Washington Department of Transportation removes road kills without reporting species details to the JBHR, so the actual number of CWTD struck by cars in Washington is probably slightly higher than the number of cases of which JBHR staff is aware. Since the 2013 translocation, ODFW has had an agreement with the Oregon Department of Transportation (ODOT) that ODOT personnel assigned to stations along Highway 30 will report any CWTD mortalities. So far, they have been contacting the Oregon State Police and occasionally ODFW staff when they find a mortality with a collar or ear tags. It is uncertain if the ODOT staff report unmarked CWTD mortalities (VandeBergh 2013, pers. comm.).
Although the number of deer collisions may increase over time as CWTD populations expand in both numbers and range, the rate of collisions in proportion to the Columbia River DPS population size is not limiting. We acknowledge that estimates of the number of deer killed on roads could be low and that increasing human development and deer population sizes could result in increased mortality rates in the future, especially for those populations near highways. Therefore, while vehicle collisions could potentially impact certain subpopulations of CWTD, they do not constitute a threat to the entire DPS now, and we do not expect them to be a threat in the foreseeable future.
Low levels of hybridization have recently been detected between black-tailed deer and CWTD on the JBHR (Piaggio and Hopken 2010, p. 15). Future genetic work could give a broader insight into the implications and occurrence of this phenomenon. However, Piaggio and Hopken concluded that although hybridization can occur between CWTD and black-tailed deer, it is not a common or current event (2010, p. 16). The two species will preferentially breed within their own taxa, and their habitat preferences differ somewhat. Therefore, hybridization does not constitute a threat now, and we have no reason to expect it will become a threat in the foreseeable future. While collisions between CWTD and vehicles do occur, frequency of collisions is dependent on the proximity of a subpopulation to roads with high traffic levels, making some subpopulations more susceptible to vehicle mortality than others. Overall, vehicle collisions have not prevented the DPS population from increasing over time and meeting recovery criteria for downlisting, and there is no evidence to suggest that they will become a threat to the DPS in the foreseeable future.
The Columbia River DPS has consistently exceeded the minimum population criterion of 400 deer over the past 2 decades. Based on the most recent comprehensive survey data from 2015, the Columbia River DPS has approximately 966 CWTD, with two subpopulations that are both viable and secure (Tenasillahe Island and Puget Island). The current range of CWTD in the lower Columbia River area has been expanded approximately 80.5 km (50 mi) upriver from its easternmost range of Wallace Island in 1983, to Ridgefield, Washington, due to a translocation of animals from the JBHR Mainland Unit, Puget Island, and Westport subpopulations. Based on observations of successful breeding and subpopulation growth to date, the recently established Ridgefield NWR population is expected to continue to grow and represent an additional viable subpopulation, as defined in the recovery plan; however, we will conduct additional demographic monitoring to accurately assess the overall response of the newly established Ridgefield NWR subpopulation and more reliably demonstrate its viability. Like the Ridgefield NWR subpopulation, we anticipate the JBHR Mainland Unit subpopulation will continue to rebound and represent a viable subpopulation in the near future.
Threats to the Columbia River DPS from habitat loss or degradation (Factor A) still remain and will likely continue into the foreseeable future in the form of habitat alteration, and some subpopulations are expected to be affected by habitat changes resulting from the effects of climate change. Predation, diseases, and parasites (Factor C) are not currently known to significantly contribute to mortality in CWTD. While there is potential for increased flood frequency to increase risk factors for hoof rot, available information does not indicate that the disease, in combination with other factors, is currently a significant limiting factor for the population or is likely to become so. Thus we do not consider disease or predation (Factor C) to be a threat. Without the protections of the Act, the existing regulatory mechanisms, including those to prevent overutilization (Factor B), for the Columbia River DPS remain inadequate (Factor D). While hybridization (Factor E) is not a threat, vehicle collisions (Factor E) may pose a threat to some subpopulations during dispersal.
As stated above, section 4 of the Act (16 U.S.C. 1533), and its implementing regulations at 50 CFR part 424, set forth the procedures for adding species to or removing species from the Federal Lists of Endangered and Threatened Wildlife and Plants. An assessment of the need for a species' protection under the Act is based on whether a species is in danger of extinction or likely to become so because of any of five factors described above in the Summary of Factors Affecting the Species section. As required by section 4(a)(1) of the Act, we considered these five factors in assessing whether the Columbia River DPS of CWTD is in danger of extinction or likely to become so in the foreseeable future throughout all of its range.
As required by the Act, we considered the five factors in assessing whether the Columbia River DPS of CWTD is endangered or threatened throughout all or a significant portion of its range. We carefully examined the best scientific and commercial information available regarding the past, present, and future threats faced by the DPS. We reviewed the information available in our files and other available published and unpublished information, and we consulted with recognized experts and State and Tribal agencies.
We find that the Columbia River DPS is still affected by habitat loss and degradation, and some subpopulations are likely to be affected in the future by habitat changes resulting from the
Because we have concluded that the Columbia River DPS of CWTD is a threatened species throughout all of its range, no portion of its range can be “significant” for purposes of the definitions of “endangered species” and “threatened species.” See the Service's Significant Portion of its Range (SPR) Policy (79 FR 37578, July 1, 2014).
This final rule revises 50 CFR 17.11(h) to reclassify the Columbia River DPS of CWTD from endangered to threatened on the List of Endangered and Threatened Wildlife. Reclassification of CWTD from endangered to threatened provides recognition of the substantial efforts made by Federal, State, and local government agencies; Tribes; and private landowners to recover the species. This rule formally recognizes that this species is no longer at imminent risk of extinction and therefore does not meet the definition of endangered, but is still impacted by habitat loss and degradation of habitat to the extent that the species meets the definition of a threatened species (a species which is likely to become an endangered species within the foreseeable future) under the Act. However, this reclassification does not significantly change the protection afforded this species under the Act. Other than the “take” that will be allowed for the specific activities outlined in the accompanying 4(d) rule, the regulatory protections of the Act will remain in place. Anyone taking, attempting to take, or otherwise possessing a CWTD, or parts thereof, in violation of section 9 of the Act will still be subject to penalties under section 11 of the Act, except for the actions covered under the 4(d) rule. Whenever a species is listed as threatened, the Act allows promulgation of a rule under section 4(d) that modifies the standard protections for threatened species found under section 9 of the Act and Service regulations at 50 CFR 17.31 (for wildlife) and 17.71 (for plants), when it is deemed necessary and advisable to provide for the conservation of the species. These rules may prescribe conditions under which take of the threatened species would not be a violation of section 9 of the Act.
The purposes of the Act are to provide a means whereby the ecosystems upon which endangered species and threatened species depend may be conserved, to provide a program for the conservation of endangered species and threatened species, and to take such steps as may be appropriate to achieve the purposes of the treaties and conventions set forth in the Act. When a species is listed as endangered, certain actions are prohibited under section 9 of the Act, as specified at 50 CFR 17.21. These include, among others, prohibitions on take within the United States, within the territorial seas of the United States, or upon the high seas; import; export; and shipment in interstate or foreign commerce in the course of a commercial activity.
The Act does not specify particular prohibitions and exceptions to those prohibitions for threatened species. Instead, under section 4(d) of the Act, the Secretary is authorized to issue regulations deemed necessary and advisable to provide for the conservation of threatened species. The Secretary also has the discretion to prohibit by regulation with respect to any threatened species any act prohibited under section 9(a)(1) of the Act. Exercising this discretion, the Service has by regulation applied those prohibitions to threatened species unless a special rule is promulgated under section 4(d) of the Act (“4(d) rule”) (50 CFR 17.31(c)). Under 50 CFR 17.32, permits may be issued to allow persons to engage in otherwise prohibited acts for certain purposes unless a special rule provides otherwise.
A 4(d) rule may include some or all of the prohibitions and authorizations set out at 50 CFR 17.31 and 17.32, but also may be more or less restrictive than those general provisions. For the Columbia River DPS of CWTD, the Service has determined that a 4(d) rule is necessary and appropriate for the conservation of the species. As a means to provide continued protection from take and also to facilitate both conservation of CWTD in the Columbia River DPS and to facilitate natural expansion of their range by increasing flexibility in management activities for our State and Tribal partners and private landowners, we are issuing a rule for this species under section 4(d) of the Act.
Under this 4(d) rule, take will generally continue to be prohibited but the following forms of take are allowed:
• Take by landowners or their agents conducting intentional harassment not likely to cause mortality if they have obtained a permit from the applicable State conservation agency;
• Take of problem CWTD (as defined under Provisions of the 4(d) Rule, below) by Federal or State wildlife management agency staff, or private landowners acting in accordance with a permit obtained from a State conservation agency;
• Take by private landowners that is accidental and incidental to an otherwise permitted and lawful activity to control damage by black-tailed deer, and if reasonable due care was practiced to avoid such taking;
• Take by black-tailed deer hunters if the take was accidental and incidental to hunting done in full compliance with the State hunting rules, and if
• Take by designated Tribal employees and State and local law enforcement officers to deal with sick, injured, or orphaned CWTD;
• Take by State-licensed wildlife rehabilitation facilities when working with sick, injured, or orphaned CWTD; and
• Take under permits issued by the Service under 50 CFR 17.32.
Other than these exceptions, the provisions of 50 CFR 17.31(a) and (b) apply.
The 4(d) rule targets these activities to facilitate conservation and management of CWTD where they currently occur through increased flexibility for State wildlife management agencies, and to encourage landowners to facilitate the expansion of the CWTD's range by increasing the flexibility of management of the deer on their property (see Justification, below). Activities on Federal lands or with any Federal agency involvement will still need to be addressed through consultation under section 7 of the Act. Take of CWTD in defense of human life in accordance with 50 CFR 17.21(c)(2) or by the Service or designated employee of a State conservation agency responding to a demonstrable but non-immediate threat to human safety in accordance with 50 CFR 17.21(c)(3)(iv) (primarily in the event that a deer interferes with traffic on a highway) is not prohibited. Any deterrence activity that does not create a likelihood of injury by significantly disrupting normal CWTD behavioral patterns such as breeding, feeding, or sheltering is not take and is therefore not prohibited under section 9. Non-injurious deterrence activities for CWTD damage control may include yelling at the deer, use of repellents, fencing and other physical barriers, properly deployed noise-making devices (including explosive devices such as propane cannons, cracker shells, whistlers, etc.), scarecrows, plant protection devices (bud caps, netting, tree tubes, etc.), and artificial lighting.
If there is potential that an activity would interrupt normal CWTD behavior to the point where the animal would stop feeding or not find adequate cover, creating a likelihood of injury, then the activity would have the potential to cause take in the form of harassment. Under this 4(d) rule, if the activity is not likely to be lethal to CWTD, it is classified as intentional harassment not likely to cause mortality and is allowed if the activity is carried out under and according to a legally obtained permit from the Oregon or Washington State conservation agency. Actions that may create a likelihood of injury, but are determined by State wildlife biologists not likely to cause mortality, may include the use of nonlethal projectiles (including paintballs, rubber bullets, pellets or “BB's” from spring- or air-propelled guns, etc.) or herding or harassing with dogs, and are only allowed if the activity is carried out under and according to a legally obtained permit from the Oregon or Washington State conservation agency.
This 4(d) rule allows a maximum of 5 percent of the DPS to be lethally taken annually for the following activities combined: (1) Damage management of problem CWTD, (2) misidentification during black-tailed deer damage management, and (3) misidentification during black-tailed deer hunting. The identification of a problem CWTD will occur when the State conservation agency or Service determines in writing that: (1) A CWTD is causing more than
The current estimated population of the DPS is 966 deer; therefore 5 percent would currently equate to 48 deer. We will set the allowable take at 5 percent of the most current annual November population estimate of the DPS based on FLIR surveys and ground counts to provide sufficient flexibility to our State wildlife agency partners in the management of CWTD and to strengthen our partnership in the recovery of the DPS. Although the fecundity and overall recruitment rate is strong and will allow the DPS to persist and continue to recover even with take up to the maximum allowable 5 percent, we do not expect that the number of deer taken per year will ever exceed 2 percent of the DPS per year for several reasons. First, no CWTD have been injured or killed as a result of management activities because damage management activities have not been required for successfully translocated CWTD, although most translocations were to NWR lands. We anticipate that the necessity of damage management activities may increase as the CWTD population increases and as CWTD are able to disperse to areas previously unavailable, such as those agricultural areas surrounding the Ridgefield NWR. Furthermore, the Service expects that most CWTD will respond to non-injurious or nonlethal means of dispersal so that lethal take of problem CWTD will not often be necessary. We are, therefore, confident that the amount of CWTD lethally taken under this 4(d) rule during CWTD damage management actions will be relatively low. Additionally, the Service expects that the potential for accidental shooting by mistaking a CWTD for a black-tailed deer will be low because there has been only one documented case of an accidental shooting of CWTD by a black-tailed deer hunter due to misidentification (Bergh 2014, pers. comm.) and there have been no documented accidental shootings of CWTD during black-tailed deer damage management. The 2015 big game hunting regulations in both Oregon and Washington provide information on distinguishing black-tailed deer from CWTD and make it clear that shooting CWTD from the Columbia River DPS is illegal under State law (Oregon Department of Fish and Wildlife 2015, p. 39; Washington Department of Fish and Wildlife 2015, pp. 18, 20). Even with this 4(d) rule in place, a hunter who shot a CWTD due to misidentification will still be required under the Act to report the incident to the Service, be required under State law to report the incident to State authorities, and be subject to potential prosecution under the discretion of State law.
Because the maximum amount of take allowed for these activities is a percentage of the DPS population in any given year, the exact number of CWTD allowed to be taken will vary from year to year in response to each calendar year's most current estimated population. As mentioned above, we do not expect that the number of deer taken will ever exceed 2 percent of the DPS per year. If take does exceed 2 percent of the DPS population in a given year, the Service will convene a meeting with the Oregon and Washington Departments of Fish and Wildlife to discuss CWTD management and strategies to minimize further take from these activities for the rest of the year. If take should exceed 5 percent of the total DPS population in any given year, no further take will be allowed for these activities in the DPS as a whole, and, should any further take occur, it would be subject to potential prosecution under the Act.
We encourage any landowner concerned about potential take of listed species on their property that is not covered under this rule (see Regulation Promulgation, below) to contact the Service to explore options for developing a safe harbor agreement or habitat conservation plan that can provide for the conservation of the species and offer management options
As habitat destruction remains a threat to the species, continued application of the prohibition on harm is needed to discourage significant habitat modification that would kill or injure CWTD. In addition, in light of the relatively small size of the subpopulations and the history of overutilization of CWTD, the species is vulnerable to hunting and poaching unless the prohibitions on take are generally maintained. As the Columbia River DPS of CWTD grows in number and range, however, the deer are facing increased interaction and potential conflict with the human environment. Reclassification of the Columbia River DPS of CWTD from endangered to threatened status under the Act allows employees of State conservation agencies operating a conservation program pursuant to the terms of a cooperative agreement with the Service in accordance with section 6(c) of the Act, and who are designated by their agencies for such purposes, and who are acting in the course of their official duties, to take CWTD to carry out conservation programs (see 50 CFR 17.31(b)). There are many activities carried out or managed by the States, Tribes, and private landowners that help reduce conflict with CWTD and thereby facilitate the movement of CWTD across the landscape, but would not be afforded take allowance under reclassification alone. These activities include CWTD damage management, black-tailed deer damage management, and black-tailed deer hunting. The 4(d) rule provides incentive to States, Tribes, and private landowners to support the movement of CWTD across the landscape by alleviating concerns about unauthorized take of CWTD.
One of the limiting factors in the recovery of the Columbia River DPS has been the concern of landowners and State wildlife agencies regarding CWTD on their property due to the potential property damage from the species. Landowners express concern over their inability to prevent or address the damage because of the threat of penalties under the Act. These concerns may lead landowners to modify unoccupied habitat in such a way that it could no longer support deer or to erect fences or other manmade structures to exclude deer from their lands. If landowners take actions to deter CWTD from areas where they could occur to avoid the burden of take restrictions, then natural range expansion and connectivity on the landscape could be negatively impacted. Increased management flexibility is intended to create an incentive for private landowners to voluntarily maintain, create, or restore habitat for the benefit of CWTD. Furthermore, State wildlife agencies expend resources addressing landowner complaints regarding potential CWTD damage to their property, or concerns from black-tailed deer hunters who are hunting legally but might accidentally shoot a CWTD even after reasonable due care was practiced to avoid such taking. For instance, the majority of translocation efforts have moved CWTD to refuge lands; however, some areas of State and private land offer high-quality habitat for CWTD, and future translocations to these areas would benefit the species by either creating a new subpopulation or creating connectivity between existing subpopulations. Small-scale agricultural lands, especially, can provide potential habitat for CWTD, as demonstrated on Puget Island, as opposed to other types of land management changes. By providing more flexibility to the States, Tribes, and landowners regarding management of CWTD, we expect to enhance support for both the movement of CWTD within areas where they already occur, as well as the expansion of the subspecies' range into additional areas of Washington and Oregon through translocations. In addition, easing the general take prohibitions on non-Federal agricultural lands is intended to encourage continued responsible land uses that provide an overall benefit to CWTD and facilitate private lands partnerships that promote conservation efforts.
The 4(d) rule addresses intentional CWTD damage management by private landowners and State and Tribal agencies; black-tailed deer damage management and hunting; and management of sick, injured, and orphaned CWTD by Tribal employees, State and local law enforcement officers, and State licensed wildlife rehabilitation facilities. Addressing these targeted activities that may normally result in take under section 9 of the Act increases the incentive for landowners and land managers to allow CWTD on their property, and provides enhanced options for State wildlife agencies with respect to CWTD damage management and black-tailed deer management, thereby encouraging the States' participation in recovery actions for CWTD.
The actions and activities allowed under the 4(d) rule, while they may have some minimal level of harm or disturbance to individual CWTD in the Columbia River DPS, are not expected to adversely affect efforts to conserve and recover the DPS. In fact, conservation efforts should be facilitated by increasing the likelihood of natural range expansion, providing support for translocations onto State and Tribal lands, and creating private lands partnerships to promote conservation efforts throughout the current range of the DPS. The take of CWTD from these activities will be strictly limited to a maximum of 5 percent of the most current annual DPS population estimate in order to have a negligible impact on the overall DPS population. Though there would be a chance for lethal take to occur, recruitment rates appear to be high enough in the DPS to allow for continued population growth despite the take that is allowed in this final rule. For example, the Service removed 34 CWTD, which constituted 20 percent of the subpopulation, from Puget Island for translocations in 2012. The estimated size of the subpopulation on Puget Island was 228 CWTD in 2015, representing an average annual population growth rate of 16 percent. If the subpopulation continues to grow 16 percent each year, then removing a maximum of 5 percent would still allow the subpopulation, and the DPS as a whole, to continue to grow.
For the reasons described above, we find that it is necessary and advisable to apply the provisions of 50 CFR 17.31(a), which prohibit take of threatened species, with exceptions intended to facilitate the growth and expansion of CWTD subpopulations within the DPS required to achieve recovery. By generally extending section 9 take prohibitions but allowing take under specified circumstances, the rule will provide needed protection to the species while allowing management flexibility to benefit the species' long-term conservation. Thus, the provisions of this rule meet the statutory requirement under section 4(d) of the Act of being necessary and advisable to provide for the conservation of the species.
The increased interaction of CWTD with the human environment increases the potential for property damage caused by CWTD, as well as the potential for conflict with legal black-tailed deer management activities. Therefore, this 4(d) rule applies the prohibitions of 50 CFR 17.31(a) with some exceptions to increase the flexibility of CWTD management for the States, Tribes, and private landowners by allowing take of CWTD resulting from CWTD damage management, and
A State conservation agency will be able to issue permits to landowners or their agents to harass CWTD on lands they own, rent, or lease if the State conservation agency determines in writing that such action is not likely to cause mortality of CWTD. The techniques employed in this harassment must occur only as specifically directed or restricted by the State permit in order to avoid causing CWTD mortality. The State conservation agency will also be able to issue a permit to landowners or their agents to lethally take problem CWTD on lands they own, rent, or lease if the State conservation agency or Service determines in writing that: (1) The CWTD are causing more than
Take of CWTD in the course of carrying out black-tailed deer damage control will be a violation of this rule unless: The taking was accidental; reported within 72 hours; reasonable care was practiced to avoid such taking; and the person causing the take was in possession of a valid black-tailed deer damage control permit from a State conservation agency. Take of CWTD in the course of hunting black-tailed deer will be a violation of this rule unless: (1) The take was accidental; (2) the take was reported within 72 hours; (3) the take was in the course of hunting black-tailed deer under a lawful State permit; and (4) reasonable due care was exercised to avoid such taking.
The increased interaction of CWTD with the human environment increases the likelihood of encounters with injured or sick CWTD. Therefore, take of CWTD will also be allowed by Tribal employees, State and local government law enforcement officers, and State-licensed wildlife rehabilitation facilities to provide aid to injured or sick CWTD. Tribal employees and local government law enforcement officers will be allowed take of CWTD for the following purposes: (1) Aiding or euthanizing sick, injured, or orphaned CWTD; (2) disposing of a dead specimen; and (3) salvaging a dead specimen that may be used for scientific study. State-licensed wildlife rehabilitation facilities will also be allowed to take CWTD for the purpose of aiding or euthanizing sick, injured, or orphaned CWTD.
We have determined that an environmental assessment or an environmental impact statement, as defined under the authority of the National Environmental Policy Act of 1969 (42 U.S.C. 4321
In accordance with the President's memorandum of April 29, 1994, Government-to-Government Relations with Native American Tribal Governments (59 FR 22951), Executive Order 13175 (Consultation and Coordination with Indian Tribal Governments), and the Department of the Interior's manual at 512 DM 2, we readily acknowledge our responsibility to communicate meaningfully with recognized Federal Tribes on a government-to-government basis. In accordance with Secretarial Order 3206 of June 5, 1997 (American Indian Tribal Rights, Federal-Tribal Trust Responsibilities, and the Endangered Species Act), we readily acknowledge our responsibilities to work directly with Tribes in developing programs for healthy ecosystems, to acknowledge that Tribal lands are not subject to the same controls as Federal public lands, to remain sensitive to Indian culture, and to make information available to Tribes.
We have coordinated the development of this reclassification and 4(d) rule with the Cowlitz Indian Tribe, which manages land where one subpopulation of CWTD population is located, Cottonwood Island. Biologists from the Cowlitz Indian Tribe are members of the CWTD Working Group and have worked with the Service, WDFW, and ODFW to incorporate conservation measures to benefit CWTD into their management plan for the island.
A complete list of all references cited in this rule is available at
The primary authors of this final rule are staff members of the Oregon Fish and Wildlife Office in Portland, Oregon (see
Endangered and threatened species, Exports, Imports, Reporting and recordkeeping requirements, Transportation.
Accordingly, we amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as set forth below:
16 U.S.C. 1361-1407; 1531-1544; and 4201-4245, unless otherwise noted.
(h) * * *
(i) Columbian white-tailed deer (
(2)
(i)
(ii)
(iii)
(A) The CWTD is causing more than
(B) Previous efforts to alleviate the damage through nonlethal methods have been ineffective; and
(C) There is a reasonable certainty that additional property losses will occur in the near future if a lethal control action is not implemented.
(iv)
(v)
(3)
(i) Intentional harassment not likely to cause mortality. A State conservation agency may issue permits to landowners or their agents to harass CWTD on lands they own, rent, or lease if the State conservation agency determines in writing that such action is not likely to cause mortality of CWTD. The techniques employed in this harassment must occur only as specifically directed or restricted by the State permit in order to avoid causing CWTD mortality.
(ii) Take of problem CWTD resulting in mortality. Take of problem CWTD is authorized under the following circumstances:
(A) Any employee or agent of the Service or the State conservation agency, who is designated by their agency for such purposes, may, when acting in the course of their official duties, take problem CWTD. This take must occur in compliance with all other applicable Federal, State, and local laws and regulations.
(B) The State conservation agency may issue a permit to landowners or their agents to take problem CWTD on lands they own, rent, or lease. Such take must be implemented only as directed and allowed in the permit obtained from the State conservation agency.
(iii) Accidental take of CWTD when carrying out State-permitted black-tailed deer damage control. Take of CWTD in the course of carrying out black-tailed deer damage control will be a violation of this rule unless the taking was accidental; reasonable care was practiced to avoid such taking; and the person causing the take was in possession of a valid black-tailed deer damage control permit from a State conservation agency. When issuing black-tailed deer damage control permits, the State conservation agency will provide education regarding identification of target species. The exercise of reasonable care includes, but is not limited to, the review of the educational material provided by the State conservation agency and identification of the target before shooting.
(iv) Accidental take of CWTD when carrying out State-permitted black-tailed deer hunting. Take of CWTD in the course of hunting black-tailed deer will be a violation of this rule unless the take was accidental; the take was in the course of hunting black-tailed deer under a lawful State permit; and reasonable due care was exercised to avoid such taking. The State conservation agency will provide educational material to hunters regarding identification of target species when issuing hunting permits. The exercise of reasonable care includes, but is not limited to, the review of the educational materials provided by the State conservation agency and identification of the target before shooting.
(4)
(5)
(6)
(A) Aiding or euthanizing sick, injured, or orphaned CWTD;
(B) Disposing of a dead specimen; and
(C) Salvaging a dead specimen that may be used for scientific study.
(ii) Such take must be reported to the Service within 72 hours, and specimens may be disposed of only in accordance with directions from the Service.
(7)
(8)
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; closure.
NMFS implements accountability measures (AMs) for commercial king mackerel in the western zone of the Gulf of Mexico (Gulf) exclusive economic zone (EEZ) through this temporary rule. NMFS has determined that the commercial quota for king mackerel in the western zone of the Gulf EEZ will be reached by October 14, 2016. Therefore, NMFS closes the western zone of the Gulf EEZ to commercial king mackerel fishing on October 14, 2016. This closure is necessary to protect the Gulf king mackerel resource.
The closure is effective at noon, local time, October 14, 2016, until 12:01 a.m., local time, on July 1, 2017.
Susan Gerhart, NMFS Southeast Regional Office, telephone: 727-824-5305, email:
The fishery for coastal migratory pelagic fish (king mackerel, Spanish mackerel, and cobia) is managed under the Fishery Management Plan for the Coastal Migratory Pelagic Resources of the Gulf of Mexico and South Atlantic (FMP). The FMP was prepared by the Gulf of Mexico and South Atlantic Fishery Management Councils (Councils) and is implemented by NMFS under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622.
The commercial quota for the Gulf migratory group king mackerel in the Gulf western zone is 1,071,360 lb (485,961 kg) for the current fishing year, July 1, 2016, through June 30, 2017 (50 CFR 622.384(b)(1)(ii)).
Regulations at 50 CFR 622.388(a)(1)(i) require NMFS to close the commercial sector for Gulf migratory group king mackerel in the western zone when the commercial quota is reached, or is projected to be reached, by filing a notification to that effect with the Office of the Federal Register. NMFS has determined the commercial quota of 1,071,360 lb (485,961 kg) for Gulf migratory group king mackerel in the western zone will be reached by October 14, 2016. Accordingly, the western zone is closed to commercial fishing for Gulf migratory group king mackerel effective at noon, local time, October 14, 2016, through June 30, 2017, the end of the current fishing year. The western zone of Gulf migratory group king mackerel is that part of the EEZ between a line extending east from the border of the United States and Mexico and 87°31.1′ W. long., which is a line extending south from the state boundary of Alabama and Florida.
Except for a person aboard a charter vessel or headboat, during the closure no person aboard a vessel that has been issued a Federal commercial permit for king mackerel may fish for or retain Gulf migratory group king mackerel in the EEZ in the closed zone (50 CFR 622.384(e)(1)). A person aboard a vessel that has a valid Federal charter vessel/headboat permit for coastal migratory pelagic fish may continue to retain king mackerel in or from the closed zone under the recreational bag and possession limits set forth in 50 CFR 622.382(a)(1)(ii) and (a)(2), provided the vessel is operating as a charter vessel or headboat (50 CFR 622.384(e)(2)). A charter vessel or headboat that also has a commercial king mackerel permit is considered to be operating as a charter vessel or headboat when it carries a passenger who pays a fee or when there are more than three persons aboard, including operator and crew.
During the closure, king mackerel from the closed zone, including those harvested under the bag and possession limits, may not be purchased or sold. This prohibition does not apply to king mackerel from the closed zone that were harvested, landed ashore, and sold prior to the closure and were held in cold storage by a dealer or processor (50 CFR 622.384(e)(3)).
The Regional Administrator, Southeast Region, NMFS, has determined this temporary rule is necessary for the conservation and management of Gulf migratory group king mackerel and is consistent with the Magnuson-Stevens Act and other applicable laws.
This action is taken under 50 CFR 622.388(a)(1)(i) and 622.384(e), and is
These measures are exempt from the procedures of the Regulatory Flexibility Act because the temporary rule is issued without opportunity for prior notice and comment.
This action responds to the best scientific information available. The Assistant Administrator for NOAA Fisheries (AA) finds good cause to waive the requirements 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 procedures are unnecessary and contrary to the public interest. Such procedures are unnecessary because the rule implementing the commercial quota and the associated AMs has already been subject to notice and public comment, and all that remains is to notify the public of the closure. Additionally, allowing prior notice and opportunity for public comment is contrary to the public interest because of the need to immediately implement this action to protect the king mackerel stock, because the capacity of the fishing fleet allows for rapid harvest of the commercial quota. Prior notice and opportunity for public comment would require time and could potentially result in a harvest well in excess of the established commercial quota.
For the aforementioned reasons, the AA also finds good cause to waive the 30-day delay in the effectiveness of this action under 5 U.S.C. 553(d)(3).
16 U.S.C. 1801
U.S. Office of Special Counsel.
Notice of proposed rulemaking and related information collection activity; Correction.
This document corrects the Addresses section to a proposed rule published in the
Kenneth Hendricks, (202) 254-3600.
In proposed rule FR Doc. 2016-20527, on page 1 in the issue of September 2, 2016, make the following correction in the
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
The FAA is proposing to revise its rules for pilot compartment view to allow ground tests to demonstrate compliance for night operations. The current regulations require night flight testing to demonstrate compliance, which is not necessary in every case. The proposed rule would relieve the burden of performing a night flight test under certain conditions.
Send comments on or before November 16, 2016.
Send comments identified by docket number (Docket No.: FAA-2016-9275) using any of the following methods:
•
•
•
•
For technical questions concerning this action, contact Clark Davenport, Aviation Safety Engineer, Safety Management Group, Rotorcraft Directorate, FAA, 10101 Hillwood Pkwy, Fort Worth, TX 76177; telephone (817) 222-5151; email
The FAA's authority to issue rules on aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority.
This rulemaking is issued under the authority described in Subtitle VII, Part A, Subpart III, Sections 44701 and 44704. Under that section, the FAA is charged with prescribing regulations promoting safe flight of civil aircraft in air commerce by prescribing minimum standards required in the interest of safety for the design and performance of aircraft. Under section 44704, the Administrator issues type certificates for aircraft, aircraft engines, propellers, and specified appliances when the Administrator finds the product is properly designed and manufactured, performs properly, and meets the regulations and minimum standards prescribed under section 44701(a). This regulation is within the scope of these authorities because it would promote safety by updating the existing minimum prescribed standards used during the type certification process to address an equivalent method of showing compliance.
The FAA's rules on airworthiness standards for the pilot compartment in rotorcraft and the requirements for each pilot's view from that compartment are located in parts 27 and 29 of title 14 of
Currently, §§ 27.773(b) and 29.773(b) require all applicants for certification for night operations to conduct a night flight test to show compliance with §§ 27.773(a) and 29.773(a). While manufacturers of newly type certificated rotorcraft will conduct night flight tests to comply with other rules and do not view this requirement as a significant additional burden, supplemental type certificate (STC) and field approval applicants have questioned the night flight test requirement for changes to the rotorcraft type design. STC and field approval applicants who add a piece of avionics equipment that minimally changes the lighting characteristics of the cockpit, for example a navigation or communication radio, have stated the requirement for a flight test is too costly compared to the scope of the modification.
As an alternative, the applicants have proposed performing a ground test simulating night conditions. In some cases, a ground test will meet the requirements of §§ 27.773(b) and 29.773(b) while significantly reducing the cost and burden to the applicant.
Upon review of the flight test requirements in §§ 27.773(b) and 29.773(b), based on the feedback received from numerous applicants, the FAA proposes to allow a ground test as an alternative to a night flight test in certain cases to show compliance for night operations. The FAA has determined that internal lighting modifications can be evaluated with a ground test, whereas external lighting modifications may require a flight test. For example, the applicant could demonstrate compliance by creating an environment where external light is blocked from entering the cockpit or where the rotorcraft is placed in a darkened hangar, paint booth, or other environment. In such a situation, the FAA has concluded that a ground test should provide the same level of safety as the existing regulations. The conditions under which a ground test would be acceptable and an acceptable means of compliance for the ground test would be addressed in Advisory Circular (AC) 27-1B, Certification of Normal Category Rotorcraft and AC 29-2C, Certification of Transport Category Rotorcraft.
Though the proposed rule would allow applicants to show compliance either by a flight test or ground test, it would not preclude the use of a night flight test. An applicant may conduct a flight test at night for other reasons and choose to use that flight to show compliance with §§ 27.773 or 29.773. The FAA finds that the proposed change to allow a ground test as an option would be relieving to industry.
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) requires agencies to analyze the economic impact of regulatory changes on small entities. Third, the Trade Agreements Act (Pub. L. 96-39) prohibits agencies from setting standards that create unnecessary obstacles to the foreign commerce of the United States. In developing U.S. standards, the Trade Act requires agencies to consider international standards and, where appropriate, that they be the basis of U.S. standards. Fourth, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires agencies to prepare a written assessment of the costs, benefits, and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, of $100 million or more annually (adjusted for inflation with base year of 1995). This portion of the preamble summarizes the FAA's analysis of the economic impacts of this proposed rule. Department of Transportation Order DOT 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 to be included in the preamble if a full regulatory evaluation of the cost and benefits is not prepared. Such a determination has been made for this proposed rule. The reasoning for this determination follows. The current regulations require night flight testing to demonstrate compliance for night operations. The proposed rule provides a ground test as an alternative to a night flight test in certain cases, such as internal lighting modifications. The requirements for a ground test are less stringent than a night flight test. Thus, the proposed rule would relieve the industry from the burden of performing a night flight test under certain conditions. The expected outcome would be a minimal economic impact with positive net benefits, and a regulatory evaluation was not prepared. The FAA requests comments with supporting justification about the FAA determination of minimal economic impact. The FAA has, therefore, determined that this proposed rule is not a “significant regulatory action” as defined in section 3(f) of Executive Order 12866, and is not “significant” as defined in DOT's Regulatory Policies and Procedures.
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 proposed rule provides a ground test as an alternative to a night flight test in certain cases, such as internal lighting modifications. The requirements for a ground test are less stringent than a night flight test. Thus, the proposed rule would relieve the industry from the burden of performing a night flight test under certain conditions. The expected outcome would be a minimal economic impact with positive net benefits on any small entity affected by this rulemaking action.
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 proposed rule and determined that offers potential regulatory relief to both domestic and international entities—thus does 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 million in lieu of $100 million. This proposed 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 would be no new requirement for information collection associated with this proposed 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 determined that there are no ICAO Standards and Recommended Practices that correspond to these proposed 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 proposed rule under the principles and criteria of Executive Order 13132, Federalism. The agency has determined that this action would 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 proposed 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 would not be a “significant energy action” under the executive order and would not be likely to have a significant adverse effect on the supply, distribution, or use of energy.
Executive Order 13609, Promoting International Regulatory Cooperation, 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.
The FAA invites interested persons to participate in this rulemaking by submitting written comments, data, or views. The agency also invites 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.
The FAA will file in the docket all comments it receives, as well as a report summarizing each substantive public contact with FAA personnel concerning this proposed rulemaking. Before acting on this proposal, the FAA will consider all comments it receives on or before the closing date for comments. The FAA will consider comments filed after the comment period has closed if it is possible to do so without incurring expense or delay. The agency may change this proposal in light of the comments it receives.
An electronic copy of rulemaking documents may be obtained from the Internet by—
1. Searching the Federal eRulemaking Portal (
2. Visiting the FAA's Regulations and Policies Web page at
3. Accessing the Government Printing Office's Web page at
Copies may also be obtained by sending a request to the Federal Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence Avenue SW., Washington, DC 20591, or by calling (202) 267-9680. Commenters must identify the docket or notice number of this rulemaking.
All documents the FAA considered in developing this proposed rule, including economic analyses and technical reports, may be accessed from the Internet through the Federal eRulemaking Portal referenced in item (1) above.
Aircraft, Aviation safety
Aircraft, Aviation safety
In consideration of the foregoing, the Federal Aviation Administration proposes to amend chapter I of title 14, Code of Federal Regulations as follows:
49 U.S.C. 106(g), 40113, 44701-44702, 44704.
(b) If certification for night operation is requested, compliance with paragraph (a) of this section must be shown by ground or night flight tests.
49 U.S.C. 106(g), 40113, 44701-44702, 44704.
(a) * * *
(2) Each pilot compartment must be free of glare and reflection that could interfere with the pilot's view. If certification for night operation is requested, this must be shown by ground or night flight tests.
Food and Drug Administration, HHS.
Proposed rule.
The Food and Drug Administration (FDA) is proposing to implement provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to require electronic submission of the device label and package insert of certain home-use devices when these devices are listed with FDA. FDA plans to make this device labeling available to the public through the Internet and would also provide search tools to facilitate locating information concerning a particular home-use device or a particular type of home-use device.
Submit either electronic or written comments on the proposed rule by January 17, 2017. In accordance with 21 CFR 10.40(c), in finalizing this rulemaking FDA will review and consider all comments submitted before the time for comment on this proposed regulation has expired.
Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by November 16, 2016; see section VI, the “Information Collection Requirements” section of this document. See section VIII of this document for the proposed effective date of a final rule based on this proposed rule.
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
Submit comments on information collection issues to the Office of Management and Budget in the following ways:
• Fax to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or email to
Antoinette (Tosia) Hazlett, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5424, Silver Spring, MD 20993, 301-796-6119, email:
FDA is proposing to require certain medical device establishments listing devices under section 510(j) of the FD&C Act (21 U.S.C. 360(j)), if the device is labeled for home use, to submit the device label and package insert of such listed medical device, in the electronic format mandated in the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Pub. L. 110-85), when the device is listed with FDA. (See section 510(p) of the FD&C Act.) FDA plans to make this device labeling information available to the public through an FDA-managed or partner Internet Web site.
The electronic submission requirements of the proposed rule would be limited to only devices labeled for home use that are regulated by the Center for Devices and Radiological Health (CDRH) as class II and class III devices. For purposes of the proposed rule, a “home-use device” is any medical device that is labeled for use outside a professional health care facility. Sampling information indicates that this device group has a higher risk of misuse due to lost or misplaced labeling and operating instructions. In addition, the proposed rule would allow the voluntary electronic submission of device labels and package inserts for any class I home-use device or other home-use device not subject to the electronic submission requirements of the rule.
FDA is issuing the provisions of this proposed rule that would implement the listing requirement for the submission of labels and package inserts for home-use medical devices under section 510(j) and section 701(a) (21 U.S.C. 371(a)) of the FD&C Act, which provides FDA the authority to issue regulations for the efficient enforcement of the FD&C Act. Section 510(p) of the FD&C Act requires that registrations and listings under section 510 be submitted to the Secretary by electronic means unless the Secretary grants a request for waiver because the use of electronic means is not reasonable for the person requesting such waiver.
FDA will use the existing FDA's Unified Registration and Listing System (FURLS) database and software systems to receive the submitted electronic labeling information and will bear the incremental cost of launching and maintaining the FDA-managed or partner Web site to display and make the submitted information available for the public to search and retrieve. The
The Medical Device Amendments of 1976 amended section 510(j) of the FD&C Act to add requirements for registration of device establishments and listing of medical devices. Section 510(j) requires that every person who registers shall list all devices manufactured, prepared, propagated, compounded, or processed by him for commercial distribution. The statute provides that, for all devices subject to the listing requirement, the list must be accompanied by copies of the device label and, as defined in this proposed rule, the package insert. (See section 510(j)(1)(B)(ii) of the FD&C Act.) Our definition of “package insert” in this proposed rule would apply only to proposed subpart F. The statute also provides additional listing requirements for the submission of labeling and advertising for certain categories of devices (see section 510(j)(1)(A) and 510(j)(1)(B)(i) of the FD&C Act), which are not relevant to this proposed rulemaking.
When section 510(j) was added to the FD&C Act in 1976, and for many years thereafter, medical device registration and listing required the submission of paper forms to FDA. The forms had to be manually transcribed by FDA into its data systems, and the data stored primarily on reels of magnetic tape and floppy disks. There was no practical way for FDA to compile, update, or access the information submitted on these forms, much less provide routine public access to the information.
Taking these factors into consideration, when FDA proposed regulations regarding the device listing requirements, we explained that, instead of requiring the submission of “information that FDA may not have immediate need for, and unless constantly updated by the owner or operator, would be out of date when needed,” FDA by regulation would require that the owner or operator maintain a historical file of labels, labeling, and for restricted devices, advertisements, and make all or part of that file available to FDA upon request. (See 42 FR 52808 at 52809 (September 30, 1977).) That approach has remained in place since the final rule was issued in 1978 (43 FR 37990 (August 25, 1978)). The regulation made clear that FDA could require the submission of device labeling upon request by letter. Id.
In 2002, Congress recognized the technological and practical impact of the Internet when it passed the Medical Device User Fee and Modernization Act (MDUFMA) (Pub. L. 107-250). Section 206 of MDUFMA amended section 502(f) of the FD&C Act (21 U.S.C. 352(f)) to authorize electronic labeling for a device intended for use in health care facilities, provided the manufacturer afforded health care facilities the opportunity to request the labeling in paper form without additional cost. Section 207 of MDUFMA added section 510(p) to the FD&C Act, giving FDA the authority to collect registrations and listings “by electronic means” at such time as FDA determined it was feasible to receive such information through electronic means. In doing so, Congress observed the following:
The Internet and increased computer usage have created a preference in many users for information for use applicable to prescription devices in electronic form. Even casual users of computers have become used to receiving electronic information . . . . The [legislation] conforms FDA practice to the norm by allowing manufacturers to provide healthcare facilities (such as hospitals, doctors' offices and clinics) labeling in this alternative medium . . . . This will better allow manufacturers to provide such facilities with information that is more robust, up-to-date, and user-friendly. . . Given the increased reliance on computer usage, [MDUFMA section 207] requires manufacturers to provide registration information required under section 510 by electronic means . . . upon a finding by [FDA] . . . that electronic receipt of such information is feasible. . . .
Subsequently, section 224 of FDAAA struck the language that required FDA to make a finding that receipt of electronic submissions “is feasible” and instead made the submission of registration and listing information by electronic means mandatory in all instances, except where FDA grants a request for waiver of the requirement for a person for whom electronic submission “is not reasonable.” (See section 510(p) of the FD&C Act.)
This preamble explains how FDA is proposing to further implement sections 510(j) and 510(p) of the FD&C Act, by amending FDA's listing regulations to require the submission of electronic versions of the label and package insert for certain home-use medical devices when these devices are listed with FDA. For purposes of this proposed rule, the term “home-use device” would mean a medical device labeled for use in any environment outside a professional health care facility.
A “professional health care facility” is either (1) any environment where personnel with medical training are continually available to oversee or administer the use of medical devices, including, but not limited to, hospitals, long-term care facilities, nursing homes, emergency medical services, clinics, physicians' offices, and outpatient treatment facilities; or (2) a clinical laboratory. A “clinical laboratory” is a facility that (1) performs testing on materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or assessment of the health of, human beings; and (2) has been certified to perform such testing under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) (42 U.S.C. 263a) in accordance with 42 CFR part 493, or is CLIA-exempt. These definitions of “professional health care facility” and “clinical laboratory” are only meant to provide guidance as to the application of proposed subpart F and are not meant for any other purpose, including the application of 42 U.S.C. 263a and 42 CFR part 493.
FDA is proposing that the home-use devices that would be subject to this proposed rule, if finalized, are those that are regulated by CDRH as class II or class III devices. This proposed rule would not apply to any class I devices, nor would it apply to devices regulated by the Center for Biologics Evaluation and Research (CBER), except to allow the voluntary submission of a device's label and package insert for such home-use devices under proposed § 807.220(a) (21 CFR 807.220(a)).
This proposed rule is intended to focus on higher-risk home-use devices. Under the FDA device classification system, the Agency classifies a device into a particular class based on the level of control necessary to provide a reasonable assurance of its safety and effectiveness, with class I requiring the least amount of control and class III requiring the most. (See sections 513(a)(1)(B) and 513(a)(1)(C)(i)(I) of the FD&C Act (21 U.S.C. 360c(a)(1)(B) and 360c (a)(1)(C)(i)(I)).) The proposed rule
Home-use devices have significant public health importance to patients, caregivers, and health care professionals. But when used in an environment where a health care professional is not available to provide supervision and assistance, the Agency recognizes that these devices can present unique concerns and challenges (Ref. 1). In this preamble, we use the term “patient” to refer to any health care recipient, including someone who is not receiving care from a health care professional,
Medical devices are different from other FDA-regulated medical products—
Those people that use home-use devices are particularly vulnerable to adverse events because they may be inexperienced in the proper use and maintenance of the devices. In 2014, there were over 800,000 adverse events associated with medical devices. Our review of adverse reports that meet the criteria for faster level of review (Code Blue reports of deaths, fires, explosions, etc.) found, on average, three to five such reported events per week as having occurred in the home environment,
When a home-use device becomes separated from its labeling—and the user no longer has ready access to the important information provided in those materials, such as indications for use, contraindications, warnings, precautions, and instructions for setup, use, and maintenance of the device—the device user may be faced with serious obstacles to the safe and effective use of the device (Ref. 3). The absence of such critical information may lead to the device being used incorrectly, which could result in the delay of proper treatment or even injury to the patient. Improper use of a device can expose both the patient and caregiver to potentially serious risks—risks that could be avoided if information presented in the device's labeling was readily available. In addition, health care professionals, including emergency personnel who need to gain a rapid understanding of the operation and limitations of a device, may be left unsure as to how to best respond to a critical situation.
When the labeling that describes how to operate a device is missing, there is a higher chance that a device might be misused. CDRH has received reports of unavailable labeling for devices that could be dangerous when used by patients or caregivers outside a professional health care facility. For example, missing labeling for something as simple as a patient lift is dangerous when an elderly caregiver needs to understand how to assemble and safely operate the lift. Another example is a patient on home hemodialysis who needs to refer to available labeling for proper warnings and precautions, water type, or filters needed.
Although many manufacturers have Internet sites that provide information concerning the devices they currently market, those sites typically focus on newer products and often do not provide any information on devices that they no longer actively market. Sites also vary considerably in the types of information provided and may lack important details concerning their devices. Although some manufacturers' Web sites provide some labeling, FDA believes that most do not provide the label and package insert for all of their home-use devices listed with FDA.
The proposed rule would help to address these concerns by making it possible for FDA to establish an electronic database, published online and accessible to the public through the Internet, of labels and package inserts for listed home-use devices that would be submitted under this proposed rule. This database would fill an important gap in the information available to patients, caregivers, and the health care community concerning these home-use devices, and would allow both broad searches to identify legally marketed home-use devices that may fill a particular need and focused searches to obtain information concerning the use of a specific home-use device. In recent years, patients have become more involved in decisions concerning their health care, including the types of treatments they will undergo, the selection of specific home-use devices to be used in their treatment, and administration of the course of treatment (Ref. 4). This trend shows no signs of abating. With less day-to-day oversight by health care professionals, consumers have assumed responsibilities that have been traditionally borne by health care professionals. For example, consumers
The FDA-managed or partner Internet Web site would provide a consolidated and easily accessible source of FDA database information concerning class II and class III home-use devices, including their approval or clearance status, intended uses, limitations, setup, and operation. The FDA database would not contain identifiable private information nor provide access to “lock out” information that is not included on the device labeling but is furnished through a source referenced in the device labeling,
FDA also intends to make available the information collected under this rule through other partner Web sites that provide medical and health information to the public. For example, “Daily Med” (
The proposed rule, if finalized, would implement provisions of sections 510(j)(1)(B)(ii) and 510(p) of the FD&C Act by amending FDA's listing regulations to provide that the label and package insert must be submitted electronically to FURLS, as part of the information required to list any home-use device regulated by CDRH as a class II or class III device. Section 510(j) requires manufacturers to list their medical devices and outlines the types of information that must accompany each listing. However, this proposed rule would apply only to class II and class III home-use devices regulated by CDRH, which represents a subset of devices that are subject to section 510(j) of the FD&C Act. For class II and class III home-use devices, the rule would amend the device listing regulations to provide that establishments listing such devices must submit to FDA a copy of the label and package insert of such home-use devices, when they are listed with FDA by electronic means, in an electronic format that we will specify and not as printed (paper) copies.
Unless a request for waiver is granted, all of the information submitted to FDA under the proposed rule would have to be submitted by electronic means, as required by section 510(p) of the FD&C Act, in a format to be specified by FDA that we can process, review, and archive. Initially, we intend to allow for the submission of labels and package inserts saved in Portable Document Format (PDF). The PDF format is a broadly used format that preserves both the content and appearance of a source document (such as a device label or package insert) and which can be read on all mainstream personal computers, regardless of the operating system, using freely available software. In addition, a wide variety of software packages and operating systems allow a source document to be saved as a PDF file. FDA believes that all listing establishments are already familiar with the PDF format, and that most already have the ability to save source documents as PDF files. We intend to make available additional information that will provide details and recommendations regarding this process by the time we publish a final rule.
At a later time, we expect to provide processes for the submission of labels and package inserts based on FDA's Structured Product Labeling (SPL) document standard. This would make it easier for FDA and the public to store, retrieve, and search information in home-use device labels and package inserts. We are considering at least two such processes—one process that would make it easy for a small business with limited means to submit SPL information by manually entering or uploading the information for one product at a time on an FDA Web page (this type of process is often referred to as a “data entry” process), and a second process that would provide an efficient way to submit SPL data for multiple devices in a single submission (this type of submission process is often referred to as a “batch submission” process). We intend to provide information explaining each process as it becomes available.
FDA plans to retain all labels and package inserts submitted under this rule in FDA's FURLS database. Not all information in the FURLS database is available to the public, so we intend to make the submitted labeling accessible to the public through an FDA-managed or partner Internet Web site, such as NLM, even after a device is no longer listed. However, if FDA bans a device under section 516 of the FD&C Act (21 U.S.C. 360f), we intend to remove any label and package insert from our FURLS database and from any other FDA or partner Web site we might use and replace those materials with a statement explaining that the device has been banned. If a device is recalled, we may add a notice to the labeling database, with additional information to help ensure the safe and effective use of the device, or advice to discontinue use of the device and additional steps to take to help ensure the health and safety of the patient or user of the device.
FDA used comments from the medical device industry, health care professionals, caregivers, and patients to help formulate the objectives and define the scope of this proposed rule. In September 2009, CDRH established the “510(k) Working Group” and the “Task Force on the Utilization of Science in Regulatory Decision Making” to address concerns about how well the 510(k) program (the primary regulatory route to market for medical devices) was meeting its public health goals of
• FDA should “take steps to improve medical device labeling, and to develop an online labeling repository to allow the public to easily access this information.” (Ref. 5)
• FDA should “revise existing regulations to clarify the statutory listing requirements for the submission of labeling.” (Ref. 6)
• FDA should “explore the feasibility of requiring manufacturers to electronically submit final device labeling to FDA . . . and also to provide regular, periodic updates to device labeling, potentially as part of annual registration and listing or through another structured electronic collection mechanism.” (Ref. 6)
The preliminary reports also recommended that if FDA requires submission of device labels, they be “posted as promptly as feasible on the Center's public 510(k) database.” (Ref. 6)
FDA received comments on these recommendations from industry, consumer, and health care professional groups. Some industry representatives expressed concern regarding the potential for disclosure of confidential or proprietary information. According to some industry representatives, device-specific information on device labels is not necessarily appropriate for the general public, but rather is intended for physicians or other health care professionals and may cause confusion if they are made available in a public database. Furthermore, industry suggested that the responsibility for disseminating labeling should rest solely with the manufacturer and should remain in the manufacturer's control. Industry also stated that many updates to labeling are made for marketing purposes and not related to regulatory requirements or device alterations.
Consumer and health care professional groups supported the recommendation of the 2010 510(k) Working Group and the Task Force preliminary reports. Their comments noted that providing access to online labeling resources would facilitate better-informed clinical decisionmaking.
In January 2011, FDA issued a “Plan of Action” outlining steps we will take to improve the 510(k) program and explaining our views and responses to comments we received concerning recommendations made in the August 2010 preliminary reports (Ref. 7). FDA agreed with comments that making labeling readily available could lead to better-informed clinical decisionmaking. Just as the FDA's central database for drug labeling conveys a public health benefit, we believe that a similar database for devices would be of significant benefit to the public health by providing useful information to health care professionals and patients. Although submission of labels and certain other labeling for all devices is a statutory requirement, FDA determined that it was important to seek additional stakeholder input at a public meeting before proposing any regulatory changes.
FDA held another public meeting in April 2011, specifically to discuss options, benefits, costs, and concerns regarding the collection of device labels and certain labeling and means of making the resulting information available to the public, including industry, health care professionals, caregivers, and patients (Ref. 8). Industry representatives did not support a system that would require submission of labels and other labeling for all devices to FDA, but generally agreed that there would be value in a more limited system, particularly with regard to devices intended for home use. Health care professionals and caregiver representatives were supportive of a broad system, but willing to consider any approach that would increase their access to reliable device information.
Reports by FDA's committees recommended that FDA fully implement section 510(j) by developing an electronic submission method for labels and package inserts for devices generally and many stakeholders supported the creation of a broad “repository” (essentially, an FDA-managed database accessible to the public through an Internet site) of labeling for
FDA also conducted a series of followup focus group interviews of health care professionals to obtain their individual views concerning a wide variety of topics relating to medical device labeling, resulting in a series of reports, including “Medical Device Labeling for Health Care Practitioners: Focus Group Study” (May 2011) (Ref. 9) and “Device Labeling Study: Practitioner Perspectives on Utility, Format, and Content of an Abbreviated Version of Labeling” (March 2013) (Ref. 10). Participants saw considerable value in having device labeling available online for quick access when needed; participants noted that labeling that is not directly placed on a device—for example, a manual—can be hard to find when needed. Unlike a device label or package insert, information made available through the Internet is always readily available and cannot be lost or misplaced. Most participants favored having access to labeling through an Internet Web site, particularly if well-organized.
Additionally, in September 2015, FDA held a public meeting to discuss issues associated with medical device patient labeling that involved development, use, and access to device information (Ref. 11). At this meeting, many external stakeholders stated their belief that providing labeling in one place for consumers that is reliable and dynamic would increase accessibility to labeling for legacy devices and to labeling updates as new information becomes available for currently marketed devices. Also, while device information from other sources such as Web sites and YouTube videos may be useful, stakeholders indicated concern that some may be potentially erroneous and contain mostly promotional information.
A device would be subject to the proposed rule if it is a “home-use device” as defined by proposed § 807.200, that is regulated by CDRH as a class II or class III medical device. Under this proposed regulation, a
Class I devices and devices regulated by CBER are not within the scope of the proposed rule, except for the authorized voluntary submission of a device's label and package insert for these home-use devices (under proposed § 807.220(a)). For more information about the definition of “home-use device,” please refer to section III.D.1 of this document.
Proposed § 807.205 would require the label and package insert of a home-use device subject to the proposed rule to be submitted whenever any provision within part 807 (21 CFR part 807) requires listing information to be submitted or updated. For example, the label and package insert would be required with such home-use device's initial listing required by § 807.22(a), with each annual listing under § 807.22(b), and whenever an action triggers a reporting requirement under § 807.28. If the label and package insert have already been submitted and have not been changed since they were last submitted to FDA, the establishment may simply certify that no change has been made to the previously submitted labeling; see proposed § 807.300(a). An updated label or package insert could be submitted voluntarily at any time; see proposed § 807.300(b).
No. The rule would limit the definition of “package insert” to include only those informational materials directed to the intended user of the device, and which are provided in a device package or which accompany the device when it is delivered to the user, including when already provided by electronic means. (See the proposed definition of
No. The proposed rule would not address the submission of advertisements or of labeling other than the device label and package insert.
No. The proposed rule would not affect the form or content of home-use device labeling. Existing labeling requirements would continue to apply, including those of part 801 (Labeling) and § 809.10 (
The owner or operator of an establishment (the remainder of this preamble will simply refer to “the establishment”) that lists a class II or class III home-use device subject to this proposed rule would be responsible for submission of the label and package insert, just as the establishment is responsible for submitting all other listing information pertaining to the device. (See proposed § 807.205.)
The proposed rule provides for the electronic submission of this information to FDA, as required by section 510(p) of the FD&C Act, in a form specified by FDA that we can process, review, and archive; see proposed § 807.205. Initially, FDA expects to specify saving the device label and package insert as PDF files and submitting those materials to FDA. Later, we expect to transition from submission of PDFs to submission of SPL-formatted information. We intend to publish information describing the entire proposed process by the time we publish a final rule. If a waiver from filing registration and listing information electronically has been obtained under § 807.21(b), the establishment would be required to submit the device labels and package insert called for in this proposed rule in the same manner as permitted for other registration and listing information covered by the waiver, as directed by § 807.34.
When the proposed rule is finalized, an establishment submitting a home-use device's label and package insert would confirm or provide the FDA-assigned premarket submission number of the device (§ 807.25(g)(4)) or the product codes for 510(k)-exempt devices (§ 807.25(g)(2)).
The failure to provide information required by section 510(j) of the FD&C Act, as implemented by part 807, including proposed subpart F, causes a device to be misbranded under section 502(o) of the FD&C Act and is a prohibited act under section 301(p) of the FD&C Act (21 U.S.C. 331(p)), which may result in seizure, injunction, or other penalties.
FDA intends to make the labels and package inserts collected under this rule available on an FDA-managed or partner Internet Web site. We intend to link the labels and package inserts submitted under this rule to the listing record for the particular device. Over time, and as resources permit, we also intend to link each device listing to other FDA information, such as the device identifier required by FDA's unique device identification system, FDA premarket submission numbers, adverse event reports, and public health notifications, so that users of the planned FDA-managed or partner Internet Web site will also be able to access public information that is maintained in FDA's other databases concerning devices marketed or manufactured in the United States.
We intend to provide several ways to search for information, such as the ability to search by:
• Proprietary name (for a specific device);
• Product code (for a generic type of device);
• Firm name (for all devices listed by a particular firm);
• FDA premarket submission number;
• Device identifier (the static portion of the unique device identifier required by §§ 801.20 and 801.40).
We also intend to provide a means to search the full text of labels and package inserts using free-form searches.
FDA is proposing to add definitions for two terms to part 807; these terms have not been defined in any prior medical device regulation:
If finalized, the definition of home-use device is meant to apply only to proposed subpart F for purposes of submitting the device's label and package insert when listing under section 510(j) of the FD&C Act. This proposed regulation would not apply for other purposes, including premarket submission determinations. Additionally, proposed § 807.200 would not apply for purposes of CLIA categorization under 42 CFR 493.15. The fact that a device would be considered a “home-use device” under this proposed regulation would not mean that the device has been “cleared by FDA for home use” within the context of 42 CFR 493.15, a regulatory provision related to the implementation of the CLIA provisions found at 42 U.S.C. 263a.
We would amend the first sentence of § 807.26(e) to strike the word “only.” This change is necessary to avoid conflict between the proposed regulatory amendments pertaining to the submission of labels and package inserts of home-use devices under new subpart F of this proposed rule and § 807.26(e), which states that owners or operators shall be prepared to submit such information “
We are proposing a new subpart to part 807, “Subpart F—Submission of Labeling When Listing Certain Home-Use Devices.” For establishments listing home-use devices subject to this proposed rule, proposed § 807.205 would require that the device label and package insert be submitted to FDA whenever any provision within part 807 requires submission of listing information regarding the device.
Proposed § 807.220 would make clear that the voluntary submission of the label and package insert of a home-use device that is not required under this proposed rule would be permitted. Proposed § 807.220(a) would make clear that for such devices, including a home-use device regulated by CBER, the owner or operator subject to part 807 could voluntarily submit the device label and package insert, which FDA could then make available to the public.
Proposed § 807.220(c) would make clear that the label and package insert for a discontinued home-use device could be submitted, which FDA could then make available to the public. This provision would provide a way for an establishment to make information about a discontinued home-use device available to the public, potentially reducing the burden of responding to requests for information about a discontinued device.
Proposed § 807.300 would explain when an updated device label and package insert must be submitted.
Proposed § 807.300(a) would reduce the burdens of the proposed rule, if finalized, following the initial submission of listing information to FDA by making it clear that resubmission of the label and package insert of a home-use device each year during the annual listing process, and in other circumstances when updated listing information must be submitted, would not be required unless changes have been made. Instead, if no change has been made to the most-recently submitted label and package insert, FDA would only require a statement to that effect. We expect this statement will be as simple as clicking a check-box within one of the processes FDA expects to provide.
Proposed § 807.300(b) would make clear that updated labeling information for a home-use device that is not required under this proposed rule, such as a CBER-regulated home-use device, could voluntarily be submitted at any time. We expect the majority of labelers will see advantages to keeping this information up-to-date, as a way of better serving current and potential users of their devices.
We would make a conforming amendment to § 807.40 to apply the requirements of proposed subpart F to listings by foreign establishments. This would ensure that both domestic and foreign establishments will be subject to the same requirements regarding the submission of labels and package inserts for home-use devices.
FDA is proposing that this rule would go into effect 90 days after publication of a final rule, if that results in an effective date prior to October 1 of the year of publication; otherwise, the rule would go into effect on January 1 of the year following publication of a final rule. This ensures adequate notice and avoids any possibility that a final rule might go into effect part way through an ongoing registration and listing cycle (October 1 through December 31 each year).
The proposed rule would implement provisions of the FD&C Act to require the submission of class II and class III home-use device labels and package inserts with device listing information submitted to FDA on or after the effective date of the rule. The rule would not be retroactive, and there would be no obligation to submit the label or package insert of a discontinued home-use device that was listed at any time prior to the effective date of a final rule; but if that device is listed during a subsequent registration and listing cycle (a cycle that begins after the effective date of a final rule), all listing requirements would have to be met, including submission of the label and package insert.
Section 510(j) of the FD&C Act requires all persons who register with the Secretary to file a list of all devices that are being manufactured, prepared, propagated, compounded, or processed by them for commercial distribution. The listing of all devices is required to be accompanied by a copy of the label, package insert, and a representative sampling of the labeling for such devices. (See section 510(j)(1)(B)(ii).) Accordingly, FDA is issuing the provisions of this proposed rule that would implement the listing requirement for the submission of labels and package inserts for home-use medical devices regulated by CDRH under section 510(j) and section 701(a), which provides FDA the authority to issue regulations for the efficient enforcement of the FD&C Act.
The provisions of the proposed rule that would require the electronic submission of labeling are issued under the authority of sections 510(p) and 701(a) of the FD&C Act. Section 510(p) requires that registrations and listings under section 510 be submitted to the Secretary by electronic means unless the Secretary grants a request for waiver because the use of electronic means is not reasonable for the person requesting such waiver.
The failure to include a device in a list required by section 510(j) causes the device to be misbranded under section 502(o) of the FD&C Act. The failure to provide any information required by section 510(j) is a prohibited act under section 301(p) of the FD&C Act.
We have examined the impacts of the proposed rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). We have developed a comprehensive Economic Analysis of Impacts that assesses the impacts of the proposed rule. We believe that this proposed rule is not a significant regulatory action as defined by Executive Order 12866.
The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because annualized costs to small entities are estimated to be less than 0.4 percent of firm revenue, we propose to certify that the proposed rule will not have a significant economic impact on a substantial number of small entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $146 million, using the most current (2015) Implicit Price Deflator for the Gross Domestic Product. This proposed rule would not result in an expenditure in any year that meets or exceeds this amount.
This rule proposes to implement provisions of the FD&C Act by requiring firms to electronically submit to FDA the device labels and package inserts, hereafter in this section of the document referred to as “labeling,” of certain home-use medical devices. In particular, all devices regulated by CDRH as class II and class III devices and labeled for use in any environment outside a professional health care facility would be covered by this rule. FDA intends to make the labeling of these devices available to the public in a searchable FDA-managed or partner Internet Web site, hereafter referred to in this section of the document as “labeling database.” Firms would be required to submit the device labeling to FDA, initially in PDF format but later in SPL format. Firms would incur three types of costs as a result of this rule: Costs to read and understand the rule, costs to reformat labeling according to the rule, and costs to train personnel to comply with the rule. FDA would incur costs to establish and maintain the public online labeling database. The public would benefit from access to information and instructions on the proper use of medical devices in home settings.
The costs and benefits of the proposed rule are summarized in the table 1, entitled “Economic Data: Costs and Benefits Statement.” This table shows the estimated average annualized costs and other quantified but not monetized effects of this rule using both 7 and 3 percent annual discount rates over a 10-year evaluation period. We estimate that the present value of costs over 10 years would range from $48.5 to $51.7 million at a 7 percent discount rate and from $52.5 to $56.5 million at a 3 percent discount rate. Annualizing these costs over 10 years yields estimated costs ranging from $6.5 to $6.9 million at a 7 percent discount rate and $6.0 to $6.4 million with a discount rate of 3 percent.
As table 1 shows, the primary benefit stems from a reduced incidence of adverse events due to the increased availability of medical device labeling. We use, as a proxy for those most likely to benefit from this proposed rule, individuals who receive instruction from home health providers on the proper and safe use of their home-use devices. We estimate that the present value number of home-use device training events over 10 years is 66.9 million using a 7 percent discount rate or 80.1 million using a 3 percent discount rate. Annualized over 10 years, we estimate the annual number of home-use device training events is 8.9 million with a 7 percent discount rate and 9.1 million with a 3 percent discount rate. Under the proposed rule, we estimate that for each home-use device training event, the rule would cost between $0.73 and $0.77 using a 7 percent discount rate; with a 3 percent discount rate, the cost per event would range from $0.66 to $0.71.
To determine the impact of the proposed rule on small entities, we compare the estimated cost of the rule to the average revenues of the small entities. Assuming that each small firm is composed of a single establishment, the annualized cost to small entities of the proposed rule is not expected to exceed 0.22 percent of firm revenue. The largest impact would be felt by firms with fewer than 100 employees. If instead we assume that each small firm is composed of three establishments, the annualized cost to small entities of the proposed rule is not expected to exceed 0.38 percent of firm revenue. Given that we estimate the cost of the proposed rule to be a very small percentage of firm revenue, the Agency proposes to certify that this proposed rule will not have a significant economic impact on a substantial number of small entities.
The full analysis of economic impacts is available in the docket for this proposed rule (Ref. 12) and at
This proposed rule contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). A description of these provisions is given in the
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.
Specifically, if a home-use device is subject to the proposed rule its label and any package insert would be required to be submitted whenever that device is listed with FDA. Device listing information must be submitted electronically to FDA once each year, during the period from October 1 through December 31. Once a device's labeling has been submitted to FDA, the establishment may thereafter either submit revised labeling with each annual listing of the device to which it pertains, or may certify that no change has been made to the previously submitted labeling. The certification option would simplify the process by not requiring the submission of materials that would duplicate materials previously submitted to FDA. The proposed rule would make clear that the voluntary submission of the label and package insert of a home-use device would be permitted in some circumstances. When finalized, the information collection requirements outlined in this section will amend the current OMB PRA approval for the current Registration and Listing Information collection approved under OMB control number 0910-0625.
FDA estimates the burden, on average, of this collection of information as follows:
To ensure that comments on information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB (see
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3407(d)), the Agency has submitted the information collection provisions of this proposed rule to OMB for review. These requirements will not be effective until FDA obtains OMB approval. FDA will publish a notice concerning OMB approval of these requirements in the
The Agency has determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
FDA proposes that this rule will go into effect 90 days after publication of a final rule, if that results in an effective date prior to October 1 of the year of publication; otherwise, FDA proposes this rule will go into effect on January 1 of the year following publication of a final rule.
We have analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. We have determined that this proposed rule, if finalized, does not contain policies that would 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. Accordingly, we
The following references are on display in the Division of Dockets Management (see
Confidential business information, Imports, Medical devices, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, we propose that 21 CFR part 807 be amended as follows:
21 U.S.C. 321, 331, 351, 352, 360, 360c, 360e, 360i, 360j, 371, 374, 381, 393; 42 U.S.C. 264, 271.
The definitions of this section apply only to this subpart and not for other purpose, including the categorization of in vitro diagnostic products under 42 CFR 493.15:
Whenever this part requires the owner or operator of an establishment to submit listing information, and the listing concerns a home-use device regulated by the Center for Devices and Radiological Health as a class II or class III medical device, the owner or operator must submit the label and package insert of that home-use device by electronic means in a format specified by FDA that we can process, review, and archive. If a waiver from filing registration and listing information electronically has been obtained under § 807.21(b), the label and package insert shall be submitted in the same manner as other registration and listing information, as directed by § 807.34.
(a) If listing a home-use device that is not regulated by the Center for Devices and Radiological Health as a class II or class III medical device, the owner or operator may submit the label and package insert for the device.
(b) If a listing of a home-use device represents more than one product catalog or model number, the owner or operator may submit the label and package insert for each catalog or model number.
(c) An owner or operator may submit the label and package insert for a home-use device that is not currently listed if that device was previously listed pursuant to this part but has been discontinued.
(a) Whenever this part requires updated listing information to be submitted, and the updated listing concerns a home-use device regulated by the Center for Devices and Radiological Health as a class II or class III medical device, the owner or operator shall determine whether any change has been made to the labeling most-recently submitted to FDA for the device. If any change has been made to the most recently submitted labeling, the owner or operator shall submit the current labeling. If no change has been made to the most recently submitted labeling, the owner or operator shall provide a statement to that effect.
(b) The owner or operator may voluntarily submit updated labeling for a listed device at any time prior to the time this part requires such labeling to be submitted.
Internal Revenue Service (IRS), Treasury.
Cancellation of notice of public hearing on proposed rulemaking.
This document provides notice of the cancellation of a public hearing on proposed regulation relating to proposed amendments to the regulations that provide user fees for installment agreements.
The public hearing, originally scheduled for October 19, 2016 at 2:00 p.m. is cancelled.
Regina Johnson of the Publications and Regulations Branch, Legal Processing Division, Associate Chief Counsel (Procedure and Administration) at (202) 317-6901 (not a toll-free number).
A notice of proposed rulemaking and notice of public hearing that appeared in the
The public comment period for these regulations expired on October 6, 2016. The notice of proposed rulemaking and notice of hearing instructed those interested in testifying at the public hearing to submit a request to speak and outline of the topics to be addressed. As of October 6, 2016, no one has requested to speak. Therefore, the public hearing scheduled October 19, 2016 at 2 p.m. is cancelled.
Postal Service
Proposed rule.
In October 2016, the Postal Service filed a notice of mailing services price adjustments with the Postal Regulatory Commission (PRC) for products and services covered by
We must receive your comments on or before November 16, 2016.
Mail or deliver comments to the manager, Product Classification, U.S. Postal Service®, 475 L'Enfant Plaza SW., RM 4446, Washington, DC 20260-5015. You may inspect and photocopy all written comments at USPS® Headquarters Library, 475 L'Enfant Plaza SW., 11th Floor N, Washington, DC by appointment only between the hours of 9 a.m. and 4 p.m., Monday through Friday by calling 1-202-268-2906 in advance. Email comments, containing the name and address of the commenter, may be sent to:
Paula Rabkin at 202-268-2537.
The Postal Service hereby gives notice that, pursuant to 39 U.S.C. 3622, on October 12, 2016, it filed with the Postal Regulatory Commission a
This proposed rule includes price changes for certain international extra services.
We propose no increase to prices for single-piece First-Class Mail International® letters, postcards, and flats. The price of a single piece 1-ounce letter is proposed to continue to be $1.15. The First-Class Mail International letter nonmachinable surcharge will not increase.
The Postal Service proposes to increase prices for certain market dominant international extra services including:
• Certificate of Mailing (5.36%)
• Registered Mail
• Return Receipt (4.1%)
• Customs Clearance and Delivery Fee (4.3%)
• International Business Reply
Fee: $14.95.
Fee: $3.85.
Fee: per piece $6.00.
Fee: Cards $1.35; Envelopes up to 2 ounces $1.85.
Following the completion of Docket No. R2017-1, the Postal Service will adjust the prices for products and services covered by the International Mail Manual. These prices will be on
Additionally, as general information, the product name of Standard Mail®, which is used in two instances in the International Mail Manual but is not an International product, will change to USPS Marketing Mail effective January 22, 2017.
Although exempt from the notice and comment requirements of the Administrative Procedure Act [5 U.S.C. 553(b), (c)] regarding proposed rulemaking by 39 U.S.C. 410(a), the Postal Service invites public comment on the following proposed revisions to the
Foreign relations, International postal services.
Accordingly, we propose to amend 39 CFR part 20 as follows:
5 U.S.C. 552(a); 13 U.S.C. 301-307; 18 U.S.C. 1692-1737; 39 U.S.C. 101, 401, 403, 404, 407, 414, 416, 3001-3011, 3201-3219, 3403-3406, 3621, 3622, 3626, 3632, 3633, and 5001.
We will publish an appropriate amendment to 39 CFR part 20 to reflect these changes.
Postal Service
Proposed Rule.
In October 2016, the Postal Service filed a notice of mailing services price adjustments with the Postal Regulatory Commission (PRC), effective January 22, 2017. This proposed rule contains the revisions to
We must receive comments on or before November 16, 2016.
Mail or deliver written comments to the manager, Product Classification, U.S. Postal Service®, 475 L'Enfant Plaza SW., Room 4446, Washington DC 20260-5015. You may inspect and photocopy all written comments at USPS® Headquarters Library, 475 L'Enfant Plaza SW., 11th Floor N, Washington, DC by appointment only between the hours of 9 a.m. and 4 p.m., Monday through Friday, by calling 1-202-268-2906 in advance. Email comments, containing the name and address of the commenter, may be sent to:
Audrey Meloni at (856) 933-4360 or Lizbeth Dobbins at (202) 268-3789.
Proposed prices will be available under Docket Number(s) R2017-1 on the Postal Regulatory Commission's Web site at
The Postal Service's proposed rule includes: Changes to prices, several mail classification updates, mailpiece marking changes, modifications to mailpiece weights and mail preparation categories, multiple product simplification efforts, a few minor revisions to the DMM to condense language and eliminate redundancy, a change to the redemption period of a money order claim from two years to one year, the addition of Official Mail Accounting System (OMAS) stamp shipment fee language, and updates to Enterprise Post Office Box Online (ePOBOL) process that changes payment periods for online Post Office Box activity.
As background, the Postal Service required bundle and pallet preparation of flat-size Standard Mail®, Periodicals, and Bound Printed Matter mailpieces for delivery within ZIP Codes
Again, FSS preparation rules remain intact for Standard Mail, Periodicals and Bound Printed Matter for applicable FSS zones as defined by Labeling List L006. The required carrier route separation is new for Standard Mail High Density and High Density Plus and for Saturation bundles. As a reminder, all presorted and carrier route Bound Printed Matter (BPM) , and Periodicals flats meeting the standards in 201.6.2 must be sorted to FSS schemes, properly bundled and placed on or in pallets, trays, sacks or approved containers, for FSS scheme ZIP Code combinations within the same facility. Mailings (excluding saturation mailings of Standard Mail) with non presorted BPM flats may be included in FSS preparation, but will not be eligible for presorted, or carrier route prices.
To reiterate, all mailpieces in a 5-digit scheme FSS bundle must be identified with an optional endorsement line (OEL), as described in DMM 708.7.0. Mailpieces entered under a combined mailing of Standard Mail and Periodicals flats (DMM 705.15.0) still include class and price markings, applicable to the price paid, in addition to the OEL.
Periodicals, Standard Mail, and Bound Printed Matter flats properly included in a FSS scheme pool qualify for the piece price applied prior to inclusion in the FSS scheme pool with the following exceptions for Standard Mail: (1) A carrier route mailpiece in a FSS bundle on a FSS scheme pallet will receive the Basic CR-Bundles/Pallet price and (2) a carrier route mailpiece in a FSS bundle on a FSS facility pallet will receive the Basic CR price. Additional information on each mail class affected is under the Bound Printed Matter, Periodicals, and Standard Mail sections in this proposal.
Currently, there are four presort levels for First-Class Mail Commercial Automation Letters and Cards: Mixed AADC Automation Letters (Cards), AADC Automation Letters (Cards), 3-Digit Automation Letters (Cards), and 5-Digit Automation Letters (Cards). To help simplify the pricing structure, the Postal Service implemented the same price for AADC Automation Letters and 3-Digit Automations Letters in Docket No. R2012-3. In Docket No. R2013-1, the similar change was made for Automation Cards. The Postal Service is now proposing to combine AADC and 3-Digit presort levels into one sortation. The new sortation name will be AADC. The existing labeling List 801 will drive the FCM AADC separations and the L003 list will become obsoleted. Origin entry separations, based on labeling List 002, will be modified to reflect origin entry AADC separations.
Currently, the “up to” weight standard for FCM Commercial Machinable Letters is 3.3 ounces. This lower weight break of up to 3.3 ounces is being increased due to mail processing improvements. Since machinable letters must follow the standards for Automation Letters (except for IMb), the same weight maximum should apply. Based on this, the Postal Service is proposing to increase the weight maximum from 3.3 ounces to 3.5 ounces. This change does not apply to the maximum weight of Booklets which are capped at 3.0 ounces.
Currently, the same price applies for one and two ounce pieces for each individual mail sortation level for First-Class Mail (FCM) Commercial Automation Letters. The Postal Service is proposing one price for up to 3.5 ounces for each individual mail sortation level for FCM Commercial Automation Letters. The weight increase will encourage mailers to insert additional information or sales offers, and will increase the value of the FCM brand. This proposal will also apply to mixed-weight FCM
The Postal Service is proposing to rename Alternate Postage to Share Mail. This
Share Mail has proven to be a viable option for senders to share information with numerous recipients. To continue the Postal Service's efforts to simplify its product line, the Share Mail payment tiers will be collapsed into one, and upfront postage payment requirements will be eliminated. Unique Intelligent Mail barcodes are no longer required nor is a signed Marketing Agreement. Picture Permit will no longer be available in order to help expedite its approval process. A customer who wishes to participate must submit a request to the Share Mail Program Office along with production pieces to ensure readability for postal processing. Share Mail relies on Intelligent Mail barcode (IMb) technology and scan data collected as the mailpiece travels through the mailstream to determine piece counts, so readability is paramount.
The Postal Service is proposing to eliminate the FSS-specific price structures for Periodicals Outside-County. FSS preparation will still be required and all FSS marking requirements will remain as is. Outside-County Periodicals flats properly included in a FSS scheme pool, qualify for the price applied prior to the FSS scheme pool. If a FSS scheme pallet is drop shipped to a DFSS facility, the pallet will receive Carrier Route pallet pricing. If a FSS facility pallet is drop shipped to a DFSS facility the pallet will receive DSCF pallet pricing. Qualifying FSS scheme pieces entered at a DFSS facility receive DSCF pound pricing. FSS scheme bundles on an FSS scheme pallet will receive carrier route bundle prices. FSS scheme bundles on an FSS facility pallet will receive 3-digit/SCF bundle pricing. FSS scheme and facility sack/trays or other authorized container will receive 3-digit/SCF sack/tray prices.
The Postal Service is proposing to rename Standard Mail to “USPS Marketing Mail”. This name change will better communicate to our customers the message that Standard Mail fits into their marketing mix.
The 2015 Household Diary Study shows that customers primarily use Standard Mail to send advertisements. According to the study, taken in Fiscal Year 2015, 84.1 percent of Standard Mail volume
The Postal Service is proposing to eliminate FSS-specific price structures for Bound Printed Matter Flats. FSS preparation will still be required and all FSS marking requirements will remain as is. Bound Printed Matter flat pieces included in an FSS scheme bundle pool qualify for zone and entry piece pricing and pound pricing. If an FSS container is drop shipped to a DFSS facility, those pieces will receive DSCF pricing.
Currently there are four presort levels for Standard Mail and Standard Mail Nonprofit Automation Letters: Mixed AADC Automation Letters, AADC Automation Letters, 3-Digit Automation Letters, and 5-Digit Automation Letters. To help simplify the pricing structure, the Postal Service implemented the same price for AADC Automation Letters and 3-Digit Automations Letters in Docket No. R2013-1. The Postal Service is now proposing to combine these two presort levels (AADC and 3-Digit) into one sortation. The new sortation name will be AADC if this proposal is adopted.
Currently, the “up to” weight standard for Standard Mail and Standard Mail Nonprofit Machinable Letters is 3.3 ounces. This lower weight break of up to 3.3 ounces is no longer needed due to improvements in mail processing equipment. Since machinable letters must follow the standards for Automation Letters (except for the IMb standards), the weight maximum should also follow. Thus the Postal Service is proposing to increase the weight maximum from 3.3 ounces to 3.5 ounces. This change does not include Standard Mail Ride-Along mailpieces which are capped at 3.3 ounces and are inserted into a host Periodicals mailpiece.
It's important for both the Industry and the Postal Service to evaluate the effects of higher weight breaks for First-Class Mail automation letters and cards along with Standard Mail letters. Collaboration and feedback throughout calendar year 2017 will be critical in helping to determine whether higher weights cause processing and/or address quality metrics to be put at risk.
There are currently six volume tiers for Standard Mail Commercial and Nonprofit Simple Samples. Based on the volume thresholds currently used by most customers, the Postal Service is proposing to collapse the existing six tiers into two new tiers: Volumes up to and equal to 200,000 pieces, and volumes greater than 200,000 pieces.
The Postal Service is proposing to eliminate the FSS-specific price structures within Standard Mail and Standard Mail Nonprofit. FSS preparation will still be required and all FSS marking requirements will remain intact. Standard Mail and Standard Mail Nonprofit flats properly included in a FSS scheme pool, qualify for the price applied prior to the FSS scheme pool with the following exceptions: (1) A carrier route mailpiece in an FSS bundle on an FSS scheme pallet will receive the Basic CR-Bundles/Pallet price, and (2) a carrier route mailpiece in a FSS bundle on an FSS facility pallet will receive the Basic CR price. If an FSS pallet is drop shipped to a DFSS facility, those pieces will receive DSCF pricing.
The current piece/pound price structure for Standard Mail and Standard Mail Nonprofit Flats, Nonautomation Letters, and Nonmachinable Letters does not provide a simple, clear view of the actual price of a mailing especially when here are nonidentical-weight pieces when some pieces are between 3.3 and 4 ounces. The Postal Service is proposing to increase the Standard Mail and Standard Mail Nonprofit Flats, and Nonautomation and Nonmachinable Letters piece price weight break structure from 3.3 ounces to 4.0 ounces. Pieces up to 4 ounces will pay the same price and a pound price will apply over 4 ounces. This proposal does not include Nonautomation Machinable Letters.
Currently, Collect on Delivery allows for both street delivery and Hold for Pickup (HFPU) options and is available at Retail locations, online, and through commercial channels. Letter Carriers may accept cash, money order or checks for the amount due up to $1,000.00 from the recipient upon delivery. Recipients of COD shipments can currently pick up their items at USPS Retail locations or wait for a USPS Letter Carrier to deliver them to a street address. Carriers may have to redeliver COD pieces at the street address if the customer is not home or able to pay on the first attempt.
The Postal Service is proposing to make Hold For Pickup the only delivery method for Collect on Delivery items. COD items would be addressed to the delivery address of the recipient's Post Office. The recipient would receive a notification message to pick-up the item at the Post Office. A reminder email,
Currently, Business Reply Mail (BRM) consists of letters, flats, and parcels. Occasionally BRM customers choose to use Business Reply Mail for return parcels because they possessed a BRM permit for inbound correspondence. The Postal Service is proposing to waive the annual permit fee for those current customers using BRM exclusively for return parcels. This will align BRM parcels with other returns products. BRM permit fees for letters and flats, and for weight-averaged BRM letters, flats & parcels, will remain.
To further support simplification, the Postal Service is also proposing to eliminate the annual permit fees for Business Reply Customers who use only QBRM Basic and High Volume Qualified for letters and cards. All other fees and postage pricing remain intact.
The Postal Service is proposing to eliminate the fees for certain outbound and return permits used for parcel shipments including associated annual account maintenance fees. This proposal streamlines the application and returns process and also eliminates the need to pay permit application fees for additional entry points. Shipping Products included under this umbrella are outbound shipments of Priority Mail Express, Priority Mail, First-Class Package Service, Parcel Select (including Parcel Select Lightweight), Bound Printed Matter, Media Mail, Library Mail and for return shipments of MRS, Parcel Return Service and BRM (parcels only).
Currently, Standard Mail Letters and Flats mailers that use this service are charged the Forwarding Fee via Address Correction Service (ACS) billing which is managed by the ACS Department of Address Management Systems in Memphis, TN. The ACS data file, Shipping Notice data file, and the Invoice data file have an implied decimal position that is conducive to the 2-decimal places for address correction services. When mailers use these files to track their ACS fees and costs, they must recognize that the Forwarded Fee product codes have an implied 3-decimal place price and must manipulate the data files provided to them through ACS so that the decimal place differences are recognized in all of the data files provided via ACS. This proposal would adjust the Standard Mail Forwarding Fee to 2-decimal point places to allow mailers to track their ACS fees and costs without making adjustments for the Forwarding Fees.
To help simplify Postal accounting procedures and comport with Banking Industry Standards, and other companies' comparable money order offerings, the Postal Service proposes to change the time limit for claims for improper payment to a limit of one year. This language will be updated on the reverse side of the domestic and international money order form so the purchaser is aware of the time limit.
The U.S. Postal Service continues to seek opportunities to streamline mailers' experience when using our products and services. For example, we plan to allow Enterprise PO Boxes Online customers to modify their current payment period to align their multiple PO Boxes, Caller Service, and Reserve payments to one due date per year, when using an Enterprise Payment Account (EPA).
Eligible customers will be allowed to pay pro-rated fees, on a one time basis to align all payments to a selected annual renewal date in the future. This method is optional and will be available for all of an eligible customer's PO Boxes and Caller Service numbers. When the true-up date is reached they will continue to pay for the 12 month term as committed when first enrolled in the Enterprise Payment Account.
Federal agencies have the option today to order stamps from the USPS Stamp Fulfillment Services in Kansas City and to pay for the stamps through their Official Mail Accounting System (OMAS) accounts.
It has been a long-standing practice to charge customers other than federal agencies a nominal handling fee for all purchases ordered through Stamp Fulfillment Services. Beginning January 1, 2017, these fees will apply to federal agencies using OMAS.
The handling fee schedule can be found in section 1560 of the
The Postal Service provides additional resources to assist customers with this price change for competitive products. These tools include price lists, downloadable price files, and
Administrative practice and procedure, Incorporation by reference, Postal Service.
Although we are exempt from the notice and comment requirements of the Administrative Procedure Act (5 U.S.C. 553(b), (c)) regarding proposed rulemaking by 39 U.S.C. 410(a), we invite public comments on the following proposed revisions to
5 U.S.C. 552(a); 13 U.S.C. 301-307; 18 U.S.C. 1692-1737; 39 U.S.C. 101, 401, 403, 404, 414, 416, 3001-3011, 3201-3219, 3403-3406, 3621, 3622, 3626, 3632, 3633, and 5001.
* * * A mailer must select signature service for Priority Mail Express COD HFPU, or Priority Mail Express with additional insurance.
3-digit prices apply to:
* * *
c. Qualifying flats sorted to a FSS scheme under 705.14.0.
b.
1. Bundles sorted onto pallets prepared under 705.8.0, 705.10.0, 705.12.0, 705.13.0 or 705.14.0, as appropriate.
3-digit automation prices apply to:
* * *
c. Qualifying flats sorted to a FSS scheme under 705.14.0.
The publisher must be able to present documentation to support the actual number of copies of each edition of an issue, by entry point, mailed to each zone, at DDU, DSCF, DADC, DFSS (DFSS entered with DSCF prices) and In-County prices. * * *
Report the number of copies mailed to each 3-digit ZIP Code area at zone prices using one of the following formats:
b. Report copies by zone (In-County DDU, In-County others, Outside-County DDU, Outside-County DSCF, Outside-County DSCF entered at a DFSS and Outside-County DADC) and by 3-digit ZIP Code, in ascending numeric order, for each zone. * * *
Use the actual price name or the authorized zone abbreviation in the listings in 17.3 and 17.4.2
Flat sized Periodicals In-County priced mailings, along with a maximum of 5,000 Outside-County pieces for the same issue (see 1.1.4) may be optionally sorted under FSS preparation standards. All other Periodicals flats including Saturation (Non-simplified addressed) and High Density priced flats destinating and qualifying to FSS zones in L006, must be prepared under 705.14.0.
Determine price eligibility as follows:
a. Pound Prices. Outside-County pieces are eligible for DSCF pound prices when placed on an SCF or more finely presorted container, deposited at the DSCF, DFSS or USPS-designated facility (see also 29.4.2b), and addressed for delivery within the DSCF's or DFSS service area. Nonletter-size pieces are also eligible when the mailer deposits 5-digit bundles at the destination delivery unit (DDU) (the facility where the carrier cases mail for delivery to the addresses on the pieces) and the 5-digit bundles are in or on the following types of containers:
1. A merged 5-digit scheme or merged 5-digit sack.
2. A merged 5-digit scheme, merged 5-digit, or 5-digit scheme pallet.
b. Container Prices. Mailers may claim the DSCF container price for SCF or FSS and more finely presorted containers that are entered at and destined within the service area of the SCF or FSS at which the container is deposited.
DSCF prices apply to eligible FSS pieces deposited at a USPS-designated FSS processing facility and correctly placed in a flat tray, sack, alternate approved container or on a pallet, labeled to a FSS scheme processed by that facility, under labeling list L006, column B or C.
* * * A mailer must select signature service for Priority Mail Express COD HFPU, or Priority Mail Express with additional insurance.
Automation prices apply to each piece that is sorted under 235.6.0 into the corresponding qualifying groups:
a. Groups of 150 or more pieces in 5-digit/scheme trays qualify for the 5-digit price. Preparation to qualify for the 5-digit price is optional. Pieces placed in full AADC trays in lieu of 5-digit/scheme overflow trays under 235.6.5 are eligible for the 5-digit prices.
b. Groups of 150 or more pieces in AADC trays qualify for the AADC price.
c. Groups of fewer than 150 pieces in AADC origin and pieces placed in mixed AADC trays in lieu of AADC overflow trays under 235.6.5 are eligible for the AADC prices.
Terms used for presort levels are defined as follows:
The requirements for mailings are as follows:
b. First-Class Mail. A single automation price First-Class Mail mailing may include pieces prepared at 5-digit, AADC, and mixed AADC prices.
Instead of preparing overflow trays with fewer than 150 pieces, mailers may include these pieces in an existing qualified tray of at least 150 or more pieces at the next tray level. (For example, if a mailer has 30 overflow 5-digit pieces for ZIP Code 20260, these pieces may be added to an existing qualified AADC tray for the correct destination (ZIP Code prefix 202) and the overflow 5-digit pieces will still qualify for the 5-digit price.). Mailers must note these trays on standardized documentation (see 708.1.2). Pieces that are placed in the next tray level must be grouped by destination and placed in the front or back of that tray. Mailers may use this option selectively for AADC ZIP Codes. This option does not apply to origin/entry trays. Preparation sequence, tray size, and Line 1 labeling:
b. AADC: Optional, but required for AADC price (150-piece minimum except no miminum for origin entry AADC); overflow allowed; group pieces by 3-digit (or 3-digit scheme) ZIP Code. For Line 1, use L801, Column B.
Line 2: “FCM LTR” and:
The minimum per piece prices (the minimum postage that must be paid for each piece) apply as follows:
c. * * * Except for Customized MarketMail pieces, discounted per piece prices also may be claimed for destination network distribution center (DNDC), destination sectional center facility (DSCF), and destination delivery unit (DDU)) under 246. * * *
* * * Discounted per pound prices also may be claimed for destination entry mailings-DNDC, DSCF, and DDU under 246.
The 5-digit price applies to flat-size pieces:
d. In an FSS bundle of 10 or more pieces properly placed in sack of at least 125 pieces or 15 pounds of pieces or on a pallet under 705.14.0.
c. In an FSS bundle of 10 or more pieces properly placed in sack of at least 125 pieces or 15 pounds of pieces or on a pallet under 705.14.0.
Basic prices apply to each piece in a carrier route bundle of 10 or more pieces that is:
a. Palletized under 705.8.0, 705.10.0, 705.12.0, 705.13.0 or 705.14.0 (FSS scheme bundles).
High density or high density plus prices apply to each piece meeting the density standards in 6.5.1 or in a carrier route bundle of 10 or more pieces that is:
a. Palletized under 705.8.0, 705.10.0, 705.12.0, 705.13.0 or 705.14.0 (FSS scheme bundles).
Automation prices apply to each piece that is sorted under 245.10.0, into the corresponding qualifying groups:
b. Groups of fewer than 150 pieces in origin/entry AADC trays qualify for the AADC price. Pieces placed in mixed AADC trays under 245.7.5 in lieu of AADC overflow trays also are eligible for AADC prices (see 245.7.5).
Automation prices apply to each piece properly sorted into qualifying groups:
a. The 5-digit price applies to flat-size pieces in a 5-digit/scheme bundle or pooled in a FSS scheme bundle of 10 or more pieces, or 15 or more pieces, as applicable;
b. The 3-digit price applies to flat-size pieces in a 3-digit/scheme bundle or pooled in a FSS scheme bundle of 10 or more pieces.
Except for Standard Mail flats mailed at Saturation prices, all Standard Mail flats and meeting the physical standards in 201.6.2 destinating to a FSS scheme in accordance with labeling list L006 must be prepared under 705.14.0.
Instead of preparing overflow trays with fewer than 150 pieces, mailers may include these pieces in an existing qualified tray of at least 150 or more pieces at the next tray level. (For example, if a mailer has 30 overflow 5-digit pieces for ZIP Code 20260, these pieces may be added to an existing qualified AADC tray for the correct destination and the overflow 5-digit pieces will still qualify for the 5-digit price). Mailers must note these trays on standardized documentation (see 708.1.2). Pieces that are placed in the next tray level must be grouped by destination and placed in the front or back of that tray. Mailers may use this option selectively for AADC ZIP Codes. This option does not apply to origin/entry AADC trays. Preparation sequence, tray size, and Line 1 labeling:
c. AADC: optional, but required for AADC price (150-piece minimum except no minimum for origin entry AADC); overflow allowed; group pieces by 3-digit (or 3-digit scheme) ZIP Code prefix. For Line 1, use L801, Column B.
Line 2: “STD LTR” and:
DSCF prices apply to pieces deposited at a USPS-designated FSS processing site and correctly placed in or on a container labeled to a FSS scheme or FSS Facility processed by that site under labeling list L006 (Column B or Column C).
* * * The nonpresorted price applies to BPM not mailed at the Presorted or carrier route prices. * * *
The presorted Bound Printed Matter price has a per piece charge and a per pound charge. * * *
Presorted and Carrier Route Bound Printed Matter mailings paid with permit imprint are charged a per pound price and a per piece price as follows:
BPM prices are based on the weight of a single addressed piece or 1 pound, whichever is higher, and the zone (where applicable) to which the piece is addressed. Price categories are as follows:
b. Presorted Price. The Presorted price applies to BPM prepared in a mailing of at least 300 BPM pieces, prepared and presorted as specified in 265.5.0, 265.8.0, 705.8.0, 705.14.0 and 705.21.0. Each parcel must bear a unique Intelligent Mail package barcode or extra services barcode, including a postal routing code, prepared under 708.5.0.
c. Carrier Route Price. The Carrier Route price applies to BPM prepared in a mailing of at least 300 pieces presorted to carrier routes, prepared and presorted as specified in 265.6.0, 265.9.0, 705.8.0 or 705.14.0. Each parcel must bear a unique Intelligent Mail package barcode or extra services barcode, including a postal routing code, prepared under 708.5.0.
BPM destination entry prices apply to BPM mailings prepared as specified in 705.8.0, 705.14.0 and 265, and addressed for delivery within the service area of a destination network distribution center, sectional center facility, or delivery unit where they are deposited by the mailer. * * *
b. A destination sectional center facility (DSCF) includes all facilities in L005 and destination flats sequencing system (DFSS) in L006.
BPM flats claiming presorted prices in FSS scheme bundles, meeting the standards in 201 and destinating to a FSS scheme in accordance with labeling list L006, must be prepared under 705.14.0.
Presorted flats and automation flats in sacks for the FSS scheme, 5-digit, 3-digit, and SCF sort levels or on pallets at the 5-digit scheme, 5-digit, 3-digit, SCF, and ASF sort levels may claim DSCF prices. Mail must be entered at the appropriate facility under 5.1.
DSCF prices apply to pieces deposited at a USPS-designated FSS processing facility and correctly placed on a container labeled to a FSS scheme or a
* * * Except for Registered Mail (see 2.0), COD HFPU (see 9.0), and Adult Signature (see 8.0), items with postage and extra service fees affixed may be placed in, but not on, a Post Office maildrop, a street letterbox, or a rural mailbox, or may be given to the carrier (for that delivery address). A mailer may schedule a Pickup on Demand, or schedule a Package Pickup using
* * * When Registered Mail, Insured Mail, Certificate of Mailing, Collect on Delivery Hold for Pickup (COD HFPU) (shipping label must already be affixed), and Adult Signature in certain circumstances, is desired, additional conditions under the standards for the extra service must be met. * * *
Except for certificate of mailing under 5.0, the mailer receives a USPS sales receipt and the postmarked (round-dated) extra service form for services purchased at retail channels. The mailer must provide the receipt when submitting an insurance claim or filing an inquiry. For articles mailed via PC Postage or other online services, the mailer may access a computer printout online that identifies the applicable extra service number, total postage paid, insurance fee amount, declared value, declared mailing date, origin ZIP Code, and delivery ZIP Code. For three or more pieces with extra or accountable services presented for mailing at one time, the mailer uses Form 3877 (firm sheet) or USPS-approved privately printed firm sheets (see 1.7.2) in lieu of the receipt portion of the individual form. All entries made on firm sheets must be computer-generated or made by typewriter, ink, or ballpoint pen. Alterations must be initialed by the mailer and accepting employee. Obliterate all unused portions of the addressee column with a diagonal line. USPS-approved privately printed firm sheets that contain the same information as Form 3877 may be approved by the local Postmaster or manager Business Mail Entry. The mailer may omit columns from privately printed Form 3877 that are not applicable to extra service requested. If the mailer wants the firm sheets receipted by the USPS (postmarked), the mailer must present the firm sheets with the articles to be mailed at a Post Office. The postmarked firm sheets become the mailer's receipts. For Registered Mail and COD HFPU (when Label 3816 is used), the mailer submits the forms in duplicate and receives one copy as a mailing receipt after the entries are verified by the postal employee accepting the mailing. Except for Registered Mail and COD HFPU items, the USPS keeps no mailing records for mail pieces bearing extra services.
Sealed domestic mail bearing First-Class Package Service or Priority Mail postage may be sent as Registered Mail COD HFPU when meeting the standards in 9.0 and as follows:
b. * * * The total fees charged for registered COD HFPU service include the proper registry fee for the value declared plus the registered COD HFPU fee. * * *
c. The registered label and the COD HFPU label must be affixed to each article. * * *
Additional insurance, up to a maximum coverage of $5,000.00, may be purchased for merchandise valued at more than $100.00 sent by Priority Mail Express. The additional insurance fee is in addition to postage and other fees. See Notice 123—Price List. Coverage is limited to the actual value of the contents, regardless of the fee paid, or the highest insurance value increment for which the fee is fully paid, whichever is lower. When “signature required” service is not requested or when “waiver of signature” is requested, additional insurance is not available.
Collect on Delivery Hold for Pickup (COD HFPU) is subject to the basic standards in 1.0, and 508.7.0 for HFPU; see 1.4 for eligible matter. Any mailer may use COD HFPU to mail an article (using a unique COD HFPU number for each article) for which the mailer has not been paid and have its price and the cost of the postage collected (not to exceed $1,000.00) from the addressee (or agent) and held for pickup at the Post Office of the addressee. COD HFPU service provides the mailer with a mailing receipt and the USPS maintains a record of delivery (including the recipient's signature). The recipient has the option to pay the COD HFPU charges (with one form of payment) by cash, pin-fed debit card, or a personal check or money order made payable to the mailer (accepted by the USPS employee upon the recipient's presentation of adequate identification). The USPS forwards the check or money order to the mailer. If payment is made by cash, a money order fee is will be collected from the recipient separately (unless the mailer is authorized to participate in electronic funds transfer (EFT) for the remittance (contact the National Customer Support Center (NCSC) (See 608.8.0) for EFT enrollment information), in addition to the COD HFPU amount. The Postal Service cannot intervene in disputes between mailers and recipients of COD HFPU mail after payment was returned to the mailer. Customers may obtain a delivery record by purchasing a return receipt. Bulk proof of delivery service (7.0) is also available if electronic return receipt service is purchased at the time of mailing.
COD HFPU service is available under the following additional conditions:
a. The name and address of the person to whom the remittance is to be sent must appear in the proper location on the COD HFPU label and in the return address area on the COD HFPU article with the postal endorsements for return
b. The mailer guarantees to pay any return postage, unless otherwise specified on the label.
c. The goods shipped are ordered by the addressee.
d. COD HFPU service may not be used for:
1. Articles sent to international destinations, or from an APO/FPO/DPO address, including official mail and shipments to Armed Forces agencies.
2. The return of merchandise about which some dissatisfaction arises, unless the new addressee consents in advance to such return.
3. The mailing of only bills or statements of account, even with the addressee's consent. If a legitimate COD HFPU shipment of merchandise is mailed, the balance due on a past or expected transaction may be included in the charges on a COD HFPU article, if the addressee consents in advance to such action. In such a case, USPS indemnity is limited to the value of the article lost or damaged, not the full COD HFPU charges to be collected.
Sealed domestic mail bearing First-Class Package Service, or Priority Mail postage may be sent as Registered Mail COD HFPU mail as provided under 9.0 and 2.1.5.
Any article sent COD HFPU also may be sent by Priority Mail Express (1-Day and 2-Day service only) when a signature is requested. The maximum amount collectible from the addressee on one article is $1,000.00, and indemnity is limited to $1,000.00. Priority Mail Express postage and the proper COD HFPU fees must be paid. Both the Priority Mail Express label and COD HFPU label must be affixed to each article.
COD HFPU mail must be presented for mailing as provided in 1.5 to the local Post Office or to rural carriers when the articles are prepared properly, with stamps for the required postage and fees affixed. If the mailer wants insurance for an amount more than the COD HFPU amount to be collected, that amount must be shown.
Each COD HFPU article
The mailer must securely affix a completed COD HFPU Label 3816 to each article. The label must be attached either above the delivery address or to the right of the return address, or to the left of the delivery address on parcels. Privately printed or computer-generated firm sheets may be used under the standards in 1.10. The mailer must submit firm sheets in duplicate and will receive one copy of the postmarked form as a mailing receipt after the entries are verified by a postal employee. The acceptance Post Office retains the second copy.
The label must show article number, name and domestic address of the mailer, hold for pickup Post Office location for the addressee, and the amount due from the mailer (for payments made in cash, the money order fee necessary to make remittance will be collected from the recipient separately and is not included in the amount due the mailer indicated on the label). The USPS is not responsible for errors that a mailer makes in stating the charges to be collected. The information required on the COD HFPU label must be handwritten, typed or computer generated in ink. The mailer may not stipulate a specific payment method on the COD HFPU label.
A firm that mails nursery stock may use Form 3816 and include instructions for disposing of shipments not delivered immediately by printing instructions on the back of the delivery office part of the COD HFPU form (item a) and on the remittance coupon (item b) as follows:
No payment is made when a money order is issued in return for a COD HFPU parcel, and is presented by the addressee (purchaser), and the money order is not endorsed by the payee (shipper) or the payee has not authorized payment to the purchaser by written approval.
For basic qualified BRM a permit holder is required to an account maintenance fee under 1.1.8, and a per-piece fee under 1.1.7 in addition to the applicable letter or card First-Class Mail postage for each returned piece. ***
In addition to the account maintenance, per-piece fees and applicable postage required under 1.1.3, a quarterly fee under 1.1.11 is required for high-volume QBRM.
The mailer may apply for a BRM permit by submitting a completed Form 3615 to the Post Office issuing the permit and except under 1.2.3 paying the annual permit fee. * * *
Except for QBRM permits, a permit fee must be paid once each 12-month period at each Post Office where a BRM permit is held. * * *
Except for QBRM permits, an annual renewal notice is provided to each BRM permit holder by the USPS. QBRM permits do not expire unless the account is unused for a period of 12 months. The renewal notice and the payment for the next 12 months must be returned by the expiration date to the Post Office that issued the permit. After the expiration date, if the permit holder has not paid the annual permit fee, then returned BRM pieces are treated as follows:
The USPS may revoke any BRM permit because of format errors or for refusal to pay the applicable permit fees (annual, accounting, quarterly, or monthly), postage, or per piece fees. If the permit was revoked due to format errors, then a former permit holder may obtain a new permit and permit number by completing and submitting a new Form 3615, paying the required BRM annual permit fee (if applicable), paying a new annual account maintenance fee (if applicable), and, for the next 2 years, submitting two samples of each BRM format to the appropriate Post Office for approval.
a. Mail with extra services (certified, COD HFPU, registered, special handling).
If a return receipt is attached to a certified, Collect on Delivery Hold for Pickup (COD HFPU),
Deliverable mail addressed to a Post Office box is not returned until after the box is declared vacant, except for certified, collect on delivery (COD HFPU), insured, registered, postage due, Adult Signature and perishable mail.
Certified, Collect on Delivery Hold For Pickup (COD HFPU), USPS Tracking, insured, registered, Signature Confirmation, Adult Signature, return receipt for merchandise, and special handling mail, is forwarded to a domestic address only without additional extra service fees, subject to the applicable postage charge.
g. Priority Mail Express, or mailpieces with USPS Tracking, Certified Mail, COD HFPU, insurance, Signature Confirmation, or Adult Signature are shipped to the destination delivery office Postmaster separately, for proper handling.
A change-of-address order to a domestic address covers Certified Mail, COD HFPU insured, Registered Mail, Signature Confirmation, Adult Signature services, and return receipt for merchandise mail unless the sender gives other instructions.
At the sender's request, the delivery Post Office holds mail, other than Registered Mail, insured, Certified Mail, Adult Signature, Signature Confirmation and return receipt for merchandise, for no fewer than 3 days nor more than 30 days.
a. Pieces sent as Registered Mail, insured, Certified Mail, Collect on Delivery Hold for Pickup (COD HFPU), Adult Signature and return receipt for merchandise.
The following conditions also apply to the delivery of Priority Mail Express, Registered Mail, Certified Mail, mail insured for more than $500.00, Adult Signature, or COD HFPU, as well as mail for which a return receipt is requested or the sender has specified restricted delivery.
f. A notice is provided to the addressee for a mailpiece that cannot be delivered. If the piece is not called for or redelivery is not requested, the piece is returned to the sender after 15 days (5 days for Priority Mail Express), unless the sender specifies fewer days on the piece.
d. A CMRA is authorized to accept the following accountable mail from their customers for mailing at the Post Office: Insured, Priority Mail Express, Certified Mail, USPS Tracking, and Signature Confirmation mail. The sender (CMRA customer) must present accountable mail items not listed to the Post Office for mailing.
l. Collect on Delivery Hold for Pickup (COD HFPU) mail.
Alternative addressing formats may not be used on:
e. Mail with the following extra services:
8. Collect on Delivery Hold for Pickup (COD HFPU).
* * * The mailing date format used in the indicia is also subject to the following conditions.
a. Complete Date. Mailers must use a complete date for the following:
2. All mailpieces with Insured Mail, COD HFPU (only when a manual office COD HFPU Label 3816 is used), or Special Handling service.
A mailer may obtain a permit to use a permit imprint indicia by submitting Form 3615 to the Post Office where mailings are made, or online under the terms and conditions in the Business Customer Gateway portal at
No application fee is required.
A permit may be revoked for use in operating any unlawful scheme or enterprise, if no mailings or payment of postage occurred during any consecutive 2-year period, for refusal to provide information about permit imprint use or mailings, and for noncompliance with any standard applicable to permit imprints. * * *
A permit imprint displaying the city, state, and permit number of a mailer's original permit may be applied to pieces in a mailing presented for verification and acceptance at another Post Office location under the following conditions:
Share Mail is an electronic postage payment mechanism for single-piece First-Class Mail letters or postcards, addressed to any domestic address, that weigh no more than one ounce each. Customers wishing to participate in this program must submit their request in writing to the Manager, New Solutions, Mailing Services, USPS, 475 L'Enfant Plaza SW., Room 5440, Washington, DC 20260-4440. Customers participating in the Share Mail postage payment program must, at a minimum, meet the following requirements:
a. Have a Centralized Account Processing System (CAPS) account link with USPS;
b. Submit production quality mailpieces to USPS for pre-approval and have received subsequent USPS approval; and
c. Have approved mailpieces that bear unique or static Intelligent Mail barcodes, an approved permit imprint indicia in the upper-right hand corner of the mailpiece, and a special facing identification mark (FIM E) (see 708.9.2e.).
Refunds are not made for the following:
b. Collect on Delivery Hold for Pickup (COD HFPU), Priority Mail Express insurance, insured mail, and Registered Mail fees, after the USPS accepts the article (even if the article is later withdrawn from the mail).
PDWA customers may elect to establish a quality control program to ensure that all missorted and accountable mail (including Certified Mail), return receipt for merchandise, USPS Tracking, Adult Signature, and Signature Confirmation) is identified and returned to the servicing Post Office prior to being opened. * * *
A customer may file an indemnity claim for insured mail, COD HFPU items, Registered Mail with postal insurance, or Priority Mail Express. See Publication 122, available on
A claim may be filed by:
e. Only the mailer, for insured or collect on delivery (COD HFPU) parcels paid using eVS under 705.2.9.
File claims as follows:
b.
Domestic indemnity claims should be filed online (preferred) at
For a claim involving articles listed in 1.1, the customer must retain evidence showing that the specific USPS service was purchased, until the claim is resolved. Examples of acceptable evidence are:
a. The original mailing receipt issued at the time of mailing (Registered Mail receipts must contain a USPS postmark). For insured mail and COD HFPU, a photocopy of the original retail mailing receipt is acceptable.
b. The outer packaging showing the names and addresses of the sender and the addressee and the proper label showing that the article was sent insured, COD HFPU, Registered Mail with postal insurance, or Priority Mail Express. (If only the outer packaging is submitted, indemnity can be limited to $100 for insured, $50 for COD HFPU, $100 for Registered Mail, and $100 for Priority Mail Express.)
d. For insurance or COD HFPU, purchased online, a printed electronic online label record or a computer printout from the application used to print the label and purchase the insurance. * * *
e. For insured mail or COD HFPU mail paid using MMS or eVS under 705.2.0, the mailer must use one of the following:
2. A printout of the part of Form 3877 that identifies the parcel by article number, the package identification code (PIC) of the insured or COD HFPU parcel, total postage paid, fee paid, declared insured value, amount due sender if COD HFPU, mailing date, origin ZIP Code, and delivery ZIP Code reported in the parcel record in the manifest file.
Insurance for loss or damage to insured, COD HFPU, or Registered Mail within the amount covered by the fee paid, or the indemnity limits for Priority Mail, or Priority Mail Express (under 4.2), is payable for the following:
c. Remittance due on a COD HFPU parcel not received by the sender, subject to the limitations set by the standards for COD HFPU service.
Indemnity is not paid for insured mail (including Priority Mail Express and Priority Mail), Registered Mail, COD HFPU, or Priority Mail and Priority Mail Express in these situations:
w. Items sent COD HFPU without the addressee's consent.
If the insured, registered, or COD HFPU article is lost the payment includes an additional amount for the postage (not fee) paid by the sender. Postage for Priority Mail Express is refunded under 604.9.5.
If a lost registered, insured, COD HFPU, or Priority Mail Express article is recovered after payment of a claim, the payee may accept the article and reimburse the USPS for the full amount paid if the article is undamaged.
a. Collect on Delivery (COD HFPU).
A combination mailpiece may be sent insured or COD HFPU. The insurance covers only the value of the parcel.
All presorted and high density plus, high density and basic carrier route Standard Mail, presorted and carrier route Bound Printed Matter (BPM), and Periodicals flats including all carrier route flats meeting the standards in 201.6.2 must be separated/pooled into FSS schemes, properly bundled and placed on or in pallets, trays, sacks, or approved alternate containers, for FSS scheme ZIP Code combinations within the same facility. Mailings that include 10 or more pieces of Standard Mail flats, 6 or more pieces of Periodicals flats, or 10 or more pieces (or 10 or more pounds) of BPM flats to an FSS scheme must be separated/pooled into FSS scheme bundles. The Postal Service also recommends the use of authorized flat trays in lieu of sacks for FSS bundles. FSS scheme bundles that are not required to be placed in a FSS scheme or FSS facility container are combined with bundles of non-FSS sorted bundles and placed on an applicable SCF, 3-digit or NDC container. Mailers must prepare FSS scheme qualifying mailpieces for each individual FSS scheme combination, and then prepare bundles of uniform size from those pieces. Mailings (excluding saturation mailings of Standard Mail) with nonpresorted BPM flats may be included in FSS preparation, but will not be eligible for presorted or carrier route prices. Mailpieces that meet the eligibility standards for 5-digit or 3-digit automation, 5-digit or 3-digit nonautomation, carrier route (except Standard Mail saturation) or presort will continue to be eligible for those piece prices when prepared in accordance with the FSS preparations standards. Mailpieces and bundles must also be prepared as follows:
All Periodicals flats (including carrier route flats) meeting the standards in 201.6.2 and destinating to FSS sites as shown in L006 must be prepared according to these standards. Mailings of In-County Periodicals flats and the associated Outside-County Periodicals flats mailings of 5,000 pieces or less may be prepared according to these standards. Periodicals are subject to the following:
a. Pricing eligibility is based on 207.11.0 through 207.14.0. FSS bundles placed on FSS facility pallets, sacks, trays, or approved alternate container will claim the 3-Digit/SCF bundle price. FSS bundles placed on a FSS scheme pallet, sack, tray or approved alternate container will claim the Carrier Route bundle price.
b. FSS scheme pallets will be assessed the Carrier Route Pallet price. FSS facility sort level pallets will be charged a 3-Digit/SCF Pallet container price. FSS scheme or facility sacks or trays will be assessed the 3-Digit/SCF Sack/Tray price. Pallets, sacks and trays entered at a DFSS will claim the DSCF entry price.
c. The Outside-County pound price for mail entered at a DFSS will be the DSCF price. The Inside-County price will claim prices for the “None” entry level.
d. Mailers must provide standardized presort documentation under 708.1.0 that demonstrates eligibility for prices in accordance with 207.14.0 and 207.25.0.
e. Each mailpiece must be identified with an optional endorsement line in accordance with Exhibit 708.7.1.1, or when authorized, using a red Label 5 SCH barcoded pressure-sensitive bundle label.
All flat-size Standard Mail mailpieces (except saturation) must be separated/pooled into 5-digit FSS scheme bundles and placed on pallets, or in sacks or approved alternate containers, for delivery to ZIP Codes having Flats Sequencing System (FSS) processing capability, as shown in L006. Standard Mail flats are subject to the following:
b. Mailers must provide standardized presort documentation under 708.1.0 that demonstrates eligibility for prices in accordance with 243.
c. Each mailpiece must be identified with an optional endorsement line in accordance with Exhibit 708.7.1.1; or when authorized, using a red Label 5 SCH barcoded pressure-sensitive bundle label.
Bound Printed Matter (BPM) flats that meet the standards in 201.6.2, must be separated/pooled into FSS scheme bundles and placed on pallets, or in flat trays, sacks, or approved alternate containers, for delivery to ZIP Codes having FSS processing capability, as shown in L006. BPM flats are subject to the following:
b. Mailers must provide standardized presort documentation under 708.1.0 that demonstrates eligibility for prices in accordance with 263.
c. Mailers must separate/pool all eligible flat-size mailpieces into FSS scheme bundles according to L006.
d. Each mailpiece must be identified with an optional endorsement line in accordance with Exhibit 708.7.1.1; or when authorized, using a red Label 5 SCH barcoded pressure-sensitive bundle label.
Apply piece prices based on the bundle level except FSS scheme bundles apply the piece prices based on the original bundle level. Pieces contained within mixed class bundles may claim prices based on the presort level of the bundle.
Mailers authorized to combine mailings of Standard Mail flats and Periodicals flats must prepare these mailings under 14.0, when the mailing includes pieces destinating within one or more of the FSS zones in L006. The following applies:
a. Each mailpiece must be identified with an optional endorsement line (OEL), including the correct ZIP Code listed in L006, Column B, in accordance with Exhibit 708.7.1.1. The OEL described in 2.2 must not be used with mailpieces prepared under this option.
When combining Standard Mail and Periodicals flats within the same bundle or combining bundles of Standard Mail flats and bundles of Periodicals flats on pallets, bundles must be placed on pallets. Preparation, sequence and labeling:
a.
1. Line 1: L001.
2. Line 2: “STD/PER FLTS”; followed by “CARRIER ROUTES” (or “CR-RTS”); followed by “SCHEME” (or “SCH”); followed by “MIX COMAIL.”
b.
1. Line 1: L001.
2. Line 2: “STD/PER FLTS CR/5D;” followed by “SCHEME” (or “SCH”); followed by “MIX COMAIL.”
The actual name of the price level (or abbreviation) is used for column headings required by 1.2 and shown below:
a. Automation First-Class Mail, Standard Mail, and barcoded Periodicals:
b. Presorted First-Class Mail, barcoded and nonbarcoded Periodicals flats, nonbarcoded Periodicals letters, and machinable and nonmachinable Standard Mail:
c. Carrier Route Periodicals and Enhanced Carrier Route Standard Mail:
The publisher must be able to present documentation to support the number of copies of each edition of an issue, by entry point, mailed to each zone, and at DDU, DSCF, DADC, DNDC, and In-County prices. * * *
Use the actual price name or the authorized zone abbreviation in the listings in 1.0 and 207.17.4.2:
An optional endorsement line (OEL) may be used to label bundles instead of applying pressure-sensitive bundle labels or facing slips to the top piece of bundles except each mailpiece in a FSS bundle must bear an optional endorsement line in human-readable text, including the correct ZIP code listed in Column B of L006, as described in Exhibit 7.1.1. * * *
Mailers authorized to combine Standard Mail flats and Periodicals flats, under 705.15.0, must apply an OEL identifying the presort level of the bundle and other applicable information as specified in 7.1 to each mailpiece. The following additional standards also apply:
c. When combined mailings of Standard Mail and Periodicals flats are prepared to FSS zones under 705.15.1.11, each mailpiece must bear an optional endorsement line in human-readable text, including the correct ZIP code listed in Column B of L006, as described in Exhibit 7.1.1.
We will publish an appropriate amendment to 39 CFR part 111 to reflect these changes if our proposal is adopted.
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve a July 6, 2016, request from the Ohio
Comments must be received on or before November 16, 2016.
Submit your comments, identified by Docket ID No. EPA-R05-OAR-2016-0396 at
Jenny Liljegren, Physical Scientist, Attainment Planning and Maintenance Section, Air Programs Branch (AR-18J), Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604, (312) 886-6832,
Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA. This supplementary information section is arranged as follows:
EPA is proposing to take several related actions. EPA is proposing to approve Ohio EPA's request to change the legal designation of the Cleveland area from nonattainment to attainment of the 2008 ozone standard. EPA is also proposing to approve, as a revision to the Ohio SIP, the state's maintenance plan (such approval being one of the CAA criteria for redesignation to attainment status) for the area. The maintenance plan is designed to keep the Cleveland area in attainment of the 2008 ozone NAAQS through 2030. Finally, EPA finds adequate and is proposing to approve the newly-established 2020 and 2030 MVEBs for the Cleveland area. The adequacy comment period for the MVEBs began on July 22, 2016, with EPA's posting of the availability of the submittal on EPA's Adequacy Web site (at
EPA has determined that ground-level ozone is detrimental to human health. On March 12, 2008, EPA promulgated a revised 8-hour ozone NAAQS of 0.075 parts per million (ppm). See 73 FR 16436 (March 27, 2008). Under EPA's regulations at 40 CFR part 50, the 2008 ozone NAAQS is attained in an area when the 3-year average of the annual 4th high daily maximum 8-hour average ozone concentrations is equal to or less than 0.075 ppm when truncated after the thousandth decimal place at all of the ozone monitoring sites in the area.
Upon promulgation of a new or revised NAAQS, section 107(d)(1)(B) of the CAA requires EPA to designate as nonattainment any areas that are violating the NAAQS, based on the most recent three years of quality-assured ozone monitoring data. The Cleveland area was designated as a marginal nonattainment area for the 2008 ozone NAAQS on May 21, 2012 (77 FR 30088) (effective July 20, 2012).
In a final implementation rule for the 2008 ozone NAAQS (SIP Requirements Rule),
Section 107(d)(3)(E) of the CAA allows redesignation of an area to attainment of the NAAQS provided that: (1) The Administrator (EPA) determines that the area has attained the NAAQS; (2) the Administrator has fully approved the applicable implementation plan for the area under section 110(k) of the CAA; (3) the Administrator determines that the improvement in air quality is due to permanent and enforceable reductions in emissions resulting from implementation of the applicable SIP, applicable Federal air pollutant control regulations, and other permanent and enforceable emission reductions; (4) the Administrator has fully approved a maintenance plan for the area as meeting the requirements of section 175A of the CAA; and (5) the state containing the area has met all requirements applicable to the area for the purposes of redesignation under section 110 and part D of the CAA.
On April 16, 1992, EPA provided guidance on redesignations in the General Preamble for the Implementation of Title I of the CAA Amendments of 1990 (57 FR 13498) and supplemented this guidance on April 28, 1992 (57 FR 18070). EPA has provided further guidance on processing redesignation requests in the following documents:
1. “Ozone and Carbon Monoxide Design Value Calculations,” Memorandum from Bill Laxton, Director, Technical Support Division, June 18, 1990;
2. “Maintenance Plans for Redesignation of Ozone and Carbon Monoxide Nonattainment Areas,” Memorandum from G.T. Helms, Chief, Ozone/Carbon Monoxide Programs Branch, April 30, 1992;
3. “Contingency Measures for Ozone and Carbon Monoxide (CO) Redesignations,” Memorandum from G.T. Helms, Chief, Ozone/Carbon Monoxide Programs Branch, June 1, 1992;
4. “Procedures for Processing Requests to Redesignate Areas to Attainment,” Memorandum from John Calcagni, Director, Air Quality Management Division, September 4, 1992 (the “Calcagni memorandum”);
5. “State Implementation Plan (SIP) Actions Submitted in Response to Clean Air Act (CAA) Deadlines,” Memorandum from John Calcagni, Director, Air Quality Management Division, October 28, 1992;
6. “Technical Support Documents (TSDs) for Redesignation of Ozone and Carbon Monoxide (CO) Nonattainment Areas,” Memorandum from G.T. Helms, Chief, Ozone/Carbon Monoxide Programs Branch, August 17, 1993;
7. “State Implementation Plan (SIP) Requirements for Areas Submitting Requests for Redesignation to Attainment of the Ozone and Carbon Monoxide (CO) National Ambient Air Quality Standards (NAAQS) On or After November 15, 1992,” Memorandum from Michael H. Shapiro, Acting Assistant Administrator for Air and Radiation, September 17, 1993 (the “Shapiro memorandum”);
8. “Use of Actual Emissions in Maintenance Demonstrations for Ozone and CO Nonattainment Areas,” Memorandum from D. Kent Berry, Acting Director, Air Quality Management Division, November 30, 1993;
9. “Part D New Source Review (Part D NSR) Requirements for Areas Requesting Redesignation to Attainment,” Memorandum from Mary D. Nichols, Assistant Administrator for Air and Radiation, October 14, 1994 (the “Nichols memorandum”); and
10. “Reasonable Further Progress, Attainment Demonstration, and Related Requirements for Ozone Nonattainment Areas Meeting the Ozone National Ambient Air Quality Standard,” Memorandum from John S. Seitz, Director, Office of Air Quality Planning and Standards, May 10, 1995.
For redesignation of a nonattainment area to attainment, the CAA requires EPA to determine that the area has attained the applicable NAAQS (CAA section 107(d)(3)(E)(i)). An area is attaining the 2008 ozone NAAQS if it meets the 2008 ozone NAAQS, as determined in accordance with 40 CFR 50.15 and appendix P of part 50, based on three complete, consecutive calendar years of quality-assured air quality data for all monitoring sites in the area. To attain the NAAQS, the 3-year average of the annual 4th high daily maximum 8-hour average ozone concentrations (ozone design values) at each monitor must not exceed 0.075 ppm when truncated after the thousandth decimal place. The air quality data must be collected and quality-assured in accordance with 40 CFR part 58 and recorded in EPA's Air Quality System (AQS). Ambient air quality monitoring data for the 3-year period must also meet data completeness requirements. An ozone design value is valid if daily maximum 8-hour average concentrations are available for at least 90% of the days within the ozone monitoring seasons,
On May 4, 2016 (81 FR 26697), based on EPA's evaluation and determination that the Cleveland area failed to attain the NAAQS by July 20, 2015, but met the attainment date extension criteria of CAA section 181(a)(5), EPA granted the Cleveland area a 1-year extension of the applicable Marginal area attainment date from July 20, 2015, to July 20, 2016. On June 27, 2016 (81 FR 41444), in accordance with section 181(b)(2)(A) of the CAA and the provisions of the SIP Requirements Rule (40 CFR 51.1103), EPA made a determination that the Cleveland area attained the standard by its July 20, 2016 attainment date based upon three years of complete, quality-assured and certified data for the 2013-2015 time period. These data are summarized in Table 1, below.
EPA will not take final action to approve the redesignation of this area if the design value of a monitoring site in the area exceeds the NAAQS after proposal but prior to final approval of the redesignation. Preliminary 2016 data indicate that this area continues to attain the 2008 ozone NAAQS. As discussed in section IV.D.3. below, Ohio EPA has committed to continue monitoring ozone in this area to verify maintenance of the ozone standard.
As criteria for redesignation of an area from nonattainment to attainment of a NAAQS, the CAA requires EPA to determine that the state has met all applicable requirements under section 110 and part D of title I of the CAA (
The September 4, 1992, Calcagni memorandum describes EPA's interpretation of section 107(d)(3)(E) of the CAA. Under this interpretation, a state and the area it wishes to redesignate must meet the relevant CAA requirements that are due prior to the state's submittal of a complete redesignation request for the area.
Section 110(a)(2) of the CAA delineates the general requirements for a SIP. Section 110(a)(2) provides that the SIP must have been adopted by the state after reasonable public notice and hearing, and that, among other things, it must: (1) include enforceable emission limitations and other control measures, means or techniques necessary to meet the requirements of the CAA; (2) provide for establishment and operation of appropriate devices, methods, systems and procedures necessary to monitor ambient air quality; (3) provide for implementation of a source permit program to regulate the modification and construction of stationary sources within the areas covered by the plan; (4) include provisions for the implementation of CAA title I part C Prevention of Significant Deterioration (PSD) and part D nonattainment New Source Review (NSR) permit programs; (5) include criteria for stationary source emission control measures, monitoring, and reporting; (6) include provisions for air quality modeling; and, (7) provide for public and local agency participation in planning and emission control rule development.
Section 110(a)(2)(D) of the CAA requires SIPs to contain measures to prevent sources in a state from significantly contributing to air quality problems in another state. To implement this provision, EPA has required certain states to establish programs to address transport of certain air pollutants,
In addition, EPA believes that other section 110 elements that are neither connected with nonattainment plan submissions nor linked with an area's ozone attainment status are not applicable requirements for purposes of redesignation. The area will still be subject to these requirements after the area is redesignated to attainment of the 2008 ozone NAAQS. The section 110 and part D requirements which are linked with a particular area's designation and classification are the relevant measures to evaluate in reviewing a redesignation request. This approach is consistent with EPA's existing policy on applicability (
We have reviewed Ohio's SIP and have concluded that it meets the general SIP requirements under section 110 of the CAA, to the extent those requirements are applicable for purposes of redesignation. On October 16, 2014 (79 FR 62019), EPA approved elements of the SIP submitted by Ohio to meet the requirements of section 110 for the 2008 ozone standard. The requirements of section 110(a)(2), however, are statewide requirements that are not linked to the 2008 ozone standard nonattainment status of the Cleveland area. Therefore, EPA concludes that these infrastructure requirements are not applicable requirements for purposes of review of the state's 2008 ozone standard redesignation request.
Section 172(c) of the CAA sets forth the basic requirements of air quality plans for states with nonattainment areas that are required to submit them pursuant to section 172(b). Subpart 2 of part D, which includes section 182 of the CAA, establishes specific requirements for ozone nonattainment areas depending on the areas' nonattainment classifications.
The Cleveland area was classified as marginal nonattainment under subpart 2 for the 2008 ozone NAAQS. As such, the area is subject to the subpart 1 requirements contained in section 172(c) and section 176 and the subpart 2 requirements contained in section 182(a) (marginal nonattainment area requirements). A thorough discussion of the requirements contained in section 172(c) and 182 can be found in the General Preamble for Implementation of Title I (57 FR 13498).
As provided in subpart 2, for marginal ozone nonattainment areas such as the Cleveland area, the specific requirements of section 182(a) apply in lieu of the attainment planning requirements that would otherwise apply under section 172(c), including the attainment demonstration and reasonably available control measures (RACM) under section 172(c)(1), reasonable further progress (RFP) under section 172(c)(2), and contingency measures under section 172(c)(9). 42 U.S.C. 7511a(a).
Section 172(c)(3) requires submission and approval of a comprehensive, accurate and current inventory of actual emissions. This requirement is superseded by the inventory requirement in section 182(a)(1) discussed below.
Section 172(c)(4) requires the identification and quantification of allowable emissions for major new and modified stationary sources in an area, and section 172(c)(5) requires source permits for the construction and operation of new and modified major stationary sources anywhere in the nonattainment area. EPA approved Ohio's NSR program on January 10, 2003 (68 FR 1366) and February 25, 2010 (75 FR 8496). However, EPA has determined that, since PSD NSR requirements will apply after redesignation, areas being redesignated need not comply with the requirement that a nonattainment NSR program be approved prior to redesignation, provided that the area demonstrates maintenance of the NAAQS without part D nonattainment NSR. A more detailed rationale for this determination is described in the Nichols memorandum. Ohio has demonstrated that the Cleveland area will be able to maintain the standard without part D nonattainment NSR in effect; therefore, EPA concludes that the state need not have a fully approved part D nonattainment NSR program prior to approval of the redesignation request.
Section 172(c)(6) requires the SIP to contain control measures necessary to provide for attainment of the NAAQS. Because attainment has been reached, no additional measures are needed to provide for attainment.
Section 172(c)(7) requires the SIP to meet the applicable provisions of section 110(a)(2). As noted above, we have determined the Ohio SIP meets the requirements of section 110(a)(2) for purposes of redesignation.
Section 176(c) of the CAA requires states to establish criteria and procedures to ensure that federally supported or funded projects conform to the air quality planning goals in the applicable SIP. The requirement to determine conformity applies to transportation plans, programs and projects that are developed, funded or approved under title 23 of the United States Code (U.S.C.) and the Federal Transit Act (transportation conformity) as well as to all other federally supported or funded projects (general conformity). State transportation conformity SIP revisions must be consistent with Federal conformity regulations relating to consultation, enforcement and enforceability that EPA promulgated pursuant to its authority under the CAA.
EPA interprets the conformity SIP requirements
Section 182(a)(1) requires states to submit a comprehensive, accurate, and current inventory of actual emissions from sources of volatile organic compounds (VOC) and NO
Under section 182(a)(2)(A), states with ozone nonattainment areas that were designated prior to the enactment of the 1990 CAA amendments were required to submit, within six months of classification, all rules and corrections to existing VOC reasonably available control technology (RACT) rules that were required under section 172(b)(3) prior to the 1990 CAA amendments. The Cleveland area is not subject to the section 182(a)(2) RACT “fix up” requirement for the 2008 ozone NAAQS because it was designated as nonattainment for this standard after the enactment of the 1990 CAA amendments and because Ohio complied with this requirement for the Cleveland area under the prior 1-hour ozone NAAQS.
Section 182(a)(2)(B) requires each state with a marginal ozone nonattainment area that implemented or was required to implement a vehicle inspection and maintenance (I/M) program prior to the 1990 CAA amendments to submit a SIP revision for an I/M program no less stringent than that required prior to the 1990 CAA amendments or already in the SIP at the time of the CAA amendments, whichever is more stringent. For the purposes of the 2008 ozone standard and the consideration of Ohio's redesignation request for this standard, the Cleveland area is not subject to the section 182(a)(2)(B) requirement because the Cleveland area was designated as nonattainment for the 2008 ozone standard after the enactment of the 1990 CAA amendments. However, the Cleveland area established an I/M program under the 1-hour ozone standard. EPA approved Ohio's enhanced I/M program (E-Check), on April 4, 1995 (60 FR 16989) and January 6, 1997 (62 FR 646). The E-Check program continues to be implemented in the Cleveland area.
Regarding the source permitting and offset requirements of section 182(a)(2)(C) and section 182(a)(4), EPA approved Ohio's NSR program on January 22, 2003 (68 FR 2909) and February 25, 2010 (75 FR 8496). However, as discussed above, Ohio has demonstrated that the Cleveland area will be able to maintain the standard without part D nonattainment NSR in effect; therefore, EPA concludes that the state need not have a fully approved part D nonattainment NSR program prior to approval of the redesignation request. The state's PSD NSR program will become effective in the Cleveland area upon redesignation to attainment.
Section 182(a)(3) requires states to submit periodic emission inventories and a revision to the SIP to require the owners or operators of stationary sources to annually submit emission statements documenting actual VOC and NO
The Cleveland area has satisfied all applicable requirements for purposes of redesignation under section 110 and part D of title I of the CAA.
Ohio has adopted and submitted and EPA has approved at various times, provisions addressing the various SIP elements applicable for the ozone NAAQS. As discussed above, EPA has fully approved the Ohio SIP for the Cleveland area under section 110(k) for all requirements applicable for purposes of redesignation under the 2008 ozone NAAQS. EPA may rely on prior SIP approvals in approving a redesignation request (
To support the redesignation of an area from nonattainment to attainment, section 107(d)(3)(E)(iii) of the CAA requires EPA to determine that the air quality improvement in the area is due to permanent and enforceable reductions in emissions resulting from the implementation of the SIP and applicable Federal air pollution control regulations and other permanent and enforceable emission reductions. EPA has determined that Ohio has demonstrated that that the observed ozone air quality improvement in the Cleveland area is due to permanent and enforceable reductions in VOC and NO
In making this demonstration, the state has calculated the change in emissions between 2011 and 2014. The reduction in emissions and the corresponding improvement in air quality over this time period can be attributed to a number of regulatory control measures that the Cleveland area and upwind areas have implemented in recent years. In addition, Ohio EPA provided an analysis to demonstrate the improvement in air quality was not due to unusually favorable meteorology. Based on the information summarized below, Ohio has adequately demonstrated that the improvement in air quality is due to permanent and enforceable emissions reductions.
The D.C. Circuit's initial vacatur of CSAPR
EPA is proposing to approve the redesignation of the Cleveland area without relying on the Ohio CSAPR Phase 2 ozone season NO
The improvement in ozone air quality in the Cleveland area from 2011 (a year when the design value for the area was above the NAAQS) to 2014 (a year when the design value was below the NAAQS) with respect to EGUs includes changes at several facilities which resulted in NO
Reductions in VOC and NO
Ohio is using a 2011 inventory as the nonattainment base year. Area, non-road mobile, airport related emissions (AIR), and point source emissions (EGUs and non-EGUs) were collected from the Ozone NAAQS Implementation Modeling platform (2011v6.1). For 2011, this represents actual data Ohio reported to EPA for the 2011 National Emissions inventory (NEI). Because emissions from state inventory databases, the NEI, and the Ozone NAAQS Emissions Modeling platform are annual totals, tons per summer day were derived according to EPA's April 29, 2002 guidance document entitled “Temporal Allocation of Annual Emissions Using EMCH Temporal Profiles” using the temporal allocation references accompanying the 2011v6.1 modeling inventory files. On-road mobile source emissions were developed in conjunction with the Ohio EPA, the Ohio Department of Transportation, the Akron Metropolitan Area Transportation Study (AMATS), and the Northeast Ohio Areawide Coordinating Agency (NOACA) and were calculated from emission factors produced by EPA's Motor Vehicle Emission Simulator (MOVES) model and data extracted from the region's travel-demand model.
For the attainment inventory, Ohio is using 2014, one of the years the Cleveland area monitored attainment of the 2008 ozone standard. Because the 2014 NEI inventory was not available at the time Ohio EPA was compiling the redesignation request, the state was unable to use the 2014 NEI inventory directly. For area, non-road mobile, and AIR, 2014 emissions were derived by interpolating between 2011 and 2018 Ozone NAAQS Emissions Modeling platform inventories. The point source sector for the 2014 inventory was developed using actual 2014 point source emissions reported to the state database, which serve as the basis for the point source emissions reported to EPA for the NEI. Summer day inventories were derived for these sectors using the methodology described above. Finally, on-road mobile source emissions were developed using the same methodology described above for the 2011 inventory.
Using the inventories described above, Ohio's submittal documents changes in VOC and NO
As shown in Table 6, the Cleveland area reduced NO
Ohio EPA performed an analysis to further support Ohio's demonstration that the improvement in air quality between the year violations occurred and the year attainment was achieved is due to permanent and enforceable emission reductions and not unusually favorable meteorology. Ohio EPA analyzed the maximum 4th high 8-hour average ozone values for May, June, July, August, and September for years 2000 to 2015. First, the maximum 8-hour average ozone concentration at each monitor in the Cleveland area was compared to the number of days where the maximum temperature was greater than or equal to 80 °F. While there is a clear trend in decreasing ozone concentrations at all monitors, there is no such trend in the temperature data.
Ohio EPA also examined the relationship between the average summer temperature for each year of the 2000-2015 period and the 4th
Finally, Ohio EPA analyzed the relationship between average summertime relative humidity and average 4th maximum 8-hour average ozone concentrations. The data did not show a correlation between relative humidity and ozone concentrations.
Ohio EPA's analyses of meteorological variables associated with ozone formation further support Ohio's demonstration that the improvement in air quality in the Cleveland area between the year violations occurred and the year attainment was achieved is due to permanent and enforceable emission reductions and not on unusually favorable meteorology.
As one of the criteria for redesignation to attainment, section 107(d)(3)(E)(iv) of the CAA requires EPA to determine that the area has a fully approved maintenance plan pursuant to section 175A of the CAA. Section 175A of the CAA sets forth the elements of a maintenance plan for areas seeking redesignation from nonattainment to attainment. Under section 175A, the maintenance plan must demonstrate continued attainment of the NAAQS for at least 10 years after the Administrator approves a redesignation to attainment. Eight years after the redesignation, the state must submit a revised maintenance plan which demonstrates that attainment of the NAAQS will continue for an additional 10 years beyond the initial 10 year maintenance period. To address the possibility of future NAAQS violations, the maintenance plan must contain contingency measures, as EPA deems necessary, to assure prompt correction of the future NAAQS violation.
The Calcagni memorandum provides further guidance on the content of a maintenance plan, explaining that a maintenance plan should address five elements: (1) An attainment emission inventory; (2) a maintenance demonstration; (3) a commitment for continued air quality monitoring; (4) a process for verification of continued attainment; and (5) a contingency plan. In conjunction with its request to redesignate the Cleveland area to attainment for the 2008 ozone standard, Ohio submitted a SIP revision to provide for the maintenance of the 2008 ozone standard through 2030, more than 10 years after the expected effective date of the redesignation to attainment. As discussed more fully below, EPA proposes to find that Ohio's ozone maintenance plan includes the necessary components, and EPA is proposing to approve the maintenance plan as a revision of the Ohio SIP.
EPA has determined that the Cleveland area attained the 2008 ozone NAAQS based on monitoring data for the period of 2013-2015 (81 FR 41444). Ohio selected 2014 as the attainment emissions inventory year to establish attainment emission levels for VOC and NO
Ohio has demonstrated maintenance of the 2008 ozone standard through 2030 by assuring that current and future emissions of VOC and NO
Ohio is using emissions inventories for the years 2020 and 2030 to demonstrate maintenance. 2030 is more than 10 years after the expected effective date of the redesignation to attainment and 2020 was selected to demonstrate that emissions are not expected to spike in the interim between the attainment year and the final maintenance year. The emissions inventories were developed as described below.
To develop the 2020 and 2030 inventories, the state collected data from the Ozone NAAQS Emissions Modeling platform (2011v6.1) inventories for years 2011, 2018 and 2025. 2020 emissions for area, non-road mobile, AIR, and point source sectors were derived by interpolating between 2018 and 2025. 2030 emissions for area, non-road mobile, AIR, and point source sectors were derived using the TREND function in Excel. If the trend function resulted in a negative value the emissions were assumed not to change. Summer day inventories were derived for these sectors using the methodology described in section IV.C.2. above. Finally, on-road mobile source emissions were developed using the same methodology described in section IV.C.2. above for the 2011 inventory. Emissions data are shown in Tables 7 through 11 below.
In summary, the maintenance demonstration for the Cleveland area shows maintenance of the 2008 ozone standard by providing emissions information to support the demonstration that future emissions of NO
Ohio has committed to continue to operate the ozone monitors listed in Table 1 above. Ohio has committed to consult with EPA prior to making changes to the existing monitoring network should changes become necessary in the future. Ohio remains
The State of Ohio has certified that it has the legal authority to enforce and implement the requirements of the maintenance plan for the Cleveland area. This includes the authority to adopt, implement, and enforce any subsequent emission control measures determined to be necessary to correct future ozone attainment problems.
Verification of continued attainment is accomplished through operation of the ambient ozone monitoring network and the periodic update of the area's emissions inventory. Ohio will continue to operate the current ozone monitors located in the Cleveland area. There are no plans to discontinue operation, relocate, or otherwise change the existing ozone monitoring network other than through revisions in the network approved by the EPA.
In addition, to track future levels of emissions, Ohio will continue to develop and submit to EPA updated emission inventories for all source categories at least once every three years, consistent with the requirements of 40 CFR part 51, subpart A, and in 40 CFR 51.102. The Consolidated Emissions Reporting Rule (CERR) was promulgated by EPA on June 10, 2002 (67 FR 39602). The CERR was replaced by the Air Emissions Reporting Requirements (AERR) on December 17, 2008 (73 FR 76539). The most recent triennial inventory for Ohio was compiled for 2014. Point source facilities covered by Ohio's emission statement rule, Ohio Administrative Code, Chapter 3745-24, will continue to submit VOC and NO
Section 175A of the CAA requires that the state must adopt a maintenance plan, as a SIP revision, that includes such contingency measures as EPA deems necessary to assure that the state will promptly correct a violation of the NAAQS that occurs after redesignation of the area to attainment of the NAAQS. The maintenance plan must identify: The contingency measures to be considered and, if needed for maintenance, adopted and implemented; a schedule and procedure for adoption and implementation; and, a time limit for action by the state. The state should also identify specific indicators to be used to determine when the contingency measures need to be considered, adopted, and implemented. The maintenance plan must include a commitment that the state will implement all measures with respect to the control of the pollutant that were contained in the SIP before redesignation of the area to attainment in accordance with section 175A(d) of the CAA.
As required by section 175A of the CAA, Ohio has adopted a maintenance plan for the Cleveland area including contingency measures to address possible future ozone air quality problems. The specific indicators adopted by Ohio to be used to determine when the contingency measures need to be considered have two levels of response, a warning level response and an action level response.
In Ohio's plan, a warning level response will be triggered when an annual 4th high 8-hour average ozone monitored value of 0.079 ppm or higher is monitored within the maintenance area. A warning level response will consist of Ohio EPA conducting a study to determine whether the ozone value indicates a trend toward higher ozone values or whether emissions appear to be increasing. The study will evaluate whether the trend, if any, is likely to continue and, if so, the control measures necessary to reverse the trend. The study will consider ease and timing of implementation as well as economic and social impacts. Implementation of necessary controls in response to a warning level response trigger will take place within 10 months from the conclusion of the most recent ozone season.
In Ohio's plan, an action level response is triggered when a two-year average of the annual 4th high 8-hour average ozone concentrations is 0.076 ppm or greater is monitored within the maintenance area. A violation of the standard within the maintenance area also triggers an action level response. When an action level response is triggered, Ohio EPA, in conjunction with the metropolitan planning organization or regional council of governments, will determine what additional control measures are needed to assure future attainment of the ozone standard. Control measures selected will be adopted and implemented within 18 months from the close of the ozone season that prompted the action level. Ohio EPA may also consider if significant new regulations not currently included as part of the maintenance provisions will be implemented in a timely manner and would thus constitute an adequate contingency measure response.
Ohio EPA included the following list of potential contingency measures in its maintenance plan:
1. Tighten VOC RACT on existing sources covered by EPA Control Technique Guidelines issued after the 1990 CAA.
2. Apply VOC RACT to smaller existing sources.
3. One or more transportation control measures sufficient to achieve at least half a percent reduction in actual area-wide VOC emissions. Transportation measures will be selected from the following, based upon the factors listed above, after consultation with affected local governments:
a. Trip reduction programs, including, but not limited to, employer-based transportation management plans, area wide rideshare programs, work schedule changes, and telecommuting;
b. traffic flow and transit improvements; and
c. other new or innovative transportation measures, not yet in widespread use, that affected local governments deem appropriate.
4. Alternative fuel and diesel retrofit programs for fleet vehicle operations.
5. Require VOC or NO
6. Increase the ratio of emission offsets required for new sources.
7. Require VOC or NO
8. Adopt additional NO
EPA finds that the maintenance plan adequately addresses the five basic components of a maintenance plan: Attainment inventory, maintenance demonstration, monitoring network, verification of continued attainment, and contingency measures. In addition, as required by section 175A(b) of the CAA, Ohio has committed to submit to EPA an updated ozone maintenance plan eight years after redesignation of the Cleveland area to cover an additional ten years beyond the initial 10 year maintenance period. Thus, EPA proposes to find that the maintenance plan SIP revision submitted by Ohio for the Cleveland area meets the requirements of section 175A of the CAA.
Under section 176(c) of the CAA, new transportation plans, programs, or projects that receive Federal funding or
Under the CAA, states are required to submit, at various times, control strategy SIPs for nonattainment areas and maintenance plans for areas seeking redesignations to attainment of the ozone standard and maintenance areas.
Under 40 CFR part 93, an MVEB for an area seeking a redesignation to attainment must be established, at minimum, for the last year of the maintenance plan. A state may adopt MVEBs for other years as well. The MVEB serves as a ceiling on emissions from an area's planned transportation system. The MVEB concept is further explained in the preamble to the November 24, 1993, Transportation Conformity Rule (58 FR 62188). The preamble also describes how to establish the MVEB in the SIP and how to revise the MVEB, if needed, subsequent to initially establishing a MVEB in the SIP.
When reviewing submitted control strategy SIPs or maintenance plans containing MVEBs, EPA must affirmatively find that the MVEBs contained therein are adequate for use in determining transportation conformity. Once EPA affirmatively finds that the submitted MVEBs are adequate for transportation purposes, the MVEBs must be used by state and Federal agencies in determining whether proposed transportation projects conform to the SIP as required by section 176(c) of the CAA.
EPA's substantive criteria for determining adequacy of a MVEB are set out in 40 CFR 93.118(e)(4). The process for determining adequacy consists of three basic steps: Public notification of a SIP submission; provision for a public comment period; and EPA's adequacy determination. This process for determining the adequacy of submitted MVEBs for transportation conformity purposes was initially outlined in EPA's May 14, 1999, guidance, “Conformity Guidance on Implementation of March 2, 1999, Conformity Court Decision.” EPA adopted regulations to codify the adequacy process in the Transportation Conformity Rule Amendments for the “New 8-Hour Ozone and PM
As discussed above, Ohio's maintenance plan includes NO
As shown in Table 12, the 2020 and 2030 MVEBs exceed the estimated 2020 and 2030 on-road sector emissions. In an effort to accommodate future variations in travel demand models and vehicle miles traveled forecast, Ohio EPA allocated a portion of the safety margin (described further below) to the mobile sector. Ohio has demonstrated that the Cleveland area can maintain the 2008 ozone NAAQS with mobile source emissions in the area of 38.85 TPSD and 30.80 TPSD of VOC and 61.56 TPSD and 43.82 TPSD of NO
A “safety margin” is the difference between the attainment level of emissions (from all sources) and the projected level of emissions (from all sources) in the maintenance plan. As noted in Table 11, the emissions in the Cleveland area are projected to have safety margins of 117.22 TPSD for NO
As shown in Table 12 above, Ohio is allocating a portion of that safety margin to the mobile source sector. Specifically, in 2020, Ohio is allocating 5.07 TPSD and 8.03 TPSD of the VOC and NO
EPA is proposing to determine that the Cleveland area has met the requirements for redesignation under section 107(d)(3)(E) of the CAA. EPA is thus proposing to approve Ohio's request to change the legal designation of the Cleveland area from nonattainment to attainment for the 2008 ozone standard. EPA is also proposing to approve, as a revision to the Ohio SIP, the state's maintenance plan for the area. The maintenance plan is designed to keep the Cleveland area in attainment of the 2008 ozone NAAQS through 2030. Finally, EPA finds adequate and is proposing to approve the newly-established 2020 and 2030 MVEBs for the Cleveland area.
Under the CAA, redesignation of an area to attainment and the accompanying approval of a maintenance plan under section 107(d)(3)(E) are actions that affect the status of a geographical area and do not impose any additional regulatory requirements on sources beyond those imposed by state law. A redesignation to attainment does not in and of itself create any new requirements, but rather results in the applicability of requirements contained in the CAA for areas that have been redesignated to attainment. Moreover, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. 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 application of those requirements would be inconsistent with the CAA; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because redesignation is an action that affects the status of a geographical area and does not impose any new regulatory requirements on tribes, impact any existing sources of air pollution on tribal lands, nor impair the maintenance of ozone NAAQS in tribal lands.
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Oxides of nitrogen, Ozone, Volatile organic compounds.
Fish and Wildlife Service, Interior.
Notification of review.
In this Candidate Notice of Review of Foreign Species (CNOR-FS), we present an updated list of plant and animal species foreign to the United States that we regard as candidates for addition to the Lists of Endangered and
We will accept information on any of the species in this Candidate Notice of Review of Foreign Species at any time.
Chief, Branch of Foreign Species, Ecological Services Program, U.S. Fish and Wildlife Service, 5275 Leesburg Pike, MS: ES, Falls Church, VA 22041-3808; telephone 703-358-2171. If you use a telecommunications device for the deaf (TDD), call the Federal Information Relay Service (FIRS) at 800-877-8339.
This CNOR-FS summarizes the status and threats that we evaluated in order to determine that species qualify as candidates, to assign a listing priority number (LPN) to each species, and to determine whether a species should be removed from candidate status. Additional material that we relied on for each candidate species is available in supporting documentation on the Internet at
Twenty foreign species are current candidates for listing. This document includes our findings on resubmitted petitions and describes our progress in revising the Lists of Endangered and Threatened Wildlife and Plants (Lists) during the period April 25, 2013, through April 7, 2016. Based on our review, we find that 19 species continue to warrant listing, but their listing remains precluded by higher-priority proposals to determine whether other species are an endangered species or a threatened species. We are removing one candidate from the list due to recovery, and we are adding a species that was originally considered to be one taxon but has recently been determined to be two full species. Additionally, in this CNOR-FS, we have assigned a listing priority number (LPN) to the new candidate species and have changed the LPNs for three candidate species.
The Endangered Species Act of 1973, as amended (Act) (16 U.S.C. 1531
Under section 4(b)(3)(A) of the Act, when we receive a petition to add a species or to remove a species from the List we must determine within 90 days, to the maximum extent practicable, whether the petition presents substantial scientific or commercial information indicating that the petitioned action may be warranted (90-day finding). Section 4(b)(3)(B) requires that, within 12 months after receiving any petition that contains substantial scientific or commercial information indicating that listing an animal or plant species may be warranted, we make one of the following findings (12-month finding): (1) Not warranted; (2) warranted; or (3) warranted, but the immediate proposal of a regulation implementing the petitioned action is precluded by other pending proposals to determine whether species are endangered or threatened species (warranted but precluded), and expeditious progress is being made to add or remove qualified species from the List (See Preclusion and Expeditious Progress below).
In accordance with section 4(b)(3)(C)(i) of the Act, when, in response to a petition, we find that listing a species is warranted but precluded, we must make a new 12-month finding annually until we publish a proposed rule to list the species or make a determination that listing is not warranted. These subsequent 12-month findings are referred to as “resubmitted” petition findings. This CNOR-FS contains our resubmitted petition findings for foreign species previously described in the Annual Notice of Review published April 25, 2013 (78 FR 24604).
We maintain this list of candidates for a variety of reasons:
(1) To notify the public that these species are facing threats to their survival;
(2) to provide advance knowledge of potential listings;
(3) to provide information that may stimulate and guide conservation efforts that will remove or reduce threats to these species and possibly make listing unnecessary;
(4) to request input from interested parties to help us identify those candidate species that may not require protection under the Act or additional species that may require the Act's protections; and
(5) to request necessary information for setting priorities for preparing listing proposals. We strongly encourage collaborative conservation efforts for candidate species. For additional information regarding such assistance, see
On September 21, 1983, we published guidance for assigning a listing priority number (LPN) for each candidate species (48 FR 43098). Guidelines for such a priority-ranking guidance system are required under section 4(h)(3) of the Act (15 U.S.C. 1533(h)(3)). Using this guidance, we assign each candidate an LPN of 1 to 12, depending on the magnitude of threats, immediacy of threats, and taxonomic status; the lower the LPN, the higher the listing priority (that is, a species with an LPN of 1 would have the highest listing priority). As explained below, we first categorize based on the magnitude of the threat(s), then by the immediacy of the threat(s), and finally by taxonomic status.
Under this priority-ranking system, magnitude of threat can be either “high” or “moderate to low.” This criterion helps ensure that the species facing the greatest threats to their continued
As used in our priority ranking system, immediacy of threat is categorized as either “imminent” or “nonimminent.” It is not a measure of how quickly the species is likely to become extinct if the threats are not addressed; rather, immediacy is based on when the threats will begin. If a threat is currently occurring or likely to occur in the very near future, we classify the threat as imminent. Determining the immediacy of threats helps ensure that species facing actual, identifiable threats are given priority for listing proposals over those for which threats are only potential or species that are intrinsically vulnerable to certain types of threats, but are not known to be presently facing such threats.
Our priority-ranking system has three categories for taxonomic status: Species that are the sole members of a genus; full species (in genera that have more than one species); and subspecies and distinct population segments of vertebrate species (DPSs). The result of the ranking system is that we assign each candidate a listing priority number of 1 to 12. For example, if the threats are of high magnitude, with immediacy classified as imminent, the listable entity is assigned an LPN of 1, 2, or 3 based on its taxonomic status (
For more information on the process and standards used in assigning LPNs, a copy of the guidance is available at:
With this CNOR-FS, we request additional information for the 20 taxa whose listings are warranted but precluded by higher-priority proposals to determine whether any species is an endangered or threatened species. We will consider this information in preparing listing documents or future resubmitted petition findings for these 20 taxa. This information will also help us to monitor the status of the taxa and conserve them. We request the submission of any further information on the species in this CNOR-FS as soon as possible, or whenever it becomes available. We especially seek information:
(1) Indicating that we should remove a taxon from consideration for listing;
(2) Documenting threats to any of the included taxa;
(3) Describing the immediacy or magnitude of threats facing these taxa;
(4) Identifying taxonomic or nomenclatural changes for any of the taxa; or
(5) Noting any mistakes, such as errors in the indicated historical ranges.
You may submit your information concerning this CNOR-FS in general or for any of the species included in this CNOR-FS as described in
We called our previous reviews of foreign species an “Annual Notice of Review,” or “ANOR.” In this review, we use the term “Candidate Notice of Review of Foreign Species (CNOR-FS)” to better align with terminology and processes used for our Candidate Notice of Review of native species—meaning those species native to the United States.
Nineteen of the species discussed in this CNOR-FS are the result of three separate petitions submitted to the U.S. Fish and Wildlife Service (Service) to list a number of foreign bird and butterfly species as endangered or threatened under the Act. We received petitions to list the 13 foreign bird species included in this CNOR-FS on November 24, 1980, and May 6, 1991. We found the petitions presented substantial scientific or commercial information indicating that listing these 13 species may be warranted on May 12, 1981 and December 16, 1991, respectively (46 FR 26464 and 56 FR 65207), and first identified them as candidates on May 21, 2004 (69 FR 2935). On January 10, 1994, we received a petition to list seven butterfly species as endangered or threatened, and we found the petition presented substantial scientific or commercial information indicating that listing these species may be warranted on May 10, 1994 (59 FR 24117). On December 7, 2004, we identified five of the seven butterflies as candidates and two were determined to be “not warranted” (69 FR 70580). Our most recent ANOR was published on April 25, 2013 (78 FR 24604). Our current revised CNOR-FS supersedes all previous ANORs/Notices.
Since the publication of our previous ANOR on April 25, 2013 (78 FR 24604), we reviewed the available information on candidate species to determine whether listing remains warranted for each species and, if so, reevaluated the relative LPN assigned to each species. We also evaluated the need to emergency list any of these species, particularly species with high listing priority numbers (
The current number of foreign species that are candidates for listing is 20. Based on our current review, we find that one species (the Codfish Island fernbird) has recovered and no longer warrants listing; therefore, we removed this species from the candidate list. We also find that the southern helmeted curassow is actually two species, the southern helmeted or horned curassow endemic to Bolivia (
This CNOR-FS summarizes the current status of, and threats to, the 20 species we previously determined qualified as candidates (78 FR 24604; April 25, 2013). It also serves to reevaluate the assigned listing priority number given any changes in taxonomy or threats, and includes our findings on resubmitted petitions for 20 foreign species. We have considered all of the new information that we have obtained since the previous finding, and we have reviewed in accordance with our Listing Priority Guidance the LPN of each taxon for which proposed listing continues to be warranted but precluded. Based on our review of the best available scientific and commercial information, with this CNOR-FS, we are removing one species from the candidate list due to recovery and we are adding an additional species to the list, the Sira curassow (
We emphasize that we are not proposing these species for listing, but we do anticipate developing and publishing proposed listing rules for these species in the future, with the objective of making expeditious progress in addressing all 20 of these foreign species within a reasonable timeframe.
Table 1 provides a summary of all updated determinations of the 20 taxa in our review. The column labeled “Priority” indicates the LPN. Following the scientific name of each taxon (third column) is the family designation (fourth column) and the common name, if one exists (fifth column). The sixth column provides the known historical range for the taxon. The avian species in table 1 are listed taxonomically.
We will continue to monitor the status of these species as new information becomes available (see Monitoring, below). Our review of new information will determine if a change in status is warranted, including the need to emergency list any species or change the LPN of any of the species. In the following sections, we describe our findings for the individual species. The summaries are based on information
Sira curassow (
The Sira curassow is a game bird that is known only from the Cerros del Sira region of Peru. Size and coloration are similar to the southern helmeted curassow, but the Sira curassow has a shorter and rounder pale-blue casque (a horn-like bony appendage above the bill) that is flattened against the head. The Sira curassow inhabits cloud-forest habitat (a type of rainforest that occurs on high mountains in the tropics) at elevations from 1,100 to 1,450 meters (m) (3,609-4,757 feet (ft)) and above.
Although historical population data are lacking, the population is currently estimated at fewer than 250 mature individuals and is declining. The primarily cause of the decline is ongoing hunting by local communities. Additionally, the Sira curassow's habitat is being degraded by subsistence agriculture, forest clearing, road building, and associated rural development. Although the Sira curassow is legally protected in a large portion of its range in El Sira Communal Reserve, illegal hunting still occurs there. The species is classified as critically endangered on the IUCN Red List. It is not threatened by international trade, and it is not listed in any appendices of the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES). In the previous ANOR, both the southern helmeted curassow and the Sira curassow had an LPN of 2. Now that the Sira curassow,
We reviewed the LPNs for all candidate species and are changing the LPNs for the following three species discussed below. More information on these species may be found in the supporting documents for this CNOR-FS.
Brasilia tapaculo (
The primary threat to the species is loss and degradation of its habitat. The Cerrado is the largest, most diverse, and possibly most threatened tropical savanna in the world. Land in the Cerrado is currently being converted to soybean and rice plantations. At current rates, the remaining natural habitat in the Cerrado is predicted to be converted to other uses by 2030. The tapaculo's gallery-forest habitat has been less affected by clearing for agriculture than the surrounding Cerrado. However, larger impacts to the Cerrado are certain to affect gallery forests; erosion and deterioration of streams is increasing, and wetland drainage and the diversion of water for irrigation and annual burning of adjacent grasslands is expected to limit the availability and extent of suitable habitat for the Brasilia tapaculo.
The Brazilian national authority on wildlife, Instituto Chico Mendes de Conservação da Biodiversidade (ICMBio), categorizes Brasilia tapaculo as endangered based on severe fragmentation of populations and continued decline in habitat. The IUCN Red List categorizes the species as “Near Threatened.” It is not threatened by international trade and is not listed in any appendices of CITES.
In the previous ANOR, we assigned the Brasilia tapaculo an LPN of 11. After reevaluating the available information, we find that a change to an LPN of 8 is appropriate. The Brasilia tapaculo does not represent a monotypic genus. The threat to the species is of moderate magnitude and is imminent. The species has a fairly wide geographic range but is endemic to the Cerrado and strongly associated with gallery forests, a very small component of the Cerrado. The drastic conversion of the Cerrado is ongoing. The populations currently appear to be found only in or next to a handful of protected areas and most of these areas are small. The species is reported as rare, even in protected areas. Thus, based on review of the best available scientific and commercial information, the LPN has been changed from 11 to 8 to reflect imminent threats of moderate magnitude.
Harris' mimic swallowtail (
Habitat destruction has been the main threat and is ongoing. Based on a number of estimates, 88 to 95 percent of the area historically covered by tropical forests within the Atlantic Forest biome has been converted or severely degraded as the result of human activities. In addition to the overall loss and degradation of its habitat, the remaining tracts of its habitat are severely fragmented. Habitat loss due to sea-level rise may also affect this coastal subspecies, and losses may be compounded by an increased demand by humans to use remaining land for housing and infrastructure.
Another factor affecting this butterfly is collection. In previous ANORs we suspected that collection may be a stressor for this species but have now noted sale of the subspecies on the internet. The Harris' mimic swallowtail is on the list of Brazilian fauna threatened with extinction, and collection and trade of the subspecies is prohibited. However, we recently found three online advertisements for the Harris' mimic swallowtail at prices ranging from 990 to 1,950 Euros each (approximately 1,118 to 2,182 U.S. dollars (USD)) indicating that illegal collection and trade may be occurring and demand for this butterfly is high. Harris' mimic swallowtail is not currently on the IUCN Red list, although it was identified as a “Threatened and Extinct Subspecies” in the family Papilionidae in the 1994 IUCN Red List. The subspecies has not been formally considered for listing in the appendices to CITES. It is also not regulated on the annexes to European Union Wildlife Trade Regulations.
In the previous ANOR, the Harris' mimic swallowtail was assigned an LPN of 6. After reevaluating the threats to this species, we have determined that a change to an LPN of 3 is appropriate. Harris' mimic swallowtail is a subspecies that is not within a monotypic genus. Although the best-studied colony has maintained a stable and viable size for nearly two decades, there is limited recent information on status. Threats are high in magnitude due to the existence of only a few, small fragmented colonies, and the potential for catastrophic events such as severe tropical storms, fire or introduction of a new disease or predator. Additionally, although the subspecies is protected by Brazilian law and the colonies are located within protected areas, the high price advertised online for specimens indicates that there is demand for the subspecies, likely from illegal collection. Because the population is very small and limited to only three known colonies, removal of individuals from the remaining small, fragmented colonies could, in combination with other stressors, contribute to local extirpations. We find these threats are of high magnitude and based on the best available information, we have changed the LPN from 6 to 3 to reflect imminent threats of high magnitude for this subspecies.
Fluminense swallowtail (
The fluminense swallowtail butterfly was the first invertebrate to be officially noted on the list of Brazilian animals threatened with extinction in 1973. It has been classified as “Vulnerable” by the IUCN Red List since 1983, although it is now marked as “Needs Updating.” The species is currently categorized by Brazil as “Imperiled.” It has not been formally considered for listing in the appendices to CITES. However, it is listed on annex B of the European Union Trade Regulation.
In the previous ANOR, the fluminense swallowtail was assigned an LPN of 5. After reevaluating the factors affecting the fluminense swallowtail and its population decline, we have determined that a change in the listing priority number to 2 is appropriate. The fluminense swallowtail does not represent a monotypic genus. The overall number of populations recorded for the species has declined and most of the remaining populations are small and fragmented. The species is currently affected by habitat destruction, which is high in magnitude and imminence. Despite the conservation measures in place, some of the remaining small populations may be impacted by illegal collection. On the basis of this new information, we have changed the LPN for the fluminense swallowtail from 5 to 2.
Codfish Island fernbird (
The Codfish Island fernbird is a small, insect-eating songbird native to Codfish Island, New Zealand. Codfish Island is a nature reserve, located 3 km (1.8 mi) off the northwest coast of Stewart Island. The subspecies was also successfully introduced to Putauhinu Island, approximately 40 km south of Codfish Island, in the late 1990s. The Codfish Island fernbird is secretive, and its main habitat is the pakihi, which consists of dense vegetation 0.9 to 2.1 m (3 to 7 ft) high. Fernbirds will also
At its lowest point, in the early 1970s, the population was estimated to be less than 100 individuals. Although there is no current estimate of the size of the Codfish Island fernbird population, the population on Codfish Island as of 2007 was believed to be “several hundred,” with an additional 200-300 birds on Putauhinu Island, based on incidental encounter rates in the various habitats. Populations on both islands appear to have expanded into all available habitats and appear to be stable and secure. Historically, Codfish Island fernbird populations were greatly reduced in number due to predation by Polynesian rats and weka (
Neither the IUCN nor BLI have assessed the status of this subspecies. The New Zealand Department of Conservation (NZDOC) categorizes the Codfish Island fernbird as a range-restricted island endemic that is “naturally uncommon.” It is not listed in any appendices of CITES.
In the previous ANOR, the Codfish Island fernbird was assigned an LPN of 12. After reevaluating the available information, we find that this subspecies no longer warrants listing. Although it is an island endemic that is restricted in range, the primary threat to the species—nonnative predators—has been removed, and the population has responded and expanded throughout its known historical range on Codfish Island, occupying all available habitats. In addition, conservation efforts by NZDOC have resulted in the establishment of a second population on Putauhinu island that is free of nonnative predators, and that population has expanded and appears to be secure. Finally, the two islands occupied by the Codfish Island fernbird have restricted access, such that reestablishment of nonnative predators is extremely unlikely. In the unlikely event of nonnative predators reappearing on either island, NZDOC has a proven track-record of success in eradicating mammalian predators from these islands. Therefore, we have determined that this subspecies no longer warrants listing and are removing it from the candidate list.
Southern helmeted curassow (
The total population of southern helmeted curassow is estimated to be between 1,500 and 7,500 individuals and is declining. Hunting is believed to be the primary threat to the species, followed by habitat loss and degradation. Although the National Parks have been important for the preservation of the species, financial and human resources needed to protect park resources are limited. Within the Parks, there are human settlements and ongoing encroachment, including illegal logging operations and forest clearing for farming. Rural development and road building limit the species' ability to disperse. Range reductions due to climate change are also predicted for the southern helmeted curassow, when warming temperatures may cause the species to shift its distribution upslope and outside of protected National Parks.
The southern helmeted curassow is classified as critically endangered on the IUCN Red List. Trade has not been noted internationally, and the species is not listed in any appendices of CITES. The species is listed in annex D of the European Union Trade Regulations.
In the previous ANOR, the southern helmeted curassow was assigned an LPN of 2. After reevaluating the threats to the species, we have determined that no change in the LPN is warranted. The southern helmeted curassow does not represent a monotypic genus. It faces threats that are high in magnitude based on its small, limited range. The few locations where it is believed to exist continue to face pressure from hunting and habitat loss and destruction, and population decline will likely continue. Because the species is experiencing ongoing significant population declines and habitat loss, we have made no change to the LPN of 2, which reflects imminent threats of high magnitude.
Bogotá rail (
In the previous ANOR, the Bogotá rail was assigned an LPN of 2. After reevaluating the threats to this species, we have determined that no change in the LPN for the species is needed. The Bogotá rail does not represent a monotypic genus. It faces threats that are high in magnitude due to the pressures on the species' habitat. Its range is very small and is rapidly contracting because of widespread habitat loss and degradation. Although portions of the Bogotá rail's range occur in protected areas, most of the savanna wetlands are unprotected. The population is small and is believed to be rapidly declining. The factors affecting the species are ongoing, and are, therefore, imminent. Thus, the LPN remains at 2 to reflect imminent threats of high magnitude.
Takahe (
When rediscovered in 1948, it was estimated that the takahe population consisted of 100 to 300 birds; in 2013, the population was estimated at 227 adult birds. Several factors have historically led to the species' decline, including hunting, competition from introduced herbivores (animals that feed on plants), and predators such as weasels and the weka, a flightless woodhen that is endemic to New Zealand. Currently, weasel predation appears to be the most significant of these threats. Weasel trapping is an effective tool at slowly increasing survival and reproductive output of takahe; however, control efforts do not completely eliminate the threat. Takahe is a long-lived bird, potentially living between 14 and 20 years, and has a low reproductive rate, with clutches consisting of one to three eggs. Severe weather in the Murchison Mountains (cold winters and high snowfall) may also be a limiting factor to the takahe. The population of takahe remains very small and has low genetic diversity relative to other species. The NZDOC is currently attempting to manage further loss of genetic diversity through translocations. Additionally, NZDOC has implemented a captive-breeding and release program to supplement the mainland population and has established several reserve populations on islands and fenced mainland sites; these actions are having a positive effect on population growth. The takahe is listed as endangered on the IUCN Red List, and New Zealand considers it to be a nationally critical species. It is not listed in any appendices of CITES as international trade is not a concern.
In the previous ANOR, the takahe was assigned an LPN of 8. After reevaluating the threats to the takahe, we have determined that no change in the classification of the magnitude and imminence of threats to the species is warranted at this time. The takahe does not represent a monotypic genus. Although it has a small population, limited suitable habitat, and may experience inbreeding depression, because the NZDOC is actively involved in measures to aid the recovery of the species, we find the threats are moderate in magnitude. Despite conservation efforts, the threats are ongoing and, therefore, imminent. Lack of suitable habitat and predation, combined with the takahe's small population size and naturally low reproductive rate, are threats to this species that are moderate in magnitude. Thus, the LPN remains at 8 to reflect imminent threats of moderate magnitude.
Chatham oystercatcher (
The Chatham oystercatcher is the rarest oystercatcher in the world, with a recent population estimate of 309 birds. The species has experienced a three-fold increase in its population since the first reliable census was conducted in 1987. Most of this increase occurred during a period of intensive management, especially predator control, from 1998 through 2004. The Chatham oystercatcher is listed as nationally critical by the NZDOC. It is classified as “Endangered” on the IUCN Red List and is not listed in any appendices of CITES.
Predation of eggs and chicks, and to a lesser extent of adults, is thought to be the main impediment to the Chatham oystercatcher population. Although Mangere and Rangatira nature reserves are free of all mammalian predators, nonnative mammalian predators inhabit Chatham and Pitt Islands. Feral cats are the most common predator on eggs. Other documented predators include gulls (
In the previous ANOR, the Chatham oystercatcher was assigned an LPN of 8. After reevaluating the threats to this species, we have determined that no change in the classification of the magnitude and imminence of threats to the species is warranted. The Chatham oystercatcher does not represent a monotypic genus. The current population estimate is very small, and the species has a limited range, but NZDOC has taken measures to recover the species and the population is slowly growing. However, threats (predation, trampling, low population numbers, and loss of eggs due to storm surges) are ongoing and, thus, are imminent. The LPN remains an 8 to reflect imminent threats of moderate magnitude.
Orange-fronted parakeet (
The species' range contracted when its population was severely reduced in the late 1800s and early 1900s for unknown reasons. Information on current population status is mixed, but optimistic. The population experienced another crash in 1990-2000 following rat invasions. The population is still small and has declined over the last decade with estimates between 290 and 690 individuals in early 2013. The 2013 estimates indicated further declines on the mainland and, during a 14-year period (approximately three generations), a reduction in the number of mature birds. More recently, the global population is reported as increasing due to successful translocations to predator-free islands and control of predators in its range on the South Island.
The most prominent factors affecting the species on the mainland are predation by nonnative mammals such as weasels and rats (
In the previous ANOR, the orange-fronted parakeet was assigned an LPN of 8. After reevaluating the factors affecting the species, we have determined that no change in the classification of the magnitude of threats to the species is warranted because NZDOC is actively managing the species. The orange-fronted parakeet does not represent a monotypic genus. Although the species' available suitable nesting habitat in beech forests is extremely limited, translocations have taken place and seem to be successful. However, the population is still small and vulnerable to several threats despite management efforts that may have stabilized the population (albeit at small numbers). Small populations may also be vulnerable to stochastic events, including disease outbreaks such as BFDV. We find that the threats to this species are still imminent; thus, the LPN remains at 8 to reflect imminent threats of moderate magnitude.
Uvea parakeet (
Historically, the primary threat to this species was the capture of juveniles for the pet trade, which involved cutting open nesting cavities to extract nestlings; this practice renders the holes unsuitable for future nesting. Since restrictions have been put into place and the species has been more closely monitored, it appears that nest poaching is no longer occurring such that it significantly affects this species, and the population has increased. Other identified threats to the species include: Habitat degradation and conversion, loss of nesting cavities to bees, loss of habitat through climate change, and the potential for introduction of nonnative predators. Artificial nests are being installed to increase available nesting sites; however, Uvea parakeets have not yet used the artificial nests provided. Uvea is a low-elevation and relatively flat island. Climate change (and associated sea-level rise) will likely result in loss of forest habitat or important food species and is considered a substantial threat to the persistence of Uvea parakeets. The limited occupied range of the species (only 34 km
In the previous ANOR, the Uvea parakeet was assigned an LPN of 8. After reevaluating the threats to this species, we have determined that no change in the classification of the magnitude and imminence of threats to the species is warranted. The Uvea parakeet does not represent a monotypic genus. The Uvea parakeet has a limited distribution on a single small island with limited remaining old-growth forest on which the bird depends for nesting cavities. The population has increased in size due to conservation, education, a ban on commercial trade, and a reduction in poaching; however, several threats (including habitat loss, loss of nesting cavities and effects from climate change) are still present and ongoing and, therefore, imminent. The LPN remains an 8 to reflect imminent threats of moderate magnitude.
Helmeted woodpecker (
The helmeted woodpecker's population is believed to have declined sharply between 1945 and 2000 in conjunction with the clearing of mature forest habitat and is currently estimated at 400-8,900 individuals. Although forest clearing has recently slowed, and the species occurs in at least 17 protected areas throughout its range, habitat degradation continues and the population is still believed to be declining. The principal threat to the helmeted woodpecker is loss, degradation, and fragmentation of its Atlantic forest habitat. Competition for nest cavities is also likely a limiting factor. The helmeted woodpecker is one of the rarest woodpecker in the Americas. It is listed as endangered in Brazil and as vulnerable by the IUCN. It is not listed in any appendices of CITES.
In the previous ANOR, the helmeted woodpecker was assigned an LPN of 8. After reevaluating the available information, we find that no change in the LPN for the helmeted woodpecker is warranted. The helmeted woodpecker does not represent a monotypic genus. The magnitude of threats to the species is moderate because the species' range is fairly large. The threats are imminent because the forest habitat upon which the species depends is still being altered and degraded. An LPN of 8 continues to be accurate for this species.
Okinawa woodpecker (
The Okinawa woodpecker is considered one of the world's rarest woodpecker species. Current population estimates are between 100 and 390 individuals and declining.
Habitat destruction and fragmentation was a significant threat. As of 2001, only 40 km
In the previous ANOR, the Okinawa woodpecker was assigned an LPN of 2. After reevaluating the available information, we find that no change in the LPN is warranted. The Okinawa woodpecker does not represent a monotypic genus. Threats to the species are of high magnitude due to the scarcity of old-growth habitat, upon which the species is dependent. Its population is very small and is believed to still be declining, and species with fragmented habitat in combination with small population sizes may be at greater risk of extinction due to synergistic effects. The threats to the species are ongoing and imminent and high in magnitude due to its restricted population size, past habitat loss, and endemism. The LPN for this species remains a 2 to reflect imminent threats of high magnitude.
Yellow-browed toucanet (
In the previous ANOR, the yellow-browed toucanet was assigned an LPN of 2. After reevaluating the available information, we find that no change in the classification of the magnitude and imminence of threats to the species is warranted at this time. The yellow-browed toucanet does not represent a monotypic genus. The estimated population is small with a restricted range. The magnitude of threats to the habitat remains high, and its population is likely declining. The LPN remains a 2 to reflect imminent threats of high magnitude.
Ghizo white-eye (
Little information is available about this species and its habitat. It is locally common in old-growth forest patches and less common elsewhere. The species has been observed in a variety of habitats on the island, but it is unknown whether sustainable populations can exist outside of forested habitats. The population is estimated to be between 250 and 999 mature individuals and is suspected to be declining due to habitat degradation, particularly since a tsunami hit the island in 2007. Habitat loss appears to be the main threat. As of 2012, the human population on the island was 7,177 and growing rapidly, and there has been prolific growth in informal human settlements and temporary housing on Ghizo, which may be adversely affecting the Ghizo white-eye and its habitat. Areas around Ghizo Town, which previously supported the species, have been further degraded since the town was devastated by the 2007 tsunami, and habitat was found less likely able to support the species in 2012. The species is also affected by conversion of forested areas to agricultural uses. The old-growth forest on Ghizo is still under pressure from clearance for local use as timber, firewood, and gardens, as are the areas of secondary growth, which are already suspected to be suboptimal habitat for this species.
The population of this species is believed to be declining and, given its fragmented habitat in combination with small population sizes, may be at greater risk of extinction due to synergistic effects. The IUCN Red List classifies this species as endangered. It is not listed in any appendices of CITES, and this species is not in international trade.
In the previous ANOR, the Ghizo white-eye was assigned an LPN of 2. After reevaluating the available information, we find that no change in the LPN for this species is warranted. The Ghizo white-eye does not represent a monotypic genus. It faces threats that are high in magnitude due to declining suitable habitat and its small, declining population size. The best available information indicates that forest clearing is occurring at a pace that is rapidly denuding the habitat; secondary-growth forest continues to be converted to agricultural purposes. Further, the human population on the small island is likely contributing to the reduction in old-growth forest for local uses such as gardens and timber. These threats to the species are ongoing, of high magnitude, and imminent. Thus, based on the best available scientific and commercial information, the LPN remains a 2 for this species.
Black-backed tanager (
The primary factor affecting this species is the rapid and widespread loss of habitat, mainly to urban expansion and beachfront development. Its habitat is under pressure from the intense development that occurs in coastal areas, particularly south of Rio de Janeiro. In addition to the overall loss and degradation of its habitat, the remaining tracts of its habitat are severely fragmented. The black-backed tanager's remaining suitable habitat in the areas of Rio de Janeiro and Paraná have largely been destroyed, and habitat loss and degradation will likely increase in the future. Additionally, although small portions of this species' range occur in six protected areas, protections appear limited. Sea-level rise may also affect this species, which inhabits coastal areas. Habitat loss due to sea-level rise may be compounded by an increased demand by humans to use remaining land for housing and infrastructure. These factors affecting the black-backed tanager's remaining habitat are ongoing due to the challenges that Brazil faces to balance its competing development and environmental priorities. The black-backed tanager is classified as vulnerable by the IUCN. It is not listed in any appendices of CITES. It is listed as vulnerable in Brazil.
In the previous ANOR, the black-backed tanager was assigned an LPN of
Lord Howe Island pied currawong (
The best current population estimate in 2005 and 2006 indicated that there were approximately 200 individuals. The Lord Howe Island pied currawong exists as a small isolated population, which makes it vulnerable to stochastic events. The potential for an introduction of other exotic predators to this island ecosystem has also been identified as an issue for this species. In addition to its small population size, direct persecution (via shootings) by humans in retaliation for predation on domestic and endemic birds has been documented. The incidence of shootings has declined since the 1970s, when conservation efforts on Lord Howe Island began, but occasional shootings were still occurring as of 2007.
Because the Lord Howe pied currawong often preys on small rodents, it may be subject to nontarget poisoning during ongoing rat-baiting programs. Experimental efforts to develop techniques to house the birds in aviaries while rat-baiting programs take place show promise for protecting the species during these eradication efforts. The subspecies' status is not addressed by IUCN. It is not listed in any appendices of CITES as trade is not an issue for this taxon. The New South Wales Threatened Species Conservation Act of 1995 lists the Lord Howe pied currawong as “Vulnerable” due to its extremely limited range and its small population size.
In the previous ANOR, the Lord Howe pied currawong was assigned an LPN of 6. After reevaluating the threats to the Lord Howe pied currawong, we have determined that no change in the LPN representing the magnitude and imminence of threats to the subspecies is warranted. The Lord Howe pied currawong does not represent a monotypic genus. It faces threats that are high in magnitude due to a combination of factors including its extremely small population size, and nontarget poisoning. Despite conservation efforts, the population of the Lord Howe pied currawong has remained small. Species with small population sizes such as these may be at greater risk of extinction due to synergistic effects of factors affecting this species. However, because conservation efforts for the species have been implemented, and the species is being closely managed and monitored, we find that the threats are nonimminent. Thus, based on the best available information, the LPN remains at 6 to reflect nonimminent threats of high magnitude.
Jamaican kite swallowtail (
Habitat loss, degradation, and fragmentation are considered to be the primary factors affecting the Jamaican kite swallowtail. Additionally, the species is vulnerable due to its small population size and limited distribution on the island. After centuries of a high rate of deforestation, the island lost much of its original forest. Eight percent of the total land area of Jamaica is natural forest with minimal human disturbance. In Rozelle, habitat modification for agricultural and industrial purposes such as mining has diminished this species' habitat. Most of the damage took place decades ago, but small farming still occurs there. The rugged terrain of the Cockpit Country has hindered large-scale exploitation of resources in the interior, but the periphery and surrounding plains are badly degraded. Major threats identified for the Cockpit Country include: Mining, forest conversion, nonnative invasive species, solid-waste disposal, incompatible agricultural practices, and collecting. Additionally, bauxite mining for aluminum production is an important economic activity for Jamaica and is a large contributor to deforestation. Jamaica's location in the hurricane belt increases its vulnerability to natural environmental events. Although the Jamaican Wildlife Protection Act of 1994 carries steep fines and penalties, illegal collection (see Harris' mimic swallowtail above) is a potential threat for the Jamaican kite swallowtail. The butterfly has been noted for sale on the internet as recently as 2015 for 150 Euros (164 USD). The species is classified as vulnerable on the IUCN Red List and IUCN indicates that this assessment needs updating. It is not is not listed in any appendices of CITES nor is it listed on annex B of the European Union Trade Regulations.
In the previous ANOR, the Jamaican kite swallowtail was assigned an LPN of 2. After reevaluating the factors affecting the Jamaican kite swallowtail, we have determined that no change in LPN is warranted. The Jamaican kite swallowtail does not represent a monotypic genus. Although alternate breeding sites are likely, the only documented site and the presumed core population for this species is in one location that is vulnerable to stochastic environmental events such as hurricanes. Although Jamaica has taken regulatory steps to preserve native swallowtail habitat, plans for conservation of two vital areas for the butterfly (Rozelle and the Cockpit Country) have not been implemented. Based on our reevaluation of the threats to this species, the LPN remains a 2 to
Hahnel's Amazonian swallowtail (
Collection (see Harris' mimic swallowtail above) is also a potential threat for Hahnel's Amazonian swallowtail. The species has been collected for commercial trade and may also be reared for trade. Locations in the wild have been kept secret given the high value of this butterfly to collectors. Two specimens of Hahnel's Amazonian swallowtail were recently noted in online sales from locations in the United States (500 USD) and Germany (approximately 166 USD). Hahnel's Amazonian swallowtail is described as data deficient by the IUCN Red List. The species is listed as endangered on the State of Pará's list of threatened species, but it is not listed by the State of Amazonas or by Brazil. Hahnel's Amazonian swallowtail is not listed in any appendices of CITES. However, it is listed on annex B of the European Union Trade Regulations.
In our previous ANOR, the Hahnel's Amazonian swallowtail was assigned an LPN of 2. After reevaluating the threats to the Hahnel's Amazonian swallowtail, we have determined that no change in the LPN is warranted. This swallowtail does not represent a monotypic genus. It faces threats that are high in magnitude and imminence due to its small endemic population, and limited and decreasing availability of its highly specialized habitat. Habitat alteration and destruction (
Kaiser-i-Hind swallowtail (
Collection for commercial trade is also regarded as a threat to the species. The Kaiser-i-Hind swallowtail is highly valued and has been collected and traded despite various prohibitions. Although it is difficult to assess the potential impacts from collection, it is possible that collection in combination with other stressors could contribute to local extirpations of small populations.
Since 1996, the Kaiser-i-Hind swallowtail has been categorized on the IUCN Red List as “Lower Risk/near threatened,” but IUCN indicates that this assessment needs updating. The Kaiser-i-Hind swallowtail has been listed in CITES appendix II since 1987. Additionally, the Kaiser-i-Hind swallowtail is listed on annex B of the European Union Trade Regulations.
After reevaluating the threats to this species, we have determined that no change in its LPN of 8 is appropriate. The Kaiser-i-Hind swallowtail does not represent a monotypic genus. The current factors, habitat destruction and illegal collection, are moderate in magnitude due to the species' wide distribution and to various protections in place within each country. We find that the threats are imminent due to ongoing habitat destruction and high market value for specimens. Based on our reassessment of the threats, we have retained an LPN of 8 to reflect imminent threats of moderate magnitude.
Colorado delta clam (
Habitat loss and degradation are considered to be the primary factors affecting the Colorado Delta clam. Additionally, the species is now
Agricultural return flow from the Mexicali Valley, coupled with aquifer inflow, is a very important freshwater source ensuring the maintenance of the estuarine environment in the Delta and the continued survival of the clam. In 2009, the U.S. completed lining of the All-American Canal to prevent water loss via seepage. Prior to lining, water seepage from the All-American Canal was an important source of recharge to the Mexicali Valley aquifer. The All-American Canal lining is predicted to reduce total recharge to the Mexicali Valley aquifer, which will reduce the freshwater inflow into the Delta. Additionally, predicted increases in drought and warmer temperatures associated with climate change will contribute to deterioration of the clam's habitat by further curtailing freshwater inflow and favoring nonnative invasive aquatic species to the detriment of native species like the Colorado Delta clam. The species has not been assessed for the IUCN Red List. It is not threatened by international trade, and it is not listed in any appendices of CITES.
In the previous ANOR, the Colorado Delta clam was assigned an LPN of 2. After reevaluating the factors affecting the clam, we have determined that no change in LPN is warranted. The Colorado Delta clam does not represent a monotypic genus. The available evidence indicates that Colorado delta clam is now restricted to one relict population at Isla Montague at the mouth of the Colorado River delta. Its habitat is currently affected by the ongoing and continuing (
To make a finding that a particular action is warranted but precluded, the Service must make two determinations: (1) That the immediate proposal and timely promulgation of a final regulation is precluded by pending listing proposals and (2) that expeditious progress is being made to add qualified species to either of the lists and to remove species from the lists (16 U.S.C. 1533(b)(3)(B)(iii)). A listing proposal is precluded if the Service does not have sufficient resources available to complete the proposal, because there are competing demands for those resources, and the relative priority of those competing demands is higher. Thus, in any given fiscal year (FY), multiple factors dictate whether it will be possible to undertake work on a listing proposal regulation or whether publication of such a proposal is precluded by higher-priority listing actions, including: (1) The amount of resources available for completing the listing function; (2) the estimated cost of completing the proposed listing; and (3) the Service's workload and prioritization of the proposed listing in relation to other actions.
The resources available for listing actions are determined through the annual Congressional appropriations process. The appropriation for the Listing Program is available to support work involving the following listing actions: Proposed and final listing rules; 90-day and 12-month findings on petitions to add species to the Lists of Endangered and Threatened Wildlife and Plants (Lists) or to change the status of a species from threatened to endangered; annual determinations on prior “warranted-but-precluded” petition findings as required under section 4(b)(3)(C)(i) of the Act; critical habitat petition findings; proposed and final rules designating critical habitat; and litigation-related, administrative, and program-management functions (including preparing and allocating budgets, responding to Congressional and public inquiries, and conducting public outreach regarding listing and critical habitat).
The work involved in preparing various listing documents can be extensive and may include, but is not limited to: Gathering and assessing the best scientific and commercial data available and conducting analyses used as the basis for our decisions; writing and publishing documents; and obtaining, reviewing, and evaluating public comments and peer review comments on proposed rules and incorporating relevant information into final rules. The number of listing actions that we can undertake in a given year also is influenced by the complexity of those listing actions; that is, more complex actions generally are more costly.
We cannot spend more than is appropriated for the Listing Program without violating the Anti-Deficiency Act (see 31 U.S.C. 1341(a)(1)(A)). In addition, in FY 1998 and for each fiscal year since then, Congress has placed a statutory cap on funds that may be expended for the Listing Program, equal to the amount expressly appropriated for that purpose in that fiscal year. This cap was designed to prevent funds appropriated for other functions under the Act (for example, recovery funds for removing species from the Lists), or for other Service programs, from being used for Listing Program actions (see House Report 105-163, 105th Congress, 1st Session, July 1, 1997).
Prior to FY 2012, there was no distinction in appropriations for listing domestic and foreign species. However, in an effort to balance foreign species listing commitments with other Listing Program responsibilities, effective FY 2012 and for each fiscal year since then, the Service's Listing Program budget has included a foreign species subcap providing that funding is not to exceed a specified amount for implementation of subsections (a), (b), (c), and (e) of section 4 of the Act for species that are not indigenous to the United States (see Conference Report 112-331, 112th Congress, 1st session, Dec. 15, 2011).
Thus, through the listing program cap and the foreign species subcap, Congress has determined the amount of money available for foreign species listing activities, including petition findings and listing determinations.
In FY 2016, the Service had $1,504,000 that could be used for listing actions for foreign species. This funding supports work in the following categories: Compliance with court orders and court-approved settlement agreements requiring that petition findings or listing determinations be completed by a specific date; section 4 (of the Act) listing actions with absolute statutory deadlines; essential litigation-related, administrative, and listing program-management functions; and high-priority listing actions for some of our candidate species.
In addition, available staff resources are also a factor in determining which high-priority species are provided with funding. The Branch of Foreign Species may, depending on available staff resources, work on species described within this CNOR-FS with an LPN of 2 or 3, and when appropriate, species with a lower priority if they overlap geographically or have the same threats as the species with the high priority.
Based on the prioritization factors mentioned above, we continue to find that proposals to list the candidate species included in this CNOR-FS are all precluded by higher-priority listing actions. Because the actions in table 2 below are either the subject of a court-approved settlement agreement or subject to an absolute statutory deadline and, thus, are higher priority than work on proposed listing determinations for the 20 species described above, publication of proposed rules for these 20 species is precluded.
As explained above, a determination that listing is warranted but precluded must also demonstrate that expeditious progress is being made to add and remove qualified species to and from the Lists. As with our “precluded” finding, the evaluation of whether progress in adding qualified species to the Lists has been expeditious is a function of the resources available for listing and the competing demands for those funds. Our expeditious progress for foreign species since publication of our previous ANOR, published on April 25, 2013 (78 FR 24604), to October 17, 2016, includes preparing and publishing the following:
Our expeditious progress also includes work on pending listing actions described above in our “precluded finding,” but for which decisions had not been completed at the time of this publication. After taking into consideration the limited resources available for listing foreign species, the competing demands for those funds, and the completed work catalogued in the tables above, we find that we are making expeditious progress to add qualified species to the Lists in FY 2016.
We have endeavored to make our listing actions as efficient and timely as possible, given the requirements of the relevant law and regulations, and constraints relating to workload and personnel. We are continually considering ways to streamline processes or achieve economies of scale, such as by publishing related actions together.
Section 4(b)(3)(C)(iii) of the Act requires us to “implement a system to monitor effectively the status of all species” for which we have made a warranted-but-precluded 12-month finding, and to “make prompt use of the [emergency listing] authority [under section 4(b)(7)] to prevent a significant risk to the well-being of any such species.” For foreign species, the Service's ability to gather information to monitor species is limited. The Service welcomes all information relevant to the status of these species, because we have no ability to gather data in foreign countries directly and cannot compel another country to provide information. Thus, this CNOR-FS plays a critical role in our monitoring efforts for foreign species.
With each CNOR-FS, we request information on the status of the species included in the CNOR-FS. Information and comments on the annual findings can be submitted at any time. We review all new information received through this process as well as any other new information we obtain using a variety of methods. We collect information directly from range countries by correspondence, from peer-reviewed scientific literature, unpublished literature, scientific meeting proceedings, and CITES documents (including species proposals and reports from scientific committees). We also obtain information through the permit-application processes under CITES, the Act, and the Wild Bird Conservation Act (16 U.S.C. 4901
A list of the references used to develop this CNOR-FS is available at
This Candidate Notice of Review of Foreign Species was primarily authored by staff of the Branch of Foreign Species and Jesse D'Elia, Ecological Services Program, U.S. Fish and Wildlife Service.
This Candidate Notice of Review of Foreign Species is published under the authority of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Proposed rule; request for comments.
NMFS proposes to implement management measures described in a framework action to the Fishery Management Plan for the Reef Fish Resources of the Gulf of Mexico (FMP), as prepared by the Gulf of Mexico (Gulf) Fishery Management Council (Gulf Council). If implemented, this proposed rule would revise the yellowtail snapper commercial and recreational fishing year and remove the requirement to use circle hooks for the commercial harvest of yellowtail snapper in the Gulf exclusive economic zone (EEZ) south of Cape Sable, Florida. The purpose of this
Written comments must be received by November 16, 2016.
You may submit comments on the proposed rule, identified by “NOAA-NMFS-2016-0058” by either of the following methods:
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Electronic copies of the framework action, which includes an environmental assessment, Regulatory Flexibility Act (RFA) analysis, and a regulatory impact review, may be obtained from
Cynthia Meyer, NMFS SERO, telephone: 727-824-5305, email:
The Gulf reef fish fishery includes yellowtail snapper and is managed under the FMP. The FMP was prepared by the Gulf Council and is implemented by NMFS through regulations at 50 CFR part 622 under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act).
The Magnuson-Stevens Act requires NMFS and regional fishery management councils to prevent overfishing and achieve on a continuing basis, the optimum yield from federally managed fish stocks. These mandates are intended to ensure that fishery resources are managed for the greatest overall benefit to the nation, particularly with respect to providing food production and recreational opportunities, while also protecting marine ecosystems. To further attain this goal, the Magnuson-Stevens Act requires fishery managers to minimize bycatch and bycatch mortality to the extent practicable.
In the southeastern United States, yellowtail snapper are harvested by both commercial and recreational fishermen, with landings coming almost exclusively from waters adjacent to Florida. Yellowtail snapper are managed separately in the Gulf and South Atlantic but are a single genetic stock. The 2012 Southeast Data, Assessment, and Review (SEDAR 27) combined the two areas for stock assessment purposes and indicated that yellowtail snapper in the Gulf and South Atlantic were not overfished and not experiencing overfishing as of 2010, the last year of data used in SEDAR 27. Yellowtail snapper has one overfishing limit, and its acceptable biological catch (ABC) is further subdivided into two regional ABCs for management purposes. The South Atlantic is allocated 75 percent of the stock yellowtail snapper ABC, and the Gulf is allocated 25 percent of the stock ABC. The annual catch limits (ACLs) are equal to the ABCs. The ACL for South Atlantic yellowtail snapper is further divided between the commercial and recreational sectors, but the ACL for yellowtail snapper in the Gulf is not divided between sectors. On average, about 97 percent of yellowtail snapper landings in the Gulf occur from commercial harvest.
This proposed rule would revise the fishing year for Gulf yellowtail snapper and the gear requirements for the yellowtail snapper commercial sector.
Previously, the fishing year for both the commercial and recreational sectors for yellowtail snapper in the Gulf and the South Atlantic was January 1 through December 31. The South Atlantic Council recently changed the yellowtail snapper fishing year in the South Atlantic to begin on August 1, and end on July 31, for both the commercial and recreational sectors (81 FR 45245, July 13, 2016). The South Atlantic Council made this change to align any ACL closure that may be required more closely with the yellowtail snapper peak spawning period. This proposed rule would similarly revise the fishing year for Gulf yellowtail snapper for both the commercial and recreational sectors to be August 1 through July 31 each year. Although the harvest of yellowtail snapper in the Gulf has not exceeded the stock ACL since ACLs were implemented in 2011 (76 FR 82044, December 29, 2011), this proposed change would similarly more closely align any required ACL closure in the Gulf with the peak spawning season. In addition, having the same fishing year for both the Gulf and South Atlantic would benefit some commercial fishermen that harvest yellowtail snapper in both regions by decreasing the compliance burden of different regulations for the same species in adjacent management areas.
In the Gulf, a person harvesting reef fish, including yellowtail snapper, is required to use non-stainless steel circle hooks when fishing with natural bait (50 CFR 622.30(a)). This measure was put in place to reduce the post-release mortality of Gulf reef fish. This proposed rule would revise this requirement to also allow the use of other non-stainless steel hook types, such as J-hooks, when commercial fishing with natural bait for yellowtail snapper in the area south of a line extending due west from 25°09' N. lat. off the west coast of Monroe County, Florida, to the Gulf and South Atlantic Councils' boundary. The northern boundary of the area for this proposed gear exemption coincides with a management boundary already used by the Florida Fish and Wildlife Conservation Commission.
Landings of yellowtail snapper in the Gulf come almost exclusively from waters adjacent to Florida, with over 97 percent of these landings, on average, by the commercial sector. The Gulf Council determined that allowing other hook types for the commercial harvest of yellowtail snapper in Federal waters off south Florida was appropriate because of the specific fishing method used only by commercial fishermen that allow for quicker de-hooking when the fish are caught using J-hooks. These fishermen attract the fish to the surface using chum and then use small hooks with natural bait and cane poles (rods with approximately 15 ft (4.6 m) of
Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that this proposed rule is consistent with the framework amendment, the FMP, the Magnuson-Stevens Act, and other applicable laws, subject to further consideration after public comment.
This proposed rule has been determined to be not significant for purposes of Executive Order 12866.
Pursuant to the Regulatory Flexibility Act, the Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration (SBA) that this proposed rule, if implemented, would not have a significant economic impact on a substantial number of small entities. The factual basis for this determination is as follows:
The purposes of this proposed rule are to eliminate certain inconsistencies between the regulations established by the Gulf and South Atlantic Councils for the harvest of yellowtail snapper in Gulf waters, to increase the operational efficiency of the yellowtail snapper component of the commercial reef fish fishery, achieve optimum yield, and decrease the regulatory burden of compliance with differing regulations established by separate regulatory agencies across the adjacent Gulf and South Atlantic jurisdictions. The Magnuson-Stevens Act provides the statutory basis for this proposed rule.
This proposed rule, if implemented, would remove the requirement to use circle hooks when commercial fishing with natural bait for yellowtail snapper and allow the use of other non-stainless steel hook types with natural baits in an area south of 25°09′ N. lat. off the west coast of Monroe County, Florida (Cape Sable) to the Gulf and South Atlantic Councils' jurisdictional boundary. In addition, this proposed rule would change the yellowtail snapper fishing year for the commercial and recreational sectors from January 1 through December 31 to August 1 through July 31.
As a result, this proposed rule would be expected to directly affect federally permitted commercial vessels that harvest yellowtail snapper in the Gulf. Over the period 2010-2014, based on Federal logbook data that include harvests from state waters, an average of 132 vessels per year recorded commercial yellowtail snapper harvests anywhere in the Gulf and an average of 70 vessels per year recorded commercial yellowtail snapper harvests in the Gulf waters off Monroe County (state and Federal waters). The maximum number of vessels with recorded commercial yellowtail snapper harvests during this period within both groups of vessels was 163 (all vessels Gulf-wide; 2014) and 73 (Monroe County area; 2010 and 2014), respectively. The proposed removal of the circle hook requirement would only be expected to directly affect federally permitted vessels that fish in the Monroe County area, whereas the proposed change in the fishing year could affect all commercial vessels that harvest yellowtail snapper in the Gulf. As a result, this proposed rule would be expected to apply to 70-163 commercial fishing vessels. The average annual gross revenue (2014 dollars) from all species harvested on all trips by the vessels identified with recorded yellowtail snapper harvests in logbook data over the period 2010-2014 within both groups of vessels was approximately $107,000 (all vessels Gulf-wide) and approximately $41,000 (Monroe County area).
No small entities associated with the recreational sector would be expected to be directly affected by the proposed change to the yellowtail snapper fishing year. Only recreational anglers are allowed to recreationally harvest yellowtail snapper in Gulf Federal waters and may be directly affected in changes to the fishing year. However, recreational anglers are not small entities under the RFA. Although for-hire businesses (charter vessels and headboats) operate in the recreational sector, these businesses only sell fishing services to recreational anglers and do not have harvest rights to the yellowtail snapper. For-hire vessels provide a platform for the opportunity to fish and not a guarantee to catch or harvest any species, though expectations of successful fishing, however defined, likely factor into the decision by anglers to purchase these services. Because the proposed change in the yellowtail snapper fishing year would not directly alter the basic service sold by for-hire vessels, this proposed action would not directly apply to or regulate their operations. Any change in vessel business would be a result of changes in angler demand for these fishing services that occurs as a result of the behavioral decision by anglers,
NMFS has not identified any other small entities that would be expected to be directly affected by this proposed rule.
For RFA purposes only, NMFS has established a small business size standard for businesses, including their affiliates, whose primary industry is commercial fishing (see 50 CFR 200.2). A business primarily engaged in commercial fishing (NAICS code 11411) is classified as a small business if it is independently owned and operated, is not dominant in its field of operation (including its affiliates), and has combined annual receipts not in excess of $11 million for all its affiliated operations worldwide. All commercial fishing vessels expected to be directly affected by this proposed rule are believed to be small business entities.
The proposed removal of the requirement to use circle hooks when commercial fishing with natural bait for yellowtail snapper south of 25°09′ N. lat. off the west coast of Monroe County, Florida (Cape Sable) to the Gulf and South Atlantic Councils' jurisdictional boundary would be expected to afford more flexibility and improve the operational efficiency of commercial fishing vessels that harvest yellowtail snapper in this area. For example, J-hooks are more effective in the commercial harvest of yellowtail snapper, allow for quicker de-hooking and less handling of undersized fish that need to be discarded, and result in decreased post-release mortality. Using J-hooks with natural bait is also an allowable gear for the commercial harvest of yellowtail snapper in Federal waters off south Florida under the management jurisdiction of the South Atlantic Council. In south Florida, many fishermen fish in the jurisdiction of both Councils and allowing the use of a common hook type for yellowtail snapper would be expected to increase their operational efficiency and reduce gear expenses. Removal of the circle
Because some commercial fishing vessels often operate in both state and Federal waters, as well as in both the Gulf and South Atlantic, the proposed change in the fishing year would be expected to result in positive economic benefits associated with improved consistency of the yellowtail snapper fishing seasons in all of these areas. Consistent seasons, and other regulations, allow fishermen greater flexibility in choosing where and when to fish in general and for specific species. When fishing for yellowtail snapper, consistent seasons would allow fishermen to operate in areas that are most productive and without concern about which regulatory jurisdiction applies. Overall, the increased operational flexibility would be expected to result in increased profit to the directly affected small businesses. These economic benefits may be small, however, and limited to those benefits associated with operational flexibility.
Based on the discussion above, NMFS determines that this proposed rule, if implemented, would result in an increase in revenue and associated profits and would not have a significant adverse economic effect on a substantial number of small entities. As a result, an initial regulatory flexibility analysis is not required.
Fisheries, Fishing, Gulf of Mexico, South Atlantic, Yellowtail snapper.
For the reasons set out in the preamble, 50 CFR part 622 is proposed to be amended as follows:
16 U.S.C. 1801
(g)
(a)
U.S. Agency for International Development (USAID) has submitted the following information collection to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments regarding this information collection are best assured of having their full effect if received within 30 days of this notification. Comments should be addressed to: Desk Officer for USAID, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Washington, DC 20503 or be sent via email to
Forest Service, USDA.
Notice of intent to prepare draft environmental impact statement/environmental impact report and public scoping meeting.
The Angeles National Forest (USFS-ANF) and the Watershed Conservation Authority WCA are lead agencies preparing a joint Draft Environmental Impact Statement (EIS)/Environmental Impact Report (EIR), pursuant to the National Environmental Policy Act (NEPA), the California Environmental Quality Act (CEQA), the Endangered Species Act, and other applicable laws, to evaluate the San Gabriel River Confluence with Cattle Canyon Improvements Project (Project). The USFS-ANF and the WCA have agreed to jointly prepare an EIS/EIR in order to optimize efficiency and avoid duplication. The EIS/EIR is intended to be sufficient in scope to address the federal, state, and local requirements and the environmental issues concerning the proposed activities and permit approvals. The Project was developed to better manage the recreation use and balance the needs for resource protection. The project site encompasses an approximate 2.5-mile reach of the East Fork of the San Gabriel River, running generally south until its confluence with Cattle Canyon Creek in Los Angeles County: T2N R8W Sections 19 and 30, T2N R9W Sections 24, 25, 26, T3N R8W Section 18. The entire project site is within the San Gabriel Mountains National Monument boundary and will continue to be managed by the USFS-ANF. The proposed actions are to develop new management strategies to protect and restore the multi-use areas for future public enjoyment. Proposed enhancements include establishment of parking spaces, development of new picnic areas, pedestrian trails, river access points and upgrades to existing facilities, improvements to paved and unpaved roadways, and restoration of riparian and upland vegetation communities.
Comments concerning the scope of the analysis must be received by December 1, 2016.
Two public scoping meetings are being held to provide you with an opportunity to learn more about the proposed action and to express comments on the proposed action and scope of the EIS/EIR. The scoping meetings will be held Wednesday, November 16, 2016, from 6:00 p.m. to 8:30 p.m., and Saturday, November 19, 2016, from 11:00 a.m. to 1:30 p.m.
Please send written scoping comments to: Cattle Canyon Improvements Project, 110 N. Wabash Ave., Glendora, CA 91741. Comments may also be sent via email to
The scoping meetings will be held at the following locations:
Additional information about public meetings is posted on:
Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information
Due to steep topography and dense chaparral, recreation is highly concentrated in areas that are relatively flat with roaded access in ANF. The heavy use combined with the lack of facilities has resulted in the degradation within the project site. Current conditions are not sustainable for long-term management. The San Gabriel River Confluence with the Cattle Canyon Improvement Project is being proposed to better manage the recreation use and balance the needs for resource protection. The future desired condition is to provide balanced, environmentally sustainable recreation opportunities to meet the needs of a growing urban and culturally diverse population, particularly for day use.
The purpose and need for the project is to provide recreation facilities and infrastructure that are high quality, well-maintained, safe, accessible and consistent with visitors' expectations; shift and concentrate recreational use to certain areas in order to minimize adverse effects over a broader area; promote stewardship of public land by providing quality and sustainable recreation opportunities that result in increased visitor satisfaction; allow for better management of the recreation resources on the Forest; and improve riparian habitat conditions in certain areas and make progress toward enhancing stream habitat conditions by restoring vegetation, minimizing invasive plants and noxious weed presence, and developing management strategies to regulate access.
The full description of the proposed action/project is on the following Web sites:
To provide better public access to the river while protecting natural resources, a total of six locations for river access points are proposed throughout the project site. Each river access point would implement the Sustainable Site Access Model and include: Parking, infrastructure to provide for potential development of future shuttle services, litter disposal, restrooms, picnic tables and seating, East Fork Scenic Trail with interpretive elements, safe river access trails, and elimination of user-created trails and parking.
Restoration would occur throughout the project site to reduce impacts from user generated trails, protect seeps/springs on east side of the road, preserve stream habitat in tributary behind oaks picnic area, and mitigate losses from trail construction. Restoration would include non-native vegetation removal and/or riparian plantings.
The project proposes a total of 270 new parking spaces designated for standard vehicles and three spaces for bus parking within the vicinity of the Oaks Picnic Area and Coyote Flat. Of the 270 parking spaces, 14 spaces would be designed and designated as accessible spaces. These spaces include angled and perpendicular bays with curbs, formal (marked) paved roadside parking, and a paved parking lot at the former fire station within the East Fork Scenic Overlook and Trailhead area. Parking would be available during day-use hours. Undesignated parking areas would be blocked by boulders and parking signage installed.
Improvements along the two-mile reach of the public right of way would include designated roadside parking, the addition of three loading area/shuttle stops, low barrier walls, signage, and a vehicle turnaround at the end of Camp Bonita Road.
Proposed actions include development of the following amenities:
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The project area is being proposed to be managed as a Day Use only area. Currently recreation sites located within the project area (Oaks Picnic Site and East Fork Trailhead Day Use Parking) are managed as Standard Amenity Recreation Fee Sites (SARF). With the development of the project new recreation sites will be eligible to be included into the SARF program. These new sites may be designated for fee collection after the project is constructed, in accordance with the Federal Lands Recreation Enhancement Act, including necessary approvals of the Recreation Advisory Committee established by that law.
In order to address substantive issues identified during scoping, project alternatives may be considered and developed by lead agencies staff, following completion of the public scoping period. If necessary, the alternatives shall fulfill the identified purpose & need for action while addressing one or more significant issues related to the proposed project.
Potential environmental effects and impacts for the proposed project and the
Permits that may be required before implementation include: A National Pollutant Discharge Elimination System General Construction Permit issued by the Los Angeles Regional Water Quality Control Board, a Section 404 Permit and Section 401 Certification (per the Clean Water Act) issued by the U.S. Army Corps of Engineers, Biological Opinion/Incidental Take Statement issued by USFWS, Section 2081 Incidental Take Permit issued by the California Department of Fish and Wildlife, and a Streambed Alteration Agreement (Section 1602 permits of the California Fish and Game Code) issued by the California Department of Fish and Wildlife. Local traffic control and encroachment permits may be required from the Los Angeles County Department of Public Works or the California Department of Transportation.
The ANF and the WCA are seeking public and agency comment on the proposed project to identify major issues. Comments received will help define the scope of the project and issues to be analyzed in depth. Comments should be as “project specific” as possible. It is important that reviewers provide their comments at such times and in such a manner that they are useful to the agency's preparation of the environmental impact statement. Therefore, comments should be provided prior to the close of the scoping comment period and should clearly articulate the reviewer's concerns and contentions in relation to the project. Reviewers may wish to refer to the Council on Environmental Quality Regulations for implementing the procedural provisions of NEPA (40 CFR 1503.3) in addressing these points.
The proposed project is consistent with the 2006 Angeles National Forest Land Management Plan, and is subject to project level, pre-decisional administrative review pursuant to 36 CFR 218, Subparts A and B. Comments received on this notice or in subsequent environmental reviews, including names and addresses of those who comment, will be considered as part of the public record on this proposed project, and are subject to the Freedom of Information Act (FOIA) and California Public Records Act (CPRA). Comments submitted anonymously will be accepted and considered; however, those who submit anonymous comments will not have standing to object to the subsequent decision.
Grain Inspection, Packers and Stockyards Administration, USDA.
Notice.
GIPSA is announcing the designation of the Washington State Department of Agriculture (Washington) to provide official services under the United States Grain Standards Act (USGSA), as amended.
Effective Date: January 1, 2015.
Sharon Lathrop, Compliance Officer, USDA, GIPSA, FGIS, QACD, 10383 North Ambassador Drive, Kansas City, MO 64153.
Sharon Lathrop, 816-891-0415,
All applications and comments are available for public inspection at the office above during regular business hours (7 CFR 1.27(c)).
In the August 26, 2014,
The current official agency, Washington, was the only applicant for designation to provide official services in these areas. As a result, GIPSA did not ask for additional comments.
GIPSA evaluated the designation criteria in USGSA 7 U.S.C. 79(f), and determined that Washington is qualified to provide official services in the geographic areas specified in the
Interested persons may obtain official services by contacting this agency at the following telephone number:
The USGSA authorizes the Secretary to designate a qualified applicant to provide official services in a specified area after determining that the applicant is better able than any other applicant to provide such official services 7 U.S.C. 79(f).
Grain Inspection, Packers and Stockyards Administration, USDA.
Notice and request for comments.
The Grain Inspection, Packers and Stockyards Administration (GIPSA) is taking several actions to post stockyards under the Packers and Stockyards Act (P&S Act). Specifically, we are proposing that eight stockyards now operating subject to the P&S Act be posted. We are also posting 15 stockyards that were identified previously as operating subject to the P&S Act.
For the proposed posting of stockyards, we will consider comments
We invite you to submit comments on this notice. You may submit comments by any of the following methods:
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Catherine M. Grasso, Program Analyst, Litigation and Economic Analysis Division at (202) 720-7201 or
GIPSA administers and enforces the P&S Act of 1921, (7 U.S.C. 181
Section 302 of the P&S Act (7 U.S.C. 202) defines the term “stockyard” as follows: “. . . any place, establishment, or facility commonly known as stockyards, conducted, operated, or managed for profit or nonprofit as a public market for livestock producers, feeders, market agencies, and buyers, consisting of pens, or other enclosures, and their appurtenances, in which live cattle, sheep, swine, horses, mules, or goats are received, held, or kept for sale or shipment in commerce.”
Section 302 (b) of the P&S Act requires the Secretary of Agriculture to determine which stockyards meet this definition, and to notify the owner of the stockyard and the public of that determination by posting a notice in each designated stockyard. Once the Secretary provides notice to the stockyard owner and the public, the stockyard is subject to the provisions of Title III of the P&S Act (7 U.S.C. 201-203 and 205-217a) until the Secretary deposts the stockyard by public notice. To post a stockyard, we assign the stockyard a facility number, notify the stockyard owner, and send an official posting notice to the stockyard owner to display in a public area of the stockyard. This process is referred to as “posting.” The date of posting is the date that the posting notices are physically displayed at the stockyard. A facility that does not meet the definition of a stockyard is not subject to the P&S Act, and therefore cannot be posted. A posted stockyard can be deposted, which occurs when the facility is no longer used as a stockyard.
We are hereby notifying stockyard owners and the public that the following eight stockyards meet the definition of a stockyard, and that we propose to designate these stockyards as posted stockyards.
We are also notifying the public that the stockyards listed in the following table meet the P&S Act's definition of a stockyard and that we have posted the stockyards. On July 27, 2015, we published a notice in the
7 U.S.C. 202.
U.S. Commission on Civil Rights.
Notice of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the South Carolina Advisory Committee will hold a meeting on Wednesday, November 9, 2016, for the purpose of discussing potential projects.
The meeting will be held on Wednesday, November 9, 2016, 12:00 p.m. EST.
The meeting will be by teleconference. Toll-free call-in number: 888-397-0286, conference ID: 9589666.
Members of the public can listen to the discussion. This meeting is available to the public through the following toll-free call-in number: 888-397-0286, conference ID: 9589666. Any interested member of the public may call this number and listen to the meeting. Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-977-8339 and providing the Service with the conference call number and conference ID number.
Members of the public are also entitled to submit written comments; the comments must be received in the regional office by October 30, 2016. Written comments may be mailed to the Southern Regional Office, U.S. Commission on Civil Rights, 61 Forsyth Street, Suite 16T126, Atlanta, GA 30303. They may also be faxed to the Commission at (404) 562-7005, or emailed to Regional Director, Jeffrey Hinton at
Records generated from this meeting may be inspected and reproduced at the Southern Regional Office, as they become available, both before and after the meeting. Records of the meeting will be available via
U.S. Commission on Civil Rights.
Notice of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Tennessee Advisory Committee will hold a meeting on Wednesday, November 30, 2016, for the purpose of discussing potential projects.
The meeting will be held on Wednesday, November 30, 2016, 12:30 p.m. EST.
The meeting will be by teleconference. Toll-free call-in number: 888-539-3696, conference ID: 7236252.
Members of the public can listen to the discussion. This meeting is available to the public through the following toll-free call-in number: 888-539-3696, conference ID: 7236252. Any interested member of the public may call this number and listen to the meeting. Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-977-8339 and providing the Service with the conference call number and conference ID number.
Members of the public are also entitled to submit written comments; the comments must be received in the regional office by November 24, 2016. Written comments may be mailed to the Southern Regional Office, U.S. Commission on Civil Rights, 61 Forsyth Street, Suite 16T126, Atlanta, GA 30303. They may also be faxed to the Commission at (404) 562-7005, or emailed to Regional Director, Jeffrey Hinton at
Records generated from this meeting may be inspected and reproduced at the Southern Regional Office, as they become available, both before and after the meeting. Records of the meeting will be available via
U.S. Commission on Civil Rights.
Announcement of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Kansas Advisory Committee (Committee) will hold a meeting on Tuesday, November 01, 2016, at 4:00 p.m. CDT. The meeting will include a discussion of completion and publication of the Committee's report regarding voting rights in the state, and a discussion of other current civil rights concerns in Kansas for future consideration.
The meeting will take place on Tuesday, October 04, 2016, at 4:00 p.m. CDT
Public call information: Dial: 877-718-5095, Conference ID: 3957006
Melissa Wojnaroski, DFO, at
Members of the public can listen to the discussion. This meeting is available to the public through the following toll-free call-in number: 877-718-5095, conference ID: 3957006. Any interested member of the public may call this number and listen to the meeting. An open comment period will be provided to allow members of the public to make a statement as time allows. The conference call operator will ask callers to identify themselves, the organization they are affiliated with (if any), and an email address prior to placing callers into the conference room. Callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-977-8339 and providing the Service with the conference call number and conference ID number.
Members of the public are also entitled to submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be mailed to the Regional Programs Unit, U.S. Commission on Civil Rights, 55 W. Monroe St., Suite 410, Chicago, IL 60615. They may also be faxed to the Commission at (312) 353-8324, or emailed to Corrine Sanders at
Records generated from this meeting may be inspected and reproduced at the Regional Programs Unit Office, as they become available, both before and after the meeting. Records of the meeting will be available via
The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).
Requests for additional information or copies of the information collection instrument and instructions should be directed to Mark Crace, BIS Liaison, (202) 482-8093,
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to Jasmeet Seehra, Office of Management and Budget (OMB), by email to
Enforcement and Compliance, International Trade Administration, Department of Commerce.
On September 9, 2016, the Department of Commerce (the Department) published the final results of the administrative review of the antidumping duty order on small diameter graphite electrodes (SDGEs) from the People's Republic of China (the PRC). The period of review (POR) is February 1, 2014, through January 31, 2015. We are amending the final results of the administrative review to correct certain ministerial errors.
Effective October 17, 2016.
Dmitry Vladimirov or Michael A. Romani, 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) 482-0665 or (202) 482-0198, respectively.
On September 9, 2016, the Department published the final results of the administrative review of the antidumping duty order on SDGEs from the PRC.
The merchandise covered by the order includes all small diameter graphite electrodes with a nominal or actual diameter of 400 millimeters (16 inches) or less and graphite pin joining systems for small diameter graphite electrodes. Small diameter graphite electrodes and graphite pin joining systems for small diameter graphite electrodes that are subject to the order are currently classified under the Harmonized Tariff Schedule of the United States (HTSUS) subheadings 8545.11.0010, 3801.10, and 8545.11.0020. While the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of the order is dispositive. A full description of the scope of the order is contained in the Final Results Issues and Decision Memorandum.
Section 751(h) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.224(f) define a “ministerial error” as an error “in addition, subtraction, or other arithmetic function, clerical error resulting from inaccurate copying, duplication, or the like, and any other similar type of unintentional error which the Secretary considers ministerial.” We analyzed the allegations submitted by the petitioners and the Fangda Group, and determined, in accordance with section 751(h) of the Act and 19 CFR 351.224(e), that we made ministerial errors in calculating the margin for the Fangda Group.
In accordance with section 751(h) of the Act and 19 CFR 351.224(e), we are amending the
We determine that the following weighted-average dumping margins exist for the period February 1, 2014, through January 31, 2015:
Pursuant to section 751(a)(2)(A) of the Act and 19 CFR 351.212(b)(1), the Department will determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries of subject merchandise in accordance with the amended final results of this review. For entries of subject merchandise during the period of review produced by Fushun Jinly, we will instruct CBP to liquidate the appropriate entries without regard to antidumping duties because Fushun Jinly's weighted-average dumping margin in these amended final results remains
We intend to issue assessment instructions to CBP 15 days after the date of publication of these amended final results of review.
The following cash deposit requirements will be effective
We intend to disclose the calculations performed for these amended final results to interested parties within five days after the public announcement of the amended final results in accordance with 19 CFR 351.224(b).
This notice serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this POR. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of the antidumping duties occurred and the subsequent assessment of double antidumping duties.
This notice also serves as a reminder to parties subject to administrative protective order (APO) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a sanctionable violation.
These amended final results of review are issued and published in accordance with sections 751(h) and 19 CFR 351.224(e) of the Act.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
On June 10, 2016, the Department of Commerce (the Department) published the preliminary results of the administrative review of the antidumping duty order on certain steel nails (nails) from the United Arab Emirates (UAE). The period of review (POR) is May 1, 2014, through April 30, 2015. The review covers five producers/exporters of the subject merchandise, Dubai Wire FZE (Dubai Wire), Oman Fasteners LLC (Oman Fasteners), Overseas Distribution Services Inc. (ODS), Overseas International Steel Industry LLC (OISI), and Precision Fasteners LLC (Precision). For these final results, we continue to find that subject merchandise has been sold in the United States at less than normal value.
Effective October 17, 2016.
Bryan Hansen or Minoo Hatten, 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) 482-3683, and (202) 482-1690, respectively.
On June 10, 2016, the Department published the preliminary results of the administrative review of the antidumping duty order on certain steel nails from the UAE.
The merchandise subject to the
All issues raised in the case and rebuttal briefs by parties to this administrative review are addressed in the Issues and Decision Memorandum. A list of the issues is attached to this notice as an appendix. The Issues and Decision Memorandum is a public document and is on file electronically
The Department preliminarily found that Oman Fasteners LLC, Overseas International Steel Industry LLC, and Precision Fasteners LLC, did not have any reviewable entries of subject merchandise during the POR.
In these final results we calculated a weighted-average dumping margin above zero or
Based on the Department's analysis of comments received and further examination of the record, we made revisions to our margin calculations for ODS. As a result, the margins for ODS and Dubai Wire have changed.
As a result of this administrative review, we determine that the following estimated weighted-average dumping margins exist for the period May 1, 2014, through April 30, 2015:
We intend to disclose the calculations performed to parties in this proceeding within five days after public announcement of the final results, in accordance with 19 CFR 351.224(b).
Pursuant to section 751(a)(2)(A) of the Act and 19 CFR 351.212(b), the Department shall determine, and CBP shall assess, antidumping duties on all appropriate entries covered by this review.
Consistent with our practice, because we continue to find that Oman Fasteners, OISI, and Precision had no shipments of subject merchandise to the United States in the final results of this review, we will instruct CBP to liquidate any existing entries of merchandise produced by Oman Fasteners, OISI, and Precision and exported by other parties at the all-others rate.
For Dubai Wire, the respondent not selected for individual examination, we will instruct CBP to apply the rate assigned to ODS, to all entries of subject merchandise produced and/or exported by Dubai Wire.
We intend to issue instructions to CBP 15 days after publication of the final results of this review.
The following deposit requirements will be effective upon publication of the notice of final results of administrative review for all shipments of nails from the UAE 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 ODS and Dubai Wire will be the rates established in the final results of this administrative review; (2) for merchandise exported by manufacturers or exporters not covered in this review but covered in a prior segment of the proceeding, 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 original 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) the cash deposit rate for all other manufacturers or exporters will continue to be 4.30 percent, the all-others rate established in the
This notice serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.
This notice also serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a sanctionable violation.
These final results of review are issued and published in accordance with sections 751(a)(1) and 777(i) of the Act.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of open public meeting.
This notice sets forth the proposed schedule and agenda of a forthcoming meeting of the Marine Fisheries Advisory Committee (MAFAC). The members will discuss and provide advice on issues outlined under
The meeting will be held November 1-3, 2016, from 9:00 a.m. to 5 p.m.
The meeting will be held at the Sheraton Silver Spring Hotel, 8777 Georgia Ave, Silver Spring, MD 20910; 301-589-0800.
Jennifer Lukens, MAFAC Executive Director; (301) 427-8004; email:
As required by section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App. 2, notice is hereby given of a meeting of MAFAC. The MAFAC was established by the Secretary of Commerce (Secretary), and, since 1971, advises the Secretary on all living marine resource matters that are the responsibility of the Department of Commerce. The complete charter and summaries of prior meetings are located online at
This meeting time and agenda are subject to change.
The meeting is convened to hear presentations and updates and to discuss policies and guidance on the following topics: proposed Columbia Basin Partnership Task Force; aquaculture resilience benefits; regional vulnerability analyses; ecosystem based fisheries management; transition; Protected Resources program review and climate change guidance; climate science and regional action plans; recreational fisheries activities and socioeconomic science; and the budget outlook for FY2017-2018. MAFAC will discuss various administrative and organizational matters, and meetings of standing subcommittees and working groups will be convened.
The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Heidi Lovett; 301-427-8034 by October 21, 2016.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; request for comments.
The Regional Administrator, NMFS West Coast Region, has determined that an application for an exempted fishing permit (EFP) warrants further consideration and requests public comment on the application. The application requests 2-year exemptions from various prohibitions under the Fishery Management Plan for U.S. West Coast Fisheries for Highly Migratory Species (HMS FMP) to test the effects and efficacy of using deep-set buoy gear (DSBG) to fish for swordfish and other highly migratory species (HMS) off the U.S. West Coast. This notice also announces NMFS' intent to extend two current DSBG EFPs through 2018 and also requests public comment on these EFPs.
Comments must be submitted in writing by November 16, 2016.
You may submit comments on this document, identified by NOAA-NMFS-2016-0133, by any of the following methods:
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Chris Fanning, NMFS, West Coast Region, 562-980-4198.
In August 2015 NMFS issued three EFPs for fishing vessels to use DSBG in the exclusive economic zone (EEZ) off the U.S. West Coast (DSBG is described as multiple hooks deployed relatively deep in the water column, using one or more weighted mainlines which are suspended with one or more buoys floating on the ocean surface) (80 FR 29662, May 22, 2015). DSBG fishing under two of these EFPs has been ongoing in 2015-2016, and the Pacific Fishery Management Council (Council) recommended these both be extended through the 2017-2018 fishing season (
In addition to the request for the two extensions, a new DSBG EFP application was submitted to the Council by Dave Stephens for two additional vessels to conduct DSBG fishing activities (herein referred to as the “Stephens EFP”) (
If the two extensions and the Stephens EFP are approved, they would exempt a limited number of federally permitted commercial fishing vessels from requirements of the HMS FMP pertaining to non-authorized gear types. The EFPs would authorize up to 13 DSBG vessels to fish year-round in areas within the EEZ off the U.S. West Coast. Aside from the exemption described above, vessels fishing under an EFP would be subject to all other regulations implementing the HMS FMP, including measures to protect sea turtles, marine mammals, and seabirds. The three applicants requested EFP issuance for two fishing seasons or the 2017 and 2018 calendar years.
The Council suggested NMFS impose requirements on the Stephens EFP consistent with one of the existing EFPs, including, but not limited to:
(1) 30 percent observer coverage on each vessel's fishing trips;
(2) fishing only in federal waters; and
(3) the operator of the fishing vessel operating under a DSBG EFP must actively tend all gear at all times and maintain the gear within sight (typically within 2-4 nautical miles of the gear) of the EFP participant fishing vessel.
NMFS is seeking public comment on the extension of the two existing EFPs, as well as the Stephens EFP application and the Council's recommended conditions.
In accordance with NOAA Administrative Order 216-6, appropriate National Environmental Policy Act documents will be completed prior to the issuance of the EFPs. Additionally, NMFS will consider all applicable laws, including Section 7(a)(2) of the Endangered Species Act (16 U.S.C. 1531
16 U.S.C. 1801
United States Patent and Trademark Office, Department of Commerce.
Notice of public roundtables and request for comments related to patent subject matter eligibility.
The United States Patent and Trademark Office (“USPTO”) seeks public input on patent subject matter eligibility in view of recent decisions by the Supreme Court and Court of Appeals for the Federal Circuit. The USPTO remains interested in feedback from members of the public to improve the USPTO's existing subject matter eligibility guidance and training examples. The USPTO is also interested in facilitating a discussion among members of the public regarding the legal contours of eligible subject matter in the U.S. patent system. The USPTO will be facilitating these discussions by hosting two roundtable events. The first roundtable will be directed to receiving feedback from members of the public to improve the USPTO's existing subject matter eligibility guidance and training examples. The second roundtable will be focused on receiving feedback regarding larger questions concerning the legal contours of eligible subject matter in the U.S. patent system. The roundtables will provide a forum for discussion of the topics identified in this notice.
The meeting dates are:
1. November 14, 2016, 1 p.m. to 5 p.m., Alexandria, VA.
Written comments will be accepted on an ongoing basis.
2. December 5, 2016, 8 a.m. to 5 p.m., Stanford, CA.
Written comments are due by January 18, 2017.
The meeting locations are:
1. United States Patent and Trademark Office, Madison Building, Madison Auditorium, 600 Dulany Street, Alexandria, Virginia 22314.
2. Paul Brest Hall, 555 Salvatierra Walk, Stanford University, Stanford, California 94305.
Submit written comments to:
Requests for additional information regarding registration and speaker presentations should be directed to the attention of Elizabeth Shaw, by telephone at 571-272-9300, or by email at
Because comments will be made available for public inspection, information that is not desired to be made public, such as an address or phone number, should not be included in the comments.
As the world's most innovative economy, the United States relies heavily on intellectual property to support economic growth and business development. The U.S. patent system is a critical piece of the nation's robust system of intellectual property rights. To obtain patent protection, the requirement of subject matter eligibility under 35 U.S.C. 101 must be satisfied. Over the past six years, the Supreme Court has issued a series of decisions—
Following
The Court held the claims to be patent ineligible.
At issue in
Finally, in
These cases continue to have a substantial effect on patent eligibility in the United States. On the one hand, they have overturned decades-old USPTO practice regarding patent eligibility of isolated genes, placing the United States at odds with the practices of major trading partners, including Europe.
In the wake of these cases, the Federal Circuit has issued several decisions applying the Supreme Court test to a broad spectrum of subject matter, from the life sciences
The USPTO has issued a series of guidance documents and training examples to instruct examiners on how to apply section 101 during examination, which incorporates previously received public input.
1. Suggestions to how to improve the Office's subject matter eligibility guidance, particularly the three recent memoranda discussed above;
2. Comments on the May 2016 Life Sciences examples and their effect on prosecution of patent applications in the life sciences, and suggestions of additional examples, or technology areas in which examples would be helpful;
3. Suggestions on how best to make examiners aware of newly issued judicial decisions, and how best to incorporate recent decisions holding claims eligible, such as
4. Concerns on how the Office's subject matter eligibility guidance and training examples, or how court decisions, are being applied by examiners.
The public is invited to submit comments on any topics related to patent subject matter eligibility under 35 U.S.C. 101 that they deem relevant. This roundtable event is not seeking additional input on the examiner guidance and training examples referenced above. Instead, the USPTO is seeking to promote conversation on how the current section 101 jurisprudence is evolving; what the optimum legal contours for patent eligibility should be; and how best to achieve these goals. Specifically, the USPTO would like to facilitate discussion and create a public record with relevant information on the actual or perceived impact of existing law on particular technology areas, and the effects on investment in research and development, and innovation generally. The USPTO would appreciate comments on whether developments in patent-eligibility law should be left primarily to the courts or whether other administrative initiatives are desirable. In addition, the USPTO would appreciate comments on whether legislative changes are desirable and, if so, views on the elements of such changes.
To facilitate the launch of this data-gathering exercise, the USPTO is particularly interested in receiving views and comments on questions presented below. However, the tenor of the questions should not be taken as an indication that the USPTO is predisposed to any particular views, positions, or actions. The USPTO also invites the public to share their views and insights on other aspects of patent subject matter eligibility that are not addressed in the questions.
1. How has the Supreme Court's interpretation of 35 U.S.C. 101 in the past several years affected the enforcement of patents and the development of subject-matter-eligibility law? In your response please:
a. Identify the scope of the problem, including specific examples;
b. identify any legal and/or technical inaccuracies;
c. suggest possible changes and/or solutions to any problems with section 101; and
d. provide explanations and/or any legal, policy, or economic analyses supporting your comments.
To be eligible for patent protection, an invention must comply with section 101 of the Patent Act, which limits entitlement to a patent to “whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter.” The four categories of invention enumerated in the statute—process, machine, manufacture, and composition of matter—exhaust the possible types of inventions for which a patent may be obtained.
2. Should the patent statute be amended to further define the statutory categories of invention,
The Supreme Court has articulated three exceptions to patent eligibility under section 101: Laws of nature, natural phenomena, and abstract ideas.
3. Do you think there should be exceptions to patentable subject matter?
a. If no, how should section 101 or other patentability provisions operate to address subject matter currently considered to fall within judicial exceptions?
b. If yes, please explain whether the judicial exceptions are sufficient in scope and if not, please identify other exceptions that should be included in the determination of patent eligible subject matter.
4. Should the patent statute be amended to define the judicial exceptions? If so, please suggest possible legislative changes, including which sections of title 35 should be amended,
5. If you identified other exceptions in your response to 3(b), please suggest possible legislative changes, including which sections of title 35 should be amended,
6. Other jurisdictions,
a. Do you think that title 35 should be amended to revise the definition for the term “invention” and/or provide a definition for the term “discovery” along with specific examples of subject matter that should not be treated as an invention and/or discovery?
b. If so, please suggest possible legislative changes, including which sections of title 35 should be amended,
7. Does the concept of preemption, either separately or in the context of the
8. What does the term “discovery” in sections 100 and 101 mean, and to what extent should a “discovery” be eligible for a patent? Please provide specific examples.
9. What does the term “invention” in sections 100 and 101 mean, and to what extent should a non-naturally occurring product of human ingenuity qualify as an “invention” to be eligible for a patent? Please provide specific examples.
10. To what extent should products that have been isolated from their natural surroundings as a result of human ingenuity be eligible for a patent? Please provide specific examples as well as scientific explanations and/or legal analyses to support your response.
11. To what extent should a “diagnostic method” be eligible for a patent? Please provide specific examples.
12. Are there lines that can or should be drawn scientifically or legislatively between different types of compositions of matter for purposes of obtaining patent protection (
13. What particular inventions or specific types of technologies that should be patent eligible are not patent eligible, or are likely to be challenged as patent ineligible, under
14. Should patents be available for methods that do not involve a machine or a transformation? If so, please provide specific examples.
15. If you support some form of “machine or transformation test,” please identify the best expression of such a test.
a. Should incorporation of the use of a general purpose computer be enough to satisfy the “machine” part of the test? If not, what more should be required?
b. Should a transformation that occurs in the human body as a result of a claimed process be enough to satisfy the “transformation” part of the test? If not, what more should be required?
16. To what extent should an invention that involves a business method be eligible for a patent? Please provide specific examples.
17. To what extent should an invention that involves computer software be eligible for a patent? Please provide specific examples.
18. What mechanisms, other than the judicial exceptions, can be used to prevent issuance of overly broad software or computer-related patents that cover wide swaths of economic activity? Do you think that other provisions of title 35 (enablement, written description, definiteness, novelty, non-obviousness) could be used more effectively to achieve this goal? If not, please explain why.
The public is invited to speak at Roundtable 1 by appearing, in person, at the USPTO in Alexandria, Virginia or one of the following USPTO Regional Offices: the Midwest Regional Office, 300 River Place Drive, Suite 2900, Detroit, Michigan 48207; The Rocky Mountain Regional Office, 1961 Stout Street, Denver, Colorado 80294; the West Coast Regional Office, 26 S. Fourth Street, San Jose, California 95113; or the Texas Regional Office, 207 South Houston Street, Suite 159, Dallas, Texas 75202. Individuals requesting to speak at one of the aforementioned Regional Offices will be provided with the opportunity to speak at the roundtable and engage with USPTO representatives in Alexandria, Virginia in real time. If requesting to speak at this roundtable, please check the appropriate location when completing the on-line registration.
Requests to Speak: Individuals interested in speaking at Roundtable 2 must complete the on-line registration no later than November 14, 2016, and include their name, contact information (telephone number and email address), the organization(s) the person represents, if any, the topics they wish to address, and the approximate length of the presentation. To ensure a balanced array of views, there is the possibility that not all persons who wish to make a presentation will be able to do so given time constraints; however, the USPTO will do its best to try to accommodate as many persons as possible. Selected speakers will be notified thereafter. However, all members of the public are encouraged to submit written comments by electronic mail message via the Internet addressed to
The public is invited to speak at Roundtable 2 by appearing, in person, at Stanford University, Stanford, California or at one of the following USPTO Regional Offices: The Midwest Regional Office, 300 River Place Drive, Suite 2900, Detroit, Michigan 48207; the Rocky Mountain Regional Office, 1961 Stout Street, Denver, Colorado 80294; or the Texas Regional Office, 207 South Houston Street, Suite 159, Dallas, Texas 75202. Individuals requesting to speak at one of the aforementioned Regional Offices will be provided with the opportunity to speak at the roundtable and engage with USPTO representatives in Stanford, California in real time. If requesting to speak at this roundtable, please check the appropriate location when completing the on-line registration.
Notice.
The Department of Defense has submitted to OMB for clearance, the following proposal for collection of information under the provisions of the Paperwork Reduction Act.
Consideration will be given to all comments received by November 16, 2016.
Fred Licari, 571-372-0493.
Title, Associated Form and OMB Number: Recreation Area and Visitor Center Visitor Comment Cards; OMB Control Number 0710-XXXX.
Comments and recommendations on the proposed information collection should be emailed to Ms. Jasmeet Seehra, DoD Desk Officer, at
You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:
•
Written requests for copies of the information collection proposal should be sent to Mr. Licari at WHS/ESD Directives Division, 4800 Mark Center Drive, East Tower, Suite 03F09, Alexandria, VA 22350-3100.
USA Installation Management Command (IMCOM), DoD.
Notice.
In compliance with the
Consideration will be given to all comments received by December 16, 2016.
You may submit comments, identified by docket number and title, by any of the following methods:
•
•
Any associated form(s) for this collection may be located within this same electronic docket and downloaded for review/testing. Follow the instructions at
To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to the USA Installation Management Command (IMCOM) Headquarters, 2405 Gun Shed Road, Bldg 2261, Room 1400, ATTN: Israel S. Garcia, Fort Sam Houston, TX 78234-1223, or call IMCOM Headquarters G32 at 210-466-0286/0259.
Respondents are IMCOM appropriated fund (APF) and non-appropriated fund (NAF) employees; members of the military (active and reserve); foreign national employees overseas; and APF and NAF contractors, including subcontractors, who have regular contact with children under age of 18, as well as applicants for those positions. This applies to all offices responsible for on-boarding and providing support for screening and background checks, including civilian and military personnel; Army Substance Abuse Programs (ASAP); Directorates of Family, Morale, Welfare, and Recreations (DFMWR); Directorates of Plans, Training Mobilization, and Security (DPTMS); Criminal Investigation Division (CID), and Installation Religious Services Offices (RSO).
Defense Manpower Data Center (DMDC), DoD.
Notice.
In compliance with the
Consideration will be given to all comments received by December 16, 2016.
You may submit comments, identified by docket number and title, by any of the following methods:
•
•
Any associated form(s) for this collection may be located within this same electronic docket and downloaded for review/testing. Follow the instructions at
To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to the Defense Manpower Data Center, Division Director, Personnel Security Assurance, ATTN: John Liu, DoD Center Monterey Bay, 400 Gigling Road, Seaside, CA 93955-6771, or call at (831) 583-2500.
DISS requires personal data collection to facilitate the initiation, investigation and adjudication of information relevant to DoD security clearances and employment suitability determinations for active duty military, civilian employees and contractors seeking such credentials. As a Personnel Security System it is the authoritative source for clearance information resulting in accesses determinations to sensitive/classified information and facilities. Specific uses include the facilitation for DoD Adjudicators and Security Managers to obtain accurate up-to-date eligibility and access information on all personnel (military, civilian and contractor personnel) adjudicated by the DoD. The DoD Adjudicators and Security Managers are also able to update eligibility and access levels of military, civilian and contractor personnel nominated for access to sensitive DoD information. By completing the OPM Shared Forms SF 86, SF 86A, SF 86C, SF 85, or SF 85P, individuals are consenting to the specific uses of their PII. Information contained in this system is derived from the appropriate DoD personnel systems; Case Adjudication Tracking System (CATS); records maintained by the DoD adjudicative agencies; and records maintained by security managers, special security officers, or other officials requesting and/or sponsoring the security eligibility determination for the individual.
Office of the Assistant Secretary of Defense for Health Affairs, DoD.
Notice.
In compliance with the
Consideration will be given to all comments received by December 16, 2016.
You may submit comments, identified by docket number and title, by any of the following methods:
•
•
To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to Joint Operational Medical Information Systems, 1501 Wilson Blvd., Suite 600, Arlington, VA 22209-2412.
The key capabilities of TMDS include but not limited to receiving medical data from AHLTA-Mobile, AHLTA-Theater, Composite Health Care System Caché (CHCS), SNAP Automated Medical System (SAMS), and Transportation Command Regulating Command arid Control Evacuation System (TRAC2ES). TMDS serves as the authoritative Theater database for service members, contractors, host nation, and foreign military medical information, allowing users to track patients' disposition and display their longitudinal medical record information. TMDS is also the authoritative data store for blood shipments and transfusion data in Theater. Capabilities include viewing all Theater clinical information, such as progress notes, laboratory history, drug history, and radiological history; viewing, tracking, and managing ill or injured patients as they move through the continuum of care; and accessing data on airlifted critically injured patients before arrival at their next point of care. Personally identifiable information (PII) and protected health information (PHI) that is collected by the system and includes: Name, social security number (SSN), Department of Defense ID (DODID), family member prefix (FMP), rank, service affiliation, birth date, race/ethnicity, gender, marital status, spouse information, emergency contact, sponsor name, and sponsor SSN.
Office of Postsecondary Education, Department of Education.
Notice.
Notice inviting applications for new awards for fiscal year (FY) 2017.
The Department views the UB Program as a critical component of its efforts to improve college access and completion for students who have been traditionally underrepresented in postsecondary education by focusing on improving college readiness. To more strategically align UB grants with broader reform strategies intended to improve postsecondary access and completion, this notice includes a competitive preference priority that encourages applicants to propose activities that are supported by moderate evidence of effectiveness (as defined in this notice). The Department is particularly interested in receiving applications that include plans to provide services for students, supported by evidence, that increase the likelihood that students will complete high school and enroll in and complete a program of postsecondary education. The Department is not specifying a particular service such as tutoring or mentoring that must be tied to evidence, but is providing an opportunity for the applicant to decide which statutorily authorized service the project will implement based on available evidence of effectiveness.
Additionally, this notice includes an invitational priority encouraging applicants to focus on increasing opportunities for students to accumulate postsecondary credits while in high school. Some of these opportunities for postsecondary coursework may be available through dual enrollment programs. Dual enrollment programs allow high school students to enroll in credit-bearing college courses while enrolled in high school. In various forms and under different names, dual enrollment programs exist in all 50 States.
Recent research
This priority is:
Applications supported by evidence of effectiveness that meets the conditions set out in the definition of “moderate evidence of effectiveness” in 34 CFR 77.1(c).
This priority is:
The Secretary encourages applicants to propose projects designed to increase opportunities for participants to earn postsecondary credits in high school, such as through providing connections to dual enrollment programs.
(i) There is at least one study of the effectiveness of the process, product, strategy, or practice being proposed that meets the WWC Evidence Standards without reservations, found a statistically significant favorable impact on a relevant outcome (with no statistically significant and overriding unfavorable impacts on that outcome for relevant populations in the study or in other studies of the intervention reviewed by and reported on by the WWC), and includes a sample that overlaps with the populations or settings proposed to receive the process, product, strategy, or practice.
(ii) There is at least one study of the effectiveness of the process, product, strategy, or practice being proposed that meets the WWC Evidence Standards with reservations, found a statistically significant favorable impact on a relevant outcome (with no statistically significant and overriding unfavorable impacts on that outcome for relevant populations in the study or in other studies of the intervention reviewed by and reported on by the WWC), includes a sample that overlaps with the populations or settings proposed to receive the process, product, strategy, or practice, and includes a large sample and a multi-site sample.
Multiple studies can cumulatively meet the large and multi-site sample requirements as long as each study meets the other requirements in this paragraph.
The regulations in 34 CFR part 79 apply to all applicants except federally recognized Indian tribes.
The regulations in 34 CFR part 86 apply to institutions of higher education only.
Contingent upon the availability of funds and the quality of applications, we may make additional awards in FY 2018 from the list of unfunded applications from this competition.
• For an applicant that is not currently receiving a UB Program grant, the maximum award amount is $257,500, based upon a per-participant cost of no more than $4,292 and a minimum of 60 participants.
• For an applicant that is currently receiving a UB Program grant, the maximum award amount is an amount equal to the applicant's base award amount for FY 2016.
The Department is not bound by any estimates in this notice.
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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.
• A “page” is 8.5″ x 11″, on one side only, with 1″ margins at the top, bottom, and both sides. Page numbers and an identifier may be within the 1″ margin.
• Each page on which there is text or graphics will be counted as one full page.
• Double space (no more than three lines per vertical inch) all text in the application narrative, including charts, tables, figures, and graphs. Titles, headings, footnotes, quotations, references, and captions may be singled spaced.
• Use a font that is either 12 point or larger, or no smaller than 10 pitch (characters per inch).
• Use one of the following fonts: Times New Roman, Courier, Courier New, or Arial. An application submitted in any other font (including Times Roman and Arial Narrow) will not be accepted.
The page limit does not apply to Part I, the Application for Federal Assistance Face Sheet (SF 424); Part II, the Budget Information Summary form (ED Form 524); Part III, the UB Program Profile form; Part III, the one-page Project Abstract form; and Part IV, the Assurances and Certifications. The page limit also does not apply to a table of contents, which you should include in the application narrative. If you include any attachments or appendices, these items will be counted as part of Part III, the application narrative, for purpose of the page-limit requirement. You must include your complete response to the selection criteria in Part III, the application narrative.
Any application addressing the competitive preference priority may include up to four additional pages for the priority. These additional pages must be used to discuss how the application meets the competitive preference priority. Any application addressing the invitational priority may include up to two additional pages for the priority. These additional pages must be used to discuss how the application meets the invitational priority. The additional pages allotted to address the competitive preference priority and the invitational priority cannot be used for or transferred to the application narrative or any other section of the application.
We will reject your application if—
• You do not apply these standards; or
• You exceed the page limit.
3.
Applications for grants under this program must be submitted electronically using the
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 program contact person listed under
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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), 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,
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
7.
a.
Applications for grants under the UB Program, CFDA number 84.047A, must be submitted electronically using the Governmentwide
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 UB Program at
Please note the following:
• When you enter the
• Applications received by
• 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
• You should review and follow the Education Submission Procedures for submitting an application through
• 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: 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
Once your application is successfully validated by
These emails do not mean that your application is without any disqualifying errors. While your application may have been successfully validated by
• 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
If you submit an application after 4:30:00 p.m., Washington, DC time, on the application deadline date, please contact the program contact person listed under
The extensions to which we refer in this section apply only to the unavailability of, or technical problems with, the
• You do not have access to the Internet; or
• You do not have the capacity to upload large documents to the
• 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: Gaby Watts, U.S. Department of Education, 400 Maryland Avenue SW., Room 5E119, Washington, DC 20202. Fax: (202) 260-7464.
Your paper application must be submitted in accordance with the mail or hand delivery instructions described in this notice.
b.
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 84.047A), 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 deadline date.
c.
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:
The Application Control Center accepts hand deliveries daily between 8:00 a.m. and 4:30 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 grant 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.
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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 assistance from the Department of Education (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).
For this competition, a panel of non-Federal reviewers will review each application in accordance with the selection criteria in 34 CFR 645.31 and the competitive preference priority. The individual scores of the reviewers will be added and the sum divided by the number of reviewers to determine the peer review score received in the review process. Additionally, in accordance with 34 CFR 645.32, the Secretary will award prior experience points to applicants that conducted a UB Program project during budget periods 2013-14, 2014-15, and 2015-16, based on their documented experience. Prior experience points, if any, will be added to the application's average reader score to determine the total score for each application.
If there are insufficient funds for all applications with the same total scores, the Secretary will choose among the tied applications so as to serve geographic
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Please note that, if the total value of your currently active grants, cooperative agreements, and procurement contracts from the Federal Government exceeds $10,000,000, the reporting requirements in 2 CFR part 200, Appendix XII, require you to report certain integrity information to FAPIIS semiannually. Please review the requirements in 2 CFR part 200, Appendix XII, if this grant plus all the other Federal funds you receive exceed $10,000,000.
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If your application is not evaluated or not selected for funding, we notify you.
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.
1. The percentage of UB students who took two years of mathematics beyond Algebra I by the 12th grade;
2. The percentage of UB students who graduated from secondary school with a regular secondary school diploma;
3. The percentage of UB students who enrolled in postsecondary education;
4. The percentage of UB students who enrolled in a program of postsecondary education by the fall term following graduation from high school and who in the first year of postsecondary education placed into college-level math and English without need for remediation;
5. The percentage of former UB students who enrolled in a program of postsecondary education and graduated on time—within four years for the bachelor's degree and within two years for the associate's degree;
6. The percentage of UB participants who enrolled in a program of postsecondary education and attained either an associate's degree within three years or a bachelor's degree within six years of enrollment;
7. The percentage of UB students expected to graduate high school in the reporting year who complete a Free Application for Federal Student Aid (FAFSA); and
8. The cost per successful participant.
Grant recipients must collect and report data on steps they have taken toward achieving these goals. Accordingly, we request that applicants include these performance measures in conceptualizing the design, implementation, and evaluation of their proposed projects.
5.
In making a continuation grant, the Secretary also considers whether the grantee is operating in compliance with the assurances in its approved application, including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).
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
Department of Education (ED), Federal Student Aid (FSA).
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 November 16, 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 Beth Grebeldinger, 202-377-4018.
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.
a. Type of Filing: Notice of Intent to File License Application and Request to Use the Traditional Licensing Process.
b. Project No.: 3777-010.
c.
d. Submitted By: Consolidated Hydro New Hampshire, LLC.
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f.
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h. Potential
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j. Consolidated Hydro New Hampshire, LLC filed its request to use the Traditional Licensing Process on August 31, 2016. Consolidated Hydro New Hampshire, LLC provided public notice of its request on August 24, 2016. In a letter issued on October 11, 2016, the Director of the Division of Hydropower Licensing approved Consolidated Hydro New Hampshire,
k. With this notice, we are initiating informal consultation with the U.S. Fish and Wildlife Service and NOAA Fisheries under section 7 of the Endangered Species Act and the joint agency regulations thereunder at 50 CFR, Part 402; and NOAA Fisheries under section 305(b) of the Magnuson-Stevens Fishery Conservation and Management Act and implementing regulations at 50 CFR 600.920. We are also initiating consultation with the New Hampshire and Maine State Historic Preservation Officers, as required by section 106, National Historic Preservation Act, and the implementing regulations of the Advisory Council on Historic Preservation at 36 CFR 800.2.
l. With this notice, we are designating Consolidated Hydro New Hampshire, LLC as the Commission's non-federal representative for carrying out informal consultation pursuant to section 7 of the Endangered Species Act and section 305(b) of the Magnuson-Stevens Fishery Conservation and Management Act; and consultation pursuant to section 106 of the National Historic Preservation Act.
m. Consolidated Hydro New Hampshire, LLC filed a Pre-Application Document (PAD; including a proposed process plan and schedule) with the Commission, pursuant to 18 CFR 5.6 of the Commission's regulations.
n. A copy of the PAD is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site (
o. The licensee states its unequivocal intent to submit an application for a new license for Project No. 3777. Pursuant to 18 CFR 16.8, 16.9, and 16.10, each application for a new license and any competing license applications must be filed with the Commission at least 24 months prior to the expiration of the existing license. All applications for license for this project must be filed by August 31, 2019.
p. Register online at
a. Project Name and Number: Grant Lake Hydroelectric Project No. 13212.
b. Date and Time of Meeting: November 1, 2016; 8:00 a.m.—12:00 p.m., AKDT.
c. Place: Teleconference.
d.
e. Purpose of Meeting: Commission Staff is hosting a Technical Meeting(s) in an effort to seek resolution of conflicts between the proposed Grant Lake Hydroelectric Project and the Iditarod National Historic Trail.
f. A stenographer will record the technical meeting, and meeting transcripts will be placed into the Commission's public record for the proceeding.
g. All local, state, and federal agencies, Indian tribes, interested non-governmental organizations, and other interested parties are invited to participate.
h. Access to the teleconference will be provided upon an emailed request to the FERC Contact in Item d above.
Take notice that on September 15, 2016, Texas Eastern Transmission, LP (Texas Eastern), 5400 Westheimer Court, Houston, TX 77056-5310, filed an application in Docket No. CP16-501-000 pursuant to Section 7(c) of the Natural Gas Act (NGA), and Part 157 of the Commission's regulations, for a certificate of public convenience and necessity to construct its Marshall County Mine Panel 17W Project. Texas Eastern states its project is designed to ensure the safe and efficient operation of Texas Eastern's existing pipeline facilities during the longwall mining activities planned by Marshall County Coal Company in the area beneath Texas Eastern's pipelines in Marshall County, West Virginia. Texas Eastern proposes to excavate, elevate, and/or replace certain sections of four different pipelines and appurtenant facilities, all as more fully set forth in the application, which is on file with the Commission and open for public inspection. The filing may also be viewed on the web at
Any questions regarding the proposed project should be directed to Lisa A. Connolly, General Manager, Rates and Certificates, Texas Eastern Transmission, LP, P.O. Box 1642, Houston, TX 77251-1642, or by calling (713) 627-4102 (telephone), or (713) 627-5947 (fax), or by email at
Pursuant to Section 157.9 of the Commission's rules, 18 CFR 157.9, within 90 days of this Notice the Commission staff will either: Complete its environmental assessment (EA) and place it into the Commission's public record (eLibrary) for this proceeding; or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the final environmental impact statement (FEIS) or EA for this proposal. The filing of the EA in the Commission's public record for this proceeding or the issuance of a Notice of Schedule for Environmental Review will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's FEIS or EA.
There are two ways to become involved in the Commission's review of this project. First, any person wishing to obtain legal status by becoming a party to the proceedings for this project should, on or before the comment date stated below, file with the Federal
However, a person does not have to intervene in order to have comments considered. The second way to participate is by filing with the Secretary of the Commission, as soon as possible, an original and two copies of comments in support of or in opposition to this project. The Commission will consider these comments in determining the appropriate action to be taken, but the filing of a comment alone will not serve to make the filer a party to the proceeding. The Commission's rules require that persons filing comments in opposition to the project provide copies of their protests only to the party or parties directly involved in the protest.
Persons who wish to comment only on the environmental review of this project should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commenters will be placed on the Commission's environmental mailing list, will receive copies of the environmental documents, and will be notified of meetings associated with the Commission's environmental review process. Environmental commenters will not be required to serve copies of filed documents on all other parties. However, the non-party commenters will not receive copies of all documents filed by other parties or issued by the Commission (except for the mailing of environmental documents issued by the Commission) and will not have the right to seek court review of the Commission's final order.
The Commission strongly encourages electronic filings of comments, protests and interventions in lieu of paper using the “eFiling” link at
Comment Date: October 20, 2016
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following exempt wholesale generator filings:
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and § 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
The Federal Deposit Insurance Corporation (FDIC), as Receiver for 10270 Williamsburg First National Bank, Kingstree, South Carolina (Receiver) has been authorized to take all actions necessary to terminate the receivership estate of Williamsburg First National 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 October 01, 2016, the Receivership Estate has been terminated, the Receiver discharged, and the Receivership Estate has ceased to exist as a legal entity.
Federal Deposit Insurance Corporation.
Pursuant to the provisions of the “Government in the Sunshine Act” (5 U.S.C. 552b), notice is hereby given that the Federal Deposit Insurance Corporation's Board of Directors will meet in open session at 10:00 a.m. on Wednesday, October 19, 2016, to consider the following matters:
Disposition of minutes of previous Board of Directors' Meetings.
Summary reports, status reports, and reports of actions taken pursuant to authority delegated by the Board of Directors.
The meeting will be held in the Board Room located on the sixth floor of the FDIC Building located at 550 17th Street NW., Washington, DC.
This Board meeting will be Webcast live via the Internet and subsequently made available on-demand approximately one week after the event. Visit
If you need any technical assistance, please visit our Video Help page at:
The FDIC will provide attendees with auxiliary aids (
Requests for further information concerning the meeting may be directed to Mr. Robert E. Feldman, Executive Secretary of the Corporation, at 202-898-7043.
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 November 1, 2016.
1.
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 October 31, 2016.
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 November 10, 2016.
1.
2.
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 November 11, 2016.
1.
Federal Retirement Thrift Investment Board.
Notice.
This notice announces the appointment of the members of the Senior Executive Service Performance Review Boards for the Federal Retirement Thrift Investment Board. The purpose of the Performance Review Boards is to make written
This notice is effective October 12, 2016.
Kelly Powell, HR Specialist, at 202-942-1681.
Title 5, U.S. Code, 4314(c)(4), requires that the appointment of Performance Review Board members be published in the
Office of Government Ethics (OGE).
Notice of request for agency and public comments.
After this first round notice and public comment period, the Office of Government Ethics (OGE) intends to submit a modified OGE Form 278e Executive Branch Personnel Public Financial Disclosure Report to the Office of Management and Budget (OMB) for review and approval of a three-year extension under the Paperwork Reduction Act of 1995.
Written comments by the public and the agencies on this proposed extension are invited and must be received on or before December 16, 2016.
Comments may be submitted to OGE, by any of the following methods:
Brandon Steele at the U.S. Office of Government Ethics; telephone: 202-482-9209; TTY: 800-877-8339; Fax: 202-482-9237;
In 2013, OGE sought and received approval for the OGE Form 278e, an electronic version of the Form 278, implemented pursuant to the e-filing system mandated under section 11(b) of the STOCK Act. The OGE Form 278e collects the same information as the OGE Form 278. It is a streamlined output report format that presents only the filer's inputs in given categories and does not report other categories not selected by the filer. In 2014, OGE sought and received approval to incorporate the OGE Form 278e into its new
OGE is proposing to make minor modifications to the OGE Form 278e to update the Privacy Act statement, improve the instructions, and make the form more user-friendly. Specifically, OGE proposes to change the titles to Part 2 and Part 5 on all versions of the form. With respect to the
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention (CDC), announces the following meeting of the aforementioned committee:
Please note that the public comment period ends at the time indicated above or following the last call for comments, whichever is earlier. Members of the public who want to comment must sign up by providing their name by mail, email, or telephone, at the addresses provided below by October 31, 2016. Each commenter will be provided up to five minutes for comment. A limited number of time slots are available and will be assigned on a first come—first served basis. Written comments will also be accepted from those unable to attend the public session.
Title XXXIII of the PHS Act established the WTC Health Program within the Department of Health and Human Services (HHS). The WTC Health Program provides medical monitoring and treatment benefits to eligible firefighters and related personnel, law enforcement officers, and rescue, recovery, and cleanup workers who responded to the September 11, 2001, terrorist attacks in New York City, at the Pentagon, and in Shanksville, Pennsylvania (responders), and to eligible persons who were present in the dust or dust cloud on September 11, 2001 or who worked, resided, or attended school, childcare, or adult daycare in the New York City disaster area (survivors). Certain specific activities of the WTC Program Administrator are reserved to the Secretary, HHS, to delegate at her discretion; other WTC Program Administrator duties not explicitly reserved to the Secretary, HHS, are assigned to the Director, NIOSH. The administration of the Advisory Committee is left to the Director of NIOSH in his role as WTC Program Administrator. CDC and NIOSH provide funding, staffing, and administrative support services for the Advisory Committee. The charter was reissued on May 12, 2015, and will expire on May 12, 2017.
The agenda will include workgroup presentations on independent peer review and the policies and procedures the WTC Health Program uses to add health conditions to the list of covered conditions.
The agenda is subject to change as priorities dictate.
To view the notice, visit
Telephone: (513) 533-8611.
In the event an individual cannot attend, written comments may be submitted. The comments should be limited to two pages and submitted through
Policy on Redaction of Committee Meeting Transcripts (Public Comment): Transcripts will be prepared and posted to
The Director, Management Analysis and Services Office, has been delegated the authority to sign
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
Study to Explore Early Development (SEED) Phase 3—New—National Center on Birth Defects and Developmental Disabilities (NCBDDD), Centers for Disease Control and Prevention (CDC).
Autism spectrum disorders (ASD) are a group of neurodevelopmental disorders characterized by qualitative impairments in social interaction and communication and stereotyped behaviors and interests. Recent systematic population surveys and routine monitoring systems in the U.S. and other countries indicate the prevalence to be 1-2%. Apart from the identification of some rare genetic conditions that are commonly associated with autism, causal mechanisms for the disorder largely remain unknown.
The Children's Health Act of 2000 mandated CDC to establish autism surveillance and research programs to address the number, incidence, and causes of autism and related developmental disabilities. Under the provisions of this act, NCBDDD funded five Centers for Autism and Developmental Disabilities Research and Epidemiology (CADDRE) through program announcements in FY2001 and FY2002; CDC's NCBDDD served as the sixth CADDRE site.
For the first funding cycle (2001-2006), each CADDRE grantee had three core objectives: To develop a protocol for a multi-site collaborative epidemiologic study focused on autism (which was eventually named the Study to Explore Early Development [SEED]); to conduct surveillance of autism and other developmental disabilities; and to conduct site-specific investigator-initiated studies on autism. In FY 2006, through a second CADDRE funding cycle, five grantees were awarded. The CADDRE activities for the second funding cycle (2006-2011) were limited to implementation of the first phase of SEED (subsequently known as SEED 1). CDC served as the sixth CADDRE SEED 1 site during this period. A second phase of SEED (SEED 2) was funded under a third funding cycle (2011-2016). Five CADDRE grantees received the awards. Again, CDC served as the sixth SEED 2 site.
A third phase of SEED (SEED 3) was funded in July 2016. Five extramural sites were funded. Together with the CDC, they will implement the SEED 3 collaborative protocol. The SEED 3 protocol for identification of study participants, recruitment, and study data collection flow will be similar to the protocols for SEED 1 and 2.
However, while all SEED phases have the same research goals and the same basic study design, data collection has been greatly streamlined and revised between SEED 1, SEED 2, and SEED 3. Many study instruments and data collection components included in the SEED 1 protocol are not included in the SEED 3 protocol; two instruments included in the SEED 3 protocol were developed subsequent to SEED 1 to capture an abbreviated version of information that had been included on some of the discontinued SEED 1 forms and to capture some additional information overlooked in the SEED 1 protocol; and instruments included in all phases of SEED underwent review and minor revision subsequent to SEED 1 to address ambiguities and difficulties experienced during SEED 1 data collection. Implementing this phase of SEED will increase the total SEED pooled sample size for investigation of high priority hypotheses. Maintaining the same basic study design and general protocol integrity will ensure that data pooling can be achieved across SEED phases.
Families will be identified from each of the 3 groups: Autism Spectrum Disorder (ASD), other developmental delay or disorder comparison group (DD), and a second comparison group of children randomly drawn from the entire study cohort population (POP). It is expected that the 6 SEED 3 study sites will have a total of 2,106 children enroll and complete the study protocol. The data collection process will take approximately 9 hours 10 minutes (ASD group); 5 hours 30 minutes (POP group); 2 hours 45 minutes (DD group) to complete, which includes (1) maternal telephone interview with questions about maternal reproductive history and
There are no costs to participants other than their time. The total estimated annual burden hours are 7,118.
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 December 16, 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, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852,
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.
Enacted on November 18, 2003, the Animal Drug User Fee Act (Pub. L. 108-130) amended the Federal Food, Drug, and Cosmetic Act and requires FDA to assess and collect user fees for certain applications, products, establishments, and sponsors. It also requires the Agency to grant a waiver from, or a reduction of those fees in certain circumstances. Thus, to implement this statutory provision of ADUFA, FDA developed a guidance entitled “Guidance for Industry: Animal Drug User Fees and Fee Waivers and Reductions.” This document provides guidance on the types of fees FDA is authorized to collect under ADUFA, and how to request waivers and reductions from FDA's animal drug user fees. Further, this guidance also describes the types of fees and fee waivers and reductions; what information FDA recommends be submitted in support of a request for a fee waiver or reduction; how to submit such a request; and FDA's process for reviewing requests.
Respondents to this collection of information are new animal drug sponsors. Requests for waivers or reductions may be submitted by a person paying any of the animal drug user fees assessed, including application fees, product fees, establishment fees, or sponsor fees.
FDA estimates the burden for this collection of information as follows:
Based on FDA's database system, from fiscal year (FY) 2014 to 2016 there were an estimated 177 sponsors subject to ADUFA. However, not all sponsors will have any submissions in a given year and some may have multiple submissions. The total number of waiver requests is based on the average number of submission types received by FDA in FY 2014 to 2016.
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 December 16, 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, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852,
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.
Under section 501 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 351), FDA has the statutory authority to issue current good manufacturing practice (cGMP) regulations for drugs, including medicated feeds. Medicated feeds are administered to animals for the prevention, cure, mitigation, or treatment of disease, or growth promotion and feed efficiency. Statutory requirements for cGMPs have been codified under part 225 (21 CFR part 225). Medicated feeds that are not manufactured in accordance with these regulations are considered adulterated under section 501(a)(2)(B) of the FD&C Act. Under part 225, a manufacturer is required to establish, maintain, and retain records for a medicated feed, including records to document procedures required during the manufacturing process to assure that proper quality control is maintained. Such records would, for example, contain information concerning receipt and inventory of drug components, batch production, laboratory assay results (
This information is needed so that FDA can monitor drug usage and possible misformulation of medicated feeds to investigate violative drug residues in products from treated animals and to investigate product defects when a drug is recalled. In addition, FDA will use the cGMP criteria in part 225 to determine whether or not the systems and procedures used by manufacturers of medicated feeds are adequate to assure that their feeds meet the requirements of the FD&C Act as to safety, and also that they meet their claimed identity, strength, quality, and purity, as required by section 501(a)(2)(B) of the FD&C Act.
A license is required when the manufacturer of a medicated feed involves the use of a drug or drugs that FDA has determined requires more control because of the need for a withdrawal period before slaughter or because of carcinogenic concerns. Conversely, a license is not required and the recordkeeping requirements are less demanding for those medicated feeds for which FDA has determined that the drugs used in their manufacture need less control. Respondents to this collection of information are commercial feed mills and mixer-feeders.
FDA estimates the burden of this collection of information as follows:
The estimate of time required for record preparation and maintenance is based on Agency communications with industry. Other information needed to finally calculate the total burden hours (
Food and Drug Administration, HHS.
Notice of public workshop.
The Food and Drug Administration (FDA), in collaboration with the Johns Hopkins University Center of Excellence in Regulatory Science and Innovation, is announcing a public workshop entitled “Substitutability of Generic Drugs: Perceptions and Reality.” The objective of this workshop is to discuss FDA and industry practices related to postmarket surveillance of generic drugs, postmarket generic drug research activities, public perceptions of generic drug quality and effectiveness, and verification of therapeutic equivalence of generic drugs. This workshop will also give stakeholders, including scientists from government, academia, and industry, patient advocacy groups, clinicians, pharmacists, and the general public an opportunity to provide their insights on future research needs in postmarket surveillance of generic drugs.
The public workshop will be held on November 18, 2016, from 8:30 a.m. to 4:30 p.m.
The public workshop will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993. Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine
Audrey Thomas, Office of Regulatory Science and Innovation, Office of the Chief Scientist, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4220, Silver Spring, MD 20993-0002, 301-796-3520,
The purpose of this public workshop is to provide an opportunity for stakeholders, including scientists from government, academia, and industry, patient advocacy groups, clinicians, pharmacists, and the general public to discuss marketed generic drugs. Generic drugs account for 88 percent of prescriptions in the United States. In light of the significant contributions of generic drugs to public health, it is important that tools are developed to monitor marketed generic drugs to ensure that they have the same safety and effectiveness as their reference listed drug. Specifically, this workshop will include presentations on: (1) Current generic drug surveillance practices at FDA and in industry, (2) public perception of generic drug quality and effectiveness, (3) generic drug substitution studies in patients, and (4) development of methods and tools to conduct postmarket surveillance of generic drugs. The workshop will include four panel sessions for interaction and discussion among the speakers and attendees.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of rare pediatric disease product applications that meet certain criteria. FDA has determined that EXONDYS 51 (eteplirsen), manufactured by Sarepta Therapeutics, meets the criteria for a priority review voucher.
Larry Bauer, Rare Diseases Program, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-4842, FAX: 301-796-9858, email:
FDA is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. Under section 529 of the FD&C Act (21 U.S.C. 360ff), which was added by FDASIA, FDA will award priority review vouchers to sponsors of rare pediatric disease product applications that meet certain criteria. FDA has determined that EXONDYS 51 (eteplirsen), manufactured by Sarepta Therapeutics, meets the criteria for a priority review voucher. EXONDYS 51 (eteplirsen) is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping.
For further information about the Rare Pediatric Disease Priority Review Voucher Program and for a link to the full text of section 529 of the FD&C Act, go to
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled “ANDA Submissions—Prior Approval Supplements Under GDUFA.” The Generic Drug User Fee Amendments of 2012 (GDUFA) enables FDA to assess user fees to fund critical and measurable improvements to FDA's generic drugs program. This guidance is intended to assist applicants preparing to submit to FDA prior approval supplements (PASs) and amendments to PASs for abbreviated new drug applications (ANDAs). It describes FDA's performance metric goals for PASs and clarifies how FDA will handle a PAS
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; or to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Tamara R. Coley, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903, 240-402-6903 or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903-0002, 240-402-7911.
FDA is announcing the availability of a guidance for industry entitled “ANDA Submissions—Prior Approval Supplements Under GDUFA.” On July 9, 2012, the President signed GDUFA (Pub. L. 112-144, Title III) into law. GDUFA is based on an agreement negotiated by FDA and representatives of the generic drug industry to address a growing number of regulatory challenges. GDUFA aims to ensure timely access to safe, high-quality, affordable generic drugs. GDUFA enables FDA to assess user fees to fund critical and measurable improvements to FDA's generic drugs program and to bring greater predictability and timeliness to the review of generic drug applications.
GDUFA requires that FDA and human generic drug manufacturers meet certain commitments. In the GDUFA Commitment Letter, FDA committed to review and act on a certain percentage of PASs within a specified period from the date of submission for receipts in fiscal years 2015 to 2017. The percentage of PASs that FDA has committed to review and act on increases with each fiscal year, and the deadlines for review depend on whether a PAS requires an inspection.
This guidance describes the performance metric goals to which FDA agreed in the Commitment Letter and clarifies how FDA will review a PAS and amendments to a PAS for an ANDA subject to the GDUFA performance metric goals. The GDUFA performance metrics described in this guidance only apply to ANDA applicants who electronically submit a PAS on or after October 1, 2014. These performance metrics do not apply to new drug applications (NDAs), biologics license applications (BLAs), supplements filed for NDAs or BLAs, or changes being effected supplements and annual report filings to NDAs, BLAs, or ANDAs.
This guidance finalizes the draft guidance that was issued under the same title on July 11, 2014 (79 FR 40112), and reflects FDA's consideration of public comments on the draft guidance. Generally, FDA revised the
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “ANDA Submissions—Prior Approval Supplements Under GDUFA.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
This guidance 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 for supplements and amendments in 21 CFR part 314 have been approved under OMB control number 0910-0001. The collection of information for manufacturer registration in 21 CFR part 207 has been approved under OMB control number 0910-0045. The collection of information for manufacturer compliance with current good manufacturing practices in 21 CFR part 211 has been approved under OMB control number 0910-0139.
Persons with access to the Internet may obtain the guidance at either
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 December 16, 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, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852,
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.
Under section 501 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), FDA has the statutory authority to issue current good manufacturing practice (cGMP) regulations for drugs, including Type A medicated articles. A Type A medicated article is a feed product containing a concentrated drug diluted with a feed carrier substance. A Type A medicated article is intended solely for use in the manufacture of another Type A medicated article or a Type B or Type C medicated feed. Medicated feeds are administered to animals for the prevention, cure, mitigation, or treatment of disease or for growth promotion and feed efficiency.
Statutory requirements for cGMPs for Type A medicated articles have been codified in part 226 (21 CFR part 226). Type A medicated articles which are not manufactured in accordance with these regulations are considered adulterated under section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B). Under part 226, a manufacturer is required to establish, maintain, and retain records for Type A medicated articles, including records to document procedures required under the manufacturing process to assure that proper quality control is maintained. Such records would, for example, contain information concerning receipt and inventory of drug components, batch production, laboratory assay results (
This information is needed so that FDA can monitor drug usage and possible misformulation of Type A medicated articles. The information could also prove useful to FDA in investigating product defects when a drug is recalled. In addition, FDA will use the cGMP criteria in part 226 to determine whether or not the systems used by manufacturers of Type A medicated articles are adequate to assure that their medicated articles meet the requirements of the FD&C Act as to safety and also meet the article's claimed identity, strength, quality, and purity, as required by section 501(a)(2)(B) of the FD&C Act. The respondents for Type A medicated articles are pharmaceutical firms that manufacture both human and veterinary drugs, those firms that produce only veterinary drugs, and commercial feed mills.
FDA estimates the burden of this collection of information as follows:
The estimate of time required for record preparation and maintenance is based on previous Agency communications with industry. Other information needed to calculate the total burden hours (
Assistant Secretary for Planning and Evaluation, HHS.
Notice of meeting.
This notice announces the public meeting of the Advisory Council on Alzheimer's Research, Care, and Services (Advisory Council). The Advisory Council on Alzheimer's Research, Care, and Services provides advice on how to prevent or reduce the burden of Alzheimer's disease and related dementias on people with the disease and their caregivers. The theme of the October meeting will be on racial and ethnic disparities in research and care for dementia. Presentations will focus on general demographics, gaps and barriers that various groups face in obtaining services, and successful interventions to reduce these gaps. Additional presentations in the afternoon will include further discussion of the 2016 Update to the National Plan, updates on progress towards a Care and Services Summit, and federal workgroup updates.
The meeting will be held on October 31st, 2016 from 9:00 am to 5:00 pm EDT.
The meeting will be held in Room 800 in the Hubert H. Humphrey Building, 200 Independence Avenue SW., Washington, DC 20201.
Rohini Khillan (202) 690-5932,
Notice of these meetings is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)(1) and (a)(2)). Topics of the Meeting: The Advisory Council will hear from a number of CMS's HCIA awardees about their projects and their results. Additional presentations in the afternoon will include an overview of the 2016 Update to the National Plan, updates on progress towards a Care and Services Summit, and federal workgroup updates.
42 U.S.C. 11225; Section 2(e)(3) of the National Alzheimer's Project Act. The panel is governed by provisions of Public Law 92-463, as amended (5 U.S.C. Appendix 2), which sets forth standards for the formation and use of advisory committees.
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.
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.
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.
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 Muscular Dystrophy Coordinating Committee (MDCC).
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.
Registration: To register, please go to:
Webcast Live: For those not able to attend in person, this meeting will be webcast at:
Any member of the public interested in presenting oral comments to the committee may notify the Contact Person listed on this notice at least 10 days in advance of the meeting. Interested individuals and representatives of organizations may submit a letter of intent, a brief description of the organization represented, and a short description of the oral presentation. Only one representative of an organization may be allowed to present oral comments and if accepted by the committee, presentations may be limited to five minutes. Both printed and electronic copies are requested for the record. In addition, any interested person may file written comments with the committee by forwarding their 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.
All visitors must go through a security check at the building entrance to receive a visitor's badge. A government issued photo ID is required. Further information can be found at the registration Web site:
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.
Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, November 03, 2016, 01:00 p.m. to November 03, 2016, 03:00 p.m., Hilton McLean Tysons Corner, 7920 Jones Branch Dr., McLean, VA, 22102 which was published in the
The meeting will be held on November 4, 2016 from 8:00 a.m. to 12:00 p.m. The meeting location remains the same. The meeting is closed to the public.
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.
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.
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 contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
U.S. Customs and Border Protection, Department of Homeland Security.
Revocation of customs brokers' licenses.
This document provides notice of the revocation of customs brokers' licenses by operation of law.
Julia D. Peterson, Branch Chief, Broker Management, Office of Trade, (202) 863-6601,
This document provides notice that, pursuant to section 641 of the Tariff Act of 1930, as amended (19 U.S.C. 1641), and section 111.30(d) of title 19 of the Code of Federal Regulations (19 CFR 111.30(d)), the following customs brokers' licenses were revoked by operation of law, without prejudice, for failure to file a triennial status report. A list of revoked customs brokers' licenses appears, below, in alphabetical order by name.
U.S. Citizenship and Immigration Services, Department of Homeland Security.
60-Day notice.
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration (USCIS) invites the general public and other Federal agencies to comment upon this proposed extension of a currently approved collection of information or new collection of information. In accordance with the Paperwork Reduction Act (PRA) of 1995, the information collection notice is published in the
Comments are encouraged and will be accepted for 60 days until December 16, 2016.
All mail submissions received must include the OMB Control Number 1615-0072 in the body of the letter, the agency name and Docket ID USCIS-2008-0077. To avoid duplicate submissions, please use only
(1)
(2)
USCIS, Office of Policy and Strategy, Regulatory Coordination Division, Samantha Deshommes, Chief, 20 Massachusetts Avenue NW., Washington, DC 20529-2140, telephone number 202-272-8377 (This is not a toll-free number. Comments are not accepted via telephone message). Please note contact information provided here is solely for questions regarding this notice. It is not for individual case status inquiries. Applicants seeking information about the status of their individual cases can check Case Status Online, available at the USCIS Web site at
You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at:
Written comments and suggestions from the public and affected agencies should address one or more of the following four points:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
(1)
(2)
(3)
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U.S. Citizenship and Immigration Services, Department of Homeland Security.
60-Day notice.
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration (USCIS) invites the general public and other Federal agencies to comment upon this proposed revision of a currently approved collection of information. In accordance with the Paperwork Reduction Act (PRA) of 1995, the information collection notice is published in the
Comments are encouraged and will be accepted for 60 days until December 16, 2016.
All mail submissions received must include the OMB Control Number 1615-0035 in the body of the letter, the agency name and Docket ID USCIS-2008-0019. To avoid duplicate submissions, please use only
(1)
(2)
USCIS, Office of Policy and Strategy, Regulatory Coordination Division, Samantha Deshommes, Chief, 20 Massachusetts Avenue NW., Washington, DC 20529-2140, telephone number 202-272-8377 (This is not a toll-free number. Comments are not accepted via telephone message). Please note contact information provided here is solely for questions regarding this notice. It is not for individual case status inquiries. Applicants seeking information about the status of their individual cases can check Case Status Online, available at the USCIS Web site at
You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at:
Written comments and suggestions from the public and affected agencies should address one or more of the following four points:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
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(2)
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U.S. Citizenship and Immigration Services, Department of Homeland Security.
60-day notice.
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) invites the general public and other Federal agencies to comment upon this proposed revision of a currently approved collection of information. In accordance with the Paperwork Reduction Act (PRA) of 1995, the information collection notice is published in the
Comments are encouraged and will be accepted for 60 days until December 16, 2016.
All mail submissions received must include the OMB Control Number 1615-0029 in the body of the letter, the agency name and Docket ID USCIS-2007-0042. To avoid duplicate submissions, please use only
(1)
(2)
USCIS, Office of Policy and Strategy, Regulatory Coordination Division, Samantha Deshommes, Chief, 20 Massachusetts Avenue NW., Washington, DC 20529-2140, Telephone number (202) 272-8377 (This is not a toll-free number. Comments are not accepted via telephone message.) Please note contact information provided here is solely for questions regarding this notice. It is not for individual case status inquiries. Applicants seeking information about the status of their individual cases can check Case Status Online, available at the USCIS Web site at
You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at:
Written comments and suggestions from the public and affected agencies should address one or more of the following four points:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
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Office of the Assistant Secretary for Policy Development and Research, HUD.
Notice.
This document designates “Difficult Development Areas” (DDAs) and “Qualified Census Tracts” (QCTs) for purposes of the Low-Income Housing Tax Credit (LIHTC) under Internal Revenue Code (IRC) Section 42 (26 U.S.C. 42). The United States Department of Housing and Urban Development (HUD) makes new DDA and QCT designations annually. Unlike the effective date of the 2016 QCTs and DDAs, which was July 1, 2016, the 2017 QCTs and DDAs are effective January 1, 2017. In order to avoid designating areas unsuitable for residential development, such as airports, HUD is implementing a minimum population requirement for metropolitan Small Difficult Development Areas (SDDAs), as described below.
For questions on how areas are designated and on geographic definitions, contact Michael K. Hollar, Senior Economist, Economic Development and Public Finance Division, Office of Policy Development and Research, Department of Housing and Urban Development, 451 Seventh Street SW., Room 8234, Washington, DC 20410-6000; telephone number 202-402-5878, or send an email to
This notice and additional information about DDAs and QCTs are available electronically on the Internet at
This notice designates DDAs for each of the 50 states, the District of Columbia, Puerto Rico, American Samoa, Guam, the Northern Mariana Islands, and the U.S. Virgin Islands. The designations of DDAs in this notice are based on modified Fiscal Year (FY) 2016 Small Area Fair Market Rents (SAFMRs), FY2016 income limits, and 2010 Census population counts, as explained below.
This notice also designates QCTs based on new income and poverty data released in the American Community Survey (ACS). HUD relies on the most recent three sets of ACS estimates to ensure that anomalous estimates, due to sampling, do not affect the QCT status of tracts.
Data from the 2010 Census on total population of metropolitan areas and nonmetropolitan areas are used in the designation of DDAs. The Office of Management and Budget (OMB) first published new metropolitan area definitions incorporating 2010 Census data in OMB Bulletin No. 13-01 on February 28, 2013. FY2016 FMRs and FY2016 income limits used to designate DDAs are based on these metropolitan statistical area (MSA) definitions, with modifications to account for substantial differences in rental housing markets (and, in some cases, median income levels) within MSAs. SAFMRs are calculated for the ZIP Code Tabulation Areas (ZCTAs), or portions of ZCTAs within the metropolitan areas defined by OMB Bulletin No. 13-01.
Data from the 2010 Census on total population of census tracts, metropolitan areas, and the nonmetropolitan parts of states are used in the designation of QCTs. The FY2016 income limits used to designate QCTs are based on these MSA definitions with modifications to account for substantial differences in rental housing markets (and in some cases median income levels) within MSAs. This QCT designation uses the OMB metropolitan area definitions published in OMB Bulletin No. 13-01 on February 28, 2013, without modification for purposes of evaluating how many census tracts can be designated under the population cap, but uses the HUD-modified definitions and their associated area median incomes for determining QCT eligibility.
Because the 2010 Decennial Census did not include questions on respondent household income, HUD uses ACS data to designate QCTs. The ACS tabulates data collected over 5 years to provide estimates of socioeconomic variables for small areas containing fewer than 20,000 persons, such as census tracts. Due to anomalies in estimates from year-to-year, HUD utilizes three sets of ACS tabulations to ensure that anomalous estimates do not affect QCT status.
The U.S. Department of the Treasury (Treasury) and its Internal Revenue Service (IRS) are authorized to interpret and enforce the provisions of the LIHTC found at IRC Section 42. The Secretary of HUD is required to designate DDAs and QCTs by IRC Section 42(d)(5)(B). In order to assist in understanding HUD's mandated designation of DDAs and QCTs for use in administering IRC Section 42, a summary of the section is provided. The following summary does not purport to bind Treasury or the IRS in any way, nor does it purport to bind HUD, since HUD has authority to interpret or administer the IRC only in instances where it receives explicit statutory delegation.
The LIHTC is a tax incentive intended to increase the availability of low-income housing. IRC Section 42 provides an income tax credit to owners of newly constructed or substantially rehabilitated low-income rental housing projects. The dollar amount of the LIHTC available for allocation by each state (credit ceiling) is limited by population. Each state is allowed a credit ceiling based on a statutory formula indicated at IRC Section 42(h)(3). States may carry forward unallocated credits derived from the credit ceiling for one year; however, to the extent such unallocated credits are not used by then, the credits go into a national pool to be redistributed to states as additional credit. State and local housing agencies allocate the state's credit ceiling among low-income housing buildings whose owners have applied for the credit. Besides IRC Section 42 credits derived from the credit ceiling, states may also provide IRC Section 42 credits to owners of buildings based on the percentage of certain building costs financed by tax-
The credits allocated to a building are based on the cost of units placed in service as low-income units under particular minimum occupancy and maximum rent criteria. In general, a building must meet one of two thresholds to be eligible for the LIHTC; either: (1) 20 percent of the units must be rent-restricted and occupied by tenants with incomes no higher than 50 percent of the Area Median Gross Income (AMGI), or (2) 40 percent of the units must be rent-restricted and occupied by tenants with incomes no higher than 60 percent of AMGI. A unit is “rent-restricted” if the gross rent, including an allowance for tenant-paid utilities, does not exceed 30 percent of the imputed income limitation (
The LIHTC reduces income tax liability dollar-for-dollar. It is taken annually for a term of 10 years and is intended to yield a present value of either: (1) 70 percent of the “qualified basis” for new construction or substantial rehabilitation expenditures that are not federally subsidized (as defined in IRC Section 42(i)(2)), or (2) 30 percent of the qualified basis for the cost of acquiring certain existing buildings or projects that are federally subsidized. The actual credit rates are determined monthly under procedures specified in IRC Section 42 and cannot be less than 9 percent for buildings that are not federally subsidized. Individuals can use the credits up to a deduction equivalent of $25,000 (the actual maximum amount of credit that an individual can claim depends on the individual's marginal tax rate). For buildings placed in service after December 31, 2007, individuals can use the credits against the alternative minimum tax. Corporations, other than S or personal service corporations, can use the credits against ordinary income tax, and, for buildings placed in service after December 31, 2007, against the alternative minimum tax. These corporations also can deduct losses from the project.
The qualified basis represents the product of the building's “applicable fraction” and its “eligible basis.” The applicable fraction is based on the number of low-income units in the building as a percentage of the total number of units, or based on the floor space of low-income units as a percentage of the total floor space of residential units in the building. The eligible basis is the adjusted basis attributable to acquisition, rehabilitation, or new construction costs (depending on the type of LIHTC involved). These costs include amounts chargeable to a capital account that are incurred prior to the end of the first taxable year in which the qualified low-income building is placed in service or, at the election of the taxpayer, the end of the succeeding taxable year. In the case of buildings located in designated DDAs or designated QCTs, or buildings designated by the state agency, eligible basis can be increased up to 130 percent from what it would otherwise be. This means that the available credits also can be increased by up to 30 percent. For example, if a 70 percent credit is available, it effectively could be increased to as much as 91 percent.
IRC Section 42 defines a DDA as an area designated by the Secretary of HUD that has high construction, land, and utility costs relative to the AMGI. All designated DDAs in metropolitan areas (taken together) may not contain more than 20 percent of the aggregate population of all metropolitan areas, and all designated areas not in metropolitan areas may not contain more than 20 percent of the aggregate population of all nonmetropolitan areas.
Similarly, IRC Section 42 defines a QCT as an area designated by the Secretary of HUD and, for the most recent year for which census data are available on household income in such tract, in which either 50 percent or more of the households have an income which is less than 60 percent of the area median gross income or which has a poverty rate of at least 25 percent. All designated QCTs in a single metropolitan area or nonmetropolitan area (taken together) may not contain more than 20 percent of the population of that metropolitan or nonmetropolitan area. Thus, unlike the restriction on DDA designations, QCTs are restricted by each individual area as opposed to the aggregate population across all metropolitan areas and nonmetropolitan areas.
IRC Section 42(d)(5)(B)(v) allows states to award an increase in basis up to 30 percent to buildings located outside of federally designated DDAs and QCTs if the increase is necessary to make the building financially feasible. This state discretion applies only to buildings allocated credits under the state housing credit ceiling and is not permitted for buildings receiving credits in connection with tax-exempt bonds. Rules for such designations shall be set forth in the LIHTC-allocating agencies' qualified allocation plans (QAPs).
In developing the list of DDAs, HUD compared housing costs with incomes. HUD used 2010 Census population for ZCTAs, and nonmetropolitan areas, and the MSA definitions, as published in OMB Bulletin No. 13-01 on February 28, 2013, with modifications, as described below. In keeping with past practice of basing the coming year's DDA designations on data from the preceding year, the basis for these comparisons is the FY2016 HUD income limits for very low-income households (very low-income limits, or VLILs), which are based on 50 percent of AMGI, and modified FMRs based on the FY2016 FMRs used for the Housing Choice Voucher (HCV) program. For metropolitan DDAs, HUD used SAFMRs based on three annual releases of ACS data, to compensate for statistical anomalies which affect estimates for some ZCTAs. For non-metropolitan DDAs, HUD used the final FY2016 FMRs as published on December 11, 2015 (80 FR 77124) and periodically through July 29, 2016 (81 FR 50003).
In formulating the FY2016 FMRs and VLILs, HUD modified the current OMB definitions of MSAs to account for differences in rents among areas within each current MSA that were in different FMR areas under definitions used in prior years. HUD formed these “HUD Metro FMR Areas” (HMFAs) in cases where one or more of the parts of newly defined MSAs that previously were in separate FMR areas. All counties added to metropolitan areas will be an HMFA with rents and incomes based on their own county data, where available. HUD no longer requires recent-mover rents to differ by five percent or more in order to form a new HMFA. All HMFAs are contained entirely within MSAs. All nonmetropolitan counties are outside of MSAs and are not broken up by HUD for purposes of setting FMRs and VLILs. (Complete details on HUD's process for determining FY2016 FMR areas and FMRs are available at
HUD's unit of analysis for designating metropolitan DDAs consists of ZCTAs, whose SAFMRs are compared to
1. For each metropolitan ZCTA and each nonmetropolitan county, HUD calculated a ratio. HUD used a modified FY2016 two-bedroom SAFMR for ZCTAs, the final FY2016 two-bedroom FMR as published for non-metropolitan counties, and the FY2016 four-person VLIL for this calculation. The modified FY2016 two-bedroom SAFMRs for ZCTAs differ from the final FY2016 SAFMRs in three ways.
First, HUD did not limit the median gross ZCTA rent to 150 percent of the median gross Core-Based Statistical Area (CBSA) rent, as in the SAFMR calculations used in HUD's demonstration project. Second, HUD adjusted median rent values in New York City to correct for the downward-bias resulting from rent control and stabilization regulations using the New York City Housing and Vacancy Survey, which is conducted by the U.S. Census Bureau.
a. The numerator of the ratio, representing the development cost of housing, was the area's FY2016 FMR, or SAFMR in metropolitan areas. In general, the FMR is based on the 40th-percentile gross rent paid by recent movers to live in a two-bedroom apartment.
b. The denominator of the ratio, representing the maximum income of eligible tenants, was the monthly LIHTC income-based rent limit, which was calculated as 1/12 of 30 percent of 120 percent of the area's VLIL (where the VLIL was rounded to the nearest $50 and not allowed to exceed 80 percent of the AMGI in areas where the VLIL is adjusted upward from its 50 percent-of-AMGI base).
2. The ratios of the FMR, or SAFMR, to the LIHTC income-based rent limit were arrayed in descending order, separately, for ZCTAs and for nonmetropolitan counties. ZCTAs with populations less than 100 were excluded in order to avoid designating areas unsuitable for residential development, such as ZCTAs containing airports.
3. The DDAs are those with the highest ratios cumulative to 20 percent of the 2010 population of all metropolitan areas and all nonmetropolitan areas. For purposes of applying this population cap, HUD excluded the population in areas designated as 2017 QCTs. Thus, an area can be designated as a QCT or DDA, but not both.
In identifying DDAs, HUD applied caps, or limitations, as noted above. The cumulative population of metropolitan DDAs cannot exceed 20 percent of the cumulative population of all metropolitan areas, and the cumulative population of nonmetropolitan DDAs cannot exceed 20 percent of the cumulative population of all nonmetropolitan areas.
In applying these caps, HUD established procedures to deal with how to treat small overruns of the caps. The remainder of this section explains those procedures. In general, HUD stops selecting areas when it is impossible to choose another area without exceeding the applicable cap. The only exceptions to this policy are when the next eligible excluded area contains either a large absolute population or a large percentage of the total population, or the next excluded area's ranking ratio, as described above, was identical (to four decimal places) to the last area selected, and its inclusion resulted in only a minor overrun of the cap. Thus, for both the designated metropolitan and nonmetropolitan DDAs, there may be minimal overruns of the cap. HUD believes the designation of additional areas in the above examples of minimal overruns is consistent with the intent of the IRC. As long as the apparent excess is small due to measurement errors, some latitude is justifiable, because it is impossible to determine whether the 20 percent cap has been exceeded. Despite the care and effort involved in a Decennial Census, the Census Bureau and all users of the data recognize that the population counts for a given area and for the entire country are not precise. Therefore, the extent of the measurement error is unknown. There can be errors in both the numerator and denominator of the ratio of populations used in applying a 20 percent cap. In circumstances where a strict application of a 20 percent cap results in an anomalous situation, recognition of the unavoidable imprecision in the census data justifies accepting small variances above the 20 percent limit.
In developing this list of QCTs, HUD used 2010 Census 100-percent count data on total population, total households, and population in households; the median household income and poverty rate as estimated in the 2008-2012, 2009-2013 and 2010-2014, ACS tabulations; the FY2016 Very Low-Income Limits (VLILs) computed at the HUD Metropolitan FMR Area (HMFA) level
HUD uses the HMFA-level AMGIs to determine QCT eligibility because the statute, specifically IRC Section 42(d)(5)(B)(iv)(II), refers to the same section of the IRC that defines income for purposes of tenant eligibility and unit maximum rent, specifically IRC Section 42(g)(4). By rule, the IRS sets these income limits according to HUD's VLILs, which, starting in FY2006 and thereafter, are established at the HMFA level. Similarly, HUD uses the entire MSA to determine how many eligible tracts can be designated under the 20 percent population cap as required by the statute (IRC Section
1. To be eligible to be designated a QCT, a census tract must have 50 percent of its households with incomes below 60 percent of the AMGI or have a poverty rate of 25 percent or more. Due to potential statistical anomalies in the ACS 5-year estimates, one of these conditions must be met in at least 2 of the 3 evaluation years for a tract to be considered eligible for QCT designation. HUD calculates 60 percent of AMGI by multiplying by a factor of 1.2 the HMFA or nonmetropolitan county FY2016 VLIL adjusted for inflation to match the ACS estimates. For example, the FY2016 VLILs were adjusted for inflation to 2013 dollars to compare with the median income estimate from the 2009-2013 ACS estimates. The inflation-adjusted 2013 VLIL was then deflated to 2012 for comparison with the 2008-2012 ACS estimates and inflated to 2014 to compare with the 2010-2014 ACS estimates.
2. For each census tract, whether or not 50 percent of households have incomes below the 60 percent income standard (income criterion) was determined by: (a) Calculating the average household size of the census tract, (b) applying the income standard after adjusting it to match the average household size, and (c) comparing the average-household-size-adjusted income standard to the median household income for the tract reported in each of the three years of ACS tabulations (2008-2012, 2009-2013 and 2010-2014). HUD did not consider estimates of median household income to be statistically reliable unless the margin of error was less than half of the estimate (or a Margin of Error Ratio, MoER, of 50 percent or less). If at least two of the three estimates were not statistically reliable by this measure, HUD determined the tract to be ineligible under the income criterion due to lack of consistently reliable median income statistics across the three ACS tabulations. Since 50 percent of households in a tract have incomes above and below the tract median household income, if the tract median household income is less than the average-household-size-adjusted income standard for the tract, then more than 50 percent of households have incomes below the standard.
3. For each census tract, the poverty rate was determined in each of the three releases of ACS tabulations (2008-2012, 2009-2013 and 2010-2014) by dividing the population with incomes below the poverty line by the population for whom poverty status has been determined. As with the evaluation of tracts under the income criterion, HUD uses a higher data quality standard for evaluating ACS poverty rate data in designating the 2017 QCTs than HUD used in previous designations. HUD did not consider estimates of the poverty rate to be statistically reliable unless both the population for whom poverty status has been determined and the number of persons below poverty had MoERs of less than 50 percent of the respective estimates. In prior designations of QCTs, HUD accepted ACS data with MoERs of up to, but not including 100 percent. If at least two of the three poverty rate estimates were not statistically reliable, HUD determined the tract to be ineligible under the poverty rate criterion due to lack of reliable poverty statistics across the ACS tabulations.
4. QCTs are those census tracts in which 50 percent or more of the households meet the income criterion in at least two of the three years evaluated, or 25 percent or more of the population is in poverty in at least two of the three years evaluated, such that the population of all census tracts that satisfy either one or both of these criteria does not exceed 20 percent of the total population of the respective area.
5. In areas where more than 20 percent of the population resides in eligible census tracts, census tracts are designated as QCTs in accordance with the following procedure:
a. The income and poverty criteria are each averaged over the three ACS tabulations (2008-2012, 2009-2013 and 2010-2014). Statistically reliable values that did not exceed the income and poverty rate thresholds were included in the average.
b. Eligible tracts are placed in one of two groups based on the averaged values of the income and poverty criteria. The first group includes tracts that satisfy both the income and poverty criteria for QCTs for at least two of the three evaluation years. The second group includes tracts that satisfy either the income criterion or the poverty criterion in at least two of three years, but not both. A tract must qualify by at least one of the criteria in at least two of the three evaluation years to be eligible, although it does not need to be the same criterion.
c. Tracts in the first group are ranked from highest to lowest by the average of the ratios of the tract average-household-size-adjusted income limit to the median household income. Then, tracts in the first group are ranked from highest to lowest by the average of the poverty rates. The two ranks are averaged to yield a combined rank. The tracts are then sorted on the combined rank, with the census tract with the highest combined rank being placed at the top of the sorted list. In the event of a tie, more populous tracts are ranked above less populous ones.
d. Tracts in the second group are ranked from highest to lowest by the average of the ratios of the tract average-household-size-adjusted income limit to the median household income. Then, tracts in the second group are ranked from highest to lowest by the average of the poverty rates. The two ranks are then averaged to yield a combined rank. The tracts are then sorted on the combined rank, with the census tract with the highest combined rank being placed at the top of the sorted list. In the event of a tie, more populous tracts are ranked above less populous ones.
e. The ranked first group is stacked on top of the ranked second group to yield a single, concatenated, ranked list of eligible census tracts.
f. Working down the single, concatenated, ranked list of eligible tracts, census tracts are identified as designated until the designation of an additional tract would cause the 20 percent limit to be exceeded. If a census tract is not designated because doing so would raise the percentage above 20 percent, subsequent census tracts are then considered to determine if one or more census tract(s) with smaller population(s) could be designated without exceeding the 20 percent limit.
As stated in OMB Bulletin 13-01, defining metropolitan areas:
“OMB establishes and maintains the delineations of Metropolitan Statistical Areas, . . . solely for statistical purposes. . . . OMB does not take into account or attempt to anticipate any non-statistical uses that may be made of the delineations, [.] In cases where . . . an agency elects to use the Metropolitan . . . Area definitions in nonstatistical programs, it is the sponsoring agency's responsibility to ensure that the delineations are appropriate for such use. An agency using the statistical delineations in a nonstatistical program may modify the delineations, but only for the purposes of that program. In such cases, any modifications should be clearly identified as delineations from the OMB statistical area delineations in order to avoid confusion with OMB's official definitions of Metropolitan . . . Statistical Areas.”
Following OMB guidance, the estimation procedure for the FMRs and income limits incorporates the current OMB definitions of metropolitan areas based on the CBSA standards, as
In the New England states (Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont), HMFAs are defined according to county subdivisions or minor civil divisions (MCDs), rather than county boundaries. However, since no part of an HMFA is outside an OMB-defined, county-based MSA, all New England nonmetropolitan counties are kept intact for purposes of designating Nonmetropolitan DDAs.
DDAs are designated annually as updated income and FMR data are made public. QCTs are designated annually as new income and poverty rate data are released.
The 2017 lists of QCTs and DDAs are effective:
(1) For allocations of credit after December 31, 2016; or
(2) for purposes of IRC Section 42(h)(4), if the bonds are issued and the building is placed in service after December 31, 2016.
If an area is not on a subsequent list of QCTs or DDAs, the 2017 lists are effective for the area if:
(1) The allocation of credit to an applicant is made no later than the end of the 730-day period after the applicant submits a complete application to the LIHTC-allocating agency, and the submission is made before the effective date of the subsequent lists; or
(2) for purposes of IRC Section 42(h)(4), if:
(a) The bonds are issued or the building is placed in service no later than the end of the 730-day period after the applicant submits a complete application to the bond-issuing agency, and
(b) the submission is made before the effective date of the subsequent lists, provided that both the issuance of the bonds and the placement in service of the building occur after the application is submitted.
An application is deemed to be submitted on the date it is filed if the application is determined to be complete by the credit-allocating or bond-issuing agency. A “complete application” means that no more than
In the case of a “multiphase project,” the DDA or QCT status of the site of the project that applies for all phases of the project is that which applied when the project received its first allocation of LIHTC. For purposes of IRC Section 42(h)(4), the DDA or QCT status of the site of the project that applies for all phases of the project is that which applied when the first of the following occurred: (a) The building(s) in the first phase were placed in service, or (b) the bonds were issued.
For purposes of this notice, a “multiphase project” is defined as a set of buildings to be constructed or rehabilitated under the rules of the LIHTC and meeting the following criteria:
(1) The multiphase composition of the project (
(2) The aggregate amount of LIHTC applied for on behalf of, or that would eventually be allocated to, the buildings on the site exceeds the one-year limitation on credits per applicant, as defined in the Qualified Allocation Plan (QAP) of the LIHTC-allocating agency, or the annual per-capita credit authority of the LIHTC allocating agency, and is the reason the applicant must request multiple allocations over 2 or more years; and
(3) All applications for LIHTC for buildings on the site are made in immediately consecutive years.
Members of the public are hereby reminded that the Secretary of Housing and Urban Development, or the Secretary's designee, has legal authority to designate DDAs and QCTs, by publishing lists of geographic entities as defined by, in the case of DDAs, the Census Bureau, the several states and the governments of the insular areas of the United States and, in the case of QCTs, by the Census Bureau; and to establish the effective dates of such lists. The Secretary of the Treasury, through the IRS thereof, has sole legal authority to interpret, and to determine and enforce compliance with the IRC and associated regulations, including
For the convenience of readers of this notice, interpretive examples are provided below to illustrate the consequences of the effective date in areas that gain or lose QCT or DDA status. The examples covering DDAs are equally applicable to QCT designations.
This notice involves the establishment of fiscal requirements or procedures that are related to rate and cost determinations and do not constitute a development decision affecting the physical condition of specific project areas or building sites. Accordingly, under 40 CFR 1508.4 of the regulations of the Council on Environmental Quality and 24 CFR 50.19(c)(6) of HUD's regulations, this notice is categorically excluded from environmental review under the National Environmental Policy Act of 1969 (42 U.S.C. 4321).
Executive Order 13132 (entitled “Federalism”) prohibits an agency from publishing any policy document that has federalism implications if the document either imposes substantial direct compliance costs on state and local governments and is not required by statute, or the document preempts state law, unless the agency meets the consultation and funding requirements of section 6 of the executive order. This notice merely designates DDAs and QCTs as required under IRC Section 42, as amended, for the use by political subdivisions of the states in allocating the LIHTC. This notice also details the technical methods used in making such designations. As a result, this notice is not subject to review under the order.
Secretary's Indian Water Rights Office, Office of the Secretary, Department of the Interior.
Notice and request for comments.
In compliance with the Paperwork Reduction Act of 1995, the Secretary's Indian Water Rights Office, Department of the Interior announces the proposed creation of a new public information collection and seeks public comments on the provisions thereof.
Consideration will be given to all comments received by
Direct all written comments to Rachel Brown, U.S. Department of the Interior, 1849 C Street NW., MS 7069-MIB, Washington, DC 20240, fax 202-208-6970, or by electronic mail to
To request a copy of the information collection request, any explanatory information and related forms, see the contact information provided in the
This notice is for a new information collection.
The Office of Management and Budget (OMB) regulations at 5 CFR part 1320, which implement the Paperwork Reduction Act of 1995, 44 U.S.C. 3501
The Secretary's Indian Water Rights Office (SIWRO) is tasked with overseeing and coordinating the Federal Government's Indian water rights settlement program and is undertaking a study on the economic outcomes associated with Indian water rights settlements (IWRS). The purpose of the study is to identify and track social and economic changes that occur as a result
(1)
(2) Annual reporting and recordkeeping burden:
(3) Description of the need and use of the information. Indian reserved water rights are vested property rights for which the United States has a trust responsibility, with the United States holding legal title to such water in trust for the benefit of Indian tribes. Federal policy supports the resolution of disputes regarding Indian water rights through negotiated settlements. Settlement of Indian water rights disputes breaks down barriers and helps create conditions that improve water resources management by providing certainty as to the rights of all water users who are parties to the disputes. At a time of increasing competition for Federal funds, it is important to quantify and describe the economic impacts and net benefits of the implementation of enacted Indian water rights settlements.
The Departments invite comments on:
(a) Whether the collection of information is necessary for the proper performance of the functions of the agencies, including whether the information will have practical utility;
(b) The accuracy of the agencies' estimate of the burden of the collection of information and the validity of the methodology and assumptions used;
(c) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(d) Ways to minimize the burden of the collection of information on respondents, including through the use of appropriate automated, electronic, mechanical, or other collection techniques or other forms of information technology.
“Burden” means the total time, effort, and financial resources expended by persons to generate, maintain, retain, disclose, or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install, and use technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, and to complete and review the collection of information; and to transmit or otherwise disclose the information.
It is our policy to make all comments available to the public for review. Before including Personally Identifiable Information (PII), such as your address, phone number, email address, or other personal information in your comment(s), you should be aware that your entire comment (including PII) may be made available to the public at any time. While you may ask us in your comment to withhold PII from public view, we cannot guarantee that we will be able to do so. If you wish to view any comments received, you may do so by scheduling an appointment with the contact provided in the
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid Office of Management and Budget control number.
Bureau of Land Management, Interior.
Notice.
The Montana Department of Natural Resources and Conservation (State) has filed a petition for classification and application to obtain public lands and mineral estate in lieu of lands to which the State was entitled, but did not receive under its Statehood Act. The State did not receive title because the lands had previously been appropriated. Under Section 7 of the Taylor Grazing Act of 1934, the Bureau of Land Management (BLM) proposes to classify sufficient acreage of public lands/minerals in Montana for title transfer to the State to satisfy this obligation to the State. Of the area proposed for State Indemnity Selection, 10,560 acres are designated as greater sage-grouse General Habitat Management area.
Comments must be received by December 16, 2016.
The BLM will not consider or include comments received after the close of the comment period or comments delivered to an address other than the one listed below. Persons asserting a claim to or interest in the lands or mineral estate described in this notice will find the requirements for filing such claims in the
The public may submit written comments by mail or hand delivery to: State Director, Montana/Dakotas State Office, Bureau of Land Management, Department of the Interior, 5001 Southgate Drive, Billings, MT 59101.
Jim Ledger, Realty Specialist, Branch of Lands, Realty, and Renewable Energy; telephone (406) 329-3733; email
Sections 2275 and 2276 of the Revised Statutes,
Section 7 of the Taylor Grazing Act of June 8, 1934, requires that such public lands and/or minerals identified for proposed transfer out of Federal ownership must first be classified. The BLM proposes to classify these lands/minerals under Section 7 of the Taylor Grazing Act of June 8, 1934 (48 Stat. 1272, as amended), 43 U.S.C. 315(f). For a period until December 16, 2016 all persons who wish to submit comments, suggestions, or objections in connection with this classification may present their views by the means shown under the
Any adverse comments will be evaluated by the BLM Montana/Dakotas State Director, who will issue a notice of determination to proceed with, modify, or cancel the proposed classification. In the absence of any action by the State Director, this classification action will be issued as the initial classification decision of the State Director.
Comments, including names and street addresses of respondents and records relating to this proposed classification, will be available for public review at the BLM Montana/Dakotas State Office at the address cited in the
The BLM intends to schedule public meetings during the 60-day comment period. The BLM will announce the public meetings 15 days prior to the meetings in newspapers of general circulation in the vicinity of the selected lands and via the Web site at
The lands/minerals included within this proposed classification are in Custer, Fallon, Prairie, Richland, and Yellowstone Counties, Montana, and are described as follows:
The areas described aggregate 13,495.74 acres.
The State expressed interest in the selection of lands withdrawn to the Bureau of Reclamation (BOR). The BOR has filed with the BLM a Notice of Intent to Relinquish, dated January 26, 2016, requesting partial revocation of an Order dated, October 15, 1904, and full revocation of an Order dated March 30, 1950. Should the revocations be approved, the following lands in Chouteau and Hill Counties are proposed for classification by this notice as available for State indemnity selection:
The areas described aggregate 2,560 acres.
The BLM will examine all lands described above for evidence of valid existing rights and any constraints that would prevent transfer. Right-of-way (ROW) holders will be afforded the opportunity to modify their existing authorization per 43 CFR 2807.15. Oil and gas, geothermal, or other leases issued under the authority of the Mineral Leasing Act of 1920 (30 U.S.C. 181
Current holders of BLM grazing use authorizations were sent the required 2-year notice in January 2016 as outlined in 43 CFR 4110.4-2(b). Upon expiration of the 2-year period or receipt of a waiver from the current holder, such authorizations will be terminated upon transfer of any of the land described above to the State of Montana. State of Montana procedures provide that upon Land Board Approval, the State will offer 10-year grazing leases to the current holders of BLM permits/leases on any transferred lands.
For a period until December 1, 2016 persons asserting a claim to, or interest in, the above-described lands or mineral estate, other than holders of leases, permits, or ROWs, may file such claim with the BLM Montana/Dakotas State Director at the address cited in the
Under 43 CFR 2091.3-1(b) the lands described above were segregated from entry upon application by the State from all forms of disposal under the public land laws, including the mining laws, except for the form of land disposal specified in this notice of classification.
The segregative effect of this classification will terminate in one of the following ways:
(1) Classification of the lands on or before the expiration of the 2-year period from the date of application;
(2) Publication of a notice of termination of the classification in the
(3) An Act of Congress; or
(4) Expiration of the 2-year period from the date of application unless notice of extension for the proposed classification for an additional period, not exceeding 2 years, is given.
43 CFR parts 2091, 2400, and 2621.
Office of Surface Mining Reclamation and Enforcement, Interior.
Notice.
We, the Office of Surface Mining Reclamation and Enforcement, are notifying the public that we intend to grant funds to eligible applicants for purposes authorized under the Abandoned Mine Land (AML) Reclamation Program. Additionally, we are notifying the public that we intend to grant funds to eligible applicants for regulating coal mining within their jurisdictional borders under the Regulatory Program. We will award these grants during fiscal year 2017.
A single point of contact or other interested state or local entities may submit written comments regarding AML and regulatory funding by December 15, 2016.
You may submit comments by any of the following methods:
•
•
Mr. Jay Bautista, Office of Surface Mining Reclamation and Enforcement, 1951 Constitution Ave. NW., MS 130-SIB, Washington, DC 20240; Telephone (202) 208-7411.
We are notifying the public that we intend to grant funds to eligible applicants for purposes authorized under the AML Reclamation Program. Additionally, we are notifying the public that we intend to grant funds to eligible applicants for regulating coal mining within their jurisdictional borders under the Regulatory Program. We will award these grants during fiscal year 2017. Eligible applicants are those states and Indian tribes with a regulatory program, regulatory development program, and/or reclamation plan approved under the Surface Mining Control and Reclamation Act of 1977 (SMCRA), as amended, 30 U.S.C. 1201
SMCRA established the Abandoned Mine Reclamation Fund to receive the AML fees used to finance reclamation of AML coal mine sites. Title IV of SMCRA authorizes the Office of Surface Mining Reclamation and Enforcement to provide grants to eligible states and Indian tribes that are funded from permanent (mandatory) appropriations. Recipients use these funds to reclaim the highest priority AML coal mine sites that were left abandoned prior to the enactment of SMCRA in 1977, eligible non-coal sites, projects that address the impacts of mineral development, and non-reclamation projects.
Title VII of SMCRA authorizes the Office of Surface Mining Reclamation and Enforcement to provide grants to states and Indian tribes to develop, administer, and enforce state regulatory programs addressing the disturbance from coal mining operations. Title V and Title VII authorize states to develop regulatory programs pursuant to SMCRA, and upon approval of regulatory programs, to assume regulatory primacy and act as the regulatory authority, and to administer and enforce their respective approved SMCRA regulatory programs. Our regulations at Title 30 of the Code of Federal Regulations, Chapter VII implement the provisions of SMCRA.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has instituted a formal enforcement proceeding relating to the December 1, 2015 cease and desist orders issued in the above-referenced investigation.
Ronald A. Traud, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-3427. Copies of non-confidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2000. General information concerning the Commission may also be obtained by accessing its Internet server (
The Commission instituted the original investigation on July 14, 2014 based on a complaint filed by Navico, Inc. of Tulsa, Oklahoma, and Navico Holding AS, of Egersund, Norway (collectively, “Navico”). 79 FR 40778 (July 14, 2014). The complaint alleged violations of Section 337 of the Tariff Act of 1930, as amended, 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 marine sonar imaging devices, including downscan and sidescan devices, products containing the same, and components thereof by reason of infringement of certain claims of U.S. Patent Nos. 8,305,840 (“the '840 patent”), 8,300,499 (“the '499 patent”), and 8,605,550 (“the '550 patent”).
On December 1, 2015, the Commission found a violation of Section 337 based on infringement of claims 1, 5, 7, 9, 11, 16-19, 23, 32, 39-41, 63, and 70-72 of the '840 patent and infringement of claims 32 and 44 of the '550 patent, but found no violation with respect to the '499 patent. 80 FR 76040-41 (Dec. 7, 2015). The Commission issued a limited exclusion order prohibiting Garmin International, Garmin USA, and Garmin Asia from importing certain marine sonar imaging devices, including downscan and sidescan devices, products containing the same, and components thereof that infringe certain claims of the '840 and '550 patent.
On August 30, 2016, Navico filed a complaint requesting that the Commission institute a formal enforcement proceeding under Commission Rule 210.75(b) to investigate violations of the December 1, 2015 cease and desist orders by Garmin International and Garmin USA (collectively, “Garmin”). Having examined the complaint and the supporting documents, the Commission has determined to institute a formal enforcement proceeding to determine whether Garmin is in violation of the December 1, 2015 cease and desist orders issued in the original investigation and what, if any, enforcement measures are appropriate. The following entities are named as parties to the formal enforcement proceeding: (1) Complainant Navico; (2) respondents Garmin International and Garmin USA; and (3) OUII.
The authority for the Commission's determination is contained in Section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in section 210.75 of the Commission's Rules of Practice and Procedure (19 CFR 210.75).
By order of the Commission.
United States International Trade Commission.
Notice of ninth update report, scheduling of public hearing, opportunity to file written submissions.
Following receipt of a letter dated September 13, 2016 from the United States Trade Representative (USTR), the U.S. International Trade Commission (Commission) has announced its schedule for preparing the ninth update report in investigation No. 332-325,
January 26, 2017: Deadline for filing requests to appear at the public hearing.
January 30, 2017: Deadline for filing pre-hearing briefs and statements.
February 9, 2017: Public hearing.
February 16, 2017: Deadline for filing post-hearing briefs and statements.
March 1, 2017: Deadline for filing all other written submissions.
September 13, 2017: Transmittal of Commission report to USTR.
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 William Deese (
The Commission instituted this investigation under section 332(g) of the Tariff Act of 1930 (19 U.S.C. 1332(g)) following receipt of an initial request from the USTR dated May 15, 1992. The request asked that the Commission assess the quantitative economic effects of significant U.S. import restraints on the U.S. economy and prepare periodic update reports after the initial report. The Commission published a notice of institution of the investigation in the
In this ninth update, as requested by the USTR in a letter dated September 13, 2016, the Commission will provide, in addition to the quantitative effects analysis similar to that included in prior reports, an assessment of how significant U.S. import restraints affect households with different incomes and
The report will, to the extent practicable, describe the cumulative effects of tariffs and customs and border procedures on goods traded in global supply chains. It will include the effect on services to the extent that they depend on goods traded across borders. The report will also provide an overview of recent literature that discusses the effect of these costs along the supply chain. Finally, the report will include case studies in relevant industries that examine supply chain inefficiencies stemming from customs and border procedures abroad.
As in previous reports in this series, the ninth update will continue to assess the economic effects of significant import restraints on U.S. consumers and firms, the income and employment of U.S. workers, and the net economic welfare of the United States. This assessment will use the Commission's computable general equilibrium model of the U.S. economy. However, as per earlier instructions from the USTR, the Commission will not assess import restraints resulting from antidumping or countervailing duty investigations, section 337 and 406 investigations, or section 301 actions.
A public hearing in connection with this investigation will be held at the United States International Trade Commission Building, 500 E Street SW., Washington, DC, beginning at 9:30 a.m. on February 9, 2017. Requests to appear at the hearing should be filed with the Secretary no later than 5:15 p.m., January 26, 2016, in accordance with the requirements in the “Submissions” section below. All pre-hearing briefs and statements should be filed not later than 5:15 p.m., January 30, 2017; and all post-hearing briefs and statements addressing matters raised at the hearing should be filed not later than 5:15 p.m., February 16, 2017. In the event that, as of the close of business on January 26, 2017, no witnesses are scheduled to appear at the hearing, the hearing will be canceled. Any person interested in attending the hearing as an observer or nonparticipant may call the Secretary to the Commission (202-205-2000) after January 26, 2017, for information concerning whether the hearing will be held.
Any submissions that contain confidential business information must also conform to the requirements of section 201.6 of the Commission's Rules of Practice and Procedure (19 CFR 201.6). Section 201.6 of the rules requires that the cover of the document and the individual pages be clearly marked as to whether they are the “confidential” or “non-confidential” version, and that the confidential business information is clearly identified by means of brackets. All written submissions, except for confidential business information, will be made available for inspection by interested parties.
The Commission will not include any confidential business information in the report that it sends to the USTR 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.
The Commission intends to publish summaries of the positions of interested persons. Persons wishing to have a summary of their position included in the report should include a summary with their written submission. The summary may not exceed 500 words, should be in MS Word format or a format that can be easily converted to MS Word, and should not include any confidential business information. The summary will be published as provided if it meets these requirements and is germane to the subject matter of the investigation. The Commission will identify the name of the organization furnishing the summary and will include a link to the Commission's Electronic Document Information System (EDIS) where the full written submission can be found.
By order of the Commission.
United States International Trade Commission.
Notice.
The Commission hereby gives notice that it will proceed with full reviews pursuant to the Tariff Act of 1930 to determine whether revocation of the countervailing duty order on imports of stainless steel sheet and strip from Korea and the antidumping duty orders on imports of stainless steel sheet and strip from Japan, Korea, and Taiwan would be likely to lead to continuation or recurrence of material injury within a reasonably foreseeable time. A schedule for the reviews will be established and announced at a later date.
Keysha Martinez (202-205-2136), Office of Investigations, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436. Hearing-impaired persons can obtain information on this matter by contacting
On October 4, 2016, the Commission determined that it should proceed to full reviews in the subject five-year reviews pursuant to section 751(c) of the Tariff Act of 1930 (19 U.S.C. 1675(c)). With respect to the reviews on subject merchandise from Korea, the Commission found that both the domestic and respondent interested party group responses to its notice of institution (81 FR 43238, July 1, 2016) were adequate. With respect to the reviews on subject merchandise from Japan and Taiwan, the Commission found that the domestic interested party group response was adequate and the respondent interested party group response was inadequate, but that circumstances warranted full reviews.
These reviews are being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to section 207.62 of the Commission's rules.
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has determined to hold a public hearing on the issues of laches, contributory infringement, and the public interest.
The public hearing is scheduled for Thursday, November 17, 2016, beginning at 10 a.m. See the Notice of Appearance section in
The Commission will hold the public hearing in the Commission's Main Hearing Room (Room 101), 500 E Street SW., Washington, DC 20436.
Copies of non-confidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone 202-205-2000. General information concerning the Commission may also be obtained by accessing its Internet server (
Panyin A. Hughes, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone 202-205-3042.
The Commission instituted this investigation on March 30, 2015, based on a complaint filed by BASF Corporation of Florham Park, New Jersey and UChicago Argonne LLC of Lemont, Illinois (collectively, “Complainants”). 80 FR 16696 (Mar. 30, 2015). The complaint alleges violations of section 337 of the Tariff Act of 1930, as amended (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 lithium metal oxide cathode materials, lithium-ion batteries for power tool products containing same, and power tool products with lithium-ion batteries containing same by reason of infringement of one or more of claims 1-4, 7, 13, and 14 of U.S. Patent No. 6,677,082 (“the '082 patent”) and claims 1-4, 8, 9, and 17 of U.S. Patent No. 6,680,143 (“the '143 patent”).
On November 5, 2015, the ALJ granted a joint motion by Complainants and Makita to terminate the investigation as to Makita based upon settlement.
On December 1, 2015, the ALJ granted an unopposed motion by Complainants to terminate the investigation as to claim 8 of the '082 patent.
On February 29, 2016, the ALJ issued his final ID, finding a violation of section 337 by Umicore in connection with claims 1-4, 7, 13, and 14 of the '082 patent and claims 1-4, 8, 9, and 17 of the '143 patent. Specifically, the ID found that the Commission has subject matter jurisdiction,
On March 14, 2016, Umicore filed a petition for review of the ID. Also on March 14, 2016, the Commission investigative attorney (“IA”) petitioned for review of the ID's finding that a laches defense fails as a matter of law in section 337 investigations. Further on March 14, 2016, Complainants filed a contingent petition for review of the ID. That same day, Umicore filed a motion under Commission Rules 210.15(a)(2) and 210.38(a) (19 CFR 210.15(a)(2) and 210.38(a)), for the Commission to reopen the record in this investigation to admit a paper published on October 29, 2015, and a press release issued that day (collectively, “documents”). On March 22, 2016, the parties filed responses to the petitions for review. On March 24, 2016, Complainants and the IA filed oppositions to Umicore's motion to reopen the record. On April 5, 2016, Umicore moved for leave to file a reply. The Commission has determined to grant Umicore's motion for leave to file a reply.
On April 8, 2016, 3M Corporation (“3M”) filed a motion to intervene under Commission Rule 210.19. 3M requests that the Commission grant it “with full participation rights in this Investigation in order to protect its significant interests in the accused materials.”
On May 11, 2016, the Commission determined to review the final ID in part. 81 FR 30548-50 (May 17, 2016). Specifically, the Commission determined to review (1) the ID's contributory and induced infringement findings; (2) the ID's domestic industry findings under 19 U.S.C. 1337(a)(3)(C); and (3) the ID's findings on laches. The Commission determined to deny Umicore's motion to reopen the record to admit certain documents.
The Commission requested the parties to brief their positions on the issues under review with reference to the applicable law and the evidentiary record, and posed specific briefing questions. On May 23, 2016, the parties filed submissions to the Commission's questions. On June 3, 2016, the parties filed responses to the initial submissions.
Pursuant to Commission rule 210.45 (19 CFR 210.45), Umicore's request for a Commission hearing was granted. Details of the hearing are set forth below.
The second panel will be limited to public interest issues. In particular, the Commission will hear presentations concerning the appropriate remedy (if any) and the effect that such remedy would have upon the public interest. Government agencies, public-interest groups, and interested members of the public may make oral presentations on the issues of remedy and the public interest. Parties to the investigation are expected to present any public interest comments during the first panel and will not participate in the second panel. The panel will be conducted in like manner as the first panel,
After the conclusion of the hearing, no additional written submissions or arguments will be permitted.
The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).
By order of the Commission.
Bureau of Alcohol, Tobacco, Firearms and Explosives, Department of Justice.
30-Day notice.
The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), will submit 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 proposed information collection was previously published in the
Comments are encouraged and will be accepted for an additional 30 days until November 16, 2016.
If you have additional comments, particularly with respect to the estimated public burden or associated response time, have suggestions, need a copy of the proposed information collection instrument with instructions, or desire any other additional information, please contact Rinell
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
• 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;
• Evaluate whether and if so how the quality, utility, and clarity of the information to be collected can be enhanced; 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,
Overview of this information collection:
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If additional information is required contact: Jerri Murray, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE., Room 3E-405B, Washington, DC 20530.
Federal Bureau of Investigation, Department of Justice.
30-Day notice.
The Department of Justice (DOJ), Federal Bureau of Investigation (FBI), Criminal Justice Information Services (CJIS) Division, will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection is published to obtain comments from the public and affected agencies. This proposed information collection was previously published in the
Comments are encouraged and will be accepted for an additional 30 days until November 16, 2016.
If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Gerry Lynn Brovey, Supervisory Information Liaison Specialist, FBI, CJIS, Resources Management Section, Administrative Unit, Module C-2, 1000 Custer Hollow Road, Clarksburg, West Virginia, 26306 (facsimile: 304-625-5093). Written comments and/or suggestions can also be directed to the Office of Management and Budget, Office of Information and Regulatory Affairs, Attention Department of Justice Desk Officer, Washington, DC 20530 or sent to
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
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(2)
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Criminal Division, Department of Justice.
30-Day notice.
The Department of Justice (DOJ), Criminal Division, United States Victims of State Sponsored Terrorism Fund, will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. This proposed information collection was previous published in the
Comments are encouraged and will be accepted for an additional days until November 16, 2016.
Written comments and/or suggestions regarding the items contained in this notice, especially the estimated public burden and associated response time, should be directed to either the Special Master, United States Victims of State Sponsored Terrorism Fund, or the Chief, Program Management and Training Unit, Asset Forfeiture and Money Laundering Section, Criminal Division, Department of Justice, 950 Pennsylvania Avenue NW., Washington, DC 20530-0001, telephone (202) 353-2046. Written comments and/or suggestions can also be sent to the Office of Management and Budget, Office of Information and Regulatory Affairs, Attention Department of Justice Desk Officer, Washington DC 20503, or sent to
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to be collected; and/or
4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
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The information collected from the Fund's Application Form will be used to determine whether claimants are eligible for compensation from the Fund, and if so, the amount of compensation to be awarded. The Application Form consists of parts related to eligibility and compensation. The eligibility parts seek the information required by the Justice for United States Victims of State Sponsored Terrorism Act to determine whether a claimant is eligible for payment from the Fund, including information related to: Participation in federal lawsuits against a state sponsor of terrorism under the Foreign Sovereign Immunities Act; being taken and held hostage at the U.S. Embassy in Tehran, Iran, from the period beginning November 4, 1979, and ending January 20, 1981; or being spouses and children of such hostages. The compensation parts seek the information required by the Justice for United States Victims of State Sponsored Terrorism Act to determine the amount of compensation for which the claimant is eligible. Specifically, the compensation parts seek information regarding any compensation from sources other than the Fund that the claimant received, is entitled to receive, or is scheduled to receive, as a result of the act of international terrorism by a state sponsor of terrorism and the amount of compensatory damages awarded to the claimant in a final judgment. The Application Form was revised with minor formatting changes. There are no substantive changes in the revised Application Form, which contains the
The Fund may require an eligible claimant to supplement his or her application by submitting additional forms. These additional supplementary forms include information related to: (1) An acknowledgment and certification by applicants and their attorneys regarding the statutory provision on the amount of attorneys' fees; (2) an authorization for the Fund to communicate with individuals identified by an applicant regarding his or her claim; (3) a proposed distribution plan and corresponding consent to the proposed distribution plan in claims filed by a personal representative of a deceased individual; (4) a Notice of Filing Claim for use by those applicants filing claims on behalf of deceased individuals; (5) a claimant's decision to change an attorney or representative; (6) a hearing request upon receipt of a decision denying the claim in whole or in part; and (7) electronic payment information.
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If additional information is required contact: Jerri Murray, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE., 3E-405B, Washington, DC 20530.
Executive Office of the President, Office of Management and Budget.
Notice of Solicitation of Comments.
Under the
In its role as coordinator of the Federal statistical system under the
Comments and recommendations on the proposed Addendum detailed in this notice must be in writing. To ensure consideration of comments, they must be received no later than 45 days from the publication date of this notice. Because of delays in the receipt of regular mail related to security screening, respondents are encouraged to send comments electronically via email, or
Please send any comments or questions about this directive to: Katherine K. Wallman, Chief Statistician, Office of Management and Budget, 1800 G St., 9th Floor, Washington, DC 20503. You may also send comments or questions via email to
Comments submitted in response to this notice may be made available to the public through relevant Web sites. For this reason, please do not include in your comments information of a confidential nature, such as sensitive personal information or proprietary information. If you send an email comment, your email address will be automatically captured and included as part of the comment that is placed in the public docket. Please note that responses to this public comment request containing any routine notice about the confidentiality of the communication will be treated as public comments that may be made available to the public notwithstanding the inclusion of the routine notice.
This document is available on the Internet on the OMB Web site at
Jennifer Park, 1800 G St., 9th Floor, Washington, DC 20503,
Consistent with the
Systematic review with the aim of continuous improvement is recognized in Federal guidelines provided in
The requirements set forth in
In November 2014, OMB requested agency and department heads for selected Executive Branch agencies and departments to provide feedback on
In response to this feedback, OMB examined its current guidance. Although similar in many respects to
This Directive provides guidance to Federal statistical agencies on the release and dissemination of statistical products. The Directive is issued under the authority of the Budget and Accounting Procedures Act of 1950 (31 U.S.C. 1104(d)), the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3504(e)), and Office of Management and Budget (OMB) policies including the Information Quality Act guidelines (67 FR 8451-8460) and OMB Circular No. A-130. Under the Information Quality Act (Pub. L. 106-554, Division C, title V, Sec. 515, Dec. 21, 2000; 114 Stat. 2763A-153 to 2763A-154; 44 U.S.C. Section 3516 note) and associated guidelines, agencies are to maximize the quality, objectivity, utility, and integrity of information, including statistical information, provided to the public. This includes making information available on an equitable and timely basis. The procedures in this Directive are intended to ensure that statistical data releases adhere to data quality standards through equitable, policy-neutral, transparent, and timely release of information to the general public.
Statistics produced by the Federal Government are used to shape policies, manage and monitor programs, identify problems and opportunities for improvement, track progress, and measure change. These statistics must meet high standards of reliability, accuracy, timeliness, and objectivity in order to provide a sound and efficient basis for decisions and actions by governments, businesses, households, and other organizations. These data must be objective and free of bias in their presentation and available to all in forms that are readily accessible and understandable.
To be collected and used efficiently, statistical products must gain and preserve the trust of the respondent and user communities; data must be collected and distributed free of any perceived or actual partisan intervention. Widespread recognition of the Federal statistical system's policy- neutral data collection and dissemination fosters such trust. This
1. Scope. This Statistical Policy Directive applies to the full range of statistical products disseminated by Federal statistical agencies or units. However, the Directive excludes coverage of the Principal Federal Economic Indicators addressed in Statistical Policy Directive No. 3, Compilation, Release, and Evaluation of Principal Federal Economic Indicators, which have their own established release and evaluation procedures. Unless otherwise specified in statute, statistical agencies or units are directly and solely responsible for the content, quality, and dissemination of their products. When implementing this Directive, statistical agencies must follow all relevant Statistical Policy Directives and guidance including the principles and practices presented in OMB's Information Quality Guidelines and Statistical Policy Directives providing standards and guidelines for statistical surveys.
2. Statistical Products. Statistical products are, generally, information dissemination products that are published or otherwise made available for public use that describe, estimate, forecast, or analyze the characteristics of groups, customarily without identifying the persons, organizations, or individual data observations that comprise such groups. Statistical products include general-purpose tabulations, analyses, projections, forecasts, or other statistical reports. For purposes of this Directive, a “statistical press release” is an announcement to media of a statistical product release that contains the title, subject matter, release date, and Internet address of, and other available information about the statistical product, as well as the name of the statistical agency issuing the product, and may include any executive summary information or key findings section as shown in the statistical product. A statistical press release announcing or presenting statistical data is defined as a statistical product and is covered by the provisions of this Directive. Federal statistical agencies or units may issue their statistical products in printed and/or electronic form, but must provide access to them on their Internet sites. Agencies should assess the needs of data users and provide a range of products to address those needs by whatever means practicable. Information to help users interpret data accurately, including transparent descriptions of the sources and methodologies used to produce the data, must be equitably available for Federal statistical products. With the exception of compilations of statistical information collected and assembled from other statistical products, these products shall contain or reference appropriate information on the strengths and limitations of the methodologies, data sources, and data used to produce them as well as other information such as explanations of other related measures to assist users in the appropriate treatment and interpretation of the data.
3. Statistical Agencies or Units. As identified under OMB's implementation guidance (72 FR 33362, 33368, June 15, 2007) for the Confidential Information Protection and Statistical Efficiency Act of 2002 (Pub. L. 107-347, Title V; 116 Stat. 2962; 44 U.S.C. Section 3501 note), a Federal statistical agency is an organizational unit of the executive branch whose activities are predominantly the collection, compilation, processing, or analysis of information for statistical purposes. Statistical purpose means the description, estimation, or analysis of the characteristics of groups, customarily without identifying the persons, organizations, or individual data observations that comprise such groups, as well as researching, developing, implementing, maintaining, or evaluating methods, administrative or technical procedures, or information resources that support such purposes. A statistical agency or unit may be labeled an administration, bureau, center, division, office, service, or similar title, so long as it is recognized as a distinct entity. When a statistical agency provides services for a separate sponsoring agency on a reimbursable basis, the provisions of this Directive normally shall apply to the sponsoring agency.
4. Timing of Release. The timing of the release of statistical products, including statistical press releases, regardless of physical form or characteristic, shall be the sole responsibility of the statistical agency or unit that is directly responsible for the content, quality, and dissemination of the data. Agencies should minimize the interval between the period to which the data refer and the date when the product is released to the public.
5. Notification of Release. Prior to the beginning of the calendar year, the releasing statistical agency shall annually provide the public with a schedule of when each regular or recurring statistical product is expected to be released during the upcoming calendar year by publishing it on its Web site. Agencies must issue any revisions to the release schedule in a timely manner on their Web sites.
6. Dissemination. Statistical agencies must ensure that all users have equitable and timely access to data that are disseminated to the public. If there are revisions to the data after an initial release, notification must also be given to the public about these changes in an equitable and timely manner. A statistical agency should strive for the widest, most accessible, and appropriate dissemination of its statistical products and ensure transparency in its dissemination practices by providing complete documentation of its dissemination policies on its Web site. The statistical agency is responsible for ensuring that this documentation remains accurate by reviewing and updating it regularly so that it reflects the agency's current dissemination practices. In unusual circumstances, the requirement that all users initially have equitable and timely access to statistical products may be waived by the releasing statistical agency if the head of the agency determines that the value of a particular type of statistical product, such as health or safety information, is so time-sensitive to specific stakeholders that normal procedures to ensure equitable and timely access to all users would unduly delay the release of urgent findings to those to whom the information is critical. All such instances must be reported to OMB within 30 calendar days of the agency's waiver determination.
Agencies should use a variety of vehicles to attain a data dissemination program designed to reach data users in an equitable and timely manner. Federal statistical agencies or units may issue their statistical products in printed and/or electronic form, but must provide access to them on their Internet sites. In undertaking any dissemination of statistical products, agencies must continue to ensure that they have fulfilled their responsibilities to preserve the confidentiality and security of respondent data. When appropriate to facilitate in-depth research, and feasible in the presence of resource constraints, statistical agencies should provide public access to microdata files with secure safeguards to protect the confidentiality of individually- identifiable responses and with readily accessible documentation, metadata, or other means to facilitate user access to and manipulation of the data.
Statistical agencies are encouraged to use a variety of forums and strategies to release their statistical products. These include conferences, exhibits, presentations, workshops, list serves, the Government Printing Office, public
To accelerate and/or expand the dissemination of data to the public, statistical agencies are encouraged to issue a statistical press release when releasing their products. To maintain a clear distinction between statistical data and policy interpretations of such data, the statistical press release must be produced and issued by the statistical agency and must provide a policy-neutral description of the data; it must not include policy pronouncements. To the extent that any policy pronouncements are to be made regarding the data, those pronouncements are to be made by Federal executive policy officials, not by the statistical agency. Accordingly, these policy officials may issue separate independent statements on the data being released by the statistical agency, and policy officials of the issuing department may review the draft statistical press release to ensure that it does not include policy pronouncements.
In cases in which the statistical unit currently relies on its parent agency for the public affairs function, the statistical agency should coordinate with public affairs officials from the parent organization on the dissemination aspects of the statistical press release process, including planning and scheduling of annual release dates.
The purpose of pre-release access is to foster improved public understanding of the data when they are first released and the accuracy of any initial commentary about the information contained in the product. To support the goal of maximizing the public's access to informed discussions of the data when they are first released, statistical agencies may provide pre-release access to their final statistical products. A statistical product is final when the releasing statistical agency determines that the product fully meets the agency's data quality standards based on all presently available information and requires no further changes. Pre-release access to final statistical products may be provided under embargo or through secure pre-release access. The releasing statistical agency determines which final statistical products will be made available under these pre-release provisions and which method of pre- release will be employed.
Embargo means that pre-release access is provided with the explicit acknowledgement of the receiving party that the information cannot be further disseminated or used in any unauthorized manner before a specific date and time.
The statistical agency may grant pre-release access via an embargo under the following conditions:
1. The agency shall establish arrangements and impose conditions on the granting of an embargo that are necessary to ensure that there is no unauthorized dissemination or use.
2. The agency shall ensure that any person or organization granted access under an embargo has been fully informed of, and has acknowledged acceptance of, these conditions.
3. In all cases, pre-release access via an embargo shall precede the official release time only to the extent necessary for an orderly release of the data.
4. If an embargo is broken, the agency must release the data to the public immediately.
For some data that are particularly sensitive or move markets, statistical agency heads may choose to provide secure pre-release access. Secure pre- release access means that pre-release access is provided only within the confines of secure physical facilities with no external communications capability. When the head of a releasing statistical agency determines that secure pre-release access is required, the agency shall provide pre-release access to final statistical products only when it uses secure pre-release procedures.
7. Announcement of Changes in Data Series. Statistical agencies shall announce, in an appropriate and accessible manner as far in advance of the change as possible, significant planned changes in data collection, analysis, or estimation methods that may affect the interpretation of their data series. In the first report affected by the change, the agency must include a complete description of the change and its effects and place the description on its Internet site, if the report is not otherwise available there.
8. Revisions and Corrections of Data. For some statistical products, statistical agencies produce preliminary estimates or initial releases that will subsequently be updated and finalized. Whenever preliminary data are released, they must be identified as preliminary and the release must indicate that an updated or final revision is expected. In applicable cases, the expected date of such revisions must be included. Reference to the preliminary release and appropriate explanations of the methodology and reasons for the revisions must be provided or referenced in any updated or final releases.
Consistent with each agency's information quality guidelines, statistical agencies must also establish and implement policies for handling unscheduled corrections due to previously unrecognized errors. Agencies have an obligation to alert users as quickly as possible to any such changes, to explain corrections or revisions that result from any unscheduled corrections, and to make appropriate changes in all product formats—including statistical press releases.
9. Granting of Exceptions. Prior to any action being taken that may be inconsistent with the provisions of this Directive, the head of a releasing statistical agency shall consult with OMB's Administrator for Information and Regulatory Affairs. If the Administrator determines that the action is inconsistent with the provisions of this Directive, the head of the releasing statistical agency may apply for an exception. The Administrator may authorize exceptions to the provisions in sections 4, 5, 6, 7, and 8 of this Directive. Any agency requesting an exception must demonstrate to the satisfaction of the Administrator that the proposed exception is necessary and is consistent with the purposes of this Directive.
10. Performance Review. Each Federal statistical agency shall submit an annual performance review of the production and dissemination of its key statistical products to the Office of Information and Regulatory Affairs. Each agency will identify its key statistical products for review purposes, in consultation with OMB.
The review shall address the following issues:
(a) The accuracy and reliability of the series,
(b) the accuracy, completeness, and accessibility of documentation describing the methods used in compiling and revising the product;
(c) the agency's performance in meeting its established release schedule and the prompt release objective of this Directive;
(d) the agency's ability to avoid disclosure prior to the scheduled release time;
(e) any additional issues (such as periodicity, electronic access, etc.) that the Administrator for Information and Regulatory Affairs specifies in writing to the agency at least 6 months in advance of the scheduled submission date.
The evaluation will be reviewed by the Administrator to determine whether the statistical products are prepared and published in conformity with OMB statistical policies, standards, and guidelines. A summary of the year's evaluations and their reviews will be included in the annual report to Congress required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3504(e)).
National Credit Union Administration (NCUA).
Notice and request for comment.
NCUA, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to comment on an extension of a previously approved collection, as required by the Paperwork Reduction Act of 1995.
Written comments should be received on or before December 16, 2016 to be assured consideration.
Interested persons are invited to submit written comments on the information collection to Troy Hillier, National Credit Union Administration, 1775 Duke Street, Alexandria, Virginia 22314; Fax No. 703-519-8579; or Email at
Requests for additional information should be directed to the address above.
Because most of the information exchanged under this regulation is between credit unions and their members, NCUA is not made aware of the requests covered under this regulation unless there is a dispute. We assume that instances of formal petitions being filed to request inspection of records is a fairly rare event. For purposes of estimating burden, we assume no more than five such petitions are filed each year.
This is an extension without changes of a previously approved collection. The adjustments in burden estimates are attributable to the inclusion of FCU members as respondents and the inclusion of costs associated with potential dispute resolution.
Public Law 104-13, 44 U.S.C. Chapter 35
By Gerard Poliquin, Secretary of the Board, the National Credit Union Administration, on October 12, 2016.
National Credit Union Administration (NCUA).
Notice.
The National Credit Union Administration (NCUA) will be submitting the following information collection requests to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, Public Law 104-13, on or after the date of publication of this notice.
Comments should be received on or before November 16, 2016 to be assured of consideration.
Send comments regarding the burden estimate, or any other aspect of the information collection, including suggestions for reducing the burden, to (1) Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for NCUA, New Executive Office Building, Room 10235, Washington, DC 20503, or email at
Copies of the submission may be obtained by emailing
By Gerard Poliquin, Secretary of the Board, the National Credit Union Administration, on October 12, 2016.
National Science Foundation.
Announcement of Membership of the National Science Foundation's Senior Executive Service Performance Review Board.
This announcement of the membership of the National Science Foundation's Senior Executive Service Performance Review Board is made in compliance with 5 U.S.C. 4314(c)(4).
Comments should be addressed to Division Director, Division of Human Resource Management, National Science Foundation, Room 315, 4201 Wilson Boulevard, Arlington, VA 22230.
Ms. Dianne Campbell Krieger at the above address or (703) 292-5194.
The membership of the National Science Foundation's Senior Executive Service Performance Review Board is as follows:
This notice describes procedures to be followed with respect to meetings conducted by the U.S. Nuclear Regulatory Commission's (NRC's) Advisory Committee on Reactor Safeguards (ACRS) pursuant to the Federal Advisory Committee Act (FACA). These procedures are set forth so that they may be incorporated by reference in future notices for individual meetings.
The ACRS is a statutory advisory Committee established by Congress to review and report on nuclear safety matters and applications for the licensing of nuclear facilities. The Committee's reports become a part of the public record.
The ACRS meetings are conducted in accordance with FACA; they are normally open to the public and provide opportunities for oral or written statements from members of the public to be considered as part of the Committee's information gathering process. ACRS reviews do not normally encompass matters pertaining to environmental impacts other than those related to radiological safety.
The ACRS meetings are not adjudicatory hearings such as those conducted by the NRC's Atomic Safety and Licensing Board Panel as part of the Commission's licensing process.
An agenda will be published in the
The following requirements shall apply to public participation in ACRS Full Committee meetings:
(a) Persons who plan to submit written comments at the meeting should provide 35 copies to the DFO at the beginning of the meeting. Persons who cannot attend the meeting, but wish to submit written comments regarding the agenda items may do so by sending a readily reproducible copy addressed to the DFO specified in the
(b) Persons desiring to make oral statements at the meeting should make a request to do so to the DFO; if possible, the request should be made five days before the meeting, identifying the topic(s) on which oral statements will be made and the amount of time needed for presentation so that orderly arrangements can be made. The Committee will hear oral statements on topics being reviewed at an appropriate time during the meeting as scheduled by the Chairman.
(c) Information regarding topics to be discussed, changes to the agenda, whether the meeting has been canceled
(d) The use of still, motion picture, and television cameras will be permitted at the discretion of the Chairman and subject to the condition that the use of such equipment will not interfere with the conduct of the meeting. The DFO will have to be notified prior to the meeting and will authorize the use of such equipment after consultation with the Chairman. The use of such equipment will be restricted as is necessary to protect proprietary or privileged information that may be in documents, folders, etc., in the meeting room. Electronic recordings will be permitted only during those portions of the meeting that are open to the public.
(e) A transcript will be kept for certain open portions of the meeting and will be available in the NRC Public Document Room (PDR), One White Flint North, Room O-1F21, 11555 Rockville Pike, Rockville, Maryland 20852-2738. A copy of the certified minutes of the meeting will be available at the same location three months following the meeting. Copies may be obtained upon payment of appropriate reproduction charges. ACRS meeting agendas, transcripts, and letter reports are available at
(f) Video teleconferencing service may be available for observing open sessions of ACRS meetings. Those wishing to use this service for observing ACRS meetings should contact Mr. Theron Brown, ACRS Audio Visual Specialist, (301-415-8066) between 7:30 a.m. and 3:45 p.m. Eastern Time at least 10 days before the meeting to ensure the availability of this service. Individuals or organizations requesting this service will be responsible for telephone line charges and for providing the equipment and facilities that they use to establish the video teleconferencing link. The availability of video teleconferencing services is not guaranteed.
In accordance with the revised FACA, the agency is no longer required to apply the FACA requirements to meetings conducted by the Subcommittees of the NRC Advisory Committees, if the Subcommittee's recommendations would be independently reviewed by its parent Committee.
The ACRS, however, chose to conduct its Subcommittee meetings in accordance with the procedures noted above for ACRS Full Committee meetings, as appropriate, to facilitate public participation, and to provide a forum for stakeholders to express their views on regulatory matters being considered by the ACRS. When Subcommittee meetings are held at locations other than at NRC facilities, reproduction facilities may not be available at a reasonable cost. Accordingly, 50 copies of the materials to be used during the meeting should be provided for distribution at such meetings.
If it is necessary to hold closed sessions for the purpose of discussing matters involving proprietary information, persons with agreements permitting access to such information may attend those portions of the ACRS meetings where this material is being discussed upon confirmation that such agreements are effective and related to the material being discussed.
The DFO should be informed of such an agreement at least five working days prior to the meeting so that it can be confirmed, and a determination can be made regarding the applicability of the agreement to the material that will be discussed during the meeting. The minimum information provided should include information regarding the date of the agreement, the scope of material included in the agreement, the project or projects involved, and the names and titles of the persons signing the agreement. Additional information may be requested to identify the specific agreement involved. A copy of the executed agreement should be provided to the DFO prior to the beginning of the meeting for admittance to the closed session.
For the Nuclear Regulatory Commission.
October 17, 24, 31, November 7, 14, 21, 2016.
Commissioners' Conference Room, 11555 Rockville Pike, Rockville, Maryland.
Public and Closed.
This meeting will be webcast live at the Web address—
This meeting will be webcast live at the Web address—
This meeting will be webcast live at the Web address—
There are no meetings scheduled for the week of November 7, 2016.
There are no meetings scheduled for the week of November 14, 2016.
There are no meetings scheduled for the week of November 21, 2016.
The schedule for Commission meetings is subject to change on short notice. For more information or to verify
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
Office of Special Counsel
Notice.
The Office of Special Counsel (OSC) publishes the names of the persons selected to serve on its SES Performance Review Board (PRB). This notice supersedes all previous notices of the PRB membership.
October 17, 2016.
Kenneth Hendricks, Acting General Counsel, U.S. Office of Special Counsel, 1730 M Street NW., Suite 218, Washington, DC 20036, (202) 254-3600
Section 4314(c) of Title 5, U.S.C. requires each agency to establish, in accordance with regulations prescribed by the Office of Personnel Management, one or more PRBs. The PRB shall review and evaluate the initial appraisal of a senior executive's performance by the supervisor, along with any response by the senior executive, and make recommendations to the final rating authority relative to the performance of the senior executive.
The following individuals have been selected to serve on the OSC's PRB: Bruce Fong, Associate Special Counsel; Bruce Gipe, Chief Operating Officer; Louis Lopez, Associate Special Counsel; Anne Wagner, Associate Special Counsel.
On July 12, 2016, the Fixed Income Clearing Corporation (“FICC”) filed with the Securities and Exchange Commission (“Commission”) proposed rule change SR-FICC-2016-003 pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
FICC proposes to amend the Government Securities Division (“GSD”) Rulebook (the “GSD Rules”)
FICC states that the GCF Repo service enables GCF Repo Participants to trade general collateral repurchase agreements based on rate, term, and underlying product throughout the day, without requiring intraday, trade-for-trade settlement on a delivery-versus-payment basis. On each trading day, GCF Repo Participants must cover their repurchase obligations by allocating collateral to FICC's account at the GCF Repo Participant's GCF Clearing Agent Bank.
The Required Fund Deposit serves as each Netting Member's margin. FICC states that the objective of the Required Fund Deposit is to mitigate potential losses to FICC associated with liquidation of the Netting Member's portfolio in the event that FICC ceases to act for a Netting Member (hereinafter referred to as a “default”). FICC determines Required Fund Deposit amounts using a risk-based margin methodology.
FICC determines the adequacy of each Netting Member's Required Fund Deposit through daily backtesting. FICC compares each Netting Member's
FICC only accepts MBS that are issued and guaranteed by U.S. government-sponsored entities (“GSEs”). Because MBS are composed of pools of mortgages, whose principal balances decrease over time because of scheduled and unscheduled payments by mortgagors, MBS notional values decrease over time. Investors in MBS issued by the GSEs are informed of the amount of this reduction in value on a monthly basis when the GSEs release new “Pool Factors” for their MBS at the beginning of every month.
FICC states that GCF Repo Participants may experience backtesting deficiencies during the Blackout Period if they allocate substantial amounts of MBS collateral to cover their repurchase obligations. Such deficiencies occur because the value of MBS collateral allocated to cover GCF Repo Participants' repurchase obligations may be overstated on the collateral reports delivered to FICC by the GCF Clearing Agent Banks, which rely on the prior month's Pool Factors to value MBS collateral pledged by GCF Repo Participants. FICC states that the Blackout Period Exposure Charge is designed to mitigate the risk posed to FICC by such deficiencies by temporarily increasing such GCF Repo Participants' Required Fund Deposits.
FICC states that the objective of the Blackout Period Exposure Charge is to increase Required Fund Deposits by an amount sufficient to maintain backtesting coverage above the 99 percent confidence threshold for GCF Repo Participants that are likely to experience backtesting deficiencies on the basis described above. Because the size of the backtesting deficiencies caused by this issue varies among impacted GCF Repo Participants, FICC must assess a Blackout Period Exposure Charge that is specific to each impacted GCF Repo Participant.
FICC examines each impacted GCF Repo Participant's historical backtesting deficiencies to identify the two largest deficiencies that occurred during a rolling 12-month look-back period. FICC then identifies an amount equal to the midpoint between the two largest historical deficiencies for such GCF Repo Participant as the presumptive Blackout Period Exposure Charge amount, subject to adjustment as further described below.
FICC states that the resulting Blackout Period Exposure Charge is added to the VaR Charge for such GCF Repo Participant pursuant to FICC's risk-based margining methodology, but that the charge is only imposed during the Blackout Period (
Although FICC uses the midpoint between the two largest historical Blackout Period deficiencies for a GCF Repo Participant as the Blackout Period Exposure Charge in most cases, FICC retains discretion to adjust the charge based on other relevant circumstances, such as material differences in the two largest deficiencies, variability in a GCF Repo Participant's use of MBS for collateral allocation, and variability in the magnitude of Pool Factor changes for certain categories of MBS. Based on FICC's assessment of the impact of these circumstances on the likelihood of, and estimated size of, future Blackout Period deficiencies for a GCF Repo Participant, FICC may, in its discretion, adjust the Blackout Period Exposure Charge for such Participant to an amount that FICC determines to be more appropriate for maintaining such GCF Repo Participant's backtesting results above the 99 percent coverage threshold (including a reasonable buffer).
If FICC determines that a Blackout Period Exposure Charge should apply to a GCF Repo Participant who was not assessed a Blackout Period Exposure Charge during the immediately preceding month or that the Blackout Period Exposure Charge applied to a GCF Repo Participant during the previous month should be increased, FICC will notify the Participant on or around the 25th calendar day of the month. FICC states that the Participant may avoid or decrease the charge by notifying FICC in writing of its intent to remove or reduce its use of MBS in collateral allocations, followed by the actual removal or reduction of MBS collateral allocations, during the Blackout Period. If such Participant elects not to adjust its portfolio (or fails to do so despite such notification to FICC), then FICC will impose a Blackout Period Exposure Charge as determined above.
FICC imposes the Blackout Period Exposure Charge as of the morning Clearing Fund call on the Record Date through and including the intraday
If changes in an impacted GCF Repo Participant's MBS collateral pledges over time materially reduce the Blackout Period Exposure Charge calculated pursuant to the procedures described above, FICC may, in its discretion, reduce the Blackout Period Exposure Charge and would so notify the Participant. If an impacted GCF Repo Participant's trailing 12-month backtesting coverage exceeds 99 percent (without taking into account historically-imposed Blackout Period Exposure Charges), the Blackout Period Exposure Charge would be removed.
Section 19(b)(2)(C) of the Act
Section 17A(b)(3)(F) of the Act requires, in part, that the rules of a clearing agency be designed to assure the safeguarding of securities and funds that are within the custody or control of the clearing agency.
As described above, FICC determined that the Required Fund Deposits collected from GCF Repo Participants during monthly Blackout Periods may not accurately reflect decreases in the value of MBS underlying the GCF Repo transactions and, therefore, the Required Fund Deposits collected may be inadequate to cover the losses that could arise if a GCF Repo Participant defaulted. The Blackout Period Exposure Charge is specifically designed to address that risk. The charge is sized based on certain backtesting deficiencies of GCF Repo Participants. Where FICC identifies deficiencies related to the use of MBS underlying GCF Repo transactions, the Blackout Period Exposure Charge may be applied and, in turn, FICC would collect more margin. Therefore, the proposed rule change enhances the safeguarding of securities and funds that are in the custody or control of FICC, consistent with Section 17(b)(3)(F) of the Act.
Rule 17Ad-22(b)(1) requires a clearing agency that performs CCP services to establish, implement, maintain and enforce written policies and procedures reasonably designed to measure its credit exposures to its participants at least once a day and limit its exposures to potential losses from defaults by its participants under normal market conditions, so that the operations of the clearing agency would not be disrupted and non-defaulting participants would not be exposed to losses that they cannot anticipate or control.
Rule 17Ad-22(b)(2) requires a clearing agency that performs CCP services to maintain and enforce written policies and procedures reasonably designed to use margin requirements to limit its credit exposures to participants under normal market conditions and use risk-based models and parameters to set margin requirements.
On the basis of the foregoing, the Commission finds that the proposed rule change is consistent with the requirements of the Act, particularly those set forth in Section 17A,
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend the continued listing requirements for exchange-traded products (“ETPs”) in the Nasdaq Rule 5700 Series, as well as a related amendment to Nasdaq Rule 5810 (Notification of Deficiency by the Listing Qualifications Department). The Exchange is also making housekeeping changes throughout the Nasdaq Rule 5700 Series and in Nasdaq Rule 5810 for improved clarity.
The text of the proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to amend the listing rules for ETPs in the Nasdaq Rule 5700 Series (Other Securities) to add additional continued listing standards as well as a related amendment to Nasdaq Rule 5810 (Notification of Deficiency by the Listing Qualifications Department). The Exchange is also making housekeeping changes throughout the Nasdaq Rule 5700 Series and in Nasdaq Rule 5810 (
The proposed rule changes are being made in concert with discussions with the SEC. Citing their concern for potential manipulation of ETPs, staff (“Staff”) of the SEC's Office of Trading and Markets (“T&M”) requested that the Exchange adopt certain additional continued listing standards for ETPs.
As a result, the proposed amended rules reflect the guidance provided by T&M Staff to clarify that most initial listing standards, as well as certain representations included in Exchange rule filings under SEC Rule 19b-4
The proposed rule changes require that ETPs listed by the Exchange without an Exchange Rule Filing must maintain the initial index or reference asset criteria on a continued basis. For example, in the case of a domestic equity index, these criteria generally include: (a) Stocks with 90% of the weight of the index must have a minimum market value of at least $75 million; (b) stocks with 70% of the weight of the index must have a minimum monthly trading volume of at least 250,000 shares; (c) the most heavily weighted component cannot exceed 30% of the weight of the index, and the five most heavily weighted stocks cannot exceed 65%; (d) there must be at least 13 stocks in the index; and (e) all securities in the index must be listed in the U.S. There are similar criteria for international indexes, fixed-income indexes and indexes with a combination of components.
If an Exchange Rule Filing is made to list a specific ETP, the proposed rule change requires that the issuer of the security comply on a continuing basis with any statements or representations contained in the applicable rule proposal, including: (a) The description of the portfolio; (b) limitations on portfolio holdings or reference assets; and (c) the applicability of Nasdaq rules and surveillance procedures.
The Nasdaq listing rules will also be modified to require that issuers of securities listed under the Nasdaq Rule 5700 Series must notify the Exchange regarding instances of non-compliance. In addition, while listed ETPs are currently subject to the delisting process in the Rule 5800 Series, the rules will be clarified to make this explicit.
The Exchange believes that its proposal is consistent with Section 6(b)
The proposed rule changes accomplish these objectives by enhancing the current continued listing standards by clarifying that most initial listing standards, as well as certain representations included in Exchange Rule Filings to list an ETP, are considered continued listing standards. Additionally, the Nasdaq listing rules will be modified to require that issuers of securities listed under the Nasdaq Rule 5700 Series must notify the Exchange regarding instances of non-compliance and to clarify that deficiencies will be subject to potential trade halts and the delisting process in the Rule 5800 Series. The Exchange believes that these amendments will enhance the Nasdaq listing rules, thereby serving to improve the national market system and protect investors and the public interest.
The Exchange does not believe that the housekeeping changes have any impact on the reasonable and equitable and not unfairly discriminatory nature of the proposal.
For these reasons, Nasdaq believes the proposed rule change is consistent with the requirements of Section 6(b)(5) of the Act.
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act, as amended. The Exchange believes that the proposed rule change to amend the listing rules for ETPs in the Nasdaq Rule 5700 Series and the notification requirement in Rule 5810 will have no impact on competition. Furthermore, since T&M Staff has provided the same guidance regarding ETP continued listing requirements to all exchanges, the Exchange believes that there will be no effect on competition.
No written comments were either solicited or received.
Within 45 days of the date of publication of this notice in the
(A) By order approve or disapprove such proposed rule change, or
(B) institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send paper comments in triplicate to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange proposes to list and trade under Nasdaq Rule 5745 (Exchange-Traded Managed Fund Shares (“NextShares”)) the common shares (“Shares”) of the exchange-traded managed funds described herein (each, a “Fund,” and collectively, the “Funds”).
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 list and trade the Shares of each Fund under Nasdaq Rule 5745, which governs the listing and trading of exchange-traded managed fund shares or NextShares, as defined in Nasdaq Rule 5745(c)(1), on the Exchange.
Gabelli NextShares
Gabelli Funds, LLC will be the Adviser to the Funds. The Adviser is not a registered broker-dealer, although it is affiliated with a broker-dealer. Gabelli Funds, LLC will also act as administrator to the Funds. The Adviser has implemented a fire wall with respect to its affiliated broker-dealer regarding access to information concerning the composition and/or changes to each Fund's portfolio. In the future event that (a) the Adviser registers as a broker-dealer or becomes newly affiliated with a broker-dealer, or (b) any new adviser or a sub-adviser to a Fund is a registered broker-dealer or becomes affiliated with a broker-dealer, it will implement a fire wall with respect to its relevant personnel and/or such broker-dealer affiliate, if applicable, regarding access to information concerning the composition and/or changes to the relevant Fund's portfolio and will be subject to procedures designed to prevent the use and dissemination of material non-public information regarding such portfolio. G.distributors, LLC, will be the principal underwriter and distributor of each Fund's Shares. BNY Mellon Investment Servicing (US) Inc. will act as the custodian, transfer agent, and sub-administrator to the Funds. Interactive Data Pricing and Reference Data, Inc. will be the intraday indicative value (“IIV”) calculator to the Funds.
Each Fund will be actively managed and will pursue the various principal investment strategies described below.
The Gabelli ESG Fund seeks to provide capital appreciation. The Gabelli ESG Fund seeks to achieve its objective by investing substantially all, and in any case no less than 80%, of its net assets plus borrowings for investment purposes in common and preferred stocks of companies that meet the Gabelli ESG Fund's guidelines for social responsibility at the time of investment. Pursuant to its social responsibility guidelines, the Gabelli ESG Fund will not invest in publicly traded fossil fuel (coal, oil, and gas) companies, the top 50 defense/weapons contractors, or in companies that derive more than 5% of their revenues from the following areas: Tobacco, alcohol, gaming, defense/weapons production, and companies involved in the manufacture of abortion related products.
The Gabelli All Cap Fund primarily seeks to provide capital appreciation. The Gabelli All Cap Fund's secondary goal is current income. Under normal market conditions, the Gabelli All Cap Fund invests at least 80% of its net assets plus borrowings for investment purposes in stocks that are listed on a recognized securities exchange or similar market. The Gabelli All Cap Fund may also invest in common and preferred securities of foreign issuers.
The Gabelli Equity Income Fund seeks a high level of total return on its assets with an emphasis on income. The Gabelli Equity Income Fund will seek to achieve its investment objective through a combination of capital appreciation and current income by investing, under normal market conditions, at least 80% of its net assets plus borrowings for investment purposes in income producing equity securities. Income producing equity securities include, for example, common stock and preferred stock.
The Gabelli Small and Mid Cap Value Fund seeks long-term capital growth. Under normal market conditions, the Gabelli Small and Mid Cap Value Fund invests at least 80% of its net assets plus borrowings for investment purposes (“80% Policy”) in equity securities (such as common stock and preferred stock) of companies with small or medium-sized market capitalizations (“small cap” and “mid cap” companies, respectively). A company's market capitalization is generally calculated by multiplying the number of a company's shares outstanding by its stock price. The Gabelli Small and Mid Cap Value Fund defines “small cap companies” as those with a market capitalization generally less than $3 billion at the time of investment and “mid cap companies” as those with a market capitalization between $3 billion and $12 billion at the time of investment. Subject to its 80% Policy, the Gabelli Small and Mid Cap Value Fund may invest in equity securities of companies of any market capitalization. In addition, the Gabelli Small and Mid Cap Value Fund may invest up to 25% of its total assets in securities of issuers in a single industry.
The Gabelli Media Mogul Fund seeks to provide capital appreciation. Under normal market conditions, the Fund invests at least 80% of net assets plus borrowings for investment purposes in companies that were spun-off from or that are tracking stocks issued by Liberty Media Corporation, as well as in companies that resulted from subsequent mergers of any such spin-offs or stocks that track performance of companies that resulted from subsequent mergers of any such spin-offs or tracking stocks, and in public companies in which Liberty Media Corporation and its successor companies invest. The current investable universe includes approximately 28 U.S. and non-U.S. listed companies in the telecommunications, media, publishing, and entertainment industries.
Shares will be issued and redeemed on a daily basis for each Fund at the next-determined net asset value (“NAV”)
The creation and redemption process for Funds may be effected “in kind,” in cash, or in a combination of securities and cash. Creation “in kind” means that an Authorized Participant—usually a brokerage house or large institutional investor—purchases the Creation Unit with a basket of securities equal in value to the aggregate NAV of the Shares in the Creation Unit. When an Authorized Participant redeems a Creation Unit in kind, it receives a basket of securities equal in value to the aggregate NAV of the Shares in the Creation Unit.
As defined in Nasdaq Rule 5745(c)(3), the Composition File is the specified portfolio of securities and/or cash that a Fund will accept as a deposit in issuing a Creation Unit of Shares, and the specified portfolio of securities and/or cash that a Fund will deliver in a redemption of a Creation Unit of Shares. The Composition File will be disseminated through the NSCC once each business day before the open of trading in Shares on such day and also will be made available to the public each day on a free Web site. Because the Funds seek to preserve the confidentiality of their current portfolio trading program, a Fund's Composition File generally will not be a pro rata reflection of the Fund's investment positions. Each security included in the Composition File will be a current holding of the Fund, but the Composition File generally will not include all of the securities in the Fund's portfolio or match the weightings of the included securities in the portfolio. Securities that the Adviser is in the process of acquiring for a Fund generally will not be represented in the Fund's Composition File until their purchase has been completed. Similarly, securities that are held in a Fund's portfolio but in the process of being sold may not be removed from its Composition File until the sale program is substantially completed. Funds creating and redeeming Shares in kind will use cash amounts to supplement the in-kind transactions to the extent necessary to ensure that Creation Units are purchased and redeemed at NAV. The Composition File also may consist entirely of cash, in which case it will not include any of the securities in the Fund's portfolio.
All persons purchasing or redeeming Creation Units of a Fund are expected to incur a transaction fee to cover the estimated cost to that Fund of processing the transaction, including the costs of clearance and settlement charged to it by NSCC or DTC, and the estimated trading costs (
Because Shares will be listed and traded on the Exchange, Shares will be available for purchase and sale on an intraday basis. Shares will be purchased and sold in the secondary market at prices directly linked to a Fund's next-determined NAV using a new trading protocol called “NAV-Based Trading.”
Bid and offer prices for Shares will be quoted throughout the day relative to NAV. The premium or discount to NAV at which Share prices are quoted and transactions are executed will vary depending on market factors, including the balance of supply and demand for Shares among investors, transaction fees and other costs in connection with creating and redeeming Creation Units of Shares, the cost and availability of borrowing Shares, competition among market makers, the Share inventory positions and inventory strategies of market makers, the profitability requirements and business objectives of market makers, and the volume of Share trading. Reflecting such market factors, prices for Shares in the secondary market may be above, at or below NAV. Funds with higher transaction fees may trade at wider premiums or discounts to NAV than other Funds with lower transaction fees, reflecting the added costs to market makers of managing their Share inventory positions through purchases and redemptions of Creation Units.
Because making markets in Shares will be simple to manage and low risk, competition among market makers seeking to earn reliable, low-risk profits should enable the Shares to routinely trade at tight bid-ask spreads and narrow premiums/discounts to NAV. As noted below, each Fund will maintain a public Web site that will be updated on a daily basis to show current and historical trading spreads and premiums/discounts of Shares trading in the secondary market.
Member firms will utilize certain existing order types and interfaces to transmit Share bids and offers to Nasdaq, which will process Share trades like trades in shares of other listed securities.
To avoid potential investor confusion, Nasdaq will work with member firms and providers of market data services to seek to ensure that representations of intraday bids, offers and execution prices of Shares that are made available to the investing public follow the “NAV−$0.01/NAV+$0.01” (or similar) display format. All Shares listed on the Exchange will have a unique identifier associated with their ticker symbols, which would indicate that the Shares are traded using NAV-Based Trading. Nasdaq makes available to member firms and market data services certain proprietary data feeds that are designed to supplement the market information disseminated through the consolidated tape (“Consolidated Tape”). Specifically, the Exchange will use the NASDAQ Basic and NASDAQ Last Sale data feeds to disseminate intraday price and quote data for Shares in real time in the “NAV−$0.01/NAV+$0.01” (or similar) display format. Member firms could use the NASDAQ Basic and NASDAQ Last Sale data feeds to source intraday Share prices for presentation to the investing public in the “NAV−$0.01/NAV+$0.01” (or similar) display format. Alternatively, member firms could source intraday Share prices in proxy price format from the Consolidated Tape and other Nasdaq data feeds (
All bids and offers for Shares and all Share trade executions will be reported intraday in real time by the Exchange to the Consolidated Tape
All executed Share trades will be recorded and stored intraday by Nasdaq to await the calculation of such Fund's end-of-day NAV and the determination of final trade pricing. After a Fund's NAV is calculated and provided to the Exchange, Nasdaq will price each Share trade entered into during the day at the Fund's NAV plus/minus the trade's executed premium/discount. Using the final trade price, each executed Share trade will then be disseminated to member firms and market data services via an FTP file to be created for exchange-traded managed funds and confirmed to the member firms participating in the trade to supplement the previously provided information to include final pricing.
Prior to the commencement of market trading in Shares, each Fund will be required to establish and maintain a public Web site through which its current prospectus may be downloaded. The Web site will include additional Fund information updated on a daily basis, including the prior business day's NAV, and the following trading information for such business day expressed as premiums/discounts to NAV: (a) Intraday high, low, average and closing prices of Shares in Exchange trading; (b) the midpoint of the highest bid and lowest offer prices as of the close of Exchange trading, expressed as a premium/discount to NAV (the “Closing Bid/Ask Midpoint”); and (c) the spread between highest bid and lowest offer prices as of the close of Exchange trading (the “Closing Bid/Ask Spread.”). The Web site will also contain charts showing the frequency distribution and range of values of trading prices, Closing Bid/Ask Midpoints and Closing Bid/Ask Spreads over time.
The Composition File will be disseminated through the NSCC before the open of trading in Shares on each business day and also will be made available to the public each day on a free Web site as noted above. Consistent with the disclosure requirements that apply to traditional open-end investment companies, a complete list of current Fund portfolio positions will be made available at least once each calendar quarter, with a reporting lag of not more than 60 days. Funds may provide more frequent disclosures of portfolio positions at their discretion.
Reports of Share transactions will be disseminated to the market and delivered to the member firms participating in the trade contemporaneous with execution. Once a Fund's daily NAV has been calculated and disseminated, Nasdaq will price each Share trade entered into during the day at the Fund's NAV plus/minus the trade's executed premium/discount. Using the final trade price, each executed Share trade will then be disseminated to member firms and market data services via an FTP file to be created for exchange-traded managed funds and confirmed to the member firms participating in the trade to supplement the previously provided information to include final pricing.
Information regarding NAV-based trading prices, best bids and offers for Shares, and volume of Shares traded will be continuously available on a real-time basis throughout each trading day on brokers' computer screens and other electronic services.
Shares will conform to the initial and continued listing criteria as set forth under Nasdaq Rule 5745. A minimum of 50,000 Shares and no less than two Creation Units of each Fund will be outstanding at the commencement of trading on the Exchange. The Exchange will obtain a representation from the issuer of the Shares that the NAV per Share will be calculated daily (on each business day that the New York Stock Exchange is open for trading) and provided to Nasdaq via the Mutual Fund Quotation Service (“MFQS”) by the fund accounting agent. As soon as the NAV is entered into MFQS, Nasdaq will disseminate the value to market participants and market data vendors via the Mutual Fund Dissemination Service (“MFDS”) so all firms will receive the NAV per share at the same time. The Reporting Authority
For each Fund, an estimated value of an individual Share, defined in Nasdaq Rule 5745(c)(2) as the “Intraday Indicative Value,” will be calculated and disseminated at intervals of not more than 15 minutes throughout the Regular Market Session
The IIV will be based on current information regarding the value of the securities and other assets held by a Fund.
If the Adviser is a registered broker-dealer or affiliated with a broker-dealer, the Adviser has implemented a fire wall with respect to its relevant broker-dealer personnel or broker-dealer affiliate, as applicable, regarding access to information concerning the composition and/or changes to each Fund's portfolio. In the future event that (a) the Adviser registers as a broker-dealer or becomes newly affiliated with a broker-dealer, or (b) any new adviser or a sub-adviser to a Fund is a registered broker-dealer or becomes affiliated with a broker-dealer, it will implement a fire wall with respect to its relevant personnel and/or such broker-dealer affiliate, if applicable, regarding access to information concerning the composition and/or changes to the relevant Fund's portfolio and will be subject to procedures designed to prevent the use and dissemination of material non-public information regarding such portfolio.
The Exchange may consider all relevant factors in exercising its discretion to halt or suspend trading in Shares. Nasdaq will halt trading in Shares under the conditions specified in Nasdaq Rule 4120 and in Nasdaq Rule 5745(d)(2)(C). Additionally, Nasdaq may cease trading Shares if other unusual conditions or circumstances exist which, in the opinion of Nasdaq, make further dealings on Nasdaq detrimental to the maintenance of a fair and orderly market. To manage the risk of a non-regulatory Share trading halt, Nasdaq has in place back-up processes and procedures to ensure orderly trading. Because, in NAV-Based Trading, all trade execution prices are linked to end-of-day NAV, buyers and sellers of Shares should be less exposed to risk of loss due to intraday trading halts than buyers and sellers of conventional exchange-traded funds (“ETFs”) and other exchange-traded securities.
Nasdaq deems Shares to be equity securities, thus rendering trading in
Every order to trade Shares of the Funds is subject to the proxy price protection threshold of plus/minus $1.00, which determines the lower and upper threshold for the life of the order and whereby the order will be cancelled at any point if it exceeds $101.00 or falls below $99.00, the established thresholds.
The Exchange represents that trading in Shares will be subject to the existing trading surveillances, administered by both Nasdaq and the Financial Industry Regulatory Authority, Inc. (“FINRA”) on behalf of the Exchange, which are designed to detect violations of Exchange rules and applicable federal securities laws.
The surveillances referred to above generally focus on detecting securities trading outside their normal patterns, which could be indicative of manipulative or other violative activity. When such situations are detected, surveillance analysis follows and investigations are opened, where appropriate, to review the behavior of all relevant parties for all relevant trading violations.
FINRA, on behalf of the Exchange, will communicate as needed with other markets and other entities that are members of the Intermarket Surveillance Group (“ISG”)
In addition, the Exchange also has a general policy prohibiting the distribution of material non-public information by its employees.
Prior to the commencement of trading in a Fund, the Exchange will inform its members in an Information Circular of the special characteristics and risks associated with trading the Shares. Specifically, the Information Circular will discuss the following: (1) The procedures for purchases and redemptions of Shares in Creation Units (and noting that Shares are not individually redeemable); (2) Nasdaq Rule 2111A, which imposes suitability obligations on Nasdaq members with respect to recommending transactions in Shares to customers; (3) how information regarding the IIV and Composition File is disseminated; (4) the requirement that members deliver a prospectus to investors purchasing Shares prior to or concurrently with the confirmation of a transaction; and (5) information regarding NAV-Based Trading protocols.
As noted above, all orders to buy or sell Shares that are not executed on the day the order is submitted will be automatically cancelled as of the close of trading on such day. The Information Circular will discuss the effect of this characteristic on existing order types. The Information Circular also will identify the specific Nasdaq data feeds from which intraday Share prices in proxy price format may be obtained.
In addition, the Information Circular will advise members, prior to the commencement of trading, of the prospectus delivery requirements applicable to the Funds. Members purchasing Shares from a Fund for resale to investors will deliver a summary prospectus to such investors. The Information Circular will also discuss any exemptive, no-action and interpretive relief granted by the Commission from any rules under the Act.
The Information Circular also will reference that the Funds are subject to various fees and expenses described in the Registration Statements. The Information Circular will also disclose the trading hours of the Shares and the applicable NAV calculation time for the Shares. The Information Circular will disclose that information about the Shares will be publicly available on the Fund's Web site.
Information regarding Fund trading protocols will be disseminated to Nasdaq members in accordance with current processes for newly listed products. Nasdaq intends to provide its members with a detailed explanation of NAV-Based Trading through a Trading Alert issued prior to the commencement of trading in Shares on the Exchange.
All statements and representations made in this filing regarding (a) the description of the Funds' 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 of the Funds on the Exchange. The issuer has represented to the Exchange that it will advise the Exchange of any failure by any Fund 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. If a Fund is not in compliance with the applicable listing requirements, the Exchange will commence delisting procedures under Nasdaq Rule 5800,
Nasdaq believes that the proposal is consistent with Section 6(b) of the Act
The Exchange believes that the proposed rule change is designed to prevent fraudulent and manipulative acts and practices in that the Shares would be listed and traded on the Exchange pursuant to the initial and
The proposed rule change is designed to promote just and equitable principles of trade and to protect investors and the public interest. The Exchange will obtain a representation from each issuer of Shares that the NAV per Share will be calculated on each business day that the New York Stock Exchange is open for trading and that the NAV will be made available to all market participants at the same time. In addition, a large amount of information would be publicly available regarding the Funds and the Shares, thereby promoting market transparency.
Prior to the commencement of market trading in Shares, the Funds will be required to establish and maintain a public Web site through which its current prospectus may be downloaded. The Web site will display additional Fund information updated on a daily basis, including the prior business day's NAV, and the following trading information for such business day expressed as premiums/discounts to NAV: (a) Intraday high, low, average and closing prices of Shares in Exchange trading; (b) the Closing Bid/Ask Midpoint; and (c) the Closing Bid/Ask Spread. The Web site will also contain charts showing the frequency distribution and range of values of trading prices, Closing Bid/Ask Midpoints, and Closing Bid/Ask Spreads over time. The Composition File will be disseminated through the NSCC before the open of trading in Shares on each business day and also will be made available to the public each day on a free Web site. The Exchange will obtain a representation from the issuer of the Shares that the IIV will be calculated and disseminated on an intraday basis at intervals of not more than 15 minutes during trading on the Exchange and provided to Nasdaq for dissemination via GIDS. A complete list of current portfolio positions for the Funds will be made available at least once each calendar quarter, with a reporting lag of not more than 60 days. Funds may provide more frequent disclosures of portfolio positions at their discretion.
Transactions in Shares will be reported to the Consolidated Tape at the time of execution in proxy price format and will be disseminated to member firms and market data services through Nasdaq's trading service and market data interfaces, as defined above. Once each Fund's daily NAV has been calculated and the final price of its intraday Share trades has been determined, Nasdaq will deliver a confirmation with final pricing to the transacting parties. At the end of the day, Nasdaq will also post a newly created FTP file with the final transaction data for the trading and market data services. The Exchange expects that information regarding NAV-based trading prices and volumes of Shares traded will be continuously available on a real-time basis throughout each trading day on brokers' computer screens and other electronic services. Because Shares will trade at prices based on the next-determined NAV, investors will be able to buy and sell individual Shares at a known premium or discount to NAV that they can limit by transacting limit orders at the time of order entry. Trading in Shares will be subject to Nasdaq Rules 5745(d)(2)(B) and (C), which provide for the suspension of trading or trading halts under certain circumstances, including if, in the view of the Exchange, trading in Shares becomes inadvisable.
The proposed rule change is designed to perfect the mechanism of a free and open market and, in general, to protect investors and the public interest in that it will facilitate the listing and trading of the Funds, which seek to provide investors with access to a broad range of actively managed investment strategies in a structure that offers the cost and tax efficiencies and shareholder protections of ETFs, while removing the requirement for daily portfolio holdings disclosure to ensure a tight relationship between market trading prices and NAV.
For the above reasons, Nasdaq believes the proposed rule change is consistent with the requirements of Section 6(b)(5) of the Act.
The Exchange does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. In fact, the Exchange believes that the introduction of the Funds would promote competition by making available to investors a broad range of actively managed investment strategies in a structure that offers the cost and tax efficiencies and shareholder protections of ETFs, while removing the requirement for daily portfolio holdings disclosure to ensure a tight relationship between market trading prices and NAV. Moreover, the Exchange believes that the proposed method of Share trading would provide investors with transparency of trading costs, and the ability to control trading costs using limit orders, that is not available for conventionally traded ETFs.
These developments could significantly enhance competition to the benefit of the markets and investors.
No written comments were either solicited or received.
Within 45 days of the date of publication of this notice in the
(A) By order approve or disapprove such proposed rule change, or
(B) institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Brent J. Fields, Secretary, Securities
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange proposes to amend the Pricing Schedule at Section IV, Part B titled “Flex Transaction Fees” to permit FLEX
The text of the proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to amend Section IV, Part B, related to FLEX pricing, to permit Multiply Listed FLEX options to be eligible for the Section II Strategy Caps.
Today, Customers are not assessed a fee for Multiply Listed FLEX options and Non-Customers are assessed a $0.25 per contract fee for Multiply Listed FLEX options. Further, the Monthly Firm Fee Cap, Monthly Market Maker Cap, and the Options Surcharge in BKX, MNX and NDX described in Section II apply to Multiply Listed FLEX options. No other fees described in Section II apply to Multiply Listed FLEX options. The FLEX transaction fees for a Firm are waived for members executing facilitation orders pursuant to Exchange Rule 1064 when such members are trading in their own proprietary account. In addition, FLEX transaction fees for a Broker-Dealer are waived for members executing facilitation orders pursuant to Exchange Rule 1064 when such members would otherwise incur this charge for trading in their own proprietary account contra to a Customer (“BD-Customer Facilitation”), if the member's BD-Customer Facilitation average daily volume (including both FLEX and non-FLEX transactions) exceeds 10,000 contracts per day in a given month. Finally, Multiply Listed FLEX options are not eligible for Section II strategy caps.
The Exchange proposes to permit Multiply Listed FLEX options to be subject to strategy cap pricing.
The following types of strategies are eligible for the pricing in Section II: dividend strategy,
The Exchange is amending the rule text to include Strategy Caps in the list of Section II pricing which is applicable to Multiply Listed FLEX options. As a result, a Multiply Listed FLEX option transaction that is part of a strategy execution would be included in the Strategy Fee cap. The proposal is designed to encourage members and member organizations to engage in both additional Multiply Listed FLEX option transactions and strategy executions on the Exchange.
The Exchange also proposes to correct a typographical error in Section IV to add a hyphen in the term BD-Customer.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Commission and the courts have repeatedly expressed their preference for competition over regulatory intervention in determining prices, products, and services in the securities markets. In Regulation NMS, while adopting a series of steps to improve the current market model, the Commission highlighted the importance of market forces in determining prices and SRO revenues and, also, recognized that current regulation of the market system “has been remarkably successful in promoting market competition in its broader forms that are most important to investors and listed companies.”
Likewise, in
Further, “[n]o one disputes that competition for order flow is `fierce.' . . . As the SEC explained, `[i]n the U.S. national market system, buyers and sellers of securities, and the broker-dealers that act as their order-routing agents, have a wide range of choices of where to route orders for execution;' [and] `no exchange can afford to take its market share percentages for granted' because `no exchange possesses a monopoly, regulatory or otherwise, in the execution of order flow from broker dealers.' . . .”
The Exchange's proposal to permit Multiply-Listed FLEX options to be eligible for the Section II Strategy Caps is reasonable because including
The Exchange believes that the proposed change is equitable and not unfairly discriminatory because all members and member organizations are eligible to transact Multiply Listed FLEX options and are eligible for the Strategy Fee Cap.
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. In terms of inter-market competition, the Exchange notes that it operates in a highly competitive market in which market participants can readily favor competing venues if they deem fee levels at a particular venue to be excessive, or rebate opportunities available at other venues to be more favorable. In such an environment, the Exchange must continually adjust its fees to remain competitive with other exchanges and with alternative trading systems that have been exempted from compliance with the statutory standards applicable to exchanges. Because competitors are free to modify their own fees in response, and because market participants may readily adjust their order routing practices, the Exchange believes that the degree to which fee changes in this market may impose any burden on competition is extremely limited.
The pricing proposed herein are intended to continue to incentivize market participants to execute additional Multiply Listed FLEX options and strategy executions on the Exchange and for this reason imposes no inter-market burden on competition. The proposal could increase competition on the Exchange by including Multiply Listed FLEX option transactions in the Strategy Fee Cap. This could result in members and member organizations engaging in both additional Multiply Listed FLEX option transactions and strategy executions in order to reach the fee cap levels. The proposed change could also increase competition between the Exchange and other option markets by making the Exchange a more desirable market with respect to pricing for Multiply Listed FLEX option transactions and strategy executions.
If the changes proposed herein are unattractive to market participants, it is likely that the Exchange will lose market share as a result. Accordingly, the Exchange does not believe that the proposed changes will impair the ability of members or competing order execution venues to maintain their competitive standing in the financial markets.
The Exchange's proposal to permit Multiply Listed FLEX options to be eligible for the Section II Strategy Caps does not impose an undue burden on intra-market competition because all members and member organizations are eligible to transact Multiply Listed FLEX options and are eligible for the Strategy Fee Cap.
No written comments were either solicited or received.
Within 45 days of the date of publication of this notice in the
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 SR-Phlx-2016-100 and should be submitted on or before November 7, 2016
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (“PRA”) (44 U.S.C. 3501
Rule 17a-4 requires approximately 4,104 active, registered exchange members, brokers and dealers (“broker-dealers”) to preserve for prescribed periods of time certain records required to be made by Rule 17a-3 and other Commission rules, and other kinds of records which firms make or receive in the ordinary course of business. Rule 17a-4 also permits broker-dealers to employ, under certain conditions, electronic storage media to maintain these required records. The records required to be maintained under Rule 17a-4 are used by examiners and other representatives of the Commission to determine whether broker-dealers are in compliance with, and to enforce their compliance with, the Commission's rules.
There are approximately 4,104 active, registered broker-dealers. The staff estimates that the average amount of time necessary to preserve the books and records as required by Rule 17a-4 is 254 hours per broker-dealer per year. In addition, the Commission is moving into this information collection the annual burden hours for paragraph (b)(11) of Rule 17a-4, which requires any broker-dealer that sponsors an internal broker-dealer system to maintain certain records relating to such system for at least three years. The Commission estimates that paragraph (b)(11) of Rule 17a-4 imposes an annual burden of 3 hours per year to maintain the requisite records. The Commission estimates that there are approximately 150 internal broker-dealer systems, resulting in an annual recordkeeping burden of 450 hours. Therefore, the Commission estimates that compliance with Rule 17a-4 requires 1,042,866 hours each year ((4,104 broker-dealers × 254 hours) + (150 broker-dealers × 3 hours). These burdens are recordkeeping burdens.
The staff believes that compliance personnel would be charged with ensuring compliance with Commission regulation, including Rule 17a-4. The staff estimates that the hourly salary of a Compliance Clerk is $65 per hour.
Based on conversations with members of the securities industry and the Commission's experience in the area, the staff estimates that the average broker-dealer spends approximately $5,000 each year to store documents required to be retained under Rule 17a-4. Costs include the cost of physical space, computer hardware and software, etc., which vary widely depending on the size of the broker-dealer and the type of storage media employed. The Commission estimates that the annual reporting and recordkeeping cost burden is $20,520,000. This cost is calculated by the number of active, registered broker-dealers multiplied by the reporting and recordkeeping cost for each respondent (4,104 active, registered broker-dealers × $5,000).
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information under the PRA unless it displays a currently valid OMB control number.
The public may view the background documentation for this information collection at the following Web site:
Pursuant to Section 19(b)(1)
The Exchange proposes to amend its rules to remove definitions and trading rules that are no longer operative after the completed full migration of all symbols to the Pillar trading platform. 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 its rules to remove definitions and trading rules that are no longer operative after the completed full migration of all symbols to the Pillar trading platform. The Exchange proposes to delete superseded rules that were applicable only to the prior trading system and to delete the “P” modifier that distinguished the Pillar trading rules from the now obsolete rules.
On April 30, 2015, the Exchange filed the first of four proposed rule changes (the “first Pillar filing”) to adopt new equity trading rules to reflect the implementation of Pillar, the Exchange's new integrated trading technology platform designed to use a single specification for connecting to the equities and options markets operated by NYSE Arca and its affiliates, New York Stock Exchange LLC and NYSE MKT LLC.
In the first Pillar filing, the Exchange anticipated rolling out the new Pillar technology platform over a period of time based upon a range of symbols. Consequently, the Exchange also proposed that it would continue to operate under its then-current trading rules for symbols that had not yet migrated to Pillar, pending the complete migration of all symbols to Pillar and the retirement of the old trading system. As proposed, the new rules governing trading on Pillar would have the same numbering as current rules, but with the modifier “P” appended to the rule number during this interim period. In addition, the Exchange proposed adding to its rulebook new “P” definitions and introductory Pillar rule text. Once all symbols had migrated to the Pillar platform, the Exchange would file a rule proposal to delete the obsolete rules, definitions and introductory Pillar rule text that were no longer operative, as well as the “P” modifiers that distinguished the interim rules.
The migration of all symbols to Pillar having been completed, the Exchange now proposes to amend its rules to delete the rules, definitions and introductory rule text that are no longer operative or necessary, as well as the “P” modifiers. The Exchange believes that removing the obsolete references that no longer have any impact on trading would add greater clarity to its rules and promote market transparency and efficiency. The rule filing history for Exchange rules that is maintained on the Exchange's Web site will reflect the prior rule filing history of the deleted trading rule in order to further promote clarity and transparency.
Specifically, the Exchange proposes within the “Rule 1 Definitions” section of the rule book:
• Deleting the introductory language that explained the use of the “P” modifier;
• Deleting the obsolete definition “NYSE Arca Book”, that now has been superseded by the equivalent Pillar definition, and deleting the “P” modifier in the remaining Pillar definition;
• Deleting the definition “Imbalance” that was linked to former Rule 7.35;
• Deleting the definition “Indicative Match Price” that also was linked to former Rule 7.35;
• Deleting the definition “NOW Recipient”, that now has been superseded by the equivalent Pillar definition of “Away Market”, and deleting the “P” modifier in the remaining Pillar definition; and
• Deleting the “P” modifier in the definition “Official Closing Price”.
Specifically, the Exchange proposes within the “Rule 7 Equities Trading” section of the rule book:
• Deleting the preamble following Rule 7 that explains the use of the “P” modifier;
• Deleting obsolete Rule 7.10 “Clearly Erroneous Executions” that has been superseded by the equivalent Pillar Rule 7.10P of the same caption, deleting the “P” modifiers in the remaining rule;
• Deleting obsolete Rule 7.11 “Limit Up-Limit Down Plan and Trading Pauses in Individual Securities Due to Extraordinary Market Volatility” that has been superseded by the equivalent Pillar Rule 7.11P of the same caption, deleting the “P” modifiers in the remaining rule;
• Deleting obsolete Rule 7.16 “Short Sales” that has been superseded by the equivalent Pillar Rule 7.16P of the same caption, deleting the “P” modifier in the remaining rule;
• Deleting obsolete Rule 7.18 “UTP Regulatory Halts” that has been superseded by the equivalent Pillar Rule 7.18P “Halts”, deleting the “P” modifier in the remaining rule;
• Deleting obsolete Rule 7.31 “Orders and Modifiers” that has been superseded by the equivalent Pillar Rule 7.31P of the same caption, deleting the “P” modifiers in the remaining rule;
• Deleting obsolete Rule 7.34 “Trading Sessions” that has been replaced by the equivalent Pillar Rule 7.34P of the same caption, deleting the “P” modifiers in the remaining rule;
• Deleting obsolete Rule 7.35 “Auctions” that has been superseded by the equivalent Pillar Rule 7.35P of the same caption, deleting the “P” modifiers in the remaining rule;
• Deleting obsolete Rule 7.36 “Order Ranking and Display” that has been superseded by the equivalent Pillar Rule 7.36P of the same caption, deleting the “P” modifiers in the remaining rule;
• Deleting obsolete Rule 7.37 “Order Execution” that has been superseded by the equivalent Pillar Rule 7.37P “Order Execution and Routing”, deleting the “P” modifiers in the remaining rule;
• Deleting obsolete Rule 7.38 “Odd and Mixed Lots” that has been superseded by the equivalent Pillar Rule 7.38P of the same caption, deleting the “P” modifiers in the remaining rule; and
• Deleting obsolete Rule 7.44 “Retail Liquidity Program” that has been superseded by the equivalent Pillar Rule 7.44P of the same caption, deleting the “P” modifiers in the remaining rule.
The proposed rule changes are consistent with Section 6(b) of the Act,
In particular, the Exchange believes that amending its rules to remove definitions and trading rules that are no longer operative after the completed full migration of all symbols to the Pillar trading system would promote the protection of investors and the public interest because it would promote clarity and transparency in Exchange rules governing what rules govern trading on the Exchange. The Exchange further believes that deleting superseded rules that were applicable only to the prior trading system, and deleting the “P” modifier that distinguished the Pillar trading rules from the now obsolete rules during this transitional period to a single trading platform and a single set of rules governing trading, would remove impediments to and perfect the mechanism of a national market system because these proposed changes would add greater clarity to the Exchange's rules and promote market transparency and efficiency.
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 rule change is not designed to address competitive issues but rather is designed to ensure a fair and orderly market by removing definitions and trading rules that are no longer operative after the completed full migration of all symbols to the Pillar trading system. As such, the proposed rule changes are intended to promote greater efficiency and transparency concerning trading on the Exchange.
No written comments were solicited or received with respect to the proposed rule change.
Because the proposed rule change does not (i) significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act
A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule change should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
In the Matter of: AB Private Credit Investors Corporation, AB Private Credit Investors Middle Market Direct Lending Fund, L.P., AB Energy Opportunity Fund, L.P., AB Private Credit Investors LLC, 1345 Avenue of the Americas, New York, NY 10105, (812-14453)
AB Private Credit Investors Corporation, AB Private Credit Investors Middle Market Direct Lending Fund, L.P., AB Energy Opportunity Fund, L.P., and AB Private Credit Investors LLC filed an application on April 30, 2015, and amendments to the application on October 5, 2015, and May 24, 2016, requesting an order under sections 17(d) and 57(i) of the Investment Company Act of 1940 (the “Act”) and rule 17d-1 under the Act that would permit certain joint transactions otherwise prohibited by sections 17(d) and 57(a)(4) of the Act and rule 17d-1 under the Act. The order would permit a business development company and certain closed end investment companies (collectively, the “Regulated Funds”) to co-invest in portfolio companies with each other and with affiliated investment funds.
On September 13, 2016, a notice of the filing of the application was issued (Investment Company Act Release No. 32261). The notice gave interested persons an opportunity to request a hearing and stated that an order disposing of the application would be issued unless a hearing was ordered. No request for a hearing has been filed, and the Commission has not ordered a hearing.
The matter has been considered and it is found, on the basis of the information set forth in the application, as amended, that participation by the Regulated Funds in the proposed transactions is consistent with the provisions, policies and purposes of the Act and is on a basis no less advantageous than that of other participants.
Accordingly,
It is ordered, under sections 17(d) and 57(i) of the Act and rule 17d-1 under the Act, that the relief requested by AB Private Credit Investors Corporation,
For the Commission, by the Division of Investment Management, under delegated authority.
Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), E.O. 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681,
For further information, including a list of the imported objects, contact the Office of Public Diplomacy and Public Affairs in the Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
The Industry Advisory Group (IAG) of the Bureau of Overseas Buildings Operations (OBO) will meet on Thursday, November 3 from 2:00 p.m. until 4:00 p.m. Eastern Daylight Time. The meeting is open to the public and will be held in the Loy Henderson Conference Room of the U.S. Department of State, located at 2201 C Street NW., (entrance on 23rd Street) Washington, DC For logistical and security reasons, the public must enter and exit the building using only the 23rd Street entrance.
This committee serves the U.S. Government in a solely advisory capacity concerning industry and academia's latest concepts, methods, best practices, innovations, and ideas related to OBO's mission to provide safe, secure, and functional facilities that represent the U.S. Government to the host nation and support our staff in the achievement of U.S. foreign policy objectives. These facilities should represent American values and the best in American architecture, engineering, technology, sustainability, art, culture, and construction execution.
The majority of the meeting will be devoted to discussions between the Department's senior management and IAG representatives with respect to industry and academia's latest concepts, methods, best practices, innovations and ideas related to property management that are applicable to OBO's vital mission. Reasonable time will be provided for members of the public to provide comment.
Admittance to the State Department building will be by means of a pre-arranged clearance list. To register for the meeting, please visit the OBO Web site at
Personal data is requested pursuant to Public Law 99-399 (Omnibus Diplomatic Security and Antiterrorism Act of 1986), as amended; Public Law 107-56 (USA PATRIOT Act); and Executive Order 13356. The purpose of the collection is to validate the identity of individuals who enter Department facilities. The data will be entered into the Visitor Access Control System (VACS-D) database.
Please see the Security Records System of Records Notice (State-36) at
Please contact
Department of State.
Notice.
The U.S. Department of State (Department) will host a listening session to solicit public comments on the development and content of a strategy to address global water challenges including, but not necessarily limited to: (1) Increasing access to safe drinking water, sanitation, and hygiene; (2) improving water resource management; and (3) promoting cooperation on shared waters. Participants will be asked to provide brief remarks (up to 3 minutes) highlighting specific challenges that should be addressed and opportunities to strengthen U.S. engagement on international water issues.
This session will take place on Friday, October 28 from 1:00-4:00 p.m. in the George C. Marshall Center at the U.S. Department of State, 2201 C St. NW., (21st Street Entrance), Washington, DC. Attendees must confirm their attendance at
Written comments may be submitted to
Written, electronic, and oral comments will be given equal weight and the Department will consider all comments received or postmarked by November 12, 2016. Comments received or postmarked after that date may be considered to the extent practicable.
For information contact Global Water Strategy Manager at the address listed in
Legislation regarding U.S. efforts on international water and sanitation issues include the Senator Paul Simon Water for the Poor Act of 2005 (found at:
Previous Reports to Congress on the implementation of the Senator Paul Simon Water for the Poor Act can be found at:
Surface Transportation Board.
Notice of roundtable discussion.
The Board will host a roundtable discussion among noted economists on an independent report that assesses the Board's rate reasonableness methodologies, including the stand-alone cost methodology, and possible alternatives.
The roundtable discussion will take place on Tuesday, October 25, 2016, from 10:00 a.m. to 12:30 p.m.
The roundtable discussion will be held in the Hearing Room on the first floor of the Board's headquarters at Patriot's Plaza, 395 E Street SW., Washington, DC 20423-0001.
Nathaniel Bawcombe: (202) 245-0376. [Assistance for the hearing impaired is available through the Federal Information Relay Service (FIRS) at 1-800-877-8339.]
The Board commissioned a study by InterVISTAS Consulting LLC (InterVISTAS) in late 2014, and the study was released by the Board on September 22, 2016. The Board asked for an independent assessment of its stand-alone cost (SAC) rate reasonableness methodology and possible alternatives. Among other things, the scope of the work required InterVISTAS to look for alternative methodologies to SAC that could be used to reduce the time, complexity, and expense historically involved in rate cases; determine whether SAC is sufficient for large rate cases; and whether the Board's simplified methodologies were appropriate alternatives to SAC. The report is available at
To promote discourse on these issues, the Board will hold an economic roundtable regarding the issues and conclusions presented in the report. The panel will include the following independent and government economists:
The roundtable discussion will be open for public observation but not public participation. In addition, the discussion will be available on the Board's Web site by live video streaming. To access the roundtable,
By the Board, Rachel D. Campbell, Director, Office of Proceedings.
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 November 7, 2016.
Send comments identified by docket number FAA-2016-6880 using any of the following methods:
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Deana Stedman, ANM-113, Federal Aviation Administration, 1601 Lind Avenue SW., Renton, WA 98057-3356, email
This notice is published pursuant to 14 CFR 11.85.
Docket No.: FAA-2016-6880.
Petitioner: 501ZD.
Section of 14 CFR Affected: § 25.841(a).
Description of Relief Sought: 501ZD has requested that the FAA allow a Cessna Citation 500 airplane to operate to a maximum cruise altitude of 41,000 feet without incorporating the provisions of Cessna/Textron Service Bulletin SB500-21-9. This would result in a maximum cabin pressure altitude of 10,000 feet during 14 CFR part 91 operations. Section 25.841(a) allows a maximum cabin pressure altitude of not more than 8,000 feet under normal operating conditions.
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of renewal of exemptions; request for comments.
FMCSA announces its decision to renew exemptions of three individuals from the requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) that interstate commercial motor vehicle (CMV) drivers have “no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause loss of consciousness or any loss of ability to control a CMV.” The exemptions enable these individuals who have had one or more seizures and are taking anti-seizure medication to continue to operate CMVs in interstate commerce.
The exemptions were effective on August 28, 2016. The exemptions will expire on August 28, 2018. Comments must be received on or before November 16, 2016.
You may submit comments bearing the Federal Docket Management System (FDMS) Docket No. FMCSA-2014-0212 using any of the following methods:
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Ms. Christine A. Hydock, Chief, Medical Programs Division, 202-366-4001,
Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption for two years 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 two-year period.
The physical qualification standard for drivers regarding epilepsy found in 49 CFR 391.41(b)(8) states that a person is physically qualified to drive a CMV if that person:
Has no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause the loss of consciousness or any loss of ability to control a CMV.
In addition to the regulations, FMCSA has published advisory criteria to assist Medical Examiners in determining whether drivers with certain medical conditions are qualified to operate a CMV in interstate commerce. [49 CFR part 391, APPENDIX A TO PART 391—MEDICAL ADVISORY CRITERIA, section H. Epilepsy: § 391.41(b)(8), paragraphs 3, 4, and 5.]
The three individuals listed in this notice have requested renewal of their exemptions from the Epilepsy and Seizure Disorders prohibition in 49 CFR 391.41(b)(8), in accordance with FMCSA procedures. Accordingly, FMCSA has evaluated these applications for renewal on their merits and decided to extend each exemption for a renewable two-year period.
Interested parties or organizations possessing information that would otherwise show that any, or all, of these drivers are not currently achieving the statutory level of safety should immediately notify FMCSA. The Agency will evaluate any adverse evidence submitted and, if safety is being compromised or if continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136(e) and 31315, FMCSA will take immediate steps to revoke the exemption of a driver.
Under 49 U.S.C. 31315(b)(1), an exemption may be granted for no longer than two years from its approval date and may be renewed upon application. In accordance with 49 U.S.C. 31136(e) and 31315, each of the three applicants has satisfied the conditions for obtaining an exemption from the Epilepsy and Seizure Disorder requirements and were published in the
The three drivers in this notice remain in good standing with the Agency, have maintained their medical monitoring and have not exhibited any medical issues that would compromise their ability to safely operate a CMV during the previous two-year exemption period. FMCSA has concluded that renewing the exemptions for each of these applicants is likely to achieve a level of safety equal to that existing without the exemption. Therefore, FMCSA has decided to renew each exemption for a two-year period. In accordance with 49 U.S.C. 31136(e) and 31315, each driver has received a renewed exemption.
As of August 28, 2016, the following three individuals have satisfied the renewal conditions for obtaining an exemption from the Epilepsy and Seizure Disorders prohibition in 49 CFR 391.41(b)(8), from driving CMVs in interstate commerce (79 FR 73394): Peter Bender (MN); Terry Hamby (NC); and Louis Lerch (IA).
These drivers were included in FMCSA-2014-0212. The exemptions were effective on August 28, 2016, and will expire on August 28, 2018.
The exemptions are extended subject to the following conditions: (1) Each driver must remain seizure-free and maintain a stable treatment during the two-year exemption period; (2) each driver must submit annual reports from their treating physicians attesting to the stability of treatment and that the driver has remained seizure-free; (3) each driver must undergo an annual medical examination by a certified Medical Examiner, as defined by 49 CFR 390.5; and (4) each driver must provide a copy of the annual medical certification to the employer for retention in the driver's qualification file, or keep a copy of his/her driver's qualification file if he/she is self-employed. The driver must also have a copy of the exemption when driving, for presentation to a duly authorized Federal, State, or local enforcement official. The exemption will be rescinded if: (1) The person fails to comply with the terms and conditions of the exemption; (2) the exemption has resulted in a lower level of safety than was maintained before it was granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136(e) and 31315.
During the period the exemption is in effect, no State shall enforce any law or regulation that conflicts with this exemption with respect to a person operating under the exemption.
Based upon its evaluation of the three exemption applications, FMCSA renews the exemptions of the aforementioned drivers from the Epilepsy and Seizure Disorders requirement in 49 CFR 391.41 (b)(8). In accordance with 49 U.S.C. 31136(e) and 31315, each exemption will be valid for two years unless revoked earlier by FMCSA.
Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.
Notice.
The purpose of this policy statement is to advise pipeline owners and operators that the Pipeline and Hazardous Materials Safety Administration (PHMSA) has now made a civil penalty framework accessible on its Web site and, effective October 17, 2016, a respondent in an enforcement case may request a proposed civil penalty calculation related to that case. It further advises pipeline owners and operators that PHMSA will, as appropriate, issue higher penalties in order to apply stronger deterrence and drive down incident risk.
A respondent in an enforcement case may request the proposed civil penalty calculation associated with its case, effective October 17, 2016. In addition, the civil penalty summary attached to this policy statement is now available on PHMSA's Web site.
Rod Dyck, Enforcement Director,
In accordance with chapter 601 of Title 49, United States Code, after notice and an opportunity for a hearing, the Associate Administrator may assess a civil penalty for a violation of a pipeline safety regulation or order (49 U.S.C. 60122). In order to provide summary guidance to operators about the penalty ranges for proposed penalties, PHMSA currently provides a civil penalty framework upon request, as referenced in an earlier notice “Pipeline Safety: Administrative Procedures; Updates and Technical Corrections” (78 FR 58897; September 25, 2013). PHMSA will now post the civil penalty framework on its Web site in order to provide greater transparency regarding administrative civil penalties. This summary will be updated periodically and is available at
PHMSA's proposed penalty calculation methodology is based upon 49 U.S.C. 60122 and 49 CFR 190.225. The Associate Administrator must consider:
(1) The nature, circumstances and gravity of the violation, including adverse impact on the environment; (2) The degree of the respondent's culpability; (3) The respondent's history of prior offenses; (4) Any good faith by the respondent in attempting to achieve compliance; and (5) The effect on the respondent's ability to continue in business. The Associate Administrator may consider: (1) The economic benefit gained from violation, if readily ascertainable, without any reduction because of subsequent damages; and (2) Such other matters as justice may require.
Consistent with this statutory direction, enforcement personnel use a proposed civil penalty calculation to document consideration of these factors and how its personnel arrive at a proposed civil penalty.
The Pipeline Safety Act of 2011 (“the 2011 Act”) increased the maximum administrative civil penalties for violation of the pipeline safety laws and regulations to $200,000 per violation per day, with a maximum of $2,000,000 for a related series of violations. These administrative civil penalty maximums apply to violations that occur or are discovered after January 3, 2012. In order to apply stronger deterrence and drive down incident risk, PHMSA intends to exercise its current authority, as appropriate, which will result in higher penalties across the board for any violation of Federal pipeline safety standards. In addition, PHMSA will give greater weight to certain factors when assessing civil penalties, specifically for violations that: (1) Are causal to incidents or that increase the severity of incidents, including those involving smaller hazardous liquid spills or resulting in methane releases; (2) are “repeat offenses” or violations of the same safety standard in the past five years; and (3) involve multiple instances of the same violation. Finally, PHMSA recently increased its maximum civil penalties to account for changes in inflation. (Pipeline Safety: Inflation Adjustment of Maximum Civil Penalties, 81 FR 42564, June 30, 2016).
Administrative civil penalties constitute only one of the enforcement tools that PHMSA employs to promote compliance with the pipeline safety regulations. While PHMSA is providing greater transparency to the regulated community, the agency retains broad discretion in its evaluation of the assessment considerations outlined in its regulations. The release of these additional materials regarding the proposed calculation of civil penalties will not otherwise alter the administrative enforcement process.
This summary provides a general overview to assist the public in understanding civil penalty calculations. Following an inspection or investigation of a pipeline facility that reveals a probable violation, the Office of Pipeline Safety prepares a Violation Report to document the violation. For any violation that warrants a civil penalty, data from the completed Violation Report is used to calculate risk-based civil penalties considering the statutory assessment factors in 49 U.S.C. 60122 and 49 CFR 190.225.
The assessment factors are listed below in the left side column of the table. The middle column explains the range of potential conduct that was observed by PHMSA in connection with the violation, generally from least to most severe. A Violation Report must make a selection within this range for each assessment factor. The right side column provides a range for the civil penalty that may be assessed under each assessment factor.
A civil penalty for a single violation is arrived at by combining the amounts assigned under each assessment factor. Application of the assessment factors in an individual case will depend on the facts specific to that case.
The total civil penalty per violation is calculated based on these assessment considerations and adjusted for the applicable daily and series limit. If a calculated penalty exceeds the maximum amount permitted by statute, the penalty will be reduced by the amount exceeding the cap. An administrative civil penalty under 49 U.S.C. 60122(a)(1) is capped at $200,000 per day for violations occurring after January 3, 2012. The maximum civil penalty for a related series of violations is $2,000,000 for violations occurring after January 3, 2012.
For an administrative civil penalty that occurs on or after August 1, 2016, the maximum civil penalty limit was increased to $205,638 per day and $2,056,380 for a related series of violations pursuant to the requirements of Section 701 of the “Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015” (Pub. L. 114-72), which amended the “Federal Civil Penalties Inflation Adjustment Act of 1990” (Pub. L. 101-410) (Inflation Adjustment Act).
Notice is hereby given, pursuant to 5 U.S.C. App. 2, 10(a)(2), that a meeting will be held at the Hay-Adams Hotel, 16th Street and Pennsylvania Avenue NW., Washington, DC, on November 1, 2016 at 10:00 a.m. of the following debt management advisory committee: Treasury Borrowing Advisory Committee of The Securities Industry and Financial Markets Association.
The agenda for the meeting provides for a charge by the Secretary of the Treasury or his designate that the Committee discuss particular issues and conduct a working session. Following the working session, the Committee will present a written report of its recommendations. The meeting will be closed to the public, pursuant to 5 U.S.C. App. 2, 10(d) and Public Law 103-202, 202(c)(1)(B) (31 U.S.C. 3121 note).
This notice shall constitute my determination, pursuant to the authority placed in heads of agencies by 5 U.S.C. App. 2, 10(d) and vested in me by Treasury Department Order No. 101-05, that the meeting will consist of discussions and debates of the issues presented to the Committee by the Secretary of the Treasury and the making of recommendations of the Committee to the Secretary, pursuant to Public Law 103-202, 202(c)(1)(B). Thus, this information is exempt from disclosure under that provision and 5 U.S.C. 552b(c)(3)(B). In addition, the meeting is concerned with information-that is exempt from disclosure under 5 U.S.C. 552b(c)(9)(A). The public interest requires that such meetings be closed to the public because the Treasury Department requires frank and full advice from representatives of the financial community prior to making its final decisions on major financing operations. Historically, this advice has been offered by debt management advisory committees established by the several major segments of the financial community. When so utilized, such a committee is recognized to be an advisory committee under 5 U.S.C. App. 2, 3.
Although the Treasury's final announcement of financing plans may not reflect the recommendations provided in reports of the Committee, premature disclosure of the Committees deliberations and reports would be likely to lead to significant financial speculation in the securities market. Thus, this meeting falls within the exemption covered by 5 U.S.C. 552b(c)(9)(A).
Treasury staff will provide a technical briefing to the press on the day before the Committee meeting, following the release of a statement of economic conditions and financing estimates. This briefing will give the press an opportunity to ask questions about financing projections. The day after the Committee meeting, Treasury will release the minutes of the meeting, any charts that were discussed at the meeting, and the Committee's report to the Secretary.
The Office of Debt Management is responsible for maintaining records of debt management advisory committee meetings and for providing annual reports setting forth a summary of Committee activities and such other matters as may be informative to the public consistent with the policy of 5 U.S.C. 552(b). The Designated Federal Officer or other responsible agency official who may be contacted for additional information is Fred Pietrangeli, Director for Office of Debt Management (202) 622-1876.
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 |