| Page Range | 63667-63888 | |
| FR Document |
| Page and Subject | |
|---|---|
| 80 FR 63887 - Minority Enterprise Development Week, 2015 | |
| 80 FR 63849 - Sunshine Act; Notice of Public Meeting | |
| 80 FR 63849 - Temporary Emergency Committee of the Board of Governors; Sunshine Act Meeting | |
| 80 FR 63840 - Sunshine Act Meeting | |
| 80 FR 63787 - Sunshine Act; Notice of Meeting | |
| 80 FR 63784 - Sunshine Act Meeting; Open Commission Meeting Thursday, October 22, 2015 | |
| 80 FR 63691 - Texas: Final Authorization of State Hazardous Waste Management Program Revision | |
| 80 FR 63734 - Texas: Final Authorization of State Hazardous Waste Management Program Revisions | |
| 80 FR 63779 - Proposed Consent Decree, Clean Air Act Citizen Suit | |
| 80 FR 63781 - Proposed CERCLA Administrative Cost Recovery Settlement: Peabody Street Asbestos Superfund Site, Salem, Massachusetts | |
| 80 FR 63782 - Proposed Consent Decree, Clean Air Act Citizen Suit | |
| 80 FR 63731 - Receipt of Several Pesticide Petitions Filed for Residues of Pesticide Chemicals in or on Various Commodities | |
| 80 FR 63737 - Privacy Act of 1974; Amended System of Records | |
| 80 FR 63745 - Certain Hot-Rolled Steel Flat Products From Brazil, the Republic of Korea, and Turkey: Postponement of Preliminary Determinations in the Countervailing Duty Investigations | |
| 80 FR 63862 - California-Arizona Meeting of the Binational Bridges and Border Crossings Group in Washington, DC | |
| 80 FR 63780 - Notice of Public Meeting and Webinar and Request for Comment on the Draft Document “Technologies for Legionella Control: Scientific Literature Review” | |
| 80 FR 63781 - Clean Air Act Advisory Committee (CAAAC): Notice of Meeting | |
| 80 FR 63747 - Schedule for Atlantic Shark Identification Workshop | |
| 80 FR 63741 - Boltless Steel Shelving Units Prepackaged for Sale From the People's Republic of China: Antidumping Duty Order | |
| 80 FR 63745 - Boltless Steel Shelving Units Prepackaged for Sale From the People's Republic of China: Amended Final Affirmative Countervailing Duty Determination and Countervailing Duty Order | |
| 80 FR 63741 - Freshwater Crawfish Tail Meat From the People's Republic of China: Initiation of Antidumping Duty New Shipper Review | |
| 80 FR 63743 - Crystalline Silicon Photovoltaic Cells, Whether or Not Assembled Into Modules, From the People's Republic of China: Preliminary Results of the Changed Circumstances Review | |
| 80 FR 63786 - Notice of Agreements Filed | |
| 80 FR 63748 - Submission for OMB Review; Comment Request | |
| 80 FR 63790 - Meeting: World Trade Center Health Program Scientific/Technical Advisory Committee (WTCHP STAC or Advisory Committee), National Institute for Occupational Safety and Health (NIOSH) | |
| 80 FR 63792 - Meeting: Clinical Laboratory Improvement Advisory Committee | |
| 80 FR 63791 - Meeting: Advisory Board on Radiation and Worker Health (ABRWH or Advisory Board), National Institute for Occupational Safety and Health (NIOSH) | |
| 80 FR 63785 - Radio Broadcasting Services; AM or FM Proposals To Change the Community of License | |
| 80 FR 63678 - Safety Zone; 520 Bridge Construction, Lake Washington, Seattle, WA | |
| 80 FR 63809 - Announcement of Requirements and Registration for the National Heart, Lung, and Blood Institute “Novel, Innovative Tools To Increase Public Awareness and Knowledge of Sickle Cell Disease Undergraduate Challenge” | |
| 80 FR 63812 - Notice of Issuance of Final Determination Concerning Certain Billiards Tables | |
| 80 FR 63817 - Announcement of the Modification of the National Customs Automation Program Test Concerning the Automated Commercial Environment Portal Account To Establish the Exporter Portal Account | |
| 80 FR 63735 - Detection and Avoidance of Counterfeit Electronic Parts-Further Implementation (DFARS Case 2014-D005) | |
| 80 FR 63822 - Implementation of the Tribal HUD-VA Supportive Housing Program | |
| 80 FR 63717 - Returning Evidence at the Appeals Council Level | |
| 80 FR 63841 - Texas Engineering Experiment Station/Texas A&M University System Nuclear Science Center Reactor | |
| 80 FR 63677 - Drawbridge Operation Regulation; Upper Mississippi River, Dubuque, IA | |
| 80 FR 63752 - Agency Information Collection Extension | |
| 80 FR 63843 - Fuel Retrievability | |
| 80 FR 63753 - Environmental Management Site-Specific Advisory Board, Hanford | |
| 80 FR 63845 - Geologic Trench Excavation for Paleoliquefaction Study at Garner and Stiles Sites | |
| 80 FR 63846 - Procedures for Meetings | |
| 80 FR 63842 - Advisory Committee on Reactor Safeguards (ACRS) Meeting of the ACRS Subcommittee on Planning and Procedures; Notice of Meeting | |
| 80 FR 63749 - Privacy Act of 1974; System of Records | |
| 80 FR 63842 - Advisory Committee on Reactor Safeguards (ACRS), Meeting of the ACRS Subcommittee on Metallurgy and Reactor Fuels; Notice of Meeting | |
| 80 FR 63846 - Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS Subcommittee on Digital I&C; Notice of Meeting | |
| 80 FR 63882 - Disciplinary Appeals Board Panel | |
| 80 FR 63871 - Indiana Southern Railroad, LLC-Temporary Trackage Rights Exemption-Norfolk Southern Railway Company | |
| 80 FR 63783 - Notice of Meeting of the EPA Children's Health Protection Advisory Committee (CHPAC) | |
| 80 FR 63881 - Notice of Availability of the Record of Decision (ROD) for the San Francisco VA Medical Center Long Range Development Plan and Environmental Impact Statement, San Francisco VA Medical Center | |
| 80 FR 63754 - City of Rochester, Minnesota Board of Public Utilities; Notice of Filing | |
| 80 FR 63761 - Empire State Hydro 301, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications | |
| 80 FR 63766 - Combined Notice of Filings | |
| 80 FR 63759 - Commission Information Collection Activities (FERC-914); Comment Request | |
| 80 FR 63667 - Commencement of Assessment of Annual Charges | |
| 80 FR 63755 - Commission Information Collection Activities (FERC-732); Comment Request | |
| 80 FR 63768 - Before Commissioners: Norman C. Bay, Chairman; Philip D. Moeller, Cheryl A. LaFleur, Tony Clark, and Colette D. Honorable; Public Service Company of New Mexico, Order Accepting Notice of Change in Status, Rejecting, Without Prejudice, Request for Market-Based Rate Authorization and Providing Clarification on Submitting Delivered Price Test Analyses and Simultaneous Transmission Import Limit Studies | |
| 80 FR 63757 - Mojave Water Agency; Notice of Preliminary Determination of a Qualifying Conduit Hydropower Facility and Soliciting Comments and Motions To Intervene | |
| 80 FR 63807 - National Cancer Institute; Notice of Closed Meetings | |
| 80 FR 63809 - National Institute on Aging; Notice of Closed Meeting | |
| 80 FR 63808 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting | |
| 80 FR 63759 - San Gorgonio Westwinds II-Windustries, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
| 80 FR 63754 - Tallbear Seville LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
| 80 FR 63753 - Seville Solar Two LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
| 80 FR 63765 - Combined Notice of Filings | |
| 80 FR 63766 - Combined Notice of Filings #2 | |
| 80 FR 63755 - Combined Notice of Filings #1 | |
| 80 FR 63762 - Seville Solar One LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
| 80 FR 63762 - Combined Notice of Filings | |
| 80 FR 63763 - Combined Notice of Filings #2 | |
| 80 FR 63763 - Combined Notice of Filings #1 | |
| 80 FR 63764 - Combined Notice of Filings #2 | |
| 80 FR 63758 - Combined Notice of Filings #1 | |
| 80 FR 63761 - Combined Notice of Filings #2 | |
| 80 FR 63756 - Records Governing Off-the-Record Communications; Public Notice | |
| 80 FR 63767 - Combined Notice of Filings #1 | |
| 80 FR 63863 - Qualification of Drivers; Exemption Applications; Diabetes Mellitus | |
| 80 FR 63869 - Qualification of Drivers; Exemption Applications; Vision | |
| 80 FR 63873 - Unblocking of Specially Designated Nationals and Blocked Persons Pursuant to Executive Order 12978 | |
| 80 FR 63873 - Unblocking of Specially Designated Nationals and Blocked Persons Pursuant to the Foreign Narcotics Kingpin Designation Act | |
| 80 FR 63872 - Additional Designations, Foreign Narcotics Kingpin Designation Act | |
| 80 FR 63832 - Notice of Public Meetings, Southwest Colorado Resource Advisory Council Oil and Gas Sub-Group | |
| 80 FR 63830 - Draft Habitat Conservation Plan and Draft Environmental Assessment; Kaufman Properties, Thurston County, Washington | |
| 80 FR 63787 - Keystone Orthopaedic Specialists, LLC and Orthopaedic Associates of Reading, Ltd.; Analysis To Aid Public Comment | |
| 80 FR 63785 - FDIC Advisory Committee on Community Banking; Notice of Meeting | |
| 80 FR 63740 - Sensors and Instrumentation Technical Advisory Committee; Notice of Open Meeting | |
| 80 FR 63848 - New Postal Product | |
| 80 FR 63847 - Information Collection Request; Submission for OMB Review | |
| 80 FR 63832 - Notice of Open Public Meeting and Teleconference for the National Park Service Alaska Region's Subsistence Resource Commission Program | |
| 80 FR 63835 - Bulk Manufacturer of Controlled Substances Application: Chattem Chemicals, Inc. | |
| 80 FR 63737 - Notice of Public Meeting of the Indiana Advisory Committee To Begin Planning a Series of Public Hearings To Study Civil Rights and the School to Prison Pipeline in Indiana | |
| 80 FR 63859 - Self-Regulatory Organizations; EDGA Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Adopt Rule 2.4, Mandatory Participation in Testing of Backup Systems | |
| 80 FR 63857 - Self-Regulatory Organizations; EDGX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Adopt Rule 2.4, Mandatory Participation in Testing of Backup Systems | |
| 80 FR 63855 - Self-Regulatory Organizations; BATS Y-Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change to Adopt Rule 2.4, Mandatory Participation in Testing of Backup Systems | |
| 80 FR 63849 - Self-Regulatory Organizations; BATS Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Adopt Rule 2.4, Mandatory Participation in Testing of Backup Systems | |
| 80 FR 63852 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Amending Representations Regarding the Names and Principal Investments of Certain WBI SMID Funds Currently Listed and Traded on the Exchange Under NYSE Arca Equities Rule 8.600 | |
| 80 FR 63838 - Bulk Manufacturer of Controlled Substances Application: Halo Pharmaceutical, Inc. | |
| 80 FR 63836 - Importer of Controlled Substances Application: Cerilliant Corporation | |
| 80 FR 63797 - Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act | |
| 80 FR 63804 - Agency Information Collection Activities; Proposed Collection; Comment Request; Center for Devices and Radiological Health Appeals Processes | |
| 80 FR 63799 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Evaluation of the Food and Drug Administration's Campaign To Reduce Tobacco Use Among Lesbian, Gay, Bisexual, and Transgender Young Adults | |
| 80 FR 63835 - Bulk Manufacturer of Controlled Substances Application: Cody Laboratories, Inc. | |
| 80 FR 63835 - Bulk Manufacturer of Controlled Substances Application: Cambrex Charles City | |
| 80 FR 63839 - Importer of Controlled Substances Application: Sigma-Aldrich International GMBH-Sigma Aldrich Co LLC | |
| 80 FR 63833 - Certain Welded Line Pipe From Korea; Termination of Investigation | |
| 80 FR 63840 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension Without Change, of a Previously Approved Collection Annuity Broker Declaration Form | |
| 80 FR 63862 - Data Collection Available for Public Comments | |
| 80 FR 63790 - SES Performance Review Board | |
| 80 FR 63839 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension With Change, of a Previously Approved Collection Sequestered Juror Information Form | |
| 80 FR 63833 - Silicomanganese From Australia; Scheduling of the Final Phase of an Antidumping Duty Investigation | |
| 80 FR 63671 - Medical Devices; Cardiovascular Devices; Classification of the Coronary Vascular Physiologic Simulation Software Device | |
| 80 FR 63878 - Agency Information Collection (Address Request Authorized by “Access to Financial Records”) Activity Under OMB Review | |
| 80 FR 63877 - Agency Information Collection (Award Attachment for Certain Children With Disabilities Born of Vietnam Veterans) Activity Under OMB Review | |
| 80 FR 63875 - Agency Information Collection (Former Prisoner of War Medical History) Activities Under OMB Review | |
| 80 FR 63880 - Agency Information Collection (Former Prisoner of War Medical History) Activities Under OMB Review | |
| 80 FR 63883 - Agency Information Collection (VA MATIC Enrollment/Change) (29-0165) Activity Under OMB Review | |
| 80 FR 63877 - Proposed Information Collection (Monthly Record of Training and Wages) Activity: Comment Request | |
| 80 FR 63879 - Proposed Information Collection (Architect-Engineer Fee Proposal, VA Form 10-6298, Daily Log (Contract Progress Report-Formal Contract), VA Form 10-6131, and Supplement Contract Progress Report, VA Form 10-61001a) Activity: Comment Request | |
| 80 FR 63879 - Agency Information Collection: Request for Certificate of Veteran Status Activity Under OMB Review | |
| 80 FR 63878 - Proposed Information Collection (Pre-Discharge Compensation Claim) Activity: Comment Request | |
| 80 FR 63876 - Proposed Information Collection (VA/DOD Joint Disability Evaluation Claim) Activity: Comment Request | |
| 80 FR 63875 - Proposed Information Collection (Application for Benefits for Certain Children With Disabilities Born of Vietnam and Certain Korea Service Veterans) Activity: Comment Request | |
| 80 FR 63883 - Proposed Information Collection (Loan Analysis); Activity: Comment Request | |
| 80 FR 63874 - Proposed Information Collection (Verification of VA Benefits) Activity: Comment Request | |
| 80 FR 63882 - Proposed Information Collection (Income Verification) Activity: Comment Request | |
| 80 FR 63884 - Proposed Information Collection (Claim for Repurchase of Loan); Activity: Comment Request | |
| 80 FR 63880 - Agency Information Collection (Supplemental Information for Change of Program or Re-Enrollment After Unsatisfactory Attendance, Conduct or Progress) (VA Form 22-8873) Activity Under OMB Review | |
| 80 FR 63806 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Inspection by Accredited Persons Program | |
| 80 FR 63793 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee Cover Sheet, Form FDA 3601 | |
| 80 FR 63804 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Administrative Practices and Procedures; Formal Evidentiary Public Hearing | |
| 80 FR 63795 - Agency Information Collection Activities; Proposed Collection; Comment Request; Food Additive Petitions and Investigational Food Additive Exemptions | |
| 80 FR 63802 - Manufacturing Site Change Supplements: Content and Submission; Draft Guidance for Industry and Food and Drug Administration Staff; Availability | |
| 80 FR 63808 - Center for Scientific Review; Notice of Closed Meetings | |
| 80 FR 63786 - Formations of, Acquisitions by, and Mergers of Bank Holding Companies | |
| 80 FR 63787 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company | |
| 80 FR 63695 - Unified Registration System | |
| 80 FR 63676 - Quarterly Listings; Safety Zones, Security Zones, Special Local Regulations, Drawbridge Operation Regulations and Regulated Navigation Areas | |
| 80 FR 63674 - Quarterly Listings; Safety Zones, Security Zones, Special Local Regulations, Drawbridge Operation Regulations and Regulated Navigation Areas | |
| 80 FR 63683 - Poly[oxy(methyl-1,2-ethanediyl)], α-[(9Z)-1-oxo-9-octadecen-1-yl]-ω-[[(9Z)-1-oxo-9-octadecen-1yl]oxy]-; Exemption From the Requirement of a Tolerance | |
| 80 FR 63815 - Modification of National Customs Automation Program (NCAP) Test Concerning Automated Commercial Environment (ACE) Entry Summary, Accounts and Revenue (ESAR) Test of Automated Entry Summary Types 51 and 52 and Certain Modes of Transportation | |
| 80 FR 63680 - Potassium Salts of Hops Beta Acids; Exemption From the Requirement of a Tolerance | |
| 80 FR 63686 - Pyrimethanil; Pesticide Tolerances | |
| 80 FR 63720 - Quid Pro Quo and Hostile Environment Harassment and Liability for Discriminatory Housing Practices Under the Fair Housing Act | |
| 80 FR 63715 - Immediate, Expedited, and Private Disaster Assistance Loan Programs | |
| 80 FR 63807 - Meeting Notice for the President's Advisory Council on Faith-based and Neighborhood Partnerships | |
| 80 FR 63832 - Notice of Designation of Potential Wilderness as Wilderness, Fire Island National Seashore |
Industry and Security Bureau
International Trade Administration
National Oceanic and Atmospheric Administration
Defense Acquisition Regulations System
Federal Energy Regulatory Commission
Centers for Disease Control and Prevention
Food and Drug Administration
National Institutes of Health
Coast Guard
U.S. Customs and Border Protection
Fish and Wildlife Service
Land Management Bureau
National Park Service
Drug Enforcement Administration
Federal Motor Carrier Safety Administration
Surface Transportation Board
Foreign Assets Control Office
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.thefederalregister.org and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions.
Federal Energy Regulatory Commission.
Final rule.
The Federal Energy Regulatory Commission (Commission) is revising its regulations to modify when the Commission will commence assessing annual charges to hydropower licensees and exemptees, other than state or municipal entities, with respect to licenses and exemptions authorizing unconstructed projects and new capacity. Specifically, the Commission will commence assessing annual charges on the date by which the licensee or exemptee is required to commence construction of an unconstructed project or new capacity, rather than on the date that project construction actually begins. The final rule provides administrative efficiency and promotes certainty among licensees, exemptees, and Commission staff as to when annual charges will commence.
Electric power, Reporting and recordkeeping requirements.
By the Commission.
In consideration of the foregoing, the Commission amends part 11, chapter I, title 18,
16 U.S.C. 792-828c; 42 U.S.C. 7101-7352.
(c) * * *
(5) For unconstructed projects, the assessments begin on the date by which the licensee or exemptee is required to commence project construction, or as that deadline may be extended, but in no case longer than four years after the issuance date of the license or exemption. For constructed projects, the assessments begin on the effective date of the license or exemption, except for any new capacity authorized therein. The assessments for new authorized capacity at licensed or exempted projects begin on the date by which the licensee or exemptee is required to commence construction of the new capacity. In the event that assessments begin during a fiscal year, the charges will be prorated.
Food and Drug Administration, HHS.
Final order.
The Food and Drug Administration (FDA) is classifying the coronary vascular physiologic simulation software 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 coronary vascular physiologic simulation software 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 21, 2015. The classification was applicable on November 26, 2014.
Shawn Forrest, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1326, Silver Spring, MD 20993-0002, 301-796-5554.
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) of the FD&C Act, 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 will classify the device by written order within 120 days. This classification will be the initial classification of the device.
On November 6, 2013, HeartFlow, Inc. submitted a request for classification of the FFR
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
Therefore, on November 26, 2014, 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 870.1415.
Following the effective date of this final classification order, any firm submitting a premarket notification (510(k)) for a coronary vascular physiologic simulation software device will need to comply with the special controls named in this final order.
The device is assigned the generic name coronary vascular physiologic simulation software device, and it is identified as a prescription device that provides simulated functional assessment of blood flow in the coronary vascular system using data extracted from medical device imaging to solve algorithms and yield simulated metrics of physiologic information (
FDA has identified the following risks to health associated with this type of device, as well as the mitigation measures required to mitigate these risks, in table 1.
FDA believes that the following special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness:
• Adequate software verification and validation based on comprehensive hazard analysis with identification of appropriate mitigations, must be performed including:
○ Full characterization of the technical parameters of the software, including any proprietary algorithm(s) used to model the vascular anatomy;
Adequate description of the expected impact of all applicable image acquisition hardware features and characteristics on performance and any associated minimum specifications;
○ Adequate consideration of privacy and security issues in the system design; and
Adequate mitigation of the impact of failure of any subsystem components (
• Adequate non-clinical performance testing must be provided to demonstrate the validity of computational modeling methods for flow measurement.
• Clinical data supporting the proposed intended use must be provided, including the following:
○ Output measure(s) must be compared to a clinically acceptable method and must adequately represent the simulated measure(s) the device provides in an accurate and reproducible manner;
○ Clinical utility of the device measurement accuracy must be demonstrated by comparison to that of other available diagnostic tests (
○ Statistical performance of the device within clinical risk strata (
○ The dataset must be adequately representative of the intended use population for the device (
○ Statistical methods must consider the predefined endpoints;
Estimates of probabilities of incorrect results must be provided for each endpoint;
Where multiple samples from the same patient are used, statistical analysis must not assume statistical independence without adequate justification;
The report must provide appropriate confidence intervals for each performance metric;
○ Sensitivity and specificity must be characterized across the range of available measurements;
○ Agreement of the simulated measure(s) with clinically acceptable measure(s) must be assessed across the full range of measurements;
○ Comparison of the measurement performance must be provided across the range of intended image acquisition hardware; and
○ If the device uses a cutoff threshold or operates across a spectrum of disease, it must be established prior to validation and it must be justified as to how it was determined and clinically validated.
• Adequate validation must be performed and controls implemented to characterize and ensure consistency (
○ Acceptable incoming image quality control measures and the resulting image rejection rate for the clinical data must be specified;
○ Data must be provided within the clinical validation study or using equivalent datasets demonstrating the consistency (
Testing must be performed using multiple operators meeting planned qualification criteria and using the procedure that will be implemented in the production use of the device; and
The factors (
• Human factors evaluation and validation must be provided to demonstrate adequate performance of the user interface to allow for users to accurately measure intended parameters, particularly where parameter settings that have impact on
• Device labeling must be provided that adequately describes the following:
○ The device's intended use, including the type of imaging data used, what the device measures and outputs to the user, whether the measure is qualitative or quantitative, the clinical indications for which it is to be used, and the specific population for which the device use is intended;
○ Appropriate warnings specifying the intended patient population, identifying anatomy and image acquisition factors that may impact measurement results, and providing cautionary guidance for interpretation of the provided measurements;
○ Key assumptions made in the calculation and determination of simulated measurements;
○ The measurement performance of the device for all presented parameters, with appropriate confidence intervals, and the supporting evidence for this performance. Per-vessel clinical performance, including where applicable localized performance according to vessel and segment, must be included as well as a characterization of the measurement error across the expected range of measurement for key parameters based on the clinical data;
○ A detailed description of the patients studied in the clinical validation (
○ Where significant human interface is necessary for accurate analysis, adequately detailed description of the analysis procedure using the device and any data features that could affect accuracy of results.
A coronary vascular physiologic simulation software device is 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) of the FD&C Act 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 coronary vascular physiologic simulation software 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 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.
The following reference has been placed on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday, and is available electronically at
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, 371.
(a)
(b)
(1) Adequate software verification and validation based on comprehensive hazard analysis, with identification of appropriate mitigations, must be performed, including:
(i) Full characterization of the technical parameters of the software, including:
(A) Any proprietary algorithm(s) used to model the vascular anatomy; and
(B) Adequate description of the expected impact of all applicable image acquisition hardware features and characteristics on performance and any associated minimum specifications;
(ii) Adequate consideration of privacy and security issues in the system design; and
(iii) Adequate mitigation of the impact of failure of any subsystem components (
(2) Adequate non-clinical performance testing must be provided to demonstrate the validity of computational modeling methods for flow measurement; and
(3) Clinical data supporting the proposed intended use must be provided, including the following:
(i) Output measure(s) must be compared to a clinically acceptable method and must adequately represent the simulated measure(s) the device provides in an accurate and reproducible manner;
(ii) Clinical utility of the device measurement accuracy must be demonstrated by comparison to that of other available diagnostic tests (
(iii) Statistical performance of the device within clinical risk strata (
(iv) The dataset must be adequately representative of the intended use population for the device (
(v) Statistical methods must consider the predefined endpoints:
(A) Estimates of probabilities of incorrect results must be provided for each endpoint,
(B) Where multiple samples from the same patient are used, statistical analysis must not assume statistical independence without adequate justification, and
(C) The report must provide appropriate confidence intervals for each performance metric;
(vi) Sensitivity and specificity must be characterized across the range of available measurements;
(vii) Agreement of the simulated measure(s) with clinically acceptable measure(s) must be assessed across the full range of measurements;
(viii) Comparison of the measurement performance must be provided across the range of intended image acquisition hardware; and
(ix) If the device uses a cutoff threshold or operates across a spectrum of disease, it must be established prior to validation, and it must be justified as to how it was determined and clinically validated;
(4) Adequate validation must be performed and controls implemented to characterize and ensure consistency (
(i) Acceptable incoming image quality control measures and the resulting image rejection rate for the clinical data must be specified, and
(ii) Data must be provided within the clinical validation study or using equivalent datasets demonstrating the consistency (
(A) Testing must be performed using multiple operators meeting planned qualification criteria and using the procedure that will be implemented in the production use of the device, and
(B) The factors (
(5) Human factors evaluation and validation must be provided to demonstrate adequate performance of the user interface to allow for users to accurately measure intended parameters, particularly where parameter settings that have impact on measurements require significant user intervention; and
(6) Device labeling must be provided that adequately describes the following:
(i) The device's intended use, including the type of imaging data used, what the device measures and outputs to the user, whether the measure is qualitative or quantitative, the clinical indications for which it is to be used, and the specific population for which the device use is intended;
(ii) Appropriate warnings specifying the intended patient population, identifying anatomy and image acquisition factors that may impact measurement results, and providing cautionary guidance for interpretation of the provided measurements;
(iii) Key assumptions made in the calculation and determination of simulated measurements;
(iv) The measurement performance of the device for all presented parameters, with appropriate confidence intervals, and the supporting evidence for this performance. Per-vessel clinical performance, including where applicable localized performance according to vessel and segment, must be included as well as a characterization of the measurement error across the expected range of measurement for key parameters based on the clinical data;
(v) A detailed description of the patients studied in the clinical validation (
(vi) Where significant human interface is necessary for accurate analysis, adequately detailed description of the analysis procedure using the device and any data features that could affect accuracy of results.
Coast Guard, DHS.
Notice of expired temporary rules issued.
This document provides notice of substantive rules issued by the Coast Guard that were made temporarily effective between January 2015 and March 2015 but expired before they could be published in the
This document lists temporary Coast Guard rules that became effective between January 2015 and March 2015 and were terminated before they could be published in the
Temporary rules listed in this document may be viewed online, under their respective docket numbers, using the Federal eRulemaking Portal at
For questions on this notice contact Yeoman First Class Maria Fiorella Villanueva, Office of Regulations and Administrative Law, telephone (202) 372-3862.
Coast Guard District Commanders and Captains of the Port (COTP) must be immediately responsive to the safety and security needs within their jurisdiction; therefore, District Commanders and COTPs have been delegated the authority to issue certain local regulations.
Timely publication of these rules in the
The following unpublished rules were placed in effect temporarily during the period between January 2015 and March 2015 unless otherwise indicated. To view copies of these rules, visit
Coast Guard, DHS.
Notice of expired temporary rules issued.
This document provides notice of substantive rules issued by the Coast Guard that were made temporarily effective between October 2014 and December 2014 but expired before they could be published in the
This document lists temporary Coast Guard rules that became effective between October 2014 and December 2014 and were terminated before they could be published in the
Temporary rules listed in this document may be viewed online, under their respective docket numbers, using the Federal eRulemaking Portal at
For questions on this notice contact Yeoman First Class Maria Fiorella Villanueva, Office of Regulations and Administrative Law, telephone (202) 372-3862.
Coast Guard District Commanders and Captains of the Port (COTPs) must be immediately responsive to the safety and security needs within their jurisdiction; therefore, District Commanders and COTPs have been delegated the authority to issue certain local regulations.
Timely publication of these rules in the
The following unpublished rules were placed in effect temporarily during the period between October 2014 and December 2014 unless otherwise indicated. To view copies of these rules, visit
Coast Guard, DHS.
Notice of deviation from drawbridge regulation.
The Coast Guard has issued a temporary deviation from the operating schedule that governs the Illinois Central Railroad Drawbridge across the Mississippi River, mile 579.9, at Dubuque, Iowa. The deviation is necessary to allow the bridge owner time to replace the tender house
This deviation is effective from 7 a.m. to 12 p.m. on November 5, 2015.
The docket for this deviation, (USCG-2015-0942) is available at
If you have questions on this temporary deviation, call or email Eric A. Washburn, Bridge Administrator, Western Rivers, Coast Guard; telephone 314-269-2378, email
The Chicago, Central & Pacific Railroad requested a temporary deviation for the Illinois Central Railroad Drawbridge, across the Upper Mississippi River, mile 579.9, at Dubuque, Iowa to remain in the closed-to-navigation position from 7 a.m. to 12 p.m., on November 5, 2015 to replace the tender house essential to the continued safe operation of the drawbridge.
The Illinois Central Railroad Drawbridge currently operates in accordance with 33 CFR 117.5, which states the general requirement that the drawbridge shall open on signal.
There are no alternate routes for vessels transiting this section of the Upper Mississippi River. The bridge cannot open in case of emergency.
The Illinois Central Railroad Drawbridge provides a vertical clearance of 19.9 feet above normal pool in the closed-to-navigation position. Navigation on the waterway consists primarily of commercial tows and recreational watercraft and will not be significantly impacted. This temporary deviation has been coordinated with waterway users. No objections were received.
In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone on Lake Washington around the east span of the 520 Bridge in Seattle, Washington due to ongoing construction. The safety zone is necessary to ensure the safety of the maritime public and workers involved in the bridge construction when construction barges are located in the east span of the bridge. The safety zone will prohibit any person or vessel from entering or remaining in the safety zone unless authorized by the Captain of the Port or his Designated Representative.
This rule is effective without actual notice from October 21, 2015 through November 30, 2015. For the purposes of enforcement, actual notice will be used from October 2, 2015 until October 21, 2015.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, call or email Ryan Griffin, Waterways Management Division, Coast Guard Sector Puget Sound; telephone (206) 217-6051, email
The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because of an unexpected extension of construction. With construction still in progress the safety zone needs to be extended until November 30, 2015. Due to the nature of the delay and the need to extend the safety zone immediately, it would be impracticable to issue an NPRM and solicit comment before finalizing this rule.
We are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making it effective less than 30 days after publication in the
The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port Puget sound (COTP) has determined that potential hazards associated with bridge construction continuing on October 2, 2015 will be a safety concern for anyone within a 100-yard radius of the 520 Bridge east span construction operations. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while the bridge is being repaired.
The safety zone established in this rule encompasses all waters within 100 yards of the east span of the 520 Bridge, located on Lake Washington and is effective from October 2, 2015 through November 30, 2015 when a construction barge is present in the safety zone. Vessels wishing to enter the safety zone must request permission to do so from the Captain of the Port by contacting the Joint Harbor Operations Center at 206-217-6001 or VHF Channel 16. If permission for entry is granted, vessels must proceed at a minimum speed for safe navigation.
We developed this rule after considering numerous statutes and
E.O.s 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under E.O. 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.
This rule is not a significant regulatory action as the safety zone established by it is both limited in size and duration and there is an alternative route for vessels with an air draft that permits safe passage under the west span of the bridge.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator, because the zone established in this rule is limited in size and duration and there is an alternative route for vessels with an air draft that permits safe passage under the west span of the bridge.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under E.O. 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in E.O. 13132.
Also, this rule does not have tribal implications under E.O. 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969(42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a temporary safety zone lasting less than 60 days that will prohibit entry within 100 yards of the east span of the 520 bridge during times of construction operations. It is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Harbors, Marine safety, Navigation (water), Reporting and Recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
(a)
(b)
(c)
Environmental Protection Agency (EPA).
Final rule.
This regulation establishes an exemption from the requirement of a tolerance for residues of the biochemical pesticide potassium salts of hops beta acids in or on honey and honeycomb for the control of Varroa mites in accordance with label directions and good agricultural practices. Interregional Research Project Number 4, on behalf of Beta Tec Hop Products, Inc., submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of potassium salts of hops beta acids in or on honey and honeycomb.
This regulation is effective October 21, 2015. Objections and requests for hearings must be received on or before December 21, 2015, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2014-0374, is available at
Robert McNally, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2014-0374 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before December 21, 2015. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2014-0374, by one of the following methods:
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•
•
In the
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .” Additionally, EPA is required to take into account the factors set forth in FFDCA section 408(b)(2)(D).
EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings.
Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability, and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.
K-HBAs are derived from the resin components of the cones of female hop plants
All applicable mammalian toxicology data requirements supporting the petition to establish an exemption from the requirement of a tolerance for the use of potassium salts of hops beta acids as an active ingredient for use to control Varroa mites in or on honey and honeycomb have been fulfilled. No significant toxicological effects were observed in the acute toxicity study or other information from the literature that was used to address the toxicity data requirements. For the Tier I subchronic toxicity studies, data and information from scientific literature were used in support of acceptable rationales to address the data requirements, focusing on the long history of exposure to K-HBAs in food preservation and in the production of beer, which is commonly consumed in the United States. K-HBAs are not structurally-related to known mutagens, nor are they in a chemical class known to contain a known mutagen. Further, from the available toxicity information, there were no systemic effects of potassium salts of hops beta acids via the oral, dermal, or inhalation routes of exposure. For a summary of the data upon which EPA relied, and its human health risk assessment based on that data, please refer to the document entitled, “Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for Potassium Salts of Hops Beta acids” (July 15, 2015), available in the docket for this action.
In examining aggregate exposure, FFDCA section 408 directs EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses).
Human dietary exposure through food to residues of K-HBAs already occurs via its use as a preservative in meats and its natural presence in beer brewing production. EPA does not expect much residue of potassium salts of hops beta acids in honey from its use as a pesticide in hives based on residue studies. In three different studies conducted over 3 years, only one honey sample from one honey super was shown to have residues of hops beta acids (0.44 part per million (ppm)), and the residue level was only slightly above the analytical limits of detection (0.41 ppm) and well below the Limit of Quantitation (1.2 ppm).
No significant exposure via drinking water is expected from its use as an active ingredient as a pesticide. K-HBAs are non-volatile and are expected to degrade rapidly, with 100% degradation in 36 hours in the light and 4 days in the dark. Furthermore, as an insecticide, K-HBAs are formulated into a viscous liquid and coated on fiber strips which are placed inside the beehive such that the product is not sprayed or applied in any way that it would be expected to contact any source of drinking water.
Should exposure occur, however, minimal to no risk is expected for the general population, including infants and children, due to the long history of dietary exposure to K-HBAs.
Non-occupational exposure to potasium salts of hops beta acids is not expected because potassium salts of hops beta acids is formulated into a viscous liquid and coated on fiber strips which are placed inside the beehive. There are no residential proposed uses. However, minimal to no risk is expected for the general population, including infants and children, due to the minimal toxicity of this chemical as
Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”
EPA has not found potassium salts of hops beta acids to share a common mechanism of toxicity with any other substances, and potassium salts of hops beta acids does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that potassium salts of hops beta acids does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at
FFDCA section 408(b)(2)(C) provides that, in considering the establishment of a tolerance or tolerance exemption for a pesticide chemical residue, EPA shall assess the available information about consumption patterns among infants and children, special susceptibility of infants and children to pesticide chemical residues, and the cumulative effects on infants and children of the residues and other substances with a common mechanism of toxicity. In addition, FFDCA section 408(b)(2)(C) provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure, unless EPA determines that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act (FQPA) Safety Factor. In applying this provision, EPA either retains the default value of 10X, or uses a different additional or no safety factor when reliable data are available to support a different additional or no safety factor.
As part of its qualitative assessment, EPA evaluated the available toxicity and exposure data on potassium salts of hops beta acids and considered its validity, completeness, and reliability, as well as the relationship of this information to human risk. EPA considers the toxicity database to be complete and has identified no residual uncertainty with regard to prenatal and postnatal toxicity or exposure. No hazard was identified based on the available studies; therefore, EPA concludes that there are no threshold effects of concern to infants, children, or adults from potassium salts of hops beta acids. As a result, EPA concludes that no additional margin of exposure (safety) is necessary.
An analytical method is not required for enforcement purposes because EPA is establishing an exemption from the requirement of a tolerance without any numerical limitation.
Based on its assessment of potassium salts of hops beta acids, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children, from aggregate exposure to potassium salts of hops beta acids. EPA is therefore establishing an exemption from the requirement of a tolerance for residues of potassium salts of hops beta acids for the control of Varroa mites in or on honey and honeycomb, in accordance with label directions and good agricultural practices.
This final rule establishes an exemption from the requirement of a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1501
This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA) (15 U.S.C. 272 note).
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, 40 CFR chapter I is amended as follows:
21 U.S.C. 321(q), 346a and 371.
An exemption from the requirement of a tolerance is established for residues of the biochemical potassium salts of hops beta acids in or on honey and honeycomb, when used for the control of Varroa mites in accordance with label directions and good agricultural practices.
Environmental Protection Agency (EPA).
Final rule.
This regulation establishes an exemption from the requirement of a tolerance for residues of poly[oxy(methyl-1,2-ethanediyl)], α-[(9Z)-1-oxo-9-octadecen-1-yl]-ω-[[(9Z)-1-oxo-9-octadecen-1yl]oxy]- (CAS Reg. No. 26571-49-3) when used as an inert ingredient in a pesticide chemical formulation. BYK USA Inc., submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of poly[oxy(methyl-1,2-ethanediyl)], α-[(9Z)-1-oxo-9-octadecen-1-yl]-ω-[[(9Z)-1-oxo-9-octadecen-1yl]oxy]- on food or feed commodities.
This regulation is effective October 21, 2015. Objections and requests for hearings must be received on or before December 21, 2015, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2015-0442, is available at
Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2015-0442 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before December 21, 2015. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2015-0442, by one of the following methods.
•
•
•
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
In the
EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be shown that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.
Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. In the case of certain chemical substances that are defined as polymers, the Agency has established a set of criteria to identify categories of polymers expected to present minimal or no risk. The definition of a polymer is given in 40 CFR 723.250(b) and the exclusion criteria for identifying these low-risk polymers are described in 40 CFR 723.250(d). Poly[oxy(methyl-1,2-ethanediyl)], α-[(9Z)-1-oxo-9-octadecen-1-yl]-ω-[[(9Z)-1-oxo-9-octadecen-1yl]oxy]- conforms to the definition of a polymer given in 40 CFR 723.250(b) and meets the following criteria that are used to identify low-risk polymers.
1. The polymer is not a cationic polymer nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment.
2. The polymer does contain as an integral part of its composition the atomic elements carbon, hydrogen, and oxygen.
3. The polymer does not contain as an integral part of its composition, except as impurities, any element other than those listed in 40 CFR 723.250(d)(2)(ii).
4. The polymer is neither designed nor can it be reasonably anticipated to substantially degrade, decompose, or depolymerize.
5. The polymer is manufactured or imported from monomers and/or reactants that are already included on the TSCA Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption.
6. The polymer is not a water absorbing polymer with a number average molecular weight (MW) greater than or equal to 10,000 daltons.
Additionally, the polymer also meets as required the following exemption criteria specified in 40 CFR 723.250(e).
7. The polymer's minimum number average MW of 2,300 is greater than 1,000 and less than 10,000 daltons. The polymer contains less than 10% oligomeric material below MW 500 and less than 25% oligomeric material below MW 1,000, and the polymer does not contain any reactive functional groups.
Thus, poly[oxy(methyl-1,2-ethanediyl)], α-[(9Z)-1-oxo-9-octadecen-1-yl]-ω-[[(9Z)-1-oxo-9-octadecen-1yl]oxy]- meets the criteria for a polymer to be considered low risk under 40 CFR 723.250. Based on its conformance to the criteria in this unit, no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure to poly[oxy(methyl-1,2-ethanediyl)], α-[(9Z)-1-oxo-9-octadecen-1-yl]-ω-[[(9Z)-1-oxo-9-octadecen-1yl]oxy]-.
For the purposes of assessing potential exposure under this exemption, EPA considered that poly[oxy(methyl-1,2-ethanediyl)], α-[(9Z)-1-oxo-9-octadecen-1-yl]-ω-[[(9Z)-1-oxo-9-octadecen-1yl]oxy]- could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational non-dietary exposure was possible. The minimum number average MW of poly[oxy(methyl-1,2-ethanediyl)], α-[(9Z)-1-oxo-9-octadecen-1-yl]-ω-[[(9Z)-1-oxo-9-octadecen-1yl]oxy]- is 2,300 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since poly[oxy(methyl-1,2-ethanediyl)], α-[(9Z)-1-oxo-9-octadecen-1-yl]-ω-[[(9Z)-1-oxo-9-octadecen-1yl]oxy]- conform to the criteria that identify a low-risk polymer, there are no concerns for risks associated with any potential exposure scenarios that are reasonably foreseeable. The Agency has determined that a tolerance is not necessary to protect the public health.
Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”
EPA has not found poly[oxy(methyl-1,2-ethanediyl)], α-[(9Z)-1-oxo-9-octadecen-1-yl]-ω-[[(9Z)-1-oxo-9-octadecen-1yl]oxy]- to share a common mechanism of toxicity with any other substances, and poly[oxy(methyl-1,2-ethanediyl)], α-[(9Z)-1-oxo-9-octadecen-1-yl]-ω-[[(9Z)-1-oxo-9-octadecen-1yl]oxy]- does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that poly[oxy(methyl-1,2-ethanediyl)], α-[(9Z)-1-oxo-9-octadecen-1-yl]-ω-[[(9Z)-1-oxo-9-octadecen-1yl]oxy]- does not have a common mechanism of toxicity with other
Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base unless EPA concludes that a different margin of safety will be safe for infants and children. Due to the expected low toxicity of poly[oxy(methyl-1,2-ethanediyl)], α-[(9Z)-1-oxo-9-octadecen-1-yl]-ω-[[(9Z)-1-oxo-9-octadecen-1yl]oxy]-, EPA has not used a safety factor analysis to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary.
Based on the conformance to the criteria used to identify a low-risk polymer, EPA concludes that there is a reasonable certainty of no harm to the U.S. population, including infants and children, from aggregate exposure to residues of poly[oxy(methyl-1,2-ethanediyl)], α-[(9Z)-1-oxo-9-octadecen-1-yl]-ω-[[(9Z)-1-oxo-9-octadecen-1yl]oxy]-.
An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.
In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.
The Codex has not established a MRL for poly[oxy(methyl-1,2-ethanediyl)], α-[(9Z)-1-oxo-9-octadecen-1-yl]-ω-[[(9Z)-1-oxo-9-octadecen-1yl]oxy]-.
Accordingly, EPA finds that exempting residues of poly[oxy(methyl-1,2-ethanediyl)], α-[(9Z)-1-oxo-9-octadecen-1-yl]-ω-[[(9Z)-1-oxo-9-octadecen-1yl]oxy]- from the requirement of a tolerance will be safe.
This action establishes a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501
This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, 40 CFR chapter I is amended as follows:
21 U.S.C. 321(q), 346a and 371.
Environmental Protection Agency (EPA).
Final rule.
This regulation establishes tolerances for residues of pyrimethanil in or on multiple commodities which are identified and discussed later in this document. Interregional Research Project Number 4 (IR-4) requested the tolerances associated with pesticide petition number (PP 4E8302), and Bayer CropScience requested the tolerances associated with PP 4F8291, under the Federal Food, Drug, and Cosmetic Act (FFDCA).
This regulation is effective October 21, 2015, except for the amendment to § 180.661 in amendatory instruction number 3, which is effective April 21, 2016. Objections and requests for hearings must be received on or before December 21, 2015, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2015-0012, is available at
Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2015-0012 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before December 21, 2015. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2015-0012, by one of the following methods:
•
•
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Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
In the
In the
Based upon review of the data supporting the petitions, EPA has revised the petitioned-for tolerance in or on fruit, pome, group 11-10. The Agency has also determined that the separate subgroup tolerances proposed in or on orange subgroup 10-10A, lemon subgroup 10-10B, and grapefruit subgroup 10-10C should be established in or on fruit, citrus, group 10-10. The reasons for these changes are explained in Unit IV.D.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . . ”
Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for pyrimethanil including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with pyrimethanil follows.
EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.
The major target organs of repeated oral exposure to pyrimethanil were the liver, kidney and thyroid. By the oral route of exposure, the rat was the most sensitive species to pyrimethanil toxicity, followed by the dog and then the mouse. Effects observed including clinical signs (for example, vomiting, diarrhea and salivation in the dog), changes in clinical chemical parameters (liver enzymes), changes in organ weights (mostly relative), and macroscopic and microscopic organ changes. These effects were accompanied by decreased body weight. Clinical signs of neurotoxicity including ataxia and dilated pupils, and decreases in motor activity, hind limb grip strength and body temperature were observed in an acute neurotoxicity study in rats (females only) at the highest dose tested (HDT). However, there was no evidence of neurotoxicity with repeated dosing in a subchronic neurotoxicity study in rats.
Special short-term exposure studies conducted for pyrimethanil demonstrated increased liver uridine diphosphate glucuronosyl transferase activity, leading to decreases in thyroid hormones (T3, T4) and compensatory increases in thyroid-stimulating hormone (TSH) in adult rats. Although the effects on the thyroid raise a potential concern for thyroid toxicity in the young, EPA concluded there is no concern for thyroid toxicity in the young based on the following: (1) The effects are not severe in nature and; (2) the wide dose spread (
Thyroid adenomas were seen in rats following long-term exposure, and it was concluded that they were mediated via disruption of the thyroid/pituitary axis. There were no concerns for mutagenicity. The EPA has classified pyrimethanil as “not likely to be carcinogenic to humans at doses that do not alter rat thyroid hormone homeostasis.” This decision was based on the following:
1. There were treatment-related increases in thyroid follicular cell tumors in male and female Sprague-Dawley rats at doses which were considered adequate to assess carcinogenicity; however, rats are substantially more sensitive than humans to the development of thyroid follicular cell tumors in response to thyroid hormone imbalance.
2. There were no treatment-related tumors seen in male or female CD-1 mice at doses which were considered adequate to assess carcinogenicity.
3. There is no mutagenicity concern and there is no evidence for thyroid carcinogenesis mediated through a mutagenic mode of action.
4. The non-neoplastic toxicological evidence (
For these reasons, EPA determined that quantification of carcinogenic risk is not required and that the NOAEL established for deriving the chronic reference dose (cRfD) would be protective of cancer effects. Due to the non-linear mode of action of pyrimethanil, exposure at the NOAEL is not expected to alter thyroid hormone homeostasis nor result in thyroid tumor formation.
Specific information on the studies received and the nature of the adverse effects caused by pyrimethanil as well
Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which the NOAEL and the LOAEL are identified. Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see
1.
i.
Such effects were identified for pyrimethanil. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 2003-2008 National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in food, EPA assumed default processing factors, empirical processing factors for orange and apple juice, tolerance-level residues, and 100 percent crop treated (PCT) for all commodities.
ii.
iii.
iv.
2.
Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Surface Water Concentration Calculator (SWCC) models, the estimated drinking water concentrations (EDWCs) of pyrimethanil and its degradate for acute exposures are estimated to be 156 parts per billion (ppb) for surface water and 128 ppb for ground water. For chronic exposures for non-cancer assessments, they are estimated to be 27.9 ppb for surface water and 117 ppb for ground water.
Current EPA policy typically recommends the EDWCs for use in dietary assessments be derived from the water source with the highest EDWCs, which for pyrimethanil is surface water for acute exposure and groundwater for chronic exposure. However, due to generally low leaching (EDWCs and incomplete breakthrough) identified in the 100-year simulation in groundwater, the surface water EDWCs are recommended for both acute and chronic exposure assessments. Therefore, for acute dietary risk assessment, the water concentration value of 156 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 27.9 ppb was used to assess the contribution to drinking water.
3.
4.
1.
2.
3.
i. The toxicity database for pyrimethanil is complete.
ii. Clinical signs of neurotoxicity (ataxia, decreased motor activity, decreased body temperature, decreased hind limb grip strength in males, and dilated pupils) were observed only in females in the acute neurotoxicity study in rats and only at the HDT (1,000 milligram/kilogram (mg/kg)). Although the limit dose was not tested in the subchronic neurotoxicity study, no clinical signs, behavioral changes, or neuropathology were seen at one-half of the limit dose (up to 430 milligram/kilogram/day (mg/kg/day)). In addition, no neurotoxic signs were seen in the rest of the toxicity database for pyrimethanil and the target organ for toxicity is the thyroid. The selected endpoints for pyrimethanil will be protective of any potential signs of neurotoxicity. Therefore, the concern for neurotoxicity is low, and there is no need for a developmental neurotoxicity study or additional uncertainty factors (UFs) to account for neurotoxicity.
iii. There is no evidence that pyrimethanil results in increased susceptibility in
iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the surface water modeling used to assess exposure to pyrimethanil in drinking water. These assessments will not underestimate the exposure and risks posed by pyrimethanil.
EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.
1.
2.
3.
4.
5.
Adequate enforcement methodology, high-performance liquid chromatography (HPLC), is available to enforce the tolerance expression.
The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address:
In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.
There are no Codex MRLs established for residues of pyrimethanil in or on cucumber or bushberry subgroup 13-07B or caneberry subgroup 13-07A commodities. A U.S. tolerance in or on pome fruit group 11-10 was petitioned-
One comment was received to the Notice of Filing for PP 4F8291, which provided general support for the proposed tolerances. There were no concerns identified in this public comment.
Based upon review of the data supporting the petitions, EPA has revised the petitioned-for tolerance in or on fruit, pome, group 11-10 from 14 ppm to 15 ppm, in order to harmonize with the Codex MRL on associated pome fruit commodities. The Agency has also determined that the separate subgroup tolerances petitioned-for in or on orange subgroup 10-10A at 10 ppm, lemon subgroup 10-10B at 11 ppm, and grapefruit subgroup 10-10C at 10 ppm should be established in or on fruit, citrus, group 10-10 at 10 ppm. A citrus group 10-10 tolerance at 10 ppm is supported by available data and harmonizes the U.S. tolerance with the Canadian MRL.
In this rulemaking, EPA is reducing the tolerance for the onion, bulb, subgroup 3-07A from 2.0 ppm to 0.20 ppm. The petitioner requested this reduction because it was a typographical error when the previous rule for pyrimethanil was published. EPA had assessed the tolerance at 0.20 ppm, but the rule was printed as 2.0 ppm. The reduction is appropriate based on available data and residue levels resulting from registered use patterns. In accordance with the World Trade Organization's Sanitary and Phytosanitary Measures Agreement, EPA is allowing the existing higher tolerance to remain in effect for 6 months following the publication of this rule in order to allow a reasonable interval for producers in the exporting countries to adapt to the requirements of these modified tolerances. On April 21, 2016, the new reduced tolerance for subgroup 3-07A will go into effect. At that time, residues of pyrimethanil on commodities contained in subgroup 3-07A will need to comply with the new tolerance of 0.20 ppm. This reduction in tolerance is not discriminatory; the same food safety standard contained in the FFDCA applies equally to domestically produced and imported foods.
Therefore, tolerances are established for residues of pyrimethanil (4,6-dimethyl-
This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501
This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, 40 CFR chapter I is amended as follows:
21 U.S.C. 321(q), 346a and 371.
The additions read as follows:
(a)
(a)
(1) * * *
Environmental Protection Agency (EPA).
Direct final rule.
The State of Texas has applied to the United States Environmental Protection Agency (EPA) for final authorization of the changes to its hazardous waste program under the Resource Conservation and Recovery Act (RCRA). EPA has determined that these changes satisfy all requirements needed to qualify for final authorization, and is authorizing the State's changes through this direct final rule. In the “Proposed Rules” section of today's
This final authorization is effective on December 21, 2015 unless the EPA receives adverse written comment by November 20, 2015. If the EPA receives such comment, EPA will publish a timely withdrawal of this direct final rule in the
Submit your comments by one of the following methods:
• Federal eRulemaking Portal:
• Email: [
• Fax: (prior to faxing, please notify the EPA contact listed below).
• Mail: [
• Hand Delivery or Courier: Deliver your comments to [
You can view and copy Texas' application and associated publicly available materials from 8:30 a.m. to 4 p.m. Monday through Friday at the following locations: Texas Commission
Alima Patterson, Region 6 Regional Authorization Coordinator, State/Tribal Oversight Section (6PD-O), Multimedia Planning and Permitting Division, (214) 665-8533, EPA Region 6, 1445 Ross Avenue, Dallas, Texas 75202-2733, and email address
States which have received final authorization from the EPA under RCRA section 3006(b), 42 U.S.C. 6926(b), must maintain a hazardous waste program that is equivalent to, consistent with, and no less stringent than the Federal program. As the Federal program changes, States must change their programs and ask the EPA to authorize the changes. Changes to State programs may be necessary when Federal or State statutory or regulatory authority is modified or when certain other changes occur. Most commonly, States must change their programs because of changes to the EPA's regulations in 40 Code of Federal Regulations (CFR) parts 124, 260 through 268, 270, 273, and 279.
New Federal requirements and prohibitions imposed by Federal regulations that EPA promulgates pursuant to the Hazardous and Solid Waste Amendments of 1984 (HSWA) take effect in authorized States at the same time that they take effect in unauthorized States. Thus, EPA will implement those requirements and prohibitions in the State of Texas, including the issuance of new permits implementing those requirements, until the State is granted authorization to do so.
On April 3, 2015, the State of Texas submitted a final complete program revision application seeking authorization of changes to its hazardous waste program that correspond to certain Federal rules promulgated between promulgated between June 13, 2011, and January 3, 2014. The adoption for RCRA Clusters XXI through XXIII (Checklists 227, 229 and 230). EPA concludes that the State of Texas's application to revise its authorized program meets all of the statutory and regulatory requirements established by RCRA, as set forth in RCRA section 3006(b), 42 U.S.C. 6926(b), and 40 CFR part 271. Therefore, EPA grants the State of Texas final authorization to operate its hazardous waste program with the changes described in the authorization application, and as outline below in Section G of this document. The State of Texas has responsibility for permitting treatment, storage, and disposal facilities (TSDFs) within its borders (except in Indian Country). In today's action under Section 18 U.S.C. 1151 does not affect Indian Country. Because the State of Texas Hazardous waste Program is not being authorized to operate in Indian Country and for carrying out the aspects of the RCRA program described in its revised program application, subject to the limitations of HSWA, as discussed above). New Federal requirements and prohibitions imposed by Federal regulations that EPA promulgates under the authority of HSWA take effect in authorized States before they are authorized for the requirements. Thus, EPA will implement those requirements and prohibitions in the State of Texas, including issuing permits, until the State is granted authorization to do so.
The effect of this decision is that a facility in the State of Texas subject to RCRA will now have to comply with the authorized State requirements instead of the equivalent Federal requirements in order to comply with RCRA. The State of Texas has enforcement responsibilities under its State hazardous waste program for violations of such program, but the EPA retains its authority under RCRA sections 3007, 3008, 3013, and 7003, which include, among others, authority to:
• Do inspections, and require monitoring, tests, analyses, or reports;
• enforce RCRA requirements and suspend or revoke permits and
• take enforcement actions after notice to and consultation with the State.
This action does not impose additional requirements on the regulated community because the regulations for which the State of Texas is being authorized by today's action are already effective under State law, and are not changed by today's action.
Along with this direct final rule, EPA is publishing a separate document in the “Proposed Rules” section of today's
EPA is providing an opportunity for public comment now, as described in Section E of this document.
If the EPA receives comments that oppose this authorization, EPA will withdraw today's direct final rule by publishing a document in the
If EPA receives comments that oppose only the authorization of a particular change to the State hazardous waste program, EPA will withdraw only that part of this rule, but the authorization of the program changes that the comments do not oppose will become effective on the date specified in this document. The
The State of Texas initially received final authorization on December 26, 1984 (49 FR 48300), to implement its Base Hazardous Waste Management Program. This authorization was clarified in a notice published March 26, 1985 (50 FR 11858). Texas received authorization for revisions to its program, effective October 4, 1985 (51 FR 3952), February 17, 1987 (51 FR 45320), March 15, 1990 (55 FR 7318), July 23, 1990 (55 FR 21383), October 21, 1991 (56 FR 41626), December 4, 1992 (57 FR 45719), June 27, 1994 (59 FR 16987), June 27, 1994 (59 FR 17273), November 26, 1997 (62 FR 47947), December 3, 1997 (62 FR 49163), October 18, 1999 (64 FR 44836), November 15, 1999 (64 FR 49673), September 11, 2000 (65 FR 43246), June 14, 2005 (70 FR 34371), December 29, 2008, (73 FR 64252), and July 13, 2009
In 1991, Texas Senate Bill 2 created the Texas Natural Resource Conservation Commission (TNRCC) which combined the functions of the former Texas Water Commission and the former Texas Air Control Board. The transfer of functions to the TNRCC from the two agencies became effective on September 1, 1993. House Bill 2912, Article 18 of the 77th Texas Legislature, 2001, changed the name of the TNRCC to the Texas Commission on Environmental Quality (TCEQ) and directed the TNRCC to adopt a timetable for phasing in the change of the agency's name. The TNRCC decided to make the change of the agency's name to the TCEQ effective September 1, 2002. The change of name became effective September 1, 2002, and the legislative history of the name change is documented at (See, Act of June 15, 2001, 77th Leg. R. S., Ch 965, Section 18.01, 2001 Tex. Gen. Laws 1985). The TCEQ may perform any act authorized by law either as the TNRCC or as the TCEQ.
The TCEQ has primary responsibility for administration of laws and regulations concerning hazardous waste. The official State regulations may be found in Title 30, Texas Administrative Code, Chapters 305, 324 and 335, effective February 21, 2013. Some of the State rules incorporate the Federal regulations by reference. Texas Water Code Section 5.103 and Section 5.105 and Texas Health and Safety Code Section 361.017 and Section 361.024 confer on the Texas Commission on Environmental Quality the powers to perform any acts necessary and convenient to the exercise of its jurisdiction. The TCEQ is authorized to administer the RCRA program. However, the Railroad Commission (RRC) has jurisdiction over the discharge, storage, handling, transportation, reclamation, or disposal of waste materials (both hazardous and non-hazardous) that result from the activities associated with the exploration, development, or production of oil or gas or geothermal resources and other activities regulated by the RRC. A list of activities that generate wastes that are subject to the jurisdiction of the RRC is found at Texas Health and Safety Code Section 401.415. Such wastes are termed “oil and gas wastes.” The TCEQ has responsibility to administer the RCRA program, however, hazardous waste generated at natural gas or natural gas liquids processing plants or reservoir pressure maintenance or repressurizing plants are subject to the jurisdiction of the TCEQ until the RRC is authorized by EPA to administer that waste under RCRA. The TCEQ jurisdiction over Solid waste can be found at Chapter 361, Sections 361.001 through 361.754 of the Texas Health and Safety Code. The TCEQ's jurisdiction encompasses hazardous and nonhazardous, industrial and municipal Solid waste. The definition of Solid waste can be found at Texas Health and Safety Code Section 361.003(34). When the RRC is authorized by EPA to administer the RCRA program for these wastes, jurisdiction over such hazardous waste will transfer from the TCEQ to the RRC. The EPA has designated the TCEQ as the lead agency to coordinate RCRA activities between the two agencies. The EPA is responsible for the regulation of any hazardous waste for which TCEQ has not been previously authorized.
Further clarification of the jurisdiction between the TCEQ and the RRC can be found in a separate document. This document, a Memorandum of Understanding (MOU), became effective on May 31, 1998.
The TCEQ has the rules necessary to implement EPA's RCRA Clusters XXI through XXIII, excluding the Hazardous Waste Technical Corrections and Clarification Rule in Cluster XXII (Checklist 228), because the TCEQ needs to make a technical corrections to their adoption of the rule. The State is seeking authorization for Revision of the Land Disposal Treatment Standards for Carbamate Wastes (Checklist 227), Conditional Exclusion for Solvent Contaminated Wipes (Checklist 229) and Conditional Exclusion for Carbon Dioxide (CO
On April 3, 2015 the State of Texas submitted a final complete program revision application, seeking authorization of their changes in accordance with 40 CFR 271.21. We now make direct final decision, subject to receipt of written comments that oppose this action that the State of Texas' hazardous waste program revision are equivalent to, consistent with, and no less stringent than the Federal program, and therefore satisfy all of requirements necessary to qualify for final authorization. Therefore, EPA grants the State of Texas final authorization for RCRA Cluster XXII through XXIII (Checklists 227, 229 and 230). The State of Texas program revisions consist of regulations which specifically govern Federal Hazardous Waste revisions promulgated between June 13, 2011, and January 3, 2014 which are listed in the chart below.
The State of Texas hazardous waste program is equivalent to the Federal program in all areas except where the State program is broader in scope. In the State of Texas, some rules are broader in scope because they cover both hazardous waste and Class 1 nonhazardous waste, whereas the Federal regulations cover only hazardous waste. Other differences which are broader in scope or more stringent contained in the past authorization packages include more frequent public notices for traditional hazardous waste permits and for Standard Permit; financial assurance requirements for persons seeking to acquire a hazardous waste permit through transfer, and deferring of variances and exemptions from the Land Disposal Restrictions to EPA.
The State of Texas will issue permits for all the provisions for which it is authorized and will administer the permits it issues. The EPA will continue to administer any RCRA hazardous waste permits or portions of permits which we issued prior to the effective date of this authorization. EPA will not issue any more new permits or new portions of permits for the provisions listed in the chart in this document after the effective date of this authorization. The EPA will continue to implement and issue permits for HSWA requirements for which Texas is not yet authorized.
Codification is the process of placing the State's statutes and regulations that comprise the State's authorized hazardous waste program into the CFR. We do this by referencing the authorized State rules in 40 CFR parts 272. We reserve the amendment of 40 CFR parts 272, subpart SS for this authorization of Texas' program changes until a later date. In this authorization application the EPA is not codifying the rules documented in this
The Office of Management and Budget (OMB) has exempted this action from the requirements of Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011). Therefore this action is not subject to review by OMB. This action authorizes State requirements for the purpose of RCRA 3006 and imposes no additional requirements beyond those imposed by State law. Accordingly, I certify that this action will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
Under RCRA 3006(b), the EPA grants a State's application for authorization as long as the State meets the criteria required by RCRA. It would thus be inconsistent with applicable law for the EPA, when it reviews a State authorization application; to require the use of any particular voluntary consensus standard in place of another standard that otherwise satisfies the requirements of RCRA. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this rule, the EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct. The EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the Executive Order. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
The Congressional Review Act, 5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Confidential business information, Hazardous waste, Hazardous waste transportation, Indian lands, Intergovernmental relations, Penalties, Reporting and recordkeeping requirements.
This action is issued under the authority of sections 2002(a), 3006, and 7004(b) of the Solid Waste Disposal Act as amended 42 U.S.C. 6912(a), 6926, 6974(b).
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Final rule; extension of effective dates.
FMCSA delays the effective and compliance dates for its August 23, 2013, Unified Registration System (URS) final rule. Because FMCSA changes the effective date (the actual date when the regulatory text that appears in the Code of Federal Regulations (CFR) will be changed) and makes technical corrections and conforming amendments to the 2013 regulatory text, the Agency has determined that it is in the best interest of the regulated entities, our State partners and the general public to present the full text of the sections affected. The 2013 URS final rule was issued to improve the registration process for motor carriers, property brokers, freight forwarders, Intermodal Equipment Providers (IEPs), hazardous materials safety permit (HMSP) applicants and cargo tank facilities required to register with FMCSA, and streamline the existing Federal registration processes to ensure the Agency can more efficiently track these entities. Today's final rule delays the implementation of the 2013 final rule in order to allow FMCSA additional time to complete the information technology (IT) systems work required to fully implement that rule.
Petitions for reconsideration must be received by November 20, 2015.
Petitions for reconsideration must be submitted to: Administrator, Federal Motor Carrier Safety Administration, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
All background documents, comments, and materials related to this rule may be viewed in docket number FMCSA-1997-2349 using either of the following methods:
• Federal eRulemaking Portal:
• Docket Management Facility (M-30), U.S. Department of Transportation, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
Mr. Jeffrey S. Loftus, 1200 New Jersey Avenue SE., Washington, DC 20590-0001, by telephone at (202) 385-2363 or via email at
This final rule is being issued to delay the effective and compliance dates of the Unified Registration System (URS) final rule, issued on August 23, 2013.
FMCSA estimated a 2-year period for development of the information technology (IT) system to implement the August 23, 2013, URS final rule, and as a result set the initial compliance date for the majority of that rule at 26 months after publication (October 23, 2015).
As a result, FMCSA is delaying the effective and compliance dates of the URS final rule, as reflected in the table at the end of this executive summary. The new dates reflect the revised schedule for completing the IT system required. In doing so, the Agency determined that a discrete portion of the IT system will be available earlier than others, and so we are adding three temporary sections, one each in parts 365, 368, and 390, to allow for implementation of that portion of the new URS. These temporary sections will apply to new U.S.- or Canada-domiciled applicants and Mexico-domiciled applicants seeking registration to operate in the commercial zones along the U.S.-Mexico border. A new applicant is defined as anyone who does not have, and has never been assigned a USDOT, Motor Carrier (MC), Mexico owned or controlled (MX), or Freight Forwarder (FF) number. These new applicants will be required to use the new online application when requesting registration and a USDOT number beginning on December 12, 2015. The new online application and associated database will not be available for use by those who already have USDOT, MC, MX, or FF numbers until September 30, 2016, so we are establishing the new overall effective date of this final rule to coincide with that availability. Once that occurs, there will no longer be a need for the separate provisions dealing with new applicants, thus the temporary sections will be in effect only from December 12, 2015 through September 29, 2016. After that time, the URS system, including the online application, will be available for submission of all requests for new registration, to track applications, to update information, and to file biennial updates.
While we are delaying the effective date for most of the URS final rule requirements until September 30, 2016, we are providing an additional three months for full compliance with some provisions. Private hazardous material carriers and exempt for-hire carriers registered with the Agency as of September 30, 2016, will be given three months from that date to file their evidence of compliance with the financial responsibility requirements. While these carriers have had to obtain adequate insurance coverage for some time now, the 2013 final rule provided the first rule requiring them to file proof of that coverage with FMCSA. As a result, FMCSA believes allowing for a three month compliance period will help alleviate potential concerns entities may have over using a new system, as well as ensure seamless operation of the URS.
Additionally, all entities registered with the Agency as of September 30, 2016, will have this same three month period to file their designation of a process service agent (Form BOC-3) using the URS online application. This delay is to ensure that regulated entities have sufficient time to become familiar with the system.
The new URS will be capable of handling both financial responsibility and designation of process agent filings on September 30, 2016, and FMCSA encourages those entities required to make these filings as early in the compliance period as they can. In order to include this staggered compliance period, we have revised § 366.2 (designation of process service agent) and sections 387.19 and 387.43 (financial responsibility) slightly from what was published on August 23, 2013, as explained in greater detail in the section-by-section discussion below.
We are making corrections to errors found in the original final rule since its publication. In parts 385, 387, 390 and 392 we are correcting inadvertent errors to the authority citations. In § 387.403, we are making conforming amendments based on other final rules that affected the registration requirements since the publication of the August 23, 2013 URS final rule. In § 390.207, we are correcting a cross reference. In § 368.8, we are removing a statement that “decisions by the Director will be final Agency orders on certain appeals”—the Agency has changed its internal delegations, and this sentence is no longer accurate. Finally, we are updating the web address for obtaining access to URS to provide a more precise location, as opposed to the main FMCSA home page. These changes are not substantive and are explained in more detail in the section-by-section
To view comments submitted to previous rulemaking notices on this subject, as well as documents identified in this preamble as available in the docket, go to
All comments received were posted without change to
FMCSA relies upon the same legal authority cited in the August 23, 2013, Unified Registration System (URS) final rule. The Agency extends the effective and compliance dates, and makes technical corrections and conforming amendments to the 2013 final rule. Because there are no substantive changes to content of the 2013 final rule, we will not expand upon the previous legal authority discussion presented in that rule.
The Administrative Procedure Act (APA) (5 U.S.C. 551-706) specifically provides exceptions to its notice and public comment rulemaking requirements where the Agency finds there is good cause (and incorporates the finding and a brief statement of reasons therefore in the rules issued) to dispense with them. Generally, good cause exists where the Agency determines that notice and public procedures are impractical, unnecessary, or contrary to the public interest (5 U.S.C. 553(b)(3)(B)). Today's URS final rule is being issued to delay the effective date of the original August 23, 2013, final rule. FMCSA will not have the technological ability to support the changes made by the August 23, 2013, final rule by its original effective date (October 23, 2013), which would
For those portions of this final rule which are correcting errors in the original August 23, 2013 final rule, we likewise find good cause to dispense with notice and public comment, as doing so is unnecessary. These correcting changes are not substantive in nature; they are being made to correct inadvertent errors and in one instance, to indicate a change in the internal delegations within the Agency. Delaying the effective date of these changes to procure notice and comment would further postpone these corrections, possibly lead to greater confusion, and thus would be contrary to the public interest.
The Federal Highway Administration (FMCSA's predecessor agency) issued an advance notice of proposed rulemaking (ANPRM) announcing plans to develop a single, online, Federal information system in August 1996.
On May 19, 2005, FMCSA published an NPRM describing a proposal to merge all of the prescribed information systems except the SSRS into a unified, online Federal system.
Upon enactment, MAP-21 affected a number of rules already being developed by FMCSA, including this one. Because MAP-21 was enacted several months after the close of the comment period for the SNPRM, the public did not have an opportunity to comment on provisions of the Act that may have an impact on the URS. Rather than delay issuance of the August 23, 2013, final rule, and to ensure an appropriate opportunity for public participation in the changes necessitated by MAP-21, FMCSA decided to initiate a separate rulemaking proceeding(s) to address most of the needed changes.
The section-by-section analysis from the August 23, 2013, URS final rule continues to apply to today's final rule, as today's actions delay the effective and compliance dates provided in that rule and make technical corrections and conforming amendments to that rule. The following analysis is limited to discussing these delayed dates, technical corrections and conforming amendments, and explaining how they are being reflected in the regulatory text. Because of the multiple CFRs affected by today's final rule, the Agency has determined that it is in the best interest of the regulated entities, our State partners and the general public to present the full regulatory text for the amended URS requirements, as opposed to simply correcting the effective date and errant provisions. This action will make it easier for the reader to follow.
Throughout the regulatory text, we updated the web address for accessing the URS; the new address provides a more precise location (
This final rule delays the effective dates for the amendments to sections 360.1, 360.3, and 360.5. FMCSA has determined that it would not be appropriate to collect new filing fees for each registration authority sought by an applicant until the new URS is able to support the new functionality those fees were designed to fund. Therefore, these provisions will now become effective on September 30, 2016, at the same time that the full functionality of the URS will also be available. Those new applicants using the URS online application before September 30, 2016, will pay the same fees as they would today using the current application forms and procedures. Beginning on September 30, 2016, all applicants will be charged a separate $300 fee for each distinct registration for which they apply with each entity that operates commercial motor vehicles in interstate commerce paying $300 for the safety registration and $300 for each additional registration. For example, a freight forwarder operating commercial motor vehicles in interstate commerce would pay $300 for the safety registration and $300 for registration as a freight forwarder. And a new private motor carrier of property that also seeks registration as a for-hire to enable the entity to transport freight for others on return trips would pay $300 for the safety registration and $300 for registration as a for-hire motor carrier of property. The full list of registration types that carry this $300 fee are:
This final rule will delay the effective dates for the amendments to sections 365.101, 365.103, 365.105, 365.107, 365.109, 365.110, 365.111, 365.119, 365.201, 365.203, 365.301, 365.401, 365.403, 365.405, 365.507, and 365.509.
This final rule also adds temporary § 365.T106, which will be in effect from December 12, 2015, through September 29, 2016. Under this temporary section, new applicants, defined as U.S.- or Canada-domiciled entities that do not have (and have never had) an active USDOT, MC, MX, or FF Number, must apply for a USDOT number and, if applicable, operating authority using the URS online application, available at
This final rule will delay the effective dates for the revisions to sections 366.1, 366.2, 366.3, 366.4, 366.5, and 366.6. The requirement for electronic filing of Form BOC-3, designation of process agent, comes into effect on September 30, 2016; however, entities already registered with FMCSA as of that date will not be required to comply until December 31, 2016. The URS will have the ability to collect the Form BOC-3 filings on September 30, 2016, and we encourage motor carriers and freight forwarders to comply with this requirement as early as they can. In addition, this final rule will no longer make a distinction between private motor carriers or exempt freight forwarders when it comes to compliance dates. The system will be able to receive all notices at the same time, and all are being provided with additional time than originally included in the August 23, 2013 final rule. Note that after September 30, 2016, new applicants (
This final rule delays the effective date for the revisions in sections 368.3, 368.4, and 368.8 until September 30, 2016, when FMCSA estimates the URS online application will be available for all users, and the majority of the functionality of the URS will be fully available.
This final rule also adds temporary § 368.T3, which will be in effect from December 12, 2015, through September 29, 2016. Under this temporary section, new applicants, defined as citizens of Mexico or motor carriers owned or controlled by a citizen of Mexico, who do not have (and have never had) an active USDOT, MC, MX, or FF number, must apply for a USDOT number and, if applicable, operating authority using the URS online application, available at
Section 368.8 also has a minor change. We have removed the last sentence, which indicated that the Director's decision would serve as the final Agency order in appeals after denials of applications. However, the Director no longer has the authority to make these decisions, as that authority has been redelegated to the Assistant Administrator. The change is being made to the regulation to reflect this change in delegation.
This final rule delays the effective date for the revisions in sections 385.301, 385.303, 385.305, 385.329, 385.405, 385.409, 385.419, 385.421, 385.603, 385.607, 385.609, and 385.713 until September 30, 2016, when FMCSA estimates the URS online application will be available for all users, and the majority of the functionality of the URS will be fully available. No additional changes have been made to the provisions found in the listed sections; they appear here as they did in the August 23, 2013 URS final rule.
This final rule delays the effective date for the revisions in sections 387.19, 387.33, 387.43, 387.301, 387.303, 387.313, 387.323, 387.403, 387.413, and 387.419 until September 30, 2016, when FMCSA estimates the URS online application will be available for all users, and the majority of the functionality of the URS will be fully available.
It also provides for a three-month compliance period for private hazardous materials and exempt for-hire motor carriers, registered with FMCSA as of September 30, 2016, to complete their electronic filing requirements. This compliance period ends on December 31, 2016. These provisions can be found in sections 387.19 and 387.43. The URS will have the ability to collect the financial responsibility filings for private hazardous materials and exempt for-hire motor carriers on September 30, 2016. We encourage insurers of these motor carriers to comply as early as they can. Note that after September 30, 2016, new applicants (
This final rule adds a change to § 387.403. On October 1, 2013, FMCSA issued a final rule to implement section 32918 of MAP-21, which amended 49 U.S.C. 13906 to require a minimum surety bond or trust fund of $75,000 and extended the bond requirement from brokers to freight forwarders. The October 1 final rule added paragraph (c) to § 387.403 to implement this change. It was not reflected in the August 23, 2013, URS final rule, and without this change, new paragraph (c) would be removed when today's final rule goes into effect. We have therefore revised § 387.403 to include paragraph (c) to ensure it remains intact after today's rule goes into effect.
This final rule will delay the effective dates for the amendments to sections 390.3, 390.5, 390.19,
This final rule also adds temporary Subpart E, consisting of § 390.T200, which will be in effect from December 12, 2015, through September 29, 2016. Under this temporary section, new applicants, defined as entities who do not have (and have never had) an active USDOT Number, must apply for a USDOT Number using the URS online application, available at
This final rule incorporates a number of corrections to § 390.3 that were made in a correcting document published on October 23, 2013.
Today's final rule corrects the authority citation for part 392. The August 23, 2013, final rule inadvertently omitted some of the statutory authorities granted to FMCSA, and today's final rule is adding them back. As these authorities have remained in effect, there is no substantive impact from this change.
FMCSA has determined that today's final rule delaying the effective date of the URS rules is not a significant regulatory action within the meaning of E.O. 12866, as supplemented by E.O. 13563, or within the meaning of DOT regulatory policies and procedures. We do not expect today's final rule to have any new costs; today's action delaying the effective date will also delay the associated costs of the August 23, 2013, final rule. As discussed previously, this delay action is necessary because the URS technological solution, required to implement the URS final rule, is not ready. Not delaying the URS final rule may result in additional costs, as allowing the URS final rule to come into effect without having the required technological pieces (such as the URS online application and the integrated database required by statute) would require motor carriers, freight forwarders, brokers, and others to use a system that does not exist, with no alternative for seeking registration authorities. This could lead to a delay in processing registrations, which could then impact the applicants. Delaying the effective date of the URS final rule avoids these potential costs, without adding new costs over what was originally estimated in the August 2013 RIA. The August 2013 RIA can be found in the docket for today's final rule.
Under the Regulatory Flexibility Act of 1980 (RFA) (5 U.S.C. 601-612), FMCSA is not required to complete a regulatory flexibility analysis. This is because this rule does not require publication of a general notice of proposed rulemaking. However, in compliance with the RFA, FMCSA has evaluated the effects of today's final rule on small entities, and determined that delaying the effective date for the URS final rule will not result in a significant economic impact on a substantial number of small entities. Accordingly, the Administrator of FMCSA hereby certifies that this rule will not have a significant economic impact on a substantial number of small entities.
Today's final rule will not impose an unfunded Federal mandate, as defined by the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1532,
The Agency analyzed today's final rule for the purpose of the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321
FMCSA also has analyzed today's rule under the Clean Air Act, as amended (CAA), section 176(c) (42 U.S.C. 7401
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), a Federal Agency must obtain approval from OMB for each collection of information it conducts, sponsors, or requires through regulations. The FMCSA analyzed the August 23, 2013, final rule and determined that its implementation would streamline the information collection burden on motor carriers and other regulated entities, relative to the baseline, or current paperwork collection processes. This included streamlining the FMCSA registration, insurance, and designation of process agent filing processes and implementing mandatory electronic online filing of these applications, as well as eliminating some outdated filing requirements. A full analysis of the impacted collections of information, both existing and new, can be found in that final rule,
Today's final rule will not effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.
Today's final rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.
Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks” (April 23, 1997, 62 FR 19885), requires that agencies issuing economically significant rules, which also concern an environmental health or safety risk that an Agency has reason to believe may disproportionately affect children, must include an evaluation of the environmental health and safety effects of the regulation on children. Section 5 of Executive Order 13045 directs an Agency to submit for a covered regulatory action an evaluation of its environmental health or safety effects on children. Today's final rule is not an economically significant rule and will not create an environmental risk to health or risk to safety that might disproportionately affect children.
This rule has been analyzed in accordance with the principles and criteria in Executive Order 13132, dated August 4, 1999 (64 FR 43255, August 10, 1999). The FMCSA consulted with State licensing agencies participating in its PRISM Program to discuss anticipated impacts of the May 2005 NPRM upon their operations. The Agency has taken into consideration their comments in its decision-making process for this rule. Thus, FMCSA has determined that this rule will not have significant Federalism implications or limit the policymaking discretion of the States.
The regulations implementing Executive Order 12372 regarding intergovernmental consultation on Federal programs and activities do not apply to today's final rule.
FMCSA has analyzed this rule under Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use,” and has determined that this is not a significant energy action within the meaning of section 4(b) of the Executive Order. Today's final rule is not economically significant, and will not have a significant adverse effect on the supply, distribution, or use of energy.
The FMCSA conducted a privacy impact assessment of the August 23, 2013, final rule as required by section 522(a)(5) of division H of the FY 2005 Omnibus Appropriations Act, Public Law 108-447, 118 Stat. 3268 (Dec. 8, 2004) [set out as a note to 5 U.S.C. 552a]. The assessment considered any impacts of the final rule on the privacy of information in an identifiable form and related matters. FMCSA determined that the August 23, 2013, final rule will impact the handling of personally identifiable information (PII). FMCSA also determined the risks and effects the rulemaking might have on collecting, storing, and sharing PII and examined and evaluated protections and alternative information handling processes in order to mitigate potential privacy risks. Today's final rule makes no changes to the information being collected, or to the manner that it is stored and shared. FMCSA believes that the PIA for the August 23, 2013, final rule adequately covers today's action; that PIA remains available for review in the docket for today's final rule.
Administrative practice and procedure, Brokers, Buses, Freight forwarders, Hazardous materials transportation, Highway safety, Insurance, Motor carriers, Motor vehicle safety, Moving of household goods, Penalties, Reporting and recordkeeping requirements, Surety bonds.
Administrative practice and procedure, Brokers, Buses, Freight forwarders, Motor carriers, Moving of household goods.
Brokers, Motor carriers, Freight forwarders, Process agents.
Administrative practice and procedure, Insurance, Motor carriers.
Administrative practice and procedure, Highway safety, Incorporation by reference, Mexico, Motor carriers, Motor vehicle safety,
Buses, Freight, Freight forwarders, Hazardous materials transportation, Highway safety, Insurance, Intergovernmental relations, Motor carriers, Motor vehicle safety, Moving of household goods, Penalties, Reporting and recordkeeping requirements, Surety bonds.
Highway safety, Intermodal transportation, Motor carriers, Motor vehicle safety, Reporting and recordkeeping requirements.
Alcohol abuse, Drug abuse, Highway safety, Motor carriers.
In consideration of the foregoing, FMCSA is amending 49 CFR chapter III, subchapter B, parts 360, 365, 366, 368, 385, 387, 390, and 392, as set forth below:
31 U.S.C. 9701; 49 U.S.C. 13908; and 49 CFR 1.87.
Certifications and copies of public records and documents on file with the Federal Motor Carrier Safety Administration (FMCSA) will be furnished on the following basis, pursuant to USDOT Freedom of Information Act regulations at 49 CFR part 7:
(a) Certificate of the Director, Office of Management and Information Services, as to the authenticity of documents, $12;
(b) Service involved in locating records to be certified and determining their authenticity, including clerical and administrative work, at the rate of $21 per hour;
(c) Copies of the public documents, at the rate of $.80 per letter size or legal size exposure. A minimum charge of $5 will be made for this service; and
(d) Search and copying services requiring information technology (IT), as follows:
(1) A fee of $50 per hour for professional staff time will be charged when it is required to fulfill a request for electronic data.
(2) The fee for computer searches will be set at the current rate for computer service. Information on those charges can be obtained from the Office of Information Technology (MC-RI).
(3) Printing will be charged at the rate of $.10 per page of computer-generated output with a minimum charge of $1. There will also be a charge for the media provided (
(e)
(1) Any Agency of the Federal Government or a State government or any political subdivision of any such government for access to or retrieval of information and data from the Unified Carrier Registration System for its own use; or
(2) Any representative of a motor carrier, motor private carrier, broker, or freight forwarder (as each is defined in 49 U.S.C. 13102) for the access to or retrieval of the information related to such entity from the Unified Carrier Registration System for the individual use of such entity.
(a)
(2)
(i) Each account will have a specific billing date within each month and a billing cycle. The billing date is the date that the bill is prepared and printed. The billing cycle is the period between the billing date in one month and the billing date in the next month. A bill for each account that has activity or an unpaid balance during the billing cycle will be sent on the billing date each month. Payment will be due 20 days from the billing date. Payments received before the next billing date are applied to the account. Interest will accrue in accordance with 31 CFR 901.9.
(ii) The Federal Claims Collection Standards, including disclosure to consumer reporting agencies and the use of collection agencies, as set forth in 31 CFR part 901, will be utilized to encourage payment where appropriate.
(iii) An account holder who files a petition for bankruptcy or who is the subject of a bankruptcy proceeding must provide the following information to the Office of Registration and Safety Information (MC-RS) at
(A) The filing date of the bankruptcy petition;
(B) The court in which the bankruptcy petition was filed;
(C) The type of bankruptcy proceeding;
(D) The name, address, and telephone number of its representative in the bankruptcy proceeding; and
(E) The name, address, and telephone number of the bankruptcy trustee, if one has been appointed.
(3) Fees will be payable through the U.S. Department of Treasury secure payment system,
(b) Any filing that is not accompanied by the appropriate filing fee will be rejected.
(c)
(d)
(2) Separate fees will be assessed for the filing of temporary operating authority applications as provided in paragraph (f)(2) of this section, regardless of whether such applications are related to an application for corresponding permanent operating authority.
(e)
(1) Filing fees are waived for an application that is filed by a Federal government agency, or a State or local government entity. For purposes of this section the phrases “Federal government agency” or “government
(2) Filing fees are waived for a motor carrier of passengers that receives a grant from the Federal Transit Administration either directly or through a third-party contract to provide passenger transportation under an agreement with a State or local government pursuant to 49 U.S.C. 5307, 5310, 5311, 5316, or 5317.
(3) The FMCSA will consider other requests for waivers or fee reductions only in extraordinary situations and in accordance with the following procedure:
(i)
(ii)
(iii)
(f)
(a)
(b)
(c)
(d)
(1) Direct labor costs shall be updated by multiplying base level direct labor costs by percentage changes in average wages and salaries of FMCSA employees. Base level direct labor costs are direct labor costs determined by the cost study in
(2) Operations overhead shall be developed on the basis of current relationships existing on a weighted basis, for indirect labor applicable to the first supervisory work centers directly associated with user fee activity. Actual updating of operations overhead shall be accomplished by applying the current percentage factor to updated direct labor, including current governmental overhead costs.
(3)(i) Office general and administrative costs shall be developed on the basis of current levels costs,
(ii) The FMCSA general and administrative costs shall be developed on the basis of current level costs;
(4) Publication costs shall be adjusted on the basis of known changes in the costs applicable to publication of material in the
(e)
(1) Fees between $1 and $30 shall be rounded to the nearest $1;
(2) Fees between $30 and $100 shall be rounded to the nearest $10;
(3) Fees between $100 and $999 shall be rounded to the nearest $50; and
(4) Fees above $1,000 shall be rounded to the nearest $100.
5 U.S.C. 553 and 559; 49 U.S.C. 13101, 13301, 13901-13906, 13908, 14708, 31133, 31138, and 31144; 49 CFR 1.87.
(a) Applications for certificates of motor carrier registration to operate as a motor carrier of property or passengers.
(h) Applications for Mexico-domiciled motor carriers to operate in foreign commerce as for-hire or private motor carriers of property (including exempt items) between Mexico and all points in the United States. Under NAFTA Annex 1, page I-U-20, a Mexico-domiciled motor carrier may not provide point-to-point transportation services, including express delivery services, within the United States for goods other than international cargo.
(a) Each applicant must apply for operating authority by electronically filing Form MCSA-1, the URS online application, to request authority pursuant to 49 U.S.C. 13902, 13903 or 13904 to operate as a:
(1) Motor carrier of property or passengers,
(2) Broker of general commodities or household goods, or
(3) Freight forwarder of general commodities or household goods.
(b) A separate filing fee in the amount set forth at 49 CFR 360.3(f) is required for each type of authority sought in paragraph (a) of this section.
(c) Form MCSA-1 is the URS online application and is available, including complete instructions, from the FMCSA Web site at
(a) Notwithstanding § 365.105, new applicants as defined in paragraph (b) of this section must apply for a USDOT number and if applicable, operating authority by electronically filing Form MCSA-1, the URS online application, to request authority pursuant to 49 U.S.C. 13902, 13903, or 13904 to operate as a:
(1) Motor carrier of property (not household goods), property (household goods) or passengers,
(2) Broker of general commodities or household goods, or
(3) Freight forwarder of general commodities or household goods.
(b) For purposes of this section, a “new applicant” is an entity applying for a USDOT number and if applicable, operating authority who does not at the time of application have an active registration or USDOT, Motor Carrier (MC), Mexico owned or controlled (MX) or Freight Forwarder (FF) number, and who has never had an active registration or USDOT, MC, MX, or FF number.
(c) Form MCSA-1 is the URS online application, and both the application and its instructions are available from the FMCSA Web site at
(d) This section is in effect from December 12, 2015 through September 29, 2016.
(a)
(1) Motor carrier of property (except household goods).
(2) Broker of general commodities or household goods.
(3) Certain types of motor carrier of passenger applications as described in Form MCSA-1, the URS online application.
(b) Motor carrier of passenger “public interest” applications as described in Form MCSA-1, the URS online application.
(c) Intrastate motor passenger applications under 49 U.S.C. 13902(b)(3) as described in Form MCSA-1, the URS online application.
(d) Motor carrier of household goods applications, including Mexico- or non-North America-domiciled carrier applicants. In addition to meeting the fitness standard under paragraph (a) of this section, an applicant seeking authority to operate as a motor carrier of household goods must:
(1) Provide evidence of participation in an arbitration program and provide a copy of the notice of the arbitration program as required by 49 U.S.C. 14708(b)(2);
(2) Identify its tariff and provide a copy of the notice of the availability of that tariff for inspection as required by 49 U.S.C. 13702(c);
(3) Provide evidence that it has access to, has read, is familiar with, and will observe all applicable Federal laws relating to consumer protection, estimating, consumers' rights and responsibilities, and options for limitations of liability for loss and damage; and
(4) Disclose any relationship involving common stock, common ownership, common management, or common familial relationships between the applicant and any other motor carrier, freight forwarder, or broker of household goods within 3 years of the proposed date of registration.
(e) Temporary authority (TA) for motor carriers. These applications require a finding that there is or soon will be an immediate transportation need that cannot be met by existing carrier service.
(1) Applications for TA will be entertained only when an emergency declaration has been made pursuant to § 390.23 of this subchapter.
(2) Temporary authority must be requested by filing the URS online application, Form MCSA-1, found at
(3) Applications for temporary authority are not subject to protest.
(4) Motor carriers granted temporary authority must comply with financial responsibility requirements under part 387 of this subchapter.
(5) Only a U.S.-domiciled motor carrier is eligible to receive temporary authority.
(a) * * *
(5) All applicants must file the appropriate evidence of financial responsibility pursuant to 49 CFR part 387 within 90 days from the date notice of the application is published in the FMCSA Register:
(i)
(ii)
(iii)
(6) Applicants also must submit Form BOC-3—Designation of Agents—Motor Carriers, Brokers and Freight Forwarders—within 90 days from the date notice of the application is published in the FMCSA Register.
(b) A summary of the application will be published in the FMCSA Register to give notice to the public in case anyone wishes to oppose the application.
For motor carriers operating commercial motor vehicles as defined in 49 U.S.C. 31132, operating authority obtained under procedures in this part does not become permanent until the applicant satisfactorily completes the New Entrant Safety Assurance Program in part 385 of this subchapter.
(a) An applicant has the right to appeal rejection of the application. The appeal must be filed at the FMCSA, Office of Registration and Safety Information, 1200 New Jersey Ave. SE., Washington, DC 20590, within 10 days of the date of the letter of rejection.
If the application is opposed, opposing parties are required to send a copy of their protest to the applicant and to FMCSA. All protests must include statements made under oath (verified statements). There are no personal appearances or formal hearings.
A person wishing to oppose a request for operating authority files a
A protest shall be filed (received at the FMCSA, Office of the Associate Administrator for Research and Information Technology, 1200 New Jersey Ave. SE., Washington, DC 20590) within 10 days after notice of the application appears in the FMCSA Register. A copy of the protest shall be sent to applicant's representative at the same time. Failure timely to file a protest waives further participation in the proceeding.
The rules in this subpart define the procedures for motor carriers, property brokers, and freight forwarders to report to FMCSA transactions that result in the transfer of operating authority and are not subject to approval by the U.S. Surface Transportation Board under 49 U.S.C. 14303.
For the purposes of this subpart, the following definitions apply:
(a)
(b)
(c)
(a) Every transfer of operating authority from one person to another person must be reported by both the transferee and transferor using the URS online application, Form MCSA-1, (available at
(b) The following information must be furnished:
(1) Full name, address and USDOT Numbers of the transferee and transferor.
(2) A copy of the operating authority being transferred.
(e) * * *
(2) Electronically file, or have its process agent(s) electronically file, Form BOC-3—Designation of Agents—Motor Carriers, Brokers and Freight Forwarders, as required by part 366 of this subchapter; and
(a) A motor carrier subject to this subpart must notify FMCSA of any changes or corrections to the information in parts I, IA, or II of Form OP-1(MX), or in Form BOC-3—Designation of Agents—Motor Carriers, Brokers and Freight Forwarders, during the application process or after having been granted provisional operating authority. The carrier must notify FMCSA in writing within 30 days of the change or correction.
49 U.S.C. 502, 503, 13303, 13304 and 13908; and 49 CFR 1.87.
The rules in this part, relating to the filing of designations of persons upon whom court or Agency process may be served, apply to for-hire and private motor carriers, brokers, freight forwarders and, as of the moment of succession, their fiduciaries (as defined at 49 CFR 387.319(a)).
(a) Designations shall be made on Form BOC-3—Designation of Agents—Motor Carriers, Brokers and Freight Forwarders. Only one completed current form may be on file. It must include all States for which agent designations are required. One copy must be retained by the carrier, broker or freight forwarder at its principal place of business.
(b) All Motor Carriers, Brokers, and Freight Forwarders that are registered with FMCSA on September 30, 2016 must file their Form BOC-3 designation by no later than December 31, 2016. All other Motor Carriers, Brokers, and Freight Forwarders must file the FORM BOC-3 designation at the time of their application for registration. Failure to file a designation in accordance with this paragraph will result in deactivation of the carrier's USDOT Number.
All persons (as defined at 49 U.S.C. 13102(18)) designated as process agents must reside in or maintain an office in the State for which they are designated. If a State official is designated, evidence of his or her willingness to accept service of process must be furnished.
(a)
(b)
(c)
Where an association or corporation has filed with the FMCSA a list of process agents for each State and DC (blanket agent), motor carriers, brokers and freight forwarders may make the required designations by using the following statement:
I designate those persons named in the list of process agents on file with the Federal Motor Carrier Safety Administration
(a) A designation may be canceled or changed only by a new designation made by the motor carrier, broker, or freight forwarder, or by the process agent or company filing a blanket designation in accordance with § 366.5. However, where a motor carrier, broker or freight forwarder's USDOT Number is inactive for at least 1 year, designation is no longer required and may be canceled without making another designation.
(b) A change to a designation, such as name, address, or contact information, must be reported to FMCSA within 30 days of the change.
(c) Whenever a motor carrier, broker or freight forwarder changes it name, address, or contact information, it must report the change to its process agents and/or the company making a blanket designation on its behalf in accordance with § 366.5 within 30 days of the change.
(d) Whenever a process agent and/or company making a blanket designation on behalf of a motor carrier, broker, or freight forwarder terminates its contract or relationship with the entity, it should report the termination to FMCSA within 30 days of the termination. If process agents and/or blanket agents do not keep their information up to date, FMCSA may withdraw its approval of their authority to make process agent designations with the Agency.
49 U.S.C. 13301, 13902 and 13908; Pub. L. 106-159, 113 Stat. 1748; and 49 CFR 1.87.
(a) Notwithstanding any other provision of this part, new applicants as defined in paragraph (b) of this section must apply for a USDOT number and operating authority by electronically filing Form MCSA-1, the URS online application (available at
(b) For purposes of this section, a “new applicant” is an citizen of Mexico or a motor carrier owned or controlled by a citizen of Mexico, applying for a USDOT number and operating authority who does not at the time of application have an active registration or USDOT, Motor Carrier (MC), Mexico owned or controlled (MX) or Freight Forwarder (FF) number, and who has never had an active registration or USDOT, MC, MX, or FF number.
(c) Form MCSA-1, is the URS online application, and both the application and its instructions are available from the FMCSA Web site at
(d) This section is in effect from December 12, 2015 through September 29, 2016.
(a) If you wish to obtain a certificate of registration under this part, you must electronically file an application that includes the following:
(1) Form MCSA-1—URS online application.
(2) Form BOC-3—Designation of Agents—Motor Carriers, Brokers and Freight Forwarders or indicate on the application that the applicant will use a process agent service that will submit the Form BOC-3 electronically.
(b) The FMCSA will only process your application for a Certificate of Registration if it meets the following conditions:
(1) The application must be completed in English;
(2) The information supplied must be accurate and complete in accordance with the instructions to Form MCSA-1, the URS online application, and Form BOC-3.
(3) The application must include all the required supporting documents and applicable certifications set forth in the instructions to Form MCSA-1, the URS online application, and Form BOC-3.
(f) Form MCSA-1 is the URS online application and is available, including complete instructions, from the FMCSA Web site at
(a) You must notify FMCSA of any changes or corrections to the information in Section A of Form MCSA-1, the URS online application, or the Form BOC-3, Designation of Agents-Motor Carriers, Brokers and Freight Forwarders, during the application process or while you have a Certificate of Registration. You must notify FMCSA in writing within 30 days of the change or correction.
An applicant has the right to appeal denial of the application. The appeal must be in writing and specify in detail why the Agency's decision to deny the application was wrong. The appeal must be filed with the FMCSA, Office of Registration and Safety Information within 20 days of the date of the letter denying the application.
49 U.S.C. 113, 504, 521(b), 5105(e), 5109, 5113, 13901-13905, 13908, 31136, 31144, 31148, 31151, and 31502; Sec. 350 of Pub. L. 107-87; and 49 CFR 1.87.
(a) Before a motor carrier of property or passengers begins interstate operations, it must register with FMCSA and receive a USDOT Number. In addition, for-hire motor carriers must obtain operating authority from FMCSA, unless exclusively providing transportation exempt from the commercial registration requirements in 49 U.S.C. chapter 139. Both the USDOT Number and operating authority are obtained by following registration procedures described in 49 CFR part 390, subpart E. Part 365 of this chapter provides detailed instructions for obtaining operating authority.
(b) This subpart applies to motor carriers domiciled in the United States and Canada.
(c) The regulations in this subpart do not apply to a Mexico-domiciled motor carrier. A Mexico-domiciled motor carrier of property or passengers must register with FMCSA by following the registration procedures described in 49 CFR parts 365, 368 and 390. Parts 365 (for long-haul carriers) and 368 (for commercial zone carriers) of this chapter provide detailed information about how a Mexico-domiciled motor carrier may obtain operating authority.
A motor carrier registers with FMCSA by completing Form MCSA-1, the URS online application which is available at
(a) The applicant for new entrant registration will be directed to the FMCSA Internet Web site (
(b) The application package will include the following:
(1) Educational and technical assistance material regarding the requirements of the FMCSRs and HMRs, if applicable.
(2) Form MCSA-, the URS online application. This form is used to obtain both a USDOT Number and operating authority.
(c) Upon completion of the application form, the new entrant will be issued an inactive USDOT Number. An applicant may not begin operations nor mark a commercial motor vehicle with the USDOT Number until after the date of the Agency's written notice that the USDOT Number has been activated. Violations of this section may be subject to the penalties under § 392.9b(b) of this chapter.
(d)
(b) If the USDOT new entrant registration was revoked because of a failed safety audit, the new entrant must do all of the following:
(1) Submit an updated Form MCSA-1, the URS online application.
(c) * * *
(1) Submit an updated Form MCSA-1, the URS online application.
(d) If the new entrant is a for-hire motor carrier subject to the registration provisions of 49 U.S.C. chapter 139 and also has had its operating authority revoked, it must re-apply for operating authority as set forth in § 390.201(b) and part 365 of this chapter.
(a)
(2) Form MCSA-1, the URS online application, will also satisfy the requirements for obtaining and renewing a USDOT Number.
(b)
(c)
(d)
(a)
Unless suspended or revoked, a safety permit (other than a temporary safety permit) is effective for two years, except that:
(a) A safety permit will be subject to revocation if a motor carrier fails to submit a renewal application (Form MCSA-1, the URS online application) in accordance with the schedule set forth for filing Form MCSA-1 in part 390, subpart E, of this subchapter; and
(b) An existing safety permit will remain in effect pending FMCSA's processing of an application for renewal if a motor carrier submits the required application (Form MCSA-1) in accordance with the schedule set forth in part 390, subpart E, of this subchapter.
(a) * * *
(1) A motor carrier fails to submit a renewal application (Form MCSA-1) in accordance with the schedule set forth in part 390, subpart E, of this subchapter.
(2) A motor carrier provides any false or misleading information on its application form (Form MCSA-1) or as part of updated information it is providing on Form MCSA-1 (see § 385.405(d)).
(a) Each applicant applying under this subpart must submit an application that consists of:
(1) Form MCSA-1, the URS online application; and
(2) A notification of the means used to designate process agents, either by submission in the application package of Form BOC-3, Designation of Agents—Motor Carriers, Brokers and Freight Forwarders, or a letter stating that the applicant will use a process agent service that will submit the Form BOC-3 electronically.
(b) The FMCSA will process an application only if it meets the following conditions:
(1) The application must be completed in English.
(2) The information supplied must be accurate, complete, and include all required supporting documents and applicable certifications in accordance with the instructions to Form MCSA-1 and Form BOC-3.
(3) The application must include the filing fee payable to the FMCSA in the amount set forth at 49 CFR 360.3(f)(1).
(4) The application must be signed by the applicant.
(c) An applicant must electronically file Form MCSA-1.
(d) Form MCSA-1 is the URS online application and is available, including complete instructions, at
(e) * * *
(2) File or have its process agent(s) electronically submit, Form BOC-3—Designation of Agents—Motor Carriers, Brokers and Freight Forwarders, as required by part 366 of this subchapter.
(a) * * *
(2) A motor carrier subject to this subpart must notify FMCSA of any changes or corrections to the information in Section A of Form MCSA-1 that occur during the application process or after the motor carrier has been granted new entrant registration. The motor carrier must report the changes or corrections within 30 days of the change. The motor carrier must use Form MCSA-1, the URS online application, to report the new information.
(b) If the provisional new entrant registration was revoked because the new entrant failed to receive a Satisfactory rating after undergoing a compliance review, the new entrant must do all of the following:
(1) Submit an updated Form MCSA-1, the URS online application;
(c) If the provisional new entrant registration was revoked because FMCSA found the new entrant failed to submit to a compliance review, the new entrant must do all of the following:
(1) Submit an updated Form MCSA-1, the URS online application;
(d) If the new entrant is a for-hire carrier subject to the registration provisions under 49 U.S.C. 13901 and also has had its operating authority revoked, it must reapply for operating authority as set forth in § 390.201(b) and part 365 of this subchapter.
49 U.S.C. 13101, 13301, 13906, 13908, 14701, 31138, and 31139; and 49 CFR 1.87.
(a) Insurers of exempt for-hire motor carriers, as defined in § 390.5 of this
(b) The requirements of this section do not apply to motor carriers excepted under § 387.7(b)(3).
(a)
For-hire motor carriers of passengers operating in interstate or foreign commerce.
(b)
(a) Insurers of for-hire motor carriers of passengers that are registered with FMCSA on September 30, 2016, must file certificates of insurance, surety bonds, and other securities and agreements with FMCSA by December 31, 2016. Insurers of all other exempt for-hire motor carriers of passengers must file certificates of insurance, surety bonds, and other securities and agreements with FMCSA at the time of the application for registration. These filings must be made electronically in accordance with the requirements and procedures set forth at § 387.323.
(b) This section does not apply to motor carriers excepted under § 387.31(b)(3).
(a)
(b) * * *
(1) * * *
(iii)
(b)
(d)
(a) Insurers must electronically file forms BMC 34, BMC 35, BMC 36, BMC 82, BMC 83, BMC 84, BMC 85, BMC 91, and BMC 91X in accordance with the requirements and procedures set forth in paragraphs (b) through (d) of this section.
(b) Each insurer must obtain authorization to file electronically by registering with the FMCSA. An individual account number and password for computer access will be issued to each registered insurer.
(c) Filings must be transmitted online via the Internet at
(d) All registered insurers agree to furnish upon request to the FMCSA a copy of any policy (or policies) and all certificates of insurance, endorsements, surety bonds, trust fund agreements, proof of qualification to self-insure or other insurance filings.
(a)
(b)
(c)
(b)
Insurers must electronically file certificates of insurance, surety bonds, and other securities and agreements and notices of cancellation in accordance with the requirements and procedures set forth at § 387.323.
49 U.S.C. 504, 508, 13301, 13902, 13908, 31132, 31133, 31136, 31144, 31151, 31502, 31504; sec. 114, Pub. L. 103-311, 108 Stat. 1673, 1677; sec. 212, 217, Pub. L. 106-159, 113 Stat. 1748, 1767, 1773; sec. 229 Pub. L. 106-159 (as transferred by sec. 4114 and amended by secs. 4130-4132, Pub. L. 109-59, 119 Stat. 1144, 1726, 1743-44); sec. 32101(d) and 32934, Pub. L. 112-141, 126 Stat. 405, 778, 830; sec. 2, Pub. L. 113-125, 128 Stat. 1388, and 49 CFR 1.81, 1.81a, and 1.87.
(a) The rules in subchapter B of this chapter are applicable to all employers, employees, and commercial motor vehicles that transport property or passengers in interstate commerce.
(b) The rules in part 383 of this chapter, Commercial Driver's License Standards; Requirements and Penalties, are applicable to every person who operates a commercial motor vehicle, as defined in § 383.5 of this subchapter, in interstate or intrastate commerce and to all employers of such persons.
(c) The rules in part 387 of this chapter, Minimum Levels of Financial Responsibility for Motor Carriers, are applicable to motor carriers as provided in §§ 387.3 or 387.27 of this chapter.
(d)
(e)
(2) Every driver and employee involved in motor carrier operations shall be instructed regarding, and shall comply with, all applicable regulations contained in this subchapter.
(3) All motor vehicle equipment and accessories required by this chapter shall be maintained in compliance with all applicable performance and design criteria set forth in this subchapter.
(f)
(1) All school bus operations as defined in § 390.5 except for the provisions of §§ 391.15(e) and (f), 392.80, and 392.82 of this chapter;
(2) Transportation performed by the Federal government, a State, or any political subdivision of a State, or an agency established under a compact between States that has been approved by the Congress of the United States;
(3) The occasional transportation of personal property by individuals not for compensation and not in the furtherance of a commercial enterprise;
(4) The transportation of human corpses or sick and injured persons;
(5) The operation of fire trucks and rescue vehicles while involved in emergency and related operations;
(6) The operation of commercial motor vehicles designed or used to transport between 9 and 15 passengers (including the driver), not for direct compensation, provided the vehicle does not otherwise meet the definition of a commercial motor vehicle, except for the provisions of §§ 391.15(e) and (f), 392.80, and 392.82, and except that motor carriers operating such vehicles are required to comply with §§ 390.15, 390.21(a) and (b)(2), 390.201 and 390.205.
(7) Either a driver of a commercial motor vehicle used primarily in the transportation of propane winter heating fuel or a driver of a motor vehicle used to respond to a pipeline emergency, if such regulations would prevent the driver from responding to an emergency condition requiring immediate response as defined in § 390.5.
(g)
(1) Part 385, subparts A and E, for carriers subject to the requirements of § 385.403 of this subchapter.
(2) Part 386, Rules of Practice for Motor Carrier, Intermodal Equipment Provider, Broker, Freight Forwarder, and Hazardous Materials Proceedings, of this subchapter.
(3) Part 387, Minimum Levels of Financial Responsibility for Motor Carriers, to the extent provided in § 387.3 of this subchapter.
(4) Subpart E of this part, Unified Registration System, and § 390.21, Marking of CMVs, for carriers subject to the requirements of § 385.403 of this subchapter. Intrastate motor carriers operating prior to January 1, 2005, are excepted from § 390.201.
(h)
(1) Subpart F, Intermodal Equipment Providers, of Part 385, Safety Fitness Procedures.
(2) Part 386, Rules of Practice for Motor Carrier, Intermodal Equipment Provider, Broker, Freight Forwarder, and Hazardous Materials Proceedings.
(3) Part 390, Federal Motor Carrier Safety Regulations; General, except § 390.15(b) concerning accident registers.
(4) Part 393, Parts and Accessories Necessary for Safe Operation.
(5) Part 396, Inspection, Repair, and Maintenance.
(i)
(1) Part 371, Brokers of Property.
(2) Part 386, Rules of Practice for Motor Carrier, Intermodal Equipment Provider, Broker, Freight Forwarder, and Hazardous Materials Proceedings.
(3) Part 387, Minimum Levels of Financial Responsibility for Motor Carriers, to the extent provided in subpart C of that part.
(4) Subpart E of this part, Unified Registration System.
(j)
(1) Part 386, Rules of Practice for Motor Carrier, Intermodal Equipment Provider, Broker, Freight Forwarder, and Hazardous Materials Proceedings.
(2) Part 387, Minimum Levels of Financial Responsibility for Motor Carriers, to the extent provided in subpart D of that part.
(3) Subpart E of this part, Unified Registration System.
(k)
(a)
(b)
(1) Before it begins operations; and
(2) Every 24 months, according to the following schedule:
(3) If the next-to-last digit of its USDOT Number is odd, the motor carrier shall file its update in every odd-numbered calendar year. If the next-to-last digit of the USDOT Number is even, the motor carrier shall file its update in every even-numbered calendar year.
(4) A person that fails to complete biennial updates to the information pursuant to paragraph (b)(2) of this section is subject to the penalties prescribed in 49 U.S.C. 521(b)(2)(B) or 49 U.S.C. 14901(a), as appropriate, and deactivation of its USDOT Number.
(c)
(d)
(e)
(f) Only the legal name or a single trade name of the motor carrier may be used on the Form MCS-150.
(g)(1) A motor carrier that fails to file the Form MCS-150 or furnishes misleading information or makes false statements upon the form, is subject to the penalties prescribed in 49 U.S.C. 521(b)(2)(B).
(2) A motor carrier that fails to update the Form MCS-150 as required in paragraph (b) will have its USDOT Number deactivated and will be prohibited from conducting transportation.
(h)(1) Upon receipt and processing of the form described in paragraph (a) of this section, FMCSA will issue the motor carrier or intermodal equipment provider an identification number (USDOT Number).
(2) A Mexico-domiciled motor carrier seeking to provide transportation of property or passengers in interstate commerce between Mexico and points in the United States beyond the municipalities and commercial zones along the United States-Mexico international border must pass the pre-authorization safety audit under § 365.507 of this subchapter. The Agency will not issue a USDOT Number until expiration of the protest period provided in § 365.115 of this chapter or—if a protest is received-after FMCSA denies or rejects the protest.
(3) The motor carrier must display the USDOT Number on each self-propelled CMV, as defined in § 390.5, along with the additional information required by § 390.21.
(b) * * *
(1) The legal name or a single trade name of the motor carrier operating the self-propelled CMV, as listed on the Form MCSA-1, the URS online application, or the motor carrier identification report (Form MCS-150) and submitted in accordance with § 390.201 or § 390.19, as appropriate.
(a) Identify its operations to the FMCSA by filing the Form MCSA-1 required by § 390.201.
(a)
(b)
(c)
(d)
(a)
(b)
(i) Identify its operations with the Federal Motor Carrier Safety Administration for safety oversight, as applicable;
(ii) Obtain operating authority required under 49 U.S.C. chapter 139, as applicable; and
(iii) Obtain a hazardous materials safety permit as required under 49 U.S.C. 5109, as applicable.
(2) A cargo tank and cargo tank motor vehicle manufacturer, assembler, repairer, inspector, tester, and design certifying engineer that is subject to registration requirements under 49 CFR 107.502 and 49 U.S.C. 5108 must satisfy those requirements by electronically filing Form MCSA-1, the URS online application, with FMCSA.
(c)
(ii) A person that fails to complete biennial updates to the information pursuant to paragraph (d)(2) of this section is subject to the penalties prescribed in 49 U.S.C. 521(b)(2)(B) or 49 U.S.C. 14901(a), as appropriate, and deactivation of its USDOT Number.
(iii) A person that furnishes misleading information or makes false statements upon Form MCSA-1, the URS online application, is subject to the penalties prescribed in 49 U.S.C. 521(b)(2)(B), 49 U.S.C. 14901(a) or 49 U.S.C. 14907, as appropriate.
(2) Upon receipt and processing of Form MCSA-1, the URS online application, FMCSA will issue the applicant an inactive identification number (USDOT Number). FMCSA will activate the USDOT Number after completion of applicable administrative filings pursuant to § 390.205(a), unless the applicant is subject to § 390.205(b).
(3) The motor carrier must display a valid USDOT Number on each self-propelled CMV, as defined in § 390.5, along with the additional information required by § 390.21.
(d)
(1) Before it begins operations; and
(2) Every 24 months as prescribed in paragraph (d)(3) of this section.
(3)(i) Persons assigned a USDOT Number must file an updated Form MCSA-1, the URS online application, every 24 months, according to the following schedule:
(ii) If the next-to-last digit of its USDOT Number is odd, the person must file its update in every odd-numbered calendar year. If the next-to-last digit of the USDOT Number is even, the person must file its update in every even-numbered calendar year.
(4)
(5)
(A) An updated Form MCSA-1, the URS online application, for the transferor, and for the transferee, if the transferee had an existing USDOT Number at the time of the transfer; or
(B) A new Form MCSA-1, the URS online application, if the transferee did not have an existing USDOT Number at the time of the transfer.
(C) A copy of the operating authority that is being transferred.
(ii) Notification of a transfer of operating authority does not relieve a registered entity from the requirement to file an updated Form MCSA-1, the URS online application, every 24 months in accordance with paragraph (d)(3) of this section.
(e)
(f)
(g)
(a) A motor carrier that registers its vehicles in a State that participates in the Performance and Registration Information Systems Management (PRISM) program (authorized under section 4004 of the Transportation Equity Act for the 21st Century [Public Law 105-178, 112 Stat. 107]) alternatively may satisfy the requirements set forth in § 390.201 by electronically filing all the required USDOT registration and biennial update information with the State according to its policies and procedures, provided the State has integrated the USDOT registration/update capability into its vehicle registration program.
(b) If the State procedures do not allow a motor carrier to file the Form MCSA-1, the URS online application, or to submit updates within the period specified in § 390.201(d)(2), a motor carrier must complete such filings directly with FMCSA.
(c) A for-hire motor carrier, unless providing transportation exempt from the commercial registration requirements of 49 U.S.C. chapter 139, must obtain operating authority as prescribed under § 390.201(b) and part 365 of this subchapter before operating in interstate commerce.
(a)(1)
(2)
(ii) A person that registers to transport hazardous materials as defined in 49 CFR 171.8 (or any quantity of a material listed as a select agent or toxin in 42 CFR part 73) in interstate commerce must file evidence of financial responsibility as required under part 387, subpart C of this subchapter.
(3)
(b) If an application is subject to a protest period, the Agency will not activate a USDOT Number until expiration of the protest period provided in § 365.115 of this subchapter or—if a protest is received—after FMCSA denies or rejects the protest, as applicable.
(a)
(i) A U.S.- or Canada-domiciled motor carrier is subject to the new entrant safety assurance program under part 385, subpart D, of this subchapter.
(ii) A Mexico-domiciled motor carrier is subject to the safety monitoring program under part 385, subpart B of this subchapter.
(iii) A Non-North America-domiciled motor carrier is subject to the safety
(2) Only the legal name or a single trade name of the motor carrier may be used on the Form MCSA-1, the URS online application.
(b)
(2) A motor carrier registering to engage in transportation that is not exempt from economic regulation by FMCSA must obtain operating authority pursuant to part 365 of this subchapter as a condition for obtaining USDOT Registration.
(c)
(1) Only the legal name or a single trade name of the intermodal equipment provider may be used on the Form MCSA-1, the URS online application.
(2) The intermodal equipment provider must identify each unit of interchanged intermodal equipment by its assigned USDOT Number.
(d)
(e)
A non-North America-domiciled motor carrier seeking to provide transportation of property or passengers in interstate commerce within the United States must pass the pre-authorization safety audit under § 385.607(c) of this subchapter as a condition for receiving registration under this part.
49 U.S.C. 504, 521, 13902, 13908, 31136, 31151, 31502; Section 112 of Public Law 103-311, 108 Stat. 1673, 1676 (1994), as amended by sec. 32509 of Public Law 112-141, 126 Stat. 405, 805 (2012); and 49 CFR 1.87.
U.S. Small Business Administration.
Advance Notice of Proposed Rulemaking (ANPRM).
The U.S. Small Business Administration (SBA) is seeking comments on this Advance Notice of Proposed Rulemaking (ANPRM) regarding the Immediate Disaster Assistance Program (IDAP), the Expedited Disaster Assistance Program (EDAP), and the Private Disaster Assistance Program (PDAP). Specifically, SBA is seeking comments on the development of proposed regulations for PDAP and EDAP and potential revisions to the existing regulations for IDAP. These programs were authorized by the Small Business Disaster Response and Loan Improvements Act of 2008. The purpose of this ANPRM is to request feedback from potential participants and the public in order to implement these programs in a way that will encourage and enable private sector lenders to participate with SBA to fund loans to disaster survivors.
Comments must be submitted on or before December 21, 2015.
You may submit comments, identified by RIN 3245-AF99, by any of the following methods: (1) Federal Rulemaking Portal:
Michelle Genovese, U.S. Small Business Administration, 409 3rd Street SW., 8th Floor, Washington, DC 20416, telephone number (202) 401-8282 or
The Small Business Disaster Response and Loan Improvements Act of 2008 created three new guaranteed disaster loan programs: The Immediate Disaster Assistance Program, the Expedited Disaster Assistance Program, and the Private Disaster Assistance Program.
The statutory provisions for IDAP may be found in Section 12084 of the Small Business Disaster Response and Loan Improvements Act of 2008, codified at 15 U.S.C. 657n. Under IDAP, SBA guarantees 85% of a loan from participating lenders to small businesses that have suffered physical or economic injury due to a disaster. IDAP loans may be made available for any disaster declared by SBA. The intent of the program is to provide small businesses with immediate access to small dollar loans in the wake of a disaster on an interim basis pending receipt of a direct disaster loan from SBA. Applicants must meet the basic eligibility requirements for a direct disaster loan from SBA and must apply for the SBA direct disaster loan in order to qualify for the IDAP loan. The IDAP loan has a maximum amount of $25,000. SBA does not charge any fees on an IDAP loan. If a direct disaster loan is later approved, proceeds from that loan must be applied first to repay the IDAP loan. However, if the direct disaster loan is declined, or if the direct disaster loan covers only a portion of the IDAP loan, the balance of the IDAP loan must have a minimum term of 120 months from the date of final disbursement of the IDAP loan. By regulation, IDAP lenders must be lenders that participate in the guaranteed loan program authorized by Section 7(a) of the Small Business Act. Additionally, by regulation, IDAP is a delegated authority loan program; non-delegated processing is not available.
On October 1, 2010, SBA issued an interim final rule (75 FR 60588) that provided regulatory requirements for the program. These regulations include details on borrower eligibility requirements, loan terms, fees, and requirements for participating lenders.
The statutory provisions for EDAP may be found in Section 12085 of the Small Business Disaster Response and Loan Improvements Act of 2008. Under EDAP, SBA would guarantee short term loans from participating lenders to small businesses that have suffered damage due to a “catastrophic” disaster. Section 7(b)(9) of the Small Business Act provides that if the President declares a major disaster, the SBA Administrator may declare eligibility for additional disaster assistance if the disaster has resulted in extraordinary levels of casualties or damage or disruption severely affecting the population, infrastructure, environment, economy,
The maximum amount of an EDAP loan would be $150,000 and SBA would not charge any fees on the loans. The term of an EDAP loan must be limited to 180 days, with extensions on a case-by-case basis. The EDAP loan may be refinanced by a direct disaster loan from SBA or other sources. The maximum interest rate must not exceed 300 basis points over the federal funds rate.
The statutory provisions for PDAP may be found in Section 12083 of the Small Business Disaster Response and Loan Improvements Act of 2008, codified at 15 U.S.C. 636(c). Under PDAP, SBA is authorized to guarantee not more than 85 percent of a loan from participating lenders to small businesses, homeowners or renters that have suffered damage due to a “catastrophic” disaster, as defined above.
Those eligible for PDAP include homeowners, renters, or small businesses that have suffered physical losses and small businesses that have suffered economic injury as a result of a catastrophic disaster. As required by the statute, any SBA lender participating in the Preferred Lenders Program (PLP) under Section 7(a) of the Small Business Act would be eligible to participate in the PDAP program, and SBA would establish criteria for additional PDAP lenders in regulations. All PDAP lenders would be eligible to make PDAP loans to small businesses, but only PLP lenders would be eligible to make PDAP loans to homeowners or renters.
The maximum amount of a PDAP loan is $2,000,000. SBA would not charge any fees on the loans. Terms and conditions of PDAP loans would be the same as SBA direct disaster loans.
These guaranteed disaster loan programs would provide disaster survivors with additional avenues for disaster relief and give 7(a) participating lenders an opportunity to partner with SBA to assist in the recovery of homeowners and small businesses in their communities after a disaster. SBA requests comments from the public on features necessary to attract lender participation while providing timely and affordable assistance to disaster survivors. Responders are invited to comment on any or all portions of this ANPRM, and may submit additional comments on issues relevant to IDAP, EDAP and PDAP not specifically covered.
General questions applicable to all three programs include, but are not limited to the following:
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Only borrowers who sustained physical or economic damages and who are located in an eligible disaster area would be eligible for loans under the guaranteed disaster loan programs. Before making a direct disaster loan for physical damage, SBA performs an on-site verification of the losses resulting from the declared disaster in order to determine the eligible loan amount. For both economic injury and physical damage loans, SBA must also verify the location of the borrower. How would a loss verification process affect lender costs? SBA seeks input from potential lenders regarding their ability to make loans in accordance with these requirements. For example, should SBA allow lenders to rely on borrowers' self-certifications when determining eligibility? Comments may address, among other things, verification of borrower eligibility, borrower rights of appeal, liability for false statements by borrowers, and the level of training/instruction required to participate in the programs.
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Social Security Administration.
Notice of proposed rulemaking (NPRM).
We propose to amend our regulations by revising our rules regarding the return of evidence at the Appeals Council (AC) level. Our current rules state that the AC will return to the claimant additional evidence it receives when the AC finds the evidence does not relate to the period on or before the
To ensure that we consider your comments, we must receive them by no later than November 20, 2015.
You may submit comments by any one of three methods—Internet, fax, or mail. Do not submit the same comments multiple times or by more than one method. Regardless of which method you choose, please state that your comments refer to Docket No. SSA-2013-0061 so that we may associate your comments with the correct regulation.
1.
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3.
Comments are available for public viewing on the Federal eRulemaking portal at
Maren Weight, Office of Appellate Operations, Social Security Administration, 5107 Leesburg Pike, Falls Church, VA 22041, (703) 605-7100. 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
The AC will consider new and material evidence submitted with a request for review when the evidence relates to the period on or before the date of the ALJ hearing decision.
When we published it in 1987 (52 FR 4004, February 9, 1987), the rule requiring the AC to return the additional evidence to the claimant made sense because cases pending at the AC level involved paper claim(s) files. Returning evidence provided a public service because claimants often submitted original documentation to the AC. Our primary purpose in returning the original documentation was to allow the claimant to use the information if he or she filed a new application. Because the AC worked with paper claim(s) files, it was more administratively efficient and cost effective to return the evidence by mail directly to the claimant.
We now use many electronic services that make the practice of returning evidence unnecessary. For example, we now scan most of the medical evidence into the electronic claim(s) file or appointed representatives submit it through our Electronic Records Express system. This technology immediately uploads records into a claimant's electronic folder, making the records available for review in real time. It is neither administratively efficient nor cost effective for us to print out documents that have been submitted to us electronically by a claimant or appointed representative in order to return them to the claimant. Additionally, in the electronic folder, we are able to identify and retain the additional information in a part of the claim(s) file that is not part of the record associated with the current application. This means that all of the evidence submitted on a prior application is immediately available for review if the claimant files a subsequent application.
Most claimants have representation at and above the hearing level. In approximately 85% of the claims pending with an appointed representative at the hearing level, the representatives have online access to the electronic folder. This means that most representatives can determine in real time whether we received and associated evidence with the claim(s) file. It is impractical and unnecessary to return evidence in these claims because the appointed representative has immediate access to the additional evidence while the claim is pending before the AC.
The administrative burden of processing and returning evidence also has increased significantly over the last few years. As the number of appeals filed with the AC continues to increase, we have experienced a corresponding increase in the number of claims that involve the submission of additional evidence. Each year, the AC receives additional evidence submissions in approximately one-third of its pending cases, most of which are multi-page submissions.
In addition to the increased costs associated with printing a significant amount of electronically submitted documents, there are many other administrative and processing time costs to returning evidence. When the AC returns evidence, employees must separate the evidence returned from the other evidence in the electronic claim(s) file, remove the notice of action from the automated printing and mailing process, and manually print, package, and mail the evidence to the claimant. This process is time-consuming, uses our scarce administrative resources with little benefit either to the public or to us, requires action by multiple employees, and delays release of the AC action document. This delay is burdensome and unnecessary in most instances because the claimant already has copies of or access to the information.
We recognize that there may be some instances in which it would remain appropriate for the AC to return evidence to the claimant, such as when the submitted evidence is an original or a certified copy of a marriage or birth certificate. In evaluating whether returning the evidence is necessary, the AC considers who submitted the information and by what means, whether the claimant is represented, and whether the claimant otherwise has access to the information. Our sub-regulatory instructions will incorporate procedures that explain when the AC will return evidence. We are not changing how the AC considers additional evidence or when the AC will give protective filing based on the receipt of additional evidence.
Given the change in our operating environment since we first published these rules in 1987, both in terms of our administrative resources and the electronic availability of evidence, we believe it is no longer administratively efficient or cost effective to return additional evidence when the AC
Executive Order 12866, as supplemented by Executive Order 13563, requires each agency to write all rules in plain language. In addition to your substantive comments on these proposed rules, we invite your comments on how to make them easier to understand.
For example:
• Would more, but shorter, sections be better?
• Are the requirements in the proposed rules clearly stated?
• Have we organized the material to suit your needs?
• Could we improve clarity by adding tables, lists, or diagrams?
• What else could we do to make the rules easier to understand?
• Do the proposed rules contain technical language or jargon that is not clear?
• Would a different format make the proposed rules easier to understand,
We consulted with the Office of Management and Budget (OMB) and determined that these proposed rules do not meet the criteria for a significant regulatory action under Executive Order 12866, as supplemented by Executive Order 13563. Thus, OMB did not review these proposed rules.
We certify that these proposed rules will not have a significant economic impact on a substantial number of small entities because they affect individuals only. Therefore, the Regulatory Flexibility Act, as amended, does not require us to prepare a regulatory flexibility analysis.
These proposed 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, Old-age, survivors, and disability insurance, Reporting and recordkeeping requirements, Social Security.
Administrative practice and procedure, Aged, Blind, Disability benefits, Public assistance programs, Reporting and recordkeeping requirements, Supplemental Security Income (SSI).
For the reasons stated in the preamble, we propose to amend 20 CFR chapter III parts 404 and 416 as set forth below:
Secs. 201(j), 204(f), 205(a)-(b), (d)-(h), and (j), 221, 223(i), 225, and 702(a)(5) of the Social Security Act (42 U.S.C. 401(j), 404(f), 405(a)-(b), (d)-(h), and (j), 421, 423(i), 425, and 902(a)(5)); sec. 5, Pub. L. 97-455, 96 Stat. 2500 (42 U.S.C. 405 note); secs. 5, 6(c)-(e), and 15, Pub. L. 98-460, 98 Stat. 1802 (42 U.S.C. 421 note); sec. 202, Pub. L. 108-203, 118 Stat. 509 (42 U.S.C. 902 note).
(b) * * * (1) The Appeals Council will consider all the evidence in the administrative law judge hearing record as well as any new and material evidence submitted to it that relates to the period on or before the date of the administrative law judge hearing decision. If you submit evidence that does not relate to the period on or before the date of the administrative law judge hearing decision, the Appeals Council will explain why it did not accept the additional evidence and will advise you of your right to file a new application. The notice will also advise you that if you file a new application within 6 months after the date of the Appeals Council's notice, your request for review will constitute a written statement indicating an intent to claim benefits in accordance with § 404.630. If you file a new application within 6 months of the date of this notice, we will use the date of the request for review as the filing date for your application.
Secs. 702(a)(5), 1631, and 1633 of the Social Security Act (42 U.S.C. 902(a)(5), 1383, and 1383b); sec. 202, Pub. L. 108-203, 118 Stat. 509 (42 U.S.C. 902 note).
(b) * * * (1) In reviewing decisions based on an application for benefits, the Appeals Council will consider the evidence in the administrative law judge hearing record as well as any new and material evidence submitted to it that relates to the period on or before the date of the administrative law judge hearing decision. If you submit evidence that does not relate to the period on or before the date of the administrative law judge hearing decision, the Appeals Council will explain why it did not accept the additional evidence and will advise you of your right to file a new application. The notice will also advise you that if you file a new application within 60 days after the date of the Appeals Council's notice, your request for review will constitute a written statement indicating an intent to claim benefits in accordance with § 416.340. If you file a new application within 60 days of the date of this notice, we will use the date of the request for review as the filing date for your application.
Office of the Assistant Secretary for Fair Housing and Equal Opportunity, HUD.
Proposed rule.
Through this rule, HUD proposes to amend its fair housing regulations to formalize standards for use in investigations and adjudications involving alleged harassment on the basis of race, color, religion, national origin, sex, familial status or disability under the Fair Housing Act. The proposed standards would specify how HUD would evaluate complaints of quid pro quo (“this for that”) harassment and hostile environment harassment and provide for uniform treatment of Fair Housing Act claims raising such allegations in the federal courts. This proposed rule defines “quid pro quo” and “hostile environment harassment,” as prohibited under the Fair Housing Act, and adds illustrations of discriminatory housing practices that constitute such harassment. In addition, the proposed rule clarifies the operation of traditional principles of direct and vicarious liability under the Fair Housing Act.
Interested persons are invited to submit comments regarding this proposed rule to the Regulations Division, Office of General Counsel, 451 7th Street SW., Room 10276, Department of Housing and Urban Development, Washington, DC 20410-0500. Communications must refer to the above docket number and title. There are two methods for submitting public comments. All submissions must refer to the above docket number and title.
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To receive consideration as public comments, comments must be submitted through one of the two methods specified above. Again, all submissions must refer to the docket number and title of the rule.
Lynn Grosso, Acting Deputy Assistant Secretary for Enforcement and Programs, Office of Fair Housing and Equal Opportunity, Department of Housing and Urban Development, 451 Seventh Street SW., Room 5204, Washington, DC 20410-2000; telephone number 202-402-5361 (this is not a toll-free number). Persons with hearing or speech impairments may contact this number via TTY by calling the toll-free Federal Relay Service at 800-877-8339.
In addition to formalizing standards for assessing claims of harassment under the Fair Housing Act, a regulation is needed to clarify when housing providers and other covered entities or individuals may be held directly or vicariously liable under the Act for illegal harassment or other discriminatory housing practices. HUD proposes to set forth by regulation how these traditional liability standards apply in the housing context because, in HUD's experience, there is significant misunderstanding among public and private housing providers as to the circumstances under which they will be subject to liability under the Fair Housing Act for discriminatory housing practices undertaken by others.
This rule proposes to codify through regulation the principles that quid pro quo and hostile environment harassment on the basis of race, color, national origin, religion, sex, disability or familial status (“protected characteristic”) violate one or more provisions of the Fair Housing Act. As noted above, the proposed rule would define “quid pro quo” and “hostile environment” harassment under the Fair Housing Act, add illustrations of prohibited “quid pro quo” and “hostile environment” harassment, and address how the traditional standards for direct and vicarious liability operate in the Fair Housing Act context, including for claims of harassment.
As proposed to be defined, “quid pro quo harassment” occurs when a person is subjected to an unwelcome request or demand because of the person's protected characteristic and submission to the request or demand is, either explicitly or implicitly, made a condition related to the person's housing. A person's conduct may constitute quid pro quo harassment even where the victim acquiesces or submits to the unwelcome request or demand.
As proposed to be defined, “hostile environment harassment” occurs when, because of a protected characteristic, a person is subjected to unwelcome conduct that is sufficiently severe or pervasive such that it interferes with or deprives the victim of his or her right to use and enjoy the housing or to exercise other rights protected by the Act. The proposed rule further explains that whether a hostile environment has been created requires an assessment of the totality of the circumstances, which includes, but is not limited to, the nature of the conduct; the context in which the conduct occurred; the severity, scope, frequency, duration, and location of the incident(s); and the relationships of the persons involved.
For purposes of clarity and guidance, the proposed rule would add to HUD's existing Fair Housing Act regulations examples of prohibited quid pro quo and hostile environment harassment under the Act.
The proposed rule also would describe “direct liability” and “vicarious liability” as applied to all violations under the Act, not solely harassment. The standards for both types of liability incorporated into the proposed rule follow well-established common law tort and agency principles and do not subject respondents or defendants to enhanced liability for violations of the Act. Under such standards, a person is directly liable for his or her own discriminatory housing practices and, in certain circumstances, is directly liable for actions taken by others, including agents, when the person knew or should have known of the discriminatory conduct and failed to take prompt corrective action that ends it. The proposed rule would also clarify that direct liability for the actions of non-agents occurs only when a person fails to fulfill a duty to take prompt action to correct and end a non-agent's discriminatory conduct, of which the person knew or should have known.
In contrast to
Because the rule does not add any new forms of liability under the Act, but rather formalizes clear, consistent, nationwide standards for evaluating harassment cases under the Fair Housing Act, the rule adds no additional costs to housing providers and others engaged in housing transactions. Rather, the rule will assist in ensuring compliance with the Act by defining quid pro quo and hostile environment harassment that violates the Act and by specifying traditional tort and agency law standards for assessing direct and vicarious liability, consistent with Supreme Court precedent. Articulating clear standards enables entities subject to the Act's prohibitions and persons protected by its terms to understand the types of conduct that constitute actionable quid pro quo and hostile environment harassment under the Act. This should facilitate more effective training to avoid discriminatory harassment in housing and should decrease the need for protracted litigation to resolve disputed claims.
Title VIII of the Civil Rights Act of 1968, as amended (the Fair Housing
In 1989, HUD promulgated fair housing regulations at 24 CFR part 100 that address discriminatory conduct in housing generally. The 1989 regulations include examples of discriminatory housing practices that have been interpreted to cover quid pro quo sexual harassment and hostile environment harassment generally. Section 100.65(b)(5) identifies, as an example of unlawful conduct, denying or limiting housing-related services or facilities because a person refused to provide sexual favors. Section 100.400(c)(2) offers as an example of illegal conduct “. . . interfering with persons in their enjoyment of a dwelling because of race, color, religion, sex, disability, familial status, or national origin of such persons, or of visitors or associates of such persons.” The 1989 regulations do not, however, define quid pro quo or hostile environment harassment, specify standards for examining such claims, or provide illustrations of other types of quid pro quo or hostile environment harassment prohibited by the Act. Nor do the 1989 regulations discuss liability standards for prohibited harassment or other discriminatory housing practices.
On November 13, 2000, HUD published a proposed rule entitled “Proposed Fair Housing Act Regulations Amendment Standards Governing Sexual Harassment Cases” (65 FR 67666) seeking comment on standards to be used in evaluating sexual harassment complaints. HUD never issued final regulations pursuant to that proposed rule. Because this proposed rule addresses harassment more broadly, based on any characteristic protected by the Act and not solely because of sex, this proposed rule is not a continuation of the 2000 rulemaking.
Over time, forms of harassment that violate the civil rights laws have coalesced into two legal doctrines—quid pro quo and hostile environment. Although HUD and the courts have recognized that the Fair Housing Act prohibits harassment because of race or color,
To date, when deciding harassment cases, courts have often looked to case law decided under Title VII of the Civil Rights Act of 1964 (42 U.S.C. 2000
Therefore, this proposed rule would provide regulations to address specifically harassment in one's home and would make clear the differences between quid pro quo and hostile environment harassment in the home and in the work place. While Title VII and Fair Housing Act case law contain many similar concepts, this proposed regulation describes the appropriate analytical framework for harassment claims under the Fair Housing Act.
The proposed rule addresses only quid pro quo and hostile environment harassment, and not conduct generically referred to as harassment that, for different reasons, may violate section 818 or other provisions of the Act. For example, a racially hostile statement by a housing provider to a tenant could indicate a discriminatory preference in violation of section 804(c) of the Act, or it could evidence intent to deny housing or discriminate in the terms or conditions of housing under sections 804(a) or 804(b), even if the statement does not create a hostile environment or establish a quid pro quo. Section 818, which makes it unlawful to “coerce, intimidate, threaten, or interfere with any person in the exercise or enjoyment of” rights protected by the Act, or on account of a person having aided others in exercising or enjoying rights protected by the Act, could be violated by conduct that creates a quid pro quo or hostile environment, or by other conduct that constitutes retaliation or another form of coercion, intimidation, threats, or interference because of a protected characteristic.
In sum, this proposed rule would provide standards that are uniformly applicable to claims of quid pro quo and hostile environment harassment under the Fair Housing Act, regardless of the section of the Act that is alleged to have been violated. These standards would be useful to victims of harassment as well as housing providers seeking to ensure their properties are free of illegal harassment. The proposed rule also provides HUD investigators and administrative law judges, other government agencies, and courts with the appropriate standards to be applied to claims of quid pro quo and hostile environment harassment in the housing context.
This proposed rule would amend 24 CFR part 100 to establish a new subpart H, entitled “Quid Pro Quo and Hostile Environment Harassment,” which would define “quid pro quo” and “hostile environment harassment” under the Fair Housing Act. This proposed rule would also add new illustrations of prohibited harassment throughout part 100 by amending existing §§ 100.60, 100.65, 100.80, 100.90, 100.120, 100.130, and 100.135, and a new § 100.7, addressing how the traditional standards for direct and vicarious liability operate in the Fair Housing Act context, including for claims of harassment.
The proposed rule establishes within proposed Subpart H a new § 100.600, entitled “Quid Pro Quo and Hostile Environment Harassment,” which addresses what conduct constitutes these types of harassment under the Fair Housing Act. This section states that quid pro quo harassment and hostile environment harassment on the basis of race, color, national origin, religion, sex, disability, or familial status violate one or more of the prohibitions against discrimination found in sections 804, 805, 806 and 818 of the Fair Housing Act.
As with other discriminatory housing practices prohibited by the Act, any person who claims to have been injured or believes such person will be injured by prohibited harassment is an aggrieved person under the Act, even if that person is not directly targeted by the harassment.
Paragraph (a)(1) of new § 100.600 would address quid pro quo harassment under the Fair Housing Act. Paragraph (a)(1) provides that quid pro quo harassment occurs when a person is subjected to an unwelcome request or demand because of race, color, religion, sex, national origin, disability, or familial status, and submission to the request or demand is, either explicitly or implicitly, made a condition related to his or her housing.
Claims of quid pro quo harassment may be established on the basis of protected characteristics other than sex. The theory, however, has most typically been associated with sex. For example, quid pro quo harassment occurs when a housing provider conditions a tenant's continued housing on the tenant's submission to unwelcome requests for sexual favors.
Paragraph (a)(2) of proposed new § 100.600 addresses hostile environment harassment under the Fair Housing Act. Paragraph (a)(2) provides that hostile environment harassment occurs when unwelcome conduct because of race, color, national origin, religion, sex, disability or familial status, is sufficiently severe or pervasive as to create an environment that unreasonably interferes with the availability, sale, rental, use, or enjoyment of a dwelling, the provision or enjoyment of facilities or services in connection therewith, or the availability or terms of residential real estate-related transactions.
Establishing hostile environment harassment requires a showing that: A person was subjected to unwelcome spoken, written or physical conduct; the conduct was because of a protected characteristic; and the conduct was, considering the totality of circumstances, sufficiently severe or pervasive that it unreasonably interfered with or deprived the victim of his or her right to use and enjoy the housing or to exercise other rights protected by the Act.
Proposed § 100.600(a)(2)(i), entitled “Totality of the circumstances,” specifies that whether hostile environment harassment exists depends upon the totality of the circumstances. Proposed § 100.600(a)(2)(i)(A) provides that the factors to be considered in determining whether a hostile environment has been created include, but are not limited to, the nature of the conduct; the context in which the conduct occurred; the severity, scope, frequency, duration, and location of the incident(s); and the relationships of the persons involved.
In considering whether the totality of the circumstances evidences hostile environment harassment, it is particularly important to consider the place where the conduct occurred. Often in a fair housing case the harassment will occur in or around the home, which should be a haven of privacy, safety and security. The Supreme Court has repeatedly recognized that heightened rights exist within the home for, among other things, privacy and freedom from intrusive speech.
Preserving the sanctity of the home, the one retreat to which men and women can repair to escape from the tribulations of their daily pursuits, is surely an important value. Our decisions reflect no lack of solicitude for the right of an individual “to be let alone” in the privacy of the home, “sometimes the last citadel of the tired, the weary, and the sick.” The State's interest in protecting the well-being, tranquility, and privacy of the home is certainly of the highest order in a free and civilized society.
When harassment occurs in the workplace, the victim can escape to his home. In contrast, when harassment occurs in and around the home, the victim has little opportunity to escape it short of moving or staying away from the home—neither of which should be required. As one court noted in a sexual harassment case under the Act, the home is “a place where [one is] entitled to feel safe and secure and need not flee.”
Proposed § 100.600(a)(2)(i)(B) provides that the absence of psychological or physical harm is not dispositive in determining whether hostile environment harassment has occurred. Evidence of such harm is but one of many factors to be considered in the totality of circumstances. However, the severity of psychological or physical harm may be considered in determining the proper amount of any damages to which an aggrieved person may be entitled.
Prohibited quid pro quo harassment and hostile environment harassment require unwelcome conduct, and proposed § 100.600(b) explains that the unwelcome conduct can be written, verbal, or other conduct and does not require physical contact. The unwelcome conduct may come in many forms, such as using threatening imagery (
As is the case with other prohibited conduct under the Act, an individual violates the Act so long as the quid pro quo or hostile environment harassment is because of a protected characteristic, even if he or she shares the same protected characteristic as the targeted person. For example, in sexual harassment claims, an individual violates the Act by harassing a person of the same sex or by harassing both men and women, so long as the unwelcome conduct is because of sex. Similarly, a person violates the Act by harassing a person of the same race or color if the unwelcome conduct is because of race or color.
With respect to sexual harassment, harassing conduct need not be motivated by sexual desire in order to support a finding of illegal discrimination. Sexually harassing conduct must occur “because of sex,” which can be shown by, for example, conduct motivated by hostility toward persons of one sex; conduct that occurs because a person acts in a manner that conflicts with gender-based stereotypes of how persons of a particular sex should act; or conduct motivated by sexual desire or control.
Proposed § 100.600(c) provides that a single incident because of race, color, religion, sex, familial status, national origin or disability can constitute an illegal quid pro quo, or, if sufficiently severe, a hostile environment in violation of the Act.
The proposed rule would add illustrations of quid pro quo and hostile environment harassment to existing §§ 100.60, 100.65, 100.80, 100.90, 100.120, 100.130, and 100.135.
In § 100.60, entitled “Unlawful refusal to sell or rent or to negotiate for the sale or rental,” the proposed rule would add the following paragraphs as illustrations of prohibited quid pro quo and hostile environment harassment under the Fair Housing Act: Conditioning the availability of a dwelling, including the price, qualification criteria, or standards or procedures for securing a dwelling, on a person's response to harassment because of race, color, religion, sex, familial status, national origin, or disability; subjecting a person to harassment because of race, color, religion, sex, familial status, national origin, or disability that causes the person to vacate a dwelling or abandon efforts to secure the dwelling. Conditioning the “availability” of a dwelling means the initial or continued availability of a dwelling, or both.
In § 100.65, entitled “Discrimination in terms, conditions, and privileges and in services and facilities,” the proposed rule would add the following paragraph as an illustration of prohibited quid pro quo and hostile environment harassment under the Fair Housing Act: Conditioning the terms, conditions, or privileges relating to the sale or rental of a dwelling or denying or limiting the services or facilities in connection with a dwelling on a person's response to harassment because of race, color, religion, sex, familial status, national origin, or disability; subjecting a person to harassment because of race, color, religion, sex, disability, familial status, or national origin that has the effect of imposing different terms, conditions, or privileges relating to the sale or rental of a dwelling or denying or limiting service or facilities in connection with the sale or rental of a dwelling.
In § 100.80, entitled “Discriminatory representation on the availability of dwellings,” the proposed rule would add the following paragraph as an illustration of a prohibited quid pro quo harassment under the Fair Housing Act: Representing to an applicant that a unit is unavailable because of the applicant's response to a request for a sexual favor or other harassment because of race, color, religion, sex, familial status, national origin, or disability.
In § 100.90, entitled “Discrimination in the provision of brokerage services,” the proposed rule would add the following paragraphs as illustrations of prohibited quid pro quo and hostile environment under the Fair Housing Act: Conditioning access to brokerage services on a person's response to harassment because of race, color, religion, sex, familial status, national origin, or disability; subjecting a person to harassment because of race, color, religion, sex, familial status, national origin, or disability that has the effect of discouraging or denying access to brokerage services.
In § 100.120, entitled “Discrimination in the making of loans and in the provision of other financial services,” the proposed rule would add the following paragraphs as illustrations of prohibited quid pro quo and hostile environment harassment under the Fair Housing Act: Conditioning the availability of a loan or other financial assistance that is or will be secured by a dwelling on a person's response to harassment because of race, color, religion, sex, familial status, national origin, or disability; subjecting a person to harassment because of race, color, religion, sex, familial status, national origin, or disability that affects the availability of a loan or other financial assistance that is or will be secured by a dwelling.
In § 100.130, entitled “Discrimination in the terms and conditions for making available loans or other financial assistance,” the proposed rule would add the following paragraphs as illustrations of prohibited quid pro quo and hostile environment harassment under the Fair Housing Act: Conditioning the aspect of a loan or other financial assistance to be provided with respect to a dwelling, or the terms or conditions thereof, on a person's response to harassment because of race, color, religion, sex, familial status, national origin, or disability; subjecting a person to harassment because race, color, religion, sex, familial status, national origin, or disability that has the effect of imposing different terms or conditions for the availability of such loans or other financial assistance.
In § 100.135, entitled “Unlawful practices in the selling, brokering, or appraising of residential real property,”
The proposed rule would not add an additional example of quid pro quo or hostile environment harassment to § 100.400, entitled “Prohibited Interference, Coercion or Intimidation,” because existing § 100.400(c)(2) already encompasses both in identifying as an example of conduct made unlawful by section 818: “Threatening, intimidating or interfering with persons in their enjoyment of a dwelling because of the race, color, religion, sex, handicap, familial status, or national origin of such persons, or of visitors or associates of such persons.”
This proposed rule would add new § 100.7 to subpart A (General), entitled “Liability for Discriminatory Housing Practices.” This proposed rule is intended to clarify standards for liability under this part, based on traditional principles of tort liability, and not to impose any new legal obligations or create or define new agency relationships or duties of care.
Proposed paragraph (a) of § 100.7 identifies direct liability under the Act. New § 100.7(a)(1)(i) proposes that a person is liable for his or her own discriminatory housing practices. New §§ 100.7(a)(1)(ii) and (a)(1)(iii) describe direct liability grounded in negligence. New § 100.7(a)(1)(ii) proposes that a person is directly liable for failing to take prompt action to correct and end a discriminatory housing practice by that person's employee or agent where the person knew or should have known of the discriminatory conduct. New § 100.7(a)(1)(iii) proposes that a person is directly liable for failing to fulfill a duty to take prompt action to correct and end a discriminatory housing practice by a third-party (
With respect to a person's direct liability for the actions of an agent, § 100.7(a)(1)(ii) recognizes that a principal who knows or should have known that his or her agent has engaged in or is engaging in unlawful conduct and allows it to continue is complicit in or has ratified the discrimination.
A principal “should have known” about the illegal discrimination of the principal's agent when the principal is found to have had knowledge from which a reasonable person would conclude that the agent was discriminating.
Similarly, an apartment owner “should have known” of tenant harassment by another tenant when the owner had knowledge from which a reasonable person would conclude that the harassment was occurring. It is important to note, however, that not every quarrel among neighbors amounts to a violation of the Fair Housing Act.
Proposed § 100.7(a)(2) provides that corrective actions must be effective in ending the discrimination, but may not injure the aggrieved persons.
Proposed paragraph (b) of § 100.7 provides that a person is vicariously liable for the discriminatory housing practices of his or her agents or employees, as specified by agency law. This provision is consistent with the holding of
As provided in new § 100.600(a)(2)(ii), the proposed rule would not extend to the Fair Housing Act the judicially-created Title VII affirmative defense to an employer's vicarious liability for hostile environment harassment committed by a supervisory employee. The Title VII affirmative defense permits an employer to avoid vicarious liability for such harassment by showing that (1) the employer exercised reasonable care to prevent and correct promptly the supervisor's harassing behavior, including implementing a policy to prevent and correct instances of sexual harassment and procedures for training and complaint filing; and (2) the employee unreasonably failed to take advantage of any preventative or corrective opportunities provided by the employer to otherwise avoid harm.
Noting that common-law principles of agency liability “may not be transferable in all their particulars to Title VII,”
The Title VII affirmative defense is not appropriately applied to harassment in the housing context because the Fair Housing Act simply follows traditional principles of vicarious liability.
Nor do the specific, practical concerns that led the Court to adopt the affirmative defense to vicarious liability for certain employment relationships arise in the housing context. In adopting the affirmative defense under Title VII, the Supreme Court distinguished between workplace harassment perpetrated by supervisors, which is often facilitated by the supervisor's agency relationship with the employer, and harassment perpetrated by co-workers, which is not similarly facilitated.
But the concerns that led the Supreme Court to distinguish workplace harassment by a supervisor from that by a fellow employee do not extend to the housing context where supervisory status of a housing provider's agent plays a far less significant role in facilitating harassment.
Instead, the affirmative defense would add additional burdens that are incompatible with the broad protections and streamlined enforcement mechanisms afforded by the Fair
While the risk of retaliation attendant to reporting harassment is serious in the employment context, such risk is even graver in the residential context. Victims of harassment by a landlord's agent not only risk eviction, a particularly severe consequence for low-income tenants whose affordable housing options are limited, they may also suffer physical harm to themselves or their family members in retaliation for filing a grievance. In the most egregious circumstances, an agent may abuse the power conferred by his agency relationship to gain access to a victim's home and inflict violence upon the victim after the victim has reported harassment. In HUD's view, a victim of hostile environment harassment should not be forced to choose between the risk of retaliation and the risk of losing his or her right to hold a housing provider liable for the acts of its agents.
While Title VII and the Fair Housing Act share a common goal of eliminating discrimination in their respective spheres, the mechanisms for doing so are fundamentally different. In addition, as discussed above, one's workplace and one's home are very different places, with the latter having substantial expectations of privacy, security and safety. Individuals have a justified expectation of freedom from unwelcome conduct in the home.
Under Executive Order 12866 (Regulatory Planning and Review), a determination must be made whether a regulatory action is significant and therefore, subject to review by the Office of Management and Budget (OMB) in accordance with the requirements of the order. Executive Order 13563 (Improving Regulations and Regulatory Review) directs executive agencies to analyze regulations that are “outmoded, ineffective, insufficient, or excessively burdensome, and to modify, streamline, expand, or repeal them in accordance with what has been learned. Executive Order 13563 also directs that, where relevant, feasible, and consistent with regulatory objectives, and to the extent permitted by law, agencies are to identify and consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public. This rule was determined to be a “significant regulatory action” as defined in section 3(f) of Executive Order (although not an economically significant regulatory action, as provided under section 3(f)(1) of the Executive Order).
This rule establishes uniform standards for use in investigations and processing cases involving harassment and liability under the Fair Housing Act. As has been discussed in the preamble to this rule, in establishing such standards, HUD is exercising its rulemaking authority to bring uniformity, clarity, and certainty to an area of legal practice.
The docket file for this rule is available for public inspection between the hours of 8 a.m. and 5 p.m. weekdays in the Regulations Division, Office of General Counsel, Department of Housing and Urban Development, Room 10276, 451 7th Street SW., Washington, DC 20410-0500. Due to security measures at the HUD Headquarters building, please schedule an appointment to review the docket file by calling the Regulations Division at 202-708-3055 (this is not a toll-free number). Persons with hearing or speech impairments may access the above telephone number via TTY by calling the toll-free Federal Relay Service at 800-877-8339.
This rule does not direct, provide for assistance or loan and mortgage insurance for, or otherwise govern or regulate, real property acquisition, disposition, leasing, rehabilitation, alteration, demolition or new construction, or establish, revise, or provide for standards for construction or construction materials, manufactured housing, or occupancy. This rule is limited to the procedures governing fair housing enforcement. Accordingly, under 24 CFR 50.19(c)(3), this rule is categorically excluded from environmental review under the National Environmental Policy Act (42 U.S.C. 4321).
The Regulatory Flexibility Act (5 U.S.C. 4321,
Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) (UMRA) establishes requirements for federal agencies to assess the effects of their regulatory actions on state, local, and tribal governments and the private sector. This proposed rule does not impose any federal mandates on any state, local, or tribal governments or the private sector within the meaning of UMRA.
Executive Order 13132 (entitled “Federalism”) prohibits an agency from publishing any rule that has federalism implications if the rule either (1) imposes substantial, direct compliance costs on state and local governments, and is not required by statute, or (2) preempts state law, unless the agency meets the consultation and funding requirements of section 6 of the Executive Order. This rule would not have federalism implications and would not impose substantial direct compliance costs on state and local governments or preempt state law within the meaning of the Executive Order.
The Catalogue of Federal Domestic Assistance Number for the equal opportunity in housing program is 14.400.
Aged, Fair housing, Individuals with disabilities, Mortgages, Reporting and recordkeeping requirements.
Accordingly, for the reasons stated in the preamble, HUD proposes to amend 24 CFR part 100 to read as follows:
42 U.S.C. 3535(d), 3600-3620.
(a)
(i) The person's own conduct that results in a discriminatory housing practice.
(ii) Failing to take prompt action to correct and end a discriminatory housing practice by that person's employee or agent, where the person knew or should have known of the discriminatory conduct.
(iii) Failing to fulfill a duty to take prompt action to correct and end a discriminatory housing practice by a third-party, where the person knew or should have known of the discriminatory conduct. The duty to take prompt action to correct and end a discriminatory housing practice by a third-party can derive from an obligation to the aggrieved person created by contract or lease (including bylaws or other rules of a homeowners association, condominium or cooperative), or by federal, state or local law.
(2) For purposes of determining liability under paragraphs (a)(1)(ii) and (iii) of this section, prompt action to correct and end the discriminatory housing practice may not include any action that penalizes or harms the aggrieved person, such as eviction of the aggrieved person.
(b)
(b) * * *
(6) Conditioning the availability of a dwelling, including the price, qualification criteria, or standards or procedures for securing the dwelling, on a person's response to harassment because of race, color, religion, sex, handicap, familial status, or national origin.
(7) Subjecting a person to harassment because of race, color, religion, sex, handicap, familial status, or national origin that causes the person to vacate a dwelling or abandon efforts to secure the dwelling.
(b) * * *
(6) Conditioning the terms, conditions, or privileges relating to the sale or rental of a dwelling, or denying or limiting the services or facilities in connection therewith, on a person's response to harassment because of race, color, religion, sex, handicap, familial status, or national origin.
(7) Subjecting a person to harassment because of race, color, religion, sex, handicap, familial status, or national origin that has the effect of imposing different terms, conditions, or privileges relating to the sale or rental of a dwelling or denying or limiting service or facilities in connection with the sale or rental of a dwelling.
(b) * * *
(6) Representing to an applicant that a unit is unavailable because of the applicant's response to a request for a sexual favor or other harassment because of race, color, religion, sex, handicap, familial status, or national origin.
(b) * * *
(5) Conditioning access to brokerage services on a person's response to harassment because of race, color, religion, sex, handicap, familial status, or national origin.
(6) Subjecting a person to harassment because of race, color, religion, sex, handicap, familial status, or national origin that has the effect of discouraging or denying access to brokerage services.
(b) * * *
(3) Conditioning the availability of a loan or other financial assistance on a person's response to harassment because of race, color, religion, sex, handicap, familial status, or national origin.
(4) Subjecting a person to harassment because of race, color, religion, sex, handicap, familial status, or national origin that affects the availability of a loan or other financial assistance.
(b) * * *
(4) Conditioning the aspect of a loan or other financial assistance to be provided with respect to a dwelling, or the terms or conditions thereof, on a person's response to harassment because of race, color, religion, sex, handicap, familial status, or national origin.
(5) Subjecting a person to harassment because of race, color, religion, sex, handicap, familial status, or national origin that has the effect of imposing different terms or conditions for the availability of such loans or other financial assistance.
(d) Practices which are unlawful under this section include, but are not limited to:
(1) Using an appraisal of residential real property in connection with the sale, rental, or financing of any dwelling where the person knows or reasonably should know that the appraisal improperly takes into consideration race, color, religion, sex, handicap, familial status, or national origin.
(2) Conditioning the terms of an appraisal of residential real property in connection with the sale, rental, or
(a)
(1)
(2)
(i)
(A) Factors to be considered to determine whether hostile environment harassment exists include, but are not limited to, the nature of the conduct, the context in which the incident(s) occurred, the severity, scope, frequency, duration, and location of the conduct, and the relationships of the persons involved.
(B) Evidence of psychological or physical harm is relevant in determining whether a hostile environment was created, as well as the amount of damages to which an aggrieved person may be entitled. However, neither psychological nor physical harm must be demonstrated to prove that a hostile environment exists.
(ii)
(b)
(c)
Environmental Protection Agency (EPA).
Notice of filing of petitions and request for comment.
This document announces the Agency's receipt of several initial filings of pesticide petitions requesting the establishment or modification of regulations for residues of pesticide chemicals in or on various commodities.
Comments must be received on or before November 20, 2015.
Submit your comments, identified by docket identification (ID) number and the pesticide petition number (PP) of interest as shown in the body of this document, by one of the following methods:
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Additional instructions on commenting or visiting the docket, along with more information about dockets generally is available at
Susan Lewis, Registration Division (RD) (7505P), main telephone number: (703) 305-7090; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under
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EPA is announcing its receipt of several pesticide petitions filed under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, requesting the establishment or modification of regulations in 40 CFR part 180 for residues of pesticide chemicals in or on various food commodities. The Agency is taking public comment on the requests before responding to the petitioners. EPA is not proposing any particular action at this time. EPA has determined that the pesticide petitions described in this document contain the data or information prescribed in FFDCA section 408(d)(2), 21 U.S.C. 346a(d)(2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the pesticide petitions. After considering the public comments, EPA intends to evaluate whether and what action may be warranted. Additional data may be needed before EPA can make a final determination on these pesticide petitions.
Pursuant to 40 CFR 180.7(f), a summary of each of the petitions that are the subject of this document, prepared by the petitioner, is included in a docket EPA has created for each rulemaking. The docket for each of the petitions is available at
As specified in FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), EPA is publishing notice of the petition so that the public has an opportunity to comment on this request for the establishment or modification of regulations for residues of pesticides in or on food commodities. Further information on the petition may be obtained through the petition summary referenced in this unit.
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21 U.S.C. 346a.
Environmental Protection Agency (EPA).
Proposed rule.
The State of Texas has applied to the Environmental Protection Agency (EPA) for Final authorization of the changes to its hazardous waste program under the Resource Conservation and Recovery Act (RCRA). EPA proposes to grant Final authorization to the State of Texas. In the “Rules and Regulations” section of this
Send your written comments by November 20, 2015.
Submit any comments identified by Docket ID No. EPA-R06-RCRA-2015-0109 by one of the following methods:
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Alima Patterson, Region 6 Regional Authorization Coordinator, State/Tribal Oversight Section (6PD-O), Multimedia Planning and Permitting Division, (214) 665-8533, EPA Region 6 1445 Ross Avenue, Dallas, Texas 75202-2733, and Email address
For additional information, please see the immediate final rule published in the “Rules and Regulations” section of this
Defense Acquisition Regulations System, Department of Defense (DoD).
Announcement of meeting; extension of comment period.
DoD is hosting a public meeting to obtain the views of experts and interested parties in Government and the private sector regarding further implementation of the requirement for detection and avoidance of counterfeit electronic parts, as required by a section of the National Defense Authorization Act for Fiscal Year 2012.
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Comments received generally will be posted without change to
Ms. Amy Williams, DPAP/DARS, at 571-372-6106.
DoD is interested in continuing a dialogue with experts and interested parties in Government and the private sector about further implementation of the requirements for detection and avoidance of counterfeit electronic parts in DoD contracts.
On May 6, 2014, DoD published a final rule under DFARS Case 2012-D055, entitled “Detection and Avoidance of Counterfeit Electronic Parts” (78 FR 26092). That final rule constituted the initial partial implementation of section 818 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2012 (Pub. L. 112-81), as modified by section 817 of the NDAA for FY 2015 (Pub. L. 113-291).
On May 9, 2014, DoD published notice of a public meeting (79 FR 26725), which was held on June 16, 2014, to address further implementation of detections and avoidance of counterfeit electronic parts.
On September 21, 2015, DoD published a proposed rule under DFARS Case 2014-D005, entitled “Detection and Avoidance of Counterfeit Electronic Parts—Further Implementation” (80 FR 56939). The due date for comments on this proposed rule is extended from November 20, 2015, to December 11, 2015.
(1) Company or organization name.
(2) Names and email addresses of persons planning to attend.
(3) Identify if desiring to make a presentation; limit to a 5-minute presentation per company or organization. This limitation may be subject to adjustment, depending on the number of entities requesting to present, in order to ensure adequate time for discussion.
One valid government-issued photo identification card will be required in order to enter the building. Attendees are encouraged to arrive at least 30 minutes early to accommodate security procedures. Public parking is not available at the Mark Center.
The TTY number for further information is: 1-800-877-8339. When the operator answers the call, let them know the agency is the Department of Defense; the point of contact is Amy Williams at 571-372-6106.
Government procurement.
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 Indiana Advisory Committee (Committee) will hold a meeting on Wednesday, November 4, 2015, from 3:00-4:30 p.m. EST for the purpose of preparing for a series of public hearings to study Civil Rights and the School to Prison Pipeline in Indiana.
Members of the public may listen to the discussion. This meeting is available to the public through the following toll-free call-in number: 888-438-5535 conference ID: 8231614. Any interested member of the public may call this number and listen to the meeting. 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 invited to make statements during the scheduled open comment period. In addition, members of the public may submit written comments; the comments must be received in the regional office within 30 days after the Committee 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 Administrative Assistant, Carolyn Allen at
Records and documents discussed during the meeting will be available for public viewing prior to and following the meeting at
The meeting will be held on Wednesday November 4, 2015, from 3:00-4:30 p.m. EST.
Melissa Wojnaroski, DFO, at 312-353-8311 or
Bureau of Industry and Security, U.S. Department of Commerce.
Notice of Proposed Amendment to Privacy Act System of Records: “COMMERCE/ITA-1, Individuals Identified in Export Transactions.”
In accordance with the Privacy Act of 1974 (Privacy Act), as amended, Title 5, United States Code (U.S.C.) 552a(e)(4) and (11); and Office of Management and Budget (OMB) Circular A-130, Appendix 1, “Federal Agency Responsibility for Maintaining Records About Individuals,” the Department of Commerce (Department) is issuing a notice of intent to amend the system of records entitled “COMMERCE/ITA-1, Individuals Identified in Export Transactions,” by transferring the system from the International Trade Administration (ITA) to the Bureau of Industry and Security (BIS), and by renaming the system to “COMMERCE/BIS-1, Individuals Identified in Export Transactions and Other Matters Subject to BIS Jurisdiction.” The purpose of this amendment is also to update: (a) The security classification, system location, and system manager and address; (b) the categories of individuals covered by the system; (c) the categories of records in the system; (d) the authority for maintenance of the system; (e) the storage, retrievability, safeguards, retention, and disposal of records; (f) the notification, record access, and contesting record procedures; (g) the routine uses by adding the breach notification routine use; (h) records source categories; and (i) exemptions claimed for the system.
The information is collected for identification purposes of individuals involved in export transactions chosen for or participating in export regulation outreach, education and information programs; individuals seeking export licenses or other authorizations from BIS, as well as related end use checks; individuals providing information pursuant to laws or regulations administered or enforced by BIS; or individuals under suspicion or investigation or having been convicted
To be considered, written comments must be submitted on or before November 20, 2015. Unless comments are received, the new system of records will become effective as proposed on the date of publication of a subsequent notice in the
Comments may be mailed to the Privacy Officer, Bureau of Industry and Security, Department of Commerce, 1401 Constitution Avenue NW., Room 6622, Washington, DC 20230.
Chief Financial Officer and Director of Administration, Bureau of Industry and Security, Department of Commerce, 1401 Constitution Avenue NW., Room 6622, Washington, DC 20230.
This notice announces the Department's proposal to amend the system of records under the Privacy Act of 1974, for Individuals Identified in Export Transactions records. The changes are needed because the existing notice for this system of records identifies ITA as the owner of the system, which is no longer the case as the system of records has been transferred to BIS. These changes clarify the scope of laws and regulations administered or enforced by BIS. Information collections would be obtained from individuals under the authority of the Export Administration Act of 1979, the Export Administration Regulations, the Security Assistance Act of 2002, the Foreign Trade Regulations, the International Emergency Economic Powers Act, the United States Additional Protocol Implementation Act, the Chemical Weapons Convention Implementation Act of 1998, the Defense Production Act of 1950, and the Fastener Quality Act. Further, these changes clarify the types of records maintained.
COMMERCE/BIS-1, Individuals Identified in Export Transactions and Other Matters Subject to BIS Jurisdiction.
Unclassified, Sensitive.
Department of Commerce, Herbert C. Hoover Building.
a. Individuals involved in export transactions. This information is maintained on domestic and foreign companies and business officials, and includes U.S. citizens involved with or working for firms abroad.
b. Individuals identified in a BIS export enforcement proceeding or investigation. Individuals alleged to have violated the Export Administration Regulations; certain other individuals identified by the Federal Bureau of Investigation (FBI) or other investigating agencies or individuals in the investigative process such as those involved in organized crime; individuals who have received warning letters; and individuals subject to prohibitions, licensing requirements, or other restrictions.
c. Individuals identified in export license applications, licenses, or other authorizations from BIS, including related end use checks.
d. Individuals identified in proceedings or investigations related to other laws and regulations administered, or enforced by BIS.
e. Individuals who have provided information to BIS to participate in export regulation outreach, education and information programs.
f. Individuals who have otherwise provided information to BIS pursuant to laws and regulations administered or enforced by BIS.
Reports and cables from U.S. Foreign Service's posts; FBI and other U.S. or foreign law enforcement or investigative agencies, investigators or informants; investigative and intelligence data; documented violations; warning letters; licensing information; export transaction information; and information obtained pursuant to other laws or regulations administered or enforced by BIS. Also includes any information on alleged or proven violators of the Export Administration Act or Regulations, the International Emergency Economic Powers Act or any other law or regulation administered or enforced by BIS and information collected to meet U.S. treaty obligations, for which BIS is responsible to implement. Examples of these categories of records and data items may include, but are not limited to: (1) Identifying Numbers; (2) General Personal Data; (3) Work-Related Data; (4) Distinguishing Features/Biometrics; and (5) System Administration/Audit Data.
Export Administration Act of 1979 (Pub L. 96-72, 50 U.S.C. app. 2401-2420), Export Administration Regulations (EAR) (15 CFR 730-799), the Security Assistance Act of 2002 (13 U.S.C. 305) and the Foreign Trade Regulations (15 CFR 30.60 and 30.73), International Emergency Economic Powers Act (IEEPA), as amended (50 U.S.C. 1701-1706), 5 U.S.C. 301, 22 U.S.C. 401, 22 U.S.C. 8544, 28 U.S.C. 533-535, 44 U.S.C. 3101, United States Additional Protocol Implementation Act (Pub. L. 109-401), Chemical Weapons Convention Implementation Act of 1998 (22 U.S.C. 6701
The purpose of this system is to maintain records that are related to the administration, enforcement, and implementation of the laws and regulations under the jurisdiction of BIS. Included in these records is information regarding individuals involved or identified in export transactions, export license applications, licenses, or other authorizations from BIS, and individuals identified in BIS export enforcement proceedings or suspected of violating statutes, regulations, or Executive Orders administered, enforced, or implemented by BIS.
1. In the event that a system or records maintained by the Department to carry out its functions indicates a violation or potential violation of law or contract, whether civil, criminal or regulatory in nature, and whether arising by general statute or particular program statute or contract, or rule, regulation, or order issued pursuant thereto, or the necessity to protect an interest of the Department, the relevant records in the system of records may be referred, as a routine use, to the appropriate agency, whether Federal, state, local or foreign, charged with the responsibility of investigating or prosecuting such violation or charged with enforcing or implementing the statute or contract, or rule, regulation or order issued pursuant thereto, or protecting the interest of the Department.
2. A record from this system of records may be disclosed, as a routine use, to a Federal, state or local agency maintaining civil, criminal or other
3. A record from this system of records may be disclosed, as a routine use, to a Federal, state, local, or international agency, in response to its request, in connection with the assignment, hiring or retention of an individual, the issuance of a security clearance, the reporting of an investigation of an individual, the letting of a contract, or the issuance of a license, grant, or other benefit by the requesting agency, to the extent that the information is relevant and necessary to the requesting agency's decision on the matter.
4. A record from this system of records may be disclosed, as a routine use, in the course of presenting evidence to a court, magistrate or administrative tribunal, including disclosures to opposing counsel in the course of settlement negotiations.
5. A record in this system of records may be disclosed, as a routine use, to a Member of Congress submitting a request involving an individual when the individual has requested assistance from the Member with respect to the subject matter of the record.
6. A record in this system of records may be disclosed, as a routine use, to the Office of Management and Budget in connection with the review of private relief legislation as set forth in OMB Circular No. A-19 at any stage of the legislative coordination and clearance process as set forth in that Circular.
7. A record in this system of records may be disclosed, as a routine use, to the Department of Justice in connection with determining whether disclosure thereof is required by the Freedom of Information Act (5 U.S.C. 552).
8. A record in this system of records may be disclosed, as a routine use, to a contractor of the Department having need for the information in the performance of the contract, but not operating a system of records within the meaning of 5 U.S.C. 552a(m).
9. A record in this system may be transferred, as a routine use, to the Office of Personnel Management: for personnel research purposes; as a data source for management information; for the production of summary descriptive statistics and analytical studies in support of the function for which the records are collected and maintained; or for related manpower studies.
10. A record from this system of records may be disclosed, as a routine use, to the Administrator, General Services Administration (GSA), or his designee, during an inspection of records conducted by GSA as part of that agency's responsibility to recommend improvements in records management practices and programs, under authority of 44 U.S.C. 2904 and 2906. Such disclosure shall be made in accordance with the GSA regulations governing inspection of records for this purpose, and any other relevant (
11. A record in this system of records may be disclosed to appropriate agencies, entities and persons when: (1) It is suspected or determined that the security or confidentiality of information in the system of records has been compromised; (2) the Department has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or whether systems or programs (whether maintained by the Department or another agency or entity) that rely upon the compromised information; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with the Department's efforts to respond to the suspected or confirmed compromise and to prevent, minimize, or remedy such harm.
12. A record in this system of records may be disclosed for law enforcement purposes to the appropriate agency or other authority, whether federal, state, local, foreign, international or tribal, charged with the responsibility of enforcing, investigating, or prosecuting a violation of any law, rule, regulation, or order in any case in which there is an indication of a violation or potential violation of law (civil, criminal, or regulatory in nature).
13. A record in this system of records may be disclosed to an agency, organization, foreign government or individual for the purpose of performing audit or oversight operations or meeting treaty obligations as authorized by law, but only such information as is necessary and relevant to such audit or oversight function or treaty obligations.
14. A record in this system of records may be disclosed to contractors and BIS or contractor agents, grantees, experts, consultants, and others performing or working on a contract, service, grant, governmental or non-governmental cooperative agreement (including under the Economy Act), or other work assignment for BIS, when necessary to accomplish an agency function related to this system of records. Individuals provided information under this routine use are subject to the same Privacy Act requirements and limitations on disclosure as are applicable to BIS employees.
15. A record in this system of records may be disclosed to the Departments of State, Justice, Homeland Security, the Treasury, Defense, or Energy, or other federal agencies, in connection with BIS licensing policy, enforcement matters, or other matters of mutual interest or concern, including through interagency databases;
16. A record in this system of records may be disclosed to the general public, in furtherance of BIS's mission, regarding individuals and entities whose export privileges have been denied or limited. This routine use includes disclosure of information to the general public in furtherance of BIS's mission regarding individuals and entities that have been denied export privileges by BIS, or who are subject to additional restrictions and license requirements. This routine use encompasses publishing this information in the
Not applicable.
Paper records in file folders and electronic records in computer files.
Filed alphabetically by individual's name or by other personal identifiers, by an identifying case number upon initiation of the case or by an identifying transaction number upon successful transmission of the export transaction information.
Paper records and discs are maintained in office areas with access limited to screened personnel whose official duties require access. Automated records are maintained on protected servers in data centers with access limited to screened personnel whose official duties require access.
Retention and disposal practices are in accordance with approved General Services Administration schedules. Generally, records are retained for periods of 5-15 years, unless a longer period is deemed necessary for investigative purposes or for permanent archival retention.
Office of the Chief Financial Officer and Director of Administration, Bureau of Industry and Security, Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230.
Information may be obtained from: Privacy Officer, Office of the Chief Financial Officer and Director of Administration, Bureau of Industry and Security, Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230. Requestor should provide name, address and case or subject, if known, pursuant to the inquiry provisions of the Department's rules which appear in 15 CFR part 4.
Requests from individuals should be addressed to: Same address as stated in the notification section above.
The department's rules for access, for contesting contents and appealing initial determinations by the individual concerned appear in 15 CFR part 4b. Use above address.
Individual exporters, those authorized by the individual exporters to furnish information, trade sources, investigative agencies, intelligence, investigative, legal, and other personnel of BIS or the Department of Commerce, informants, Department of Homeland Security, Federal Bureau of Investigation, Central Intelligence Agency, Department of Justice, Department of Defense, Department of Energy, and Department of State on an official “need to know” basis. Also, individuals authorized to furnish information pursuant to laws or regulations administered by BIS.
Pursuant to 5 U.S.C. 552a(j)(2), all information about an individual in the record which meets the criteria stated in 5 U.S.C. 552a(j)(2) are exempted from the notice, access and contest requirements of the agency regulations and from all parts of 5 U.S.C. 552a except subsections (b), (c)(1) and (2), (e)(4)(A) through (F), (e)(6), (7), (9), (10), and (11), and (i). Pursuant to 5 U.S.C. 552a(k)(1) and (k)(2) on condition that the 5 U.S.C. 552a(j)(2) exemption is held to be invalid, all investigatory material in the record which meets the criteria stated in 5 U.S.C. 552a(k)(1) and (k)(2) are exempted from the notice, access, and contest requirements (under 5 U.S.C. 552a(c)(3), (d), (e)(1), (e)(4)(G), (H), and (I), and (f)) of the agency regulations because of the necessity to exempt this information and material in order to accomplish the law enforcement function of the agency, to prevent subjects of investigation from frustrating the investigatory process, to prevent the disclosure of investigative techniques, to fulfill commitments made to protect the confidentiality of sources, to maintain access to sources of information, and to avoid endangering these sources and law enforcement personnel. Section 12(c) of the Export Administration Act of 1979 also protects certain parts of this information and material related to or concerning export licenses from disclosure, and other certain parts of this information may be protected from disclosure by the Chemical Weapons Convention Implementation Act of 1998, the Additional Protocol Implementation Act of 2006, and the Defense Production Act of 1950.
The Sensors and Instrumentation Technical Advisory Committee (SITAC) will meet on November 5, 2015, 9:30 a.m., in the Herbert C. Hoover Building, Room 6087B, 14th Street between Constitution and Pennsylvania Avenues NW., Washington, DC. The Committee advises the Office of the Assistant Secretary for Export Administration on technical questions that affect the level of export controls applicable to sensors and instrumentation equipment and technology.
1. Welcome and Introductions.
2. Remarks from the Bureau of Industry and Security Management.
3. Industry Presentations.
4. New Business.
5. Discussion of matters determined to be exempt from the provisions relating to public meetings found in 5 U.S.C. app. 2 §§ 10(a)(1) and 10(a)(3).
The open session will be accessible via teleconference to 20 participants on a first come, first serve basis. To join the conference, submit inquiries to Ms. Yvette Springer at
A limited number of seats will be available during the public session of the meeting. Reservations are not accepted. To the extent that time permits, members of the public may present oral statements to the Committee. The public may submit written statements at any time before or after the meeting. However, to facilitate distribution of public presentation materials to the Committee members, the Committee suggests that the materials be forwarded before the meeting to Ms. Springer.
For more information contact Yvette Springer on (202) 482-2813.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (the Department) is initiating a new shipper review (NSR) of the antidumping duty order on freshwater crawfish tail meat from the People's Republic of China (PRC) with respect to Hubei Qianjiang Huashan Aquatic Food and Product Co., Ltd. (Hubei Qianjiang).
Effective Date: October 21, 2015.
Hermes Pinilla, AD/CVD Operations Office I, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; Telephone: (202) 482-3477.
The antidumping duty order on freshwater crawfish tail meat from the PRC published in the
Pursuant to section 751(a)(2)(B)(i)(I) of the Act and 19 CFR 351.214(b)(2)(i), Hubei Qianjiang certified that it did not export subject merchandise to the United States during the period of investigation (POI).
In addition to the certifications described above, pursuant to 19 CFR 351.214(b)(2), Hubei Qianjiang submitted documentation establishing the following: (1) The date on which it first shipped subject merchandise for export to the United States; (2) the volume of its first shipment; and (3) the date of its first sale to an unaffiliated customer in the United States.
The period of review (POR) for this NSR is September 1, 2014, through August 31, 2015.
Pursuant to section 751(a)(2)(B) of the Act and 19 CFR 351.214(d)(1), the Department finds that the request from Hubei Qianjiang meets the threshold requirements for initiation of a NSR for shipments of freshwater crawfish tail meat from the PRC produced and exported by Hubei Qianjiang.
Unless extended, the Department intends to issue the preliminary results of this NSR no later than 180 days from the date of initiation and final results of the review no later than 90 days after the date the preliminary results are issued.
We will instruct U.S. Customs and Border Protection to allow, at the option of the importer, the posting, until the completion of the review, of a bond or security in lieu of a cash deposit for each entry of the subject merchandise from Hubei Qianjiang in accordance with section 751(a)(2)(B)(iii) of the Act and 19 CFR 351.214(e). Because Hubei Qianjiang certified that it produced and exported subject merchandise, the sale of which is the basis for the request for a NSR, we will apply the bonding privilege to Hubei Qianjiang only for subject merchandise which was produced and exported by Hubei Qianjiang.
To assist in its analysis of the
Interested parties requiring access to proprietary information in the NSR should submit applications for disclosure under administrative protective order in accordance with 19 CFR 351.305 and 351.306.
This initiation and notice are published in accordance with section 751(a)(2)(B) of the Act and 19 CFR 351.214 and 351.221(c)(1)(i).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Based on affirmative final determinations by the Department of Commerce (the “Department”) and the International Trade Commission (“ITC”), the Department is issuing an
Effective date: October 21, 2015.
Kabir Archuletta or Irene Gorelik, AD/CVD Operations, Office V, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-2593 or (202) 482-6905, respectively.
On August 26, 2015, the Department published the final determination of sales at less than fair value in the antidumping duty investigation of boltless steel shelving units prepackaged for sale from the PRC.
The scope of this order covers boltless steel shelving units prepackaged for sale, with or without decks (“boltless steel shelving”). The term “prepackaged for sale” means that, at a minimum, the steel vertical supports (
The scope includes all boltless steel shelving meeting the description above, regardless of (1) vertical support or post type (including but not limited to open post, closed post and tubing); (2) horizontal support or beam/brace profile (including but not limited to Z-beam, C-beam, L-beam, step beam and cargo rack); (3) number of supports; (4) surface coating (including but not limited to paint, epoxy, powder coating, zinc and other metallic coating); (5) number of levels; (6) weight capacity; (7) shape (including but not limited to rectangular, square, and corner units); (8) decking material (including but not limited to wire decking, particle board, laminated board or no deck at all); or (9) the boltless method by which vertical and horizontal supports connect (including but not limited to keyhole and rivet, slot and tab, welded frame, punched rivet and clip).
Specifically excluded from the scope are:
• Wall-mounted shelving, defined as shelving that is hung on the wall and does not stand on, or transfer load to, the floor;
• wire shelving units, which consist of shelves made from wire that incorporates both a wire deck and wire horizontal supports (taking the place of the horizontal beams and braces) into a single piece with tubular collars that slide over the posts and onto plastic sleeves snapped on the posts to create the finished shelving unit;
• bulk-packed parts or components of boltless steel shelving units; and
• made-to-order shelving systems.
Subject boltless steel shelving enters the United States through Harmonized Tariff Schedule of the United States (“HTSUS”) statistical subheadings 9403.20.0018, 9403.20.0020, 9403.20.0025, and 9403.20.0026, but may also enter through HTSUS 9403.10.0040. While HTSUS subheadings are provided for convenience and Customs purposes, the written description of the scope of this order is dispositive.
In accordance with sections 735(b)(1)(A)(i) and 735(d) of the Act, the ITC has notified the Department of its final determination in this investigation, in which it found that imports of boltless steel shelving from the PRC are materially injuring or threatening material injury to a U.S. industry. Therefore, in accordance with section 735(c)(2) of the Act, we are publishing this antidumping duty order.
As a result of the ITC's final determination, in accordance with section 736(a)(1) of the Act, the Department will direct U.S. Customs and Border Protection (“CBP”) to assess, upon further instruction by the Department, antidumping duties equal to the amount by which the normal value of the merchandise exceeds the export price (or constructed export price) of the merchandise, for all relevant entries of boltless steel shelving from the PRC. These antidumping duties will be assessed on unliquidated entries from the PRC entered, or withdrawn from warehouse, for consumption on or after April 1, 2015, the date on which the Department published the
In accordance with section 735(c)(1)(B) of the Act, we will instruct CBP to continue to suspend liquidation on entries of subject merchandise from the PRC. We will also instruct CBP to require cash deposits equal to the estimated amount by which the normal value exceeds the U.S. price as indicated in the chart below, adjusted where appropriate for export subsidies and estimated domestic subsidy pass-through.
Accordingly, effective on the date of publication of the ITC's final affirmative injury determination, CBP will require, at the same time as importers would normally deposit estimated duties on this subject merchandise, a cash deposit equal to the estimated weighted-average antidumping duty margins, adjusted where appropriate for export subsidies and estimated domestic subsidy pass-through, as discussed above.
Section 733(d) of the Act states that instructions issued pursuant to an affirmative preliminary determination may not remain in effect for more than four months except where exporters representing a significant proportion of exports of the subject merchandise request the Department to extend that four-month period to no more than six months. At the request of an exporter that accounted for a significant proportion of exports of boltless steel shelving from the PRC, we extended the four-month period to no more than six months.
Therefore, in accordance with section 733(d) of the Act and our practice, we will instruct CBP to terminate the suspension of liquidation and to liquidate, without regard to antidumping duties, unliquidated entries of boltless steel shelving from the PRC entered, or withdrawn from warehouse, for consumption after September 27, 2015, the date the provisional measures expired, and through the day preceding the date of publication of the ITC's final injury determination in the
The weighted-average antidumping duty margin percentages are as follows:
This notice constitutes the antidumping duty order with respect to boltless steel shelving from the PRC, pursuant to section 736(a) of the Act. Interested parties may contact the Department's Central Records Unit, Room B8024 of the main Commerce building, for copies of an updated list of antidumping duty orders currently in effect.
This order is published in accordance with sections 736(a) of the Act and 19 CFR 351.211(b).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
On March 18, 2015, the Department of Commerce (the “Department”) initiated a changed circumstance review (“CCR”) of the antidumping duty order on crystalline silicon photovoltaic cells, whether or not assembled into modules (“solar cells”), from the People's Republic of China (“PRC”) in response to a request from Neo Solar Power Corporation (“Neo Solar”), DelSolar Co., Ltd. (“DelSolar Taiwan”), and DelSolar (Wujiang) Ltd. (“DelSolar Wujiang”).
Effective date: October 21, 2015.
Erin Kearney, AD/CVD Operations, Office IV, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-0167.
On December 7, 2012, the Department published the AD order on solar cells from the PRC in the
The Department initiated this CCR on March 18, 2015.
The merchandise covered by this order is crystalline silicon photovoltaic cells, and modules, laminates, and panels, consisting of crystalline silicon photovoltaic cells, whether or not partially or fully assembled into other products, including, but not limited to, modules, laminates, panels and building integrated materials. Merchandise covered by this order is currently classified in the Harmonized Tariff System of the United States (“HTSUS”) under subheadings 8501.61.0000, 8507.20.80, 8541.40.6020, 8541.40.6030, and 8501.31.8000. These HTSUS subheadings are provided for convenience and customs purposes; the written description of the scope of this order is dispositive.
A complete description of the scope of the order is contained in the Preliminary Decision Memorandum.
In accordance with section 751(b)(1) of the Act, we are conducting this CCR based upon the information contained in the submissions of Neo Solar, DelSolar Taiwan, and DelSolar Wujiang.
Based on record evidence, we preliminarily determine that Neo Solar is not the successor-in-interest to DelSolar Taiwan. Specifically, we find that material changes occurred after DelSolar Taiwan merged with, and became part of, Neo Solar, including significant changes in management, the board of directors, and ownership. In addition, we find that Neo Solar did not demonstrate that its operations, with respect to the subject merchandise, were materially similar to the operations of DelSolar Taiwan when it comes to supplier relationships and customer base. Thus, we preliminarily determine that Neo Solar does not operate as the same business entity as DelSolar Taiwan with respect to the subject merchandise. A list of topics discussed in the Preliminary Decision Memorandum appears in the Appendix to this notice.
If the Department upholds these preliminary results in the final results, Neo Solar will be subject to the cash deposit rate currently assigned to the PRC-wide entity (
Interested parties may submit case briefs no later than 14 days after the date of publication of these preliminary results of review in the
Any interested party may submit a request for a hearing to the Assistant Secretary of Enforcement and Compliance using ACCESS within 14 days of publication of this notice in the
Unless extended, in accordance with 19 CFR 351.216(e), the Department intends to issue the final results of this changed circumstances review not later than 270 days after the date on which the review was initiated.
The Department is issuing and publishing these results in accordance with sections 751(b)(1) and 777(i) of the Act and 19 CFR 351.216 and 351.221(c)(3)(i).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Sergio Balbontin at (202) 482-6478 (Brazil); Katie Marksberry at (202) 482-7906 (Republic of Korea); Emily Halle at (202) 482-0176 (Turkey), AD/CVD Operations, Enforcement and Compliance, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230.
On August 31, 2015, the Department of Commerce (the Department) initiated countervailing duty (CVD) investigations of imports of certain hot-rolled steel flat products (hot-rolled steel) from Brazil, the Republic of Korea (Korea), and Turkey.
Section 703(c)(1)(B) of the Act permits the Department to postpone the time limit for the preliminary determination if it concludes that the parties concerned are cooperating and determines that the case is extraordinarily complicated by reason of the number and complexity of the transactions to be investigated or adjustments to be considered, the novelty of the issues presented, or the number of firms whose activities must be investigated, and additional time is necessary to make the preliminary determination. Under this section of the Act, the Department may postpone the preliminary determination until no later than 130 days after the date on which the Department initiated the investigation.
The Department determines that the parties involved in these hot-rolled steel CVD investigations are cooperating, and that the investigations are extraordinarily complicated. Additional time is required to analyze the questionnaire responses and issue appropriate requests for clarification and additional information.
Therefore, in accordance with section 703(c)(1)(B) of the Act and 19 CFR 351.205(f)(1), the Department is postponing the time period for the preliminary determinations of these investigations by 65 days, to January 8, 2016. Pursuant to section 705(a)(1) of the Act and 19 CFR 351.210(b)(1), the deadline for the final determinations will continue to be 75 days after the date of the preliminary determinations.
This notice is issued and published pursuant to section 703(c)(2) of the Act and 19 CFR 351.205(f)(1).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Based on affirmative final determinations by the Department of Commerce (the “Department”) and the International Trade Commission (“ITC”), the Department is issuing a countervailing duty (“CVD”) order on boltless steel shelving units prepackaged for sale (“boltless steel shelving”) from the People's Republic of China (the “PRC”). Also, as explained in this notice, we are amending our
Paul Walker, AD/CVD Operations, Office V, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: 202.482.2593.
On August 26, 2015, the Department published the
On October 7, 2015, the ITC notified the Department of its final determination pursuant to section 705(d) of the Act that an industry in the United States is materially injured within the meaning of section 705(b)(1)(A)(i) of the Act by reason of subsidized imports of subject merchandise from the PRC.
The scope of this investigation covers boltless steel shelving, with or without decks. The term “prepackaged for sale” means that, at a minimum, the steel vertical supports (
The scope includes all boltless steel shelving meeting the description above, regardless of (1) vertical support or post type (including but not limited to open post, closed post and tubing); (2) horizontal support or beam/brace profile (including but not limited to Z-beam, C-beam, L-beam, step beam and cargo rack); (3) number of supports; (4) surface coating (including but not limited to paint, epoxy, powder coating, zinc and other metallic coating); (5) number of levels; (6) weight capacity; (7) shape (including but not limited to rectangular, square, and corner units); (8) decking material (including but not limited to wire decking, particle board, laminated board or no deck at all); or (9) the boltless method by which vertical and horizontal supports connect (including but not limited to keyhole and rivet, slot and tab, welded frame, punched rivet and clip).
Specifically excluded from the scope are:
• Wall-mounted shelving, defined as shelving that is hung on the wall and does not stand on, or transfer load to, the floor;
• wire shelving units, which consist of shelves made from wire that incorporates both a wire deck and wire horizontal supports (taking the place of the horizontal beams and braces) into a single piece with tubular collars that slide over the posts and onto plastic sleeves snapped on the posts to create the finished shelving unit;
• bulk-packed parts or components of boltless steel shelving units; and
• made-to-order shelving systems.
Subject boltless steel shelving enters the United States through Harmonized Tariff Schedule of the United States (“HTSUS”) statistical subheadings 9403.20.0018, 9403.20.0020, 9403.20.0025, and 9403.20.0026, but may also enter through HTSUS 9403.10.0040. While HTSUS subheadings are provided for convenience and Customs purposes, the written description of the scope of this investigation is dispositive.
A ministerial error is defined 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.
On August 24, 2015, Petitioner submitted a ministerial error allegation claiming that the Department made a ministerial error by assigning a rate of 80.45 percent to the companies which did not respond to the Q&V questionnaire, when it should have assigned the rate of 80.39 percent to these companies, as noted in the I&D Memo. The GOC agrees with Petitioner's allegation.
The Department reviewed the record and agrees that Petitioner's allegation constitutes a ministerial error within the meaning of 19 CFR 351.224(f). Pursuant to 19 CFR 351.224(f), the Department made an unintentional error by listing the incorrect rate assigned to companies which did not respond to the Q&V questionnaire, which constitutes a ministerial error.
In accordance with sections 705(b)(1)(A)(i) and 705(d) of the Act, the ITC has notified the Department of its final determination that the industry in the United States producing boltless steel shelves is materially injured by reason of subsidized imports of boltless steel shelves from the PRC. Therefore, in accordance with section 705(c)(2) and 706(a) of the Act, we are publishing this countervailing duty order.
As a result of the ITC's final determination, in accordance with section 706(a) of the Act, the Department will direct CBP to assess, upon further instruction by the Department, countervailing duties on unliquidated entries of boltless steel shelving from the PRC entered, or withdrawn from warehouse, for consumption on or after December 1, 2014, the date of publication of the
In accordance with section 706 of the Act, the Department will direct CBP to reinstitute suspension of liquidation, effective on the date of publication of the ITC's notice of final determination in the
This notice constitutes the countervailing duty order with respect to boltless steel shelving from the PRC, pursuant to section 706(a) of the Act. Interested parties may contact the Department's Central Records Unit, Room B8024 of the main Commerce Building, for copies of an updated list of countervailing duty orders currently in effect.
This amended final determination is issued and published in accordance with section 705(e) of the Act and 19 CFR 351.224(e) and (f). This order is issued and published in accordance with section 706(a) of the Act and 19 CFR 351.211(b).
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public workshop.
NMFS published a notice on September 10, 2015, announcing the dates and locations of three Atlantic Shark Identification Workshops to be held during October through December of 2015. Attendance at an Atlantic Shark Identification Workshop is mandatory for all federally permitted Atlantic shark dealers in order to meet certain regulatory requirements and to maintain valid permits. Based upon recent analysis indicating the need for an additional workshop in the New York and southern New England area to accommodate shark dealers who purchase smooth dogfish, this notice announces a free Atlantic Shark Identification Workshop that will be conducted during December of 2015 in Bohemia, NY. Additional Atlantic Shark Identification Workshops will be conducted during 2016 and will be announced in a future notice.
The Atlantic Shark Identification workshop will be held on December 10, 2015. See
The Atlantic Shark Identification Workshop will be held in Bohemia, NY. See
Rick Pearson by phone: (727) 824-5399, or by fax: (727) 824-5398.
The complete workshop schedule, registration information, and a list of frequently asked questions regarding these workshops are posted on the Internet at:
Since January 1, 2008, Atlantic shark dealers have been prohibited from receiving, purchasing, trading, or bartering for Atlantic sharks unless a valid Atlantic Shark Identification Workshop certificate is on the premises of each business listed under the shark dealer permit that first receives Atlantic sharks (71 FR 58057; October 2, 2006). Dealers who attend and successfully complete a workshop are issued a certificate for each place of business that is permitted to receive sharks. These certificate(s) are valid for 3 years. Approximately 115 free Atlantic Shark Identification Workshops have been conducted since January 2007.
Currently, permitted dealers may send a proxy to an Atlantic Shark Identification workshop. However, if a dealer opts to send a proxy, the dealer must designate a proxy for each place of business covered by the dealer's permit which first receives Atlantic sharks. Only one certificate will be issued to each proxy. A proxy must be a person who is currently employed by a place of business covered by the dealer's permit; is a primary participant in the identification, weighing, and/or first receipt of fish as they are offloaded from a vessel; and who fills out dealer reports. Atlantic shark dealers are prohibited from renewing a Federal shark dealer permit unless a valid Atlantic Shark Identification Workshop certificate for each business location that first receives Atlantic sharks has been submitted with the permit renewal application. Additionally, trucks or other conveyances that are extensions of a dealer's place of business must possess a copy of a valid dealer or proxy Atlantic Shark Identification Workshop certificate.
Since 2010, as part of their 2008 Interstate Coastal Shark Fishery Management Plan (FMP), the Atlantic States Marine Fisheries Commission (ASMFC) has required all state dealers who purchase sharks to hold a Federal commercial shark dealer permit. A recent comparison of dealers who have reported purchasing smooth dogfish in 2015 with a current list of Federal shark dealer permit holders indicated that a number of state dealers in some Atlantic coastal states did not hold a Federal commercial shark dealer permit. On October 8, 2015, ASMFC notified all states from Maine through Florida of this issue, and reminded them of the requirement that all shark dealers must hold a Federal commercial shark dealer permit. In addition, NMFS is currently in final rulemaking for Amendment 9 to the 2006 Consolidated HMS FMP (August 7, 2014, 79 FR 4627), which will establish an effective date for many of the smooth dogfish regulations that were finalized in Amendment 3 to the 2006 Consolidated HMS FMP, including the requirement for vessel and dealer permits. Given ASMFC's recently discovered need to ensure that all state dealers purchasing smooth dogfish are federally permitted and in anticipation of the final rule for Amendment 9 and its requirements, NMFS has determined that an additional Atlantic Shark Identification Workshop is needed to accommodate shark dealers in the New York and southern New England area. Affected dealers may also attend the previously scheduled November 12, 2015, workshop in Mount Pleasant, SC, or the December 3, 2015, workshop in Largo, FL (80 FR 54533).
December 10, 2015, 12 p.m.-4 p.m., LaQuinta Inn & Suites, 10 Aero Road, Bohemia, NY 11706.
To register for a scheduled Atlantic Shark Identification Workshop, please contact Eric Sander at
To ensure that workshop certificates are linked to the correct permits, participants will need to bring the following specific items to the workshop:
• All participants must bring proof of identification.
• Atlantic shark dealer permit holders must bring proof that the attendee is an owner or agent of the business (such as articles of incorporation), a copy of the applicable permit, and proof of identification.
• Atlantic shark dealer proxies must bring documentation from the permitted dealer acknowledging that the proxy is attending the workshop on behalf of the permitted Atlantic shark dealer for a specific business location, a copy of the appropriate valid permit, and proof of identification.
The Atlantic Shark Identification Workshops are designed to reduce the number of unknown and improperly identified sharks reported in the dealer reporting form and increase the accuracy of species-specific dealer-reported information. Reducing the number of unknown and improperly identified sharks will improve quota monitoring and the data used in stock assessments. These workshops will train shark dealer permit holders or their proxies to properly identify Atlantic shark carcasses.
16 U.S.C. 1801
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).
In 2010, we implemented a new suite of regulations for the Northeast (NE) multispecies fishery through Amendment 16 to the Multispecies Fishery Management Plan (Amendment 16). This action updated status determination criteria for all regulated NE multispecies or ocean pout stocks; adopted rebuilding programs for NE multispecies stocks newly classified as being overfished and subject to overfishing; revised management measures, including significant revisions to the sector management measures, necessary to end overfishing, rebuild overfished regulated NE multispecies and ocean pout stocks, and mitigate the adverse economic impacts of increased effort controls. It also implemented new requirements under Amendment 16 for establishing acceptable biological catch (ABC), annual catch limits (ACLs), and accountability measures (AMs) for each stock managed under the FMP, pursuant to the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act).
This revision incorporates a number of recent changes related to regulatory actions. Framework Adjustment 48 to the FMP (78 FR 26118; May 3, 2013) proposed to exempt sector vessels targeting monkfish from the additional at-sea monitoring coverage necessary to monitor groundfish catch. This measure was intended to allocate limited at-sea monitoring resources to monitor those trips that catch the most groundfish. To implement this measure, NMFS added a question to both the pre-trip notification and Northeast Fisheries Observer Program notification to allow fishermen to indicate what fishery they intend to participate in. This change allowed NMFS to identify trips that may qualify for this exemption, in order to deploy observers and at-sea monitors appropriately to achieve the coverage levels required by the FMP. Framework 48 also eliminated the dockside monitoring program established under Amendment 16 because NMFS determined dealer reporting combined with dockside intercepts by enforcement personnel are sufficient to ensure reliable landings data. Elimination of the dockside monitoring program was not included in the applicable non-substantive change request and thus this change will be included in the revision/extension.
As part of Framework Adjustment 53 to the FMP (80 FR 25110; May 1, 2015), NMFS implemented a requirement that vessels that declare trips into the Gulf of Maine Broad Stock Area and any other broad stock area (
This information collection request may be viewed at
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
National Security Agency/Central Security Service, DoD.
Notice to alter a System of Records.
The National Security Agency/Central Security Service proposes to alter a system of records notice GNSA 18, entitled “Operations Records.” This system is used to maintain records on foreign intelligence, counterintelligence, and information assurance/cybersecurity matters relating to the missions of the National Security Agency. The National Security Agency does not collect such records for the purpose of suppressing or burdening criticism or dissent, or for disadvantaging individuals based on their ethnicity, race, gender, sexual orientation, or religion.
Comments will be accepted on or before November 20, 2015. This proposed action will be effective on the date following the end of the comment period unless comments are received which result in a contrary determination.
You may submit comments, identified by docket number and title, by any of the following methods:
*
Follow the instructions for submitting comments.
*
Director, Civil Liberties and Privacy, Rebecca Richards, National Security Agency/Central Security Service, Civil Liberties and Privacy Office, Suite 6310, 9800 Savage Road, Ft. Meade, Maryland, 20755.
The Office of the Secretary of Defense notices for systems of records subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended, have been published in the
The proposed systems reports, as required by 5 U.S.C. 552a(r) of the Privacy Act, as amended, were submitted on October 15, 2015 to the House Committee on Oversight and Government Reform, the Senate Committee on Homeland Security and Governmental Affairs, and the Office of Management and Budget (OMB) pursuant to paragraph 4c of Appendix I to OMB Circular No. A-130, “Federal Agency Responsibilities for Maintaining Records About Individuals,” dated February 8, 1996, (February 20, 1996, 61 FR 6427).
Operations Records (November 30, 2010, 75 FR 74019)
Delete entry and replace with “Individuals identified in foreign intelligence, counterintelligence, or information assurance/cybersecurity reports and supportive materials, including individuals involved in matters of foreign intelligence interest, information assurance/cybersecurity interest, the compromise of classified information, or terrorism.”
Delete entry and replace with “Records may consist of any type of information acquired or maintained about an individual as NSA pursues its lawfully authorized missions, including but not limited to: an individual's name; Social Security Number (SSN); employee identification number; administrative information; biographic information when associated with an individual, such as phone number and email address; intelligence requirements; foreign intelligence, counterintelligence, and information assurance/cybersecurity analysis and reporting; operational records; articles, public-source data, and other published information on individuals and events of interest to NSA/CSS; actual or purported compromises of classified intelligence; countermeasures in connection therewith; and identification of classified source documents and distribution thereof.”
Delete entry and replace with “National Security Agency Act of 1959, as amended (Pub. L. 86-36) (codified at 50 U.S.C. 3601
Delete entry and replace with “To maintain records on foreign intelligence, counterintelligence, and information assurance/cybersecurity matters relating to the missions of the National Security Agency.
The National Security Agency does not collect such records for the purpose of suppressing or burdening criticism or dissent, or for disadvantaging individuals based on their ethnicity, race, gender, sexual orientation, or religion.”
Delete entry and replace with “In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act of 1974, as amended these records contained therein may specifically be disclosed outside the DoD as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:
To U.S. Government agencies, including state and local agencies, and in some circumstances, foreign government agencies or their representatives, and private entities to provide, and in order to obtain, foreign intelligence, counterintelligence, information assurance/cybersecurity information, and other information, in accordance with applicable law and policy. The National Security Agency does not collect or provide such records to afford a competitive advantage to U.S. companies or U.S. business sectors commercially.
To U.S. Government officials regarding compromises of classified information including the document(s) apparently compromised, implications of disclosure of intelligence sources and methods, investigative data on compromises, and statistical and substantive analysis of the data.
To any U.S. Government or foreign government organization in order to facilitate any security, employment, detail, liaison, or contractual decision by any U.S. Government organization.
To the President's Foreign Intelligence Advisory Board, the Intelligence Oversight Board, and the Privacy and Civil Liberties Oversight Board, and any successor organizations, when requested by those entities, or when NSA/CSS determines that disclosure will assist in oversight functions.
Records may further be disclosed to agencies involved in the protection of intelligence sources and methods to facilitate such protection and to support intelligence analysis and reporting.
The DoD Blanket Routine Uses set forth at the beginning of the NSA/CSS compilation of systems of records notices may apply to this system. The complete list of DoD blanket routine uses can be found online at:
Delete entry and replace with “Information may be retrieved by any unique identifier or other criteria, to include an individual's name, Social Security Number (SSN), and/or employee identification number.”
Delete entry and replace with “Buildings are secured by a series of guarded pedestrian gates and checkpoints. Access to facilities is limited to security-cleared personnel and escorted visitors only. Within the facilities themselves, access to paper records and computer printouts are controlled by limited-access facilities and lockable containers. Access to electronic records is controlled by computer password protection and
Delete entry and replace with “SIGINT Operational Data: Temporary, review annually for destruction.
SIGINT Collection Records: Temporary, close inactive files annually and transfer to the NSA/CSS Records Center. Review every 5 years for destruction.
SIGINT Analysis Information and Records: Permanent, transfer to the NSA/CSS Records Center when 5 years old, transfer to the NSA/CSS Archives after 20 years, and transfer to the National Archives and Records Administration when 25 years old.
SIGINT Product: Permanent, transfer to NSA/CSS Records Center when 5 years old, transfer to the NSA/CSS Archives after 20 years, and transfer to the National Archives and Records Administration when 50 years old.
Counterintelligence Records: Permanent, transfer to the NSA/CSS Records Center when 3 years old, transfer to the NSA/CSS Archives when 20 years old, and transfer to the National Archives and Records Administration when 25 years old.
Information Assurance and Communication Security data: Temporary, review every year for destruction.
Information Assurance and Communications Security Monitoring Reports: Permanent, transfer to the NSA/CSS Records Center when 5 years old, transfer to the NSA/CSS Archives when 20 years old, and transfer to the National Archives and Records Administration when 25 years old.”
Delete entry and replace with “Individuals themselves; U.S. agencies and organizations; media, including periodicals, newspapers, and broadcast transcripts; public and classified sources; intelligence source documents; investigative reports; and correspondence.”
Delete entry and replace with “Information specifically authorized to be classified under E.O. 13526, as implemented by DoDM 5200.1, may be exempt pursuant to 5 U.S.C. 552a(k)(1).
Investigatory material compiled for law enforcement purposes, other than material within the scope of subsection 5 U.S.C. 552a(j)(2), may be exempt pursuant to 5 U.S.C. 552a(k)(2). However, if an individual is denied any right, privilege, or benefit for which he would otherwise be entitled by Federal law or for which he would otherwise be eligible, as a result of the maintenance of the information, the individual will be provided access to the information exempt to the extent that disclosure would reveal the identity of a confidential source. NOTE: When claimed, this exemption allows limited protection of investigative reports maintained in a system of records used in personnel or administrative actions.
Investigatory material compiled solely for the purpose of determining suitability, eligibility, or qualifications for federal civilian employment, military service, federal contracts, or access to classified information may be exempt pursuant to 5 U.S.C. 552a(k)(5), but only to the extent that such material would reveal the identity of a confidential source.
An exemption rule for this record system has been promulgated according to the requirements of 5 U.S.C. 553(b)(1), (2), and (3), (c) and (e) and published in 32 CFR part 322. For additional information contact the system manager.”
Operations Records.
National Security Agency/Central Security Service, Ft. George G. Meade, MD 20755-6000.
Individuals identified in foreign intelligence, counterintelligence, or information assurance/cybersecurity reports and supportive materials, including individuals involved in matters of foreign intelligence interest, information assurance/cybersecurity interest, the compromise of classified information, or terrorism.
Records may consist of any type of information acquired or maintained about an individual as NSA pursues its lawfully authorized missions, including but not limited to: An individual's name; Social Security Number (SSN); employee identification number; administrative information; biographic information when associated with an individual, such as phone number and email address; intelligence requirements; foreign intelligence, counterintelligence, and information assurance/cybersecurity analysis and reporting; operational records; articles, public-source data, and other published information on individuals and events of interest to NSA/CSS; actual or purported compromises of classified intelligence; countermeasures in connection therewith; and identification of classified source documents and distribution thereof.
National Security Agency Act of 1959, as amended (Pub. L. 86-36) (codified at 50 U.S.C. 3601
To maintain records on foreign intelligence, counterintelligence, and information assurance/cybersecurity matters relating to the missions of the National Security Agency.
The National Security Agency does not collect such records for the purpose of suppressing or burdening criticism or dissent, or for disadvantaging individuals based on their ethnicity, race, gender, sexual orientation, or religion.
In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act of 1974, as amended these records contained therein may specifically be disclosed outside the DoD as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:
To U.S. Government agencies, including state and local agencies, and in some circumstances, foreign government agencies or their representatives, and private entities to provide, and in order to obtain, foreign intelligence, counterintelligence, information assurance/cybersecurity information, and other information, in accordance with applicable law and policy. The National Security Agency does not collect or provide such records to afford a competitive advantage to U.S. companies or U.S. business sectors commercially.
To U.S. Government officials regarding compromises of classified information including the document(s)
To any U.S. Government or foreign government organization in order to facilitate any security, employment, detail, liaison, or contractual decision by any U.S. Government organization.
To the President's Foreign Intelligence Advisory Board, the Intelligence Oversight Board, and the Privacy and Civil Liberties Oversight Board, and any successor organizations, when requested by those entities, or when NSA/CSS determines that disclosure will assist in oversight functions.
Records may further be disclosed to agencies involved in the protection of intelligence sources and methods to facilitate such protection and to support intelligence analysis and reporting.
The DoD `Blanket Routine Uses' published at the beginning of the NSA/CSS' compilation of systems of records notices apply to this system.
Paper records in file folders and electronic storage media.
Information may be retrieved by any unique identifier or other criteria, to include an individual's name, Social Security Number (SSN), and/or employee identification number.
Buildings are secured by a series of guarded pedestrian gates and checkpoints. Access to facilities is limited to security-cleared personnel and escorted visitors only. Within the facilities themselves, access to paper records and computer printouts are controlled by limited-access facilities and lockable containers. Access to electronic records is controlled by computer password protection and those who are cleared on a need to know basis in the performance of their duties.”
SIGINT Operational Data: Temporary, review annually for destruction.
SIGINT Collection Records: Temporary, close inactive files annually and transfer to the NSA/CSS Records Center. Review every 5 years for destruction.
SIGINT Analysis Information and Records: Permanent, transfer to the NSA/CSS Records Center when 5 years old, transfer to the NSA/CSS Archives after 20 years, and transfer to the National Archives and Records Administration when 25 years old.
SIGINT Product: Permanent, transfer to NSA/CSS Records Center when 5 years old, transfer to the NSA/CSS Archives after 20 years, and transfer to the National Archives and Records Administration when 50 years old.
Counterintelligence Records: Permanent, transfer to the NSA/CSS Records Center when 3 years old, transfer to the NSA/CSS Archives when 20 years old, and transfer to the National Archives and Records Administration when 25 years old.
Information Assurance and Communication Security data: Temporary, review every year for destruction.
Information Assurance and Communications Security Monitoring Reports: Permanent, transfer to the NSA/CSS Records Center when 5 years old, transfer to the NSA/CSS Archives when 20 years old, and transfer to the National Archives and Records Administration when 25 years old.
Director, National Security Agency/Central Security Service, Ft. George G. Meade, MD 20755-6000.
Individuals seeking to determine whether information about themselves is contained in this system should address written inquiries to the National Security Agency/Central Security Service, Freedom of Information Act/Privacy Act Office, 9800 Savage Road, Suite 6248, Ft. George G. Meade, MD 20755-6248.
Written inquiries should contain the individual's full name, address and telephone number.
Individuals seeking access to information about themselves contained in this system should address written inquiries to the National Security Agency/Central Security Service, Freedom of Information Act/Privacy Act Office, 9800 Savage Road, Suite 6248, Ft. George G. Meade, MD 20755-6248.
Written inquiries should contain the individual's full name, address and telephone number.
The NSA/CSS rules for contesting contents and appealing initial determinations are published at 32 CFR part 322 or may be obtained by written request addressed to the National Security Agency/Central Security Service, Freedom of Information Act/Privacy Act Office, 9800 Savage Road, Suite 6248, Ft. George G. Meade, MD 20755-6248.
Individuals themselves; U.S. agencies and organizations; media, including periodicals, newspapers, and broadcast transcripts; public and classified sources; intelligence source documents; investigative reports; and correspondence.
Information specifically authorized to be classified under E.O. 13526, as implemented by DoDM 5200.1, may be exempt pursuant to 5 U.S.C. 552a(k)(1).
Investigatory material compiled for law enforcement purposes, other than material within the scope of subsection 5 U.S.C. 552a(j)(2), may be exempt pursuant to 5 U.S.C. 552a(k)(2). However, if an individual is denied any right, privilege, or benefit for which he would otherwise be entitled by Federal law or for which he would otherwise be eligible, as a result of the maintenance of the information, the individual will be provided access to the information exempt to the extent that disclosure would reveal the identity of a confidential source. NOTE: When claimed, this exemption allows limited protection of investigative reports maintained in a system of records used in personnel or administrative actions.
Investigatory material compiled solely for the purpose of determining suitability, eligibility, or qualifications for federal civilian employment, military service, federal contracts, or access to classified information may be exempt pursuant to 5 U.S.C. 552a(k)(5), but only to the extent that such material would reveal the identity of a confidential source.
An exemption rule for this record system has been promulgated according to the requirements of 5 U.S.C. 553(b)(1), (2), and (3), (c) and (e) and published in 32 CFR part 322. For additional information contact the system manager.
Department of Energy.
Notice and request for comments.
The Department of Energy (DOE) pursuant to the Paperwork Reduction Act of 1995, intends to extend for three years, an information collection request with the Office of Management and Budget (OMB). Comments are invited on: (a) Whether the extended information collection is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed information collection, including 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 information collection on respondents, including through the use of automated collection techniques or other forms of information technology.
Comments regarding this collection must be received on or before December 21, 2015. If you anticipate difficulty in submitting comments within that period, contact the person listed below as soon as possible.
Written comments may be sent to Sandra Dentinger, AU-70, Germantown Building, U.S. Department of Energy, 1000 Independence Ave. SW., Washington, DC 20585-1290, by fax at 301-903-2194 or by email at
Requests for additional information or copies of the information collection instrument and instructions should be directed to the person listed above in
The information collection request contains the following: (1) OMB No: 1910-0300; (2) Information Collection Request Title: Environment, Safety and Health; (3) Type of Review: Renewal; (4) Purpose: The collections are used by DOE to exercise management oversight and control over its contractors in the ways in which the DOE contractors provide goods and services for DOE organizations and activities in accordance with the terms of their contract(s); the applicable statutory, regulatory and mission support requirements of the Department. The collections are: Computerized Accident/Incident Reporting System (CAIRS); Occurrence Reporting and Processing System (ORPS); Noncompliance Tracking System (NTS); Radiation Exposure Monitoring System (REMS); Annual Fire Protection Summary Application; Safety Basis Information System; and Lessons Learned System; (5) Annual Estimated Number of Respondents: 1,004; (6) Annual Estimated Number of Total Responses: 79,634; (7) Response Obligation: Required, except for Noncompliance Tracking System (see Statutory Authority section below); (8) Annual Estimated Number of Burden Hours: 41,733; (9) Annual Estimated Reporting and Recordkeeping Cost Burden: $0.
Section 641 of the Department of Energy Organization Act, codified at 42 U.S.C. 7251, and the following additional authorities:
Office of Environmental Management, Department of Energy.
Notice of open meeting: Correction.
The Department of Energy (DOE) published in the
In the
In the
This is a supplemental notice in the above-referenced proceeding of Seville Solar Two LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is November 3, 2015.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the
Take notice that on September 25, 2015, pursuant to section 358.1(d) of the Federal Energy Regulatory Commission (Commission),
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. On or before the comment date, it is not necessary to serve motions to intervene or protests on persons other than the Applicant.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
This is a supplemental notice in the above-referenced proceeding of Tallbear Seville LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is November 3, 2015.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Federal Energy Regulatory Commission, DOE.
Comment request.
In compliance with the requirements of the Paperwork Reduction Act of 1995, 44 U.S.C. 3507(a)(1)(D), the Federal Energy Regulatory Commission (Commission or FERC) is submitting its information collection [FERC-732, Electric Rate Schedules and Tariffs: Long-Term Firm Transmission Rights in Organized Electricity Markets] to the Office of Management and Budget (OMB) for review of the information collection requirements. Any interested person may file comments directly with OMB and should address a copy of those comments to the Commission as explained below. The Commission previously issued a Notice in the
Comments on the collection of information are due by November 20, 2015.
Comments filed with OMB, identified by the OMB Control No. 1902-0245, should be sent via email to the Office of Information and Regulatory Affairs:
A copy of the comments should also be sent to the Commission, in Docket No. IC15-10-000, by either of the following methods:
•
•
Ellen Brown may be reached by email at
The FERC-732 regulations require that transmission organizations (that are public utilities with one or more organized electricity markets) choose one of two ways to file:
• File tariff sheets making long-term firm transmission rights available that are consistent with each of the guidelines established by FERC
• File an explanation describing how their existing tariffs already provide long-term firm transmission rights that are consistent with the guidelines.
Additionally, the Commission requires each transmission organization to make its transmission planning and expansion procedures and plans available to the public.
FERC-732 enables the Commission to exercise its wholesale electric rate and electric power transmission oversight and enforcement responsibilities in accordance with the FPA, the Department of Energy Organization Act (DOE Act), and EPAct 2005.
This constitutes notice, in accordance with 18 CFR 385.2201(b), of the receipt of prohibited and exempt off-the-record communications.
Order No. 607 (64 FR 51222, September 22, 1999) requires Commission decisional employees, who make or receive a prohibited or exempt off-the-record communication relevant to the merits of a contested proceeding, to deliver to the Secretary of the Commission, a copy of the communication, if written, or a summary of the substance of any oral communication.
Prohibited communications are included in a public, non-decisional file associated with, but not a part of, the decisional record of the proceeding. Unless the Commission determines that the prohibited communication and any responses thereto should become a part of the decisional record, the prohibited off-the-record communication will not
Exempt off-the-record communications are included in the decisional record of the proceeding, unless the communication was with a cooperating agency as described by 40 CFR 1501.6, made under 18 CFR 385.2201(e) (1) (v).
The following is a list of off-the-record communications recently received by the Secretary of the Commission. The communications listed are grouped by docket numbers in ascending order. These filings are available for electronic review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
On October 13, 2015, the Mojave Water Agency filed a notice of intent to construct a qualifying conduit hydropower facility, pursuant to section 30 of the Federal Power Act (FPA), as amended by section 4 of the Hydropower Regulatory Efficiency Act of 2013 (HREA). The proposed Deep Creek Hydroelectric Project would have an installed capacity of 800 kilowatts (kW) and would be located at the Mojave Water Agency's existing Deep Creek Recharge Facility. The project would be located near the City of Apple Valley in San Bernardino County, California.
A qualifying conduit hydropower facility is one that is determined or deemed to meet all of the criteria shown in the table below.
Deadline for filing motions to intervene is 30 days from the issuance date of this notice.
Anyone may submit comments or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210 and 385.214. Any motions to intervene must be received on or before the specified deadline date for the particular proceeding.
The Commission strongly encourages electronic filing. Please file motions to intervene and comments using the Commission's eFiling system at
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following electric securities filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
This is a supplemental notice in the above-referenced proceeding of San Gorgonio Westwinds II—Windustries, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is November 3, 2015.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
Federal Energy Regulatory Commission, DOE.
Comment request.
In compliance with the requirements of the Paperwork Reduction Act of 1995, 44 U.S.C. 3507(a)(1)(D), the Federal Energy Regulatory Commission (Commission or FERC) is submitting its information collection (FERC-914, Cogeneration and Small Power Production—Tariff Filings) to the Office of Management and Budget (OMB) for review of the information
Comments on the collection of information are due by November 20, 2015.
Comments filed with OMB, identified by the OMB Control No. 1902-0231, should be sent via email to the Office of Information and Regulatory Affairs:
A copy of the comments should also be sent to the Commission, in Docket No. IC15-11-000, by either of the following methods:
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Ellen Brown may be reached by email at
In Orders Nos. 671 and 671-A
FERC implemented the Congressional mandate of the Energy Policy Act of 2005 (EPAct 2005) to establish criteria for new qualifying cogeneration facilities by: (1) Amending the exemptions available to qualifying facilities from the FPA and from PUHCA [resulting in the burden imposed by FERC-914, the subject of this statement]; (2) ensuring that these facilities are using their thermal output in a productive and beneficial manner; that the electrical, thermal, chemical and mechanical output of new qualifying cogeneration facilities is used fundamentally for industrial, commercial, residential or industrial purposes; and there is continuing progress in the development of efficient electric energy generating technology; (3) amending the FERC Form 556
On August 20, 2015, Empire State Hydro 301, LLC filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act (FPA), proposing to study the feasibility of the Diamond Mills Hydroelectric Project (Diamond Mills Project or project) to be located at the existing Diamond Mills Dam on Esopus Creek in Saugerties, Ulster County, New York. The sole purpose of a preliminary permit, if issued, is to grant the permit holder priority to file a license application during the permit term. A preliminary permit does not authorize the permit holder to perform any land-disturbing activities or otherwise enter upon lands or waters owned by others without the owners' express permission.
The proposed project would consist of the following: (1) An 140-acre impoundment with a normal volume of 826 acre-feet; (2) an existing 350-foot-long, 32-foot-high concrete gravity dam with a spillway length of 340 feet; (3) an existing 30-foot-long, 9-foot-high auxiliary spillway; (4) an existing 10-foot-long, 6-foot-diameter penstock; (5) two new 750-kilowatt turbines; (6) a new 50-foot-long, 30-foot-wide powerhouse; (7) a new 300-foot-long, 12.7-kilovolt transmission line; and (8) appurtenant facilities. The estimated annual generation of the Diamond Mills Project would be 5,300 megawatt-hours.
Deadline for filing comments, motions to intervene, competing applications (without notices of intent), or notices of intent to file competing applications: 60 days from the issuance of this notice. Competing applications and notices of intent must meet the requirements of 18 CFR 4.36.
The Commission strongly encourages electronic filing. Please file comments, motions to intervene, notices of intent, and competing applications using the Commission's eFiling system at
More information about this project, including a copy of the application, can be viewed or printed on the “eLibrary” link of the Commission's Web site at
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
This is a supplemental notice in the above-referenced proceeding of Seville Solar One LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
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:
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
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:
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the Commission received the following electric rate filings:
Description: Report Filing: Refund Report Under Docket ER15-501 to be effective N/A.
Description: § 205(d) Rate Filing: 2015-10-15 Retail Choice Data Submission to be effective 12/15/2015.
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
284.123(g) Protests Due: 5 p.m. ET 12/8/15.
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 date(s). Protests may be considered, but intervention is necessary to become a party to the proceeding.
Any person desiring to protest in any of the above proceedings must file in accordance with Rule 211 of the Commission's Regulations (18 CFR 385.211) on or before 5:00 p.m. Eastern time on the specified comment date.
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following 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:
1. In this order, we accept the notice of change in status filed by Public Service Company of New Mexico (PNM) to report a transaction in which it purchased the interests in Delta Person, Limited Partnership (Delta Person).
2. On August 18, 2014, as amended on December 17, 2014 and February 18, 2015,
3. Additionally, PNM requests market-based rate authorization in the PNM balancing authority area.
4. PNM included an updated market power analysis with its August 18, 2014 Filing. PNM states that it passes the pivotal supplier screen and the wholesale market share screen in the summer season; however, PNM represents that it fails the wholesale market share screen in the winter, fall, and spring seasons. PNM notes that the failure of the indicative screens creates a rebuttable presumption of horizontal market power. However, PNM states it has rebutted that presumption by demonstrating that PNM passes a DPT analysis for the PNM balancing authority area.
5. Additionally, PNM submitted historical evidence related to a request for proposal (RFP) issued by the City of Gallup, New Mexico, representing that PNM was not selected as the winner and that the results of the RFP should be considered as alternative evidence to rebut the presumption that PNM may have market power in the PNM balancing authority area.
6. On December 19, 2014, the Director of the Division of Electric Power Regulation—West requested additional information from PNM with regard to the DPT analysis and SIL study (Data Request).
7. Notice of PNM's August 18, 2014 filing, as amended on December 17, 2014 and on February 18, 2015, was published in the
8. Pursuant to Rule 214 of the Commission's Rules of Practice and Procedure, 18 CFR 385.214 (2015), Navopache's timely, unopposed motion to intervene serves to make it a party to this proceeding.
9. We accept PNM's notice of change in status filing. However, as discussed below, we reject, without prejudice, PNM's request for market-based rate authority in the PNM balancing authority area and PNM's related SIL study. We find that PNM has failed to rebut the presumption of horizontal market power in the PNM balancing authority area, and therefore, has not supported its request for market-based rate authority in the PNM balancing authority area. Also, as discussed below, we take this opportunity to identify deficiencies in PNM's DPT analysis and provide general clarification regarding DPT analyses and SIL studies. We note that our efforts to provide such clarification in this order are hampered by the fact that PNM's most recent February 18, 2015 DPT analysis and SIL submittals were all filed as non-public.
10. The Commission allows power sales at market-based rates if the seller and its affiliates do not have, or have adequately mitigated, horizontal and vertical market power.
11. The Commission adopted two indicative screens for assessing horizontal market power: the pivotal supplier screen and the wholesale market share screen.
12. PNM prepared the pivotal supplier and wholesale market share screens for the PNM balancing authority area, consistent with the requirements of Order No. 697.
13. As the Commission has previously explained, the DPT analysis identifies potential suppliers based on market prices, input costs, and transmission availability, and calculates each supplier's economic capacity (EC)
14. As with the indicative screens, applicants and interveners may present evidence, such as historical sales and transmission data, which may be used to calculate market shares and market concentration and to refute or support the results of the DPT analysis. In Order No. 697, the Commission encouraged applicants to present the most complete analysis of competitive conditions in the market as the data allow.
15. PNM's DPT analysis for the PNM balancing authority area indicates that PNM is not pivotal in any season/load period using either the EC measure or the AEC measure.
16. PNM states that the Commission allows a seller to present alternative evidence to rebut the results of the indicative screens. PNM requests that the RFP results be considered as additional alternative evidence to rebut the presumption that PNM may have market power in the PNM balancing authority area.
17. According to PNM, on September 26, 2013, the City of Gallup issued an RFP for long-term power supply and scheduling services for a minimum of five years. The RFP represents that the City of Gallup serves approximately 10,500 customers and averages approximately 215,000,000 kilowatt-hours (kWh) in annual sales provided from wholesale energy purchases of around 220,000,000 kWh bought from PNM and 15,000,000 kWh from Western Area Power Administration. PNM states that, as the City of Gallup's existing supplier, it responded to the RFP. PNM further states that the City of Gallup received bids from five suppliers. Further, PNM represents that it was not selected as the winner in the RFP and ranked third in the competitiveness of its bid. PNM states that Continental Divide Electric Cooperative was selected as the winning bidder, having submitted a bid that was significantly lower than those submitted by either PNM or the other bidders.
18. PNM contends that the fact that there were a number of bidders in the RFP, several of whose bids were lower than the bid submitted by PNM, in and of itself, demonstrates that PNM lacks market power in the PNM balancing authority area. PNM further states that this alternative evidence is bolstered by the fact that a neighboring utility that maintains market-based rate authority in the PNM balancing authority area also underbid PNM, making it difficult to justify the notion that PNM has market power. Moreover, PNM states that the RFP is significant recent real-world evidence that corroborates the results of its DPT analysis demonstrating that PNM lacks market power in the PNM balancing authority area.
19. Although PNM presents this RFP as alternative evidence to rebut the results of the indicative screens, we find that this alternative evidence does not sufficiently demonstrate that PNM lacks market power in that balancing authority area. We do not believe that the City of Gallup's load is a sufficient proxy for the load PNM served during the study period.
20. In Order No. 697, the Commission provided the option for a seller to submit a DPT analysis when that seller fails an indicative screen.
21. The Commission, prior to Order No. 697, provided industry guidance concerning the DPT in the Merger Policy Statement.
22. The first part of the product market analysis, that is, the calculation of all potential suppliers given the prevailing market price. The EC of a supplier is the amount of generating capacity owned or controlled by a potential supplier with variable costs low enough that energy from such capacity could be economically delivered to the destination market. The EC calculation can be described as follows.
23. The first step in calculating a potential supplier's EC is to calculate the variable cost of each unit.
24. The second step is to add to the estimate of the unit's variable generation cost any and all applicable transmission costs that a supplier would incur to deliver the energy into the study area. Commission regulations state that these costs include the maximum transmission rate in a transmission provider's tariff as well as the estimated cost of supplying energy losses.
25. The final step in calculating economically competitive capacity is to determine whether the computed generation cost of a unit is price competitive in the study area. The supplier should compare the computed cost of a generating unit (including all aforementioned generation, transmission, and other costs), to the computed market price plus five (5) percent in the study area.
26. The AEC of the units and all suppliers must also be calculated. AEC includes “capacity from generating units that are not used to serve native load (or are contractually committed).”
27. Furthermore, as stated in the Merger Policy Statement, the presumption underlying the AEC measure is that the lowest running cost units are used to serve native load and other firm contractual obligations and would not be available for other sales.
28. The second part of the analysis, evaluating whether generation with AEC can reach the study area, and the use of this information to compute market shares and concentration statistics, is discussed below.
29. Turning to PNM's calculation, we find that the analysis as presented is flawed and from it we are unable to conclude that PNM rebutted the presumption of PNM's horizontal market power in the PNM balancing authority area. The deficiencies pertain to the following: (i) Data integrity; (ii) identification of potential supply; (iii) calculation of variable costs; (iv) accounting for power purchase agreements; (v) calculation of transmission rates; (vi) calculation of AEC; (vii) use of historical transaction data to corroborate results; and (viii) preparation of the SIL study. Each of these items is discussed further below.
30. PNM submitted compact discs (CDs) that included its DPT model and underlying work papers with links to other data sources that are not available on its CDs. For instance, when opening some of the files on the CDs submitted on August 18, 2014 and on February 18, 2015, there is an error message that states “There are links to data sources that cannot be updated.”
31. We remind applicants that including workable links to data sources in the spreadsheets enables the
32. PNM appears to have included generating units that are no longer operational when it calculated EC. EC is the amount of generating capacity owned or controlled by a potential supplier with variable costs low enough that energy from such capacity could be economically delivered to the destination market. Including, for example, the San Onofre Nuclear Generating Station (San Onofre) as operational and reporting units 2 and 3 of this plant as having EC in all seasons of the DPT analysis is inconsistent with the definition of EC.
33. Similarly, PNM identifies many units as having their output committed under long-term power purchase contracts, but still considers the units to have EC in the model. For example, PNM identifies Whitewater Hill Wind Partners as having EC when Whitewater Hill Wind Partners has affirmed to the Commission that the output of its facility is fully committed to an unaffiliated third party.
34. Commission regulations require that a potential supplier's EC be adjusted by long-term firm contracts.
35. As mentioned above, Commission regulations state that for each generating plant or unit owned or controlled by each potential supplier in a DPT analysis, the applicant must also provide variable cost components, which must include at a minimum: (A) variable operation and maintenance, including both fuel and non-fuel operation and maintenance; and (B) environmental compliance.
36. In its August 18, 2014 Filing, PNM states that it constructed a supply curve “in the model for each entity by estimating its unit-specific incremental dispatch costs. The incremental cost is calculated by multiplying the fuel cost for the unit by the unit's efficiency (heat rate) and adding any additional variable costs that may apply,
37. Fuel is a significant component of variable cost, and natural gas- and coal-fired generation is a significant portion of the generation analyzed by PNM.
38. For natural gas, PNM computes seasonal prices at the two locations mentioned above by averaging all of the hourly prices for each location in each season/load level. These two locations seem to be the hubs that are closest to the PNM balancing authority area. However, PNM also includes in its spreadsheets hourly gas prices for 22 locations in the WECC region.
39. Additionally, PNM uses only three natural gas prices in its model, one for each of the summer, winter and shoulder seasons. To do this, for the one-hour Summer Super Peak 1 (S_SP1)
40. Further, PNM submitted work papers that include an average coal price for 83 plants with unique EIA identification numbers. Only seven of these plants appear to be in the WECC region, although there are more than seven coal-fired plants in WECC. These average prices were calculated from monthly “Detailed Coal Transactions From December 2012 to November 2013,”
41. Sellers should account for some measure of regional differences in fuel price. As described above, PNM used one natural gas price for each of the three seasons' seasonal gas price estimate for all gas-fired generation in the entire WECC, which are derived from the average prices at two hubs. That is, PNM used the same natural gas fuel costs for generators in Alberta, Northern and Southern California and New Mexico even though PNM's own spreadsheets detail the locational variation in natural gas prices across the WECC region. As explained above, the fuel cost of each generating facility is one of the main factors in determining whether the output of that facility should be included as EC in a DPT analysis. Oversimplifying the variable cost calculations by assuming that all gas-fired generators have the same input cost regardless of their location may cause certain units, whose actual gas prices are lower than these averages, to be inappropriately considered uneconomic and may cause units whose actual gas prices are higher than these averages to be inappropriately considered economic. Thus, regional price variation for input fuels should be considered in a model that includes competing supply capacity from a large geographic footprint, and a generator's fuel cost should be estimated from a nearby price point unless the seller explains why another methodology is reasonable. Furthermore, we note an apparent contradiction between the seven coal prices used in the generation data set and the single coal price reported for WECC of $1.97
42. For the reasons stated above, we cannot conclude that PNM has rebutted the presumption of market power because of the flaws in its analysis.
43. As mentioned above, Commission regulations state that sellers must calculate, at a minimum, variable cost for a unit used in the DPT analysis. For each such generating unit, the seller must also provide variable cost components, which include operation and maintenance costs.
44. PNM's DPT model contains a worksheet, “Generation Dataset,” that contains variable cost calculations for the WECC generators that PNM included in its model. There are 4,293 observations in this dataset and 2,118 of these observations have a zero dollar cost for VOM.
45. Although the Data Request did not specifically request that PNM provide actual values for VOM costs, we take this opportunity to provide clarification to PNM and other DPT filers. Although VOM costs may be a small component of hourly costs, we do not expect these costs for most generating units to have a zero value
46. Therefore, it appears that PNM underestimates the variable cost of a significant portion of generation in its DPT model, which potentially overestimates the amount of EC calculated in its DPT analysis.
47. As mentioned above, another step in the calculation of a supplier's EC is accounting for long-term firm purchase contracts. EC refers to “the amount of generating capacity owned or controlled by a potential supplier with variable costs low enough that energy from such capacity could be economically delivered to the destination market.”
48. As noted above, Commission regulations require information on all long-term firm purchases and sales “for each sale and purchase of capacity” as part of the DPT analysis.
49. The Data Request sought information from PNM concerning how certain sellers could be considered competitive suppliers for purposes of the DPT analysis when each of those seller's native load appeared to exceed its generation capacity. Specifically, PNM was asked to explain whether one particular supplier, Tri State Generation & Transmission Association Inc. (TriState), could have any uncommitted capacity to compete with PNM given that TriState's peak load is reported to be greater than its generation capacity. The Data Request did not specifically identify any other sellers in a similar situation to TriState. However, the Data Request directed PNM to identify every potential supplier for whom its study deducted native load obligations, the amount of those obligations and the source of their native load values.
50. In its Response to the Data Request, PNM stated that there are differences between the reporting in the data sources that the Commission used to formulate its questions and the data source(s) PNM used in its calculation of competitive supply. PNM further added that TriState “has substantial purchase agreements, including ownership in [WECC] output facilities that would not be tracked by Velocity.”
51. We appreciate PNM's Response to the Data Request but find that more information is necessary. While PNM provided information on TriState's purchasing, it did not disclose the amount of power purchased under these contracts that would enable TriState to meet its native load requirements and have sufficient generation to be a competitive supplier in the DPT analysis. PNM also did not meet the reporting requirements for long-term contracts of sales and purchases in 18 CFR 33.3(d)(3) for TriState or for any other suppliers, such as Whitewater Hill Wind Partners, whose output is fully committed under long-term contract to another entity. Additionally, in its Response to the Data Request, PNM did not indicate whether there are other potential suppliers with long-term contracts or adjust its model to reflect any other potential suppliers with native load obligations greater than their respective generation capacity.
52. Generation units in a supplier's portfolio whose output is committed under long-term firm contracts should not be considered available to compete in the study area as AEC. Including such capacity may overstate the amount of AEC that a potential supplier can contribute or inaccurately attribute that capacity to the wrong potential supplier in a DPT analysis. Additionally, incorrectly attributing capacity to sellers that have sold the output of their facilities to unaffiliated entities under purchase power agreements impacts the market concentration results of the DPT analysis. Lastly, PNM did not adjust its model as requested in the Data Request or otherwise explain that such adjustment was not required. For these reasons, we are unable to rely on PNM's DPT analysis.
53. As mentioned above, Commission regulations require a DPT analysis to account for any and all applicable transmission costs that a supplier would incur to deliver the energy into the study area and add these costs to the estimate of the available unit's variable generation cost. Commission regulations state that these costs must include the maximum transmission rate in a transmission provider's tariff as well as the estimated cost of supplying energy losses.
54. PNM did not include all applicable transmission costs in its EC calculation. In the December 17, 2014 Filing, PNM's DPT analysis used a universal $2.00 transmission rate for all peak periods and a $1.00 transmission rate for all off-peak periods for all generators, regardless of location.
55. In the Data Request, PNM was requested to provide the transmission rate schedule for the PNM balancing authority area and all of the balancing authority areas where competing suppliers are located, and to provide cites to the relevant open access transmission tariff(s).
56. In Response to the Data Request, PNM stated that it assumed transmission rates for purposes of the model because it lacks details on specific transmission rates for some of the WECC transmission providers. PNM stated that this assumption has a
57. We note that these maximum rates for the peak periods ranged from $1.26 to $10.02 and averaged $4.96. Likewise, the maximum rates for the off-peak periods ranged from $0.72 to $9.00 and averaged $3.59. In Response to the Data Request, PNM provided a sensitivity analysis that used the average of these
58. However, we find the remaining portion of PNM's Response to the Data Request to be unresponsive to the question asked and not in compliance with Commission regulations. PNM did not re-run the DPT analysis with the maximum rate for
59. As mentioned above, alternative suppliers should be able to reach the market both economically and physically.
60. After computing the EC of potential competing suppliers, an applicant should compute the AEC of those suppliers. AEC is “the amount of generating capacity meeting the definition of EC less the amount of generating capacity needed to serve the potential supplier's native load commitments.”
61. The Data Request directed PNM to explain whether its DPT model first allocated the lowest running cost units to a supplier's native load and cited to the Merger Policy Statement.
62. In the Merger Policy Statement, the Commission stated that the AEC measure “includes capacity from generating units that are not used to serve native load (or are contractually committed).”
63. Commission regulations state that “[t]he applicant must provide historical trade data and historical transmission data to corroborate the results of the horizontal Competitive Analysis Screen.”
64. The Data Request directed PNM to identify suppliers with AEC and document their contribution to competing supply entering the PNM study area.
65. Although the Data Request did not specifically ask PNM to provide historical transaction data to corroborate the results of its DPT analysis, we take this opportunity to provide clarification for PNM and others who may file a DPT
66. As mentioned above, alternative suppliers must be able to reach the market both economically and physically. We provide clarification regarding determining the physical capability of a supplier with EC and AEC to reach the study area.
67. The physical ability of a supplier to reach the market or study area requires the use of a SIL study as a basis for transmission access for both the indicative screens and the DPT analysis.
68. The SIL study calculates the aggregated simultaneous transfer capability into the balancing authority area being studied. It is intended to provide a reasonable simulation of historical conditions and is not a theoretical maximum import capability or best import case scenario.
69. The Commission recognizes that it is a complex process for a seller to estimate transmission capability using the model of its transmission system in a simplified manner so that elements are accurately accounted for in SIL studies. Therefore, the Commission previously has provided guidance so that sellers can more accurately measure the amount of available transmission capability into the study area. One area of concern has been the proper modeling and scaling of jointly-owned generating plants in a SIL study, particularly when units have long-term firm transmission reservations.
70. In
71. In its Response to the Data Request, PNM filed revised work papers and SIL information. PNM also submitted a table listing the long-term firm transmission reservations for exports out of the PNM balancing
72. PNM's first sensitivity study “does not scale resources with potential commitments outside of the PNM [balancing authority area].”
73. The practice of capturing long-term firm export reservations in Submittal 2 is inconsistent with the instructions and purpose of Submittal 2, which is to identify and sum the long-term firm transmission reservations from affiliated remote generating resources in the first-tier to serve native load in the study area.
74. In
75. Thus, we clarify that, for purposes of generation scaling for the SIL, the appropriate method of modeling a generation unit in the study area that is jointly-owned between the seller and one or more unaffiliated sellers in the first-tier area is to represent the unit as multiple units in the model based on ownership percentage such that the multiple units fully represent the generation commitments and impacts on the transmission system. One unit will represent the seller's generation capacity in the study area, and one or more additional units will represent the capacity owned by unaffiliated entities within the first-tier area.
76. Finally, we clarify that entities should complete the “Description of Remote Resources” column as necessary
77. As described above, we are unable to validate the results of PNM's SIL model, its calculations of EC and AEC, and its DPT analysis. Thus, we find that PNM has not adequately rebutted the presumption of horizontal market power caused by its failure of the indicative screens in the PNM balancing authority area. Therefore, we reject, without prejudice, PNM's request for market-based rate authorization in the PNM balancing authority area. We encourage other market-based rate applicants to make use of the guidance and clarification offered herein.
78. PNM states that its purchase of Delta Person does not affect PNM's horizontal market power because PNM was already deemed to control the output of the Delta Person facility under a long-term contract with Delta Person.
79. Based on PNM's representations, we find that PNM satisfies the Commission's requirements for market-based rates regarding horizontal market power in all balancing authority areas in which PNM currently has market-based rate authority,
80. PNM represents that of it and its affiliates, only PNM owns or controls transmission facilities subject to Commission jurisdiction. PNM states that open access to these transmission facilities is provided pursuant to the terms of PNM's Open Access Transmission Tariff on file with the Commission.
81. PNM states that it purchases coal under various long-term agreements but does not currently own any coal mines or mineral rights. PNM represents that these coal purchase contracts are used exclusively to supply coal to power plants owned and operated by PNM.
82. Finally, PNM states that it has not erected barriers to entry into the relevant market, the PNM balancing authority area, and will not erect barriers to entry into the relevant market.
83. Based on PNM's representations, we find that PNM satisfies the Commission's requirements for market-based rates regarding vertical market power.
84. Based on PNM's satisfaction of the Commission's requirements for market-based authorization regarding horizontal and vertical market power in the markets where it has market-based rate authority, we accept PNM's notice of change in status.
85. An entity with market-based rate authorization must file an Electric Quarterly Report (EQR) with the Commission, consistent with Order Nos. 2001
86. PNM must timely report to the Commission any change in status that would reflect a departure from the characteristics the Commission relied upon in granting market-based rate authority.
87. Additionally, PNM must file an updated market power analysis for all regions in which it is designated as a Category 2 seller in compliance with the regional reporting schedule adopted in Order No. 697.
(A) PNM's notice of change in status is hereby accepted for filing, as discussed in the body of this order.
(B) PNM's request for market-based authority in the PNM balancing authority area is hereby rejected, without prejudice, as discussed in the body of this order.
(C) PNM's SIL study is hereby rejected, without prejudice, as discussed in the body of this order.
(D) The Secretary is hereby directed to publish a copy of this order in the
By the Commission.
Environmental Protection Agency (EPA).
Notice of proposed consent decree; request for public comment.
In accordance with section 113(g) of the Clean Air Act, as amended (“CAA” or the “Act”), notice is hereby given of a proposed consent decree to address a lawsuit filed by the Environmental Integrity Project and Sierra Club (collectively, “Plaintiffs”):
Written comments on the proposed consent decree must be received by
Submit your comments, identified by Docket ID number EPA-HQ-OGC-2015-0691, online at
Amy Branning, Air and Radiation Law Office, Office of General Counsel, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone: (202) 564-1744; fax number: (202) 564-5603; email address:
The proposed consent decree would resolve a lawsuit filed by the Environmental Integrity Project and Sierra Club seeking to compel the Administrator to take action under CAA section 505(b)(2). Under the terms of the proposed consent decree, EPA would agree to sign its response granting or denying the petition filed by the Plaintiffs regarding Southwestern Electric Power Company for operation of the H.W. Pirkey Power Plant in Harrison County, Texas, pursuant to section 505(b)(2) of the CAA, on or before February 12, 2016.
Under the terms of the proposed consent decree, EPA would expeditiously deliver notice of EPA's response to the Office of the Federal Register for review and publication following signature of such response. In addition, the proposed consent decree outlines the procedure for the Plaintiffs to request costs of litigation, including attorney fees.
For a period of thirty (30) days following the date of publication of this notice, EPA will accept written comments relating to the proposed consent decree from persons who are not named as parties or intervenors to the litigation in question. EPA or the Department of Justice may withdraw or withhold consent to the proposed consent decree if the comments disclose facts or considerations that indicate that such consent is inappropriate, improper, inadequate, or inconsistent with the requirements of the Act. Unless EPA or the Department of Justice determines that consent to this proposed decree should be withdrawn, the terms of the consent decree will be affirmed.
The official public docket for this action (identified by Docket ID No. EPA-HQ-OGC-2015-0691 contains a copy of the proposed consent decree. The official public docket is available for public viewing at the Office of Environmental Information (OEI) Docket in the EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave. NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OEI Docket is (202) 566-1752.
An electronic version of the public docket is available through
It is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing online at
You may submit comments as provided in the
If you submit an electronic comment, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your comment and with any disk or CD-ROM you submit. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. Any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket,
Use of the
Environmental Protection Agency (EPA).
Notice of public meeting and request for comment.
The U.S. Environmental Protection Agency (EPA) announces the release of a draft document, “Technologies for
The public meeting will be held on November 9, 2015, from 1:00 p.m. to 5:30 p.m., eastern time. Persons wishing to attend the meeting in-person or online via webinar must register by November 3, 2015, as described in the
The public meeting will be held at the EPA Potomac Yard South Building, 1st Floor Conference Center (One Potomac Yard, 2777 S. Crystal Drive, Arlington, VA 22202). All attendees must show government-issued photo identification (
For technical questions, contact César Cordero, Standards and Risk Management Division, Office of Ground Water and Drinking Water at (202) 564-3716 or
The draft document provides an overview of
The draft document and other related information will be available in the Water Docket, identified by docket identification (ID) number EPA-HQ-OW-2015-0595, which is available at
For additional submission methods, the full EPA public comment policy and general guidance on making effective comments, please visit
When preparing the document for external peer review, EPA will consider written comments received prior to November 23, 2015.
Persons wishing to attend the public meeting in-person or online via webinar must register in advance no later than 5:00 p.m., eastern time on November 3, 2015. To register, go online to Eventbrite at
At the public meeting, EPA will present an overview of the draft document and will solicit public comments about the scientific aspects of available
Through this notice, EPA is announcing an opportunity for the public to provide input on the draft document in writing and/or verbally at the public meeting and webinar. EPA will conduct an independent, expert peer review following the public review and comment period.
Comments from the public and external peer reviewers will be considered as EPA finalizes the document.
The Agency is particularly interested in input from the public related to the following questions:
1. How well does the document accurately characterize the available, peer reviewed literature on the effectiveness of different technologies for control of
2. What is your perspective on whether the characterization of each technology is balanced and supported by the available, peer reviewed scientific information?
3. What suggestions do you have to improve the document so that it can better support informed public health protection decisions and avoid or minimize unintended consequences?
Environmental Protection Agency (EPA).
Notice of meeting.
The Environmental Protection Agency (EPA) announces an upcoming public meeting of the Clean Air Act Advisory Committee (CAAAC). The EPA established the CAAAC on November 19, 1990, to provide independent advice and counsel to EPA on policy issues associated with implementation of the Clean Air Act of 1990. The Committee advises on economic, environmental, technical, scientific and enforcement policy issues.
The meeting will be held on November 18, 2015, tentatively from 8:30 a.m. to 4:30 p.m.
The CAAAC will hold its face-to-face meeting at the Hyatt Regency Crystal City hotel, 2799 Jefferson Davis Highway, Arlington, VA 22202.
For more information about the CAAAC, please contact Jim Ketcham-Colwill, Interim Designated Federal Officer (DFO), Office of Air and Radiation, U.S. EPA by email at
For information on access or services for individuals with disabilities, please contact Lorraine Reddick at (202) 564-1293 or
Environmental Protection Agency (EPA).
Notice of proposed settlement; request for public comments.
Notice is hereby given of a proposed administrative settlement for recovery of past response costs concerning the Peabody Street Asbestos Superfund Site, located in Salem, Essex County, Massachusetts with the settling parties Massachusetts Electric Company and National Grid USA. The proposed settlement requires the settling parties to pay $850,000, plus interest, to the Hazardous Substance Superfund. In exchange, EPA will provide the settling parties a covenant not to sue. The settlement has been approved by the Environmental and Natural Resources Division of the United States Department of Justice. For 30 days following the date of publication of this notice, the Agency will receive written comments relating to the settlement for recovery of response costs. The Agency will consider all comments received and may modify or withdraw its consent to this cost recovery settlement if comments received disclose facts or considerations which indicate that the settlement is inappropriate, improper, or inadequate. The Agency's response to any comments received will be available for public inspection at the Salem Public Library, 370 Essex Street, Salem, MA 01970 and at the Environmental Protection Agency—Region I, 5 Post Office Square, Suite 100, Boston, MA 02109-3912.
Comments must be submitted by November 20, 2015.
Comments should be addressed to Kevin Pechulis, Enforcement Counsel, U.S. Environmental Protection Agency, 5 Post Office Square, Suite 100 (OES04-2), Boston, MA 02109-3912 (Telephone No. 617-918-1612) and should reference the Peabody Street Asbestos Superfund Site, U.S. EPA Docket No: 01-2015-0052.
A copy of the proposed settlement may be obtained from Stacy Greendlinger, Office of Site Remediation and Restoration, U.S. Environmental Protection Agency, Region I, 5 Post Office Square, Suite 100 (OSRR02-2), Boston, MA 02109-3912, (617) 918-1403;
This proposed administrative settlement for recovery of past response costs concerning the Peabody Street Asbestos Superfund Site, located in Salem, Essex County, Massachusetts is made in accordance with Section 122(i) of the Comprehensive Environmental Response, Compensation, and Liability Act, as amended (“CERCLA”), 42 U.S.C. 9622(i). The settling parties to this administrative settlement include: Massachusetts Electric Company and National Grid USA. The settlement includes a covenant not to sue the settling parties pursuant to Section 106 of CERCLA, 42 U.S.C. 9606, and Section 107(a) of CERCLA, 42 U.S.C. 9607(a). For 30 days following the date of publication of this notice, the Agency will receive written comments relating to the settlement for recovery of response costs (Section XIV of the proposed settlement).
Environmental Protection Agency (EPA).
Notice of proposed consent decree; request for public comment.
In accordance with section 113(g) of the Clean Air Act, as amended (“CAA” or the “Act”), notice is hereby given of a proposed consent decree to address a lawsuit filed by Sierra Club and Physicians For Social Responsibility—Los Angeles (“Plaintiffs”) in the United States District Court for the Central District of California:
Written comments on the proposed consent decree must be received by November 20, 2015.
Submit your comments, identified by Docket ID number EPA-OGC-2015-0677, online at
Geoffrey L. Wilcox, Air and Radiation Law Office (2344A), Office of General Counsel, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone: (202) 564-5601; fax number: (202) 564-5603; email address:
The proposed consent decree would resolve a lawsuit filed by the Plaintiffs seeking to compel EPA to take actions required under CAA section 110(k)(2)-(4). The Plaintiffs' lawsuit alleged that EPA has a mandatory duty to take final action to approve or disapprove, in whole or in part, the portions of the South Coast Air Quality Management District's Final 2012 Air Quality Management Plan that address attainment of the 2006 PM
For a period of thirty (30) days following the date of publication of this notice, the Agency will accept written comments relating to the proposed consent decree from persons who are not named as parties or intervenors to the litigation in question. EPA or the Department of Justice may withdraw or withhold consent to the proposed consent decree if the comments disclose facts or considerations that indicate that such consent is inappropriate, improper, inadequate, or inconsistent with the requirements of the Act. Unless EPA or the Department of Justice determines that consent to this proposed consent decree should be withdrawn, the terms of the consent decree will be affirmed.
The official public docket for this action (identified by EPA-OGC-2015-0677) contains a copy of the proposed partial consent decree. The official public docket is available for public viewing at the Office of Environmental Information (OEI) Docket in the EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave. NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OEI Docket is (202) 566-1752.
An electronic version of the public docket is available through
It is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing online at
You may submit comments as provided in the
If you submit an electronic comment, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your comment and with any disk or CD ROM you submit. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. Any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment.
Use of the
Environmental Protection Agency.
Notice of meeting.
Pursuant to the provisions of the Federal Advisory Committee Act, Public Law 92-463, notice is hereby given that the next meeting of the Children's Health Protection Advisory Committee (CHPAC) will be held November 12 and 13, 2015 at the National Archives Museum (700 Pennsylvania Avenue NW., Washington, DC 20408) in the Jefferson Room. The CHPAC advises the Environmental Protection Agency on science, regulations, and other issues relating to children's environmental health.
November 12 and 13, 2015.
700 Pennsylvania Avenue NW., Washington, DC 20408. Enter on 7th Street near Constitution Avenue.
Martha Berger, Office of Children's Health Protection, USEPA, MC 1107T, 1200 Pennsylvania Avenue NW., Washington, DC 20460, (202) 564-2191 or
The meetings of the CHPAC are open to the public. The CHPAC will meet on Thursday, November 12 from 1 p.m. to 5:30 p.m. and Friday, November 13 from 9 a.m. to 4 p.m. in the Jefferson Room. An agenda will be posted to
The Federal Communications Commission will hold an Open Meeting on the subjects listed below on Thursday, October 22, 2015, which is scheduled to commence at 10:30 a.m. in Room TW-C305, at 445 12th Street SW., Washington, DC
The meeting site is fully accessible to people using wheelchairs or other mobility aids. Sign language interpreters, open captioning, and assistive listening devices will be provided on site. Other reasonable accommodations for people with disabilities are available upon request. In your request, include a description of the accommodation you will need and a way we can contact you if we need more information. Last minute requests will be accepted, but may be impossible to fill. Send an email to:
Additional information concerning this meeting may be obtained from the Office of Media Relations, (202) 418-0500; TTY 1-888-835-5322. Audio/Video coverage of the meeting will be broadcast live with open captioning over the Internet from the FCC Live Web page at
For a fee this meeting can be viewed live over George Mason University's Capitol Connection. The Capitol Connection also will carry the meeting live via the Internet. To purchase these services, call (703) 993-3100 or go to
Federal Communications Commission.
Notice.
The following applicants filed AM or FM proposals to change the community of license: Bowen Broadcasting, Inc., Station NEW, Facility ID 198781, BNPH-20150910ABY, From Bastrop, LA, To Calhoun, LA; Bridgelight, LLC, Station WJUX, Facility ID 43653, BPED-20150923ALI, From Monticello, NY, To South Fallsburg, NY; Catholic Radio Network, Inc., Station KQOH, Facility ID 76946, BPED-20150810AED, From Marshfield, MO, To Fair Grove, MO; Colt Communications, LLC, Station WNTN, Facility ID 48781, BP-20150730ACM, From Newton, MA, To Cambridge, MA; Contemporary Communications, LLC, Station NEW, Facility ID 198749, BNPH-20150928AAY, From Dermott, AR, To Moorhead, MS; De La Hunt, Edward Paul, Station KKWZ, Facility ID 165964, BPH-20151001AFK, From Crary, ND, To Rugby, ND; Flinn Broadcasting Corporation, Station KWLR, Facility ID 23849, BPH-20150804ABN, From Maumelle, AR, To Bigelow, AR; Genesis Communications Of Tampa Bay, Inc., Station WHBO, Facility ID 41383, BP-20150820ABA, From Pinellas Park, FL, To Largo, FL; Grundy County Broadcasters, Inc., Station WCSJ, Facility ID 17039, BP-20150828ABM, From Morris, IL, To Geneva, IL; Point Five, LLC, Station NEW, Facility ID 191522, BMPH-20150507ACA, From Barstow, CA, To Hinkley, CA; River Rat Radio, LLC., Station NEW, Facility ID 198737, BNPH-20150911AHR, From Quartzsite, AZ, To Parker Strip, AZ; Southeastern Oklahoma Radio, LLC, Station KTMC-FM, Facility ID 67592, BPH-20150831ABE, From Mcalester, OK, To Krebs, OK; Telesouth Communications, Inc., Station WTNM, Facility ID 51086, BPH-20150728ACE, From Oxford, MS, To Courtland, MS; Two Rivers Broadcasting, Inc., Station KQZZ, Facility ID 56710, BPH-20151001AFQ, From Devils Lake, ND, To Crary, ND; Walking By Faith Ministries, Inc., Station WAML, Facility ID 52617, BP-20150831ADB, From Laurel, MS, To Collins, MS.
The agency must receive comments on or before December 21, 2015.
Federal Communications Commission, 445 Twelfth Street SW., Washington, DC 20554.
Tung Bui, 202-418-2700.
The full text of these applications is available for inspection and copying during normal business hours in the Commission's Reference Center, 445 12th Street SW., Washington, DC 20554 or electronically via the Media Bureau's Consolidated Data Base System,
Federal Deposit Insurance Corporation (FDIC).
Notice of open meeting.
In accordance with the Federal Advisory Committee Act, notice is hereby given of a meeting of the FDIC Advisory Committee on Community Banking, which will be held in Washington, DC. The Advisory
Thursday, November 5, 2015, from 9:00 a.m. to 3:00 p.m.
The meeting will be held in the FDIC Board Room on the sixth floor of the FDIC Building located at 550 17th Street NW., Washington, DC.
Requests for further information concerning the meeting may be directed to Mr. Robert E. Feldman, Committee Management Officer of the FDIC, at (202) 898-7043.
The Commission hereby gives notice of the filing of the following agreements under the Shipping Act of 1984. Interested parties may submit comments on the agreements to the Secretary, Federal Maritime Commission, Washington, DC 20573, within twelve days of the date this notice appears in the
By Order of the Federal Maritime Commission.
The 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 13, 2015.
A. Federal Reserve Bank of Dallas (Robert L. Triplett III, Senior Vice President) 2200 North Pearl Street, Dallas, Texas 75201-2272:
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 November 3, 2015.
A. Federal Reserve Bank of Chicago (Colette A. Fried, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690-1414:
1.
B. Federal Reserve Bank of Minneapolis (Jacquelyn K. Brunmeier, Assistant Vice President) 90 Hennepin Avenue, Minneapolis, Minnesota 55480-0291:
1.
Kimberly Weaver, Director, Office of External Affairs, (202) 942-1640.
Federal Trade Commission.
Proposed Consent Agreement.
The consent agreement in this matter settles alleged violations of federal law prohibiting unfair methods of competition. The attached Analysis to Aid Public Comment describes both the allegations in the draft complaint and the terms of the consent order—embodied in the consent agreement—that would settle these allegations.
Comments must be received on or before November 16, 2015.
Interested parties may file a comment at
Robert Canterman (202-326-2701), Bureau of Competition, 600 Pennsylvania Avenue NW., Washington, DC 20580.
Pursuant to Section 6(f) of the Federal Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule 2.34, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis to Aid Public Comment describes the terms of the consent agreement, and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC Home Page (for October 15, 2015), on the World Wide Web, at
You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before November 16, 2015. Write “Keystone Orthopaedic Specialists, LLC.,—Consent Agreement; File No.141-0025” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the public Commission Web site, at
Because your comment will be made public, you are solely responsible for making sure that your comment does not include any sensitive personal information, like anyone's Social Security number, date of birth, driver's license number or other state identification number or foreign country equivalent, passport number, financial account number, or credit or debit card number. You are also solely responsible for making sure that your comment does not include any sensitive health information, like medical records or other individually identifiable health information. In addition, do not include any “[t]rade secret or any commercial or financial information which . . . is privileged or confidential,” as discussed in Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2). In particular, do not include competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names.
If you want the Commission to give your comment confidential treatment, you must file it in paper form, with a request for confidential treatment, and you have to follow the procedure explained in FTC Rule 4.9(c), 16 CFR 4.9(c).
Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online. To make sure that the Commission considers your online comment, you must file it at
If you file your comment on paper, write “Keystone Orthopaedic Specialists, LLC.,—Consent Agreement; File No.141-0025” on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610 (Annex D), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex D), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service.
Visit the Commission Web site at
The Federal Trade Commission has accepted, subject to final approval, an Agreement Containing a Consent Order (“Consent Agreement”) with Keystone Orthopaedic Specialists, LLC (“Keystone”), and Orthopaedic Associates of Reading, Ltd. (“Orthopaedic Associates”) (together “Respondents”). The Consent Agreement settles charges that Respondents violated Section 7 of the Clayton Act, as amended, 15 U.S.C. 18, and Section 5 of the FTC Act, as amended, 15 U.S.C. 45.
The Consent Agreement has been placed on the public record for 30 days to receive comments from interested persons. Comments received during this period will become part of the public record. After 30 days, the Commission will review the Consent Agreement and the comments received, and will decide whether it should withdraw from the Consent Agreement, modify it, or make it final.
The purpose of this analysis is to facilitate public comment on the Consent Agreement. The analysis is not intended to constitute an official interpretation of the Consent Agreement or to modify its terms in any way. Further, the Consent Agreement has been entered into for settlement purposes only and does not constitute an admission by Respondents that they violated the law or that the facts alleged in the Complaint (other than jurisdictional facts) are true.
Nineteen orthopedists affiliated with six independent orthopedic practices in Berks County, Pennsylvania, merged to form Keystone in January 2011 (the “Merger”). One of those practices is Respondent Orthopaedic Associates, and the other five practices are Advanced Orthopaedics of Reading, Arthritis & Joint Replacement Center of Reading, P.C., Berkshire Orthopedic Associates, Inc., Commonwealth Orthopaedic Associates, Inc., and Reading Neck and Spine Center, P.C. (“Keystone Component Practices”). The Keystone Component Practices became divisions of Keystone after the Merger.
Before the Merger, competition among orthopedists in Berks County was robust. At that time, 25 orthopedists in 11 independent practices competed to provide orthopedic physician services. The Merger substantially eliminated this competition by combining 19 out of 25, or 76 percent, of the orthopedists practicing in Berks County into one practice. Only six other orthopedists remained as competitors. After the Merger, the Keystone orthopedists ceased to do business through their respective independent practices and began doing business exclusively through Keystone. Three years after the Merger, in 2014, six orthopedists left Keystone and resumed doing business as Orthopaedic Associates for business reasons independent of the Commission's investigation.
The relevant line of commerce in which to analyze the Merger's effects is the provision of orthopedic physician services. Orthopedic physician services include surgery and other services provided by physicians who specialize as orthopedists to treat injuries and diseases of the musculoskeletal system.
The relevant geographic market in which to assess the competitive effects of the Merger is Berks County, Pennsylvania. Patients in Berks County generally do not leave the county to obtain orthopedic physician services, and health plans are unable to serve their members in Berks County without including Berks County orthopedists in their provider networks.
Before the Merger, the Keystone Component Practices competed with each other, and health plans could form a network with some of the Keystone Component Practices. The Merger eliminated this competition and created
Recruiting new orthopedists to Berks County is difficult, expensive, and time intensive. Neither entry by new practices nor expansion by the remaining practices following the Merger has been timely or sufficient to offset the actual anticompetitive harm from the Merger. Nor is future entry to be timely, likely, or sufficient to do so.
The Merger has not produced merger-specific efficiencies sufficient to offset the actual anticompetitive harm from the Merger.
The proposed Decision and Order (“Order”) is designed to maintain competition in the relevant market, including by prohibiting future anticompetitive consolidation, and by allowing health plans to cancel and renegotiate the contracts they entered with Keystone after the Merger was consummated.
In evaluating the remedies in the proposed Order, it is important to note that market conditions have changed since the 2011 Merger. Market concentration levels are lower now than after the Merger was consummated in 2011 due to orthopedists leaving Keystone. Most significantly, for reasons independent of and pre-dating the Commission's investigation, six orthopedists separated from Keystone in 2014 and resumed doing business separately and independently as Orthopaedic Associates. Following the separation, Orthopaedic Associates has become a major player in the market with eight orthopedists. Keystone, in contrast, currently has 11 orthopedists, down from 19 when the Merger was consummated.
Had Orthopaedic Associates remained a part of Keystone, the Commission likely would have sought divestiture. As it is, the unique circumstance of Orthopaedic Associates' separation from Keystone for business reasons pre-dating the Commission's investigation resulted in structural changes that factored into the Commission's decision not to pursue further structural relief. But a recombination of the two groups could raise serious antitrust concern. Therefore, the proposed Order is designed to maintain competition in the relevant market by, among other things, preserving the Orthopaedic Associates' separation, and by allowing health plans to avail themselves of current market conditions by renegotiating existing Keystone contracts. Orthopaedic Associates is a named Respondent because its orthopedists helped form Keystone and benefitted from Keystone's post-merger price increases. Moreover, putting Orthopaedic Associates under Order is necessary to obtain appropriate relief, as discussed below.
Paragraph II of the proposed Order preserves Orthopaedic Associates' separation by requiring Keystone and Orthopaedic Associates to obtain prior approval from the Commission before acquiring any interest in each other.
Paragraph III requires Keystone and Orthopaedic Associates to obtain prior approval from the Commission before either practice may acquire another orthopedic practice located in Berks County. Keystone and Orthopaedic Associates also must obtain prior approval before entering into any employment, membership, or other agreement of affiliation with an orthopedist who during the prior year provided services in Berks County.
The proposed Order also prohibits Keystone and Orthopaedic Associates from engaging in illegal concerted activity apart from merging or acquiring other practices in Berks County. Under the Horizontal Merger Guidelines, mergers may harm competition where a “market shows signs of vulnerability to coordinated conduct.” In this case, the Commission is concerned that the effects of this consummated merger could linger because of the close ties developed between Keystone and Orthopaedic Associates. Keystone and the orthopedists affiliated with Orthopaedic Associates jointly negotiated with payors and shared price information for over three years before the Orthopaedic Associates orthopedists left Keystone. Therefore, Paragraph IV includes provisions prohibiting certain joint activity among competing orthopedists who are members of or employed by Keystone or Orthopaedic Associates in order to limit the risk of coordination.
Paragraph IV.A prohibits Keystone and Orthopaedic Associates from jointly negotiating or refusing to deal with payors, and from engaging in this conduct with other orthopedists in Berks County. Paragraph IV.B prohibits Keystone and Orthopaedic Associates from facilitating exchanges of information among orthopedists concerning whether, and on what terms, to contract with a payor. Paragraph IV.C bars attempts to engage in any action prohibited by Paragraphs IV.A or IV.B. Paragraph IV.D proscribes inducing anyone to engage in any action prohibited by Paragraphs IV.A through IV.C.
Certain kinds of agreements that do not raise antitrust concerns are excluded from the general bar on joint negotiations. Paragraph IV does not preclude Keystone or Orthopaedic Associates from engaging in conduct that is reasonably necessary to form or participate in “qualified risk-sharing” or “qualified clinically-integrated” joint arrangements, as defined in the Order. Paragraph V requires Keystone and Orthopaedic Associates to notify the Commission before initiating certain contacts regarding contracts with payors pursuant to these joint arrangements. Paragraph V also sets out the information necessary to satisfy the notification requirement.
Paragraph VI imposes other notification obligations on Keystone and Orthopaedic Associates and requires the termination of certain contracts that were entered into after the Merger. Paragraphs VI.A and VI.B require Keystone and Orthopaedic Associates to distribute the Complaint and Order to their respective orthopedist members and personnel identified in the Order, and to each payor that they have a record of having been in contact with since January 1, 2010.
Paragraph VI.C requires Keystone and Orthopaedic Associates to terminate, without penalty, any existing contracts with payors for the provision of orthopedic physician services at the earlier of a written request from a payor to terminate or the earliest termination or renewal date under the contract. Paragraph VI.C also allows a payor to extend a contract beyond the termination or renewal date for a period of no longer than one year from the date the order becomes final to allow payors sufficient time to renegotiate contracts with Keystone and Orthopaedic Associates. The contract termination requirement allows payors to avail themselves of current conditions in renegotiating contracts, where Keystone is no longer the dominant provider. Paragraph VI.D requires Keystone and Orthopaedic Associates to distribute payor requests for contract termination to their respective orthopedist members. Paragraph VI.E requires Keystone and Orthopaedic Associates to provide new
Paragraphs VII, VIII, and IX impose various obligations on Keystone and Orthopaedic Associates to report or provide access to information to the Commission to facilitate the monitoring of compliance with the Order. Finally, Paragraph X provides that the Order will expire in 10 years from the date it is issued.
By direction of the Commission.
General Services Administration.
Notice.
Notice is hereby given of the appointment of new members to the General Services Administration Senior Executive Service Performance Review Board. The Performance Review Board assures consistency, stability, and objectivity in the performance appraisal process.
Antonia T. Harris, Chief Human Capital Officer, Office of Human Resources Management, General Services Administration, 1800 F Street NW., Washington, DC 20405, 202-501-0398.
Section 4314(c)(1), through (5) 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 SES performance review board(s). The board is responsible for making recommendations to the appointing and awarding authority on the performance appraisal ratings and performance awards for the Senior Executive Service employees.
The following have been designated as members of the Performance Review Board of the General Services Administration:
Adam Neufeld, Deputy Administrator—Chair.
Antonia Harris, Chief Human Capital Officer.
Jerome Fletcher, Associate Administrator for Small Business Utilization.
Christine Harada, Associate Administrator for Governmentwide Policy.
Thomas Sharpe, Jr., Commissioner, Federal Acquisition Service.
Kevin Youel Page, Deputy Commissioner, Federal Acquisition Service.
Norman Dong, Commissioner, Public Buildings Service.
Michael Gelber, Deputy Commissioner, Public Buildings Service.
Giancarlo Brizzi, Principal Deputy Associate Administrator for Governmentwide Policy.
Joanna Rosato, Regional Commissioner, Public Buildings Service, Mid-Atlantic Region.
Kim Brown, Regional Commissioner, Federal Acquisition Service, Great Lakes Region.
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:
Time and Date: 9 a.m.-5 p.m., Eastern Standard Time, December 1, 2015
Place: Jacob J. Javits Federal Building, 26 Federal Plaza, New York, New York 10278. This meeting is also available by teleconference. The USA toll-free, dial-in number is 1-888-455-9749, and when prompted enter passcode—6542002. To view the web conference, enter the following web address in your web browser:
Public Comment Time and Date: 11:20 a.m.-12 p.m., Eastern Standard Time, December 1, 2015
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 November 27, 2015. 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.
Status: Open to the public, limited only by the number of telephone lines. The conference line will accommodate up to 50 callers; therefore it is suggested that those interested in calling in to listen to the committee meeting share a line when possible.
Background: The Advisory Committee was established by Public Law 111-347 (The James Zadroga 9/11 Health and Compensation Act of 2010, Title XXXIII of the Public Health Service Act), enacted on January 2, 2011 and codified at 42 U.S.C. 300mm-300mm-61.
Purpose: The purpose of the Advisory Committee is to review scientific and medical evidence and to make recommendations to the Administrator of the World Trade Center (WTC) Health Program regarding additional WTC Health Program eligibility criteria and potential additions to the list of covered WTC-related health conditions, as well as providing consultation on research to the Administrator of the World Trade Center Health Program. Title XXXIII of the Public Health Service Act established within the Department of Health and Human Services (HHS), the World Trade Center (WTC) Health Program, to be administered by the Administrator of the World Trade Center Health Program. The WTC Health Program provides: (1) Medical monitoring and treatment benefits to eligible emergency responders and recovery and cleanup workers (including those who are Federal employees) who responded to the September 11, 2001, terrorist attacks, and (2) initial health evaluation, monitoring, and treatment benefits to residents and other building occupants and area workers in New York City, who were directly impacted and adversely affected by such attacks (“survivors”). Certain specific activities of the Administrator of the World Trade Center Health Program are reserved to the Secretary, HHS, to delegate at her discretion; other duties of the Administrator of the World Trade Center Health Program not explicitly reserved to the Secretary, HHS, are assigned to the Director, NIOSH. The administration of the Advisory Committee established under Section 300mm-1(a) is left to the Director of NIOSH in his role as Administrator of the World Trade Center Health Program. CDC and NIOSH provide funding,
Matters for Discussion: The Advisory Committee will continue its deliberations from the meeting on June 4, 2015, addressing the need for research on developmental or health effects in children. The agenda will include presentations on children's health research that has been conducted related to exposures from the 9/11 terrorist attacks. Also, a panel of children's researchers will discuss children's research issues with the Advisory Committee.
The agenda is subject to change as priorities dictate.
Public Comment Sign-up and Submissions to the Docket: To sign up to provide public comments or to submit comments to the docket, send information to the NIOSH Docket Office by one of the following means:
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
Contact Person for More Information: Paul J. Middendorf, Ph.D., Designated Federal Officer, NIOSH, CDC, 2400 Century Parkway NE., Mail Stop E-20, Atlanta, GA 30345, telephone 1 (888) 982-4748; email:
The Director, Management Analysis and Services Office, has been delegated the authority to sign
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), and pursuant to the requirements of 42 CFR 83.15(a), 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 wish to provide public comments should plan to attend the public comment session at the start time listed.
In December 2000, the President delegated responsibility for funding, staffing, and operating the Advisory Board to HHS, which subsequently delegated this authority to the CDC. NIOSH implements this responsibility for CDC. The charter was issued on August 3, 2001, renewed at appropriate intervals, and will expire on August 3, 2017.
The agenda is subject to change as priorities dictate.
In the event an individual cannot attend, written comments may be submitted to the contact person well in advance of the meeting. Any written comments received will be provided at the meeting in accordance with the redaction policy provided below.
Policy on Redaction of Board Meeting Transcripts (Public Comment): (1) If a person making a comment gives his or her personal information, no attempt will be made to redact the name; however, NIOSH will redact other personally identifiable information, such as contact information, social security numbers, case numbers, etc., of the commenter.
(2) If an individual in making a statement reveals personal information (
(3) If a commenter reveals personal information concerning a living third party, that information will be reviewed by the NIOSH FOIA coordinator, and upon determination, if deemed appropriated, such information will be redacted, unless the disclosure is made by the third party's authorized representative under the Energy Employees Occupational Illness Compensation Program Act (EEOICPA) program.
(4) In general, information concerning a deceased third party may be disclosed; however, such information will be redacted if (a) the disclosure is made by an individual other than the survivor claimant, a parent, spouse, or child, or the authorized representative of the deceased third party; (b) if it is unclear whether the third party is living or deceased; or (c) the information is unrelated or irrelevant to the purpose of the disclosure.
The Board will take reasonable steps to ensure that individuals making public comment are aware of the fact that their comments (including their name, if provided) will appear in a transcript of the meeting posted on a public Web site. Such reasonable steps include: (a) A statement read at the start of each public comment period stating that transcripts will be posted and names of speakers will not be redacted; (b) A printed copy of the statement mentioned in (a) above will be displayed on the table where individuals sign up to make public comments; (c) A statement such as outlined in (a) above will also appear with the agenda for a Board Meeting when it is posted on the NIOSH Web site; (d) A statement such as in (a) above will appear in the
Contact Person For More Information: Theodore Katz, Designated Federal Officer, NIOSH, CDC, 1600 Clifton Road NE., MS E-20, Atlanta, Georgia 30333, telephone: (513) 533-6800, toll free: 1-800-CDC-INFO, email:
The Director, Management Analysis and Services Office, has been delegated the authority to sign
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 committee meeting.
8:30 a.m.-5 p.m.., November 18, 2015.
8:30 a.m.-12 p.m., November 19, 2015.
Agenda items are subject to change as priorities dictate.
If using a mobile device to access the materials, please verify that the device's browser is able to download the files from the CDC's Web site before the meeting. Alternatively, the files can be downloaded to a computer and then emailed to the portable device. An internet connection, power source, and limited hard copies may be available at the meeting location, but cannot be guaranteed.
The Director, Management Analysis and Services Office, has been delegated the authority to sign
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 21, 2015.
You may submit comments as follows:
Submit electronic comments in the following way:
• Federal eRulemaking Portal:
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• 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
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
The Federal Food, Drug, and Cosmetic Act, as amended by the Medical Device User Fee and Modernization Act of 2002 (Pub. L. 107-250), and the Medical Device User Fee Amendments of 2007 (title II of the Food and Drug Administration Amendments Act of 2007), authorizes FDA to collect user fees for certain medical device applications. Under this authority, companies pay a fee for certain new medical device applications or supplements submitted to the Agency for review. Because the submission of user fees concurrently with applications and supplements is required, the review of an application cannot begin until the fee is submitted. Form FDA 3601, the “Medical Device User Fee Cover Sheet,” is designed to provide the minimum necessary information to determine whether a fee is required for review of an application, to determine the amount of the fee required, and to account for and track user fees. The form provides a cross-reference between the fees submitted for an application with the actual submitted application by using a unique number tracking system. The information collected is used by FDA's Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research to initiate the administrative screening of new medical device applications and supplemental applications.
The total number of annual responses is based on the average number of cover sheet submissions received by FDA in recent years. The number of received annual responses includes cover sheets for applications that were qualified for small businesses and fee waivers or reductions. The estimated hours per response are based on past FDA experience with the various cover sheet submissions, and range from 5 to 30 minutes. The hours per response are based on the average of these estimates (18 minutes).
FDA estimates the burden of this collection of information as follows:
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 21, 2015.
You may submit comments as follows:
Submit electronic comments in the following way:
• Federal eRulemaking Portal:
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
• Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
Section 409(a) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 348(a)) provides that a food additive shall be deemed to be unsafe unless its use is permitted by a regulation which prescribes the condition(s) under which it may safely be used, or unless it is exempted by regulation for investigational use. Section 409(b) of the FD&C Act specifies the information that must be submitted by a petitioner in order to establish the safety of a food additive and to secure the issuance of a regulation permitting its use.
To implement the provisions of section 409 of the FD&C Act, procedural regulations have been issued under 21 CFR part 571. These procedural regulations are designed to specify more thoroughly the information that must be submitted to meet the requirement set down in broader terms by the FD&C Act. The regulations add no substantive requirements to those indicated in the FD&C Act, but attempt to explain these requirements and provide a standard format for submission to speed processing of the petition. Labeling requirements for food additives intended for animal consumption are also set forth in various regulations contained in 21 CFR parts 501, 573, and 579. The labeling regulations are considered by FDA to be cross-referenced to § 571.1, which is the subject of this same OMB clearance for food additive petitions.
With regard to the investigational use of food additives, section 409(j) of the FD&C Act provides that any food additive or any food bearing or containing such an additive, may be exempted from the requirements of this section if intended solely for investigational use by qualified experts. Investigational use of a food additive is typically to address the safety and/or intended physical or technical effect of the additive.
FDA estimates the burden of this collection of information as follows:
We base our estimate of the total annual responses on submissions received during fiscal years 2014 and 2015. We base our estimate of the hours per response upon our experience with the petition and filing processes.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on the proposed collection of certain information by our 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 21, 2015.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the
With respect to the following collection of information, we invite comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
The DSNDCPA (Pub. L. 109-462) amends the Federal Food, Drug, and Cosmetic Act (the FD&C Act) with respect to serious adverse event reporting and recordkeeping for dietary supplements and non-prescription drugs marketed without an approved application. Section 761(b)(1) of the FD&C Act (21 U.S.C. 379aa-1(b)(1)) requires the manufacturer, packer, or distributor whose name under section 403(e)(1) of the FD&C Act (21 U.S.C. 343(e)(1)) appears on the label of a dietary supplement marketed in the United States to submit to us all serious adverse event reports associated with the use of a dietary supplement, accompanied by a copy of the product label. The manufacturer, packer, or distributor of a dietary supplement is required by the DSNDCPA to use the MedWatch form (Form FDA 3500A) when submitting a serious adverse event report to FDA. In addition, under section 761(c)(2) of the FD&C Act, the submitter of the serious adverse event report (referred to in the statute as the “responsible person”) is required to submit to FDA a follow up report of any related new medical information the responsible person receives within 1 year of the initial report.
Section 761(e)(1) of the FD&C Act requires that responsible persons maintain records related to the dietary supplement adverse event reports they receive, whether or not the adverse event is serious. Under the statute, the records must be retained for a period of 6 years.
As required by section 3(d)(3) of the DSNDCPA, we issued guidance to describe the minimum data elements for serious adverse event reports for dietary supplements. In the
The guidance recommends that the responsible person document their attempts to obtain the minimum data elements for a serious adverse event report. Along with these records, the guidance recommends that the responsible person keep the following other records: (1) Communications between the responsible person and the initial reporter of the adverse event and between the responsible person and any other person(s) who provided information about the adverse event; (2) the responsible person's serious adverse event report to us with attachments; (3) any new information about the adverse event received by the responsible person; (4) any reports to us of new information related to the serious adverse event report.
We estimate the annual reporting burden of this collection of information as follows:
This estimate is based on our experience with similar adverse event reporting programs and the number of serious adverse event reports and followup reports received in the past 3 years. All dietary supplement manufacturers, packers, or distributors are subject to serious adverse event mandatory reporting.
We received 2,435 initial serious adverse event reports in fiscal year (FY) 2012, 3,414 in FY2013, and 2,745 in FY2014. We averaged these figures (2,860 rounded to the nearest 10) as a basis for our estimated number of annual reports. We also used an average of the number of firms filing reports (170 rounded to the nearest 10). Finally, we estimate that it will take respondents an average of 2 hours per report to collect information about a serious adverse event associated with a dietary supplement and report the information to us on Form FDA 3500A. Thus, the estimated burden associated with submitting initial dietary supplement serious adverse event reports is 5,720 hours (2,860 responses × 2 hours) as shown in row 1 of Table 1.
If a respondent that has submitted a serious adverse event report receives new information related to the serious adverse event within 1 year of submitting the initial report, the respondent must provide the new information to us in a followup report. We estimate that 25 percent of serious adverse event reports related to dietary supplements will have a followup report submitted, resulting in approximately 715 followup reports submitted annually (2,860 × 0.25 = 715). Dividing the annual number of reports among the 170 firms reporting results in approximately 17 reports for 42 respondents. We estimate that each followup report will require an hour to assemble and submit, including the time needed to copy and attach the initial serious adverse event report as recommended in the guidance. Thus the estimated burden for followup reports of new information is 715 hours (715 responses × 1 hour) as shown in row 2 of Table 1.
All dietary supplement manufacturers, packers, or distributors are subject to serious adverse event recordkeeping. We estimate that there are 1,700 such respondents, based on the figure 1,460 as provided in our final rule of June 25, 2007 (72 FR 34751) on the “Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements,” and factoring a two percent annual growth rate. Estimating that each recordkeeper will keep approximately 74 records per year results in an annual burden of 125,800 records. Estimating that assembling and filing these records, including any necessary photocopying, will take approximately 30 minutes, or 0.5 hours, per record, results in an annual burden of 62,900 hours (125,800 records × 0.50 hours = 62,900 total hours.
Once the documents pertaining to an adverse event report have been assembled and filed in accordance with the safety reporting portal, we expect the records retention burden to be minimal, as we believe most establishments would normally keep this kind of record for at least several years after receiving the report, as a matter of usual and customary business practice.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by November 20, 2015.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
The 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-31) amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to grant FDA authority to regulate the manufacture, marketing, and distribution of tobacco products to protect public health and to reduce tobacco use by minors. Section 1003(d)(2)(D) of the FD&C Act (21 U.S.C. 393(d)(2)(D)) supports the development and implementation of FDA public education campaigns related to tobacco use. Accordingly, FDA is currently developing and implementing public education campaigns to help prevent and reduce tobacco use among lesbian, gay, bisexual, and transgender (LGBT) young adults and thereby reduce the public health burden of tobacco. Overall the campaigns will feature events; advertisements on television and radio and in print; digital communications including social media; and other forms of media.
In support of the provisions of the Tobacco Control Act that require FDA to protect the public health and to reduce tobacco use, FDA requests OMB approval to collect information needed to evaluate FDA's campaign to reduce tobacco use among LGBT young adults. Comprehensive evaluation of FDA's public education campaigns is needed to ensure campaign messages are effectively received, understood, and accepted by those for whom they are intended. Evaluation is an essential organizational practice in public health and a systematic way to account for and improve public health actions.
FDA plans to conduct two studies to evaluate the effectiveness of its LGBT young adult tobacco prevention campaign: (1) An outcome evaluation study to evaluate the effectiveness of its LGBT young adult tobacco prevention campaign, and (2) a media tracking questionnaire to assess awareness of and receptivity to campaign messages. The timing of these studies will be designed to follow the multiple, discrete waves of media advertising planned for the campaigns.
Before the beginning of data collection for the outcome evaluation study, the 5-minute screening instrument will be tested in a small pilot study of LGBT young adults aged 18 to 24. The outcome evaluation study will then begin with a baseline survey of LGBT young adults aged 18 to 24 before the campaign launch. The baseline will be followed by three followup surveys of the target audience of young adults at approximately 6-month intervals after the campaign's launch. Information will be collected
All information will be collected through in-person and Web-based questionnaires. Young adult respondents will be recruited in 24 U.S. cities (12 campaign and 12 comparison cities) from two sources: (1) Intercept surveys in LGBT social venues (
The media tracking survey consists of assessments of LGBT young adults aged 18 to 24 conducted in the periods in between the primary outcome evaluation survey waves to monitor the target audience's awareness of and receptivity to campaign activities. The media tracking survey will assess awareness of the campaign and receptivity to campaign messages. These data will provide critical evaluation feedback to the campaigns and will be conducted with sufficient frequency to match the cyclical patterns of events and media advertising and variation in exposure to allow for mid-campaign refinements. For the media tracking surveys, we will recruit LGBT young adults aged 18 to 24 from all campaign cities through social media.
The information collected is necessary to inform FDA's efforts and measure the effectiveness and public health impact of the campaigns. Data from the media tracking surveys will be used to estimate awareness of and exposure to the campaigns among young adults in target markets where the campaigns are active. Data from the outcome evaluation study will be used to examine statistical associations between awareness of and exposure to the campaigns and subsequent changes in specific outcomes of interest, which will include knowledge, attitudes, beliefs, and intentions related to tobacco use.
FDA's burden estimate is based on prior experience with in-person studies similar to the Agency's plan presented in this document, as well as previous research using social media advertising to recruit young adult participants. Since the 60-day notice was published, FDA has revised the estimated burden. The estimated burden has been revised to account for both participant eligibility and response rates among participants to be recruited via in-person intercept screening in LGBT bars and night clubs as only response rates were estimated in the 60-day notice. In addition, the burden table presented in this document now reports the annual burden estimate, which has been corrected from the 60-day notice, which reported total burden (rather than annual burden).
To reduce overall burden hours, participants who screen and complete the baseline outcome evaluation questionnaire will be re-contacted to complete the first followup campaign evaluation questionnaire; those who complete the first followup campaign evaluation questionnaire will be re-contacted to complete the second followup campaign evaluation questionnaire; and so on. Re-contacted individuals will not need to complete the screener again. We expect a 65 percent eligibility rate and 50 percent response rate for individuals recruited in person and a combined eligibility and response rate of 30 percent for individuals recruited via social media. In each successive round of data collection, we expect 50 percent of re-contacted individuals to complete the followup questionnaire; therefore, additional screenings will be conducted for each followup in order to maintain the target sample size for each followup questionnaire.
In-person recruitment will take place in a variety of LGBT venues (
To obtain the target number of completed questionnaires (“completes”) for the outcome evaluation study, 24,744 (8,248 annualized, or annually over the 3-year approval period) young adults (18,177 (6,059 annualized) recruited in person and 6,567 (2,189 annualized) recruited via social media) will participate in a screening process (“screener”). The estimated burden per screener is 5 minutes (0.083 hour), for a total of 2,055 hours (685 annualized) (1,512 hours (504 annualized) for participants recruited in person and 543 hours (181 annualized) for persons recruited via social media). Before the beginning of data collection, the 5-minute screener will be tested in a small pilot study of 81 young adults (27 annualized) for a total of 6 hours (2 hours annualized).
A total of 12,612 (4,204 annualized) LGBT young adults (9,456 (3,152 annualized) of those screened in person and 3,156 (1,052 annualized) of those screened through social media) will complete questionnaires in four rounds of data collection (baseline and three post-campaign rounds). The estimated burden per complete is 30 minutes (0.5 hour) for the baseline questionnaire and 40 minutes (0.667 hour) for each followup complete, for a total of 7,884 hours (2,628 annualized) (5,916 hours (1,972 annualized) for those recruited in person and 1,968 hours (656 annualized) for those recruited via social media).
To obtain the target number of completes (1,503 completes (501 annualized)) for the media tracking survey, 5,004 (1,668 annualized) young adults will be recruited via social media ads to complete a screener for all three waves of the media tracking survey. The estimated burden per screener response is 5 minutes (0.083 hour), for a total of 415 (138 annualized) hours for all waves of media tracking screener. An estimated 501 (167 annualized) LGBT young adults will complete each of the three waves of the media tracking survey (assuming a 30 percent combined eligibility and response rate to screeners via social media). The estimated burden per completed media tracking questionnaire is 40 minutes (0.667 hour), for a total of 999 (333 annualized) hours for the three waves. The total burden for the media tracking survey (screeners and completes) is 1,413 hours (471 annualized).
The target number of completed campaign questionnaires (
In the
(Comment) The commenter did not believe the amount of hours was justified for learning about the LGBT population. Additionally, the commenter did not see an explanation of the value of collecting this information.
(Response) FDA disagrees with this comment. The Tobacco Control Act
FDA is currently developing a national campaign targeting LGBT young adults ages 18-24 years. The purpose of the proposed study is to evaluate the campaign's reach and its effectiveness in changing their knowledge, beliefs, and attitudes regarding tobacco. FDA's public health education campaigns are a necessary and worthwhile investment to reduce the significant burden of tobacco use and ultimately make tobacco a part of America's past, not its future.
FDA estimates the burden of this collection of information as follows:
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled “Manufacturing Site Change Supplements: Content and Submission”. This draft guidance describes the decision-making steps that FDA recommends to determine whether a premarket approval application (PMA) supplement should be submitted when a manufacturer intends to change the manufacturing site (including a change to the processing, packaging, or sterilization site) of its legally marketed PMA-approved device. This guidance also discusses the general factors FDA intends to consider to determine whether a preapproval inspection is necessary before approval of the PMA supplement. This draft guidance is not final nor is it in effect at this time.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by January 19, 2016.
You may submit comments as follows:
Submit electronic comments in the following way:
• Federal eRulemaking Portal:
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• 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
An electronic copy of the guidance document is available for download from the Internet. See the
William MacFarland, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Silver Spring, MD 20993-0002, 301-796-5547; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911.
Under section 515(d)(6) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360e(d)(6)), a PMA supplement must be submitted for review and approval by FDA before making a change that affects the device's safety or effectiveness, unless such change is a modification in a manufacturing procedure or method of manufacture, which would be eligible for a 30-day notice. The PMA regulations provide general criteria in § 814. 39 (21 CFR 814.39) for determining when PMA holders are required to submit a PMA supplement or are eligible to submit a 30-day notice. Pursuant to § 814.39(a)(3), a PMA holder must submit a PMA supplement for review and approval by FDA concerning the “use of a different facility or establishment to manufacture, process, or package the device” that affects the safety or effectiveness of a device before implementing the change. With respect to establishment inspections, section 510(h) of the FD&C Act (21 U.S.C. 360(h)) requires every registered establishment to be subject to inspections pursuant to section 704 of the FD&C Act (21 U.S.C. 374) and to be inspected at least once in the 2-year period after registration and at least once in every successive 2-year period thereafter.
In March 1996, CDRH sent a letter to the medical device industry that announced a 1-year pilot program to improve the processing of PMA supplements for changes in manufacturing sites. The letter discussed the need to improve the speed and efficiency of CDRH review and approval of manufacturing site change supplements, and stated that CDRH did not require preapproval inspection for all site changes. CDRH later developed the draft guidance entitled “Likelihood of Facilities Inspections When Modifying Devices Subject to Premarket Approval,” which was issued on August 5, 1999. This guidance was never finalized.
The PMA supplements described in the March 1996 letter and the 1999 draft guidance were called “site change supplements” or, if no preapproval inspection was required, they were termed “express supplements.” FDA now identifies all such submissions as “site change supplements” with a designation of whether or not an inspection is needed before the change can be implemented. Based on feedback from industry and the Agency's experience over many years, FDA has made substantial revisions and updates to the 1999 draft guidance and is reissuing it for comment as this Level 1 draft guidance.
This guidance document explains: (1) What constitutes a manufacturing site change and when a manufacturer should submit a PMA supplement for a site change; (2) what documentation a manufacturer should submit in the site change supplement; and (3) the general factors that FDA intends to consider when determining whether to conduct an establishment inspection prior to approval of a site change supplement. This guidance is intended to help industry decide when a change in manufacturing site should be submitted in a PMA site change supplement. The guidance is also intended to help industry predict when a preapproval inspection in connection with a PMA supplement for a manufacturing site change will likely be needed to evaluate the firm's implementation of Quality System regulation requirements, 21 CFR part 820. As a result, this guidance should help manufacturers manage the timeframes associated with implementing the changes in the manufacturing site and any processes, methods, procedures, qualifications, and validations.
Please note that this guidance only applies to a manufacturer of a device with an approved PMA, a product development protocol, or a humanitarian device exemption. This guidance does not address manufacturing site changes for devices cleared under premarket notification (510(k)) submissions.
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on manufacturing site change supplements' content and submission. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative
Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the Internet. A search capability for all CDRH guidance documents is available at
This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 814, subparts B and E have been approved under OMB control number 0910-0231; the collections of information in 21 CFR part 814, subpart H have been approved under OMB control number 0910-0332; and the collections of information in 21 CFR part 820 have been approved under OMB control number 0910-0073.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a collection of information entitled “Administrative Practices and Procedures; Formal Evidentiary Public Hearing” has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
On May 12, 2015, the Agency submitted a proposed collection of information entitled “Administrative Practices and Procedures; Formal Evidentiary Public Hearing” to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0191. The approval expires on September 30, 2018. A copy of the supporting statement for this information collection is available on the Internet at
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 21, 2015.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION”. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
The guidance document entitled “Guidance for Industry and Food and Drug Administration Staff; Center for Devices and Radiological Health Appeals Processes” describes the processes available to outside stakeholders to request additional review of decisions or actions by CDRH employees. FDA is seeking approval for the new reporting burden associated with requests for additional review of decisions and actions by CDRH employees as described in the guidance.
Individuals outside of FDA who disagree with a decision or action taken by CDRH and wish to have it reviewed or reconsidered have several processes for resolution from which to choose, including: Requests for supervisory review of an action; petitions; and hearings. Of these, by far the most commonly used is a request for supervisory review under 21 CFR 10.75 (a “10.75 appeal”). Section 517A of the FD&C Act, added by section 603 of the FDA Safety and Innovation Act of 2012, includes new requirements pertaining to the process and timelines for 10.75 appeals of “significant decisions” regarding 510(k) premarket notifications, applications for premarket approvals (PMAs), and applications for investigational device exemptions (IDEs).
A request for review under section 10.75 should be based on the information that was already present in the administrative file at the time of the decision that is being reviewed as provided in 21 CFR 10.75(d). New section 517A of the FD&C Act refers to significant decisions regarding the information in the administrative file for premarket notifications (section 510(k)); PMAs (section 515); and IDEs (section 520(g)) submissions is collected under existing regulations which specify the information manufacturers must submit so that FDA may properly evaluate the safety and effectiveness of medical devices. The information collections associated with these regulations are currently approved by the Office of Management and Budget as follows: The collections of information in 21 CFR part 807, subpart E (premarket notification) have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 814 (premarket approval) have been approved under OMB control number 0910-0231; and the collections of information in 21 CFR part 812 (investigational device exemption) have been approved under OMB control number 0910-0078.
While CDRH already possesses in the administrative file the information that would form the basis of a decision on a matter under appeal, the submission of particular information regarding the request itself and the data and information relied on by the requestor in the appeal would facilitate timely resolution of the decision under review. The guidance describes the collection of information not expressly specified under existing regulations: The submission of the request for review, minor clarifications as part of the request, and supporting information.
FDA estimates the burden of this collection of information as follows:
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 21, 2015.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions”.
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION”. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal
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.
The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Pub. L. 107-250) was signed into law on October 26, 2002. Section 201 of MDUFMA added a new paragraph (g) to section 704 of the Federal, Food, Drug, and Cosmetic Act (21 U.S.C. 374), directing FDA to accredit third parties (accredited persons) to conduct inspections of eligible manufacturers of class II or class III devices. FDA's guidance document entitled “Implementation of the Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002; Accreditation Criteria” provides information for those interested in participating in this voluntary program.
FDA estimates the burden of this collection of information as follows:
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the President's Advisory Council on Faith-based and Neighborhood Partnerships announces the following meetings:
Name: President's Advisory Council on Faith-based and Neighborhood Partnerships Council Meetings
Time and Date: Thursday, November 5th, 2015 1:00 p.m.-4:30 p.m. (EST) and Friday, November 6th, 2015 9:30 a.m.-12:30 p.m. (EST)
Place: Meeting will be held at a location to be determined in the White House complex, 1600 Pennsylvania Ave. NW., Washington, DC. Space is extremely limited. Photo ID and RSVP are required to attend the event. Please RSVP to Ben O'Dell at
The meeting will be available to the public through a conference call line. Register to participate in the conference call on Thursday, November 5th at the Web site
Status: Open to the public, limited only by space available. Conference call limited only by lines available.
Purpose: The Council brings together leaders and experts in fields related to the work of faith-based and neighborhood organizations in order to: Identify best practices and successful modes of delivering social services; evaluate the need for improvements in the implementation and coordination of public policies relating to faith-based and other neighborhood organizations; and make recommendations for changes in policies, programs, and practices.
Contact Person for Additional Information: Please contact Ben O'Dell for any additional information about the President's Advisory Council meeting at
Agenda: More information for the agenda for the meeting will be provided to those who register to attend in person or by conference call.
Public Comment: There will be an opportunity for public comment at the end of the meeting. Comments and questions can be sent in advance to
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 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
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.
15 U.S.C. 3719.
The National Heart, Lung, and Blood Institute (NHBLI), a component of the National Institutes of Health (NIH) announces the “Novel, Innovative Tools to Increase Public Awareness and Knowledge of Sickle Cell Disease Undergraduate Challenge” to help address the lack of awareness about sickle cell disease and its associated complications and to improve successful implementation of effective interventions for sickle cell disease (SCD) in real world settings. In addition, by directing the Challenge at undergraduate students, the Challenge also aims to advance the field of implementation science through research training, mentoring, and highlighting the contributions of a new generation of undergraduate researchers using a systems science approach to address multi-faceted problems.
The Challenge begins October 21, 2015. Submission Period: November 30, 2015 to March 7, 2016, 11:59 p.m. PDT, Judging Period: March 14, 2016 to March 25, 2016, Winners Notified by email: April 5, 2016, Winners Announced: April 19, 2016.
Helena O. Mishoe, Ph.D., MPH, Associate Director for Research Training and Diversity, (email:
Sickle cell disease is the most common genetic disorder in the United States. About 100,000 Americans are thought to be living with SCD, and each year another 1,000 babies are born with the disease. Sickle cell disease is an inherited disease that results in abnormal hemoglobin, the protein in human red blood cells that carries oxygen to all tissues in the body. Hemoglobin is essential for life. A specific single mutation in the gene (DNA) for hemoglobin, when inherited from both parents, causes SCD. The sickle hemoglobin distorts the shape of the red blood cell into a `sickle' or crescent moon shape that flows poorly through small blood vessels. This can cause problems in virtually any organ by reducing the delivery of oxygen and inflaming the surrounding tissue. These abnormal sickle cells usually die after only about 10 to 20 days (as compared to normal red blood cells that live about 120 days). Over time, organ damage occurs, possibly resulting in a stroke in the brain, kidney damage, or complications in other organ systems. SCD also causes significant pain in the affected tissues. This pain, which can begin in childhood, often escalates as adulthood approaches, severely affecting the quality of life of individuals with SCD. Sickle cell disease not only affects the individual but also his or her family and communities.
There is a lack of awareness about SCD and its associated complications among the general public and affected communities. This unawareness can contribute to the stigma associated with SCD, the lack of understanding of how the disease affects individuals and families' daily lives, and to less than optimal care experienced by many patients. To help address this problem, the NHLBI is launching the “Novel, Innovative Tools to Increase Public Awareness and Knowledge of Sickle Cell Disease Undergraduate Challenge” (the “Challenge”) to incentivize the development of innovative information dissemination tools that may be used to (i) increase the general public's awareness of SCD; (ii) provide information on SCD and its complications to individuals, caregivers, families, and communities affected by SCD in an easily comprehensible
Statutory Authority of the Funding Source: The general purpose of the NHLBI is the conduct and support of research, training, health information dissemination, and other programs with respect to heart, blood vessel, lung, and blood diseases and with respect to the use of blood and blood products and the management of blood resources. Sections 418 and 420 of the Public Health Service Act (42 U.S.C. 285b, 285b-2). This Challenge is consistent with and advances the mission of the NHLBI and its Center for Translation Research and Implementation Science. Among other things, this Center (1) plans, fosters, and supports an integrated and coordinated program of research to understand the multi-level processes and factors that are associated with successful integration of evidence-based interventions within specific clinical and public health settings such as worksites, communities, and schools; and (2) identifies and makes readily available to implementation and dissemination practitioners emergent knowledge about the late phases of translation research, especially for rapid and sustained adoption of effective interventions in real world settings. Funds for the Challenge have been provided by contributions to the NHLBI Gift Fund that are accepted under the authority established in Sections 231, 405(b)(1)(H), and 497 of the Public Health Service (PHS) Act, as amended (42 U.S.C. 238, 284(b)(1)(H), and 289f).
Subject of the Challenge: Through this Challenge, the NHLBI is challenging undergraduate students to create novel, innovative information dissemination tools that may be used to increase the general public's awareness of SCD, provide information on SCD and its complications (particularly pain) to individuals, caregivers, families, and communities affected by SCD in an easily comprehensible manner, and that may lead to rapid and sustained adoption of effective interventions for SCD in real world settings.
More specifically, the goals of the Challenge are to: (1) Generate novel, innovative tools that may be used to increase public awareness and knowledge of SCD and associated complications that could potentially improve patient care; (2) advance the field of implementation science through research training, mentoring, and highlighting the contributions of a new generation of undergraduate researchers using a systems science approach to address multi-faceted problems; and (3) encourage “team science” by providing undergraduate students valuable experiences to pursue science collectively as they engage in complex problem solving to improve health outcomes for SCD.
Rules for Participating in the Challenge: This Challenge is open to any “Student Team”, defined as a group of at least 3 and not more than 5 individuals each of whom is at least 18 years of age and currently enrolled as a full-time student pursuing a bachelor's or associates degree.
The Student Team must also be trans-disciplinary, that is, composed of undergraduate students from diverse disciplines such as fine arts, performing arts, humanities, psychology, science, engineering, graphic design, IT (hardware, software), mathematics, statistics, environmental science, computational modeling and others.
To participate in and be eligible to win the Challenge, the Student Team must also:
a. Have an individual from the teaching staff at the Academic Institution as a mentor to the team. The mentor should hold the position as a Professor, Associate Professor, Assistant Professor, Instructor, or a Teaching Assistant within the same Academic Institution as the Student Team. The teaching staff member can mentor only one team; however, a team may have more than one mentor (co-mentors may be located at a different institution);
b. Agree to submit only one entry into this Challenge through one student member of the Student Team appointed as “Team Captain” by that Student Team. The Team Captain will carry out all correspondence with NHLBI regarding the Student Team's entry. The Team Captain must be a citizen or permanent resident of the United States;
c. On behalf of the Student Team, the Team Captain must certify the Student Team's eligibility as part of the online submission process; and
d. Agree that the Student Team's mentor(s) shall not be eligible to share in the prize.
In addition, the following rules apply:
(1) To be eligible to win a prize under this Challenge, an individual or team—
a. Shall have registered to participate in the Challenge under the rules promulgated by the Department of Health and Human Services (HHS), National Heart, Lung, and Blood Institute (NHLBI), Center for Translation Research and Implementation Science (CTRIS), as published in this Notice;
b. Shall have complied with all the requirements set forth in this Notice;
c. In the case of a private entity, shall be incorporated in and maintain a primary place of business in the United States;
d. In the case of an individual, shall be a citizen or permanent resident of the United States. The Student Team Captain must be a citizen or permanent resident of the United States. However, the Student Team may include undergraduate students who are foreign citizens and/or non-permanent U.S. residents who are studying in the United States on a valid visa if such students satisfy all the other criteria. Foreign students, if part of the winning Student Team, will not receive a monetary prize or be reimbursed for any costs associated with attending the annual NHLBI/National Sickle Cell Disease meeting (August 2016) to present and demonstrate the winning entry. As acknowledgement of their participation, however, the names of foreign students who are part of a winning Student Team will be listed among the winning team members when results are announced and at the annual NHLBI/National Sickle Cell Disease meeting;
e. May not be a Federal entity;
f. May not be a Federal employee acting within the scope of the employee's employment and further, in the case of HHS employees, may not work on their submission(s) during assigned duty hours;
g. May not be an employee of the NIH, a judge of the Challenge, or any other party involved with the design, production, execution, or distribution of the Challenge or the immediate family of such a party (
h. Agrees to abide by all applicable local, state, and federal laws, regulations, and policies.
(2) Federal grantees may not use Federal funds to develop their Challenge submissions unless use of such funds is consistent with the purpose of their grant award and specifically requested to do so due to the Challenge design.
(3) Federal contractors may not use Federal funds from a contract to develop their Challenge submissions or to fund efforts in support of their Challenge submission.
(4) Submissions must not infringe upon any copyright or any other rights of any third party.
(5) By participating in this Challenge, each individual and team agrees to assume any and all risks and waives any and all claims against the Federal government and its “related entities” (as defined in the COMPETES Act), except in the case of willful misconduct, for
(6) Based on the subject matter of the Challenge, the type of work that it will possibly require, as well as an analysis of the likelihood of any claims for death, bodily injury, property damage, or loss potentially resulting from Challenge participation, no individual or team participating in the Challenge is required to obtain liability insurance or demonstrate financial responsibility in order to participate in this Challenge.
(7) By participating in this Challenge, each individual and team agrees to indemnify the Federal government against third party claims for damages arising from or related to Challenge activities.
(8) An individual or team shall not be deemed ineligible because the individual or team used Federal facilities or consulted with Federal employees during the Challenge if the facilities and employees are made available to all individuals and team participating in the Challenge on an equitable basis.
(9) By participating in this Challenge, each individual and team grants to the NIH and NHLBI an irrevocable, paid-up, royalty-free nonexclusive worldwide license to post, link to, share, sublicense, and display publicly on the Web the team's submission. Each individual and team will retain all other intellectual property rights in their submissions, as applicable.
(10) NIH and the NHLBI reserves the right, in its sole discretion, to (a) cancel, suspend, or modify the Challenge, and/or (b) not award any prizes if no entries are deemed worthy.
(11) Each individual (whether participating singly or in a group) or entity agrees to follow all applicable federal, state, and local laws, regulations, and policies.
(12) Each individual (whether participating singly or in a group) and entity participating in this Challenge must comply with all terms and conditions of these rules, and participation in this Challenge constitutes each such participant's full and unconditional agreement to abide by these rules. Winning is contingent upon fulfilling all requirements herein.
Registration and Submission Process for Student Teams: To register and enter a submission for this Challenge, the Team Captain can: Access the
Alternatively, the Team Captain can go directly to
Submission Requirements: Each Student Team must submit a creative and innovative information dissemination tool, using any combination of media that is designed to reach out to the public to inform and increase awareness of sickle cell disease (SCD) and lead to rapid and sustained adoption of effective interventions for SCD in real world settings. Examples of such information dissemination tools include, but are not limited to, a video, a software application, a game, a Web site, a marketing campaign, a social media campaign, a grass roots campaign, or an exhibit. All materials must be written or composed in English. A complete submission is defined as follows:
• The fully functional tool or software application (“tool”) developed and tested by the Student Team. The Student Team must provide NHLBI with continuous access to the tool after submission and until winners are announced. As applicable, include a detailed description of the tool, instructions on how to install and operate it, and system requirements. The tool must be designed for use with the most widely-available computing platforms: including, but not limited to: Windows-based Operating Systems; Mac OSX; iOS mobile computing platforms, and Android mobile computing platforms.
• A written entry (not to exceed 6 pages) that clearly and concisely includes the following:
○ A concise and informative title (150 characters or less).
○ A description of the tool, why it is innovative, the problem that the tool addresses, and the expected outcomes (goals) of using the tool.
○ A summary of the science and/or technology underlying the tool and its development.
○ A description of how the tool was tested among the population(s) of interest (
○ A description of the populations/communities involved in the test. Tools that include proposals on how to reach a range of users, including those with disabilities and underserved populations are encouraged.
○ Preliminary data describing the outcome(s) of testing the tool in the population(s) of interest and whether the tool met the anticipated goals. Were any outcomes unanticipated and what can be learned from them? What challenges or barriers were faced and what improvements could be made?
• A video (not to exceed two (2) minutes) that clearly articulates the problem and how the Student Team's submission addresses the problem. The video must deliver a clear and understandable message using non-technical language, have a unified voice, and emphasize new methods and insights not provided in the written submission to create a novel presentation while telling a compelling story, be visually striking, and edited to a high standard. Participants should be aware that this short video is required even if the tool described above is also a video.
• A set of seven (7) slides in PDF format that describes the submission. Address the judging criteria and describe the key features of the submission as they relate to the goals of the Challenge.
In addition, the submission must not use HHS, NIH, or NHLBI logos or official seals and must not claim endorsement.
Student Teams may be required to make their proposed solution compliant with Section 508 accessibility and usability requirements at their own
Amount of the Prize; Award Approving Official: The Award Approving Official will be the Director of the NHLBI. The NHLBI may select up to three winners to receive a monetary prize. Any money awarded to a winning Student Team will be distributed equally among the Student Team's eligible undergraduate students. The Student Team Captain must be a citizen or permanent resident of the United States. Mentors and any team members that do not meet the applicable citizenship/residency requirements will not be eligible to receive any monetary prize award and will not be reimbursed for meeting registration or travel expenses to the annual NHLBI/National Sickle Cell Disease meeting (August 2016), as discussed below.
• 1st Prize—$7,000 with up to an additional $2,000 to reimburse the Student Team for eligible expenses to register for and travel to the annual NHLBI/National Sickle Cell Disease meeting to present and demonstrate its winning entry.
• 2nd Prize—$5,000 with up to an additional $2,000 to reimburse the Student Team for eligible expenses to register and travel to the annual NHLBI/National Sickle Cell Disease meeting to present and demonstrate its winning entry.
• 3rd Prize—$3,000 with up to an additional $2,000 to reimburse the Student Team for eligible expenses to register and travel to the annual NHLBI/National Sickle Cell Disease meeting to present and demonstrate its winning entry.
• Up to three Student Teams may also receive “Honorable Mentions” but no monetary prize, or support to register and travel to the annual NHLBI/National Sickle Cell Disease meeting will be provided. “Honorable Mentions” winning entries will be recognized on the NHLBI Web site and/or other media venues.
Payment of the Prize: Prizes awarded under this Challenge will be paid by electronic funds transfer and may be subject to Federal income taxes. HHS/NIH will comply with the Internal Revenue Service withholding and reporting requirements, where applicable.
Basis upon Which Submissions Will be Evaluated: Five to seven Federal employees will serve as judges. They could include members from any NHLBI Extramural Division/Office/Center, the Division of Intramural Research, and other NIH Federal employees. Each submission will be rated on the following criteria:
Significance (20 points): Potential impact and significance of the submission to improve public awareness and knowledge about SCD and associated complications and the successful implementation of effective interventions for SCD in real world settings. This must include scientifically accurate information.
Innovation (25 points): Submission is an innovative and creative information management tool that is:
Usability and design (25 points): User friendliness and user comprehension
Quality of pilot test and outcomes (30 points): Assess approach and feasibility
The NHLBI reserves the right to disqualify a submission if the tool fails to function as expressed in the description provided by the submitting Student Team or if the tool provides inaccurate or incomplete information. Submissions must be free of malware. The NHLBI may test the tool to determine whether malware or other security threats may be present and reserves the right to disqualify the submission if, in NHLBI's judgment, the tool may damage government or others' equipment or operating environment.
U.S. Customs and Border Protection, Department of Homeland Security.
Notice of final determination.
This document provides notice that U.S. Customs and Border
The final determination was issued on October 15, 2015. A copy of the final determination is attached. Any party-at-interest, as defined in 19 CFR 177.22(d), may seek judicial review of this final determination no later than November 20, 2015.
Grace A. Kim, Valuation and Special Programs Branch, Regulations and Rulings, Office of International Trade (202) 325-7941.
Notice is hereby given that on October 15, 2015 pursuant to subpart B of Part 177, U.S. Customs and Border Protection Regulations (19 CFR part 177, subpart B), CBP issued a final determination concerning the country of origin of certain billiards tables, which may be offered to the U.S. Government under an undesignated government procurement contract. This final determination, HQ H268491, was issued under procedures set forth at 19 CFR part 177, subpart B, which implements Title III of the Trade Agreements Act of 1979, as amended (19 U.S.C. 2511-18). In the final determination, CBP concluded that, based upon the facts presented, the assembly and installation processes performed in the United States, using imported components, substantially transform the imported components into billiards tables. Therefore, the country of origin of the billiards tables is the United States for purposes of U.S. Government procurement.
Section 177.29, CBP Regulations (19 CFR 177.29), provides that a notice of final determination shall be published in the
This is in response to your letter, dated August 12, 2015, requesting a final determination on behalf of The Brunswick Corporation (“Company”), pursuant to subpart B of part 177 of the U.S. Customs and Border Protection (“CBP”) Regulations (19 CFR part 177). Under these regulations, which implement Title III of the Trade Agreements Act of 1979 (“TAA”), as amended (19 U.S.C. 2511
This final determination concerns the country of origin of the Company's four billiards tables. We note that as a U.S. manufacturer, the Company is a party-at-interest within the meaning of 19 CFR 177.22(d)(1) and is entitled to request this final determination. Diagrams of the tables were submitted with your request.
There are four families of billiards tables at issue: Centurion (“Table A”), Metro (“Table B”), Gold Crown V (“Table C”), and Black Wolf II (“Table D”) (collectively “tables”). The tables are designed and developed in the U.S. and each table is produced in the U.S. from components and subassemblies sourced from various countries, including the U.S. Due to the size and weight of each table, the Company ships the individual components to the U.S. customers' location and assembles the tables on-site. The assembly and installation of the tables must be performed by certified Company installers who are employed and extensively trained by licensed U.S.-based Company dealers.
The assembly of Table A consists of the following: 1) assembly of base frame and legs, 2) slate assembly, 3) attachment of billiard cloth to slate, 4) assembly of rail and apron, and 5) assembly of the gully return system
Table B has a different design than Table A and is higher in quality. The assembly of Table B is the same as Table A, except that step 4 involves the attachment of rail cloth, and the billiard cloth is also not pre-installed on the rail cushions prior to delivery. There are approximately 71 steps and 82 parts. After the billiard cloth is attached to the slate, the installers must wrap the rail cushions in billiard cloth. The loose billiard cloth is draped over each of the six rails and a wooden feather strip (same length of the rail) is pounded into place to affix the billiard cloth to the rail and excess cloth is trimmed. After the six rails are wrapped, the rails and apron are installed on the table and the bed spot is affixed. The assembly of Table B requires the same time as assembly of Table A, but an additional 2 hours to wrap all six rails. The installation cost combined with the value of U.S. components, amounts to 35.3% of the total cost. Other components are sourced from Brazil, Indonesia and Taiwan.
Table C is very similar to Table B, but due to the different design and materials, the assembly process is claimed to be more complex and costly. Specifically, the assembly of the rails and pocket castings requires shimming and alignment to ensure a quality fit. The assembly of the apron is also more complex due to Table C's higher fit and finish, and inclusion of corner castings and a ball storage box. There are approximately 77 steps and 91 parts. The assembly of Table C requires the same amount of time to assemble as Table B. The installation cost combined with the value of U.S. components, amounts to 28.7% of the total cost. Other components are sourced from Brazil, Indonesia, and Taiwan.
The assembly of Table D is similar to Table A, with the exception of delineation of the rail and apron assembly process. There are approximately 60 steps and 71 parts. While Table D is similar to the other tables in this request, Table D is unique because it requires the complete assembly of both legs. The assembly of Table D requires an average of 8 man hours and two certified installers. Since the rails are pre-wrapped, only an additional 45 minutes are required to level the table. The installation cost combined with the value of U.S. components, amounts to 49.4% of the total cost. Other components are sourced from Brazil, Indonesia, Vietnam, and Taiwan.
What is the country of origin of the four billiards tables for purposes of U.S. government procurement?
Pursuant to subpart B of part 177, 19 CFR 177.21
Under the rule of origin set forth under 19 U.S.C. 2518(4)(B):
An article is a product of a country or instrumentality only if (i) it is wholly the growth, product, or manufacture of that country or instrumentality, or (ii) in the case of an article which consists in whole or in part of materials from another country or instrumentality, it has been substantially transformed into a new and different article of commerce with a name, character, or use distinct from that of the article or articles from which it was so transformed.
In rendering advisory rulings and final determinations for purposes of U.S. government procurement, CBP applies the provisions of subpart B of part 177 consistent with the Federal Acquisition Regulations.
48 CFR 25.003.
In order to determine whether a substantial transformation occurs when components of various origins are assembled into completed products, CBP considers the totality of the circumstances and makes such determinations on a case-by-case basis. The country of origin of the item's components, extent of the processing that occurs within a country, and whether such processing renders a product with a new name, character, and use are primary considerations in such cases. Additionally, factors such as the resources expended on product design and development, extent and nature of post-assembly inspection and testing procedures, and the degree of skill required during the actual manufacturing process may be relevant when determining whether a substantial transformation has occurred. No one factor is determinative.
In
In Headquarters Ruling Letter (“HQ”) W563456, dated July 31, 2006, CBP held that certain office chairs assembled in the U.S. were products of the U.S. for purposes of U.S. government procurement. The office chairs were assembled from over 70 U.S. and foreign components. In finding that the imported parts were substantially transformed in the U.S., CBP stated that the assembly processes that occurred in the U.S. were complex and meaningful, required the assembly of a large number of components, and rendered a new and distinct article of commerce that possessed a new name, character, and use. CBP noted that the U.S.-origin seat and back frame assemblies, which were made with the importer's trademark fabric, together with the tilt assembly, were of U.S. origin and gave the chair its unique design profile and essential character. In HQ 561258, dated April 15, 1999, CBP determined that the assembly of numerous imported workstation components with the U.S.-origin work surface into finished workstations constituted a substantial transformation. CBP held that the imported components lost their identity as leg brackets, drawer units, panels etc. when they were assembled together to form a workstation. In HQ H083693, dated March 23, 2010, CBP held that a certain wood chest assembled in the U.S. was a product of the U.S. for purposes of U.S. government procurement. The wood chest was assembled from over twenty U.S. and foreign components in a twenty-step process which took approximately forty-one minutes. CBP held that the components used to manufacture the wood chest, when combined with a U.S. origin laminate top, were substantially transformed as a result of the assembly operations performed in the U.S.
In the instant case, the tables' components range from 71 to 91 which can only be assembled by two skilled installers, operating under the control and training of the Company and its authorized network of dealers. The assembly of the components requires the installers to maintain proper leveling throughout, while building different parts of the billiards table, which is essential to the ball running true during play. We find that the assembly processes that occur in the U.S. are complex and meaningful, require the assembly of a large number of components, and render a new and distinct article of commerce that possesses a new name, character, and use. Therefore, we find that the imported components lose their individual identities and become an integral part of the billiards tables as a result of the U.S. assembly operations and combination with U.S. components; and that the components acquire a different name, character, and use as a result of the assembly operations performed in the U.S. While not dispositive, we note, in addition, that the engineering, design, and development of the tables occur in the U.S. Accordingly, the assembled billiards tables will be considered products of the U.S. for purposes of U.S. Government procurement.
Based on the facts of this case, we find that the country of origin of all four billiards tables is the U.S. for purposes of U.S. Government procurement. Notice of this final determination will be given in the
U.S. Customs and Border Protection, Department of Homeland Security.
General notice.
This document announces U.S. Customs and Border Protection's (CBP's) plan to modify the National Customs Automation Program (NCAP) test concerning the Entry Summary, Accounts and Revenue (ESAR) test program in the Automated Commercial Environment (ACE) to allow importers and brokers to file electronically entry summary data for entry types 51 and 52, in addition to entry types 01, 03, and 11 that are already available for electronic filing, for merchandise arriving by truck, rail, vessel, and air, as well as arriving by mail, pedestrian, and passenger (hand-carried).
The ACE ESAR test modifications set forth in this document will begin on or about November 20, 2015. This test will continue until concluded by way of a document published in the
Comments concerning this notice and any aspect of this test may be submitted at any time during the test via email to Josephine Baiamonte, Director, Business Transformation, ACE Business Office, Office of International Trade at
For technical questions related to the Automated Commercial Environment (ACE) or Automated Broker Interface (ABI) transmissions, contact your assigned client representative. Interested parties without an assigned client representative should direct their questions to Steven Zaccaro at
The National Customs Automation Program (NCAP) was established by Subtitle B of Title VI—Customs Modernization (Customs Modernization Act), in the North American Free Trade Agreement Implementation Act, Public Law 103-182, 107 Stat. 2057 (19 U.S.C. 1411). Through NCAP, the initial thrust of customs modernization was on trade compliance and the development of the Automated Commercial Environment (ACE), the planned successor to the Automated Commercial System (ACS). ACE is an automated and electronic system for processing commercial trade data which is intended to streamline business processes, facilitate growth in trade, ensure cargo security, and foster participation in global commerce, while ensuring compliance with U.S. laws and regulations and reducing costs for U.S. Customs and Border Protection (CBP) and all of its communities of interest. The ability to meet these objectives depends on successfully modernizing CBP's business functions and the information technology that supports those functions.
CBP's modernization efforts are accomplished through phased releases of ACE component functionality designed to replace specific legacy ACS functions. Each release will begin with a test and, if the test is successful, will end with the mandatory use of the new ACE feature, thus retiring the legacy ACS function. Each release builds on previous releases and sets forth the foundation for subsequent releases.
For the convenience of the public, a chronological listing of
The Customs Modernization Act provides the Commissioner of CBP with authority to conduct limited test programs or procedures designed to evaluate planned components of the NCAP. The ACE ESAR Test, as modified in this notice, is authorized pursuant to § 101.9(b) of title 19 of the Code of Federal Regulations (19 CFR 101.9(b)), which provides for the testing of NCAP programs or procedures.
On October 18, 2007, CBP published a General Notice in the
This notice announces that CBP will modify the ESAR test in order to allow brokers and importers, who are also ACE participants, to file electronically, for air, ocean, rail, and truck modes of transportation, as well as for mail, pedestrian, and passenger (hand-carried) modes of transportation, the ACE entry summary for entry type 51 (
Importer and broker volunteers who wish to participate in this test must have an ACE Portal Account (
(1) Use statement or single pay for payment processing; and
(2) Use a software package that has completed ABI certification testing for ACE.
Test participants must meet all the eligibility criteria described in this document in order to participate in the test program.
The ACE ESAR test is open to all importers and customs brokers filing ACE Entry Summaries for cargo
Applicants will be notified by a CBP client representative if they have been selected to participate in this test.
The filing capabilities and functionalities for the ACE ESAR tests that were set forth in previous
This ACE Entry Summary, Accounts and Revenue test, as modified, will begin on or about November 20, 2015. This test will conclude by way of a document published in the
All interested parties are invited to comment on any aspect of this test at any time. CBP requests comments and feedback on all aspects of this test, including the design, conduct and implementation of the test, in order to determine whether to modify, alter, expand, limit, continue, end, or fully implement this program.
For purposes of this test, any provision in title 19 of the Code of Federal Regulations including, but not limited to, the provisions found in parts 141, 142, 143, and 149 thereof relating to entry summary filing and processing that are inconsistent with the requirements set forth in this notice are waived for the duration of the test.
All requirements, terms and conditions, and aspects of the ACE test discussed in previous notices are hereby incorporated by reference into this notice and continue to be applicable, unless changed by this notice.
The collection of information contained in this ACE Entry Summary, Accounts and Revenue test has been approved by the Office of Management and Budget (OMB) in accordance with the requirements of the Paperwork Reduction Act (44 U.S.C. 3507) and assigned OMB control number 1651-0022. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by OMB.
All data submitted and entered into ACE is subject to the Trade Secrets Act (18 U.S.C. 1905) and is considered confidential, except to the extent as otherwise provided by law. As stated in previous notices, participation in this or any of the previous ACE tests is not confidential and upon a written Freedom of Information Act (FOIA) request, a name(s) of an approved participant(s) will be disclosed by CBP in accordance with 5 U.S.C. 552.
A test participant may be subject to civil and criminal penalties, administrative sanctions, liquidated damages, or discontinuance from participation in this test for any of the following:
(1) Failure to follow the terms and conditions of this test;
(2) Failure to exercise reasonable care in the execution of participant obligations;
(3) Failure to abide by applicable laws and regulations that have not been waived; or
(4) Failure to deposit duties or fees in a timely manner.
If the Director, Business Transformation, ACE Business Office (ABO), Office of International Trade, finds that there is a basis for discontinuance of test participation privileges, the test participant will be provided a written notice proposing the discontinuance with a description of the facts or conduct warranting the action. The test participant will be offered the opportunity to appeal the Director's decision in writing within 10 calendar days of receipt of the written notice. The appeal must be submitted to Acting Executive Director, ABO, Office of International Trade, by emailing
The Acting Executive Director will issue a decision in writing on the proposed action within 30 working days after receiving a timely filed appeal from the test participant. If no timely appeal is received, the proposed notice becomes the final decision of the Agency as of the date that the appeal period expires. A proposed discontinuance of a test participant's privileges will not take effect unless the appeal process under this paragraph has been concluded with a written decision adverse to the test participant.
In the case of willfulness or those in which public health, interest, or safety so requires, the Director, Business Transformation, ABO, Office of International Trade, may immediately discontinue the test participant's privileges upon written notice to the test participant. The notice will contain a description of the facts or conduct warranting the immediate action. The test participant will be offered the opportunity to appeal the Director's decision within 10 calendar days of receipt of the written notice providing for immediate discontinuance. The appeal must be submitted to Acting Executive Director, ABO, Office of International Trade, by emailing
A chronological listing of
• ACE Portal Accounts and Subsequent Revision Notices: 67 FR 21800 (May 1, 2002); 69 FR 5360 and 69 FR 5362 (February 4, 2004); 69 FR 54302 (September 8, 2004); 70 FR 5199 (February 1, 2005).
• ACE System of Records Notice: 71 FR 3109 (January 19, 2006).
• Terms/Conditions for Access to the ACE Portal and Subsequent Revisions: 72 FR 27632 (May 16, 2007); 73 FR 38464 (July 7, 2008).
• ACE Non-Portal Accounts and Related Notice: 70 FR 61466 (October 24, 2005); 71 FR 15756 (March 29, 2006).
• ACE Entry Summary, Accounts and Revenue (ESAR I) Capabilities: 72 FR 59105 (October 18, 2007).
• ACE Entry Summary, Accounts and Revenue (ESAR II) Capabilities: 73 FR 50337 (August 26, 2008); 74 FR 9826 (March 6, 2009).
• ACE Entry Summary, Accounts and Revenue (ESAR III) Capabilities: 74 FR 69129 (December 30, 2009).
• ACE Entry Summary, Accounts and Revenue (ESAR IV) Capabilities: 76 FR 37136 (June 24, 2011).
• Post-Entry Amendment (PEA) Processing Test: 76 FR 37136 (June 24, 2011).
• ACE Announcement of a New Start Date for the National Customs Automation Program Test of Automated Manifest Capabilities for Ocean and Rail Carriers: 76 FR 42721 (July 19, 2011).
• ACE Simplified Entry: 76 FR 69755 (November 9, 2011).
• National Customs Automation Program (NCAP) Tests Concerning Automated Commercial Environment (ACE) Document Image System (DIS): 77 FR 20835 (April 6, 2012).
• National Customs Automation Program (NCAP) Tests Concerning Automated Commercial Environment (ACE) Simplified Entry: Modification of Participant Selection Criteria and Application Process: 77 FR 48527 (August 14, 2012).
• Modification of NCAP Test Regarding Reconciliation for Filing Certain Post-Importation Preferential Tariff Treatment Claims under Certain FTAs: 78 FR 27984 (May 13, 2013).
• Modification of Two National Customs Automation Program (NCAP) Tests Concerning Automated Commercial Environment (ACE) Document Image System (DIS) and Simplified Entry (SE): 78 FR 44142 (July 23, 2013).
• Modification of Two National Customs Automation Program (NCAP) Tests Concerning Automated Commercial Environment (ACE) Document Image System (DIS) and Simplified Entry (SE); Correction: 78 FR 53466 (August 29, 2013).
• Modification of NCAP Test Concerning Automated Commercial Environment (ACE) Cargo Release (formerly known as Simplified Entry): 78 FR 66039 (November 4, 2013).
• Post-Summary Corrections to Entry Summaries Filed in ACE Pursuant to the ESAR IV Test: Modifications and Clarifications: 78 FR 69434 (November 19, 2013).
• National Customs Automation Program (NCAP) Test Concerning the Submission of Certain Data Required by the Environmental Protection Agency and the Food Safety and Inspection Service Using the Partner Government Agency Message Set Through the Automated Commercial Environment (ACE): 78 FR 75931 (December 13, 2013).
• Modification of National Customs Automation Program (NCAP) Test Concerning Automated Commercial Environment (ACE) Cargo Release for Ocean and Rail Carriers: 79 FR 6210 (February 3, 2014).
• Modification of National Customs Automation Program (NCAP) Test Concerning Automated Commercial Environment (ACE) Cargo Release to Allow Importers and Brokers to Certify From ACE Entry Summary: 79 FR 24744 (May 1, 2014).
• Modification of National Customs Automation Program (NCAP) Test Concerning Automated Commercial Environment (ACE) Cargo Release for Truck Carriers: 79 FR 25142 (May 2, 2014).
• Modification of National Customs Automation Program (NCAP) Test Concerning Automated Commercial Environment (ACE) Document Image System: 79 FR 36083 (June 25, 2014).
• Announcement of eBond Test: 79 FR 70881 (November 28, 2014).
• eBond Test Modifications and Clarifications: Continuous Bond Executed Prior to or Outside the eBond Test May Be Converted to an eBond by the Surety and Principal, Termination of an eBond by Filing Identification Number, and Email Address Correction: 80 FR 899 (January 7, 2015).
• Modification of National Customs Automation Program (NCAP) Test Concerning Automated Commercial Environment (ACE) Document Image System Relating to Animal and Plant Health Inspection Service (APHIS) Document Submissions: 80 FR 5126 (January 30, 2015).
• Modification of National Customs Automation Program (NCAP) Test Concerning the use of Partner Government Agency Message Set through the Automated Commercial Environment (ACE) for the Submission of Certain Data Required by the Environmental Protection Agency (EPA): 80 FR 6098 (February 4, 2015).
• Announcement of Modification of ACE Cargo Release Test to Permit the Combined Filing of Cargo Release and Importer Security Filing (ISF) Data: 80 FR 7487 (February 10, 2015).
• Modification of NCAP Test Concerning ACE Cargo Release for Type 03 Entries and Advanced Capabilities for Truck Carriers: 80 FR 16414 (March 27, 2015).
• Automated Commercial Environment (ACE) Export Manifest for Air Cargo Test; 80 FR 39790 (July 10, 2015).
• National Customs Automation Program (NCAP) Concerning Remote Location Filing Entry Procedures in the Automated Commercial Environment (ACE) and the Use of the Document Image System for the Submission of Invoices and the Use of eBonds for the Transmission of Single Transaction Bonds: 80 FR 40079 (July 13, 2015).
• Modification of National Customs Automation Program (NCAP) Test Concerning the Automated Commercial Environment (ACE) Partner Government Agency (PGA) Message Set Regarding Types of Transportation Modes and Certain Data Required by the National Highway Traffic Safety Administration (NHTSA): 80 FR 47938 (August 10, 2015).
• Modification of National Customs Automation Program (NCAP) Test Concerning the Submission of Certain Data Required by the Food and Drug Administration (FDA) Using the Partner Government Agency (PGA) Message Set Through the Automated Commercial Environment (ACE): 80 FR 52051 (August 27, 2015).
• Automated Commercial Environment (ACE) Export Manifest for Rail Cargo Test: 80 FR 54305 (September 7, 2015).
U.S. Customs and Border Protection, Department of Homeland Security.
General notice.
This document announces U.S. Custom and Border Protection's (CBP's) plan to modify the National
Except as stated below, the modification of the ACE Portal Account Test described in this notice is effective October 21, 2015. The testing of the AESDirect functionality described in this notice will begin no earlier than October 1, 2015. This modified test will continue until concluded by way of announcement in the
Comments concerning this notice and any aspect of the modified ACE Portal Account Test may be submitted at any time during the testing period via email to Josephine Baiamonte, ACE Business Office (ABO), Office of International Trade at
For technical questions related to the application or request for an ACE Portal Account contact the ACE Account Service Desk by calling 1-866-530-4172, selecting option 1, then option 2, or by emailing
The National Customs Automation Program (NCAP) was established by Subtitle B of Title VI—Customs Modernization in the North American Free Trade Agreement Implementation Act, Public Law 103-182, 107 Stat. 2057, 2170, December 8, 1993 (Customs Modernization Act). See 19 U.S.C. 1411. Through NCAP, the initial thrust of customs modernization was on trade compliance and the development of ACE, the planned successor to the Automated Commercial System (ACS). ACE is an automated and electronic system for commercial trade processing which is intended to streamline business processes, facilitate growth in trade, ensure cargo security, and foster participation in global commerce, while ensuring compliance with U.S. laws and regulations and reducing costs for CBP and all of its communities of interest. The ability to meet these objectives depends on successfully modernizing CBP's business functions and the information technology that supports those functions. CBP's modernization efforts are accomplished through phased releases of ACE component functionality designed to replace specific legacy ACS functions and add new functionality. Each release will begin with a test and, if the test is successful, will end with implementation of the functionality through the promulgation of regulations governing the new ACE feature and the retirement of the legacy ACS function.
For the convenience of the public, a chronological listing of
On May 1, 2002, the former U.S. Customs Service, now CBP, published a General Notice in the
Subsequent General Notices expanded the types of ACE Portal Accounts. On February 4, 2004, CBP published a General Notice in the
On May 16, 2007, CBP published a General Notice in the
On July 7, 2008, CBP published a General Notice in the
CBP has also permitted certain parties to participate in ACE without establishing ACE Portal Accounts,
AES is the electronic method for the U.S. Principal Party in Interest (USPPI) or its authorized agent to file export commodity and transportation information, known as Electronic Export Information (EEI), directly with CBP and the Census Bureau. EEI is the electronic equivalent to the Shipper's Export Declaration (SED), a paper form previously used by exporters to report export information.
On April 5, 2014, AES was re-engineered and incorporated into ACE. General information and a list of AES certified software vendors is available on the following Web site:
AES offers several options for transmitting export commodity and transportation data, which includes the choice of using software developed by the user, software purchased from a vendor, a Value Added Network (VAN) electronic mailbox, the facilities of a port authority or service center, or AESDirect, a free internet application supported by the Census Bureau. AESDirect came on-line in October 1999 and allows USPPIs or their authorized agents to file EEI free of charge using a variety of electronic transmission methods, the most popular of which is a web-based portal through which users may file any required EEI. AESDirect also provides USPPIs or their authorized agents with access to export reports that compile the data from EEI filings associated with a user account.
The Customs Modernization Act authorizes the Commissioner of CBP to conduct limited test programs or procedures designed to evaluate planned components of the NCAP. The ACE Portal Account Test, as modified in this notice, is authorized pursuant to § 101.9(b) of title 19 of the Code of Federal Regulations (19 CFR 101.9(b)), which provides for the testing of NCAP programs or procedures. See Treasury Decision (T.D.) 95-21.
This notice announces CBP's plan to modify the ACE Portal Account Test to establish limited export functionality within the ACE Portal Account. Features of this new portal account type, as well as the eligibility and documentation requirements for applying for an ACE Exporter Portal Account, are described below.
The ACE Exporter Portal Account provides exporters a new “exporter view” to the ACE Portal that permits exporters to access the export data associated with an Employer Identification Number (EIN),
Beginning no earlier than October 1, 2015, the ACE Exporter Account Portal will enable USPPIs or their authorized agents to transmit EEI by selecting the “Submit AESDirect Filings” link in the exporter view. Selecting this link will direct USPPIs or their authorized agents to a Web page prompting users to accept the Terms and Conditions governing the use of ACE AESDirect. After accepting these Terms and Conditions, USPPIs or their authorized agents will gain access to the AESDirect portal in ACE that will allow them to file their required EEI.
ACE AESDirect is intended to replace the legacy AESDirect operated by the Census Bureau and provide online internet filing and upload capabilities to facilitate the transmission of EEI. During the testing period of the ACE AESDirect portal, USPPIs or their authorized agents may continue to use legacy AESDirect for filing EEI. Once ACE AESDirect is fully operational, the Census Bureau plans to discontinue the legacy AESDirect filing application. AESDirect filing functionality through the ACE Exporter Account Portal will initially be available to certain USPPIs that have been selected by the Census Bureau. After this brief initial phase, CBP will announce the public availability of this functionality on its Web site at
The owner of an ACE Exporter Portal Account will have the ability to create and maintain through the ACE Portal information regarding the name, address, and contact information for the corporate and individual account owner for the exporter account. Exporters will use the existing account structure established for the use of importers within the ACE portal.
New ACE users without an existing portal account will be required to apply for an ACE Exporter Portal Account, as
Existing ACE Portal Account owners should follow instructions in Section B.2 below. Current ACE account holders must request an exporter account view within their existing portal account to access these functions. An existing ACE user who requests an ACE Exporter Portal Account will be asked to provide corporate and contact information to complete the process.
The account owner for new and existing ACE portal accounts may register additional EINs for subsidiary business units. To do so, the account owner must first register the principal EIN and then add subsidiary EINs to the account. A company operating under a single EIN will be designated as the account owner upon registration. If a subsidiary EIN is added to the account that has not yet been verified by CBP, the Census Bureau must vet and approve the newly added EIN before the subsidiary can access the Exporter Portal Account.
ACE test participants must agree to the “Terms and Conditions for Account Access of the Automated Commercial Environment (ACE) Portal.” See 72 FR 27632 (May 16, 2007) and 73 FR 38464 (July 7, 2008). New ACE users will be prompted to accept these Terms and Conditions during the application process. Upon completion of the application process, the applicant will receive an email message and be prompted to log in with the exporter's username and password which will create the ACE Exporter Portal Account. Once an account is created, the exporter will be provided with “exporter view” from the exporter home page.
Parties who do not have an ACE Portal Account may apply for an Exporter Portal Account according to the instructions on the following Web site:
Once the ACE Exporter Portal Account application has been completed, the applicant will receive an email message to confirm submission of the application and direct the applicant how to log on to ACE to complete the account setup process and access the ACE Exporter Portal Account.
Parties that have an existing ACE Portal Account may request an Exporter Portal Account through their established ACE portal account. For these accounts, the account owner may establish access to the Exporter Portal Account functionality according to the instructions on the following Web site:
Once the existing ACE Account Owner completes the process, the Exporter Portal Account will be created and the account owner will be able to access the Exporter Portal Account functionality.
Except as stated below, the modification of the ACE Portal Account Test announced in this notice is effective on October 21, 2015. The testing of the AESDirect functionality announced in this notice will begin no earlier than October 1, 2015. This modified test will continue until concluded by way of announcement in the
All interested parties are invited to comment on any aspect of this ACE Portal Account Test, as modified by this notice, for the duration of the modified test. CBP requests comments and feedback on all aspects of this modification, including the design, conduct and implementation of the modification, in order to determine whether to modify, alter, expand, limit, continue, end, or fully implement this modification.
The ACE Exporter Portal Account application has been approved by the Office of Management and Budget (OMB) in accordance with the requirements of the Paperwork Reduction Act (44 U.S.C. 3507) and assigned OMB control number 1651-0105. The information collection conducted under AES, including AESDirect, has been previously approved by OMB in accordance with the requirements of the Paperwork Reduction Act and assigned OMB control number 0607-0152. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by OMB.
All data submitted and entered into ACE is subject to the Trade Secrets Act (18 U.S.C. 1905) and is considered confidential, except to the extent as otherwise provided by law. EEI is also subject to the confidentiality provisions of 15 CFR 30.60. As stated in previous notices, participation in the ACE Portal Account Test or any of the previous ACE tests is not confidential and upon a written Freedom of Information Act (FOIA) request, a name(s) of an approved participant(s) will be disclosed by CBP in accordance with 5 U.S.C. 552.
A test participant may be subject to civil and criminal penalties, administrative sanctions, liquidated damages, or discontinuance from participation in the ACE Portal Account Test, as modified by this notice, for any of the following:
(1) Failure to follow the terms and conditions of this test;
(2) Failure to exercise reasonable care in the execution of participant obligations;
(3) Failure to abide by applicable laws and regulations that have not been waived; or
(4) Failure to deposit duties, taxes or fees in a timely manner.
If the Director, Business Transformation Division, ACE Business Office (ABO), Office of International Trade, finds that there is a basis for discontinuance of test participation privileges, the test participant will be provided a written notice proposing the discontinuance with a description of the facts or conduct warranting the action. The test participant will be offered the opportunity to appeal the Director's decision in writing within 10 calendar days of receipt of the written notice. The appeal must be submitted to the Executive Director, ABO, Office of International Trade, by emailing
The Executive Director will issue a decision in writing on the proposed action within 30 working days after receiving a timely filed appeal from the test participant. If no timely appeal is received, the proposed notice becomes the final decision of the Agency as of the date that the appeal period expires. A proposed discontinuance of a test participant's privileges will not take effect unless the appeal process under this paragraph has been concluded with a written decision adverse to the test participant.
In the case of willfulness or those in which public health, interest, or safety so requires, the Director, Business Transformation Division, ABO, Office of International Trade, may immediately discontinue the test participant's privileges upon written notice to the test participant. The notice will contain a description of the facts or conduct warranting the immediate action. The test participant will be offered the opportunity to appeal the Director's decision within 10 calendar days of receipt of the written notice providing for immediate discontinuance. The appeal must be submitted to the Executive Director, ABO, Office of International Trade, by emailing
A chronological listing of
• ACE Portal Accounts and Subsequent Revision Notices: 67 FR 21800 (May 1, 2002); 69 FR 5360 and 69 FR 5362 (February 4, 2004); 69 FR 54302 (September 8, 2004); 70 FR 5199 (February 1, 2005).
• ACE System of Records Notice: 71 FR 3109 (January 19, 2006).
• Terms/Conditions for Access to the ACE Portal and Subsequent Revisions: 72 FR 27632 (May 16, 2007); 73 FR 38464 (July 7, 2008).
• ACE Non-Portal Accounts and Related Notice: 70 FR 61466 (October 24, 2005); 71 FR 15756 (March 29, 2006).
• ACE Entry Summary, Accounts and Revenue (ESAR I) Capabilities: 72 FR 59105 (October 18, 2007).
• ACE Entry Summary, Accounts and Revenue (ESAR II) Capabilities: 73 FR 50337 (August 26, 2008); 74 FR 9826 (March 6, 2009).
• ACE Entry Summary, Accounts and Revenue (ESAR III) Capabilities: 74 FR 69129 (December 30, 2009).
• ACE Entry Summary, Accounts and Revenue (ESAR IV) Capabilities: 76 FR 37136 (June 24, 2011).
• Post-Entry Amendment (PEA) Processing Test: 76 FR 37136 (June 24, 2011).
• ACE Announcement of a New Start Date for the National Customs Automation Program Test of Automated Manifest Capabilities for Ocean and Rail Carriers: 76 FR 42721 (July 19, 2011).
• ACE Simplified Entry: 76 FR 69755 (November 9, 2011).
• National Customs Automation Program (NCAP) Tests Concerning Automated Commercial Environment (ACE) Document Image System (DIS): 77 FR 20835 (April 6, 2012).
• National Customs Automation Program (NCAP) Tests Concerning Automated Commercial Environment (ACE) Simplified Entry: Modification of Participant Selection Criteria and Application Process: 77 FR 48527 (August 14, 2012).
• Modification of NCAP Test Regarding Reconciliation for Filing Certain Post-Importation Preferential Tariff Treatment Claims under Certain FTAs: 78 FR 27984 (May 13, 2013).
• Modification of Two National Customs Automation Program (NCAP) Tests Concerning Automated Commercial Environment (ACE) Document Image System (DIS) and Simplified Entry (SE): 78 FR 44142 (July 23, 2013).
• Modification of Two National Customs Automation Program (NCAP) Tests Concerning Automated Commercial Environment (ACE) Document Image System (DIS) and Simplified Entry (SE); Correction: 78 FR 53466 (August 29, 2013).
• Modification of NCAP Test Concerning Automated Commercial Environment (ACE) Cargo Release (formerly known as Simplified Entry): 78 FR 66039 (November 4, 2013).
• Post-Summary Corrections to Entry Summaries Filed in ACE Pursuant to the ESAR IV Test: Modifications and Clarifications: 78 FR 69434 (November 19, 2013).
• National Customs Automation Program (NCAP) Test Concerning the Submission of Certain Data Required by the Environmental Protection Agency and the Food Safety and Inspection Service Using the Partner Government Agency Message Set Through the Automated Commercial Environment (ACE): 78 FR 75931 (December 13, 2013).
• Modification of National Customs Automation Program (NCAP) Test Concerning Automated Commercial Environment (ACE) Cargo Release for Ocean and Rail Carriers: 79 FR 6210 (February 3, 2014).
• Modification of National Customs Automation Program (NCAP) Test Concerning Automated Commercial Environment (ACE) Cargo Release to Allow Importers and Brokers to Certify From ACE Entry Summary: 79 FR 24744 (May 1, 2014).
• Modification of National Customs Automation Program (NCAP) Test Concerning Automated Commercial
• Modification of National Customs Automation Program (NCAP) Test Concerning Automated Commercial Environment (ACE) Document Image System: 79 FR 36083 (June 25, 2014).
• Announcement of eBond Test: 79 FR 70881 (November 28, 2014).
• eBond Test Modifications and Clarifications: Continuous Bond Executed Prior to or Outside the eBond Test May Be Converted to an eBond by the Surety and Principal, Termination of an eBond by Filing Identification Number, and Email Address Correction: 80 FR 899 (January 7, 2015).
• Modification of National Customs Automation Program (NCAP) Test Concerning Automated Commercial Environment (ACE) Document Image System Relating to Animal and Plant Health Inspection Service (APHIS) Document Submissions: 80 FR 5126 (January 30, 2015).
• Modification of National Customs Automation Program (NCAP) Test Concerning the use of Partner Government Agency Message Set through the Automated Commercial Environment (ACE) for the Submission of Certain Data Required by the Environmental Protection Agency (EPA): 80 FR 6098 (February 4, 2015).
• Announcement of Modification of ACE Cargo Release Test to Permit the Combined Filing of Cargo Release and Importer Security Filing (ISF) Data: 80 FR 7487 (February 10, 2015).
• Modification of NCAP Test Concerning ACE Cargo Release for Type 03 Entries and Advanced Capabilities for Truck Carriers: 80 FR 16414 (March 27, 2015).
• Automated Commercial Environment (ACE) Export Manifest for Air Cargo Test: 80 FR 39790 (July 10, 2015).
• National Customs Automation Program (NCAP) Concerning Remote Location Filing Entry Procedures in the Automated Commercial Environment (ACE) and the Use of the Document Image System for the Submission of Invoices and the Use of eBonds for the Transmission of Single Transaction Bonds: 80 FR 40079 (July 13, 2015).
• Modification of National Customs Automation Program (NCAP) Test Concerning the Automated Commercial Environment (ACE) Partner Government Agency (PGA) Message Set Regarding Types of Transportation Modes and Certain Data Required by the National Highway Traffic Safety Administration (NHTSA): 80 FR 47938 (August 10, 2015).
• Automated Commercial Environment (ACE) Export Manifest for Rail Cargo Test: 80 FR 54305 (September 7, 2015).
Office of the Assistant Secretary for Public and Indian Housing, HUD.
Notice.
This Notice sets forth the policies and procedures for the administration of a supportive housing and rental demonstration program called the Tribal HUD-VA Supportive Housing program (Tribal HUD-VASH). The program will provide rental assistance and supportive services to Native American veterans who are Homeless or At Risk of Homelessness living on or near a reservation or other Indian areas. HUD is making available $4 million in grant funding to Indian tribes and tribally designated housing entities (TDHEs) to fund this rental assistance and associated administrative fees. Indian tribes and TDHEs participating in this program must partner with the Department of Veterans Affairs (VA) to provide healthcare assistance to eligible Native American veterans.
Randall Akers, Office of Native American Programs, Office of Public and Indian Housing, Department of Housing and Urban Development, 451 7th Street SW., Room 4126, Washington, DC 20410, telephone number (202) 402-7914. (This is not a toll-free number.)
Since Fiscal Year (FY) 2008, the Housing Choice Voucher (HCV) program has provided rental assistance under a supportive housing program for Homeless veterans authorized by section 8(o)(19) of the United States Housing Act of 1937 (42 U.S.C. 1437f(o)(19)). The initiative, known as the HUD-VA Supportive Housing (HUD-VASH) program, was initially authorized by the Consolidated Appropriations Act, 2008 (Pub. L. 110-161, approved December 26, 2007).
The HUD-VASH program combines HCV rental assistance for Homeless veterans with Case Management and clinical services provided by or through the VA through Veterans Administration Medical Centers (VAMC). Historically, this program has not reached Native American veterans in tribal communities due to legal impediments preventing tribes and TDHEs from participating in the HUD-VASH program.
In the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235, approved December 16, 2014) (“2015 Appropriations Act”), Congress authorized funding for a demonstration program in order to expand the HUD-VASH program into Indian Country. The 2015 Appropriations Act directed HUD to coordinate with Indian tribes, TDHEs, and other appropriate tribal organizations on the design of this program, and to ensure the effective delivery of housing assistance and supportive services to Native American veterans who are Homeless or At Risk of Homelessness. It also authorized HUD to make appropriate adjustments to the HUD-VASH model, and to waive or specify alternative requirements (except for requirements related to fair housing, nondiscrimination, labor standards, and the environment) for any provision of any statute or regulation that it administers if it finds that they are necessary for the effective delivery and administration of rental assistance under the program.
On January 26, 2015, HUD sent a “Dear Tribal Leader” letter to tribal leaders, tribal organizations, and TDHE directors soliciting comments on a Tribal HUD-VASH demonstration program (Tribal HUD-VASH). HUD also held a national listening session at the National American Indian Housing Council's Legislative Conference held on February 2, 2015, followed by regional listening sessions held at each of the six Office of Native American Programs (ONAP) field offices. HUD also received a number of comments
Case Management—For purposes of Tribal HUD VASH, Case Management is a specialized component of healthcare management, requiring highly skilled, trained professionals. Case Management emphasizes a collaborative process that assesses, advocates, plans, implements, coordinates, monitors, and evaluates health care options and services so that they meet the needs of the individual patient.
Community Based Outpatient Clinic (CBOC)—A Community Based Outpatient Clinic (CBOC) is a VA-operated clinic or a VA-funded or reimbursed health care facility or site that is geographically distinct or separate from the parent medical facility.
Fair Market Rent (FMR)—Fair Market Rent means the rent, as established by HUD, for units of varying sizes (by number of bedrooms), that must be paid in the market area to rent privately owned, existing, decent, safe and sanitary rental housing of modest (non-luxury) nature with suitable amenities.
Homeless and At Risk of Homelessness—For purposes of Tribal HUD-VASH, HUD is adopting the definitions of “Homeless” in Section 103(a) of the McKinney-Vento Homeless Assistance Act (42 U.S.C. 11302(a)) and “At Risk of Homelessness” in Section 401(1) of the McKinney-Vento Homeless Assistance Act (42 U.S.C. 11360(1)). However, the income provision at 42 U.S.C. 11360(1)(A) does not apply to the Tribal HUD-VASH program. Instead, HUD is adopting the low-income eligibility requirements in Section 4(14) of NAHASDA. Accordingly, a veteran will be eligible for this program if he or she otherwise meets the definition of “Homeless” or “At Risk of Homelessness”, and is a low-income Indian, as defined in NAHASDA (
Project-Based Rental Assistance (PBRA)—Rental housing assistance tied to a specific housing unit or units. The housing assistance stays with the unit or units and any household living in the unit must meet program requirements. If the household moves out of the subsidized unit, they no longer receive rental housing assistance.
Tenant-Based Rental Assistance (TBRA)—Rental housing assistance tied to a specific household. The eligible applicant selects and rents a unit (whether private or TDHE-owned) that meets program requirements, and the tribe or TDHE makes rent subsidy payments on behalf of the household. The assistance stays with the household; if the household moves to a different unit that meets program qualifications, the tribe or TDHE makes rental payments to the owner of the new unit on the household's behalf.
HUD is establishing the program requirements of Tribal HUD-VASH with the publication of this Notice. In accordance with the 2015 Appropriations Act, this Notice also makes appropriate adjustments to program requirements through the issuance of statutory and regulatory waivers that HUD has deemed necessary for the effective delivery and administration of rental assistance under the program. Generally, rental assistance under this program will be subject to all requirements of NAHASDA that are applicable to rental assistance funded under the Indian Housing Block Grant (IHBG) program. This includes the NAHASDA statute (25 U.S.C. 4101
Housing assistance under this program will be made available by grants to tribes and TDHEs that are eligible to receive IHBG funding under NAHASDA. Tribes will be able to request Tenant-Based and/or Project-Based Rental Assistance by the number of bedrooms in a rental unit. Grants will be awarded based on the number rental units (Tenant-Based and Project-Based Rental Assistance) approved by HUD. Grants will include an additional amount for administrative costs, which will be described in more detail later in this notice. Grant funding will be awarded based on 12 months of funding. Participating tribes/TDHEs will draw down funds from the HUD Line of Credit Control System (LOCCS) on a monthly basis to cover rental assistance payments.
Eligible Homeless veterans will receive case management services through the Department of Veterans Affairs. A tribe/TDHE should work with the local VAMC to determine how Case Management will be delivered to Native American veterans. VA may provide these services directly through the local VAMC, or through a Community-Based Outpatient Clinic (CBOC). Alternatively, the VA may engage in a contractual relationship with a tribal healthcare provider or the Indian Health Service (IHS) for service delivery. A tribe/TDHE may partner with VA to provide office space within the tribal area for the VA caseworker to operate. Additionally, VA, in coordination with the tribe/TDHE may partner with IHS to provide space for VA case management activities at an IHS facility. Native American veterans participating in this program will be housed based on a Housing First approach, where Homeless veterans are provided housing assistance and then offered the supportive services that may be needed to foster long-term stability and prevent a return to Homelessness. This approach assumes that supportive services are more effective when the individual or household is housed, and the daily stress of being Homeless is relieved. Key components of the Housing First model include a simple application process for participating veterans, a harm reduction approach from VA, and no conditions of tenancy beyond those included in the lease and the requirements in this Notice. Housing First specifically does not require sobriety or testing for substance abuse to obtain or sustain tenancy, and thus must not be required in the lease. More information on Housing First is available at:
The 2015 Appropriations Act authorizes HUD to set aside an amount from the HUD-VASH program for a tribal demonstration program. HUD has set aside $4 million for this purpose, which HUD anticipates will provide sufficient grant funding to support approximately 600 rental housing units and associated administrative fees for Tribal HUD-VASH.
Pursuant to the 2015 Appropriations Act, awards under this program must be based on need, administrative capacity, and other factors that HUD specifies in this Notice after coordination with the VA. The method of allocating assistance under this program was developed
Tribes/TDHEs selected in each ONAP region will be invited to apply for Tribal HUD-VASH shortly after publication of this Notice. To receive a grant, tribes/TDHES will be required to submit a Tribal HUD-VASH application, described below in Section V of this Notice. If a tribe or TDHE declines to participate or does not need its full allocation, HUD will invite the next highest tribe within an ONAP region ranked by need and capacity. A tribe/TDHE that participates in the Tribal HUD-VASH program must partner with its VAMC.
In general, tribes will be awarded grants equal to an amount that can fund rental assistance payments for between 15-25 rental housing units, which is equal to the capacity of one Tribal HUD-VASH case manager. If there are other tribes in the area with eligible veterans who can be served by the same case manager, the tribe invited to apply may either sub-grant to another entity or directly serve Tribal HUD-VASH recipients from the other tribe. Should the tribe sub-grant to another entity, HUD strongly encourages the tribe invited to ensure that the sub-grantee has sufficient capacity and is in good standing with HUD. The lead tribe would only be eligible for one grant award, not to exceed 25 units of assistance. If there are situations where a tribe/TDHE has a need to serve fewer than 15 Native American veterans, and VA determines there is the capacity within its existing HUD VASH staff to assist Native American veterans, the tribe/TDHE may be awarded fewer than 15 units of assistance.
The grant award will be based on the number of units requested by a tribe/THDE, the rents established by the tribe, and a per-unit administrative fee. Once an allocation has been awarded, a tribe/TDHE may provide assistance to additional Native American veterans if there are funds remaining from the initial grant, and the VA is able to provide Case Management support at no additional cost.
Applicants should submit electronic applications to:
Eligible applicants are Indian tribes as defined in section 4(13) of NAHASDA or TDHEs authorized by one or more tribes pursuant to section 4(22) of NAHASDA and 24 CFR 1000.206 and invited by HUD to apply for Tribal HUD-VASH per the allocation method described under Section IV of this notice.
The applicant must submit all forms required in this section, along with other information listed below.
1. Contact Information: Tribe/TDHE and point of contact; mailing address; phone number; and email address; including name, title, and signature of person authorized to submit the application.
2. Other Identifying Information: Employer/taxpayer identification number (EIN/TIN) and organizational DUNS number.
1. System for Award Management (SAM): Evidence of registration with SAM.
2. Units of Assistance Requested: Provide the estimated total number of rental housing units that the Indian tribe or TDHE plans to provide to Native American veterans with assistance under this program, and whether the assistance will be Tenant-Based Rental Assistance, Project-Based Rental Assistance, or a combination of both. Provide a table detailing the estimated number of units requested by the number of bedrooms and the corresponding rent, as well as a written justification for the rent structure (see Section VI. H. Rent). If the applicant seeks both Tenant-Based and Project-Based Assistance, provide separate tables. Fair Market Rents can be found at
3. Tenant-Based Rental Assistance vs. Project-Based Rental Assistance
In the Tribal HUD-VASH application, the tribe/TDHE must determine if the rental housing assistance provided under the program will be Tenant-Based Rental Assistance and/or Project-Based Rental Assistance. After receiving the grant, a tribe/TDHE may make a determination to convert from one type of rental assistance to the other for any unutilized grant funds. If the switch is from Tenant-Based to Project-Based Rental Assistance, then the tribe/TDHE must comply with paragraph C.5.b below, and submit the Project-Based Rental Assistance information requested below in paragraph C.6 for HUD approval prior to the actual switch.
a. Tenant-Based Rental Assistance: A tribe/THDE may apply for a grant under this program to provide Tenant-Based Rental Assistance to Native American veterans. The tribe/TDHE will either assist the Native American veteran in locating privately- owned housing and enter into a contract with the owner of the housing, or provide housing in a unit that is owned or operated by the tribe/TDHE. Tenant-Based Rental Assistance will be subject to requirements further described in this Notice.
b. Project-Based Rental Assistance: A tribe/THDE may apply for a grant under this program to provide Project-Based Rental Assistance to Native American veterans. To be considered for Project-Based Rental Assistance, a tribe/TDHE's IHBG LOCCS balance cannot exceed three times its most current FY grant, unless the tribe received an IHBG that was less than $75,000 in that year.
The tribe/TDHE will provide a monthly rental assistance payment for a specific housing unit in which an eligible Native American veteran will reside. The housing unit will be specifically designated as a unit that is available for Native American veterans eligible under this program. Project-Based Rental Assistance may be provided to privately owned housing with a contract with the owner of the housing, or a unit that is owned or operated by the tribe/TDHE. Project-Based Rental Assistance will be subject to requirements further described in this Notice.
6. Project-Based Rental Assistance Submission: If requesting funds for Project-Based Rental Assistance, also provide the following information:
a. The number of units and the type of structure to which the assistance units will be attached.
b. The ownership of the project and evidence of site control.
c. If a tribe/TDHE proposes to use its grant to provide rental assistance payments for rental housing units not yet constructed or rehabilitated, provide:
i. A project timeline, including the length of time the Tribal HUD-VASH assistance would not be used while waiting for the units to be completed (projects with timeframes longer than 2 years until completion will not be approved);
ii. A detailed budget for the project including all sources and uses of funding; and
iii. Evidence showing experience of the tribe/TDHE in developing new housing.
7. Tribal Resolution: If an application is submitted by a TDHE on behalf of an Indian tribe(s), a tribal resolution(s) must be submitted authorizing the TDHE to submit the application under this program.
8. Mitigation Plan: Per the 2015 Appropriations Act, HUD must consider administrative capacity before making awards. HUD will examine a range of capacity indicators, including outstanding financial audits; unresolved HUD monitoring findings, OIG findings or audit findings; high unexpended grant balances; and overall administrative capacity to administer a new program. If the invitation requires an applicant to submit a mitigation plan as a precondition to receiving an award due to capacity concerns identified by HUD, the applicant must submit the mitigation plan with the application. The mitigation plan must be approved by HUD before funds will be awarded.
9. Disclosure of Lobbying Activities (SFLLL): This form must be submitted by State-recognized Indian tribes and TDHEs established only under state law.
10. Code of Conduct: If the applicant's Code of Conduct (code) is not listed on HUD's Web site at
11. Community Involvement: The applicant is encouraged to involve the community in developing and implementing the Tribal HUD-VASH program. Please include a description of actions taken to allow for citizen participation.
HUD will review each application and will respond to each application within 30 days of receipt. Upon HUD's approval of the application, a Tribal HUD-VASH grant will be awarded to a tribe/TDHE. HUD will issue a grant agreement to be signed by the tribe/TDHE, and will disburse funds through the HUD LOCCS system.
The 2015 Appropriations Act requires tribes and TDHEs that receive funding under Tribal HUD-VASH to administer the program in accordance with NAHASDA and the IHBG regulations at 24 CFR part 1000, except as modified in this Notice. The program requirements for the HCV program found at 24 CFR part 982 and the project-based voucher (PBV) program requirements found at 24 CFR part 983 do not apply unless specifically made applicable in this Notice. The following notices also do not apply to Tribal HUD-VASH: PIH 2015-11, PIH 2014-23, PIH 2011-50 PIH-2010-40, and 77 FR 17086.
In addition, the 2015 Appropriations Act authorizes HUD, in coordination with the VA, to waive, or specify alternative requirements for, any provision of any statute or regulation
Native American veterans first will be screened by the VA in accordance with VA screening procedures and by applying the eligibility criteria in paragraph B., below. Native American veterans determined by the VA to be eligible for the program will be referred to the tribe/TDHE for additional screening based on the eligibility requirements also listed in paragraph B., below. Native American veterans determined eligible for assistance under this program will then be provided with rental assistance. A tribe/TDHE may not provide rental assistance under this program unless it receives a referral from the VA and the referred Native American veteran meets the eligibility criteria for housing assistance as described in paragraph B., below.
1. VA Screening: The VA determines the initial eligibility of Native American veterans in the Tribal HUD-VASH program. VA screens for the following program eligibility requirements:
a. Eligible for VA health care (based on factors such as length of time in active duty, service, and type of discharge as noted on the Native American veteran's
b. A determination of Homeless or At Risk of Homelessness in accordance with this Notice.
c. A clinical need for Case Management services (a disabling physical or mental condition, or substance use that contributes significantly to the Native American veteran's housing status), as determined by VA.
d. The Native American veteran's agreement to participate in VA Case Management.
2. VA will prioritize eligible Native American veterans based on their level of need for Case Management. Those veterans with the greatest need for Case Management will be the first to be referred to a participating tribe/TDHE for rental assistance.
3. For the purposes of this program, eligibility status for housing does not extend to a deceased veteran's family.
4.
a. A determination that the veteran is “Indian” as defined in section 4(10) of NAHASDA.
b. A determination that the Native American veteran is income-eligible. To be eligible, a veteran household's annual income must be no more than 80 percent of area median income for the Indian area. Tribes/TDHEs will be subject to the same definition of “annual income” as in 24 CFR 1000.10. Tribes may follow their existing IHBG policies on calculating income in compliance with 24 CFR 1000.10, or they may establish new policies specific to the Tribal HUD-VASH program. Native American veterans may qualify for assistance under this program if they meet the income eligibility requirements in this Notice at the time they enter the Tribal HUD-VASH program. HUD is adopting the definitions of Homeless and At Risk of Homelessness that are in the McKinney-Vento Act, but the income requirements of McKinney-Vento do not apply to this program.
Tribes and TDHEs may not provide assistance under this program to any over-income Native American veteran that would otherwise be deemed eligible under the over-income or essential family categories in Sections 201(b)(2) and (3) of NAHASDA, unless the household met the income requirements at the time that they entered the program. To ensure that those Homeless and At Risk of Homeless Native American veterans with the greatest housing need will be first served by this program, HUD has found it necessary to waive of Sections 201(b) (2) and (3) of NAHASDA, and regulations at 24 CFR 1000.104-1000.110, to limit eligibility to Native American veterans whose income is no more than 80 percent of area median income for the Indian area.
c. A determination that the veteran is not registered as a lifetime sex offender. HUD is establishing the following alternative requirements to section 207(b) of NAHASDA, and 24 CFR 1000.120 relating to tenant selection. HUD is applying the screening requirements similar to 24 CFR 982.553(a)(2) relating to registered lifetime sex offenders. Tribes/TDHEs are required to establish written standards that prohibit admission if the veteran or any member of the household is subject to a lifetime registration requirement (Tier III offense) under any State sex offender registration program. As part of the eligibility screening process, a tribe/TDHE must perform a background check to see if the referred veteran or any household member is subject to a lifetime sex offender registration requirement in the State where the housing is located and in other States where the household members are known to have resided. If a household member other than the Homeless or At Risk of Homelessness veteran (which would result in denial of admission for the household) is subject to lifetime registration under a State sex offender registration, the remaining household members may be served if the veteran agrees to remove the sex offender from its household composition. This requirement is necessary to ensure consistent policy across HUD-VASH programs relating to providing assistance to registered sex-offenders.
5. Written documentation of all referrals and eligibility screening must be maintained in the veteran's file by the tribe/TDHE.
Once the tribe/TDHE performs all the activities listed above and the Native American veteran is deemed eligible, the tribe must offer rental housing assistance provided by this program to the participant. Tenant-Based Rental Assistance must be provided with an initial search term of 120 days from the date such assistance is offered. Project-Based Rental Assistance must be offered in the form of the next available project-based unit.
To ensure consistency with the standard HUD-VASH program and to serve the maximum number of Native American veterans in need of housing stability, tribes/TDHEs will not be allowed to deny assistance to an otherwise eligible Native American veteran who has been referred by the case manager on any grounds other than preferences based on tribal membership in accordance with the tribe/TDHE's written admissions and occupancy
In addition to maintaining records of referral and eligibility determination as required in paragraph B.5. above, a tribe/TDHE must also collect, keep on file, and report, additional household demographic, personal (including social security numbers), and rental information using a HUD-50058 form revised for the Tribal HUD-VASH program. This information also is required to be reported through an electronic reporting system as prescribed by HUD.
At initial occupancy, tribes/TDHEs will need to collect Social Security numbers (SSNs) for Homeless or At Risk of Homelessness veterans and their household members. This information must be maintained in the veteran's physical file. An original document issued by a federal, state, or tribal government agency, which contains the name of the individual and the SSN of the individual along with other identifying information, is acceptable in accordance with the standards in 24 CFR 5.216(g). In the case of the Homeless or At Risk of Homelessness veteran, the tribe/TDHE must accept the
As part of the VA Case Management duties, the veteran's case manager will assist the veteran in locating appropriate housing for the veteran. VA responsibilities for Case Management also include (1) providing appropriate treatment, referrals, and supportive services to the veteran prior to tribe/TDHE issuance of rental assistance; (2) identifying the social service and medical concerns of the veteran and providing, or ensuring the provision of, regular ongoing Case Management, outpatient health services, crisis intervention, and other supportive services as needed throughout the veteran's participation period; and (3) maintaining records and providing information for evaluation purposes, as required by HUD and the VA.
As a condition of receiving rental assistance under this program, an eligible veteran must agree to receive the Case Management services noted above. If a Tribal HUD-VASH case manager determines that a veteran fails to participate without good cause in Case Management, the participant's rental assistance may be terminated. However, a determination by the case manager that the participant veteran no longer requires Case Management is not grounds for termination of assistance.
Once a unit is located or ready to be occupied by a veteran, the tribe/TDHE must make a determination that the unit meets applicable local housing codes and quality standards in accordance with section 207(a)(2) of NAHASDA.
Under the 2015 Appropriations Act, assistance under this program is limited to Native American veterans that are Homeless or At Risk of Homelessness living on or near a reservation or other Indian areas. Accordingly, tribes/TDHEs participating in this program must house Native American veterans either on or near reservations, or within NAHASDA-authorized Indian areas, with the exception of units developed to house Homeless veterans on the grounds of a VA facility.
Assistance under this program may not be provided to Native American veterans who will be residing in a housing unit that qualifies as Formula Current Assisted Stock under the IHBG program.
Due to the limited availability of housing stock on or near reservations or in NAHASDA Indian Areas that is not developed, or has been otherwise assisted, with NAHASDA funding, HUD has found it necessary to establish alterative requirements regarding the maximum rent for a unit assisted under NAHASDA. These alternative requirements affect sections 203(a) of NAHASDA, and regulations at 24 CFR 1000.124, and 1000.130, which limit the maximum rent that can be charged to 30 percent of a household's adjusted monthly income. The alternative requirement allows a tribe/TDHE to determine rents by bedroom size based on the local FMR, market conditions and/or unit operating costs. Tribes/TDHEs must submit a justification as to how rent is determined in their program application. For both, housing units owned or operated by the tribe/TDHE, and privately owned units, rents may not exceed 110 percent of FMR. If a tribe/TDHE deems it necessary to charge more than 110 percent of FMR (or to place a veteran in a privately-owned unit with a rent that exceeds 110 percent of FMR), it must obtain HUD's prior approval to do so. For example, a tribe/TDHE may find it necessary to request such approval in order to address a request for a reasonable accommodation or in instances where rental market conditions render it difficult to find rent at 110 percent of FMR. HUD encourages tribes/TDHEs to establish rents at a level that is less than 110 percent of the FMR, particularly in housing that is owned or operated by the tribe/TDHE, to allow more Native American veterans to receive assistance. These alternative requirements do not apply to any other HUD-assisted housing that may be subject to other rent restrictions.
Eligible Native American veterans and their families will be required to make a monthly tenant rent contribution payment that is no more than 30 percent of their monthly adjusted income (as defined in NAHASDA and implementing regulations). The tribe/TDHE will pay the difference between the rent and the tenant rent contribution payment. Consistent with 24 CFR 1000.132, the tribe/TDHE may determine if utilities are included in the rent for the unit. The tribe/TDHE may also make this determination when negotiating rental assistance payment contracts with private -owners of housing. Tribes/TDHEs may establish a tenant rent contribution payment
A tribe/TDHE must enter into a contract with the owner of the privately-owned rental housing units in which the Native American veteran will reside. The contract will govern rental assistance provided under this program to the owner by the tribe/TDHE. Specific terms and conditions will be required. HUD is currently developing additional guidance on the required contract contents.
HUD has found it necessary to establish alternative requirements to section 104(a) of NAHASDA, and 24 CFR 1000.62-1000.64, relating to program income received by the tribe/TDHE under this program to ensure program funds continue to be used to provide affordable housing to low-income Native American families. Amounts paid to the tribe/TDHE to cover the rental assistance payment of Native American veterans and their families in tribe/TDHE-owned or operated housing; tenant rent contribution payments collected under this program; and any other income earned from the disbursement of grant funds, including income earned on funds received from such payments; will be considered program income, and must be spent on affordable housing activities, which will be subject to the requirements of NAHASDA and any other applicable Federal law. Notwithstanding Section 104(a) of NAHASDA, and 24 CFR 1000.62-1000.64, such income may not be spent on housing-related activities, as that term is defined in 24 CFR 1000.10. HUD strongly encourages tribes/TDHEs to use this program income to further provide affordable housing assistance to Homeless or At Risk of Homelessness Native American veterans eligible under this program first, before providing assistance to other low-income Native American families. Additionally, all such amounts must be tracked and reported in the Federal Financial Report (SF-425) to ensure compliance with this requirement.
To ensure the maximum level of affordability and participation in this demonstration program, HUD has found it necessary to establish alternative requirements to section 205(a)(2) of NAHASDA and 24 CFR 1000.141 and 1000.142 relating to minimum affordability periods based on the useful life of properties. The alternative requirement will affect Project-Based Rental Assistance (both privately owned or tribally owned or operated) provided under this program. Tribes/TDHEs must ensure that such properties are subject to binding commitments that ensure that the units will remain affordable and available to low-income Native American veterans and their families for a minimum period of 15 years from the time of initial lease-up. Binding commitments must run with the land and remain in place regardless of transfer of ownership, except in the circumstances described in Section 205(a)(2)(A) and (B) of NAHASDA. If a tribe/TDHE no longer has a need to house Homeless or At Risk of Homelessness Native American veterans before the affordability period has ended due to changed circumstances, a tribe/TDHE must request HUD's prior approval to house low-income Indian families in such units. HUD will approve such requests if the tribe/TDHE can demonstrate that there are no Native American eligible Homeless veterans that are eligible to occupy these units.
In accordance with the environmental requirements in 24 CFR 1000.20, the tribe/TDHE may not enter into a project-based rental assistance contract or lease before completion of an environmental review and either HUD approval of a Request for Release of Funds under 24 CFR part 58 or HUD approval of the property under 24 CFR part 50. However, in accordance with 24 CFR 50.19(b)(11) and 24 CFR 58.35(b)(1), tenant-based rental assistance is excluded from environmental review.
HUD has found it necessary to establish alternative requirements to section 101(h) of NAHASDA, and 24 CFR 1000.236-1000.239 to ensure that administrative fees received under this program can pay for, and are limited to, administrative and planning expenses related to this program. Tribes/TDHEs participating in the program will receive a flat administrative fee of $1,020 per unit, for a 12-month period, which can also be used for start-up funding. These funds will be included as part of the grant issued under this program.
A tribe/TDHE may use up to this amount for eligible administrative and planning expenses related only to this Tribal HUD-VASH program. These funds may not be used to pay for administrative and planning expenses related to the tribe/TDHE's IHBG program or any other program. If, after covering all administrative Tribal HUD-VASH expenses, there is a residual administrative fee amount, these funds may be used to provide additional rental assistance to Native American veterans and their families under Tribal HUD-VASH.
Eligible administrative expenses include but are not limited to: (1) Eligibility determinations; (2) intake and briefings; (3) owner outreach efforts; (4) unit inspections; (5) rent negotiations; (6) annual and interim reexaminations; (7) tenant fraud investigations and hearings; (8) processing subsequent moves; (9) the costs associated with making rental assistance payments to owners; and (10) complying with reporting requirements.
HUD is waiving section 202(9) of NAHASDA and 24 CFR 1000.239 relating to reserve accounts established to accumulate amounts for administration and planning. Given the need to ensure the timely expenditure of funds under this program, and the limited scope of this demonstration program, tribes/TDHEs may not draw down funds under this program and deposit them in a reserve account to accumulate amounts for administration and planning.
HUD is establishing alternative requirements to 24 CFR 1000.128(b) relating to income reexamination requirements. HUD has found it necessary to require interim reexaminations if a Native American veteran's household income decreases so that the rental assistance payment may increase to cover the cost of rent. Further, if the program is given renewal authority, it will be necessary to conduct annual reexaminations to capture annual fluctuations in income and rent as well as track demographic data necessary for the reporting requirements of the program.
Tribes/TDHEs must conduct an interim reexamination if the Native American veteran's income decreases between annual certifications. If there have been any changes in income, rent, or household composition they must be reported using the relevant sections of the HUD-50058 Form. A paper copy of this information must be kept in the veteran's file and be transmitted electronically to HUD at the time of the interim reexamination.
In the event of renewal funding for the program, the tribes/TDHEs must
If, upon annual reexamination, a Native American veteran or his/her household is determined to be over-income, the tribe can continue to serve the Native American veteran/household and not have it count towards its 10 percent over-income cap under 24 CFR 1000.110(c). If the Native American veteran/household's adjusted rent contribution payment, based on the income increase, is equal to the rent for the unit, then the Tribal HUD-VASH rental assistance is no longer needed and this assistance must be used on the next eligible Native American veteran. In this instance, the over-income Native American veteran can continue to receive Case Management services from the VA for as long as the VA deems the care necessary.
As required by Congress, tribes/TDHEs must submit demographic and financial information generated by the Tribal HUD VASH program. Grant funds received under this program must be reported annually in a tribe/TDHE's Indian Housing Plan and Annual Performance Report. Information on grant funds and program income received under this program also must be reported quarterly on the Federal Financial Report (SF-425). Tribes and TDHEs must fill out relevant demographic and rental information on the HUD Form 50058, and keep a physical record of this form. Additionally tribes/TDHEs will be required to transmit data from this form electronically on a monthly, quarterly, or annual basis via a method provided by HUD. HUD encourages tribes to make effective use of evidence in identifying or selecting the practices and strategies for implementing HUD VASH. All tribes and TDHEs must agree to cooperate in HUD-funded research and evaluation studies.
In accordance with the 2015 Appropriations Act, if the Tribal HUD-VASH rental assistance is no longer needed by a Native American veteran, this assistance must be issued to other eligible Native American veterans as identified by a case manager and as described further in this Notice.
Participating tribes and TDHEs must comply with requirements of section 207 of NAHASDA on termination of assistance. In addition, before determining whether to terminate assistance, tribes and TDHEs must contact the case manager to determine if ongoing Case Management services could mitigate the conditions that are leading to a potential termination. Participating tribes and TDHEs are subject to Section 504 of the Rehabilitation Act and HUD's regulation at 24 CFR part 8, which would include providing reasonable accommodations to individuals with disabilities throughout the termination process.
HUD anticipates that grants under this program will be subject to renewal on an annual basis. However, renewal is subject to the availability of future appropriations. Tribal HUD-VASH funding will be renewed on an annual basis based on the amount of rental assistance payments reported electronically using the HUD-50058 form. When calculating the annual grant award, HUD may subtract any funds from the previous year's grant that were not used for administrative costs or rental assistance payments. If funding is not available, tribes/TDHEs should use their best efforts to allocate IHBG funds to support Homeless or At Risk of Homelessness Native American veterans and their families that are currently being assisted through Tribal HUD-VASH.
HUD is waiving section 204(b) of NAHASDA and 24 CFR 1000.58 relating to the investment of grant funds. Given the need to ensure the timely expenditure of funds under this program, and the limited scope of this demonstration program, tribes/TDHEs may not draw down funds under this program to invest in securities or other obligations.
Because of the urgent housing needs of Native American veterans and their families, the relatively limited amount of funding under this program, the limited scope of this demonstration program, and the need to ensure the timely expenditure of funding, HUD finds it necessary for the effective delivery and administration of assistance under this program to waive Title IV of NAHASDA, and all implementing regulations at 24 CFR part 1000 as they relate to termination, reduction and limitation of assistance, and reallocation of such assistance to other tribes/TDHEs under this program. HUD is establishing alternative requirements to Title IV of NAHASDA, and relevant implementing regulations 24 CFR part 1000.
To ensure compliance with program requirements, HUD will conduct remote and on-site monitoring, as appropriate. After HUD has provided sufficient warning and time to cure, HUD may find it necessary to terminate, reduce, or limit the availability of the grant to a tribe/TDHE for poor performance or substantial noncompliance with program requirements. Poor performance, as determined by HUD may include actions outside of the tribe/TDHE's responsibility such as lack of adequate referrals or poor quality of supportive services provided by a contracted case management entity, or other reasons. Poor performance also includes an inadequate voucher utilization rate by the tribe or TDHE. Substantial noncompliance with program requirements is noncompliance that HUD determines: (1) Has a material effect on the tribe/TDHE's Tribal HUD-VASH program; (2) represents a material pattern or practice of activities constituting willful noncompliance with program requirements, even if a single instance of noncompliance would not be substantial; or (3) places the tribe/TDHE's Tribal HUD-VASH program at substantial risk of fraud, waste, or abuse. HUD may also terminate or reduce grant funds in situations where a tribe/TDHE is not carrying out activities due to a lack of Homeless Native veterans who need housing, or the recipient's failure to comply with its mitigation plan.
If HUD determines that a tribe/TDHE lacks Homeless Native veterans who need housing, is performing poorly, or is in substantial noncompliance with program requirements, HUD will provide written notice to the tribe/
If, after receiving notice informing it of HUD's decision to terminate, reduce, or limit the availability of assistance, the tribe/TDHE fails to submit a timely appeal or request for reconsideration, fails to demonstrate to HUD's satisfaction good cause to maintain its grant funds under this program, or fails to cure its noncompliance or poor performance within the time specified by HUD, HUD is authorized to terminate, reduce, or limit the availability of the tribe/TDHE's grant funds under this program. HUD may use its discretion to reallocate the grant funds resulting from such reduction or termination, to any other tribe/TDHE that is in compliance with program requirements and is not deemed to be a poor performer, and that still has a need to house Homeless Native veterans. Grant funds may be reallocated among tribe/TDHEs within the same ONAP region, or among tribes/TDHEs in different ONAP regions, based on administrative capacity, the utilization of previously awarded Tribal HUD-VASH assistance, and current geographic need as determined by the VA and HUD.
To the extent that any provision of Title VI of NAHASDA or any implementing regulation at 24 CFR part 1000 conflicts with the appeal process described above including, but not limited to, the opportunity for an administrative hearing, the provisions of this Notice will apply.
Tribes/TDHEs shall be subject to all nondiscrimination requirements that are applicable under NAHASDA and the IHBG regulations at 24 CFR part 1000 and in particular 24 CFR 1000.12
HUD is waiving the requirement to submit applications for grant funding through
A Finding of No Significant Impact with respect to the environment has been made in accordance with HUD regulations at 24 CFR part 50, which implement section 102(2)(C) of the National Environmental Policy Act of 1969 (42 U.S.C. 4332(2)(C)). The Finding of No Significant Impact is available for public inspection during regular business hours in the Regulations Division, Office of General Counsel, Department of Housing and Urban Development, 451 7th Street SW., Room 10276, Washington, DC 20410-0500. Due to security measures at the HUD Headquarters building, please schedule an appointment to review the Finding by calling the Regulations Division at (202) 402-3055 (this is not a toll-free number). Individuals with speech or hearing impairments may access this number via TTY by calling the Federal Relay Service at (800) 877-8339.
Fish and Wildlife Service, Interior.
Notice of availability; request for comments.
We, the U.S. Fish and Wildlife Service (Service), have received an application from Kaufman Real Estate LLC, Kaufman Holdings Inc., and Liberty Leasing & Construction, Inc. (applicants), for an incidental take permit (ITP) pursuant to the Endangered Species Act of 1973, as amended (ESA). The applicants request a 20-year ITP that would authorize “take” of five listed species incidental to otherwise lawful land development and habitat conservation activities on parcels they own in Thurston County, Washington. The application includes a draft habitat conservation plan (HCP), which describes the actions the applicants will take to minimize and mitigate the impacts of the take on covered species. The Service also announces the availability of a draft environmental assessment (EA) addressing the draft HCP and proposed permit. We invite comments from all interested parties regarding the permit application, including the draft HCP and EA.
To ensure consideration, please submit written comments by November 20, 2015.
You may view or download copies of the draft HCP and draft EA and obtain additional information on the Internet at
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Tim Romanski, Conservation Planning and Hydropower Branch Chief, Washington Fish and Wildlife Office (see
We have received an application from Kaufman Real Estate LLC, Kaufman Holdings Inc., and Liberty Leasing & Construction, Inc. (applicants), for an incidental take permit (ITP) pursuant to section 10(a)(1)(B) of the Endangered Species Act of 1973, as amended (ESA). The applicants request a 20-year ITP that would authorize “take” of the endangered Taylor's checkerspot butterfly (
Section 9 of the ESA prohibits “take” of fish and wildlife species listed as endangered or threatened. Under the ESA, the term “take” means to harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect, or to attempt to engage in any such conduct (16 U.S.C. 1532(19)). The term “harm,” as defined in our regulations, includes significant habitat modification or degradation that results in death or injury to listed species by significantly impairing essential behavioral patterns, including breeding, feeding, or sheltering (50 CFR 17.3). The term “harass” is defined in our regulations as intentional or negligent actions that create the likelihood of injury to listed species to such an extent as to significantly disrupt normal behavioral patterns, which include, but are not limited to, breeding, feeding, or sheltering (50 CFR 17.3).
Section 10(a)(1)(B) of the Act contains provisions that authorize the Service to issue ITPs to non-Federal entities for the take of endangered and threatened species caused by otherwise lawful activities, provided the following criteria are met: (1) The taking will be incidental; (2) the applicant will, to the maximum extent practicable, minimize and mitigate the impact of such taking; (3) the applicant will ensure that adequate funding for the plan will be provided; (4) The taking will not appreciably reduce the likelihood of the survival and recovery of the species in the wild; and (5) the applicant will carry out any other measures that the Service may require as being necessary or appropriate for the purposes of the plan. Regulations governing permits for endangered and threatened species are found in 50 CFR 17.22 and 17.32, respectively.
The Service proposes to issue the requested 20-year ITP based on the applicants' commitment to implement the draft HCP, if permit issuance criteria are met. Covered activities include construction, land development, and conservation of the covered species. The area covered under the draft HCP consists of 13 project development sites totaling 204 acres, and 2 conservation sites totaling 87 acres. Take of the covered species would occur primarily on the already fragmented project development sites and be mitigated for by managing larger blocks of habitat for the covered species on the conservation sites. An endowment will be funded by the applicants to manage the conservation sites for 100 years.
The proposed issuance of an ITP is a Federal action that triggers the need for compliance with the National Environmental Policy Act of 1969, as amended (42 U.S.C. 4321
The three alternatives analyzed in the EA are a no-action alternative, the proposed action, and an individual permits alternative. Under the no-action alternative, take of listed species would be avoided by limiting construction and development on the project development sites to areas where impacts to listed species could be avoided. Because no impacts to listed species are expected under this alternative, no HCP would be needed and no ITP would be issued. The proposed action alternative is the implementation of the proposed HCP and issuance of the requested 20-year ITP as described above under Proposed Action. The individual permits alternative would be issuance of incidental take permits for each of the 13 project development sites as they are developed rather than combining them under one ITP as proposed.
You may submit your comments and materials by one of the methods listed in the
All comments and materials we receive become part of the public record associated with this action. Before including your address, phone number, email address, or other personally identifiable information (PII) in your comments, you should be aware that your entire comment—including your PII—may be made publicly available at any time. While you can ask us in your comment to withhold your PII from public review, we cannot guarantee that we will be able to do so. Comments and materials we receive, as well as supporting documentation we use in preparing the EA, will be available for public inspection by appointment, during normal business hours, at our Washington Fish and Wildlife Office (see
After completion of the EA, we will determine whether the proposed action warrants a finding of no significant impact or whether an environmental impact statement should be prepared. We will evaluate the permit application, associated documents, and any comments we receive, to determine whether the permit application meets the requirements of section 10(a)(1)(B) of the ESA. We will also evaluate whether issuance of the requested section 10(a)(1)(B) permit would comply with section 7 of the ESA by conducting an intra-Service section 7 consultation
We provide this notice in accordance with the requirements of section 10 of the ESA (16 U.S.C. 1531
Bureau of Land Management, Interior.
Notice of public meeting.
In accordance with the Federal Land Policy and Management Act and the Federal Advisory Committee Act of 1972, the U.S. Department of the Interior, Bureau of Land Management (BLM) Southwest Resource Advisory Council (RAC) Oil and Gas Sub-Group is scheduled to meet as indicated below.
The Southwest RAC Oil and Gas Sub-Group meeting will be held on November 19, 2015, in Dolores, Colorado.
The Southwest RAC Oil and Gas Sub-Group meeting will be held November 19 at the Dolores Public Lands Office, 29211 Highway 184, Dolores, CO 81323. The meeting will begin at 10 a.m. and adjourn at approximately 12 p.m. A public comment period regarding matters on the agenda will be held at 11 a.m.
Barbara Sharrow, BLM Colorado Southwest District Acting District Manager, 970-240-5300; or Shannon Borders, Public Affairs Specialist, 970-240-5300; 2505 S. Townsend Ave., Montrose, CO 81401. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 to contact the above individual during normal business hours. The FIRS is available 24 hours a day, seven days a week, to leave a message or question with the above individual. You will receive a reply during normal business hours.
The Southwest RAC Oil and Gas Sub-Group identifies key priorities for the Southwest RAC to recommend to the Secretary of the Interior through the BLM. At this meeting, the sub-group will discuss the BLM's proposed Master Leasing Plan in western La Plata and eastern Montezuma counties. This meeting is open to the public. The public may present written comments to the sub-group. The meeting will also have time, as identified above, allocated for hearing public comments. Depending on the number of people wishing to comment and time available, the time for individual oral comments may be limited.
National Park Service, Interior.
Notice of designation.
The Otis Pike Fire Island High Dunes Wilderness Act, Public Law 96-585, December 23, 1980, designated approximately 1,360 acres as wilderness in the Fire Island National Seashore. Due to existing boardwalks and a pit toilet, this Act also designated approximately 18 acres of potential wilderness within Fire Island National Seashore that could be re-designated as wilderness upon elimination of these non-conforming uses. The National Park Service (NPS) described the wilderness and potential wilderness areas on maps entitled “Wilderness Plan—Fire Island National Seashore,” dated December 1980. In November 1983, the NPS adopted the “Wilderness Management Plan, Fire Island National Seashore” which also contained the legal description of the wilderness boundaries and a map showing the wilderness and the potential wilderness areas. On October 12, 1999, 17 acres of potential wilderness were re-designated as wilderness (see
On October 29, 2012, Hurricane Sandy moved through Fire Island National Seashore, destroying the boardwalk nature trail west of the Wilderness Visitor Center, the boardwalk dune crossing, and pit toilet at Old Inlet. The footprint of the two boardwalks and pit toilet is infrastructure that existed within the boundaries of the remaining one acre (more or less) of potential wilderness, entirely in Federal ownership. Upon destruction, the non-conforming uses of this potential wilderness addition were eliminated. Section (C) of the Otis Pike Fire Island High Dunes Wilderness Act authorized the Secretary of the Interior to designate administratively as wilderness any lands previously designated as potential wilderness upon publication in the
Accordingly, this notice hereby converts the one acre of potential wilderness in the Otis Pike Fire Island High Dune Wilderness, within Fire Island National Seashore, to designated wilderness. The one acre (more or less) shall be added to the 1,379 acres of designated wilderness within the Otis Pike Fire Island High Dune Wilderness, and managed in accordance with the Wilderness Act of 1964.
The maps and legal description are on file at the headquarters of the Fire Island National Seashore, 120 Laurel Street, Patchogue, NY 11772, and at the Office of the Director, 1849 C Street NW., Washington, DC 20240.
National Park Service, Interior.
Meeting notice.
As required by the Federal Advisory Committee Act (16 U.S.C. Appendix 1-16), the National Park Service (NPS) is hereby giving notice that the National Park Service Subsistence Resource Commission for Gates of the Arctic National Park (SRC) will hold a meeting to develop and continue work on NPS subsistence program recommendations, and other related regulatory proposals and resource management issues. The NPS SRC program is authorized under Section 808 of the Alaska National Interest Lands Conservation Act, (16 U.S.C. 3118), title VII.
The Gates of the Arctic National Park SRC will meet from 9:00 a.m. to 5:00 p.m. or until business is completed on Monday, November 9, 2015 and Tuesday, November 10, 2015.
The Gates of the Arctic National Park SRC will meet at the Gates of the Arctic Park and Preserve office located at 4175 Geist Road in Fairbanks, AK. Teleconference participants must call the Gates of the Arctic National Park and Preserve office at (907) 457-5752 by Friday, November 5, 2015, to receive teleconference passcode information.
For more detailed information regarding the Gates of the Arctic National Park SRC meeting, or if you are interested in applying for SRC membership, contact Designated Federal Official Greg Dudgeon, Superintendent, at (907) 457-5752 or Clarence Summers, Subsistence Manager, at (907) 644-3603.
SRC meeting locations and dates may change based on inclement weather or exceptional circumstances. If the meeting date and location are changed, the Superintendent will issue a press release and use local newspapers and radio stations to announce the rescheduled meeting.
The meeting is open to the public and will have time allocated for public testimony. The public is welcome to present written or oral comments to the SRC. The meeting will be recorded and meeting minutes will be available upon request from the Superintendent for public inspection approximately six weeks after the meeting. Before including your address, telephone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you may ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
United States International Trade Commission.
Notice.
On October 13, 2015, the Department of Commerce published notice in the
Angela M.W. Newell (202-708-5409), Office of Investigations, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436. Hearing-impaired individuals are advised that information on this matter can be obtained by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its internet server (
This investigation is being terminated under authority of title VII of the Tariff Act of 1930 and pursuant to section 207.40(a) of the Commission's Rules of Practice and Procedure (19 CFR 207.40(a)). This notice is published pursuant to section 201.10 of the Commission's rules (19 CFR 201.10).
By order of the Commission.
United States International Trade Commission.
Notice.
The Commission hereby gives notice of the scheduling of the final phase of antidumping duty investigation No. 731-TA-1269 (Final) pursuant to the Tariff Act of 1930 (“the Act”) to determine whether an industry in the United States is materially injured or threatened with material injury, or the establishment of an industry in the United States is materially retarded, by reason of imports of silicomanganese from Australia, provided for in subheading 7202.30.00 of the Harmonized Tariff Schedule of the United States, preliminarily determined by the Department of Commerce to be sold at less-than-fair-value.
Michael Szustakowski ((202) 205-3169), 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 the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its Internet server (
For further information concerning the conduct of this phase of the investigation, hearing procedures, and rules of general application, consult the Commission's Rules of Practice and Procedure, part 201, subparts A and B (19 CFR part 201), and part 207, subparts A and C (19 CFR part 207).
Additional written submissions to the Commission, including requests pursuant to section 201.12 of the Commission's rules, shall not be accepted unless good cause is shown for accepting such submissions, or unless the submission is pursuant to a specific request by a Commissioner or Commission staff.
In accordance with sections 201.16(c) and 207.3 of the Commission's rules, each document filed by a party to the investigation must be served on all other parties to the investigation (as identified by either the public or BPI service list), and a certificate of service must be timely filed. The Secretary will not accept a document for filing without a certificate of service.
This investigation is being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to section 207.21 of the Commission's rules.
By order of the Commission.
Notice of application.
Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.33(a) on or before December 21, 2015.
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODXL, 8701 Morrissette Drive, Springfield, Virginia 22152. Request for hearings should be sent to: Drug Enforcement Administration, Attention: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152.
The Attorney General has delegated her authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Deputy Assistant Administrator of the DEA Office of Diversion Control (“Deputy Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.33(a), this is notice that on July 22, 2015, Chattem Chemicals, Inc., 3801 St Elmo Avenue, Chattanooga, Tennessee 37409 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances:
The company plans to manufacture the listed controlled substances in bulk for distribution and sale to its customers.
Notice of application.
Registered bulk manufacturers of the affected basic class, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.33(a) on or before December 21, 2015.
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODXL, 8701 Morrissette Drive, Springfield, Virginia 22152. Request for hearings should be sent to: Drug Enforcement Administration, Attention: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152.
The Attorney General has delegated her authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Deputy Assistant Administrator of the DEA Office of Diversion Control (“Deputy Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR 1301.33(a), this is notice that on March 17, 2015, Cody Laboratories, Inc., Steve Hartman—Vice President of Compliance, 601 Yellowstone Avenue, Cody, Wyoming applied to be registered as a bulk manufacturer of methadone intermediate (9254), a basic class of controlled substance listed in schedule II.
The company plans to manufacture the listed controlled substance as an intermediate in the manufacture of an active pharmaceutical ingredient to sell to its customers.
Notice of application.
Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.33(a) on or before December 21, 2015.
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODXL, 8701 Morrissette Drive, Springfield, Virginia 22152. Request for hearings should be sent to: Drug Enforcement Administration, Attention: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152. Comments and requests for hearings on applications to import raw material are not appropriate. 72 FR 3417 (January 25, 2007).
The Attorney General has delegated her authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporter of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Deputy Assistant Administrator of the DEA Office of Diversion Control (“Deputy Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR 1301.33(a), this is notice that on August 21, 2015, Cambrex Charles City, 1205 11th Street, Charles City, Iowa 50616 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances:
The company plans to manufacture the listed controlled substances in bulk for sale to its customers, for dosage form development, for clinical trials, and for use in stability qualification studies.
Notice of application.
Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.34(a) on or before November 20, 2015. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before November 20, 2015.
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODXL, 8701 Morrissette Drive, Springfield, Virginia 22152. Request for hearings should be sent to: Drug Enforcement Administration, Attention: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152. Comments and requests for hearing on applications to import narcotic raw material are not appropriate. 72 FR 3417 (January 25, 2007).
The Attorney General has delegated her authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Deputy Assistant Administrator of the DEA Office of Diversion Control (“Deputy Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR 1301.34(a), this is notice that on July 2, 2015, Cerilliant Corporation, 811 Paloma Drive, Suite A, Round Rock, Texas 78665-2402, applied to be registered as an importer of the following basic classes of controlled substances:
The company plans to import small quantities of the listed controlled substances for the manufacture of analytical reference standards and distribution to their research and forensic customers.
In reference to drug code 7360 the company plans to import a synthetic cannabidiol. No other activity for this drug code is authorized for this registration.
Placement of these drug codes onto the company's registration does not translate into automatic approval of subsequent permit applications to import controlled substances.
Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of FDA approved or non-approved finished dosage forms for commercial sale.
Notice of application.
Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.33(a) on or before December 21, 2015.
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODXL, 8701 Morrissette Drive, Springfield, Virginia 22152. Request for hearings should be sent to: Drug Enforcement Administration, Attention: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152.
The Attorney General has delegated her authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Deputy Assistant Administrator of the DEA Office of Diversion Control (“Deputy Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR 1301.33(a), this is notice that on July 24, 2015, Halo Pharmaceutical, Inc., 30 North Jefferson Road, Whippany, New Jersey 07981 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances:
The company plans to manufacture Hydromorphone HCl for sale to other manufacturers and to manufacture other controlled substances for distribution to its customers. Dihydromorphine is an intermediate in the manufacture of Hydromorphone and is not for commercial distribution.
Notice of application.
Registered bulk manufacturers of the affected basic class, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.34(a) on or before November 20, 2015. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before November 20, 2015.
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA
The Attorney General has delegated her authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Deputy Assistant Administrator of the DEA Office of Diversion Control (“Deputy Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR 1301.34(a), this is notice that on May 29, 2015, Sigma-Aldrich International GMBH—Sigma Aldrich Co. LLC, Sigma Aldrich Company LLC, 3500 Dekalb Street, Saint Louis, Missouri 63118 applied to be registered as an importer of Butylone (7541), a basic class of controlled substance listed in schedule I.
The company plans to import the above listed controlled substance for analytical research and testing of equipment.
U.S. Marshals Service, Department of Justice.
30-Day notice.
The Department of Justice (DOJ), U.S. Marshals Service (USMS), 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 previously published in the
Comments are encouraged and will be accepted for an additional 30 days until November 20, 2015.
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 Nicole Feuerstein, Publications Specialist, U.S. Marshals Service, CS-3, 10th Floor, Washington, DC 20530-0001 (phone: 202-307-5168). 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 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.
2.
3.
4.
5.
6.
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.
Civil Division, Department of Justice.
60-Day notice.
The Department of Justice (DOJ), Civil 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.
Comments are encouraged and will be accepted for 60 days until December 21, 2015.
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 James G. Touhey, Jr., Director, Torts Branch (FTCA), Civil Division, P.O. Box 888, Benjamin Franklin Station, Washington, DC 20044 (phone: 202-616-4400).
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.
2.
3.
4.
5.
6.
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., Washington, DC 20530.
9:30 a.m., Tuesday, October 27, 2015.
NTSB Conference Center, 429 L'Enfant Plaza SW., Washington, DC 20594.
The one item is open to the public.
Telephone: (202) 314-6100.
The press and public may enter the NTSB Conference Center one hour prior to the meeting for set up and seating.
Individuals requesting specific accommodations should contact Rochelle Hall at (202) 314-6305 or by email at
The public may view the meeting via a live or archived webcast by accessing a link under “News & Events” on the NTSB home page at
Schedule updates, including weather-related cancellations, are also available at
Candi Bing at (202) 314-6403 or by email at
Peter Knudson at (202) 314-6100 or by email at
Nuclear Regulatory Commission.
License renewal; issuance.
The U.S. Nuclear Regulatory Commission (NRC) issued a renewal of Facility Operating License No. R-83, held by the Texas Engineering Experiment Station/Texas A&M University System (TEES/TAMUS or the licensee) for the continued operation of its Nuclear Science Center (NSC or the facility) Training, Research, Isotope Production, General Atomics (TRIGA) reactor (NSCR or the reactor) for an additional 20 years.
The operating license renewal No. R-83 is effective on October 1, 2015.
Please refer to Docket ID NRC-2015-0210 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document using any of the following methods:
•
•
•
Geoffrey A. Wertz, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-0893; email:
The NRC has issued renewed Facility Operating License No. R-83, held by the licensee, which authorizes continued operation of the TEES/TAMUS Nuclear Science Center (NSC, or the facility), TRIGA (Training, Research, Isotope Production, General Atomics) reactor (NSCR, or the reactor), located in College Station, Texas. The NSCR is heterogeneous pool-type, natural convection, light-water cooled, and shielded TRIGA reactor. The NSCR is licensed to operate at a steady-state power level of 1,000 kilowatts thermal. The renewed Facility Operating License No. R-83 will expire 20 years from its date of issuance.
The renewed facility operating license complies with the standards and requirements of the Atomic Energy Act of 1954, as amended (the Act), and the Commission's rules and regulations. The Commission has made appropriate findings as required by the Act and the Commission's regulations in chapter I of title 10 of the
The NRC staff prepared a safety evaluation report for the renewal of Facility Operating License No. R-83 and concluded, based on that evaluation, that the licensee can continue to operate the facility without endangering the health and safety of the public. The NRC staff also prepared an Environmental Assessment and Finding of No Significant Impact for the renewal of the facility operating license, noticed in the
The documents identified in the following table are available to interested persons through ADAMS accession numbers, as indicated.
For the Nuclear Regulatory Commission.
The ACRS Subcommittee on Metallurgy and Reactor Fuels will hold a meeting on November 20, 2015, Room T-2B1, 11545 Rockville Pike, Rockville, Maryland.
The meeting will be open to public attendance.
The agenda for the subject meeting shall be as follows:
The Subcommittee will discuss Spent Fuel Storage and Transportation. The Subcommittee will hear presentations by and hold discussions with the NRC staff and other interested persons regarding this matter. The Subcommittee will gather information, analyze relevant issues and facts, and formulate proposed positions and actions, as appropriate, for deliberation by the Full Committee.
Members of the public desiring to provide oral statements and/or written comments should notify the Designated Federal Official (DFO), Christopher Brown (Telephone 301-415-7111 or Email:
Detailed meeting agendas and meeting transcripts are available on the NRC Web site at
If attending this meeting, please enter through the One White Flint North building, 11555 Rockville Pike, Rockville, MD. After registering with security, please contact Mr. Theron Brown (Telephone 240-888-9835) to be escorted to the meeting room.
The ACRS Subcommittee on Planning and Procedures will hold a meeting on November 4, 2015, Room T-2B3, 11545 Rockville Pike, Rockville, Maryland.
The meeting will be open to public attendance with the exception of a portion that may be closed pursuant to 5 U.S.C. 552b(c)(2) and (6) to discuss organizational and personnel matters
The agenda for the subject meeting shall be as follows:
The Subcommittee will discuss proposed ACRS activities and related matters. The Subcommittee will gather information, analyze relevant issues and facts, and formulate proposed positions and actions, as appropriate, for deliberation by the Full Committee.
Members of the public desiring to provide oral statements and/or written comments should notify the Designated Federal Official (DFO), Quynh Nguyen (Telephone 301-415-5844 or Email:
Information regarding changes to the agenda, whether the meeting has been canceled or rescheduled, and the time allotted to present oral statements can be obtained by contacting the identified DFO. Moreover, in view of the possibility that the schedule for ACRS meetings may be adjusted by the Chairman as necessary to facilitate the conduct of the meeting, persons planning to attend should check with the DFO if such rescheduling would result in a major inconvenience.
If attending this meeting, please enter through the One White Flint North building, 11555 Rockville Pike, Rockville, MD. After registering with security, please contact Mr. Theron Brown (240-888-9835) to be escorted to the meeting room.
Nuclear Regulatory Commission.
Draft interim staff guidance; request for comment.
The U.S. Nuclear Regulatory Commission (NRC) is requesting public comment on its draft SFM-Interim Staff Guidance (ISG)—2, Revision 2, “Fuel Retrievability.” This revision to the guidance was developed to improve regulatory clarity due to uncertain duration of spent fuel storage in an independent spent fuel storage installation (ISFSI). The revision would provide improved guidance to the staff on the process to determine whether spent fuel storage systems are designed to allow ready retrieval of spent fuel.
Submit comments by November 20, 2015. Comments received after this date will be considered if it is practical to do so, but the Commission is able to ensure consideration only for comments received before this date.
You may submit comments by any of the following methods (unless this document describes a different method for submitting comments on a specific subject):
• Federal Rulemaking Web site: Go to
• Mail comments to: Cindy Bladey, Office of Administration, Mail Stop: OWFN-12-H08, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.
For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the
Emma Wong, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-7091, email:
Please refer to Docket ID NRC-2015-0241 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:
• Federal Rulemaking Web site: Go to
• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at
• NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.
Please include Docket ID NRC-2015-0241 in the subject line of your comment submission, in order to ensure that the NRC is able to make your comment submission available to the public in this docket.
The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC posts all comment submissions at
If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment submissions into ADAMS.
Section 141(b)(1)(C) of the Nuclear Waste Policy Act (NWPA) of 1982, as amended, requires that each monitored retrievable storage (MRS) facility be designed “to provide for the ready retrieval of such spent fuel and waste for further processing or disposal.” The NRC codified this portion of the NWPA in its 1988 final rulemaking, “Licensing Requirements for the Independent Spent Fuel Storage of Spent Nuclear Fuel and High-Level Radioactive Waste” (53 FR 31651; August 19, 1988). The NRC inserted, “Storage systems must be designed to allow ready retrieval of spent fuel or high-level radioactive waste for further processing or disposal,” in section 72.122(l) of title 10 of the
The NRC's current position on how a licensee may satisfy the requirement for “ready retrieval” under section 72.122(l) is delineated in draft ISG No. 2, Revision 1 (ADAMS Accession No. ML100550861). In essence, draft ISG-2, Rev. 1 provides guidance to the NRC staff that a licensee may demonstrate ready retrieval through a two-part approach: 1) Ability to remove the individual spent fuel assemblies or canned assemblies by normal means (
As the duration of spent fuel storage at an ISFSI or MRS facility increases, the practical impact of the application of the first part of ready retrieval—the ability of the fuel assembly to be removed from the canister or cask by normal means—has led the staff to take a closer look at retrievability. To ensure that the application of the first part of “ready retrieval” is met as the duration of fuel storage increases, periodic monitoring or inspection may be needed to verify the condition of the fuel and the internal components of the dry storage system, and could identify the need for possible remediation of the fuel and the internal components of the dry storage system. Because of the difficulties in accessing the fuel and the interior components, inspection, monitoring, and potential remediation may involve opening the confinement boundary of the system in order to verify the condition of the fuel and internal components. However, opening the dry storage system would expose workers to additional dose and, particularly for welded canisters, degrade or eliminate the confinement boundary.
Consistent with the NRC's ongoing work reviewing the regulatory framework for spent fuel storage and transportation (see COMSECY-10-0007, ADAMS Accession No. ML101390216), the NRC staff began exploring alternatives to the guidance on the application of ready retrieval. The staff's review has centered around whether to eliminate the first part of the guidance on ready retrieval—the ability to remove individual fuel assemblies from a canister or cask by normal means—but maintaining the second part—the ability of the canister or cask to be safely removed from the storage location. By eliminating the first part of the guidance, the dry cask storage system (
In an effort to engage stakeholders in this discussion, NRC staff held two public meetings on July 27, 2011, and August 16, 2012, to obtain stakeholder feedback on these topics. Additionally, in January 2013, the NRC issued a
The NRC staff has also considered how dry storage of spent nuclear fuel is implemented in other countries, and international guidance for spent fuel storage. The NRC staff has participated in several multilateral working groups related to extended spent fuel storage. The NRC staff reviewed the International Atomic Energy Agency's Specific Safety Guide No. SSG-15, “Storage of Spent Nuclear Fuel.” This guide is consistent with the NRC's current position of retrievability and will remain consistent with planned changes. Additionally, the NRC staff is aware that the spent fuel storage systems in Germany undergo periodic inspections at 10-year intervals, which are focused on the accessible cask components and confinement boundary (seals). The aging management program required by 10 CFR part 72 for renewal also provides for periodic inspections in the United States.
By this action, the NRC is requesting public comments on draft ISG 2, Revision 2. This ISG proposes certain revisions to NRC guidance on implementation of the requirements in 10 CFR part 72. The NRC staff will make a final determination regarding issuance of the revised ISG after it considers any public comments received in response to this request.
This draft ISG, if finalized, would provide guidance to the NRC staff for reviewing an application for an ISFSI license with respect to compliance with the retrievability requirement of 10 CFR 72.122(l). Issuance of this draft ISG, if finalized, would not constitute backfitting as defined in the backfitting provisions in 10 CFR 72.62 which are applicable to ISFSIs. Issuance of the draft ISG, if finalized, would also not constitute backfitting under 10 CFR 50.109, or otherwise be inconsistent with the issue finality provisions in 10 CFR part 52 for generally licensed ISFSIs. The staff's position is based upon the following considerations.
1. The draft ISG positions, if finalized, do not constitute backfitting, inasmuch as the ISG is internal guidance to the NRC staff.
The ISG provides interim guidance to the staff on how to review an application for NRC regulatory approval in the form of licensing. Changes in internal staff guidance are not matters for which either ISFSI or nuclear power plant applicants or licensees are protected under the backfitting provisions in 10 CFR parts 50 or 72, or the issue finality provisions of part 52.
2. Backfitting and issue finality do not—with limited exceptions not
Applicants and potential applicants are not, with certain exceptions, protected by the backfitting provisions in 10 CFR 72.62 or 10 CFR 50.109, or any issue finality provisions under part 52. This is because neither the backfitting provisions nor the issue finality provisions under part 52—with certain exclusions discussed below—were intended to apply to every NRC action which substantially changes the expectations of current and future applicants. The exceptions to the general principle are applicable whenever an applicant references a part 52 license (
3. The NRC has no intention to impose the ISG on existing ISFSI or nuclear power plant licenses either now or in the future (absent a voluntary request for change from the licensee).
The NRC staff does not intend to impose or apply the positions described in the ISG to existing (already issued) licenses (
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Environmental assessment and finding of no significant impact; issuance.
The U.S. Nuclear Regulatory Commission (NRC) has prepared an Environmental Assessment (EA) to evaluate the potential environmental impacts that may arise as a result of excavating trenches to observe geologic features for a paleoliquefaction research project at two sites located in northeastern Arkansas. The NRC has concluded that a Finding of No Significant Impact (FONSI) is appropriate.
October 21, 2015.
Please refer to Docket ID NRC-2012-0271 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document using any of the following methods:
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•
•
Thomas Weaver, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-2383; email:
The NRC is performing a paleoliquefaction research project to characterize past earthquakes in the Central and Eastern United States. Geologic observations of paleoliquefaction, defined as historic or pre-historic liquefaction, in excavated trenches are planned at two sites in northeastern Arkansas. Liquefaction features are geologic features such as sand blows and sand dikes formed during earthquakes as a result of ground shaking and water pressure developed in the ground during shaking. The results from this research will be used to update models implemented in probabilistic seismic hazard analyses to characterize ground motion at new nuclear power plant sites in accordance with the NRC's regulation in section 100.23(d)(1) of title 10 of the
The NRC has prepared an EA to evaluate the potential environmental impacts that may arise as a result of this research project in accordance with the requirements of 10 CFR part 51, the NRC's regulations that implement Section 102(2) of the National Environmental Policy Act of 1969, as amended. Based on the EA, and in accordance with 10 CFR 51.31(a), the NRC has concluded that a FONSI is appropriate. The excavation of the trenches at the two sites in northeastern Arkansas will commence following publication of this Notice.
The NRC has prepared the EA to evaluate the potential environmental impacts of the excavation of the trenches at two sites in northeastern Arkansas, described in the EA as the Garner and Stiles sites. In accordance with Section 7 of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
The NRC determined that the proposed excavation of the trenches will result in no adverse effects to any historic or cultural resources that may be located at the Garner or Stiles sites. The NRC's evaluation of archeologic artifacts discovered at the Garner site concludes that the site is ineligible for the National Register of Historic Places (NHRP). The Arkansas State Historic Preservation Officer stated in a September 3, 2014, letter to the NRC that NHRP eligibility for the Garner site is undetermined and noted that the proposed excavation of the trenches is similar to NRHP significance testing. If significant archeological material data is uncovered at the Garner site, the NRC
In its September 3, 2014 letter, the Arkansas State Historic Preservation Officer (SHPO) was supportive of the proposed excavation of the trenches at both sites. The Arkansas SHPO concurred with the NRC regarding no adverse effects at the Stiles site. The Quapaw Tribe has concurred with the Arkansas SHPO findings.
The NRC has determined that there will be no significant impacts to any other resource areas (
On the basis of the EA and as further described in the FONSI, the NRC has concluded that there are no significant environmental impacts from the proposed excavation of the trenches and has determined not to prepare an environmental impact statement.
For the Nuclear Regulatory Commission.
The ACRS Subcommittee on Digital I&C will hold a briefing on November 19, 2015, Room T-2B1, 11545 Rockville Pike, Rockville, Maryland.
The meeting will be open to public attendance with the exception of portions that may be closed to protect information that is proprietary pursuant to 5 U.S.C. 552b(c)(4). The agenda for the subject meeting shall be as follows:
The Subcommittee will review the Cyber Security SECY paper on Control of Access. The Subcommittee will hear presentations by and hold discussions with the NRC staff, and other interested persons regarding this matter. The Subcommittee will gather information, analyze relevant issues and facts, and formulate proposed positions and actions, as appropriate, for deliberation by the Full Committee.
Members of the public desiring to provide oral statements and/or written comments should notify the Designated Federal Official (DFO), Christina Antonescu (Telephone 301-415-6792 or Email:
Detailed meeting agendas and meeting transcripts are available on the NRC Web site at
If attending this meeting, please enter through the One White Flint North building, 11555 Rockville Pike, Rockville, MD. After registering with security, please contact Mr. Theron Brown (Telephone 240-888-9835) to be escorted to the meeting room.
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 or rescheduled, and the time allotted to present oral statements can be obtained by contacting the DFO.
(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.
Peace Corps.
30-Day notice and request for comments.
The Peace Corps will submit the following information collection request to the Office of Management and Budget (OMB) for approval. In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Peace Corps invites the general public to comment on this request for approval of a new proposed information collection, Peace Corps Volunteers Long Term Health Outcomes Survey (OMB Control Number 0420—pending). This process is conducted in accordance with 5 CFR 1320.10.
Submit comments on or before November 20, 2015.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name/or OMB approval number and should be sent via email to:
Denora Miller, FOIA Officer, Peace Corps, 1111 20th Street NW., Washington, DC 20526, (202) 692-1236, or email at
The information in the Peace Corps Volunteers Long Term Health Outcomes survey will be compiled and analyzed by the U.S. Department of Health and Human Services, Centers for Disease Control and Prevention in conjunction with the Peace Corps, Office of Health Services, Epidemiology and Surveillance Unit to determine what the long term health outcomes of Peace Corps Volunteer service are.
TITLE: Peace Corps Volunteers Long Term Health Outcomes Survey.
a. Estimated number of Returned Peace Corps Volunteers: 44,787.
b. Estimated number of respondents: 11,196.
c. Frequency of response: One time.
d. Completion time: 15 minutes.
e. Annual burden hours: 2,799 hours.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning the addition of Priority Mail Contract 148 negotiated service agreement to the competitive product list. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
In accordance with 39 U.S.C. 3642 and 39 CFR 3020.30
The Postal Service contemporaneously filed a redacted contract related to the proposed new product under 39 U.S.C. 3632(b)(3) and 39 CFR 3015.5. Request, Attachment B.
To support its Request, the Postal Service filed a copy of the contract, a copy of the Governors' Decision authorizing the product, proposed changes to the Mail Classification Schedule, a Statement of Supporting Justification, a certification of compliance with 39 U.S.C. 3633(a), and an application for non-public treatment of certain materials. It also filed supporting financial workpapers.
The Commission establishes Docket Nos. MC2016-6 and CP2016-6 to consider the Request pertaining to the proposed Priority Mail Contract 148 product and the related contract, respectively.
The Commission invites comments on whether the Postal Service's filings in the captioned dockets are consistent with the policies of 39 U.S.C. 3632, 3633, or 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comments are due no later than October 22, 2015. The public portions of these filings can be accessed via the Commission's Web site (
The Commission appoints Kenneth R. Moeller to serve as Public Representative in these dockets.
1. The Commission establishes Docket Nos. MC2016-6 and CP2016-6 to consider the matters raised in each docket.
2. Pursuant to 39 U.S.C. 505, Kenneth R. Moeller is appointed to serve as an officer of the Commission to represent the interests of the general public in these proceedings (Public Representative).
3. Comments are due no later than October 22, 2015.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning an additional Global Expedited Package Services 3 negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
On October 14, 2015, the Postal Service filed notice that it has entered into an additional Global Expedited Package Services 3 (GEPS 3) negotiated service agreement (Agreement).
To support its Notice, the Postal Service filed a copy of the Agreement, a copy of the Governors' Decision authorizing the product, a certification of compliance with 39 U.S.C. 3633(a), and an application for non-public treatment of certain materials. It also filed supporting financial workpapers.
The Commission establishes Docket No. CP2016-7 for consideration of matters raised by the Notice.
The Commission invites comments on whether the Postal Service's filing is consistent with 39 U.S.C. 3632, 3633, or 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comments are due no later than October 22, 2015. The public portions of the filing can be accessed via the Commission's Web site (
The Commission appoints Lyudmila Y. Bzhilyanskaya to serve as Public Representative in this docket.
1. The Commission establishes Docket No. CP2016-7 for consideration of the matters raised by the Postal Service's Notice.
2. Pursuant to 39 U.S.C. 505, Lyudmila Y. Bzhilyanskaya is appointed to serve as an officer of the Commission to represent the interests of the general public in this proceeding (Public Representative).
3. Comments are due no later than October 22, 2015.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
Thursday, November 12, 2015, at 10:15 a.m.; and Friday, November 13, at 8:30 a.m. and 10:00 a.m.
Washington, DC, at U.S. Postal Service Headquarters, 475 L'Enfant Plaza SW., in the Benjamin Franklin Room.
Thursday, November 12, at 10:15 a.m.—Closed; Friday, November 13, at 8:30 a.m.—Open; and Friday November 13, at 10:30 a.m.—Closed.
Julie S. Moore, Secretary of the Board, U.S. Postal Service, 475 L'Enfant Plaza SW., Washington, DC 20260-1000. Telephone: (202) 268-4800.
Notice is hereby given that the Railroad Retirement Board will hold a meeting on November 3, 2015, 10:00 a.m. at the Board's meeting room on the 8th floor of its headquarters building, 844 North Rush Street, Chicago, Illinois 60611. The agenda for this meeting follows:
(1) Executive Committee Reports
(2) Use of Medical Specialists in the Disability Application Process
The person to contact for more information is Martha P. Rico, Secretary to the Board, Phone No. 312-751-4920.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange filed a proposal to adopt business continuity and disaster recovery plans (“BC/DR plans”) testing requirements for certain Exchange Members
The text of the proposed rule change is available at 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 parts of such statements.
As adopted by the Commission, Regulation SCI applies to certain self-regulatory organizations (including the Exchange), alternative trading systems (“ATSs”), plan processors, and exempt clearing agencies (collectively, “SCI entities”), and will require these SCI entities to comply with requirements with respect to the automated systems central to the performance of their regulated activities. Among the requirements of Regulation SCI is Rule 1001(a)(2)(v), which requires the Exchange and other SCI entities to maintain “[b]usiness continuity and disaster recovery plans that include maintaining backup and recovery capabilities sufficiently resilient and geographically diverse and that are reasonably designed to achieve next business day resumption of trading and two-hour resumption of critical SCI systems following a wide-scale disruption.”
With respect to an SCI entity's BC/DR plans, including its backup systems, paragraph (a) of Rule 1004 of Regulation SCI requires each SCI entity to: “[e]stablish standards for the designation of those members or participants that the SCI entity reasonably determines are, taken as a whole, the minimum necessary for the maintenance of fair and orderly markets in the event of the activation of such plans.”
First, in paragraph (a) of Rule 2.4, the Exchange proposes to include language from paragraph (a) of Rule 1004 of Regulation SCI to summarize the Exchange's obligation pursuant to such rule. Specifically, the Exchange proposes to state that “[p]ursuant to Regulation SCI and with respect to the Exchange's business continuity and disaster recovery plans, including its backup systems, the Exchange is required to establish standards for the designation of Members that the Exchange reasonably determines are, taken as a whole, the minimum necessary for the maintenance of fair and orderly markets in the event of the activation of such plans.” The Exchange further proposes that paragraph (a) indicate that the “Exchange has established standards and will designate Members according to those standards” as set forth in the proposed Rule. In addition, the Exchange proposes to make clear that all Members are permitted to connect to the Exchange's backup systems as well as to participate in testing of such systems. Proposed paragraph (a) is consistent with the Commission's adoption of Regulation SCI, which encouraged “SCI entities to permit non-designated members or participants to participate in the testing of the SCI entity's BC/DR plans if they request to do so.”
Second, in paragraph (b) of Rule 2.4, the Exchange proposes to specify the criteria that will result in a Member receiving a designation requiring it to connect to the Exchange's backup systems and to participate in functional and performance testing as announced by the Exchange, which shall occur at least once every 12 months. Specifically, proposed paragraph (b) would require all Members that account for a meaningful percentage of the Exchange's volume and Members that participate as Lead Market Makers (“LMMs”) with respect to one or more securities listed on the Exchange to connect to the Exchange's backup systems and to participate in functional and performance testing.
The Exchange notes that it encourages all Members to connect to the Exchange's backup systems and to participate in testing of such systems. In fact, the Exchange provides logical ports free of charge to all Members that connect to Exchange backup systems in order to help reduce the economic burden of maintaining connectivity to Exchange backup systems. However, in adopting the requirements of Rule 2.4(b), including both the requirement to maintain connectivity to Exchange backup systems and to participate in mandatory testing of such systems, the Exchange intends to subject to the Rule only those Members that the Exchange believes are necessary to maintain fair and orderly markets at the Exchange. The Exchange believes that designating Members to participate in mandatory testing because they either account for a meaningful percentage of the Exchange's overall volume or maintain exclusive responsibilities with respect to Exchange-listed securities is a reasonable means to ensure the maintenance of a fair and orderly
In addition to paragraphs (a) and (b) described above, the Exchange also proposes to adopt Interpretation and Policy .01, which would provide additional detail regarding the notice that will be provided to Members that have been designated pursuant to subparagraph (b) of the Rule as well as the Exchange's method for measuring the volume threshold. As proposed, Interpretation and Policy .01 would state that for purposes of identifying Members that account for a meaningful percentage of the Exchange's overall volume, the Exchange will measure volume executed on the Exchange on a quarterly basis. The percentage of volume that the Exchange considers to be meaningful for purposes of this Interpretation and Policy .01 will be determined by the Exchange and will be published in a circular distributed to Members. The Exchange will publish the first circular consistent with this proposal prior to the Regulation SCI compliance date of November 3, 2015. The proposed Interpretation and Policy would also require the Exchange to notify individual Members quarterly that are subject to proposed paragraph (b) based on the prior calendar quarter's volume. Finally, as proposed, if a Member has not previously been subject to the requirements of proposed paragraph (b), then such Member would have until the next calendar quarter before such requirements are applicable. The Exchange believes the proposed notice requirements are necessary to provide Members with proper advance notice in the event they become subject to proposed Rule 2.4(b). The proposed timeframes would also provide Members with adequate time to become compliant with such Rule due to the necessary infrastructure changes it may take to connect to the Exchange's backup systems for a Member that is not already connected.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. To the contrary, the proposal is not a competitive proposal but rather is necessary for the Exchange's compliance with Regulation SCI.
The Exchange has neither solicited nor received written comments on the proposed rule change.
The Exchange has designated this rule filing as non-controversial under Section 19(b)(3)(A) of the Act
At any time within 60 days of the filing of the proposed rule change, the Commission may summarily temporarily suspend such rule change if it appears to the Commission that such action is: (1) Necessary or appropriate in the public interest; (2) for the protection of investors; or (3) otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposal is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for Web site viewing and printing in the Commission's Public Reference Room, 100 F Street NE., Washington, DC 20549, on official business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of such filing will also be available for inspection and copying at the principal office of the Exchange. All comments received will be posted without change; the Commission does not edit personal identifying information from submissions. You should submit only information that you wish to make available publicly.
All submissions should refer to File No. SR-BATS-2015-86 and should be submitted on or before November 12, 2015.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to section 19(b)(1)
The Exchange proposes to change representations regarding the names and principal investments of each of the following: WBI SMID Tactical Growth Shares; WBI SMID Tactical Value Shares; WBI SMID Tactical Yield Shares; WBI SMID Tactical Select Shares; WBI Large Cap Tactical Growth Shares; WBI Large Cap Tactical Value Shares; WBI Large Cap Tactical Yield Shares; and WBI Large Cap Tactical Select Share (each a “Fund” and, collectively, the “Funds”). Shares of the Funds have been approved for listing and trading on the Exchange under NYSE Arca Equities Rule 8.600. The text of 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 Commission has approved a proposed rule change relating to listing and trading on the Exchange of shares (“Shares”) of the Funds under NYSE Arca Equities Rule 8.600,
The Shares are offered by Absolute Shares Trust (the “Trust”), a statutory trust organized under the laws of the State of Delaware and registered with the Commission as an open-end management investment company.
The principal investment objective of each Fund is to seek long-term capital appreciation and the potential for current income, while also seeking to protect principal during unfavorable market conditions. As described in the Prior Release, the Sub-Adviser manages each Fund's portfolio based on a proprietary selection process as described in the Prior Release (the “Selection Process”). The Selection Process attempts to provide consistent, attractive returns net of expenses with potentially less volatility and risk to capital than traditional approaches,
As described in the Prior Release, under normal market conditions, the Fund invests at least 80% of its net assets in the exchange-listed equity securities of small-capitalization and mid-capitalization domestic and foreign companies selected on the basis of the Selection Process.
In addition, going forward, the Fund's name will change to WBI Tactical SMG Shares.
As described in the Prior Release, under normal market conditions, the Fund invests at least 80% of its net assets in the exchange-listed equity securities of small-capitalization and mid-capitalization domestic and foreign companies selected by the Sub-Adviser utilizing the Selection Process. Going forward, the Fund will seek to invest principally in the exchange-listed equity securities of small-capitalization and mid-capitalization domestic and foreign companies, cash and Cash Equivalents, selected by the Sub-Adviser utilizing the Selection Process.
In addition, going forward, the Fund's name will change to WBI Tactical SMV Shares.
As described in the Prior Release, under normal market conditions, the Fund invests at least 80% of its net assets in the exchange-listed dividend-paying equity securities of small-capitalization and mid-capitalization domestic and foreign companies selected by the Sub-Adviser utilizing the Selection Process. Going forward, the Fund will seek to invest principally in the exchange-listed dividend-paying equity securities of small-capitalization and mid-capitalization domestic and foreign companies, cash and Cash Equivalents, selected by the Sub-Adviser utilizing the Selection Process.
In addition, going forward, the Fund's name will change to WBI Tactical SMY Shares.
As described in the Prior Release, under normal market conditions, the Fund invests at least 80% of its net assets in the exchange-listed equity securities of small-capitalization and mid-capitalization domestic and foreign companies selected by the Sub-Adviser utilizing the Selection Process. Going forward, the Fund will seek to invest principally in the exchange-listed equity securities of small-capitalization and mid-capitalization domestic and foreign companies, cash and Cash Equivalents, selected by the Sub-Adviser utilizing the Selection Process.
In addition, going forward, the Fund's name will change to WBI Tactical SMS Shares.
As described in the Prior Release, under normal market conditions, the Fund invests at least 80% of its net assets in the exchange-listed equity securities of large capitalization domestic and foreign companies selected by the Sub-Adviser utilizing the Selection Process. Going forward, the Fund will seek to invest principally in the exchange-listed equity securities of large capitalization domestic and foreign companies, cash and Cash Equivalents, selected by the Sub-Adviser utilizing the Selection Process.
In addition, going forward, the Fund's name will change to WBI Tactical LCG Shares.
As described in the Prior Release, under normal market conditions, the Fund invests at least 80% of its net assets in the exchange-listed equity securities of large capitalization domestic and foreign companies selected by the Sub-Adviser utilizing the Selection Process. Going forward, the Fund will seek to invest principally in the exchange-listed equity securities of large capitalization domestic and foreign companies, cash and Cash Equivalents, selected by the Sub-Adviser utilizing the Selection Process.
In addition, going forward, the Fund's name will change to WBI Tactical LCV Shares.
As described in the Prior Release, under normal market conditions, the Fund invests at least 80% of its net assets in the exchange-listed dividend-paying equity securities of large capitalization domestic and foreign companies selected by the Sub-Adviser utilizing the Selection Process. Going forward, the Fund will seek to invest principally in the exchange-listed dividend-paying equity securities of large capitalization domestic and foreign companies, cash and Cash Equivalents, selected by the Sub-Adviser utilizing the Selection Process.
In addition, going forward, the Fund's name will change to WBI Tactical LCY Shares.
As described in the Prior Release, under normal market conditions, the Fund invests at least 80% of its net assets in the exchange-listed equity securities of large capitalization domestic and foreign companies
In addition, going forward, the Fund's name will change to WBI Tactical LCS Shares.
Except for the changes described above, all other representations made in the Prior Release remain unchanged.
The basis under the Act for this proposed rule change is the requirement under section 6(b)(5)
As noted above, the Selection Process attempts to provide consistent, attractive returns net of expenses with potentially less volatility and risk to capital than traditional approaches, whatever market conditions may be. While the Funds would continue to invest in the types of securities described in the Prior Release, the proposed change to represent that each Fund will seek to invest principally in specified exchange-listed equity securities, cash and Cash Equivalents, rather than at least 80% of its net assets in specified exchange-listed equity securities, would provide additional flexibility to seek each Funds' investment objective of protecting principal. The inclusion of cash and Cash Equivalents in each Fund's principal investments, rather than the use of such instruments solely for temporary defensive purposes, would facilitate each Fund's ability to protect principal, which could serve as a significant benefit for investors.
The proposed rule change is designed to promote just and equitable principles of trade and to protect investors and the public interest in that the Shares are listed and traded on the Exchange pursuant to the initial and continued listing criteria in NYSE Arca Equities Rule 8.600. Except for the changes described above, all other representations made in the Prior Release remain unchanged.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purpose of the Act. The Exchange believes the proposed rule change is designed to allow the Fund to invest in securities that would permit a Fund to better implement the Selection Process as described in the Prior Release, and will enhance competition among issues of Managed Fund Shares that invest in equity securities.
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 prior to 30 days from the date on which it was filed, or such shorter time as the Commission may designate, if consistent with the protection of investors and the public interest, the proposed rule change has become effective pursuant to section 19(b)(3)(A) of the Act and Rule 19b-4(f)(6)(iii) thereunder.
The Exchange has asked the Commission to waive the 30-day operative delay so that the proposal may become operative immediately upon filing. The Commission believes that waiver of the 30-day operative delay period is consistent with the protection of investors and the public interest. The Commission notes that the proposal would allow the Funds greater flexibility in seeking their investment objective of protecting principal during unfavorable market conditions, which could benefit investors and the public interest. Therefore, the Commission designates the proposed rule change to be operative upon filing.
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.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange filed a proposal to adopt business continuity and disaster recovery plans (“BC/DR plans”) testing requirements for certain Exchange Members
The text of the proposed rule change is available at 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 parts of such statements.
As adopted by the Commission, Regulation SCI applies to certain self-regulatory organizations (including the Exchange), alternative trading systems (“ATSs”), plan processors, and exempt clearing agencies (collectively, “SCI entities”), and will require these SCI entities to comply with requirements with respect to the automated systems central to the performance of their regulated activities. Among the requirements of Regulation SCI is Rule 1001(a)(2)(v), which requires the Exchange and other SCI entities to maintain “[b]usiness continuity and disaster recovery plans that include maintaining backup and recovery capabilities sufficiently resilient and geographically diverse and that are reasonably designed to achieve next business day resumption of trading and two-hour resumption of critical SCI systems following a wide-scale disruption.”
With respect to an SCI entity's BC/DR plans, including its backup systems, paragraph (a) of Rule 1004 of Regulation SCI requires each SCI entity to: “[e]stablish standards for the designation of those members or participants that the SCI entity reasonably determines are, taken as a whole, the minimum necessary for the maintenance of fair and orderly markets in the event of the activation of such plans.”
First, in paragraph (a) of Rule 2.4, the Exchange proposes to include language from paragraph (a) of Rule 1004 of Regulation SCI to summarize the Exchange's obligation pursuant to such rule. Specifically, the Exchange proposes to state that “[p]ursuant to Regulation SCI and with respect to the Exchange's business continuity and disaster recovery plans, including its backup systems, the Exchange is required to establish standards for the designation of Members that the Exchange reasonably determines are, taken as a whole, the minimum necessary for the maintenance of fair and orderly markets in the event of the activation of such plans.” The Exchange further proposes that paragraph (a) indicate that the “Exchange has established standards and will designate Members according to those standards” as set forth in the proposed Rule. In addition, the Exchange proposes to make clear that all Members are permitted to connect to the Exchange's backup systems as well as to participate in testing of such systems. Proposed paragraph (a) is consistent with the Commission's adoption of Regulation SCI, which encouraged “SCI entities to permit non-designated members or
Second, in paragraph (b) of Rule 2.4, the Exchange proposes to specify the criteria that will result in a Member receiving a designation requiring it to connect to the Exchange's backup systems and to participate in functional and performance testing as announced by the Exchange, which shall occur at least once every 12 months. Specifically, proposed paragraph (b) would require all Members that account for a meaningful percentage of the Exchange's volume to connect to the Exchange's backup systems and to participate in functional and performance testing.
The Exchange notes that it encourages all Members to connect to the Exchange's backup systems and to participate in testing of such systems. In fact, the Exchange provides logical ports free of charge to all Members that connect to Exchange backup systems in order to help reduce the economic burden of maintaining connectivity to Exchange backup systems. However, in adopting the requirements of Rule 2.4(b), including both the requirement to maintain connectivity to Exchange backup systems and to participate in mandatory testing of such systems, the Exchange intends to subject to the Rule only those Members that the Exchange believes are necessary to maintain fair and orderly markets at the Exchange. The Exchange believes that designating Members to participate in mandatory testing because they account for a meaningful percentage of the Exchange's overall volume is a reasonable means to ensure the maintenance of a fair and orderly market on the Exchange.
In addition to paragraphs (a) and (b) described above, the Exchange also proposes to adopt Interpretation and Policy .01, which would provide additional detail regarding the notice that will be provided to Members that have been designated pursuant to subparagraph (b) of the Rule as well as the Exchange's method for measuring the volume threshold. As proposed, Interpretation and Policy .01 would state that for purposes of identifying Members that account for a meaningful percentage of the Exchange's overall volume, the Exchange will measure volume executed on the Exchange on a quarterly basis. The percentage of volume that the Exchange considers to be meaningful for purposes of this Interpretation and Policy .01 will be determined by the Exchange and will be published in a circular distributed to Members. The Exchange will publish the first circular consistent with this proposal prior to the Regulation SCI compliance date of November 3, 2015. The proposed Interpretation and Policy would also require the Exchange to notify individual Members quarterly that are subject to proposed paragraph (b) based on the prior calendar quarter's volume. Finally, as proposed, if a Member has not previously been subject to the requirements of proposed paragraph (b), then such Member would have until the next calendar quarter before such requirements are applicable. The Exchange believes the proposed notice requirements are necessary to provide Members with proper advance notice in the event they become subject to proposed Rule 2.4(b). The proposed timeframes would also provide Members with adequate time to become compliant with such Rule due to the necessary infrastructure changes it may take to connect to the Exchange's backup systems for a Member that is not already connected.
The Exchange believes that its proposal is consistent with section 6(b) of the Act
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. To the contrary, the proposal is not a competitive proposal but rather is necessary for the Exchange's compliance with Regulation SCI.
The Exchange has neither solicited nor received written comments on the proposed rule change.
The Exchange has designated this rule filing as non-controversial under section 19(b)(3)(A) of the Act
At any time within 60 days of the filing of the proposed rule change, the Commission may summarily temporarily suspend such rule change if it appears to the Commission that such action is: (1) Necessary or appropriate in the public interest; (2) for the protection of investors; or (3) otherwise in
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposal is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange filed a proposal to adopt business continuity and disaster recovery plans (“BC/DR plans”) testing requirements for certain Exchange Members
The text of the proposed rule change is available at 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 parts of such statements.
As adopted by the Commission, Regulation SCI applies to certain self-regulatory organizations (including the Exchange), alternative trading systems (“ATSs”), plan processors, and exempt clearing agencies (collectively, “SCI entities”), and will require these SCI entities to comply with requirements with respect to the automated systems central to the performance of their regulated activities. Among the requirements of Regulation SCI is Rule 1001(a)(2)(v), which requires the Exchange and other SCI entities to maintain “[b]usiness continuity and disaster recovery plans that include maintaining backup and recovery capabilities sufficiently resilient and geographically diverse and that are reasonably designed to achieve next business day resumption of trading and two-hour resumption of critical SCI systems following a wide-scale disruption.”
With respect to an SCI entity's BC/DR plans, including its backup systems, paragraph (a) of Rule 1004 of Regulation SCI requires each SCI entity to:
First, in paragraph (a) of Rule 2.4, the Exchange proposes to include language from paragraph (a) of Rule 1004 of Regulation SCI to summarize the Exchange's obligation pursuant to such rule. Specifically, the Exchange proposes to state that “[p]ursuant to Regulation SCI and with respect to the Exchange's business continuity and disaster recovery plans, including its backup systems, the Exchange is required to establish standards for the designation of Members that the Exchange reasonably determines are, taken as a whole, the minimum necessary for the maintenance of fair and orderly markets in the event of the activation of such plans.” The Exchange further proposes that paragraph (a) indicate that the “Exchange has established standards and will designate Members according to those standards” as set forth in the proposed Rule. In addition, the Exchange proposes to make clear that all Members are permitted to connect to the Exchange's backup systems as well as to participate in testing of such systems. Proposed paragraph (a) is consistent with the Commission's adoption of Regulation SCI, which encouraged “SCI entities to permit non-designated members or participants to participate in the testing of the SCI entity's BC/DR plans if they request to do so.”
Second, in paragraph (b) of Rule 2.4, the Exchange proposes to specify the criteria that will result in a Member receiving a designation requiring it to connect to the Exchange's backup systems and to participate in functional and performance testing as announced by the Exchange, which shall occur at least once every 12 months. Specifically, proposed paragraph (b) would require all Members that account for a meaningful percentage of the Exchange's volume to connect to the Exchange's backup systems and to participate in functional and performance testing.
The Exchange notes that it encourages all Members to connect to the Exchange's backup systems and to participate in testing of such systems. In fact, the Exchange provides logical ports free of charge to all Members that connect to Exchange backup systems in order to help reduce the economic burden of maintaining connectivity to Exchange backup systems. However, in adopting the requirements of Rule 2.4(b), including both the requirement to maintain connectivity to Exchange backup systems and to participate in mandatory testing of such systems, the Exchange intends to subject to the Rule only those Members that the Exchange believes are necessary to maintain fair and orderly markets at the Exchange. The Exchange believes that designating Members to participate in mandatory testing because they account for a meaningful percentage of the Exchange's overall volume is a reasonable means to ensure the maintenance of a fair and orderly market on the Exchange.
In addition to paragraphs (a) and (b) described above, the Exchange also proposes to adopt Interpretation and Policy .01, which would provide additional detail regarding the notice that will be provided to Members that have been designated pursuant to subparagraph (b) of the Rule as well as the Exchange's method for measuring the volume threshold. As proposed, Interpretation and Policy .01 would state that for purposes of identifying Members that account for a meaningful percentage of the Exchange's overall volume, the Exchange will measure volume executed on the Exchange on a quarterly basis. The percentage of volume that the Exchange considers to be meaningful for purposes of this Interpretation and Policy .01 will be determined by the Exchange and will be published in a circular distributed to Members. The Exchange will publish the first circular consistent with this proposal prior to the Regulation SCI compliance date of November 3, 2015. The proposed Interpretation and Policy would also require the Exchange to notify individual Members quarterly that are subject to proposed paragraph (b) based on the prior calendar quarter's volume. Finally, as proposed, if a Member has not previously been subject to the requirements of proposed paragraph (b), then such Member would have until the next calendar quarter before such requirements are applicable. The Exchange believes the proposed notice requirements are necessary to provide Members with proper advance notice in the event they become subject to proposed Rule 2.4(b). The proposed timeframes would also provide Members with adequate time to become compliant with such Rule due to the necessary infrastructure changes it may take to connect to the Exchange's backup systems for a Member that is not already connected.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. To the contrary, the proposal is not a competitive proposal but rather is necessary for the Exchange's compliance with Regulation SCI.
The Exchange has neither solicited nor received written comments on the proposed rule change.
The Exchange has designated this rule filing as non-controversial under Section 19(b)(3)(A) of the Act
At any time within 60 days of the filing of the proposed rule change, the Commission may summarily temporarily suspend such rule change if it appears to the Commission that such action is: (1) Necessary or appropriate in the public interest; (2) for the protection of investors; or (3) otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposal is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange filed a proposal to adopt business continuity and disaster recovery plans (“BC/DR plans”) testing requirements for certain Exchange Members
The text of the proposed rule change is available at 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 parts of such statements.
As adopted by the Commission, Regulation SCI applies to certain self-regulatory organizations (including the Exchange), alternative trading systems (“ATSs”), plan processors, and exempt clearing agencies (collectively, “SCI entities”), and will require these SCI entities to comply with requirements with respect to the automated systems central to the performance of their regulated activities. Among the requirements of Regulation SCI is Rule 1001(a)(2)(v), which requires the Exchange and other SCI entities to maintain “[b]usiness continuity and disaster recovery plans that include maintaining backup and recovery capabilities sufficiently resilient and geographically diverse and that are reasonably designed to achieve next business day resumption of trading and two-hour resumption of critical SCI systems following a wide-scale disruption.”
With respect to an SCI entity's BC/DR plans, including its backup systems, paragraph (a) of Rule 1004 of Regulation SCI requires each SCI entity to: “[e]stablish standards for the designation of those members or participants that the SCI entity reasonably determines are, taken as a whole, the minimum necessary for the maintenance of fair and orderly markets in the event of the activation of such plans.”
First, in paragraph (a) of Rule 2.4, the Exchange proposes to include language from paragraph (a) of Rule 1004 of Regulation SCI to summarize the Exchange's obligation pursuant to such rule. Specifically, the Exchange proposes to state that “[p]ursuant to Regulation SCI and with respect to the Exchange's business continuity and disaster recovery plans, including its backup systems, the Exchange is required to establish standards for the designation of Members that the Exchange reasonably determines are, taken as a whole, the minimum necessary for the maintenance of fair and orderly markets in the event of the activation of such plans.” The Exchange further proposes that paragraph (a) indicate that the “Exchange has established standards and will designate Members according to those standards” as set forth in the proposed Rule. In addition, the Exchange proposes to make clear that all Members are permitted to connect to the Exchange's backup systems as well as to participate in testing of such systems. Proposed paragraph (a) is consistent with the Commission's adoption of Regulation SCI, which encouraged “SCI entities to permit non-designated members or participants to participate in the testing of the SCI entity's BC/DR plans if they request to do so.”
Second, in paragraph (b) of Rule 2.4, the Exchange proposes to specify the criteria that will result in a Member receiving a designation requiring it to connect to the Exchange's backup systems and to participate in functional and performance testing as announced by the Exchange, which shall occur at least once every 12 months. Specifically, proposed paragraph (b) would require all Members that account for a meaningful percentage of the Exchange's volume to connect to the Exchange's backup systems and to participate in functional and performance testing.
The Exchange notes that it encourages all Members to connect to the Exchange's backup systems and to participate in testing of such systems. In fact, the Exchange provides logical ports free of charge to all Members that connect to Exchange backup systems in order to help reduce the economic burden of maintaining connectivity to Exchange backup systems. However, in adopting the requirements of Rule 2.4(b), including both the requirement to maintain connectivity to Exchange backup systems and to participate in mandatory testing of such systems, the Exchange intends to subject to the Rule only those Members that the Exchange believes are necessary to maintain fair and orderly markets at the Exchange. The Exchange believes that designating Members to participate in mandatory testing because they account for a meaningful percentage of the Exchange's overall volume is a reasonable means to ensure the maintenance of a fair and orderly market on the Exchange.
In addition to paragraphs (a) and (b) described above, the Exchange also proposes to adopt Interpretation and Policy .01, which would provide additional detail regarding the notice that will be provided to Members that have been designated pursuant to subparagraph (b) of the Rule as well as the Exchange's method for measuring the volume threshold. As proposed, Interpretation and Policy .01 would state that for purposes of identifying Members that account for a meaningful percentage of the Exchange's overall volume, the Exchange will measure volume executed on the Exchange on a quarterly basis. The percentage of volume that the Exchange considers to be meaningful for purposes of this Interpretation and Policy .01 will be determined by the Exchange and will be
The Exchange believes that its proposal is consistent with Section 6(b) of the Act
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. To the contrary, the proposal is not a competitive proposal but rather is necessary for the Exchange's compliance with Regulation SCI.
The Exchange has neither solicited nor received written comments on the proposed rule change.
The Exchange has designated this rule filing as non-controversial under Section 19(b)(3)(A) of the Act
At any time within 60 days of the filing of the proposed rule change, the Commission may summarily temporarily suspend such rule change if it appears to the Commission that such action is: (1) Necessary or appropriate in the public interest; (2) for the protection of investors; or (3) otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposal is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
All comments received will be posted without change; the Commission does not edit personal identifying information from submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File No. SR-EDGA-2015-40 and should be submitted on or before November 12, 2015.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
60-day notice and request for comments.
The Small Business Administration (SBA) intends to request approval, from the Office of Management and Budget (OMB) for the collection of information described below. The Paperwork Reduction Act (PRA) of 1995, 44 U.S.C. chapter 35 requires federal agencies to publish a notice in the
Submit comments on or before December 21, 2015.
Send all comments to Mary Frias, Loan Specialist, Office of Financial Assistance, Small Business Administration, 409 3rd Street SW., Washington, DC 20416.
Mary Frias, Loan Specialist, Office of Financial Assistance,
The servicing agent agreement is executed by the borrower, and the certified development company as the loan servicing agent. The agreement is primarily used by the certified development company as the loan servicing agent and acknowledges the imposition of various fees allowed in SBA's 504 loan program.
SBA is requesting comments on (a) Whether the collection of information is necessary for the agency to properly perform its functions; (b) whether the burden estimates are accurate; (c) whether there are ways to minimize the burden, including through the use of automated techniques or other forms of information technology; and (d) whether there are ways to enhance the quality, utility, and clarity of the information.
60-Day notice and request for comments.
The Small Business Administration (SBA) intends to request approval, from the Office of Management and Budget (OMB) for the collection of information described below. The Paperwork Reduction Act (PRA) of 1995, 44 U.S.C Chapter 35 requires federal agencies to publish a notice in the
Submit comments on or before December 21, 2015.
Send all comments to Barbara Brannan, Management Analyst, Office of Surety Guarantee, Small Business Administration, 409 3rd Street SW., Washington, DC 20416.
Barbara Brannan, Management Analyst, Office of Surety Guarantee,
The Small Business Administration's (SBA) Surety Bond Guarantees (SBG) Program was created to encourage surety companies to issue bonds for small contractors. The information collected on these forms is used to evaluate the eligibility of applicants for the program. Changes are being made to SBA Form 990, Surety Bond Guarantee Agreement, SBA Form 991, Surety Bond Guarantee Agreement Addendum, SBA Form 994, Application for Surety Bond Guarantee Assistance, SBA Form 994B, Surety Bond Guarantee Underwriting Review, SBA Form 994F, Schedule of Work in Process, and SBA Form 994H, Default Report, Claim for Reimbursement & Records of Administrative Action.
SBA is requesting comments on (a) Whether the collection of information is necessary for the agency to properly perform its functions; (b) whether the burden estimates are accurate; (c) whether there are ways to minimize the burden, including through the use of automated techniques or other forms of information technology; and (d) whether there are ways to enhance the quality, utility, and clarity of the information.
Department of State.
Notice.
Delegates from the United States and Mexican Governments, the states of Arizona and California, and the Mexican states of Baja California and Sonora, will participate in the California-Arizona Meeting of the U.S.-Mexico Binational Bridges and Border Crossings Group on Wednesday, October 28, 2015 in Ensenada, Baja California, Mexico. The purpose of this meeting is to discuss operational matters involving existing and proposed international bridges and border crossings and their related infrastructure, and to exchange views on policy as well as technical information. This meeting includes a public session on Wednesday, October 28, 2015, from 9:00 a.m. until 10:15 a.m. This session allows proponents of proposed bridges and border crossings and related projects to make presentations to the delegations and members of the public.
For further information on the meeting and to attend the public session, please contact the Mexico Desk's Border Affairs Unit, via email at
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of applications for exemptions; request for comments.
FMCSA announces receipt of applications from 44 individuals for exemption from the prohibition against persons with insulin-treated diabetes mellitus (ITDM) operating commercial motor vehicles (CMVs) in interstate commerce. If granted, the exemptions would enable these individuals with ITDM to operate CMVs in interstate commerce.
Comments must be received on or before November 20, 2015.
You may submit comments bearing the Federal Docket Management System (FDMS) Docket No. FMCSA-2015-0068 using any of the following methods:
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Charles A. Horan, III, Director, Carrier, Driver and Vehicle Safety Standards, (202) 366-4001,
Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption from the Federal Motor Carrier Safety Regulations for a 2-year period if it finds “such exemption would likely achieve a level of safety that is equivalent to or greater than the level that would be achieved absent such exemption.” The statute also allows the Agency to renew exemptions at the end of the 2-year period. The 44 individuals listed in this notice have recently requested such an exemption from the diabetes prohibition in 49 CFR 391.41(b)(3), which applies to drivers of CMVs in interstate commerce. Accordingly, the Agency will evaluate the qualifications of each applicant to determine whether granting the exemption will achieve the required level of safety mandated by statute.
Mr. Armenta, 30, has had ITDM since 2004. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Armenta understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Armenta meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds an operator's license from California.
Mr. Barrera, 50, has had ITDM since 2010. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Barrera understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Barrera meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2015 and certified that he has stable nonproliferative diabetic retinopathy. He holds an operator's license from Texas.
Mr. Barry, 60, has had ITDM since 1981. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Barry understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Barry meets the requirements of the vision standard at 49 CFR
Mr. Benelli, 68, has had ITDM since 2012. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Benelli understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Benelli meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class B CDL from Pennsylvania.
Mr. Bridges, 67, has had ITDM since 2008. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Bridges understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Bridges meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Missouri.
Mr. Burgess, 61, has had ITDM since 2015. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Burgess understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Burgess meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from North Carolina.
Mr. Chick, 60, has had ITDM since 2015. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Chick understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Chick meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2015 and certified that he has stable nonproliferative diabetic retinopathy. He holds a Class A CDL from Vermont.
Mr. Collins, 59, has had ITDM since 2010. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Collins understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Collins meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a chauffer's license from Louisiana.
Mr. Cyr, 60, has had ITDM since 2012. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Cyr understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Cyr meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class B CDL from Maine.
Mr. Daniel, 60, has had ITDM since 2005. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Daniel understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Daniel meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Wyoming.
Mr. Finch, 81, has had ITDM since 2009. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Finch understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Finch meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2015 and certified that he has stable nonproliferative diabetic retinopathy. He holds a Class A CDL from New Jersey.
Mr. Fisher, 60, has had ITDM since 2011. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in
Mr. Fry, 41, has had ITDM since 1989. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Fry understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Fry meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2015 and certified that he has stable nonproliferative diabetic retinopathy. He holds an operator's license from Illinois.
Mr. Garrison, 43, has had ITDM since 1993. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Garrison understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Garrison meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds an operator's license from Arkansas.
Mr. Herron, 48, has had ITDM since 2014. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Herron understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Herron meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class B CDL from Nevada.
Mr. Hinspeter, 67, has had ITDM since 2014. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Hinspeter understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Hinspeter meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Iowa.
Mr. Holliday, 54, has had ITDM since 2000. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Holliday understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Holliday meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds an operator's license from Alabama.
Mr. Howe, 34, has had ITDM since 2015. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Howe understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Howe meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Illinois.
Mr. Leaders, 61, has had ITDM since 2010. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Leaders understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Leaders meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds an operator's license from Minnesota.
Mr. Manko, 56, has had ITDM since 2014. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Manko understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Manko meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class B CDL from New York.
Mr. Martinez, 57, has had ITDM since 2014. His endocrinologist examined him in 2015 and certified that he has had no
Mr. McLeran, 49, has had ITDM since 2014. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. McLeran understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. McLeran meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds an operator's license from Texas.
Mr. McNeill, 55, has had ITDM since 2010. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. McNeill understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. McNeill meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from North Carolina.
Mr. Minga, 69, has had ITDM since 2006. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Minga understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Minga meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Mississippi.
Mr. Mowery, 64, has had ITDM since 2005. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Mowery understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Mowery meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds an operator's license from Iowa.
Ms. Murphy, 44, has had ITDM since 2013. Her endocrinologist examined her in 2015 and certified that she has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. Her endocrinologist certifies that Ms. Murphy understands diabetes management and monitoring has stable control of her diabetes using insulin, and is able to drive a CMV safely. Ms. Murphy meets the requirements of the vision standard at 49 CFR 391.41(b)(10). Her optometrist examined her in 2015 and certified that she does not have diabetic retinopathy. She holds a Class A CDL from Pennsylvania.
Mr. Okello, 56, has had ITDM since 2006. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Okello understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Okello meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class B CDL from Minnesota.
Mr. Ortega, 52, has had ITDM since 2014. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Ortega understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Ortega meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2015 and certified that he has stable proliferative diabetic retinopathy. He holds a Class A CDL from Illinois.
Mr. Ostrowski, 50, has had ITDM since 2002. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Ostrowski understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Ostrowski meets the requirements of the
Mr. Parker, 69, has had ITDM since 2015. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Parker understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Parker meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Oregon.
Mr. Quaglieri, 21, has had ITDM since 2005. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Quaglieri understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Quaglieri meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds an operator's license from New Jersey.
Mr. Ramos, 56, has had ITDM since 2013. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Ramos understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Ramos meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Rhode Island.
Mr. Rosenbaum, 71, has had ITDM since 2013. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Rosenbaum understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Rosenbaum meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds an operator's license from Indiana.
Mr. Ruhs, 68, has had ITDM since 2005. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Ruhs understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Ruhs meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Iowa.
Mr. Scandurro, 59, has had ITDM since 2013. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Scandurro understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Scandurro meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2015 and certified that he has stable nonproliferative diabetic retinopathy. He holds a chauffer's license from Louisiana.
Mr. Small, 26, has had ITDM since 2008. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Small understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Small meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds an operator's license from California.
Mr. Soto, 25, has had ITDM since 2009. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Soto understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Soto meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a chauffer's license from Michigan.
Mr. Staples, 57, has had ITDM since 2015. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function
Mr. Stevens, 57, has had ITDM since 1984. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Stevens understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Stevens meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class B CDL from Massachusetts.
Mr. Streich, 58, has had ITDM since 2014. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Streich understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Streich meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Washington.
Mr. Stydinger, 55, has had ITDM since 2013. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Stydinger understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Stydinger meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Pennsylvania.
Mr. Thomason, 60, has had ITDM since 2015. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Thomason understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Thomason meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2015 and certified that he has stable nonproliferative diabetic retinopathy. He holds a Class A CDL from California.
Mr. Wright, 55, has had ITDM since 2014. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Wright understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Wright meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds an operator's license from Pennsylvania.
Mr. Zamora, 44, has had ITDM since 2012. His endocrinologist examined him in 2015 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (2 or more) severe hypoglycemic episodes in the last 5 years. His endocrinologist certifies that Mr. Zamora understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Zamora meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2015 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Texas.
In accordance with 49 U.S.C. 31136(e) and 31315, FMCSA requests public comment from all interested persons on the exemption petitions described in this notice. We will consider all comments received before the close of business on the closing date indicated in the date section of the notice.
FMCSA notes that section 4129 of the Safe, Accountable, Flexible and Efficient Transportation Equity Act: A Legacy for Users requires the Secretary to revise its diabetes exemption program established on September 3, 2003 (68 FR 52441).
Section 4129 requires: (1) Elimination of the requirement for 3 years of experience operating CMVs while being treated with insulin; and (2) establishment of a specified minimum period of insulin use to demonstrate stable control of diabetes before being allowed to operate a CMV.
In response to section 4129, FMCSA made immediate revisions to the diabetes exemption program established by the September 3, 2003 notice. FMCSA discontinued use of the 3-year driving experience and fulfilled the requirements of section 4129 while continuing to ensure that operation of CMVs by drivers with ITDM will achieve the requisite level of safety
Section 4129(d) also directed FMCSA to ensure that drivers of CMVs with ITDM are not held to a higher standard than other drivers, with the exception of limited operating, monitoring and medical requirements that are deemed medically necessary.
The FMCSA concluded that all of the operating, monitoring and medical requirements set out in the September 3, 2003 notice, except as modified, were in compliance with section 4129(d). Therefore, all of the requirements set out in the September 3, 2003 notice, except as modified by the notice in the
You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so that FMCSA can contact you if there are questions regarding your submission.
To submit your comment online, go to
We will consider all comments and material received during the comment period and may change this proposed rule based on your comments. FMCSA may issue a final rule at any time after the close of the comment period.
To view comments, as well as any documents mentioned in this preamble, To submit your comment online, go to
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of renewal of exemptions; request for comments.
FMCSA announces its decision to renew the exemptions from the vision requirement in the Federal Motor Carrier Safety Regulations for 64 individuals. FMCSA has statutory authority to exempt individuals from the vision requirement if the exemptions granted will not compromise safety. The Agency has concluded that granting these exemption renewals will provide a level of safety that is equivalent to or greater than the level of safety maintained without the exemptions for these commercial motor vehicle (CMV) drivers.
Each group of renewed exemptions are effective from the dates stated in the discussions below. Comments must be received on or before November 20, 2015.
You may submit comments bearing the Federal Docket Management System (FDMS) numbers: Docket No. [Docket No. FMCSA-1999-5578; FMCSA-1999-5748; FMCSA-2002-12844; FMCSA-2003-15268; FMCSA-2003-15892; FMCSA-2004-17984; FMCSA-2005-20560; FMCSA-2005-21711; FMCSA-2006-26653; FMCSA-2007-27515; FMCSA-2007-27897; FMCSA-2007-29019; FMCSA-2009-0121; FMCSA-2009-0154; FMCSA-2009-0206; FMCSA-2011-0057; FMCSA-2011-0124; FMCSA-2011-0189; FMCSA-2013-0028; FMCSA-2013-0029; FMCSA-2013-0030; FMCSA-2013-0165; FMCSA-2013-0166], using any of the following methods:
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Charles A. Horan, III, Director, Carrier, Driver and Vehicle Safety Standards, 202-366-4001,
Under 49 U.S.C. 31136(e) and 31315, FMCSA may renew an exemption from the vision requirements in 49 CFR 391.41(b)(10), which applies to drivers of CMVs in interstate commerce, for a two-year period if it finds “such exemption would likely achieve a level of safety that is equivalent to or greater than the level that would be achieved absent such exemption.” The procedures for requesting an exemption (including renewals) are set out in 49 CFR part 381.
This notice addresses 64 individuals who have requested renewal of their exemptions in accordance with FMCSA procedures. FMCSA has evaluated these 64 applications for renewal on their merits and decided to extend each exemption for a renewable two-year period. Each individual is identified according to the renewal date.
The exemptions are extended subject to the following conditions: (1) That each individual has a physical examination every year (a) by an ophthalmologist or optometrist who attests that the vision in the better eye continues to meet the requirements in 49 CFR 391.41(b)(10), and (b) by a medical examiner who attests that the individual is otherwise physically qualified under 49 CFR 391.41; (2) that each individual provides a copy of the ophthalmologist's or optometrist's report to the medical examiner at the time of the annual medical examination; and (3) that each individual provide a copy of the annual medical certification to the employer for retention in the driver's qualification file and retains a copy of the certification on his/her person while driving for presentation to a duly authorized Federal, State, or local enforcement official. Each exemption will be valid for two years unless rescinded earlier by FMCSA. 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.
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 for additional two year periods. The following group(s) of drivers will receive renewed exemptions effective in the month of November and are discussed below.
As of November 6, 2015, and in accordance with 49 U.S.C. 31136(e) and 31315, the following 31 individuals have satisfied the conditions for obtaining a renewed exemption from the vision requirements (68 FR 37197; 68 FR 48989; 70 FR 17504; 70 FR 30997; 70 FR 42615; 70 FR 48797; 70 FR 61493; 72 FR 8417; 72 FR 21313; 72 FR 32703; 72 FR 36099; 72 FR 39879; 72 FR 40360; 72 FR 40362; 72 FR 52419; 72 FR 54971; 74 FR 26461; 74 FR 26464; 74 FR 34394; 74 FR 34630; 74 FR 37295; 74 FR 41971; 74 FR 43217; 74 FR 48343; 74 FR 49069; 74 FR 57551; 76 FR 18824; 76 FR 29024; 76 FR 34136; 76 FR 37168; 76 FR 37173; 76 FR 53708; 76 FR 54530; 76 FR 55463; 76 FR 55465; 76 FR 62143; 76 FR 66123; 76 FR 67246; 78 FR 27281; 78 FR 34143; 78 FR 41188; 78 FR 41975; 78 FR 47818; 78 FR 52602; 78 FR 56986; 78 FR 57679; 78 FR 63307; 78 FR 77782; 78 FR 78477; 79 FR 24298; 79 FR 53708):
The drivers were included in one of the following dockets: Docket Nos. FMCSA-2003-15268; FMCSA-2005-20560; FMCSA-2005-21711; FMCSA-2006-26653; FMCSA-2007-27515; FMCSA-2007-27897; FMCSA-2009-0121; FMCSA-2009-0154; FMCSA-2009-0206; FMCSA-2011-0057; FMCSA-2011-0124; FMCSA-2011-0189; FMCSA-2013-0028; FMCSA-2013-0029; FMCSA-2013-0030; FMCSA-2013-0165. Their exemptions are effective as of November 6, 2015 and will expire on November 6, 2017.
As of November 25, 2015, and in accordance with 49 U.S.C. 31136(e) and 31315, the following individual, Dennis E. White (PA), has satisfied the conditions for obtaining a renewed exemption from the vision requirements (78 FR 62935; 78 FR 76395):
The driver is included in the following docket: Docket Nos. FMCSA-2013-0166. Their exemption is effective as of November 25, 2015 and will expire on November 25, 2017.
As of November 26, 2015, and in accordance with 49 U.S.C. 31136(e) and 31315, the following individual, Albert M. Divella (NV), has satisfied the conditions for obtaining a renewed exemption from the vision requirements (78 FR 62935; 78 FR 76395).
The driver is included in the following docket: Docket No. FMCSA-2013-0166. Their exemption is effective as of November 26, 2015 and will expire on November 26, 2017.
As of November 28, 2015, and in accordance with 49 U.S.C. 31136(e) and 31315, the following 17 individuals have satisfied the conditions for obtaining a renewed exemption from the vision requirements (69 FR 33997; 69 FR 61292; 70 FR 48797; 70 FR 61493; 71 FR 55820; 72 FR 39879; 72 FR 52421; 72 FR 54971; 72 FR 58362; 72 FR 67344; 73 FR 65009; 74 FR 41971; 74 FR 49069; 74 FR 57553; 76 FR 4413; 76 FR 62143; 76 FR 70212):
The drivers were included in one of the following dockets: Docket No. FMCSA-2004-17984; FMCSA-2005-21711; FMCSA-2007-27897; FMCSA-2007-29019. Their exemptions are effective as of November 28, 2015 and will expire on November 28, 2017.
As of November 30, 2015, and in accordance with 49 U.S.C. 31136(e) and 31315, the following 14 individuals
The drivers were included in one of the following dockets: Docket No. FMCSA-1999-5578; FMCSA-1999-5748; FMCSA-2002-12844; FMCSA-2003-15892; FMCSA-2005-21711. Their exemptions are effective as of November 30, 2015 and will expire on November 30, 2017.
Each of the 64 applicants listed in the groups above has requested renewal of the exemption and has submitted evidence showing that the vision in the better eye continues to meet the requirement specified at 49 CFR 391.41(b)(10) and that the vision impairment is stable. In addition, a review of each record of safety while driving with the respective vision deficiencies over the past two years indicates each applicant continues to meet the vision exemption requirements.
These factors provide an adequate basis for predicting each driver's ability to continue to drive safely in interstate commerce. Therefore, FMCSA concludes that extending the exemption for each renewal applicant for a period of two years is likely to achieve a level of safety equal to that existing without the exemption.
FMCSA will review comments received at any time concerning a particular driver's safety record and determine if the continuation of the exemption is consistent with the requirements at 49 U.S.C. 31136(e) and 31315. However, FMCSA requests that interested parties with specific data concerning the safety records of these drivers submit comments by November 20, 2015.
FMCSA believes that the requirements for a renewal of an exemption under 49 U.S.C. 31136(e) and 31315 can be satisfied by initially granting the renewal and then requesting and evaluating, if needed, subsequent comments submitted by interested parties. As indicated above, the Agency previously published notices of final disposition announcing its decision to exempt these 64 individuals from the vision requirement in 49 CFR 391.41(b)(10). The final decision to grant an exemption to each of these individuals was made on the merits of each case and made only after careful consideration of the comments received to its notices of applications. The notices of applications stated in detail the qualifications, experience, and medical condition of each applicant for an exemption from the vision requirements. That information is available by consulting the above cited
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.
You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so that FMCSA can contact you if there are questions regarding your submission.
To submit your comment online, go to
We will consider all comments and material received during the comment period and may change this proposed rule based on your comments. FMCSA may issue a final rule at any time after the close of the comment period.
To view comments, as well as any documents mentioned in this preamble, To submit your comment online, go to
Pursuant to a written trackage rights agreement dated June 29, 2015, Norfolk Southern Railway Company (NSR) has agreed to grant overhead temporary trackage rights to Indiana Southern Railroad, LLC (ISRR), over NSR's line of
The transaction may be consummated on or after November 4, 2015, the effective date of the exemption (30 days after the verified notice was filed).
The purpose of the transaction is to allow ISRR limited overhead trackage rights and the ability to provide local rail service to one customer located on the line segment. The parties' agreement provides that the trackage rights are temporary in nature and are scheduled to expire on January 1, 2020.
As a condition to this exemption, any employees affected by the trackage rights will be protected by the conditions imposed in
This notice is filed under 49 CFR 1180.2(d)(7).
Board decisions and notices are available on our Web site at
By the Board, Rachel D. Campbell, Director, Office of Proceedings.
Office of Foreign Assets Control, Treasury.
Notice.
The U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of one individual and one entity whose property and interests in property have been blocked pursuant to the Foreign Narcotics Kingpin Designation Act (Kingpin Act) (21 U.S.C. 1901-1908, 8 U.S.C. 1182).
The designation by the Acting Director of OFAC of the individual and entity identified in this notice pursuant to section 805(b) of the Kingpin Act is effective on October 15, 2015.
Assistant Director, Sanctions Compliance & Evaluation, Office of Foreign Assets Control, U.S. Department of the Treasury, Washington, DC 20220, Tel: (202) 622-2490.
This document and additional information concerning OFAC are available on OFAC's Web site at
The Kingpin Act became law on December 3, 1999. The Kingpin Act establishes a program targeting the activities of significant foreign narcotics traffickers and their organizations on a worldwide basis. It provides a statutory framework for the imposition of sanctions against significant foreign narcotics traffickers and their organizations on a worldwide basis, with the objective of denying their businesses and agents access to the U.S. financial system and the benefits of trade and transactions involving U.S. companies and individuals.
The Kingpin Act blocks all property and interests in property, subject to U.S. jurisdiction, owned or controlled by significant foreign narcotics traffickers as identified by the President. In addition, the Secretary of the Treasury, in consultation with the Attorney General, the Director of the Central Intelligence Agency, the Director of the Federal Bureau of Investigation, the Administrator of the Drug Enforcement Administration, the Secretary of Defense, the Secretary of State, and the Secretary of Homeland Security, may designate and block the property and interests in property, subject to U.S. jurisdiction, of persons who are found to be: (1) Materially assisting in, or providing financial or technological support for or to, or providing goods or services in support of, the international narcotics trafficking activities of a person designated pursuant to the Kingpin Act; (2) owned, controlled, or directed by, or acting for or on behalf of, a person designated pursuant to the Kingpin Act; or (3) playing a significant role in international narcotics trafficking.
On October 15, 2015, the Acting Director of OFAC designated the following individual and entity whose property and interests in property are blocked pursuant to section 805(b) of the Kingpin Act.
PENG, Bo (a.k.a. “PENG, Kevin”); DOB 06 Dec 1983; POB Jiangsu, China; citizen China; Email Address
KAIKAI TECHNOLOGY CO., LTD. (a.k.a. EASTNINE CHEMICALS CO., LTD.; f.k.a. EASTNINE INTERNATIONAL TRADING CO., LTD.; a.k.a. NANJING KAIKAI POLYURETHANE CO., LTD.; a.k.a. NANJING KAIKAI TECHNOLOGY CO., LTD.), No. 3 Fangcao Garden, Longjiang District, Nanjing, Jiangsu 210038, China; Des Voeux Road, Hong Kong; No. 2, Zhongxin Group, Yanshanhe Village, Yangmiao Town, Yangzhou, Jiangsu 210038, China; Goldencard Building,
Office of Foreign Assets Control, Treasury.
Notice.
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of three individuals whose property and interests in property have been unblocked pursuant to the Foreign Narcotics Kingpin Designation Act (Kingpin Act) (21 U.S.C.s 1901-1908, 8 U.S.C. 1182). In addition, OFAC is updating the identifying information for one individual that was previously designated pursuant to the Kingpin Act.
The unblocking and removal from the list of Specially Designated Nationals and Blocked Persons (SDN List) of the individuals identified in this notice whose property and interests in property were blocked pursuant to the Kingpin Act, is effective on October 15, 2015.
Assistant Director, Sanctions Compliance & Evaluation, Department of the Treasury, Office of Foreign Assets Control, Washington, DC 20220, Tel: (202) 622-2420.
This document and additional information concerning OFAC are available from OFAC's Web site at
On December 3, 1999, the Kingpin Act was signed into law by the President of the United States. The Kingpin Act provides a statutory framework for the President to impose sanctions against significant foreign narcotics traffickers and their organizations on a worldwide basis, with the objective of denying their businesses and agents access to the U.S. financial system and to the benefits of trade and transactions involving U.S. persons and entities.
The Kingpin Act blocks all property and interests in property, subject to U.S. jurisdiction, owned or controlled by significant foreign narcotics traffickers as identified by the President. In addition, the Secretary of the Treasury consults with the Attorney General, the Director of the Central Intelligence Agency, the Director of the Federal Bureau of Investigation, the Administrator of the Drug Enforcement Administration, the Secretary of Defense, the Secretary of State, and the Secretary of Homeland Security when designating and blocking the property or interests in property, subject to U.S. jurisdiction, of persons or entities found to be: (1) Materially assisting in, or providing financial or technological support for or to, or providing goods or services in support of, the international narcotics trafficking activities of a person designated pursuant to the Kingpin Act; (2) owned, controlled, or directed by, or acting for or on behalf of, a person designated pursuant to the Kingpin Act; and/or (3) playing a significant role in international narcotics trafficking.
On October 15, 2015, the Associate Director of the Office of Global Targeting removed from the SDN List the individuals listed below, whose property and interests in property were blocked pursuant to the Kingpin Act:
1. CORTES VILLASENOR, Luis, Av. Vallarta No. 3060, Colonia Vallarta San Jorge, Guadalajara, Jalisco, Mexico; DOB 03 Mar 1971; POB Mexico City, Mexico; R.F.C. COVL7103034L4 (Mexico) (individual) [SDNTK] (Linked To: GRUPO FRACSA, S.A. DE C.V.; Linked To: GRUPO CONSTRUCTOR SEGUNDO MILENIO, S.A. DE C.V.).
2. MONTOYA ZAPATA, Catalina Alexandra, c/o BIO FORESTAL S.A., Medellin, Colombia; c/o GANADERIA LA SORGUITA S.A., Medellin, Colombia; c/o INVERPUNTO DEL VALLE S.A., Cali, Colombia; c/o PARQUES TEMATICOS S.A., Medellin, Colombia; c/o PROMO RAIZ S.A., Medellin, Colombia; DOB 28 Apr 1985; POB Yarumal, Antioquia, Colombia; Cedula No. 32299453 (Colombia) (individual) [SDNTK].
3. PACHECO PARRA, Ana Yesennia (a.k.a. PACHECO CHAVEZ, Ana Yesennia), c/o C.I. OKCOFFEE COLOMBIA S.A., Bogota, Colombia; c/o C.I. OKCOFFEE INTERNATIONAL S.A., Bogota, Colombia; c/o INVERPUNTO DEL VALLE S.A., Cali, Colombia; c/o PARQUES TEMATICOS S.A., Medellin, Colombia; c/o PROMO RAIZ S.A., Medellin, Colombia; Carrera 22A No. 159B-18 P-3, Bogota, Colombia; DOB 22 Feb 1982; POB Miraflores, Boyaca, Colombia; Cedula No. 52866649 (Colombia) (individual) [SDNTK].
ALVAREZ TOSTADO, Jose (a.k.a. CASTELLANOS ALVAREZ TOSTADO, Juan Jose; a.k.a. GONZALEZ, Jose) (DOB 27 Aug 55; POB Mexico) (individual) [SDNTK]
The listing for this entity now appears as follows:
ALVAREZ TOSTADO, Jose (a.k.a. CASTELLANOS ALVAREZ TOSTADO, Juan Jose) (DOB 27 Aug 1955; POB Mexico; Nationality Mexican) (individual) [SDNTK]
Office of Foreign Assets Control, Treasury.
Notice.
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of the individuals whose property and interests in property have been unblocked pursuant to Executive Order 12978 of October 21, 1995, Blocking Assets and Prohibiting Transactions With Significant Narcotics Traffickers.
The unblocking and removal from the list of Specially Designated Nationals and Blocked Persons (SDN List) of the six individuals identified in this notice whose property and interests in property were blocked pursuant to
Assistant Director, Sanctions Compliance & Evaluation, Department of the Treasury, Office of Foreign Assets Control, Washington, DC 20220, Tel: (202) 622-2490.
This document and additional information concerning OFAC are available from OFAC's Web site (
On October 21, 1995, the President, invoking the authority,
Section 1 of the Order blocks, with certain exceptions, all property and interests in property that are in the United States, or that hereafter come within the United States or that are or hereafter come within the possession or control of United States persons, of: (1) The foreign persons listed in an Annex to the Order; (2) any foreign person determined by the Secretary of Treasury, in consultation with the Attorney General and the Secretary of State: (a) To play a significant role in international narcotics trafficking centered in Colombia; or (b) to materially assist in, or provide financial or technological support for or goods or services in support of, the narcotics trafficking activities of persons designated in or pursuant to the Order; and (3) persons determined by the Secretary of the Treasury, in consultation with the Attorney General and the Secretary of State, to be owned or controlled by, or to act for or on behalf of, persons designated pursuant to the Order.
On October 15, 2015, the Associate Director of the Office of Global Targeting removed from the SDN List the individuals listed below, whose property and interests in property were blocked pursuant to the Order:
Individuals:
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
The Veterans Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
VA Form 26-8937 solicits comments on information needed for lenders to determine they have evidence from VA that there is no debt, or if a debt exists, an acceptable repayment plan has been agreed to by the veteran, or payments under a plan already in effect are current.
Written comments and recommendations on the proposed collection of information should be received on or before December 21, 2015.
Submit written comments on the collection of information through Federal Docket Management System (FDMS) at
Nancy J. Kessinger at (202) 632-8924 or FAX (202) 632-8925.
Under the PRA of 1995 (Pub. L. 104-13; 44 U.S.C. 3501-21), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to Section 3506(c)(2)(A) of the PRA.
With respect to the following collection of information, VBA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of VBA's functions, including whether the information will have practical utility; (2) the accuracy of VBA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.
By direction of the Secretary.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
The Veterans Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
VA Form 21-0304 is used to gather information necessary to determine eligibility for a monetary allowance for a child born with Spina Bifida or certain birth defects who is a natural child of a Vietnam Veteran.
Written comments and recommendations on the proposed collection of information should be received on or before December 21, 2015.
Submit written comments on the collection of information through Federal Docket Management System (FDMS) at
Nancy J. Kessinger at (202) 632-8924 or FAX (202) 632-8925.
Under the PRA of 1995 (Pub. L. 104-13; 44 U.S.C. 3501-21), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to section 3506(c)(2)(A) of the PRA.
With respect to the following collection of information, VBA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of VBA's functions, including whether the information will have practical utility; (2) the accuracy of VBA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.
By direction of the Secretary.
Veterans Health Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Veterans Health Administration (VHA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden and includes the actual data collection instrument.
Written comments and recommendations on the proposed collection of information should be received on or before November 20, 2015.
Submit written comments on the collection of information through
Crystal Rennie, Enterprise Records Service (005R1B), Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, (202) 632-7492 or email
Under the PRA of 1995 (Pub. L. 104-13; 44 U.S.C. 3501-3521), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to Section 3506(c)(2)(A) of the PRA.
With respect to the following collection of information, VHA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of VHA's functions, including whether the information will have practical utility; (2) the accuracy of VHA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.
VA physician will obtain the information on the VA Form 10-0048 during a medical examination. If these questions were not asked, the physician would be unable to assess the health care, disability compensation or rehabilitation needs of the Former Prisoner Of War (FPOW). The importance of collecting this very detailed information when the veteran is first seen is critical, not only with the physician evaluating the veteran but also by the rating specialist who will rate this claim. The rater also reviews the statements given by the veteran on this form not only at the first claim submission but in future years when other disabilities are claimed. Feedback from POW physicians in the field indicates their appreciation of the well thought out content and structure of the form. It is useful not only for Compensation and Pension examinations but also as a guide and reference for treatment planning for the FPOW patient. The questions in the form make it relevant for FPOWS of current as well as prior conflicts.
By direction of the Secretary.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
The Veterans Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
VA Form 21-0819 is used to gather the necessary information to determine eligibility for active duty service members who may be eligible for DoD Disability Evaluation Board and VA compensation. Without this information, determination of entitlement would not be possible.
Written comments and recommendations on the proposed collection of information should be received on or before December 21, 2015.
Submit written comments on the collection of information through Federal Docket Management System (FDMS) at
Nancy J. Kessinger at (202) 632-8924 or FAX (202) 632-8925.
Under the PRA of 1995 (Pub. L. 104-13; 44 U.S.C. 3501-21), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to Section 3506(c)(2)(A) of the PRA.
With respect to the following collection of information, VBA invites comments on: (1) Whether the proposed
By direction of the Secretary.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
The Veterans Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
Written comments and recommendations on the proposed collection of information should be received on or before December 21, 2015.
Submit written comments on the collection of information through Federal Docket Management System (FDMS) at
Nancy J. Kessinger at (202) 632-8924 or FAX (202) 632-8925.
Under the PRA of 1995 (Pub. L. 104-13; 44 U.S.C. 3501-21), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to Section 3506(c)(2)(A) of the PRA.
With respect to the following collection of information, VBA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of VBA's functions, including whether the information will have practical utility; (2) the accuracy of VBA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.
By direction of the Secretary.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-21), this notice announces that the Veterans Benefits Administration, Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden and it includes the actual data collection instrument.
Comments must be submitted on or before November 20, 2015.
Submit written comments on the collection of information through
Crystal Rennie, Enterprise Records Service (005R1B), Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, (202) 632-7492 or email
VA Form 21-0307 provides information to a child of a Vietnam Veteran with spina bifida or certain birth defects to inform them of potential entitlement to VA health care benefits and vocational training programs. Without the information provided on this form, potentially eligible children would not be able to apply for these benefits.
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The
By direction of the Secretary.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
The Veterans Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
The Pre-Discharge Compensation Claim is used by service members to file claims under the Benefits Delivery at Discharge or Quick Start programs under Title 38 U.S.C. 5101(a). Without this information, VA would be unable to effectively administer this law.
Written comments and recommendations on the proposed collection of information should be received on or before December 21, 2015.
Submit written comments on the collection of information through Federal Docket Management System (FDMS) at
Nancy J. Kessinger at (202) 632-8924 or FAX (202) 632-8925.
Under the PRA of 1995 (Pub. L. 104-13; 44 U.S.C. 3501-21), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to Section 3506(c)(2)(A) of the PRA.
With respect to the following collection of information, VBA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of VBA's functions, including whether the information will have practical utility; (2) the accuracy of VBA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.
By direction of the Secretary.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument.
Comments must be submitted on or before November 20, 2015.
Submit written comments on the collection of information through
Crystal Rennie, Enterprise Records Service (005R1B), Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420, (202) 632-7492 or email
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The
By direction of the Secretary.
Office of Management, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Office of Management (OM), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument.
Written comments and recommendations on the proposed collection of information should be received on or before November 20, 2015.
Submit written comments on the collection of information through
Crystal Rennie, Enterprise Records Service (005R1B), Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, (202) 632-7492 or email
Under the PRA of 1995 (Pub. L. 104-13; 44 U.S.C. 3501-3521), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to section 3506(c)(2)(A) of the PRA.
a. Architect—Engineer Fee Proposal, VA Form 10-6298.
b. Daily Log (Contract Progress Report—Formal Contract), VA Form 10-6131.
c. Supplement Contract Progress Report, VA Form 10-61001a.
a. An Architect-engineering firm selected for negotiation of a contract with VA is required to submit a fee proposal based on the scope and complexity of the project. VA Form 10-6298 is used to obtain such proposal and supporting cost or pricing data from the contractor and subcontractor.
b. VA Forms 10-6131 and 10-6001a are used to record data necessary to assure the contractor provides sufficient labor and materials to accomplish the contract work. VA Form 10-6131 is used for national contracts and VA Form 10-6001a is used for smaller VA Medical Center station level projects and as an option on major projects before the interim schedule is submitted. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The
a. VA Form 10-6298—1,000.
b. VA Form 10-6131—3,591.
c. VA Form 10-6001a—750.
a. VA Form 10-6298—4 hours.
b. VA Form 10-6131—12 minutes.
c. VA Form 10-6001a—12 minutes.
a. VA Form 10-6298—250.
b. VA Form 10-6131—17,955.
c. VA Form 10-6001a—3,750.
By direction of the Secretary.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
The Veterans Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
Written comments and recommendations on the proposed collection of information should be received on or before December 21, 2015.
Submit written comments on the collection of information through Federal Docket Management System (FDMS) at
Nancy J. Kessinger at (202) 632-8924 or FAX (202) 632-8925. Please refer to “OMB Control No. 2900-0745.”
Under the PRA of 1995 (Pub. L.104-13; 44 U.S.C. 3501-21), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to section 3506(c)(2)(A) of the PRA.
With respect to the following collection of information, VBA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of VBA's functions, including whether the information will have practical utility; (2) the accuracy of VBA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The
By direction of the Secretary.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument.
Comments must be submitted on or before November 20, 2015.
Submit written comments on the collection of information through
Crystal Rennie, Enterprise Records Service (005R1B), Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, (202) 632-7492 or email
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The
By direction of the Secretary.
Veterans Health Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Veterans Health Administration (VHA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden and includes the actual data collection instrument.
Written comments and recommendations on the proposed collection of information should be received on or before November 20, 2015.
Submit written comments on the collection of information through
Crystal Rennie, Enterprise Records Service (005R1B), Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, (202) 632-7492 or email
Under the PRA of 1995 (Pub. L. 104-13; 44 U.S.C. 3501-3521), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to Section 3506(c)(2)(A) of the PRA.
With respect to the following collection of information, VHA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of VHA's functions, including whether the information will have practical utility; (2) the accuracy of VHA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.
VA physician will obtain the information on the VA Form 10-0048 during a medical examination. If these questions were not asked, the physician would be unable to assess the health care, disability compensation or rehabilitation needs of the Former Prisoner Of War (FPOW). The importance of collecting this very detailed information when the veteran is first seen is critical, not only with the physician evaluating the veteran but also by the rating specialist who will rate this claim. The rater also reviews the statements given by the veteran on this form not only at the first claim submission but in future years when other disabilities are claimed. Feedback from POW physicians in the field indicates their appreciation of the well thought out content and structure of the form. It is useful not only for Compensation and Pension examinations but also as a guide and reference for treatment planning for the FPOW patient. The questions in the form make it relevant for FPOWS of current as well as prior conflicts.
By direction of the Secretary.
Department of Veterans Affairs.
Notice of Availability ROD.
The Department of Veterans Affairs (VA), San Francisco Health Care System (SFHCS) announces the availability of the Record of Decision (ROD) for the Long Range Development Plan (LRDP)/Environmental Impact Statement (EIS) for the San Francisco VA Medical Center (SFVAMC).
Copies of the ROD are available by request by writing to Robin Flanagan, Planning Office, SFVAMC 4150 Clement Street, San Francisco, CA 94121, telephone (415) 750-2049. The document is also available on the internet at the SFVAMC Web site:
Robin Flanagan, San Francisco VA Medical Center, 4150 Clement Street, San Francisco, CA 94121 or by telephone, (415) 750-2049.
SFVAMC, the only VA medical center in San Francisco County, has major space and parking deficiencies at its existing Fort Miley Campus. The mission of SFVAMC is to continue to be a major primary and tertiary care health care center providing cost-effective and high-quality care to eligible Veterans in the San Francisco Bay Area and North Coast. SFVAMC strives to deliver needed care to Veterans while contributing to health care knowledge through research and education. VA can better meet its mission by integrating clinical care, education, and research, because such integration makes for more efficient and progressive overall care for Veterans. SFVAMC is also a ready resource for Department of Defense (DoD) as backup for Federal emergencies and serves as the local Federal Coordinating Center (FCC) in the event of a national emergency. SFVAMC has completed the waiting period for the Final EIS and is going forward with the ROD.
VA issues the ROD for the Final LRDP/EIS as approved by, the VA Sierra Pacific Network (VISN 21) Director. The LRDP/EIS analyzed four alternatives, including a no-action alternative. The full range of foreseeable environmental
VA's decision is to implement Alternative 1 (hereinafter referred to as the “selected action”), which was identified in the final LRDP/EIS as the preferred alternative. VA's selected action consists of LRDP construction, retrofitting, and operation on the 29-acre Fort Miley Campus to meet seismic safety requirements, and to provide an additional 554,452 net new gross square feet (gsf), which will include 322,200 gsf of medical facilities space and 232,252 gsf for 306 net new parking garage spaces. This will allow the SFVAMC to continue offering combined clinical, research, and educational programs to satisfy the needs of all San Francisco Bay Area and North Coast Veterans over the next 15 years. Under the selected action, VA would construct the LRDP in phases, with the first phase including 384,000 gsf of net new development, as well as seismic retrofits schedule for completion by 2020. The second phase would include an additional 170,000 gsf of net new development scheduled for completion by 2026.
The ROD includes a summary of the purpose and need for action, identifies the selected action and all alternatives considered by the SFVAMC, lists measures to minimize environmental harm, details about the monitoring and mitigation plans, and describes the environmentally preferable alternative.
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. Robert L. Nabors II, Chief of Staff, Department of Veterans Affairs, approved this document on October 15, 2015, for publication.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
The Veterans Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
VA Form 21-0161a is used to gather information to determine entitlement to income-dependent benefits.
Written comments and recommendations on the proposed collection of information should be received on or before December 21, 2015.
Submit written comments on the collection of information through Federal Docket Management System (FDMS) at
Nancy J. Kessinger at (202) 632-8924 or FAX (202) 632-8925.
Under the PRA of 1995 (Pub. L. 104-13; 44 U.S.C. 3501-21), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to Section 3506(c)(2)(A) of the PRA.
With respect to the following collection of information, VBA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of VBA's functions, including whether the information will have practical utility; (2) the accuracy of VBA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.
By direction of the Secretary.
Department of Veterans Affairs.
Notice with request for comments.
Section 203 of the Department of Veterans Affairs Health Care Personnel Act of 1991 (Pub. L. 102-40), dated May 7, 1991, revised the disciplinary grievance and appeal procedures for employees appointed under 38 U.S.C. 7401(1). It also required the periodic designation of employees of the Department who are qualified to serve on Disciplinary Appeals Boards. These employees constitute the Disciplinary Appeals Board Panel from which Board members in a case are appointed. This notice announces that the roster of employees on the Panel is available for review and comment. Employees, employee organizations,
Names that appear on the Panel may be selected to serve on a Board or as a grievance examiner after November 20, 2015.
Requests for the list of names of employees on the Panel and written comments may be directed to: Secretary of Veterans Affairs, Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420. Requests and comments may also be faxed to (202) 495-5200.
Larry Ables, Employee Relations & Performance Management Service, Office of Human Resources Management, Department of Veterans Affairs, 810 Vermont Avenue NW., Mailstop 051, Washington, DC 20420. Mr. Ables may be reached at (202) 461-6172.
Public Law 102-40 requires that the availability of the roster be posted in the
The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Robert L. Nabors II, Chief of Staff, Department of Veterans Affairs, approved this document on October 13, 2015, for publication.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
The Veterans Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
The holder of a vendee account which has been guaranteed by the Department of Veterans Affairs (VA) may request VA to repurchase a loan as provided in 38 CFR 36.4600(d).
Written comments and recommendations on the proposed collection of information should be received on or before December 21, 2015.
Submit written comments on the collection of information through Federal Docket Management System (FDMS) at
Nancy J. Kessinger at (202) 632-8924 or FAX (202) 632-8925.
Under the PRA of 1995 (Pub. L. 104-13; 44 U.S.C. 3501-21), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to Section 3506 (c)(2)(A) of the PRA.
With respect to the following collection of information, VBA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of VBA's functions, including whether the information will have practical utility; (2) the accuracy of VBA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.
By direction of the Secretary.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument.
Comments must be submitted on or before November 20, 2015.
Submit written comments on the collection of information through
Crystal Rennie, Enterprise Records Service (005R1B), Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, (202) 632-7492 or email
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The
By direction of the Secretary.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
The Veterans Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
The holder of a vendee account which has been guaranteed by the Department of Veterans Affairs (VA) may request VA to repurchase a loan as provided in 38 CFR 36.4600(d).
Written comments and recommendations on the proposed collection of information should be received on or before December 21, 2015.
Submit written comments on the collection of information through Federal Docket Management System (FDMS) at
Nancy J. Kessinger at (202) 632-8924 or FAX (202) 632-8925.
Under the PRA of 1995 (Pub. L. 104-13; 44 U.S.C. 3501-21), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to section 3506(c)(2)(A) of the PRA.
With respect to the following collection of information, VBA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of VBA's functions, including whether the information will have practical utility; (2) the accuracy of VBA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.
By direction of the Secretary.
| 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 |