Page Range | 46827-47000 | |
FR Document |
Page and Subject | |
---|---|
81 FR 46994 - Sunshine Act Meeting | |
81 FR 46988 - Sunshine Act Meeting | |
81 FR 46957 - Privacy Act of 1974, as Amended; System of Records Notice | |
81 FR 46925 - Sunshine Act; Notice of FRTIB Board Member Meeting | |
81 FR 46970 - Sunshine Act Meeting Notice | |
81 FR 46920 - Sunshine Act Meeting Notice | |
81 FR 46926 - Agency Information Collection Activities: Proposed Collection; Comment Request | |
81 FR 46887 - Agency Information Collection Activities: Proposed Collection; Comment Request-FDPIR Nutrition Paraprofessional Training Assessment for Indian Tribal Organizations | |
81 FR 46904 - Crystalline Silicon Photovoltaic Cells, Whether or Not Assembled Into Modules, From the People's Republic of China: Final Results of Countervailing Duty Administrative Review; 2013 | |
81 FR 46866 - Air Plan Approval; New Hampshire; Regional Haze 5-Year Report | |
81 FR 46956 - Importer of Controlled Substances Application: Rhodes Technologies | |
81 FR 46956 - Bulk Manufacturer of Controlled Substances Application: Cambrex Charles City | |
81 FR 46925 - Agency Information Collection Activities: Submission for OMB Review; Comment Request | |
81 FR 46883 - Fisheries of the Exclusive Economic Zone Off Alaska; Bering Sea and Aleutian Islands Management Area; Amendment 113 | |
81 FR 46906 - Multilayered Wood Flooring From the People's Republic of China: Rescission of Antidumping Duty New Shipper Review; 2013-2014 | |
81 FR 46899 - Multilayered Wood Flooring From the People's Republic of China: Final Results of Antidumping Duty Administrative Review; 2013-2014 | |
81 FR 46913 - Proposed Information Collection; Comment Request | |
81 FR 46970 - Guidance for Closure of Activities Related to Recommendation 2.1, Flooding Hazard Reevaluation | |
81 FR 46904 - Meeting of the United States Manufacturing Council | |
81 FR 46940 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Bar Code Label Requirement for Human Drug and Biological Products | |
81 FR 46848 - Reef Fish Fishery of the Gulf of Mexico; 2016 Recreational Accountability Measures and Closure for Gulf of Mexico Gray Triggerfish | |
81 FR 46951 - Agency Information Collection Activities: Petition for Nonimmigrant Worker, Form I-129; Extension, Without Change, of a Currently Approved Collection | |
81 FR 46952 - Agency Information Collection Activities: Registration for Classification as a Refugee, Form I-590; Revision of a Currently Approved Collection | |
81 FR 46957 - Annual Determination of Average Cost of Incarceration | |
81 FR 46833 - Safety Zone; Navy UNDET, Apra Outer Harbor, GU | |
81 FR 46907 - State Alternative Plan Program (SAPP) and the First Responder Network Authority Nationwide Public Safety Broadband Network | |
81 FR 46898 - In the Matter of: Fang Liwu, Nan Hu Xi Yuan 50505, Chai Yang District, Wang Ging, Beijing, China; Order Denying Export Privileges | |
81 FR 46941 - Agency Information Collection Activities: Proposed Collection: Public Comment Request-Scholarships for Disadvantaged Students Program | |
81 FR 46827 - Program Fraud Civil Remedies: Civil Monetary Penalty Inflation Adjustment | |
81 FR 46918 - Rio Grande LNG, LLC; Application for Long-Term, Multi-Contract Authorization To Export Liquefied Natural Gas to Non-Free Trade Agreement Nations | |
81 FR 46917 - Excess Uranium Management: Effects of DOE Transfers of Excess Uranium on Domestic Uranium Mining, Conversion, and Enrichment Industries; Request for Information | |
81 FR 46954 - Notice of Proposed Reinstatement of Terminated Oil and Gas Lease WYW160587, Wyoming | |
81 FR 46924 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company | |
81 FR 46954 - Notice of Proposed Reinstatement of Terminated Oil and Gas Lease WYW178491, Wyoming | |
81 FR 46954 - Renewal of Approved Information Collection; OMB Control No. 1004-0132 | |
81 FR 46943 - Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort | |
81 FR 46935 - Agency Information Collection Activities; Proposed Collection; Comment Request; Protection of Human Subjects: Informed Consent; Institutional Review Boards | |
81 FR 46941 - Pediatric Clinical Investigator Training Workshop; Correction | |
81 FR 46956 - Certain Windscreen Wipers and Components Thereof; Notice of a Commission Determination Not To Review an Initial Determination Granting a Joint Motion To Terminate the Investigation Based on a Settlement Agreement | |
81 FR 46920 - Alaska Energy Authority; Notice of Availability of Final Environmental Assessment | |
81 FR 46938 - E2C(R2) Periodic Benefit-Risk Evaluation Report and E2C(R2) Periodic Benefit-Risk Evaluation Report-Questions and Answers; International Council for Harmonisation; Guidances for Industry; Availability | |
81 FR 46928 - Pre-Clinical Evaluation of Red Blood Cells for Transfusion; Public Workshop | |
81 FR 46848 - Inspection of Towing Vessels | |
81 FR 46833 - Drawbridge Operation Regulation; State Boat Channel, Captree Island, NY | |
81 FR 46942 - Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Rural Health Care Coordination Network Partnership | |
81 FR 46951 - Approval of Barrios Measurement Services LLC, as a Commercial Gauger | |
81 FR 46946 - Accreditation and Approval of Camin Cargo Control, Inc., as a Commercial Gauger and Laboratory | |
81 FR 46947 - Accreditation and Approval of Camin Cargo Control, Inc., as a Commercial Gauger and Laboratory | |
81 FR 46988 - Submission for OMB Review; Comment Request | |
81 FR 46978 - Proposed Collection; Comment Request | |
81 FR 46988 - Order Granting Limited Exemptions from Exchange Act Rule 10b-17 and Rules 101 and 102 of Regulation M to PowerShares DWA Momentum & Low Volatility Rotation Portfolio Pursuant to Exchange Act Rule 10b-17(b)(2) and Rules 101(d) and 102(e) of Regulation M | |
81 FR 46945 - Accreditation and Approval of Camin Cargo Control, Inc., as a Commercial Gauger and Laboratory | |
81 FR 46948 - Accreditation and Approval of SGS North America, Inc., as a Commercial Gauger and Laboratory | |
81 FR 46950 - Accreditation and Approval of SGS North America, Inc., as a Commercial Gauger and Laboratory | |
81 FR 46949 - Accreditation and Approval of SGS North America, Inc., as a Commercial Gauger and Laboratory | |
81 FR 46945 - Approval of SGS North America, Inc., As a Commercial Gauger | |
81 FR 46947 - Approval of Marine Technical Surveyors, Inc., as a Commercial Gauger | |
81 FR 46996 - Petition for Exemption; Summary of Petition Received; Homeland Surveillance and Electronics LLC | |
81 FR 46997 - Petition for Exemption; Summary of Petition Received; Flirtey Inc. | |
81 FR 46996 - Petition for Exemption; Summary of Petition Received; Area-I, Incorporated | |
81 FR 46997 - Petition for Exemption; Summary of Petition Received; Continuum Dynamics Inc. | |
81 FR 46974 - International Product Change-Inbound Market Dominant Registered Service Agreement | |
81 FR 46994 - Request for Public Comments To Compile the National Trade Estimate Report on Foreign Trade Barriers | |
81 FR 46958 - Quarterly Public Meeting | |
81 FR 46895 - Designation for the West Sacramento, CA; and Richmond, VA Areas | |
81 FR 46886 - Notice of Availability of a Pest Risk Analysis for the Importation of Fresh Star Apple Fruit From Vietnam Into the Continental United States | |
81 FR 46927 - Administration on Disabilities, President's Committee for People With Intellectual Disabilities | |
81 FR 46835 - Safety Zone; Fleet Week Maritime Festival, 2016, Pier 66, Elliott Bay; Seattle, WA | |
81 FR 46928 - Agency Information Collection Activities; Proposed Extension With No Changes of a Currently Approved Collection; Submission for OMB Review; Comment Request; State Program Report | |
81 FR 46890 - Final Directive for National Saw Program | |
81 FR 46927 - Agency Information Collection Activities: Submission for OMB Review; Comment Request; OAA Title III-C Evaluation | |
81 FR 46974 - Self-Regulatory Organizations; Bats EDGX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change to EDGX Rule 13.4(a), Stating It Will Utilize IEX Market Data From the CQS/UQDF for Purposes of Order Handling, Routing, and Related Compliance Processes | |
81 FR 46990 - Self-Regulatory Organizations; BOX Options Exchange LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Introduce New Risk Protections on the Exchange and Provide Enhancements to Current Risk Protections | |
81 FR 46979 - Self-Regulatory Organizations; NASDAQ PHLX LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Adopt Rules To Implement the Quoting and Trading Provisions of the Plan To Implement a Tick Size Pilot Program | |
81 FR 46975 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Related to the Automated Improvement Mechanism | |
81 FR 46986 - Self-Regulatory Organizations; C2 Options Exchange, Incorporated; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Related to the Automated Improvement Mechanism | |
81 FR 46984 - Self-Regulatory Organizations; Bats EDGA Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change to EDGA Rule 13.4(a), Stating It Will Utilize IEX Market Data From the CQS/UQDF for Purposes of Order Handling, Routing, and Related Compliance Processes | |
81 FR 46828 - Emergency Permit Control Regulations; Technical Amendments | |
81 FR 46895 - Proposed Information Collection; Comment Request; 2017 Puerto Rico Census Test | |
81 FR 46922 - Privacy Act System of Records | |
81 FR 46836 - Approval and Promulgation of State Implementation Plan Revisions to Permits, Rules and Approval Orders; Utah | |
81 FR 46865 - Approval and Promulgation of State Implementation Plan Revisions to Permits, Rules and Approval Orders; Utah | |
81 FR 46852 - Approval and Revision of Air Plans; Arizona; Regional Haze State and Federal Implementation Plans; Reconsideration | |
81 FR 46917 - State Energy Advisory Board (STEAB) | |
81 FR 46972 - Information Collection: NRC Form 314, Certificate of Disposition of Materials | |
81 FR 46916 - Environmental Management Site-Specific Advisory Board, Oak Ridge Reservation | |
81 FR 46916 - National Petroleum Council | |
81 FR 46944 - Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting | |
81 FR 46945 - National Heart, Lung, and Blood Institute; Notice of Closed Meeting | |
81 FR 46973 - Submission of Information Collection for OMB Review; Comment Request; Filings for Reconsideration | |
81 FR 46999 - Public Meeting Concerning Test Device for Human Occupant Restraint (THOR) | |
81 FR 46953 - Intent To Grant an Exclusive License | |
81 FR 46998 - Notice of Receipt of Petition for Decision That Nonconforming Model Year 2011 Ducati Multistrada Motorcycles Are Eligible for Importation | |
81 FR 46915 - President's Board of Advisors on Historically Black Colleges and Universities | |
81 FR 46958 - Biweekly Notice; Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving No Significant Hazards Considerations | |
81 FR 46851 - Proposed Establishment of Temporary Restricted Areas R-2509E, R-2509W, and R-2509N; Twentynine Palms, CA; Withdrawal | |
81 FR 46913 - Board on Coastal Engineering Research | |
81 FR 46929 - Prescription Drug User Fee Act; Public Meeting; Request for Comments | |
81 FR 46870 - Process Reform for Executive Branch Review of Certain FCC Applications and Petitions Involving Foreign Ownership | |
81 FR 46839 - Expedited Approval of Alternative Test Procedures for the Analysis of Contaminants Under the Safe Drinking Water Act; Analysis and Sampling Procedures | |
81 FR 46832 - Inversions and Related Transactions; Correction | |
81 FR 46850 - Notice of Proposed Rulemaking | |
81 FR 46944 - Agency Information Collection Request; 30-Day Public Comment Request, Grants.gov |
Animal and Plant Health Inspection Service
Food and Nutrition Service
Forest Service
Grain Inspection, Packers and Stockyards Administration
Census Bureau
Industry and Security Bureau
International Trade Administration
National Oceanic and Atmospheric Administration
National Telecommunications and Information Administration
Engineers Corps
Federal Energy Regulatory Commission
Centers for Medicare & Medicaid Services
Community Living Administration
Food and Drug Administration
Health Resources and Services Administration
National Institutes of Health
Coast Guard
U.S. Citizenship and Immigration Services
U.S. Customs and Border Protection
Geological Survey
Land Management Bureau
Drug Enforcement Administration
Prisons Bureau
Federal Aviation Administration
National Highway Traffic Safety Administration
Internal Revenue Service
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.
Office of Personnel Management (OPM).
Interim rule.
This rule adjusts the level of civil monetary penalties contained in U.S. Office of Personnel Management regulations implementing the Program Fraud Civil Remedies Act of 1986, with an initial “catch-up” adjustment under the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 and Office of Management and Budget guidance.
You may submit comments, identified by RIN 3206-AN39, by any of the following methods:
1. Internet—Send comments via email to
2. Fax—(202) 606-0082.
3. Mail—Office of the General Counsel, ATTN: Katherine Pickar, Office of Personnel Management, 1900 E St. NW., Washington, DC 20415.
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 RIN 3206-AN39.
Katherine M. Pickar, Office of the General Counsel, Office of Personnel Management, 1900 E St. NW., Washington, DC 20415,
On November 2, 2015, the President signed into law the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Sec. 701 of Pub. L. 114-74) (“the Act”). The Act requires agencies to: (1) Adjust the level of civil monetary penalties with an initial “catch-up” adjustment through an interim final rulemaking, and (2) make subsequent annual adjustments for inflation. The purpose of these adjustments is to maintain the deterrent effect of civil penalties.
This rule adjusts the following civil monetary penalties:
This interim final rule is being issued without prior public notice or opportunity for public comments. The 2015 Act's amendments to the Inflation Adjustment Act require the agency to adjust penalties initially through an interim final rulemaking, which does not require the agency to complete a notice and comment process prior to promulgating the interim final rule. The amendments also explicitly require the agency to make subsequent annual adjustments notwithstanding 5 U.S.C. 553 (the section of the Administrative Procedure Act that normally requires agencies to engage in notice and comment). Additionally, the formula used for adjusting the amount of civil penalties is given by statute, with no discretion provided to OPM regarding the substance of the adjustments. OPM is charged only with performing ministerial computations to determine the amount of adjustment to the civil penalties due to increases in the Consumer Price Index for all Urban Consumers (CPI-U).
The Office of Management and Budget (OMB) issued guidance on calculating the catch-up adjustment.
For purposes of the initial adjustment under the 2015 Act, while 5 CFR part 185 was not promulgated until 1995, the civil penalties listed in part 185 were established in 1986 with the enactment of the Program Fraud Civil Remedies Act of 1986, Public Law 99-509, §§ 6101-6104, 100 Stat. 1874 (October 21, 1986), codified at 31 U.S.C. 3801-3812. The amount of the penalties have not been changed since 1986. The 1986
OPM, with the concurrence of the Office of Management and Budget (OMB), has determined that this is not a significant regulatory action under Executive Order 12866, as supplemented by Executive Order 13563. Therefore, no regulatory impact analysis is required.
The Regulatory Flexibility Act (RFA) requires an agency to prepare a regulatory flexibility analysis for rules unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. The RFA applies only to rules for which an agency is required to first publish a proposed rule. See 5 U.S.C. 603(a) and 604(a). The Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 requires agencies to adjust civil penalties with an initial catch-up adjustment through an interim final rule. An interim final rule does not include first publishing a proposed rule. Thus, the RFA does not apply to this final rule.
This rule is not a major rule under the Small Business Regulatory Enforcement Fairness Act. This rule:
(a) Does not have an annual effect on the economy of $100 million or more.
(b) Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions.
(c) Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of United States-based enterprises to compete with foreign-based enterprises.
This rule does not involve a Federal mandate that may result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $100 million or more and that such rulemaking will not significantly or uniquely affect small governments.
This rule does not have takings implications.
This rule does not have federalism implications. The rule does not have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government.
This rule complies with the requirements of E.O. 12988. Specifically, this rule:
(a) Does not unduly burden the judicial system.
(b) Meets the criteria of section 3(a) requiring that all regulations be reviewed to eliminate errors and ambiguity and be written to minimize litigation; and
(c) Meets the criteria of section 3(b)(2) requiring that all regulations be written in clear language and contain clear legal standards.
In accordance with Executive Order 13175, OPM has evaluated this rule and determined that it has no tribal implications.
This document does not contain information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13.
Administrative practice and procedure, Claims, Fraud, Penalties.
For the reasons set forth in the preamble, amend part 185 of title 5 of the Code of Federal Regulations as follows:
28 U.S.C. 2461 note; 31 U.S.C. 3801-3812.
Food and Drug Administration, HHS.
Final rule; technical amendments.
The Food and Drug Administration (FDA or we) is amending certain regulations pertaining to registration and process filings related to acidified foods and thermally processed low-acid foods packaged in hermetically sealed containers (historically referred to as “low-acid canned foods” or “LACF”). The amendments reflect new FDA process filing form numbers, make changes to addresses or locations where such forms can be found or must be sent, remove obsolete references to the effective dates that occurred years ago, and update a reference to another Federal Agency.
This rule is effective August 18, 2016. See section VI for further information on the filing of objections. Submit either electronic or written objections and requests for a hearing by August 18, 2016.
You may submit objections and requests for a hearing as follows:
Submit electronic objections in the following way:
•
• If you want to submit an objection with confidential information that you do not wish to be made available to the public, submit the objection 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 objections submitted to the Division of Dockets Management, FDA will post your objection, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit an objection with confidential information that you do not wish to be made publicly available, submit your objections 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
Susan Brecher, Center for Food Safety and Applied Nutrition (HFS-302), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740-3835, 240-402-1781.
Among other things, our current regulations at part 108 (21 CFR part 108) provide that a commercial processor, when first engaging in the manufacture, processing, or packing of acidified foods or low-acid canned foods, must, not later than 10 days after first so engaging, register and file with FDA information including the name of the establishment, principal place of business, the location of each establishment in which that processing is carried on, the processing method, and a list of foods so processed in each establishment (§§ 108.25(c)(1) and 108.35(c)(1) (21 CFR 108.25(c)(1) and 108.35(c)(1))). In addition, our regulations require the submission of process filing forms. Specifically, our regulations require that commercial processors engaged in the processing of acidified foods must, not later than 60 days after registration, and before packing any new product, provide FDA with information on the scheduled processes for each acidified food in each container size (§ 108.25(c)(2)). An analogous requirement for process filing applies to commercial processors of low-acid canned foods (§ 108.35(c)(2)). The regulations specify the specific process filing forms to be used (Forms FDA 2541a and 2541c), and also state where the forms can be obtained and where the forms should be sent.
We recently engaged in an effort to modernize our forms and to provide a means for submitting the forms using electronic “smart form” technology. This effort involved the drafting of four new process filing forms: Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g. (For more information about the new process filing forms, see “Guidance for Industry: Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g (Food Process Filing Forms) to FDA in Electronic or Paper Format,” available at
We are issuing this final rule under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). Section 404(a) of the FD&C Act (21 U.S.C. 344(a)) provides that whenever the Secretary of Health and Human Services (the Secretary) finds after investigation that the distribution in interstate commerce of any class of food may, by reason of contamination with micro-organisms during the manufacture, processing, or packing thereof in any locality, be injurious to health, and that such injurious nature cannot be adequately determined after such articles have entered interstate commerce, the Secretary then shall issue regulations providing for the issuance, to manufacturers, processors, or packers of such class of food in such locality, of permits to which shall be attached such conditions governing the manufacture, processing, or packing of such class of food, for such temporary period of time, as may be necessary to protect the public health. Under section 404 of the FD&C Act, our regulations in part 108 have long required registration of food processing establishments, filing of process information, and maintenance
The new process filing forms described in section I will make it easier for firms to submit information to us and will improve the accuracy of the information submitted in the forms. In conjunction with these changes in the forms, in the
In addition, we proposed to make changes to the addresses or locations where forms can be found or must be sent. Finally, we proposed to remove obsolete references to dates that occurred years ago and update the name of the Agency of the U.S. Department of Agriculture that administers the meat and poultry inspection programs under the Federal Meat Inspection Act and the Poultry Products Inspection Act.
We received one comment on the proposed rule. This comment alerted us to the omission of the word “and” in the name of the Federal Agency that administers the meat and poultry inspection programs under the Federal Meat Inspection Act and the Poultry Products Inspection Act. The name of that Federal Agency is the “Food Safety and Inspection Service,” not the “Food Safety Inspection Service,” and we have revised the rule accordingly.
The final rule makes those technical amendments to § 108.25, “Acidified Foods,” and § 108.35, “Thermal Processing of Low-Acid Foods Packaged in Hermetically Sealed Containers” that we described in the proposed rule and summarized in section I of this document, with the correction noted in section IV of this document. See the amended regulatory text of §§ 108.25(c)(1) and (2) and 108.35(c)(1) and (2) and (i). The final rule will cause the new process filing forms to fully replace the forms currently listed in part 108 (
This rule is effective as shown in the
Any objections received in response to the regulation may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at
We are publishing this final rule under the formal rulemaking process.
The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. The final rule amends §§ 108.25 and 108.35 to delete obsolete references to long-expired effective dates, make changes to FDA addresses or locations, and reflect new process filing forms. With regard to the new process filing forms, we are replacing references to Forms FDA 2541a and FDA 2541c with references to four new process filing forms: Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g. Some of the data entry fields on the four new process filing forms are not on current Forms FDA 2541a and FDA 2541c. The new forms add certain data entry fields to improve the efficiency of our review of the process filings. For example, the new forms include data entry fields for the “food product group” (such as liquid, ready-to-eat “breakfast foods”). In addition, the new forms provide for “smart form” technology using an electronic submission system. The updated process filing portion of the electronic submission system queries the processor about the processes used to produce the food and presents only those data entry fields that are applicable. As a result, processors will no longer need to evaluate whether particular data entry fields are applicable to their products. For example, when a processor submits a process filing for a product that is processed using a low-acid retorted method with a process mode of “agitating,” smart form technology would bypass questions that are not applicable to this process mode option. We estimate that the additional time it would take processors to complete the new information requested on the new forms would be offset by the time processors will save by not having to evaluate whether certain data entry fields on Form FDA 2541a or FDA 2541c are applicable to their products. Hence, we certify that the rule will not have a significant economic impact on a substantial number of small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that Agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before issuing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold
FDA has determined, under 21 CFR 25.30(i), that this final rule 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 rule contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). These collections of information have been previously approved under OMB control number 0910-0037, which expires September 30, 2017.
We have analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we conclude that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.
Administrative practice and procedure, Foods, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, part 108 is amended as follows:
21 U.S.C. 342, 344, 371.
(c)(1)
(2)
(c) * * *
(1)
(2)
(ii) If a packer intentionally makes a change in a previously filed scheduled process by reducing the initial temperature or retort temperature, reducing the time of processing, or changing the product formulation, the container, or any other condition basic to the adequacy of scheduled process, he shall prior to using such changed process obtain substantiation by qualified scientific authority as to its adequacy. Such substantiation may be obtained by telephone, telegram, or other media, but must be promptly recorded, verified in writing by the authority, and contained in the packer's files for review by the Food and Drug Administration. Within 30 days after first use, the packer shall submit to the LACF Registration Coordinator (HFS-303), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740 a complete description of the modifications made and utilized, together with a copy of his file record showing prior substantiation by a qualified scientific authority as to the safety of the changed process. Any intentional change of a previously filed scheduled process or modification thereof in which the change consists solely of a higher initial temperature, a higher retort temperature, or a longer processing time, shall not be considered a change subject to this paragraph, but if that modification is thereafter to be regularly scheduled, the modified process shall be promptly filed as a scheduled process, accompanied by full information on the specified forms as provided in this paragraph.
(i) This section shall not apply to the commercial processing of any food processed under the continuous inspection of the meat and poultry inspection program of the Food Safety and Inspection Service of the Department of Agriculture under the Federal Meat Inspection Act (34 Stat. 1256, as amended by 81 Stat. 584 (21 U.S.C. 601
Internal Revenue Service (IRS), Treasury.
Final and temporary regulations; correcting amendment.
This document contains corrections to a correction document for final and temporary regulations (TD 9761) that was published in the
This correction is effective on July 19, 2016 and applicable on June 23, 2016.
Rose E. Jenkins at (202) 317-6934 (not a toll free number).
The final and temporary regulations (TD 9761) that are the subject of this correction are under sections 304, 367, 956, 7701(l), and 7874 of the Internal Revenue Code.
In correcting amendment FR Doc. 2016-14649, published in the issue of Thursday, June 23, 2016 (81 FR 40810), make the following correction:
On page 40811, in the first column, remove amendatory instruction 6.
Income taxes, Reporting and recordkeeping requirements.
Accordingly, 26 CFR part 1 is corrected by making the following correcting amendments:
26 U.S.C. 7805 * * *
(a) * * *
(4) * * *
(iv) * * *
(B) * * * Because LFS was a controlled foreign corporation and a member of the EAG with respect to the inversion transaction on the completion date, and DT was not a United States shareholder with respect to LFS on or before the completion date, LFS is excluded from the definition of expatriated foreign subsidiary pursuant to § 1.7874-12T(a)(9)(ii). * * *
(B) * * * Because LFSS was not a member of the EAG with respect to the inversion transaction on the completion date, LFSS is not excluded from the definition of expatriated foreign subsidiary pursuant to § 1.7874-12T(a)(9)(ii). * * *
(h) * * *
(ii) * * * Accordingly, the excluded amount is $112.50x calculated as 150 (200, the total number of prior acquisition shares, less 50, the allocable redeemed shares) multiplied by $0.75x (the fair market value of a single share of FA stock on the completion date with respect to the DT2 acquisition). * * *
Coast Guard, DHS.
Notice of deviation from drawbridge regulation.
The Coast Guard has issued a temporary deviation from the operating schedule that governs the Captree State Parkway Bridge across the State Boat Channel, mile 30.7 at Captree Island, New York. This deviation is necessary to allow the bridge owner to perform painting and steel repairs.
This deviation is effective from September 6, 2016 to December 16, 2016.
The docket for this deviation, [USCG-2016-0645] is available at
If you have questions about this temporary deviation, call or email Judy Leung-Yee, Project Officer, First Coast Guard District, telephone (212) 514-4330, email
The Captree State Parkway Bridge, mile 30.7, across the State Boat Channel, has a vertical clearance in the closed position of 29 feet at mean high water and 30 feet at mean low water. The existing bridge operating regulations are found at 33 CFR 117.799(i).
The waterway is transited by seasonal recreational traffic.
New York State DOT, the owner of the bridge, requested a temporary deviation from the normal operating schedule to perform painting and steel repairs.
Under this temporary deviation, the Captree State Parkway Bridge will not open for marine traffic from September 6, 2016 to December 16, 2016.
Vessels able to pass under the bridge in the closed position may do so at anytime. The bridge will not be able to open for emergencies and there is no immediate alternate route for vessels to pass.
The Coast Guard will inform the users of the waterways through our Local Notice and Broadcast to Mariners of the change in operating schedule for the bridge so that vessel operations can arrange their transits to minimize any impact caused by the temporary deviation.
In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone for navigable waters within a 700-yard radius on the surface and 1400-yard radius underwater of the Navy underwater detonation operations in the waters of Apra Outer Harbor, Guam. The Coast Guard believes this safety zone regulation is necessary to protect all persons and vessel that would otherwise transit or be within the affected areas from possible safety hazards associated with underwater detonation operations. Entry of vessels or persons into these zones is prohibited unless specifically authorized by the Captain of the Port Guam.
This rule is effective from 8 a.m. through 4 p.m. on July 28, 2016.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, call or email Chief Kristina Gauthier, Sector Guam, U.S. Coast Guard; telephone (671) 355-4866, 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 doing so would be impracticable and contrary to public interest. The final details for this event were not known to the Coast Guard until there was insufficient time remaining before the operation to publish an NPRM. Thus, delaying the effective dates of this rule to wait for a comment period to run would be impracticable because it would inhibit the Coast Guard's ability to protect vessels and waterway users from the hazards associated with this operation.
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 Guam has determined that potential hazards associated with the U.S. Navy training exercise, which include detonation of underwater explosive on July 28, 2016, will be a safety concern for anyone within a 700-yard radius on the surface and 1400-yard radius underwater of the operation. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone during the exercise. Mariners and divers approaching too close to such exercises could potentially expose the mariner to flying debris or other hazardous conditions.
The safety zone will cover all navigable waters within 700-yards on the surface and 1400-yards underwater of vessels and machinery being used by the Navy. The duration of the zone is intended to protect personnel, vessels, and the marine environment in these navigable waters during the underwater detonation exercise. No vessel or person will be permitted to enter the safety zones without obtaining permission from the COTP or a designated representative.
We developed this rule after considering numerous statutes and Executive order related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.
This regulatory action determination is based on the size, location, duration, and time-of-year of the safety zone. Vessel traffic will be able to safely transit around this safety zone which will impact a small designated area of waters in Apra Outer Harbor for 8 hours. Moreover, the Coast Guard will issue Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone and the rule allows vessels to seek permission to enter the zone.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian
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 safety zone lasting eight hours that will prohibit entry within 700-yards on the surface and 1400-yards underwater of vessels and machinery being used by Navy personnel. 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, 195; 33 CFR 1.05-1(g), 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1
(a)
(b)
(c)
(d)
(e)
(f)
Coast Guard, DHS.
Notice of enforcement of regulation.
The Fleet Week Maritime Festival's Pier 66 Safety Zone in Elliott Bay, WA will be subject to enforcement from 8 a.m. until 8 p.m. on August 2, 2016, but within this time period the zone will only be enforced 30 minutes prior to the beginning, during, and 30 minutes following the conclusion of the parade of ships. This action is necessary to promote safety on navigable waters. During the enforcement period, entry into, transit through, mooring, or anchoring within this zone is prohibited unless authorized by the Captain of the Port, Puget Sound or his designated representative.
The regulations in 33 CFR 165.1330 will be subject to enforcement from 8 a.m. until 8 p.m. on August 2, 2016.
If you have questions on this notice of enforcement, call or email LT Kate Haseley, Sector Puget Sound Waterways Management Division, Coast Guard; telephone (206) 217-6051,
The safety zone for the Fleet Week Maritime Festival in 33 CFR 165.1330 will be subject to enforcement from 8 a.m. until 8 p.m. on August 2, 2016; however, it will only be enforced 30 minutes prior to the beginning, during, and 30 minutes following the conclusion of the parade of ships. The COTP may issue a general permission to enter the zone during some of this time period if he or she determines the zone need not be enforced for a certain period of time because the parade of ships starts late or ends early. If the COTP issues a general permission to enter, the public would be notified via a Broadcast Notice to Mariners.
In accordance with the general regulations in 33 CFR part 165, subpart C, no vessel operator may enter, transit, moor, or anchor within this safety zone, except for vessels authorized by the Captain of the Port, Puget Sound or his designated representative, thirty
In order to transit through this safety zone, authorization must be granted by the Captain of the Port, Puget Sound or his designated representative. All vessel operators desiring entry into this safety zone shall gain authorization by contacting either the on-scene patrol craft on VHF Ch 13 or Ch 16, or Coast Guard Sector Puget Sound Joint Harbor Operations Center (JHOC) via telephone at (206) 217-6002. Vessel operators granted permission to enter this safety zone will be escorted by the on-scene patrol until no longer within the safety zone.
This document is issued under authority of 33 CFR 165.1330 and 5 U.S.C. 552(a). In addition to this notice of enforcement in the
Environmental Protection Agency.
Direct final rule.
The Environmental Protection Agency (EPA) is taking direct final action to approve State Implementation Plan (SIP) revisions submitted by the State of Utah on February 10, 2012 and August 29, 2014. These submittals request SIP revisions to remove changes to the major source baseline date that were disapproved by the EPA on July 15, 2011. The submittals also address the EPA's February 6, 2014 disapproval of several permit rules related to the public availability of good engineering practice stack height demonstrations in the public comment process for an approval order, and the process for making emission reductions enforceable in an approval order. The EPA is taking this action in accordance with section 110 of the Clean Air Act (CAA).
This rule is effective on September 19, 2016 without further notice, unless EPA receives adverse comments by August 18, 2016. If adverse comments are received, the EPA will publish a timely withdrawal of the direct final rule in the
Submit your comments, identified by Docket ID No. EPA-R08-OAR-2016-0221, at
Jody Ostendorf, Air Program, U.S. Environmental Protection Agency (EPA), Region 8, Mail Code 8P-AR, 1595 Wynkoop Street, Denver, Colorado 80202-1129, (303) 312-7814,
The EPA is publishing this rule without a prior proposed rule because we view this as a noncontroversial action and anticipate no adverse comment. However, in the “Proposed Rules” section of today's
If the EPA receives adverse comment, we will publish a timely withdrawal in the
A.
B.
• Identify the rulemaking by docket number and other identifying information (subject heading,
• Follow directions—The agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.
• Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.
• Describe any assumptions and provide any technical information and/or data that you used.
• If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
• Provide specific examples to illustrate your concerns, and suggest alternatives.
• Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
• Make sure to submit your comments by the comment period deadline identified.
Utah's February 10, 2012 submittal removes changes to the major source baseline date that were disapproved by the EPA on July 15, 2011. The EPA disapproved R307-405-3(3)(a)(i) because it defined “Major Source Baseline Date” in a manner inconsistent with the federal definition found at 40 CFR 52.21(b)(14). The EPA approves these revisions.
The August 29, 2014 SIP revisions address the EPA's February 6, 2014 disapproval of R307-410-2, Permits: Emissions Impact Analysis, Definitions; R307-410-6, Permits: Emissions Impact Analysis, Stack Heights and Dispersion Techniques; and R307-401-12, Permit: New and Modified Sources, Reduction in Air Contaminants. The submittal also amends R307-410-2 to incorporate by reference the date of the Code of Federal Regulations referenced in R307-101-3. The EPA approves these revisions. The submittal amends R307-410-6 to require the director to notify the public of the availability of a demonstration that the source stack height meets good engineering practice, and to provide an opportunity for public hearing on it as required by 40 CFR 51.164. This conforms to what is required by R307-401-7, Public Notice, and the EPA approves this revision.
Finally, the submittal amends R307-401-12 to exempt an owner or operator of a stationary source of air contaminants that reduces or eliminates air contaminants from the requirement to submit a notice of intent and obtain an approval order prior to construction if certain conditions are met. Those conditions are: a) the project does not increase the potential to emit of any air contaminant or cause emissions of any new air contaminant; and b) the director is notified of the change and the reduction of air contaminants is made enforceable through an approval order in accordance with the notification requirements of R307-401-12. The EPA approves these revisions.
The EPA is taking direct final action to approve the SIP revisions submitted by the State of Utah on February 10, 2012 and August 29, 2014. The EPA is approving the proposed SIP revisions as a direct final action without prior proposal because the agency views the revisions as noncontroversial and anticipates no adverse comments. However, in the Proposed Rules section of today's
In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of the Utah rules described in the amendments to 40 CFR part 52 set forth below. Therefore, these materials have been approved by the EPA for inclusion in the State Implementation Plan, have been incorporated by reference by the EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of the EPA's approval, and will be incorporated by reference by the Director of the Federal Register in the next update to the SIP compilation.
Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state actions, provided that they meet the criteria of the Clean Air Act. Accordingly, this direct final action merely approves a state law as meeting federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact in a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045(62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and
• Does not provide the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
The SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by
Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
42 U.S.C. 7401
40 CFR part 52 is amended to read as follows:
1. The authority citation for Part 52 continues to read as follows:
42 U.S.C. 7401
The revisions and addition read as follows:
(c) * * *
Environmental Protection Agency (EPA).
Final rule.
This action announces the U.S. Environmental Protection Agency's (EPA's) approval of alternative testing methods for use in measuring the levels of contaminants in drinking water and determining compliance with national primary drinking water regulations. The Safe Drinking Water Act authorizes EPA to approve the use of alternative testing methods through publication in the
This action is effective July 19, 2016.
The EPA has established a docket for this action under Docket ID No. EPA-HQ-2016-0281. All documents in the docket are listed on the
The Safe Drinking Water Hotline (800) 426-4791 or Glynda Smith, Technical Support Center, Standards and Risk Management Division, Office of Ground Water and Drinking Water (MS 140), Environmental Protection Agency, 26 West Martin Luther King Drive, Cincinnati, OH 45268; telephone number: (513) 569-7652; email address:
Public water systems are the regulated entities required to measure contaminants in drinking water samples. In addition, EPA Regions as well as states and tribal governments with authority to administer the regulatory program for public water systems under the Safe Drinking Water Act (SDWA) may measure contaminants in water samples. When EPA sets a monitoring requirement in its national primary drinking water regulations for a given contaminant, the Agency also establishes in the regulations standardized test procedures for analysis of the contaminant. This action makes alternative testing methods available for particular drinking water contaminants beyond the testing methods currently established in the regulations. EPA is providing public water systems required to test water samples with a choice of using either a test procedure already established in the existing regulations or an alternative test procedure that has been approved in this action or in prior expedited approval actions. Categories and entities that may ultimately be affected by this action include:
This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. This table lists the types of entities that EPA is now aware could potentially be affected by this action. Other types of entities not listed in the table could also be impacted. To determine whether your facility is affected by this action, you should carefully examine the applicability language in the Code of Federal Regulations (CFR) at 40 CFR 141.2 (definition of public water system). If you have questions regarding the applicability of this action to a particular entity, consult the person listed in the preceding
In this action, EPA is approving 16 analytical methods for determining contaminant concentrations in drinking water samples collected under SDWA. Regulated parties required to sample and monitor may use either the testing methods already established in existing regulations or the alternative testing methods being approved in this action or in prior expedited approval actions. The new methods are listed along with other methods similarly approved through previous expedited actions in 40 CFR part 141, appendix A to subpart C and on EPA's drinking water methods Web site at
When EPA determines that an alternative analytical method is “equally effective” (
This action does not add regulatory language, but does, for informational purposes, update an appendix to the regulations at 40 CFR part 141 that lists all methods approved under Section 1401(1) of SDWA. Accordingly, while this action is not a rule, it is updating CFR text and therefore is being published in the “Final Rules” section of the
EPA is approving 16 methods that are equally effective relative to methods previously promulgated in the regulations. By means of this rule, these 16 methods are added to appendix A to subpart C of 40 CFR part 141.
ASTM International. EPA compared the most recent versions of seven ASTM International methods to the earlier versions of those methods that are currently approved in 40 CFR part 141. Changes between the earlier approved version and the most recent version of each method are summarized in Smith (2015). The revisions primarily involve editorial changes (
EPA is thus approving the use of the following ASTM methods for the contaminants and their respective regulations listed in the following table:
The ASTM methods are available from ASTM International, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959 or
1. Hach Method 10241—Spectrophotometric Measurement of Free Chlorine (Cl
The currently approved methods for free chlorine in drinking water are listed in the tables at 40 CFR 141.74(a)(2) and 40 CFR 141.131(c)(1). One of the most widely used approved methods is Standard Method 4500-Cl G-00 (APHA 2000a), which uses a N,N-diethyl-p-phenylenediamine (DPD) indicator for spectrophotometric determination of residual chlorine concentrations in drinking water. The DPD methodology can be subject to interferences associated with the presence of manganese, chloramines, and other oxidants. Hach Method 10241 is not subject to such interferences.
A multi-laboratory study compared the performance characteristics of Hach Method 10241 to the performance characteristics of the approved Standard Method 4500-Cl G-00. A variety of samples, including drinking water samples from both surface water and ground water sources, were fortified with known chlorine concentrations and analyzed by each method. The results are summarized in the validation study report (Hach Company 2015b). EPA has determined that Hach Method 10241 is equally as effective as the approved Standard Method 4500-Cl G-00. The basis for this determination is discussed in Adams and Smith (2016). Therefore, EPA is approving Hach Method 10241 for determining free chlorine concentrations in drinking water. Hach Method 10241 can be obtained from Hach Company, 5600 Lindbergh Drive, Loveland, Colorado 80539. (
2. Hach Method 8026—Spectrophotometric Measurement of Copper in Finished Drinking Water (Hach Company 2015c). In Hach Method 8026, cuprous copper is measured colorimetrically by complexation with bicinchoninic acid. The intensity in color is proportional to the copper concentration, and spectrophotometer measurements are taken at 560 nm. Cupric copper present in samples is chemically reduced to cuprous copper. Metal and hardness interferences in samples are mitigated through the use of a chelating agent. The method is performed by the addition of
The currently approved methods for the analysis of copper in drinking water are listed in the table at 40 CFR 141.23(k)(1). The approved methods are based on atomic spectroscopy technologies. Hach Method 8026 employs a spectrophotometer, and is based on known complexation principles and simple color/absorbance measurements to determine copper concentrations.
A multi-laboratory validation study was conducted to compare the performance of Hach Method 8026 to EPA Method 200.7 (USEPA 1994), one of the approved methods for the analysis of copper in drinking water. Multiple finished drinking water samples drawn from both ground water and surface water sources were used in the validation study. Precision, accuracy and sensitivity data were collected by analyzing drinking water samples fortified with varying concentrations of copper standards. The results are summarized in the validation study report (Hach Company 2015d). EPA has determined that Hach Method 8026 is equally as effective as the approved EPA Method 200.7. The basis for this determination is discussed in Adams and Smith (2016). Therefore, EPA is approving Hach Method 8026 for the analysis of copper in drinking water. Hach Method 8026 can be obtained from Hach Company, 5600 Lindbergh Drive, Loveland, Colorado 80539. (
3. Hach Method 10261—Total Organic Carbon in Finished Drinking Water by Catalyzed Ozone Hydroxyl Radical Oxidation Infrared Analysis (Hach Company 2015e). Hach Method 10261 is a method for the determination of total organic carbon (TOC) in drinking water using an advanced oxidation process and non-dispersive infrared spectroscopy. In this method, ozone and a base are added to water to produce hydroxyl radicals. The hydroxyl radicals oxidize organic carbon to produce carbon dioxide and sodium oxalate. The sodium oxalate is further oxidized to carbon dioxide using acidification and a manganese catalyst. The carbon dioxide produced by both oxidation processes is then measured using non-dispersive infrared spectroscopy.
The currently approved methods for the analysis of TOC in drinking water are listed in 40 CFR 141.131(d)(3). The approved oxidation method, Standard Method 5310 C-00 (APHA 2000b), may not completely oxidize certain organic compounds. Hach Method 10261 uses a more efficient advanced oxidation process to ensure more complete oxidation.
A multi-laboratory validation study was conducted to compare the performance of Hach Method 10261 to the approved Standard Method 5310 C-00. Multiple finished drinking water samples drawn from both ground water and surface water sources were used in the validation study. Precision, accuracy and sensitivity data were collected by analyzing drinking water samples fortified with varying concentrations of TOC. The results are summarized in the validation study report (Hach Company 2015f). EPA has determined that Hach Method 10261 is equally as effective as the approved Standard Method 5310 C-00. The basis for this determination is discussed in Adams and Smith (2016). Therefore, EPA is approving Hach Method 10261 for the analysis of TOC in drinking water. Hach Method 10261 can be obtained from Hach Company, 5600 Lindbergh Drive, Loveland, Colorado 80539. (
4. Hach Method 10267—Spectrophotometric Measurement of Total Organic Carbon (TOC) in Finished Drinking Water (Hach Company 2015g). Hach Method 10267 is used for the determination of TOC in drinking water using acid persulfate digestion and visible spectrum spectrophotometry. In this method, samples are oxidized using acid persulfate digestions to convert TOC into carbon dioxide. The generated carbon dioxide is passed through a gas-permeable membrane into an indicator solution that is measured spectrophotometrically at 435 nm. Hach Method 10267 uses pre-packaged reagents to simplify sample preparation and quickly perform the analysis. Interfering inorganic carbon is removed from the sample prior to digestion by acidification and agitation.
The currently approved methods for the analysis of TOC in drinking water are listed in 40 CFR 141.131(d)(3). A multi-laboratory validation study was conducted to compare the performance of Hach Method 10267 to the approved Standard Method 5310 C-00 (APHA 200b). Multiple finished drinking water samples drawn from both ground water and surface water sources were used in the validation study. Precision, accuracy and sensitivity data were collected by analyzing drinking water samples fortified with varying concentrations of TOC. The results are summarized in the validation study report (Hach Company 2015h). EPA has determined that Hach Method 10267 is equally as effective as the approved Standard Method 5310 C-00. The basis for this determination is discussed in Adams and Smith (2016). Therefore, EPA is approving Hach Method 10267 for the analysis of TOC in drinking water. Hach Method 10267 can be obtained from Hach Company, 5600 Lindbergh Drive, Loveland, Colorado 80539. (
5. Hach Method 10272—Spectrophotometric Measurement of Copper in Finished Drinking Water (Hach Company 2015i). In Hach Method 10272, cuprous copper is measured colorimetrically by complexation with bicinchoninic acid. The intensity in color is proportional to the copper concentration, and spectrophotometer measurements are taken at 560 nm. Cupric copper present in samples is chemically reduced to cuprous copper. Metal and hardness interferences in samples are mitigated through the use of a chelating agent. The method is performed through the use of a copper Chemkey and portable analyzer.
The currently approved methods for the analysis of copper in drinking water are listed in the table at 40 CFR 141.23(k)(1). The approved methods are based on atomic spectroscopy technologies. Hach Method 10272 uses a spectrophotometer, simple color/absorbance measurements to determine copper concentrations, and incorporates portability and streamlining into the analysis.
A multi-laboratory validation study was conducted to compare the performance of Hach Method 10272 to EPA Method 200.7 (USEPA 1994), one of the approved methods for the analysis of copper in drinking water. Multiple finished drinking water samples drawn from both ground water and surface water sources were used in the validation study. Precision, accuracy and sensitivity data were collected by analyzing drinking water samples fortified with varying concentrations of copper standards. The results are summarized in the validation study report (Hach Company 2015j). EPA has determined that Hach Method 10272 is equally as effective as the approved EPA Method 200.7. The basis for this determination is discussed in Adams and Smith (2016). Therefore, EPA is approving Hach Method 10272 for the analysis of copper in drinking water. Hach Method 10272 can be obtained from Hach Company, 5600 Lindbergh Drive, Loveland, Colorado 80539. (
6. Hach Method 10258—Determination of Turbidity by 360° Nephelometry (Hach Company 2016). In Hach Method 10258 turbidity is determined in conventional-filtered and membrane-filtered treated drinking water using a 360 degree nephelometer.
The currently approved methods for the analysis of turbidity in treated drinking water are listed in the regulations at 40 CFR 141.74(a)(1). A multi-facility validation study was conducted to compare the performance of Hach Method 10258 to the approved Hach FilterTrak Method 10133 (Hach Company 2000) for the analysis of turbidity in treated drinking water. Seven public drinking water facilities participated in the study. Three facilities produced treated water using both conventional-filtration and membrane-filtration, two facilities produced only conventional-filtration treated water, and two facilities produced only membrane-filtration treated water. Source waters encompassed both surface waters and ground waters under the direct influence of surface water. Turbidity comparison data were collected at each facility by operating the instrument collecting the Hach Method 10258 turbidity data in parallel with an instrument collecting turbidity data using the approved Hach FilterTrack Method 10133. Precision and accuracy (based on recovery of matrix spike injections) data were collected over a range of spike levels (0.0015-0.500 NTU) and calibration verification data were collected from each facility. The results are summarized in the validation study report (Hach Company 2014). EPA has determined that Hach Method 10258 is equally as effective as the approved Hach FilterTrak Method 10133. The basis for this determination is discussed in Adams and Smith (2016). Therefore, EPA is approving Hach Method 10258 for the analysis of turbidity in treated drinking water. Hach Method 10258 can be obtained from Hach Company, 5600 Lindbergh Drive, Loveland, Colorado 80539. (
7. Nitrate Elimination Company, Inc. (NECi)—Method for Nitrate Reductase Nitrate-Nitrogen Analysis of Drinking Water (NECi 2016a). The NECi nitrate reductase method is used for the determination of nitrate plus nitrite (as nitrogen) in drinking water. In this method, a eukaryotic nitrate reductase is used to catalyze the conversion of nitrate to nitrite in the presence of nicotinamide adenine dinucleotide as a reductant in a buffer with a near neutral pH. The combined nitrite (both the original and reduced nitrate) is reacted with sulfanilamide and N-(1-napthyl) ethylenediamine dihydrochloride to produce a chromophore. The combined nitrite concentration is then measured spectrophotometrically at ~540 nm. The method entails the use of a discrete analyzer that incorporates a spectrophotometric detector.
The currently approved methods for the analysis of nitrate and nitrite in drinking water are listed in 40 CFR 141.23(k)(1). The approved EPA Method 353.2 (USEPA 1993a) uses cadmium to reduce nitrate to nitrite and subsequently measures the combined nitrite colorimetrically. The NECi nitrate reductase method provides an environmentally friendly approach to nitrate-nitrogen analysis by eliminating the use of toxic cadmium and requires only a fraction of the sample volume used in the approved EPA method.
A multi-laboratory validation study was conducted to compare the performance of the NECi nitrate reductase method to the approved EPA Method 353.2. Multiple finished drinking water samples drawn from both ground water and surface water sources were used in the validation study. Precision, accuracy and sensitivity data were collected by analyzing drinking water samples fortified with varying concentrations of nitrate standards. The results are summarized in the validation study report (NECi 2016b). EPA has determined that the NECi nitrate reductase method is equally as effective as the approved EPA Method 353.2. The basis for this determination is discussed in Adams and Wendelken (2016). Therefore, EPA is approving the NECi nitrate reductase method for the analysis of nitrate and nitrite in drinking water. The NECi nitrate reductase method can be obtained from the Nitrate Elimination Company, Inc. (NECi) at Superior Enzymes, Inc., 334 Hecla St., Lake Linden, Michigan 49945.
8. Thermo Fisher Scientific Drinking Water Orthophosphate Method for Thermo Scientific Gallery Discrete Analyzer (Thermo Fisher 2016a). The Thermo Fisher orthophosphate drinking water method employing Thermo Scientific Gallery discrete analyzers is used for the colorimetric determination of orthophosphate in drinking water. In this method, orthophosphate is reacted with ammonium molybdate and antimony potassium tartrate in an acidic medium to form an antimony-phospho-molybdate complex. The complex is subsequently reduced by ascorbic acid to form an intensely blue complex that can be measured spectrophotometrically at 880 nm.
The currently approved methods for the analysis of orthophosphate in drinking water are listed in 40 CFR 141.23(k)(1). Standard Methods 4500-P E (APHA, 1995) is an approved method that uses ascorbic acid to reduce reacted orthophosphate into a complex that can be measured spectrophotometrically. The Thermo Fisher orthophosphate method incorporates an automated discrete analyzer, which minimizes the use of chemical reagents, generation of waste and human handling errors.
A validation study was conducted to compare the performance of the automated Thermo Fisher orthophosphate discrete analyzer method to the approved Standard Method 4500-P E. Multiple finished drinking water samples drawn from both ground water and surface water sources were used in the validation study. Precision, accuracy and sensitivity data were collected by analyzing drinking water samples fortified with varying concentrations of orthophosphate standards. The results are summarized in the validation study report (Thermo Fisher 2016b). EPA has determined that the Thermo Fisher discrete analyzer method for orthophosphate is equally as effective as the approved Standard Method 4500-P E. Therefore, EPA is approving the Thermo Fisher method for the analysis of orthophosphate in treated drinking water. The basis for this determination is discussed in Adams (2016). The Thermo Fisher discrete analyzer method for orthophosphate can be obtained from Thermo Fisher Scientific, Ratastie 2, 01620 Vantaa, Finland.
9. Mitchell Method M5331, Revision 1.2—Determination of Turbidity by LED or Laser Nephelometry (Mitchell 2016). Mitchell Method M5331, Revision 1.1 (Mitchell 2009) was approved for the determination of turbidity in drinking water by light emitting diode (LED) nephelometry in the August 2009 expedited methods approval action (USEPA 2009). The currently approved methods for turbidity are listed in 40 CFR 141.74(a)(1) and different sources, including lasers, have been approved. The Mitchell Method M5331 has been updated to incorporate the option of using a solid-state laser in place of a LED as the light source for the turbidimeter. The vendor cites multiple advantages associated with the use of lasers relative to LEDs (Mitchell 2015). Mitchell Method M5331, Revision 1.1 specifies a light source of 525 ± 15 nm, and now lasers at 520 nm and 532 nm are readily available. In addition to
As noted in Section II, under the terms of SDWA Section 1401(1), this streamlined method approval action is not a rule. Accordingly, the Congressional Review Act, 5 U.S.C. 801
Environmental protection, Chemicals, Indians-lands, Intergovernmental relations, Reporting and recordkeeping requirements, Water supply.
For the reasons stated in the preamble, 40 CFR part 141 is amended as follows:
42 U.S.C. 300f, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-4, 300j-9, and 300j-11.
The revisions and additions read as follows:
Coast Guard, DHS.
Final rule; information collection approval.
The Coast Guard announces that the Office of Management and Budget (OMB) has approved the collection of information described in the Inspection of Towing Vessels final rule published on June 20, 2016. In that rule, which establishes safety regulations governing the inspection, standards, and safety management systems of towing vessels, we stated that before the Coast Guard could enforce the collection of information requirements in the rule, OMB would need to approve the Coast Guard's request to collect this information. This document announces that approval. On June 23, 2016, OMB approved this Coast Guard request and assigned this collection of information OMB control number 1625-0117.
On June 23, 2016, OMB approved a new collection of information assigned OMB control number 1625-0117. That approval expires on June 30, 2019. Based on this OMB approval, the Coast Guard may start enforcing applicable collection of information requirements in the Inspection of Towing Vessels final rule published in the
If you have questions about this rule, call or email Lieutenant Commander William Nabach, Project Manager, CG-OES-2, Coast Guard, telephone 202-372-1386, email
On June 23, 2016, the Office of Management and Budget (OMB) approved a new collection of information for the Inspection of Towing Vessels final rule published on June 20, 2016 (81 FR 40004). In that rule, which establishes safety regulations governing the inspection, standards, and safety management systems of towing vessels, we stated that before the Coast Guard could enforce the collection of information requirements in the rule, OMB would need to approve the Coast Guard's request to collect this information. This document announces the approval of that collection which has been assigned OMB control number 1625-0117. OMB's approval of that collection will expire on June 30, 2019.
On July 12, 2016, OMB approved the insertion of “CFR” in the title of the collection of information so it conforms with the title presented in the final rule: Towing Vessels—Title 46 CFR Subchapter M. We have included that notice of action in the docket as well as OMB's June 23, 2016 notice of action.
The Inspection of Towing Vessels final rule becomes effective July 20, 2016, and the Coast Guard may start enforcing that rule's applicable collection of information requirements on that date. As noted in the summary of that rule, certain existing towing vessels subject to this rule will have an additional 2 years before having to comply with most of its requirements, but we anticipate receiving applications from organizations seeking to become third-party organizations soon after the rule becomes effective.
A copy of the two approval memos from OMB and the Inspection of Towing Vessels final rule are in docket USCG-2006-24412 which is available on the Internet by going to
This document, which announces approval of the collection of information assigned OMB control number 1625-0117, is issued under authority of 5 U.S.C. 552(a).
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; closure.
NMFS implements accountability measures (AMs) for the gray triggerfish recreational sector in the exclusive economic zone (EEZ) of the Gulf of Mexico (Gulf) for the 2016 fishing year through this temporary rule. NMFS has determined that the 2015 recreational annual catch limit (ACL) for Gulf gray triggerfish was exceeded; therefore, NMFS reduces the gray triggerfish recreational ACL and annual
This rule is effective from 12:01 a.m., local time, August 1, 2016, until 12:01 a.m., local time, on January 1, 2017.
Rich Malinowski, NMFS Southeast Regional Office, telephone: 727-824-5305, email:
NMFS manages the Gulf reef fish fishery, which includes gray triggerfish, under the Fishery Management Plan for the Reef Fish Resources of the Gulf (FMP). The Gulf of Mexico Fishery Management Council (Council) prepared the FMP and NMFS implements the FMP under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622. All gray triggerfish weights discussed in this temporary rule are in round weight.
The 2016 recreational ACL for Gulf gray triggerfish specified in 50 CFR 622.41(b)(2)(iii) is 241,200 lb (109,406 kg) and the recreational ACT is 217,100 lb (98,475 kg). However, in 2015, the recreational harvest of gray triggerfish exceeded the 2015 recreational ACL by 39,997 lb (18,142 kg). Therefore, consistent with the requirements specified in 50 CFR 622.41(b)(2)(ii), NMFS reduces the recreational ACL for gray triggerfish in 2016 to 201,223 lb (91,273 kg) and the recreational ACT to 177,123 lb (80,342 kg).
Under 50 CFR 622.41(b)(2)(i), NMFS is required to close the recreational sector for gray triggerfish when the recreational ACT is reached, or is projected to be reached, by filing a notification to that effect with the Office of the Federal Register. NMFS has determined the 2016 recreational ACT was reached prior to the annual season closure, which is effective from June 1 through July 31 each year. Accordingly, the recreational sector for Gulf gray triggerfish will not re-open on August 1, because NMFS is closing recreational harvest of triggerfish for the 2016 fishing year effective at 12:01 a.m., local time, August 1, 2016, until 12:01 a.m., local time, January 1, 2017, the start of the next fishing year.
During the recreational closure, the bag and possession limits for gray triggerfish in or from the Gulf EEZ are zero. The prohibition on possession in the Gulf on board a vessel for which a valid Federal charter vessel/headboat permit for Gulf reef fish has been issued applies regardless of whether gray triggerfish were harvested in state or Federal waters.
The recreational sector for gray triggerfish will reopen on January 1, 2017, the beginning of the 2017 recreational fishing year.
The Regional Administrator, Southeast Region, NMFS, has determined this temporary rule is necessary for the conservation and management of Gulf gray triggerfish and is consistent with the Magnuson-Stevens Act and other applicable laws.
This action is taken under 50 CFR 622.41(b)(2)(i) and is exempt from review under Executive Order 12866.
These measures are exempt from the procedures of the Regulatory Flexibility Act because the temporary rule is issued without opportunity for prior notice and comment.
This action responds to the best scientific information available. The Assistant Administrator for NOAA Fisheries (AA), finds that the need to immediately implement this action to close the recreational sector for gray triggerfish constitutes good cause to waive the requirements to provide prior notice and opportunity for public comment on this temporary rule pursuant to the authority set forth in 5 U.S.C. 553(b)(B), because such procedures are unnecessary and contrary to the public interest. Such procedures are unnecessary because the rule establishing the closure provisions was subject to notice and comment, and all that remains is to notify the public of the closure. Such procedures are contrary to the public interest because of the need to immediately implement this action to protect gray triggerfish. Prior notice and opportunity for public comment would require time and would potentially allow the recreational sector to exceed the recreational ACL.
For the aforementioned reasons, the AA also finds good cause to waive the 30-day delay in the effectiveness of this action under 5 U.S.C. 553(d)(3).
16 U.S.C. 1801
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to modify the Class E airspace extending upward from 700 feet above the surface at Sonoma County Airport, Napa, CA, by removing an irregular shaped area located approximately 20 miles southwest of Napa County Airport. This airspace area is discontinuous from the airspace surrounding Napa County Airport and is not essential to instrument flight rules (IFR) operation at the airport. This proposal would also update the airport geographic coordinates. This action is necessary for the safety and management of instrument flight rules (IFR) operations at the airport, with the minimum amount of airspace restriction.
Comments must be received on or before September 2, 2016.
Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, West Building Ground Floor W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590; telephone: 1-800-647-5527, or (202-366-9826). You must identify FAA Docket No. FAA-2016-5574; airspace Docket No. 16-AWP-5, at the beginning of your comments. You may also submit comments through the Internet at
FAA Order 7400.9Z, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
FAA Order 7400.9, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
Tom Clark, Federal Aviation Administration, Operations Support Group, Western Service Center, 1601 Lind Avenue SW., Renton, WA 98057; telephone (425) 203-4511.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would amend Class E airspace at Napa County Airport, Napa CA.
Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2016-5574; Airspace Docket No. 16ANM-5.” The postcard will be date/time stamped and returned to the commenter.
An electronic copy of this document may be downloaded through the Internet at
You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Office (see
This document proposes to amend FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z is publicly available as listed in the
The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) part 71 by modifying class E airspace extending upward from 700 feet above the surface at Napa County Airport, Napa, CA, by removing an irregular shaped area located approximately 20 miles southwest of the airport. This airspace area is discontinuous from the airspace surrounding Napa County Airport and is not necessary to support IFR operations. This proposal also would update the airport geographic coordinates to lat. 38°12′48″ N., long. 122°16′51″ W., to coincide with the FAA's aeronautical database.
Class E airspace designations are published in paragraph 6005 of FAA Order 7400.9Z, dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from 700 feet above the surface within a 6.5-mile radius of Napa County Airport.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM); withdrawal.
This action withdraws the NPRM published in the
Effective date: 0901 UTC, July 19, 2016.
Colby Abbott, Airspace Policy Group, Office of Airspace Services, Federal Aviation Administration, 800 Independence Avenue SW., Washington DC, 20591; telephone (202) 267-8783.
An NPRM was published in the
Airspace, Prohibited areas, Restricted areas.
In consideration of the foregoing, the NPRM for FR Doc. FAA-2016-4282, Airspace Docket No. 16-AWP-3, as published in the
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854; 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve a source-specific revision to the Arizona State Implementation Plan (SIP) that addresses requirements for best available retrofit technology (BART) at Cholla Generating Station (Cholla). The EPA proposes to find that the SIP revision fulfills the requirements of the Clean Air Act (CAA) and the EPA's Regional Haze Rule (RHR) for BART at Cholla. In conjunction with this proposed approval, we propose to withdraw those portions of the federal implementation plan (FIP) that address BART for Cholla. We previously partially granted petitions for reconsideration of that FIP from Cholla's owners, Arizona Public Service Company (APS) and PacifiCorp. We are now proposing to find that final withdrawal of the FIP, as it applies to Cholla, would constitute our action on APS's and PacifiCorp's petitions for reconsideration of the FIP.
Written comments must be received on or before September 2, 2016. Requests for public hearing must be received on or before August 3, 2016.
Submit your comments, identified by Docket ID No. EPA-R09-OAR-2016-0292 at
Vijay Limaye, U.S. EPA, Region 9, Planning Office, Air Division, Air-2, 75 Hawthorne Street, San Francisco, CA 94105. Vijay Limaye can be reached at telephone number (415) 972-3086 and via electronic mail at
Throughout this document, “we,” “us” and “our” refer to the EPA.
For the purpose of this document, we are giving meaning to certain words or initials as follows:
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The EPA has established docket number EPA-R09-OAR-2016-0292 for this action. Generally, documents in the docket for this action are available electronically at
If anyone contacts the EPA by August 3, 2016 requesting to speak at a public hearing, the EPA will schedule a public hearing and announce the hearing in the
This section provides a brief overview of the requirements of the CAA and RHR, as they apply to this particular action. Please refer to our previous rulemakings on the Arizona Regional Haze SIP for additional background regarding the visibility protection provisions of the CAA and the RHR.
In section 169A of the 1977 Amendments to the CAA, Congress created a program for protecting visibility in the nation's national parks and wilderness areas. This section of the CAA establishes as a national goal the “prevention of any future, and the remedying of any existing, impairment of visibility in mandatory Class I Federal areas which impairment results from manmade air pollution.”
In 1999, we promulgated the RHR, which requires states to develop and implement SIPs to ensure reasonable progress toward improving visibility in mandatory Class I Federal areas (Class I areas)
In 2005, the EPA published the Guidelines for BART Determinations under the Regional Haze Rule at Appendix Y to 40 CFR part 51 (“BART Guidelines”) on July 6, 2005. The BART Guidelines assist states in determining which of their sources should be subject to the BART requirements and in determining appropriate emission limits for each such “subject-to-BART” source. In making BART determinations for fossil fuel-fired electric generating plants with a total generating capacity in excess of 750 megawatts, states must use the approaches set forth in the BART Guidelines. States are encouraged, but not required, to follow the BART Guidelines in making BART determinations for other types of sources. In lieu of requiring source-specific BART controls, states also have the flexibility to adopt an alternative measure as long as the alternative provides greater reasonable progress towards natural visibility conditions than BART (
In addition to the visibility protection requirements of the CAA and the RHR, SIP revisions concerning regional haze are also subject to the general requirements of CAA section 110. In particular, they are subject to the requirement in CAA section 110(l) that SIP revisions must not “interfere with any applicable requirement concerning attainment and reasonable further progress (as defined in [CAA section 171]), or any other applicable requirement of [the CAA],” as well as the requirement in CAA section 110(a)(2)(A) that SIPs must include enforceable emission limits.
Cholla Generating Station consists of four primarily coal-fired electricity generating units with a total plant-wide generating capacity of 1,150 megawatts. Unit 1 is a 126 MW tangentially-fired, dry-bottom boiler that is not BART-eligible. Units 2, 3 and 4 have capacities of 272 MW, 272 MW and 410 MW, respectively, and are tangentially-fired, dry-bottom boilers that are each BART-eligible. Units 1, 2, and 3 are owned and operated by APS and Unit 4 is owned by PacifiCorp and operated by APS.
On February 28, 2011, the Arizona Department of Environmental Quality (ADEQ) submitted a Regional Haze SIP under Section 308 of the RHR (“Arizona Regional Haze SIP”) to EPA. This submittal included BART analyses and determinations for nitrogen oxides (NO
• Step 1: Identify the Existing Control Technologies in Use at the Source,
• Step 2: Identify All Available Retrofit Control Options,
• Step 3: Eliminate All Technically Infeasible Control Options,
• Step 4: Evaluate Control Effectiveness of Remaining Technologies,
• Step 5: Evaluate the Energy and Non-Air Quality Environmental Impacts and Document Results,
• Step 6: Evaluate Visibility Impacts, and
• Step 7: Select BART.
On December 5, 2012, we issued a final rule approving in part and disapproving in part ADEQ's BART determinations for three sources, including Cholla.
On January 15, 2015, APS and PacifiCorp submitted an “Application for Significant Permit Revision and Five-Factor BART Reassessment for Cholla” to ADEQ. APS and PacifiCorp requested that ADEQ conduct a revised BART analysis and determination based on new facts (“BART Reassessment”) and submit this BART Reassessment to the EPA as a revision to the Arizona Regional Haze SIP. Under the Cholla BART Reassessment, APS and PacifiCorp would commit to the following measures in lieu of implementing the FIP requirements for the Cholla Generating Station:
• Unit 2 would be permanently shut down by April 1, 2016;
• Unit 3 and Unit 4 would continue to operate with currently installed LNB and separated over fire air (SOFA). In addition, by April 30, 2025, APS and PacifiCorp would permanently cease burning coal at both units with the option to convert to pipeline-quality natural gas by July 31, 2025, with a ≤20 percent annual average capacity factor.
On October 22, 2015, ADEQ submitted a revision to the Arizona Regional Haze SIP that incorporates the Cholla BART Reassessment (“Cholla SIP Revision”). The Cholla SIP Revision is the subject of this proposal.
The Cholla SIP Revision consists of a revised BART analysis and determination for NO
In the Cholla SIP Revision, ADEQ determined that, if Unit 2 were shut down by April 1, 2016, no BART determination for Unit 2 would be necessary “because the enforceable shutdown date is within the five-year BART window.”
ADEQ's BART re-analysis for Units 3 and 4 consists of an evaluation of each of the five BART factors, effectively replacing step 5 (evaluation of costs of compliance, energy and non-air quality environmental impacts, and remaining useful life) and step 6 (evaluation of visibility benefits) of ADEQ's prior BART analysis for Cholla in the Arizona Regional Haze SIP.
ADEQ evaluated the costs of compliance for three control options: (1) LNB and SOFA, (2) SNCR with LNB and SOFA, and (3) SCR with LNB and SOFA. Two fuel-use scenarios were used as a comparison: (1) Twenty years of operation on coal and (2) eight years of operation on coal followed by twelve years of operation on natural gas (as provided for under the BART Reassessment). The cost-effectiveness values for each control option under each of these scenarios are shown in Tables 1 and 2. For all options, the costs associated with the BART Reassessment are due to lower utilization periods (coal firing until 2025 instead of for 20 years) as well as significantly lower NO
ADEQ indicated that the energy impacts of LNB, SOFA, and SNCR are minimal and that there are no non-air quality environmental impacts associated with LNB and SOFA. ADEQ also noted that SNCR and SCR would result in ammonia slip and that the transport and handling of anhydrous ammonia presents potential safety hazards.
ADEQ noted that, under the Cholla BART Reassessment, use of the existing LNB and SOFA would be continued at Units 3 and 4. ADEQ proposed no additional controls for these two units. Unit 2 would be shut down in April 2016, while Unit 1 (the non-BART unit) would cease burning coal in 2025.
ADEQ used a 20-year amortization period in order to calculate the costs of compliance for Units 3 and 4 because neither unit is subject to an enforceable shutdown date.
ADEQ included the results of modeling conducted by APS and PacifiCorp to predict the degree of visibility improvement associated with the three BART scenarios. This modeling predicted visibility impacts at the thirteen Class I areas within 300 km of the Cholla facility under a baseline scenario (based on 2001-2003 emissions with all four units operating), as well as the three BART control scenarios:
• BART Option 1: Unit 1 with 2001-2003 baseline controls (pre-LNB), Unit 2 shut down, LNB/SOFA on Units 3 and 4;
• BART Option 2: Unit 1 with 2001-2003 baseline controls (pre-LNB), Unit 2 shut down, LNB/SOFA and SNCR on Units 3 and 4; and
• BART Option 3: Unit 1 with 2001-2003 baseline controls (pre-LNB), Unit 2 shut down, LNB/SOFA and SCR on Units 3 and 4.
ADEQ's BART determination for Cholla Units 3 and 4 in the Cholla SIP Revision effectively replaces step 7 (select BART) of its prior BART analysis for NO
In addition to the BART re-analysis and determinations, the Cholla SIP Revision also includes a demonstration of “noninterference” under CAA section 110(l). In particular, ADEQ considered whether the Cholla SIP Revision would interfere with (1) any applicable requirement concerning attainment of any National Ambient Air Quality Standards (NAAQS) or (2) any other applicable requirement of the CAA.
ADEQ noted that Cholla is located in Navajo County, Arizona, which is currently designated as attainment or unclassifiable for the following NAAQS: Carbon monoxide (CO), lead (Pb), nitrogen dioxide (NO
ADEQ's demonstration of noninterference with attainment focused on the NAAQS for PM
For its PM
ADEQ also compared SO
ADEQ also analyzed the emission control strategies for NO
Similarly, with regard to ozone, for which NO
With regards to the other applicable CAA requirements, ADEQ considered whether the Cholla BART Reassessment would interfere with (1) the requirements of the Regional Haze program or (2) the CAA's air toxics requirements.
In evaluating potential interference with the RHR, ADEQ relied primarily on the results of air quality modeling (using CALPUFF) performed by APS and PacifiCorp to assess the visibility impacts of Cholla under the Cholla SIP Revision compared to the existing SIP and FIP requirements.
Concerning air toxics, ADEQ noted that in addition to ceasing operation of Unit 2, the Cholla facility proposes to implement sorbent injection at Units 1, 3, and 4 by March 2016 to reduce air toxics and achieve compliance with the EPA's Mercury and Air Toxics (MATS) rule. Therefore, ADEQ concluded that the Cholla BART Reassessment will not interfere with any air toxics requirements of the CAA.
The Cholla Permit Revision, which is incorporated as Appendix A to the Cholla SIP Revision, was issued by ADEQ on October 16, 2015. The Permit Revision incorporates emission limits and compliance dates as well as monitoring, recordkeeping, and reporting requirements to implement both the Cholla BART Reassessment and ADEQ's prior BART determinations for SO
We have evaluated the Cholla SIP Revision for compliance with the requirements of the CAA, the RHR, and the BART Guidelines.
The Cholla Permit Revision requires Unit 2 to be permanently retired by no later than April 1, 2016.
We find that ADEQ's BART analysis for Cholla Units 3 and 4 is consistent with the requirements of the CAA, RHR, and the BART Guidelines. In particular, we find that ADEQ's BART re-analysis addresses the flaws that were the basis for our disapproval of ADEQ's prior BART analysis for Cholla.
With regard to the cost of compliance, in its previous BART analysis for Cholla, ADEQ included certain line item costs not allowed by the EPA Control Cost Manual (CCM),
We note that in May 2016, EPA revised the CCM chapter that concerns SCR systems.
With regard to visibility modeling, in its previous BART analysis for Cholla, ADEQ considered the benefits from controls on only one emitting unit at a time and overlooked significant benefits at multiple Class I areas, thereby understating the full visibility benefits of the candidate controls.
In considering the results of this modeling, it should be noted that the baseline scenario included emissions from Unit 2, but the control scenarios did not include any emissions from Unit 2. As a result, the total visibility improvement anticipated under each of the control scenarios represents not only the visibility benefits of controls on Units 3 and 4, but also the visibility benefits of the closure of Unit 2. We consider this to be a reasonable approach because it is consistent with the requirement of the BART Guidelines for states to consider the visibility improvement from controls applied to the entire BART-eligible source.
We also note that ADEQ did not quantify the expected visibility benefits of SCR and SNCR on Units 3 and 4 after these units are converted to gas in 2025, but characterized these benefits as “negligible.” In order to evaluate ADEQ's characterization, we scaled the modeled visibility benefits of SCR under the coal-fired scenario to roughly estimate what the benefits would be under the gas-fired scenario. The results of this scaling indicate that, under the gas-fired scenario, the approximate benefits of SNCR would be 0.07 dv at the most-improved Class I area and 0.31 dv cumulatively over all affected Class I areas, while the approximate benefits of SCR would be 0.15 dv at the most-improved Class I area and 0.77 dv cumulatively over all affected Class I areas.
In the Cholla SIP Revision, ADEQ also appropriately accounted for the requirements that will apply to Units 3 and 4 as of 2025,
We note that ADEQ did diverge slightly from the BART Guidelines in its calculation of the incremental cost-effectiveness of SCR. In particular, ADEQ calculated the incremental cost, as well as incremental visibility benefits, based on a comparison between SCR with LNB+SOFA and LNB+SOFA only. This differs from the approach to calculating incremental cost-effectiveness that is set forth in the BART Guidelines, under which incremental cost-effectiveness is calculated by comparing “the costs and performance level of a control option
Based on our findings that the Cholla SIP Revision addresses the flaws that were the basis for our disapproval of ADEQ's prior BART analysis for Cholla and otherwise meets the requirements of the CAA, RHR, and the BART Guidelines, we propose to approve ADEQ's BART re-analysis for Cholla Units 3 and 4.
We also find that ADEQ's BART determination for NO
With regard to SCR, we find that it was reasonable for ADEQ to conclude that the costs of SCR were not warranted by the visibility benefits in this instance. In particular, with regard to costs, we are not aware of any instance in which the EPA has determined SCR to be BART where the average cost-effectiveness of SCR was greater than $6,000/ton and the incremental cost-effectiveness (calculated in accordance with the BART Guidelines) was greater than $10,000/ton, as is the case with Cholla Units 3 and 4. Similarly, we are not aware of any instance in which the EPA has disapproved a state's BART determination that rejected SCR as BART based on similar cost-effectiveness values. Furthermore, while the total visibility benefits of the SCR-based control scenario (“BART Option 3”) are large (2.20 dv at the most improved area and 17.89 dv cumulative across all affected areas), as noted in the previous section, these benefits include not only the effect of SCR installation on Units 3 and 4, but also the retirement of Unit 2. Thus, we believe it was appropriate for ADEQ to focus primarily on what it characterized as the “incremental” visibility benefits,
With regard to SNCR, we find that it was reasonable for ADEQ to conclude that the costs of SNCR were not warranted by the visibility benefits. In particular, with regard to costs, we are not aware of any instance in which the EPA has determined SNCR to be BART where the average cost-effectiveness of SNCR was greater than $3,000/ton and
Therefore, we propose to approve ADEQ's determination that BART for NO
CAA section 110(l) requires that any revision to an implementation plan shall not be approved by the EPA Administrator if the revision would interfere with any applicable requirement concerning attainment and reasonable further progress (RFP) or any other applicable requirement of the Act.
With regard to applicable requirements concerning attainment and RFP, as explained by ADEQ, Cholla is located in north central Navajo County, Arizona, which is designated as unclassifiable/attainment for all of the NAAQS for which the EPA has issued designations.
In summary, Cholla is located in area that is designated unclassifiable/attainment or has not yet been designated for each of the current NAAQS. Thus, the Arizona SIP does not currently rely on emission limitations at Cholla to satisfy any attainment or RFP requirements. Given that the Cholla SIP Revision will result in equivalent or lower emissions of NO
The other requirements of the CAA that apply to Cholla are:
• Standards of Performance for New Stationary Sources (NSPS), 40 CFR part 60, subpart D;
• National Emission Standards for Hazardous Air Pollutants (NESHAP), 40 CFR part 63, subpart UUUUU (also known as MATS);
• Compliance Assurance Monitoring (CAM), 40 CFR part 64; and
• BART and other visibility protection requirements under CAA section 169A and the RHR.
The Cholla SIP Revision would not affect the applicable NESHAP, NSPS and CAM requirements. Therefore, we propose to find that the Cholla SIP Revision would not interfere with the applicable NESHAP, NSPS and CAM requirements.
We also propose to find that Cholla SIP Revision would not interfere with the visibility protection requirements of the CAA and the RHR. Our proposed approval of the BART Reassessment is based on our determination that, taking into consideration the differences in the facts underlying the EPA's prior BART analysis for NO
CAA section 110(a)(2)(A) requires SIPs to include enforceable emission limitations as necessary or appropriate to meet the applicable requirements of the Act. In addition, SIPs must contain regulatory requirements related to monitoring, recordkeeping, and reporting for applicable emission limitations.
For the reasons described above, the EPA proposes to approve the Cholla SIP Revision. Because this approval would fill the gap in the Arizona Regional Haze SIP left by the EPA's prior partial disapproval with respect to Cholla, we propose to withdraw the provisions of the Arizona Regional Haze FIP that apply to Cholla. We also propose to find that withdrawal of the FIP would constitute our action on APS's and PacifiCorp's petitions for reconsideration of the Arizona Regional Haze FIP.
As shown in Tables 6 and 7, the Cholla SIP Revision will result in reduced emissions of both SO
In this rule, the EPA is proposing to include in a final EPA rule, regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by reference “Significant Permit Revision No. 61713 to Operating Permit No. 53399” issued by ADEQ on October 16, 2015. The EPA has made, and will continue to make, this document available electronically through
This action is not a significant regulatory action and was therefore not submitted to the Office of Management and Budget (OMB) for review. This rule applies to only one facility and is therefore not a rule of general applicability.
This action does not impose an information collection burden under the PRA. This rule applies to only one facility. Therefore, its recordkeeping and reporting provisions do not constitute a “collection of information” as defined under 44 U.S.C. 3502(3) and 5 CFR 1320.3(c).
I certify that this action will not have a significant economic impact on a substantial number of small entities. This action will not impose any requirements on small entities. Firms primarily engaged in the generation, transmission, and/or distribution of electric energy for sale are small if, including affiliates, the total electric output for the preceding fiscal year did not exceed 4 million megawatt hours. Both owners of Cholla, APS and PacifiCorp, exceed this threshold.
This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments.
This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.
This action does not have tribal implications, as specified in Executive Order 13175. It will not have substantial direct effects on any 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. Thus, Executive Order 13175 does not apply to this action.
The EPA interprets EO 13045 as applying only to those regulatory actions that concern health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk.
This action is not subject to Executive Order 13211 because it is not a significant regulatory action under Executive Order 12866.
This rulemaking does not involve technical standards. The EPA is not revising any technical standards or imposing any new technical standards in this action.
The EPA believes the human health or environmental risk addressed by this action will not have potential disproportionately high and adverse human health or environmental effects on minority, low-income, or indigenous populations. The results of this evaluation are contained in section VI above.
Pursuant to CAA section 307(d)(1)(B), the EPA proposes to determine that this action is subject to the provisions of section 307(d). Section 307(d) establishes procedural requirements specific to certain rulemaking actions under the CAA. Pursuant to CAA section 307(d)(1)(B), the withdrawal of the provisions of the Arizona Regional Haze FIP that apply to Cholla is subject to the requirements of CAA section 307(d), as it constitutes a revision to a FIP under CAA section 110(c). Furthermore, CAA section 307(d)(1)(V) provides that the provisions of section
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Particulate matter, Reporting and recordkeeping requirements, Sulfur dioxide, Visibility.
42 U.S.C. 7401
42 U.S.C. 7401
(f) * * *
(1)
(2)
(3)
(ii) [Reserved]
(4)
(ii) The owners/operators of each unit subject to this paragraph (f) shall comply with the applicable PM
(5)
(A) At all times after the compliance date specified in paragraph (f)(4) of this section, the owner/operator of each coal-fired unit shall maintain, calibrate, and operate a CEMS, in full compliance with the requirements found at 40 CFR part 75, to accurately measure SO
(B) The owner/operator of each unit shall comply with the quality assurance procedures for CEMS found in 40 CFR part 75. In addition to these 40 CFR part 75 requirements, relative accuracy test audits shall be calculated for both the NO
(ii)
(A) [Reserved]
(B)
(C) If a valid NO
(iii)
(B) [Reserved]
(C) If a valid SO
(D) If both a valid inlet and outlet SO
(10)
(i) [Reserved]
(ii)
Environmental Protection Agency.
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve State Implementation Plan (SIP) revisions submitted by the State of Utah on February 10, 2012 and August 29, 2014. These submittals request SIP revisions to remove changes to the major source baseline date that were disapproved by the EPA on July 15, 2011. The submittals also address the EPA's February 6, 2014 disapproval of several permit rules related to the public availability of good engineering practice stack height demonstrations in the public comment process for an approval order, and the process for making emission reductions enforceable in an approval order. The EPA is taking this action in accordance with section 110 of the Clean Air Act (CAA).
Written comments must be received on or before August 18, 2016.
Submit your comments, identified by Docket ID No. EPA-R08-OAR-2016-0221, at
Jody Ostendorf, Air Program, U.S. Environmental Protection Agency (EPA), Region 8, Mail Code 8P-AR, 1595 Wynkoop Street, Denver, Colorado 80202-1129, (303) 312-7814,
In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by reference the Utah rules
In the “Rules and Regulations” section of this
If the EPA receives no adverse comments, the EPA will not take further action on this proposed rule. If the EPA receives adverse comments, the EPA will withdraw the direct final rule and it will not take effect. The EPA will address all public comments in a subsequent final rule based on this proposed rule.
The EPA will not institute a second comment period on this action. Any parties interested in commenting must do so at this time. For further information, please see the
Please note that if the EPA receives adverse comment on a distinct provision of this rule and if that provision may be severed from the remainder of the rule, the EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment. See the information provided in the Direct Final action of the same title which is located in the Rules and Regulations Section of this
42 U.S.C. 7401
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve a State Implementation Plan (SIP) revision submitted by the State of New Hampshire on December 16, 2014. New Hampshire's SIP revision addresses requirements of the Clean Air Act (CAA) and EPA's rules that require states to submit periodic reports describing progress toward reasonable progress goals (RPGs) established for regional haze and a determination of the adequacy of the State's existing Regional Haze SIP. In addition, the December 16, 2014 submittal includes a revised regulation that reduces the total suspended particulate (TSP) emission limit for the State's sole Tangential-Firing, Dry-Bottom Boiler.
Written comments must be received on or before August 18, 2016.
Submit your comments, identified by Docket ID Number EPA-R01-OAR-2014-0909 at
Anne McWilliams, Air Quality Unit, U.S. Environmental Protection Agency, EPA New England Regional Office, 5 Post Office Square—Suite 100, (Mail Code OEP05-02), Boston, MA 02109—3912, telephone number (617) 918-1697, fax number (617) 918-0697, email
Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.
Organization of this document. The following outline is provided to aid in locating information in this preamble.
States are required to submit a progress report in the form of a SIP revision every five years that evaluates progress towards the RPGs for each mandatory Class I Federal area
On December 16, 2014, NH DES submitted a revision to the New Hampshire SIP detailing the progress made in the first planning period toward implementation of the Long Term Strategy (LTS) outlined in the 2010 Regional Haze SIP submittal, the visibility improvement measured at the State's Class I areas, and a determination of the adequacy of the State's existing Regional Haze SIP. EPA is proposing to approve New Hampshire's December 16, 2014 SIP revision on the basis that it satisfies the requirements of 40 CFR 51.308(g) and (h).
Under 40 CFR 51.308(g), States must submit a regional haze progress report as a SIP revision every five years and must address the seven elements found in 40 CFR 51.308(g). As described in further detail in section III of this proposed rulemaking, 40 CFR 51.308(g) requires: (1) A description of the status of measures in the approved Regional Haze SIP; (2) a summary of emissions reductions achieved; (3) an assessment of visibility conditions for each Class I area in the state; (4) an analysis of changes in emissions from sources and activities within the state; (5) an assessment of any significant changes in anthropogenic emissions within or outside the state that have limited or impeded progress in Class I areas impacted by the state's sources; (6) an assessment of the sufficiency of the approved Regional Haze SIP; and (7) a review of the state's visibility monitoring strategy.
Under 40 CFR 51.308(h), states are required to submit, at the same time as the progress report SIP, a determination of the adequacy of their existing Regional Haze SIP and to take one of the following four possible actions based on information in the progress report: (1) Submit a negative declaration to EPA that no further substantive revision to the state's existing Regional Haze SIP is needed; (2) provide notification to EPA (and other state(s) that participated in the regional planning process) if the state determines that the existing Regional Haze SIP is, or may be, inadequate to ensure reasonable progress at one or more Class I areas due to emissions from sources in other state(s) that participated in the regional haze planning process, and collaborated with these other state(s) to develop additional strategies to address deficiencies; (3) provide notification with supporting information to EPA if the state determines that its existing Regional Haze SIP is, or may be, inadequate to ensure reasonable progress at one or more Class I areas due to emissions from sources in another county; or (4) revise its Regional Haze SIP to address deficiencies within one year if the state determines that its existing Regional Haze SIP is or may be inadequate to ensure reasonable progress in one or more Class I areas due to emission from sources within the state.
On December 14, 2014, New Hampshire submitted the “Regional Haze 5-Year Progress Report” (Progress Report) to EPA as a SIP revision.
New Hampshire has two Class I areas within its borders: Great Gulf Wilderness Area (Great Gulf) and Presidential Range-Dry River Wilderness Area (Dry River), both located within the White Mountains National Forest. Emissions from New Hampshire's sources were also found to impact visibility at one nearby Class I area, Acadia National Park in Maine (Acadia).
Through the consultation process, New Hampshire agreed to pursue the coordinated course of action agreed to by the Mid-Atlantic/Northeast Visibility Union (MANE-VU)
This section summarizes each of the seven elements that must be addressed by the progress report under 40 CFR 51.308(g), and describes how New Hampshire's progress report SIP addresses each element. This section also includes EPA's analysis of New Hampshire's SIP, and our proposed determination as to whether the State satisfied each element.
The provisions in 40 CFR 51.308(g)(1) require a description of the status of implementation of all measures included in the Regional Haze SIP for achieving RPGs for Class I areas both within and outside the state. New Hampshire's 2010 Regional Haze SIP RPGs are based on: Control measures for the State's two subject-to-BART sources; control measures for one additional EGU stack; and sulfur dioxide (SO
In addition, the New Hampshire 2014 Progress Report also includes the status of SO
EPA proposes that New Hampshire's analysis adequately addresses the provisions under 40 CFR 51.308(g)(1). The State demonstrates the implementation of measures within the State, including BART and targeted SO
The provision under 40 CFR 51.308(g)(2) requires a summary of the emission reductions achieved in the state through the measures subject to the requirements under 40 CFR 51.308(g)(1). During the development of the Regional Haze SIP for the first planning period, MANE-VU and New Hampshire determined that SO
EPA proposes to find that New Hampshire has adequately addressed the provision under 40 CFR 51.308(g)(2). New Hampshire has detailed the SO
The provisions under 40 CFR 51.308(g)(3) require that states with Class I areas within their borders provide the following information for the most impaired and least impaired days
New Hampshire is home to two Class I areas, Great Gulf and Dry River. The Interagency Monitoring of Protected Visual Environments program (IMPROVE) monitor within Great Gulf is representative of both New Hampshire Class I areas. In the Progress Report, NH DES provides the data for the baseline 2000-2004 5-Year Average visibility, the most recent 2009-2013 5-Year Average visibility, the 2018 RPG from the 2010 Regional Haze SIP, and the calculated visibility improvement.
The baseline visibility for Great Gulf was 22.8 dv on the 20% most impaired days and 7.7 dv on the least impaired days. The most recent five-year average visibility data shows an improvement of 6.1 dv on the 20% most impaired days and 1.8 dv improvement on the 20% least impaired days. The 2014 Progress Report also demonstrates that the State has already achieved and surpassed the 2018 RPG for the 20% most impaired days and ensured no visibility degradation for the 20% least impaired days for the first planning period.
EPA is proposing to find that New Hampshire provided the required information regarding visibility conditions to meet the requirements under 40 CFR 51.308(g)(3), specifically providing baseline visibility conditions (2000-2004), current conditions based on the most recently available IMPROVE monitoring data (2009-2013), and the difference between current visibility conditions and baseline visibility conditions.
The provisions under 40 CFR 51.308(g)(4) require an analysis tracking emissions changes of visibility-impairing pollutants from the state's sources by type or category over the past five years based on the most recent updated emissions inventory. In its progress report SIP to address the requirements of 40 CFR 51.308(g)(4), New Hampshire presents data from statewide emissions inventories developed for the years 2002, 2007, 2013 (EGUs only), and projected inventories for 2018 for SO
EPA is proposing that New Hampshire has adequately addressed the provisions under 40 CFR 51.308(g)(4). NH DES compared the most recent updated emission inventory data available at the time of the development of the Progress Report with the baseline emissions for the Regional Haze SIP. The progress report appropriately details the 2007 SO
The provisions under 40 CFR 51.308(g)(5) require an assessment of any significant changes in anthropogenic emissions within or outside the state that have occurred over the past five years that have limited or impeded progress in reducing pollutant emissions and improving visibility in Class I areas impacted by the state's sources. In its progress report SIP, New Hampshire states that sulfates continue to be the biggest single contributor to regional haze at Great Gulf, Dry River, and Acadia. While New Hampshire mainly focused its analysis on addressing large SO
EPA proposes to conclude that New Hampshire has adequately addressed the provisions under 40 CFR 51.308(g)(5). The State adequately demonstrated that there are no significant changes in emissions of SO
The provisions under 40 CFR 51.308(g)(6) require an assessment of whether the current Regional Haze SIP is sufficient to enable the state, or other states, to meet the RPGs for Class I areas affected by emissions from the state. In its progress report SIP, NH DES states that it believes that the elements and strategies relied on in its original Regional Haze SIP are sufficient to enable New Hampshire and neighboring states to meet all established RPGs. To support this conclusion, NH DES notes that 2013 EGU SO
EPA proposes to conclude that New Hampshire has adequately addressed the provisions under 40 CFR 51.308(g)(6). EPA views this requirement as an assessment that should evaluate emissions and visibility trends and other readily available information. In its Progress Report, New Hampshire described the improving visibility trends detailed in the NESCAUM report and the downward emissions trends in key pollutants in the State and the MANE-VU region. With a focus on SO
The provisions under 40 CFR 51.308(g)(7) require a review of the state's visibility monitoring strategy and an assessment of whether any modifications to the monitoring strategy are necessary. New Hampshire's visibility monitoring strategy relies upon participation in the IMPROVE network. The IMPROVE monitor at the Great Gulf area is located approximately 1 mile east of the wilderness boundary and also serves as the monitor for the Dry River area whose northern most limit lies only 5 miles southwest of the monitor location. NH DES finds that there is no indication of a need for additional monitoring sites or equipment.
EPA proposes to find that New Hampshire has adequately addressed the provisions under 40 CFR 51.308(g)(7) by reviewing the state's visibility monitoring strategy and assessing whether any modifications to the monitoring strategy are necessary.
Under 40 CFR 51.308(h), states are required to take one of four possible actions based on the information gathered and conclusions made in the progress report SIP. In its progress report SIP, New Hampshire took the action provided for by the provisions under 40 CFR 51.308(h)(1), which allow a state to submit a negative declaration to EPA.
In the 2014 SIP submittal, New Hampshire determined that the existing Regional Haze SIP requires no further substantive revision at this time to achieve the RPGs for Class I areas affected by the state's sources. The basis for the State's negative declaration is the finding that visibility has improved at all Class I areas in the MANE-VU region. In addition, SO
EPA proposes to conclude that New Hampshire has adequately addressed the provisions under 40 CFR 51.308(h) because the visibility and emission trends indicate that the Great Gulf and Dry River Areas, in addition to Acadia which is the Class I area impacted by New Hampshire sources, will be able to meet or exceed the RPGs for 2018.
On August 22, 2012, EPA approved New Hampshire's Env-A 2300 Mitigation of Regional Haze into New
EPA is proposing to find that New Hampshire's revised Env-A 2302.02 strengthens the existing SIP and is therefore proposing to approve, and incorporate into the New Hampshire SIP, revised Env-A 2302.02.
EPA is soliciting public comments on the issues discussed in this notice or on other relevant matters. These comments will be considered before taking final action. Interested parties may participate in the Federal rulemaking procedure by submitting written comments to the EPA New England Regional Office listed in the
EPA is proposing to approve New Hampshire's December 16, 2014 Regional Haze 5-Year Progress Report as meeting the requirements of 40 CFR 51.308(g) and (h). In addition, EPA is proposing to approve, and incorporate into the New Hampshire SIP, New Hampshire's revised section Env-A 2302.02 Emission Standards Applicable to Tangential-Firing, Dry Bottom Boilers.
In this rulemaking, the EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by reference New Hampshire's revised Env-A 2302.02 Emission Standards Applicable to Tangential-Firing, Dry-Bottom Boilers, effective November 22, 2014. The EPA has made, and will continue to make, these documents generally available electronically through
Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this proposed action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this proposed action:
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Regional Haze, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
Federal Communications Commission.
Proposed rule.
In this Notice of Proposed Rulemaking (NPRM), the Federal Communications Commission (Commission) proposes changes to our rules and procedures related to certain applications and petitions for declaratory ruling involving foreign ownership (together, “applications”). The Commission refers certain applications to the relevant Executive Branch agencies for their input on any national security, law enforcement, foreign policy, and trade policy concerns that may arise from the foreign ownership interests held in the applicants and petitioners (together,
Submit comments on or before August 18, 2016, and replies on or before September 2, 2016.
You may submit comments, identified by IB Docket No. 16-155, by any of the following methods:
•
•
•
For detailed instructions on submitting comments and additional information on the rulemaking process, see the
David Krech or Veronica Garcia-Ulloa, Telecommunications and Analysis Division, International Bureau, FCC, (202) 418-1480 or via email to
This is a summary of the Commission's Notice of Proposed Rulemaking in IB Docket No. 16-155, adopted on June 24, 2016 and released on June 24, 2016. The full text of this document is available for inspection and copying during normal business hours in the FCC Reference Center, 445 12th Street SW., Washington, DC 20554. The document also is available for download over the Internet at:
Pursuant to §§ 1.415, 1.419, interested parties may file comments and reply comments on or before the dates indicated above. Comments may be filed using the Commission's Electronic Comment Filing System (ECFS).
•
•
• All hand-delivered or messenger-delivered paper filings for the Commission's Secretary must be delivered to FCC Headquarters at 445 12th St. SW., Room TW-A325, Washington, DC 20554. The filing hours are 8:00 a.m. to 7:00 p.m. All hand deliveries must be held together with rubber bands or fasteners. Any envelopes and boxes must be disposed of
• Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9300 East Hampton Drive, Capitol Heights, MD 20743.
• U.S. Postal Service first-class, Express, and Priority mail must be addressed to 445 12th Street SW., Washington DC 20554.
1. In this Notice of Proposed Rulemaking, we propose changes to our rules and procedures related to certain applications and petitions for declaratory ruling involving foreign ownership. On May 10, 2016, the National Telecommunications and Information Administration (NTIA) filed a letter on behalf of the Executive Branch requesting that the Commission make changes to its processes that would help facilitate a more streamlined Executive Branch review process. The Executive Branch asks the Commission to require applicants seeking international section 214 authorizations or transfer of such authorizations, submarine cable landing licenses, satellite earth station authorizations, and section 310(b) foreign ownership rulings to provide certain information as part of their applications. The Executive Branch specifically asks that applicants with reportable foreign ownership provide certain information regarding ownership, network operations, and related matters, and that all applicants, regardless of whether they have reportable foreign ownership, certify that they will comply with applicable law enforcement assistance requirements and respond truthfully and accurately to lawful requests for information and/or legal process. The NTIA Letter states that such requirements will improve the ability of the Executive Branch to expeditiously and efficiently review referred applications, particularly in regard to identifying and assessing applications that raise national security or law enforcement concerns. The letter further states that the proposed certifications, in many cases, may eliminate the need for national security or law enforcement conditions, and thus facilitate expeditious responses to the Commission on specific applications.
2. Based on the NTIA Letter and the comments received, we propose specific changes in our rules, designed to address the Executive Branch's request in a manner that furthers our mandate to serve the public interest. We also propose to adopt time frames for Executive Branch review of applications and other changes to our processing rules. We seek comment on those proposed changes. We believe that implementation of these rule changes would speed the action on applications while continuing to take into consideration relevant national security, law enforcement, foreign policy, and trade policy concerns.
3. The Commission refers certain applications to the Executive Branch when there is reportable foreign ownership in the applicant. Specifically, where an applicant has a ten percent or greater direct or indirect owner that is not a U.S. citizen, Commission practice has been to refer an application for: (1) International section 214 authority; (2) assignment or transfer of control of domestic or international section 214 authority; (3) a submarine cable landing license; and (4) assignment or transfer of control of a submarine cable landing license. The Commission also refers petitions seeking authority to exceed the section 310(b) foreign ownership limits for broadcast and common carrier wireless licensees, including common carrier satellite earth stations.
4. Our understanding is that the national security and law enforcement agencies generally initiate review of an application by sending the applicant a
5. Upon completion of review, the Executive Branch notifies the Commission of its recommendation in typically one of two forms. The national security and law enforcement agencies may have no comment, in which case they file a letter to this effect, and the Commission moves forward with its action on the application. Alternatively, the agencies may advise the Commission that they have no objection to the grant of an application so long as the applicant complies with the terms of the relevant LOA or NSA. In such case, a grant of the application will typically be subject to the express condition that the applicant abide by the commitments and undertakings contained in the LOA and or NSA. More specifically, a typical authorization states that a failure to comply and/or remain in compliance with any of the commitments and undertakings in the LOA or NSA shall constitute a failure to meet a condition of such authorization, and thus grounds for declaring that the authorization has been terminated under the terms of the condition without further action on the part of the Commission. See IB Public Notice, 30 FCC Rcd at 11018; see,
6. On May 12, 2016, the International Bureau released a public notice seeking comment on the May 10, 2016 NTIA Letter. Based on the NTIA Letter and the comments we have received, we identify below several proposals to make the Executive Branch review process more efficient and transparent. These include proposals that address the following requests set out in the NTIA Letter: (1) Requiring certain applicants with reportable foreign ownership to file information regarding ownership, network operations, and related matters; and (2) requiring applicants, regardless of whether they have reportable foreign ownership, to certify they will comply with certain law enforcement assistance requirements and respond truthfully and accurately to lawful requests for information and/or legal process. They also include additional proposals to establish time frames for Executive Branch review of applications and modify our processing rules. We seek comment on these and other ways to expedite the review process and increase transparency while ensuring that relevant Executive Branch concerns receive consideration as part of the Commission's public interest review.
7. TYPES OF APPLICATIONS. We propose that only certain types of applications may be required to provide the information and certifications requested by the Executive Branch in the NTIA Letter. In the NTIA Letter, the Executive Branch requests that applicants seeking international section 214 authorizations or transfer of such authorizations, submarine cable landing licenses, satellite earth station authorizations, and section 310(b) foreign ownership rulings, provide certain information and certifications as part of their applications. We currently refer to the Executive Branch applications with reportable foreign ownership for international section 214 authorizations, applications to assign or transfer control of domestic or international section 214 authority, submarine cable landing licenses and applications to assign or transfer control of such licenses, and petitions for section 310(b) foreign ownership rulings (broadcast, common carrier wireless, and common carrier satellite earth stations). We do not propose to expand the types of applications that we refer to the Executive Branch.
8. Currently, we refer applications for transfer of control of domestic section 214 authority that have reportable foreign ownership and that do not have a corresponding international section 214 transfer of control application. The NTIA Letter does not seek to review these types of applications, nor do we propose to include these applications among those we will refer to the Executive Branch or to require the requested information and certifications. We seek comment on this and whether there are situations where we should refer a domestic-only section 214 authority transfer of control application to the Executive Branch.
9. EchoStar/Hughes and SIA raise concerns that the NTIA Letter seeks to require non-common carrier earth station licenses to be subject to the information and certification requests by the Executive Branch. We have not been referring earth station applications to the Executive Branch because most earth stations are authorized on a non-common carrier basis, and we do not collect ownership information in the applications. An earth station application, however, may be included as part of a referral of associated applications, such as an international section 214 application or an assignment or transfer of control application. We propose to maintain our current practice and only refer common carrier earth station applications if the applicant requires a section 310(b) foreign ownership ruling. Consequently, an applicant for an earth station license would not be required to provide the information and certifications sought by the Executive Branch as part of its application, but would only need to provide such information as part of its section 310(b) petition if it required a foreign ownership ruling. Similarly, we propose that an applicant for a broadcast or common carrier wireless license not be required to provide the information as part of its application, but only need to provide such information as part of its section 310(b) petition if it required a foreign ownership ruling. We seek comment on whether these are the appropriate types of applications to be required to provide the information and certifications requested by the Executive Branch and be considered for referral to the Executive Branch for national security, law enforcement, foreign policy, and trade policy concerns.
10. OWNERSHIP, NETWORK OPERATIONS, AND OTHER INFORMATION REQUIREMENTS. We propose to require applicants with reportable foreign ownership to provide information on ownership, network
11.
12. To help ensure that the relevant departments and agencies have the information needed to review an application promptly, the Executive Branch requests that we require applicants with reportable foreign ownership seeking international section 214 authorizations or transfer of such authorization, submarine cable landing licenses, and satellite earth station authorizations, as well as petitioners for section 310(b) foreign ownership rulings, to provide as part of their applications detailed and comprehensive information in the following areas:
(1) Corporate structure and shareholder information;
(2) Relationships with foreign entities;
(3) Financial condition and circumstances;
(4) Compliance with applicable laws and regulations; and
(5) Business and operational information, including services to be provided and network infrastructure.
13. The Executive Branch asks the Commission “to adopt requirements that focus on the above categories of information to be collected, while also providing sufficient flexibility for the Commission to prescribe and, as necessary, modify the specific questions posed to applicants.” The Executive Branch recommends that the Commission propose and seek comment on specific questions through an information collection process consistent with the Paperwork Reduction Act of 1995 (PRA) process. For illustrative purposes, the Executive Branch also filed sample questions that show the types and extent of the information it seeks to obtain. The introductory language for the sample questions states that the questions seek “information regarding the business organization and services, network infrastructure, relationships with foreign entities or persons, historical regulatory and penal actions, and capabilities to comply with applicable legal requirements, and would be shared with relevant Executive Branch departments and agencies to assist in the review of public interest factors.”
14. The NTIA Letter states that this information is necessary for the agencies to assess whether an application with reportable foreign ownership raises national security or law enforcement concerns, including preventing abuses of U.S. communications systems, protecting the confidentiality, integrity and availability of U.S communications, protecting the national infrastructure, preventing fraudulent or other criminal activity, and preserving the ability to effectuate legal process for communications data. It states that receiving the information at the time of referral, rather than having to request it after referral, will help the Executive Branch begin review of the application promptly after referral. Commenters state that requiring these categories of information may help expedite the process, but may go beyond the information the Executive Branch currently requests. For example, one commenter asserts that seeking information on financial condition and circumstances and compliance with applicable laws and regulations “seems far outside the scope of [the Executive Branch's] review of applications for `national security, law enforcement, foreign policy, or trade concerns.'” Others argue that the requested information is duplicative of information provided as part of the Commission's application. We seek comment on this request and on the proposed categories of information. Are there more narrowly tailored questions that can adequately serve the goals sought in the NTIA Letter? Are there additional questions that should be included, and, if so, what are those questions?
15.
16.
17. We also seek comment on whether the use of a publicly available set of standardized questions for which the answers must be provided at the time of filing an application will help to streamline the Executive Branch review process. For instance, will the inclusion of responses to the standardized questions at the time the application is filed result in more timely review than the use of individualized questions that are sent to the applicant after the application has been filed? Many of the commenters support having the questions publicly available and the answers provided at the time the application is filed, stating that this should expedite Executive Branch review. CTIA, while supporting publicly-available standardized questions, recommends that the answers not be provided when the application is filed because the answers would likely delay and complicate applications. CTIA instead suggests that applicants “certify in their application that they will provide complete responses to the questionnaire within a particular time frame after filing the application.” We seek comment on whether the answers should be provided when the application is filed with the Commission, and if not, how a later filing would serve the goal of expediting Executive Branch review of the applications.
18. We propose that, although the questions would be standardized, they vary by category of application. For example, an applicant for an international section 214 authorization would not be required to provide information about cable landing location sites. We also seek comment on whether there is information that the Executive Branch may require that cannot be provided when an application is filed, but which could be made available later in the review process. For example, Level 3 notes that submarine cable landing applicants usually cannot provide answers to all the questions at the time the application is filed. Should an application be considered complete and acceptable for filing if there is information that an applicant cannot provide at the time of filing? Are there specific questions for submarine cable applicants or other applicants that should not be required at the time the applicant files?
19.
20. We recognize that the responses to some of these threshold questions may contain confidential commercial information. Some of the threshold questions would seek personally identifiable information (PII). Any questions that seek PII would require the Commission to assess whether by obtaining and using such PII it would be creating a system of records under the Privacy Act. 5 U.S.C. 552a. With respect to any information we may receive that includes PII, we intend to comply fully with the requirements of that statute and related statutes that protect PII. The Commission's rules provide a mechanism for requesting confidential treatment of such information. Under these rules, such information will be accorded confidential treatment until the Commission acts on the confidentiality request and all subsequent agency review and judicial stay proceedings have been exhausted. To the extent the information qualifies as trade secrets or confidential commercial or financial information that is exempt from disclosure under the Freedom of Information Act, our rules require a “persuasive showing” for public release of the information, showing among other factors that the information is relevant to a public interest issue before the Commission. In application proceedings, the Commission may rely upon protective orders to limit disclosure and use of competitively sensitive and other confidential information. We seek comment on whether these established procedures serve to provide appropriate protections in such situations. Given the scope of this information, the likelihood that some of it may already be public, and the relevance of context in evaluating competitive concerns, we do not propose to designate such information in our rules as the kind that is presumed confidential and therefore does not require the filing of a request for confidentiality. We seek comment on this view. We seek comment on whether some of this information can be presumed to be confidential and request that commenters specify which types of information should be presumed confidential.
21. If we require the responses to the questions to be filed with the Commission, we seek comment on whether the Commission should take special steps to ensure that the responses to threshold questions submitted by applicants are secure, such as having applicants submit their responses through a secure portal. We note that the Commission has experience in receiving confidential information and sharing that information with other agencies. Currently, the Commission has in place secure portals, such as the Network Outage Reporting System (NORS). We would anticipate developing a similar system to facilitate the receiving, reviewing, sharing, and generally storing any confidential or sensitive information in the applicants' submissions in response to the threshold questions. We also invite suggestions about other heightened security measures that the Commission can undertake to ensure the protection
22. In this case, our proposals contemplate sharing of confidential information submitted as part of the application with Executive Branch agencies, who would continue to review it in the first instance for national security, law enforcement, foreign policy, and trade policy concerns. Under our rules, such sharing is subject to the requirement that the Executive Branch agencies must comply with the protections applicable both to the Commission and to themselves relating to the unlawful disclosure of information. Because current practice already involves submission of similar information for review by these agencies, and in light of their legitimate need for the information, we propose to amend section 0.442 of the Commission's rules to make clear that sharing with Executive Branch agencies under these restrictions is permissible without the pre-notification procedures of that rule. We seek comment on this proposal. Are the obligations of the various Executive Branch agencies different than the Commission's obligation to protect the information? If so, what are the differences and what is the possible impact of those differences?
23. We seek comment on whether there are reasons why the Commission should or should not undertake the initial review of the answers for completeness. We seek comment on whether there are concerns with Commission staff receiving, reviewing, storing, and forwarding to the Executive Branch such personally identifiable and business sensitive information. What are the benefits and burdens of the Commission receiving and reviewing the threshold questions? We invite suggestions on heightened confidentiality protections for sensitive and proprietary financial, operational, and privacy related information that applicants would provide as part of the Commission's application process.
24. CERTIFICATION REQUIREMENTS. We propose to add a certification requirement to our rules, and seek comment on the scope of this proposal. The Executive Branch requests that the Commission require
25. The NTIA Letter observes that national security and law enforcement review frequently requires time both to negotiate assurances from an applicant that it will comply with applicable law enforcement assistance requirements and to draft an individualized LOA upon which the Executive Branch will rely to address national security and law enforcement concerns. It states that the proposed certification would simplify and expedite the review process. The Executive Branch therefore requests that an applicant certify that, with respect to the communications services to be provided under the requested license or authorization, it will:
(1) Comply with applicable provisions of the Communications Assistance for Law Enforcement Act (CALEA);
(2) make communications to, from, or within the United States, as well as records thereof, available in a form and location that permits them to be subject to lawful request or valid legal process under U.S. law, for services covered under the requested Commission license or authorization; and
(3) agree to designate a point of contact located in the United States who is a U.S. citizen or lawful permanent resident for the execution of lawful requests and/or legal process.
26.
27.
28.
29. We also seek comment on whether the certifications regarding compliance with CALEA and making communications within the United States as well as records thereof available in a form and location that permits them to be subject to lawful request or valid legal process under U.S. law, should be applied to all applicants or only applied to certain applicants. We also seek comment on whether the certifications regarding compliance with CALEA and making communications within the United States, as well as records thereof, available in a form and location that permits them to be subject to lawful request or valid legal process under U.S. law should be applied more narrowly than proposed in the NTIA Letter. Should they only apply to common carrier licensees? For example, the Broadcaster Representatives argue that the CALEA compliance and intercept capabilities have nothing to do with broadcasting, or with broadcast licensees or applicants that file a petition for a foreign ownership ruling under section 310(b). The Broadcaster Representatives state that broadcasters “do not have compliance obligations” under CALEA and recommend the Commission consider differentiating the requirements in the broadcast context. We seek comment on considerations of the scope and implications of the certifications proposal.
30. TIME FRAMES FOR EXECUTIVE BRANCH REVIEW. We propose to adopt a 90-day period for the Executive Branch to complete its review of referred applications and petitions. In rare instances, we propose to allow a one-time additional 90-day extension provided the Executive Branch demonstrates that issues of complexity warrant such an extension and provides to the Commission the status of its review every 30 days thereafter. We also propose that the time period would start from the date the application is placed on the Commission's acceptable for filing public notice. We believe that time frames will bring additional clarity and certainty to the review process. Such transparency would benefit the Commission and applicants alike, by keeping all parties better informed of the application's status and facilitating expectations for resolution of pending cases. Several commenters agree, stating that time frames (including a 90-day period) should be established for Executive Branch review in order to promote transparency and certainty of action. Because these time frames will affect multiple types of applications with requirements that are set out in different parts of the Commission's rules, we propose to establish a new subpart U in Part 1 of the rules for referral of applications to the Executive Branch.
31.
32.
33.
34. In keeping with current practice, we propose to continue to request that the Executive Branch notify us within the comment period established by the public notice if it will require additional time to review the application (
35. A 90-day period is consistent with the existing timelines for action on non-streamlined international 214 and cable landing license applications. Moreover, a 90-day review period is consistent with review periods used by other agencies as well. For example, CFIUS conducts national security reviews of mergers, acquisitions, and takeovers by, or with, any foreign person that could result in foreign control of a U.S. business (a “covered transaction”) under a similar time frame. After an organization submits notice of a transaction to the Committee, CFIUS has up to 90 days to complete its review of the transaction.
36. We recognize that, in some unusual cases, the Executive Branch may need more than 90 days to investigate and/or resolve any national security, law enforcement, foreign policy, or trade policy issues. Allowing the Executive Branch up to an additional 90 days (
37. Under our proposal, the Executive Branch would complete its review within the 90-day period or notify the Commission no later than the initial 90-day date that it requires additional time for review and, every 30 days thereafter, would notify the Commission on the status of review. We propose that the notification would explain why the Executive Branch requires additional time to complete review, along with an estimate of the additional time required. We invite comment on factors that would provide a basis for an extension. If the explanation includes classified or other information that should not be made public, the agencies would have the ability to file a short statement in the public record, and provide a more thorough explanation to Commission staff in a non-public record.
38. We seek comment on the proposed 90-day and 180-day time periods. Are these appropriate? Should they apply to all the applications that are referred to the Executive Branch or should there be different time periods for different types of applications? If different periods should be adopted, what would be the rationale for such a
39.
40. We also propose to place similar requirements on the applicant to be responsive to requests by the agencies to negotiate mitigation, a process which we expect to occur within the 90-day review period following referral of an application, as discussed in the paragraphs above. Thus, under this proposed approach, an applicant would have seven days after receiving a draft mitigation agreement to respond to it (either by signing it or offering a counter-proposal). If an applicant desires more than seven days to respond to the draft mitigation agreement, it must submit an extension request directly to the Executive Branch. The 90-day clock would stop for the duration of the extension, just as it would stop for extensions to respond to follow-up questions. Negotiation of the mitigation agreement could involve several rounds of seven-day review periods (or longer if extensions are sought) if multiple drafts and counter-proposals are exchanged. Failure of an applicant to respond within the seven days or any approved extension period would result in dismissal of the application, without prejudice. We seek comment on these proposals. In particular, we request comment on whether seven days is sufficient time to respond to follow-up questions, and what impact allowing a longer period would have on the 90-day period for Executive Branch review.
41. CATEGORIES OF REFERRALS. Although we propose to continue to refer certain applications to the Executive Branch agencies, we seek comment on whether there are categories of applications with foreign ownership that the Commission should generally not refer to the Executive Branch. For example, currently the Commission does not refer a
42. OTHER CHANGES TO THE APPLICATION PROCESS. We also propose other revisions to the application process to streamline the review process. First, we propose to amend our rules to clarify that applicants for international section 214 authorizations, assignments or transfers of control of domestic or international section 214 authority, and applications for submarine cable landing licenses or to assign or transfer control of such licenses must include in their applications the voting interests, in addition to the equity interests, of individuals or entities with ten percent or greater direct or indirect ownership in the applicant. Second, we propose to require these applicants to include in their applications a diagram of the applicant's ownership, showing the ten percent or greater direct or indirect ownership interests in the applicant. We believe that these two rule revisions will facilitate faster review of applications by Commission staff.
43. The current rules require applicants to provide the name, address, citizenship, and principal businesses of any individual or entity that owns directly or indirectly at least ten percent of the equity of the applicant. These rules originated when equity and voting ownership were usually the same. Today, applicants often have multiple classes of ownership and equity interests that differ from the voting interests. It is important for the Commission to know for potential control purposes who has voting interests in the applicant. The Commission has recognized this in other rules, where it requires an applicant to provide both equity and voting interests in an applicant. Although most applicants provide the voting information in their international section 214 and submarine cable license applications, others do not. If the filing does not provide information about the voting interests, either by providing separate equity and voting share information or noting that the voting interests track the equity interests, it is the practice of Commission staff to contact applicants and request the information. Having to request this information delays review of the
44. We also believe that inclusion of a diagram showing the ten-percent-or-greater interests in the applicant can help speed the processing of an application. Many applicants have complex ownership structures, particularly those with private equity ownership. A diagram can help distill a lengthy description of an ownership structure and make it more easily understood. The Commission has found this especially helpful in the context of foreign ownership petitions and recently included such a requirement in the rules regarding the contents of a request for declaratory ruling under section 310(b) of the Act. While many applicants already provide ownership diagrams in their applications, Commission staff often request such a diagram from an applicant after the application has been filed. We believe that requiring the application to include the diagram would impose a minimal burden on applicants which would be offset by the Commission staff's ability to process applications more expeditiously. We seek comment on this proposal.
45. Finally, we propose a clean-up edit to the cable landing license rules. In 2014, the Commission removed the effective competitive opportunities test for cable landing licenses. The Commission at that time failed to amend the reporting requirement for licensees affiliated with a carrier with market power in a cable's destination market to remove the limitation that it apply only to destination markets in World Trade Organization (WTO) Member countries. We propose to remove that limitation and apply the reporting requirements to licensees affiliated with a carrier with market power in a cable's destination market for all countries, whether or not they are a WTO Member. We seek comment on this proposal.
46. CONCLUSION. The Commission seeks to streamline and to bring more transparency to the Executive Branch referral process while continuing to give consideration to relevant national security, law enforcement, foreign policy, and trade policy concerns. We seek comment on the proposals we make to implement the suggestions submitted by the Executive Branch. We also seek comment on establishing appropriate time frames for Executive Branch review of an application with reportable foreign ownership and other changes to our processing rules. We tentatively conclude that implementation of these proposals would provide for more timely and transparent review while ensuring that relevant national security, law enforcement, foreign policy, and trade policy concerns receive consideration.
47. This document contains new and modified information collection requirements. The Commission, as part of its continuing effort to reduce paperwork burdens, invites the general public and the Office of Management and Budget (OMB) to comment on the information collection requirements contained in this document, as required by the Paperwork Reduction Act of 1995, Public Law 104-13. Public and agency comments are due September 19, 2016. Comments should address: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimates; (c) ways to enhance the quality, utility, and clarity of the information collected; (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and (e) way to further reduce the information collection burden on small business concerns with fewer than 25 employees. In addition, pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198,
48. As required by the Regulatory Flexibility Act (RFA), the Commission has prepared this Initial Regulatory Flexibility Analysis (IRFA) of the possible significant economic impact on small entities by the policies and rules proposed in this Notice of Proposed Rule Making (NPRM). We request written public comments on this IRFA. Commenters must identify their comments as responses to the IRFA and must file the comments by the deadlines provided in the NPRM. The Commission will send a copy of the NPRM, including this IRFA, to the Chief Counsel for Advocacy of the Small Business Administration. In addition, the NPRM and IRFA (or summaries thereof) will be published in the
49. This NPRM seeks comment on the proposed changes to our rules and procedures related to the review of certain applications and petitions for declaratory ruling involving foreign ownership by the Executive Branch agencies. The Commission's objective is to improve the timeliness and transparency of the Executive Branch review process. Industry has expressed concern about the uncertainty and lengthy review times that make it difficult to put a business plan in place. In response, the Executive Branch agencies filed a letter requesting the Commission make changes to its processes that would help facilitate a more streamlined review. The proposed rules seek to remedy the uncertainty and time frame for review.
50. The NPRM proposes several changes to our rules. Specifically, it proposes to:
1. Standardize the threshold questions that the national security and law enforcement agencies routinely ask applicants with foreign ownership and require applicants to provide the information as part of the application process. The NPRM proposes to collect information on: Corporate structure and shareholder information; relationship with foreign entities; financial condition and circumstances; compliance with applicable laws and regulations; and business and operational information, including services to be provided and network infrastructure. The specific questions would be adopted through the Paperwork Reduction Act (PRA) process and would be publicly available on a Web site, as a downloadable document, so it is readily available to applicants prior to filing its application. This proposal would help provide transparency and expedite the review process.
2. Include in the rules a requirement that applicants certify that they will comply with routine mitigation measures. The Executive Branch agencies state that the proposed certification requirement reflects current laws and obligations applicable to applicants, but ensures that the applicants focus on those laws and obligations at the beginning of the application process. This would also help reduce the number of individualized Letters of Assurances that the Executive Branch agencies would need to negotiate, thus expediting response to the Commission.
3. Include applicable time frames for the Executive Branch agencies to complete its review of FCC applications. A 90-day clock is proposed upon referral of an application to the agencies, with an additional one-time 90 day extension in rare circumstances. Under the proposed rules, the Executive Branch would complete its review within the 90-day period or notify the Commission no later than the initial 90-day date that it requires additional time for review and, every 30 days thereafter, would notify the Commission on the status of review. The notification would explain why the Executive Branch requires additional time to complete review, along with an estimate of the additional time required. This proposal will help improve the timeliness of review and allow agencies
51. The proposed action is authorized under sections 4(i), 4(j), 214, 303, 309, 310 and 413 of the Communications Act as amended, 47 U.S.C. 154(i), 154(j), 214, 303, 309, 310 and 413, and the Cable Landing License Act of 1921, 47 U.S.C. 34 through 39, and Executive Order No. 10530, section 5(a) reprinted as amended in 3 U.S.C. 301.
52. The RFA directs agencies to provide a description of, and, where feasible, an estimate of, the number of small entities that may be affected by the rules adopted herein. Below, we describe and estimate the number of small entity applicants that may be affected by the adopted rules.
1. Wired Telecommunications Carriers.
2. Competitive Local Exchange Carriers (Competitive LECs), Competitive Access Providers (CAPs), Shared-Tenant Service Providers, and Other Local Service Providers.
3. Interexchange Carriers (IXCs).
4. Prepaid Calling Card Providers.
5. Local Resellers.
6. Toll Resellers.
7. Other Toll Carriers.
8. Wireless Telecommunications Carriers (except Satellite).
9. All Other Telecommunications.
10. Satellite Telecommunications and All Other Telecommunications.
11. Radio Broadcasting.
53. The NPRM proposes a number of rule changes that would affect reporting, recordkeeping and other compliance requirements for applicants who file international section 214 authorizations, submarine cable landing licenses or applications to assign or transfer control of such authorizations, and section 310 rulings (common carrier wireless, common carrier satellite earth stations or broadcast) (applicants). The proposed threshold questions request information already routinely asked by the Executive Branch agencies after filing the application but the proposed rules will require applicants with reportable foreign ownership to submit answers to the threshold questions at the time of filing their FCC application. Information requested will be on: Corporate structure and shareholder information; relationship with foreign entities; financial condition and circumstances; compliance with applicable laws and regulations; and business and operational information, including services to be provided and network infrastructure. Applicants would have a time frame by when they need to respond to any follow-up questions relevant to the application. Applicants would also be required to certify that they will comply with the Communications Assistance to Law Enforcement (CALEA); will make communications to, from, or within United States, as well as records thereof, available in a form and location that permits them to be subject to a valid and lawful request or legal process in accordance with U.S. law; certify that applicants would designate a point of contact in the U.S. that is a U.S. citizen or lawful permanent resident; certify that all information at time of submission is accurate and notify when information submitted is no longer accurate; and if an applicant fails to fulfill obligations contained in certifications they will be subject to all remedies available to the United States Government.
54. The RFA requires an agency to describe any significant, specifically small business, alternatives that it has considered in reaching its proposed approach, which may include the following four alternatives (among others): “(1) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance and reporting requirements under the rules for such small entities; (3) the use of performance rather than design standards; and (4) an exemption from coverage of the rule, or any part thereof, for such small entities.”
55. In this NPRM, the proposed changes for Executive Branch's review of FCC applications involving foreign ownership would help improve the timeliness and transparency of the review process, thus lessening the burden of the licensing process on all applicants, including small entities. The threshold questions would be publicly available, thus providing transparency and helping expedite Executive Branch's review. The proposed certifications will help reduce the need for routine mitigation, which should facilitate a faster response by the Executive Branch on its review and advance the shared goal of making the Executive Branch review process as efficient as possible. Time frames for review of FCC applications referred to the Executive Branch have also been proposed, which will help prevent unnecessary delays and make the process more efficient and transparent, which ultimately benefits all applicants, including small entities.
56. The NPRM seeks comment from all interested parties. The Commission is aware that some of the proposals under consideration may impact small entities. Small entities are encouraged to bring to the Commission's attention any specific concerns they may have with the proposals outlined in the NPRM.
57. The Commission expects to consider the economic impact on small entities, as identified in comments filed in response to the NPRM, in reaching its final conclusions and taking action in this proceeding.
58. Our proposed rules require applicants to certify that they will comply with federal rules related to assistance to law enforcement. Some of the federal rules that may duplicate with our proposed rules are:
1. Communications Assistance to Law Enforcement Act. 47 U.S.C. 1001 through 10.
2. Wiretap Act. 18 U.S.C. 2510
3. Stored Communications Act. 18 U.S.C. 2701
4. Pen Register and Trap and Trace Statute. 18 U.S.C. 3121
Classified information, Privacy.
Administrative practice and procedure, Communications common carriers, Telecommunications.
Communications common carriers, Reporting and recordkeeping requirements.
For the reasons discussed in the preamble, the Federal Communications Commission proposes to amend 47 CFR parts 0, 1, and 63 as follows:
Sec. 5, 48 Stat. 1068, as amended; 47 U.S.C. 155, 225, unless otherwise noted.
(d) * * *
(3) A party who furnished records to the Commission in confidence will not be afforded prior notice when the
The authority citation for part 1 is revised to read as follows:
15 U.S.C. 79,
(a) * * *
(8) * * *
(i) The place of organization and the information and certifications required in § 63.18 paragraphs (h), (o), (p) and (q) of this chapter.
(11)(i) If applying for authority to assign or transfer control of an interest in a cable system, the applicant shall complete paragraphs (a)(1) through (a)(3) of this section for both the transferor/assignor and the transferee/assignee. Only the transferee/assignee needs to complete paragraphs (a)(8) through (a)(9) of this section. The applicant shall provide the ownership diagram required under paragraph (a)(8)(i) of this section and include both the pre-transaction and post-transaction ownership of the licensee. At the beginning of the application, the applicant should also include a narrative of the means by which the transfer or assignment will take place. The application shall also specify, on a segment specific basis, the percentage of voting and ownership interests being transferred or assigned in the cable system, including in a U.S. cable landing station. The Commission reserves the right to request additional information as to the particulars of the transaction to aid it in making its public interest determination.
(j) On the date of filing with the Commission, the applicant shall also send a complete copy of the application, or any major amendments or other material filings regarding the application, to: U.S. Coordinator, EB/CIP, U.S. Department of State, 2201 C Street NW., Washington, DC 20520-5818; Office of Chief Counsel/NTIA, U.S. Department of Commerce, 14th St. and Constitution Ave. NW., Washington, DC 20230; and Defense Information Systems Agency, ATTN: GC/DO1, 6910 Cooper Avenue, Fort Meade, MD 20755-7088, and shall certify such service on a service list attached to the application or other filing.
(k) * * *
(5) Certifying that all ten percent or greater direct or indirect equity and/or voting interests in the applicant are U.S. citizens or entities organized in the United States.
(l)
(l) Each petitioner subject to a referral to the Executive Branch pursuant to § 1.6001 must file the national security and law enforcement information. The information will include:
(1) Corporate structure and shareholder information;
(2) Relationships with foreign entities;
(3) Financial condition and circumstances;
(4) Compliance with applicable laws and regulations; and
(5) Business and operational information, including services to be provided and network infrastructure. The instructions for submitting the information to be filed are available on the FCC Web site. The required information shall be submitted separately from the petition and shall be filed via an FCC Web site.
(m) Each petitioner shall make the following certifications:
(1) To comply with all applicable Communications Assistance to Law Enforcement Act (CALEA) requirements and related rules and regulations, including any and all FCC orders and opinions governing the application of CALEA and assistance to law enforcement (
(2) To make communications to, from, or within the United States, as well as records thereof, available in a form and location that permits them to be subject to a valid and lawful request or legal process in accordance with U.S. law;
(3) To designate a point of contact located in the United States and who is a U.S. citizen or lawful permanent resident, for the service of the requests and/or valid legal process described in paragraph (m)(2) of this section and the receipt of other communications from the U.S. government;
(4) That all information submitted, whether at the time of submission of the petition or subsequently in response to either Commission or Executive Branch agency request, is substantially accurate and complete in all significant respects to the best of petitioner's knowledge at the time of the submission. While the petition is pending, as defined in § 1.65(a), the petitioner agrees to promptly inform the Commission and, if the petitioner originally submitted the information in response to the request of another Executive Branch agency, that agency, if the information in the application is no longer substantially accurate and complete in all significant respects; and
(5) That the petitioner understands that if the applicant fails to fulfill any of the conditions to the grant of its petition and/or the information provided to the United States Government is materially false, fictitious, or fraudulent, the petitioner may be subject to all remedies available to the United States Government, including but not limited to revocation or termination of the applicant's Commission authorization, and criminal and civil penalties, including penalties under 18 U.S.C. 1001.
(a) The Commission, in its discretion, may refer applications, petitions, and other filings with foreign ownership to the Executive Branch for review for national security, law enforcement, foreign policy, and trade policy concerns.
(b) The Commission will consider any recommendations from the Executive Branch regarding whether a pending matter affects national security, law enforcement, foreign policy and/or trade policy as part of its public interest analysis. The Commission will make an independent decision and will evaluate concerns raised by the Executive Branch in light of all the issues raised in the context of a particular application, petition, or other filing.
(a) The Commission shall refer any applications, petitions, or other filings for which it determines to seek Executive Branch review at the time such application, petition, or other filing is placed on an accepted for filing public notice.
(b) If the Executive Branch does not otherwise notify the Commission by filing in the record for the application, petition, or other filing within the comment period established by the public notice, the Commission will deem that the Executive Branch does not have any national security, law enforcement, foreign policy, and trade policy concerns with the application, petition, or other filing and will act on the application, petition, or other filing as appropriate based on its determination of the public interest.
If the Executive Branch notifies the Commission that it needs additional time for its review of the application, petition, or other filing referred in accordance with § 1.6002(b):
(a) The Executive Branch shall notify the Commission by filing in the record for the application, petition, or other filing no later than 90 days from the date of public notice for the application, petition, or other filing whether it:
(1) Has national security, law enforcement, foreign policy, and trade policy concerns with the application, petition or other filing;
(2) Has no concerns;
(3) Has no concerns provided that the grant of the application, petition or other filing is conditioned; or
(4) Needs additional time to review the application, petition, or other filing.
(b) In cases of extraordinary complexity, when the Executive Branch notifies the Commission that it needs more than the 90-day period for review of the application, petition, or other filing under paragraph (a) of this section, the Executive Branch may request a one-time 90-day extension to review the application, petition, or other filing, provided that it:
(1) Explains why it was unable to complete its review within the initial 90-day review period and;
(2) Provides the Commission with updates on the status of its review every 30 days (at the 120-day and 150-day dates after release of the public notice). The Executive Branch must notify the Commission by filing in the record for the application, petition, or other filing no later than 180 days from the date of public notice for the application, petition or other filing whether it:
(i) Has national security, law enforcement, foreign policy, and trade policy concerns with the application, petition, or other filing;
(ii) Has no concerns; or
(iii) Has no concerns if the grant of the application, petition, or other filing is conditioned.
(c)(1) The Executive Branch shall file its notifications as to the status of its review in the public record for the application, petition, or other filing.
(2) In circumstances where the notification of the Executive Branch contains nonpublic information, the Executive Branch shall file a public version of the notification in the public record for the application, petition, or other filing and shall file the nonpublic information with the Commission pursuant to § 0.457 of this chapter.
Sections 1, 4(i), 4(j), 10, 11, 201-205, 214, 218, 403 and 651 of the Communications Act of 1934, as amended, 47 U.S.C. 151, 154(i), 154(j), 160, 201 through 205, 214, 218, 403, and 571, unless otherwise noted.
(a) * * *
(4)(i) The name, address, citizenship and principal business of any person or entity that directly or indirectly owns ten percent or more of the equity interests and/or voting interests, or a controlling interest, of the applicant, and the percentage of equity and/or voting interest owned by each of those entities (to the nearest one percent). Where no individual or entity directly or indirectly owns ten percent or more of the equity interests and/or voting interests, or a controlling interest, of the applicant, a statement to that effect.
(ii) An ownership diagram that illustrates the applicant's vertical ownership structure, including the direct and indirect ownership (equity and voting) interests held by the individuals and entities named in response to paragraph (a)(4)(i) of this section. Each such individual or entity shall be depicted in the ownership diagram and all controlling interests labeled as such.
(c) * * *
(3) An individual or entity that is not a U.S. citizen holds a ten percent or greater direct or indirect equity or voting interest in any applicant; or
(h)(1) The name, address, citizenship and principal businesses of any individual or entity that directly or indirectly owns ten percent or more of the equity interests and/or voting interests, or a controlling interest, of the applicant, and the percentage of equity and/or voting interest owned by each of those entities (to the nearest one percent). Where no individual or entity directly or indirectly owns ten percent or more of the equity interests and/or
(2) An ownership diagram that illustrates the applicant's vertical ownership structure, including the direct and indirect ownership (equity and voting) interests held by the individuals and entities named in response to paragraph (h)(1) of this section. Each such individual or entity shall be depicted in the ownership diagram and all controlling interests labeled as such.
(3) The applicant shall also identify any interlocking directorates with a foreign carrier.
Note to paragraph (h): Ownership and other interests in U.S. and foreign carriers will be attributed to their holders and deemed cognizable pursuant to the following criteria: Attribution of ownership interests in a carrier that are held indirectly by any party through one or more intervening corporations will be determined by successive multiplication of the ownership percentages for each link in the vertical ownership chain and application of the relevant attribution benchmark to the resulting product, except that wherever the ownership percentage for any link in the chain that is equal to or exceeds 50 percent or represents actual control, it shall be treated as if it were a 100 percent interest. For example, if A owns 30 percent of company X, which owns 60 percent of company Y, which owns 26 percent of “carrier,” then X's interest in “carrier” would be 26 percent (the same as Y's interest because X's interest in Y exceeds 50 percent), and A's interest in “carrier” would be 7.8 percent (0.30 × 0.26 because A's interest in X is less than 50 percent). Under the 25 percent attribution benchmark, X's interest in “carrier” would be cognizable, while A's interest would not be cognizable.
(p) With respect to each applicant for which an individual or entity that is not a U.S. citizen holds a ten percent or greater direct or indirect equity or voting interest in the applicant, file national security and law enforcement information regarding the applicant. The information may include:
(1) Corporate structure and shareholder information;
(2) Relationships with foreign entities;
(3) Financial condition and circumstances;
(4) Compliance with applicable laws and regulations; and
(5) Business and operational information, including services to be provided and network infrastructure. The instructions for submitting the information to be filed are available on the FCC Web site. The required information shall be submitted separately from the application and shall be filed via an FCC Web site.
(q) Each applicant shall make the following certifications:
(1) To comply with all applicable Communications Assistance to Law Enforcement Act (CALEA) requirements and related rules and regulations, including any and all FCC orders and opinions governing the application of CALEA and assistance to law enforcement (
(2) To make communications to, from, or within the United States, as well as records thereof, available in a form and location that permits them to be subject to a valid and lawful request or legal process in accordance with U.S. law;
(3) To designate a point of contact located in the United States and who is a U.S. citizen or lawful permanent resident, for the service of the requests and/or valid legal process described in paragraph (q)(2) of this section and the receipt of other communications from the U.S. government;
(4) That all information submitted, whether at the time of submission of the application or subsequently in response to either Commission or Executive Branch agency request, is substantially accurate and complete in all significant respects to the best of applicant's knowledge at the time of the submission. While the application is pending, as defined in § 1.65(a) of this chapter, the applicant agrees to promptly inform the Commission and, if the applicant originally submitted the information in response to the request of another Executive Branch agency, that agency, if the information in the application is no longer substantially accurate and complete in all significant respects; and
(5) That the applicant understands that if the applicant fails to fulfill any of the conditions to the grant of its application and/or the information provided to the United States Government is materially false, fictitious, or fraudulent, the applicant may be subject to all remedies available to the United States Government, including but not limited to revocation or termination of the applicant's Commission authorization, and criminal and civil penalties, including penalties under 18 U.S.C. 1001.
(e) * * *
(2) The application shall include the information requested in paragraphs (a) through (d) of § 63.18 for both the transferor/assignor and the transferee/assignee. The information requested in paragraphs (h) through (p) of § 63.18 is required only for the transferee/assignee. The ownership diagram required under § 63.18(h)(2) shall include both the pre-transaction and post-transaction ownership of the authorization holder. At the beginning of the application, the applicant shall include a narrative of the means by which the proposed transfer or assignment will take place.
(f) * * *
(2) * * *
(i) The information requested in paragraphs (a) through (d) and (h) of § 63.18 for the transferee/assignee. The ownership diagram required under § 63.18(h)(2) shall include both the pre-transaction and post-transaction ownership of the authorization holder;
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of availability of amendment to fishery management plan; request for comments.
The North Pacific Fishery Management Council (Council) has submitted Amendment 113 to the Fishery Management Plan for Groundfish of the Bering Sea and
Submit comments on or before September 19, 2016.
You may submit comments on this document, identified by NOAA-NMFS-2015-0155, by any one of the following methods:
•
•
Electronic copies of Amendment 113 to the FMP and the Environmental Assessment/Regulatory Impact Review/Initial Regulatory Flexibility Analysis (collectively, the “Analysis”) prepared for this action may be obtained from
Julie Scheurer, 907-586-7228.
The Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) requires that each regional fishery management council submit any fishery management plan amendment it prepares to NMFS for review and approval, disapproval, or partial approval by the Secretary. The Magnuson-Stevens Act also requires that NMFS, upon receiving a fishery management plan amendment, immediately publish a notice in the
Amendment 113 to the FMP was adopted by the Council in October 2015. The objective of Amendment 113 is to modify the BSAI Pacific cod fishery to prioritize the harvest of a portion of the Aleutian Islands Pacific cod TAC by catcher vessels directed fishing for Aleutian Islands Pacific cod and delivering their catch for processing to Aleutian Islands shoreplants, thereby supporting social and economic development in the western Aleutian Islands fishing communities in which those vessels operate and shoreplants are located. The harvest set-aside would provide the opportunity for Aleutian Islands catcher vessels, shoreplants, and the communities where Aleutian Islands shoreplants are located to receive benefits from a portion of the Aleutian Islands Pacific cod fishery, while the notification and performance requirements would preserve an opportunity for the complete harvest of the BSAI Pacific cod resource.
A combination of physical, biological, economic, and management factors, such as the relatively low Pacific cod stock abundance in the Aleutian Islands and the potential influx of excess at-sea processing capacity from rationalized fisheries, have affected harvesting and processing opportunities for Pacific cod for some participants in the Aleutian Islands and created the risk that Aleutian Islands fishing communities may not be able to sustain their participation in the Aleutian Islands Pacific cod fishery. The Council determined that Amendment 113 is necessary to provide benefits and stability to fishery-dependent fishing communities in the Aleutian Islands. Amendment 113 is consistent with long-standing policies recommended by the Council and regulations established by NMFS to provide harvesting and processing protections for non-rationalized fisheries and opportunities for fishing communities engaged in fisheries in the Aleutian Islands.
If approved, Amendment 113 would amend four sections of the FMP as described below. First, a new row entitled “Aleutian Islands Catcher Vessel Harvest Set-Aside” would be added to Table ES-2 in the Executive Summary, below the row entitled “Retention and Utilization Requirements”, to read, “Under certain conditions, up to five thousand metric tons of the AI Pacific cod TAC (excluding CDQ) is reserved exclusively for harvest by vessels directed fishing for AI Pacific cod and delivering their catch for processing to Aleutian Islands shoreplants west of 170 degrees W. long. from January 1 through March 15.” This harvest set-aside would be referred to as the “Aleutian Islands Catcher Vessel Harvest Set-Aside” in regulations.
Second, Amendment 113 would make two modifications in Section 3.2.3.4.3, “Apportionment of Total Allowable Catch”. Under subheading “3) Pacific cod”, the subheading “C) Seasonal Allocations” would be changed to read “B) Seasonal Allocations”. This change would be an editorial correction only. The second change in Section 3.2.3.4.3 would add a new subsection entitled “C) Bering Sea Trawl CV A-Season Sector Limitation” under subheading “3) Pacific cod”. This new subsection would state that if the Aleutian Islands Catcher Vessel Harvest Set-Aside is in effect, the trawl CV sector may not catch more than an amount that is equal to the trawl CV sector's A-season Pacific cod allocation minus the lesser of either the Aleutian Islands non-CDQ Pacific cod directed fishing allowance or 5,000 mt in the Bering Sea subarea before March 21.
Third, a new subsection 3.6.5, entitled “Aleutian Islands Catcher Vessel Harvest Set-Aside”, would be added at the end of Section 3.6, “Catch Restrictions”. This new subsection would include the five main
• First, “Aleutian Islands shoreplant,” for purposes of the Aleutian Islands Catcher Vessel Harvest Set-Aside, would be defined to mean a processing facility physically located on land west of 170 degrees W. long.
• In the Aleutian Islands Pacific cod fishery, up to 5,000 mt of the non-CDQ directed fishing allowance would be reserved exclusively for harvest by vessels directed fishing for Aleutian Islands Pacific cod and delivering their catch for processing to Aleutian Islands shoreplants from January 1 until March 15. This exclusive harvest reservation is the “Aleutian Islands Catcher Vessel Harvest Set-Aside.” Any amount of the Aleutian Islands Pacific cod non-CDQ directed fishing allowance in excess of the Aleutian Islands Catcher Vessel Harvest Set-Aside would be available for harvest by all non-CDQ sectors with available A-season allocations of Pacific cod and could be processed by any eligible processor.
• If less than 1,000 mt of the Aleutian Islands Catcher Vessel Harvest Set-Aside has been landed at Aleutian Islands shoreplants by February 28, the Bering Sea Trawl CV A-Season Sector Limitation and the Aleutian Islands Catcher Vessel Harvest Set-Aside would be suspended for the remainder of the year.
• Either the City of Adak or the City of Atka would be required to notify NMFS each year of its intent to process Aleutian Islands Pacific cod in the upcoming year for the Aleutian Islands Catcher Vessel Harvest Set-Aside to go into effect. Regulations implementing Amendment 113 will specify the date and the method by which the City of Adak or the City of Atka must notify NMFS. If neither the City of Adak nor the City of Atka notifies NMFS by the annual deadline of its intent to process Aleutian Islands Pacific cod, the Bering Sea Trawl CV A-Season Sector Limitation and the Aleutian Islands Catcher Vessel Harvest Set-Aside for Pacific cod would not apply for the upcoming year.
• If the entire Aleutian Islands non-CDQ Pacific cod directed fishing allowance is harvested prior to March 15, the Bering Sea Trawl CV A-Season Sector Limitation and the Aleutian Islands Catcher Vessel Harvest Set-Aside for Pacific cod would not apply for the remainder of the year.
Finally, a section would be added to Appendix A, summarizing the main provisions of Amendment 113.
The Council considered a range of dates, set-aside amounts, and performance requirements before adopting its preferred alternative for Amendment 113. The Council determined and NMFS agrees that the combination of measures within Amendment 113 would give Aleutian Islands Pacific cod fishery participants and Aleutian Islands shoreplants sufficient opportunity to harvest and process the set-aside for Aleutian Islands Pacific cod. The Council also determined and NMFS agrees that the notification and performance requirements would prevent stranding BSAI Pacific cod TAC and preserve opportunities for the complete harvest of the BSAI Pacific cod resource.
NMFS is soliciting public comments on proposed Amendment 113 through the end of the comment period (see
16 U.S.C. 1801
Animal and Plant Health Inspection Service, USDA.
Notice of availability.
We are advising the public that we have prepared a pest risk analysis that evaluates the risks associated with importation of fresh star apple fruit from Vietnam into the continental United States. Based on the analysis, we have determined that the application of one or more designated phytosanitary measures will be sufficient to mitigate the risks of introducing or disseminating plant pests or noxious weeds via the importation of fresh star apple fruit from Vietnam. We are making the pest risk analysis available to the public for review and comment.
We will consider all comments that we receive on or before September 19, 2016.
You may submit comments by either of the following methods:
•
•
Supporting documents and any comments we receive on this docket may be viewed at
Mr. Tony Román, Senior Regulatory Policy Specialist, Regulatory Coordination and Compliance, PPQ, APHIS, 4700 River Road Unit 133, Riverdale, MD 20737-1231; (301) 851-2242.
Under the regulations in “Subpart-Fruits and Vegetables” (7 CFR 319.56-1 through 319.56-75, referred to below as the regulations), the Animal and Plant Health Inspection Service (APHIS) prohibits or restricts the importation of fruits and vegetables into the United States from certain parts of the world to prevent plant pests from being introduced into or disseminated within the United States.
Section 319.56-4 contains a performance-based process for approving the importation of certain fruits and vegetables that, based on the findings of a pest risk analysis, can be safely imported subject to one or more of the five designated phytosanitary measures listed in paragraph (b) of that section.
APHIS received a request from the national plant protection organization (NPPO) of Vietnam to allow the importation of fresh star apple fruit (
• The fresh star apple fruit must be imported as commercial consignments only;
• Each consignment of fresh star apple fruit must be accompanied by a phytosanitary certificate issued by the NPPO of Vietnam;
• Each consignment of fresh star apple fruit must be treated in accordance with 7 CFR part 305; and
• Each consignment of fresh star apple fruit is subject to inspection upon arrival at the port of entry to the United States.
Therefore, in accordance with § 319.56-4(c), we are announcing the availability of our PRA and RMD for public review and comment. The documents may be viewed on the
After reviewing any comments we receive, we will announce our decision regarding the import status of fresh star apple fruit from Vietnam in a subsequent notice. If the overall conclusions of our analysis and the Administrator's determination of risk remain unchanged following our consideration of the comments, then we will authorize the importation of fresh star apple fruit from Vietnam into the continental United States subject to the requirements specified in the RMD.
7 U.S.C. 450, 7701-7772, and 7781-7786; 21 U.S.C. 136 and 136a; 7 CFR 2.22, 2.80, and 371.3.
Food and Nutrition Service (FNS) United States Department of Agriculture (USDA).
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, this notice invites the general public and other public agencies to comment on this proposed information collection. This collection is a new information collection for the Food Distribution Program on Indian Reservations.
Written comments on this notice must be received on or before September 19, 2016.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions that were used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Comments may be sent to Akua White, Nutritionist, Nutrition Services and Access Branch USDA, Food and Nutrition Service, 3101 Park Center Drive, Room 508, Alexandria, VA 22302-1500. Comments may also be sent via fax to the attention of Akua White at 703-305-2964 or via email to
All responses to this notice will be summarized and included in the request for Office of Management and Budget approval. All comments will be a matter of public record.
To request more information on the proposed project or to obtain a copy of the data collection plans, contact Akua White, Nutritionist, Nutrition Services and Access Branch, USDA, Food and Nutrition Service, 3101 Park Center Drive, Room 508, Alexandria, VA 22301-1500. Fax: 703-305-2964; Email:
The activities to be undertaken subject to this notice include:
The initial sample will consist of 36 ITO Directors. Assuming that 80 percent respond to the invitation email, the resulting respondent sample will include approximately 29 ITO Directors. Of the ITO Directors accepting the invitation to participate in telephone interviews, 80 percent (approximately 23) are expected to participate. In-depth interviews will be conducted with the 23 ITO Directors (with an expected 100 percent response rate).
Interviews with ITO Directors will yield a sample of 36 FDPIR Staff. Assuming that 80 percent respond to the invitation email, the resulting respondent sample will include approximately 29 FDPIR Staff. Of the FDPIR Staff accepting the invitation to participate in telephone interviews, 80 percent (approximately 23) are expected to participate. In-depth interviews will be conducted with the 23 FDPIR Staff (with an expected 100 percent response rate).
The initial sample of Key Stakeholders will consist of 23 individuals. Assuming that 65 percent respond to the invitation email, the resulting sample will include approximately 19 individuals. In-depth interviews will be conducted with the 15 Key Stakeholders (with an expected response rate of 80 percent). The 34 non-respondents include 13 ITO Directors, 13 FDPIR Staff, and 8 Key Stakeholders.
Forest Service, USDA.
Notice of final directive.
The Forest Service is publishing a final directive revising Forest Service Manual (FSM) 2350 to establish training, evaluation, and certification requirements for the use of chain saws and crosscut saws on National Forest System (NFS) lands. In addition, the Agency is revising Forest Service Handbook (FSH) 6709.11, section 22.48 (Safety Handbook), to remove duplicate text. The final directive applies to the use of chain saws and crosscut saws by Forest Service and other governmental employees, volunteers, training consultants, and cooperators on NFS lands.
The final directive is effective July 19, 2016.
The record for this final directive is available for inspection and copying at the office of the Director, Recreation, Heritage, and Volunteer Resources Staff, USDA, Forest Service, 5th Floor, Sidney R. Yates Federal Building, 1400 Independence Avenue SW., Washington, DC, during regular business hours (8:30 a.m. to 4:00 p.m.) Monday through Friday, except holidays. Those wishing to inspect these documents are encouraged to call ahead at (202) 205-1227 to facilitate access to the building.
Jonathan Stephens, National Trails Program Manager, (202) 205-1701 or
Beginning in the 1970s, the Forest Service's nine regions developed regional policies related to sawyer training and saw use. Sawyers covered by those policies often maintained trails on national forests and grasslands, helped fight wildfires, and worked in wilderness where crosscut saws are required. Forest Service and other governmental employees, cooperators, training consultants, and volunteers who worked in more than one region had to comply with multiple regional policies, and certifications obtained in one region were not always honored in another.
A national saw directive is needed to standardize training, evaluation, certification, and safety procedures for sawyers operating on NFS lands. The final directive will allow the Forest Service to facilitate the safe use of chain saws and crosscut saws while optimizing the critical skills and cooperative opportunities for trail maintenance and other projects on NFS lands. The final directive will be codified in Forest Service Manual (FSM) 2358 and will supersede duplicative text in the Health and Safety Code Handbook, Forest Service Handbook (FSH) 6709.11, chapter 20, and all Forest Service Regional Supplements to that Handbook.
The following provides an overview of the final directive for the Forest Service's National Saw Program.
On June 17, 2015, the Forest Service published notice of a proposed directive in the
The final directive will be incorporated into FSM 2358. FSM 2358 will contain cross-references to FSM 6700, where appropriate. The National Saw Program Manager will work with Safety and Occupational Health staff as well as other Agency staff to administer the final directive effectively in the context of other Agency programs.
The Forest Service will review cooperators' existing and new sawyer training, evaluation, and certification programs to determine if they comply with the final directive. The process for review is enumerated in the Forest Service Saw Operations Guide (FSSOG), which will be issued at the same time as the final directive and which will be available at
This final directive revises the administrative policies and procedures for using crosscut saws and chain saws on NFS lands. Agency regulations at 36 CFR 220.6(d)(2) exclude from documentation in an environmental assessment or impact statement “rules, regulations, or policies to establish Service-wide administrative procedures, program processes, or instructions.” The Agency has concluded that this final directive falls within this category of actions and that no extraordinary circumstances exist which would require preparation of an environmental assessment or environmental impact statement.
Per Executive Order (E.O.) 12866, the Office of Management and Budget (OMB) has determined that the final directive is not significant. This final directive, which establishes the Forest Service's National Saw Program, will not have an annual effect of $100 million or more on the economy, nor will it adversely affect productivity, competition, jobs, the environment, public health and safety, or State or local governments. This final directive will not interfere with an action taken or planned by another agency, nor will it raise new legal or policy issues. The final directive also will not alter the budgetary impact of entitlement, grant, user fee, or loan programs or the rights and obligations of beneficiaries of those programs.
E.O. 13563 reaffirms the principles of E.O. 12866 while calling for improvements in the nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. The E.O. directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. E.O. 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. The Agency has developed the final directive consistent with these requirements.
The Agency has considered this final directive in light of the Regulatory Flexibility Act (5 U.S.C. 601
Pursuant to Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538), the Agency has assessed the effects of this final directive on State, local, and Tribal governments and the private sector. The final directive will not compel the expenditure of $100 million or more by any State, local, or Tribal government or anyone in the private sector. Therefore, a statement under section 202 of the act is not required.
The Agency has analyzed the final directive in accordance with the principles and criteria contained in E.O. 12630. The Agency has determined that the final directive will not pose the risk of a taking of private property. A takings implication assessment is therefore not required.
The Agency has considered this final directive under the requirements of E.O. 13132 and has determined that the final directive conforms with the federalism principles set out in this E.O.; will not impose any compliance costs on the States; and will not have substantial direct effects on the States, the relationship between the Federal Government and the States, or the distribution of power and responsibilities among the various levels of government. Therefore, the Agency has determined that no further assessment of federalism implications is necessary.
The final directive has been reviewed under E.O. 12988, entitled “Civil Justice Reform.” Upon adoption of the final directive, (1) all State and local laws and regulations that conflict with the final directive or that impede its full implementation will be preempted; (2) no retroactive effect will be given to the final directive; and (3) administrative proceedings will not be required before parties may file suit in court to challenge its provisions.
In accordance with E.O. 13175, entitled “Consultation and Coordination with Indian Tribal Governments”; USDA Departmental Regulation 1350-02 (Tribal Consultation, Coordination and Collaboration); and Forest Service Handbook 1509.13, Chapter 10 (Consultation with Indian Tribes and Alaska Native Corporations), the Agency conducted outreach to Tribes to determine their interest in consulting on the proposed directive during the public comment period. The opportunity for tribal consultation was available for 90 additional days after the close of the public comment period, giving Tribes 150 days to review the proposed directive and request consultation. No interest in consultation was expressed by Tribes or tribal organizations during the outreach period. Opportunities to engage Tribes regarding implementation of the final directive will be explored, including information-sharing via Web sites and notices to major tribal organizations with an interest in the use of chain saws and crosscut saws on NFS lands. Tribes interested in requesting information about the final directive may contact Jonathan Stephens by email at
The final directive does not contain any recordkeeping or reporting requirements or other information collection requirements as defined in 5 CFR part 1320 that are not already required by law or not already approved for use. Accordingly, the review provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
The Agency has reviewed the final directive under E.O. 13211 and has determined that the final directive is not a significant energy action as defined in the E.O. Therefore, a statement of energy effects is not required.
Grain Inspection, Packers and Stockyards Administration, USDA.
Notice.
GIPSA is announcing the designation of California Agri Inspection Co., Ltd. (California Agri); and Virginia Department of Agriculture and Consumer Services (Virginia) to provide official services under the United States Grain Standards Act (USGSA), as amended.
Sharon Lathrop, Compliance Officer, USDA, GIPSA, FGIS, QACD, 10383 North Ambassador Drive, Kansas City, MO 64153.
Sharon Lathrop, 816-891-0415,
In the July 1, 2015,
The current official agencies, California Agri and Virginia, were the only applicants for designation to provide official services in these areas. As a result, GIPSA did not ask for additional comments.
GIPSA evaluated the designation criteria in section 79(f) of the USGSA (7 U.S.C. 79(f)) and determined that California Agri and Virginia are qualified to provide official services in the geographic areas specified in the
Interested persons may obtain official services by contacting these agencies at the following telephone numbers:
Section 79(f) of the USGSA authorizes the Secretary to designate a qualified applicant to provide official services in a specified area after determining that the applicant is better able than any other applicant to provide such official services (7 U.S.C. 79 (f)).
U.S. Census Bureau, Commerce.
Notice.
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
To ensure consideration, written comments must be submitted on or before September 19, 2016.
Direct all written comments to Jennifer Jessup, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 14th and Constitution Avenue NW., Washington, DC 20230 (or via the Internet at
Requests for additional information or copies of the information collection instrument(s) and instructions should be directed to Robin A. Pennington, Census Bureau, HQ-2K281N, Washington, DC 20233; (301) 763-8132 (or via email at
The Census Bureau will conduct a 2017 Puerto Rico Census Test, with components designed to test new approaches or validate existing approaches and systems integration related to (1) Address Canvassing, including In-Office and In-Field components; (2) Optimizing Self-Response, including contact strategies, language support, and questionnaire content; (3) Update Enumerate, including technical and operational testing; and (4) Nonresponse Followup, including technological and operational improvements. The Address Canvassing component of the 2017 Puerto Rico Census Test is included in the Address Canvassing Testing package because the background, description, and systems to be used are the same in both the stateside and Puerto Rico operations.
Optimizing Self-Response, one of four key innovation areas for the 2020 Census, is focused on improving our methods for increasing the number of people who take advantage of self-response options and refining the questionnaire content to increase the efficiency and effectiveness of census operations, and at the same time reducing costs.
Another key innovation area for the 2020 Census is Reengineering Field Operations. Making our methods for enumerating the households that do not initially respond more efficient can contribute to a less costly census while maintaining high-quality results. Our redesigned methods need to be tested in Puerto Rico because of a number of differences from stateside operations.
A test in Puerto Rico includes a review of other innovations that are unique to this U.S. territory. Because of the unique structure of addresses in Puerto Rico, newly defined algorithms were necessary to update and maintain the address frame. These algorithms make it now possible to refresh the address frame with U.S. Postal Service data. Another innovation is the introduction of the self-response methodology that in the past has been the standard methodology used in urban and suburban areas of the States. In the 2000 and 2010 censuses, data collection throughout Puerto Rico used only the
The 2017 Puerto Rico Census Test is designed to evaluate several strategies to optimize the rate at which the public self-responds to the census. A higher rate of self-response will mean fewer cases for the Nonresponse Follow-up operation, saving taxpayer money by reducing costs. For the first time in Puerto Rico, the Census Bureau is introducing both a mail contact strategy and an Internet response strategy. The Census Bureau began testing both strategies in Puerto Rico for the 2015 National Content Test and will continue to test these strategies in the
We plan to study the following in the 2017 Puerto Rico Census Test:
• Comparing the self-response rates for the “Choice” panel and the Internet instrument uptake rates, where we invite the respondent to use the Internet in the initial letter mailing (“Internet Push”).
• Measuring the effects of incorporating household contact strategies, as tested to date, to encourage self-response, including letter and postcard reminders.
The Bureau will continue its testing and further evaluation of questionnaire content that we studied stateside:
• Testing of a combined race and Hispanic-origin question that is similar to one the Census Bureau used in the 2015 National Content Test. Based on results from the 2010 Race and Hispanic Origin Alternative Questionnaire Experiment (Compton, et. al. 2012), the 2017 Puerto Rico Census Test provides an opportunity to further test a combined race and Hispanic-origin question.
• Testing new response categories for opposite sex and same sex husband/wife/spouse and unmarried partner for the relationship question.
The 2017 Puerto Rico Census Test will allow the Census Bureau to continue to refine, optimize, and assess the operational procedures and technical design of the Nonresponse Follow-up operation. This will build upon the results of previous stateside field tests where the NRFU operation had been conducted. Specifically:
• Operational procedures
○ Testing continued refinements to the field data collection instrument for enumeration, including where potential problems exist in our questionnaire pathing and interview software user interface issues.
○ Continuing refinement of our re-designed method of enumerating multi-unit structures, designed to identify vacant households with a minimal number of contact attempts, and minimization of respondent burden.
○ Continuing refinement of our Quality Control Reinterview process, to detect and deter falsification by field enumerators. This may include, for instance, new methodologies for sampling reinterview cases, and further use of administrative records and paradata to identify/rule out potential falsification.
○ Continuing evaluation of our enumerator training procedures and content, including both online training modules and in-classroom training.
○ Continuing our refinement and operational testing of field supervisor to enumerator ratio, based on the results of previous tests to ensure that staffing ratios of enumerators to supervisors are validated as feasible during field operations.
○ Adding special collection of certain rural Puerto Rico addresses in the enumeration instrument.
○ Integrating a Non-ID Field Verification assignment into the NRFU workload. The Non-ID Field Verification cases are intended to verify whether the living quarters associated with Non-ID self-responses that cannot be matched to the Census Bureau address frame actually do exist and were assigned to the correct census block.
• Technical Design
○ Continuing refinement of the alerts generated by the operational control system to identify potentially problematic field behavior in real time.
○ Continuing refinement of the optimization and routing algorithms used to make field assignments.
○ Continuing work to integrate into the Census Bureau's enterprise data collection systems.
The 2017 Puerto Rico Census Test will allow the Census Bureau to test the Update Enumerate operation, which combines listing methodologies of Address Canvassing with the enumeration methodologies from Nonresponse Follow-up. This operation was used in the 2010 Census for about 1 percent of all addresses, mostly in geographic areas that:
• Do not have city-style addresses;
• Do not receive mail through city-style addresses;
• Receive mail at post office boxes;
• Have unique challenges associated with accessibility;
• Have been affected by natural disasters; or
• Have high concentrations of seasonally vacant housing.
The following objectives are being tested for Update Enumerate:
• Integrating listing and enumeration operations and systems;
• Building on previous stateside test experiences to evaluate the impact on cost and quality of the contact strategy on enumerator productivity and efficiency;
• Testing refinements to the field data collection instrument for enumeration, including such things as allowing collection of data from “other” address for in-movers and whole household “usual home elsewhere” cases;
• Testing field supervisor to enumerator ratios to ensure that staffing ratios of enumerators to supervisors are validated as feasible during field operations.
The Census Bureau will conduct the 2017 Puerto Rico Census Test concurrently in Carolina, Loíza, and Trujillo Alto
The housing units in the selected areas included in the 2017 Puerto Rico Census Test will be contacted by mail and invited to complete their questionnaire via the Internet. Internet
This test will allow us to interactively prompt a respondent (while they are still online filling out the form) for additional address and location information if the respondent's address cannot be matched to an address with a Census ID or geocoded. A non-ID respondent whose address cannot be matched to our address database will be prompted during his or her Internet self-response session to confirm the address information they provided while filling out the form or to indicate the location of their address on an on-screen map. This test will allow us to better understand requirements related to scalability of planned systems and determine metrics for ongoing monitoring and evaluation. If the address match is not resolved during automated processing, Census Bureau staff will attempt to manually match or geocode addresses. We estimate that about one percent of the overall non-ID respondents will be contacted as part of the manual matching process. Additionally, we plan to test a mechanism for validating all non-ID responses by matching the response data to a composite file consisting of federal administrative records and third-party data.
If a household does not ultimately respond to the self-response portion of the test by a specified date, it is included in the universe for the NRFU portion of the test, during which enumerators will attempt to follow up with the nonresponding households to collect data. In advance of the full deployment of enumerators following up with nonresponding households, a small number of the nonresponding cases may be subject to early follow-up to allow for the live testing of systems, data collection applications, and field procedures and to provide the field data collection supervisors to gain experience with the enumeration application.
The Census Bureau will conduct NRFU with mobile smartphone devices provided via a contract with the Census Bureau to provide devices, peripherals, and service plans. The devices will utilize a Census Bureau provided enumeration application solution for conducting the NRFU field data collection.
A sample of cases that have been enumerated via Nonresponse Follow-up will be selected for reinterview. This operation is intended to help us pinpoint possible cases of enumerator falsification. Like the NRFU operation before it, NRFU-RI will use the Census Bureau provided enumeration software on mobile devices. We will also test centralized phone contacts of the reinterview cases before sending them to an enumerator in the field, providing potential cost avoidance opportunities.
Households that self-respond to the Census without an ID and cannot be matched to our address frame (either via automated methods or clerical review) may be sent to the field for NRFU enumerators to conduct a field verification operation. This sub-operation is intended to verify that the housing unit exists, and if possible, to collect coordinate data to enable accurate attribution to a census block.
Update Enumerate for the 2017 Puerto Rico Census Test will test three of the components of the operation: Update Enumerate Production, Update Enumerate Follow-up, and Update Enumerate Reinterview. In addition to the field operation, the Census Bureau is testing mailing out an invitation package to housing units with a mailable address to generate self-response before the operation begins. If a household self-responds, the UE fieldworker (enumerator) will not enumerate that house while listing the geographic area. This is a cost savings to Update Enumerate since the enumerator will not have to spend time collecting the enumeration of self-responding households.
Enumerators visit specific geographic areas to identify every place where people could live or stay comparing what they see on the ground to the existing census address list and either verify or correct the address and location information. Much like Address Canvassing, enumerators classify each living quarter (LQ) as a housing unit or group quarter (GQ). If the LQ is classified as a GQ, no attempt is made to enumerate since the plan for the 2020 Census is to have a separate operation enumerate GQs.
The enumerators will attempt to conduct an interview for each housing unit. If someone answers, the enumerators will provide a Confidentiality Notice and ask about the address in order to verify or update the information, as appropriate. The enumerators will then ask if there are any additional LQs in the structure or on the property. If there are additional LQs, the enumerators will collect/update that information, as appropriate. The enumerator will then interview the respondent using the questionnaire on the mobile device.
If no one is home at a non responding housing unit, the enumerator will leave a Notice of Visit inviting a respondent for each household to go online with an ID to complete the 2017 Puerto Rico Census Test questionnaire. The Notice of Visit will also include the phone number for Census Questionnaire Assistance (CQA) if the respondent has any questions or would prefer to respond to the questionnaire on the phone.
The UE operation will have a UE Follow-up component for those households that were not enumerated on the first visit and have not responded via the Internet or CQA. The UE Follow-up will use the same contact strategies and business rules as Nonresponse Follow-up. UE enumerators will conduct the operation using Census Bureau provided listing and enumeration application on a Census Bureau provided mobile device, which securely collects and transmits respondent data.
A sample of cases enumerated via Update Enumerate or Update Enumerate Follow-up will be selected for reinterview. The intention of this operation is to help us pinpoint possible cases of enumerator falsification. Update Enumerate Reinterview will use the Census Bureau's enumeration software on mobile devices. We will also test centralized phone contacts of the reinterview cases before sending them to an enumerator in the field, providing potential cost savings.
Telephone questionnaire assistance will be available in Spanish as well as English.
Estimated Number of Respondents:
Non-ID Processing Cases requiring a phone call to the respondent to derive a match to a census address or to assign to a census block: 200.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.
On July 20, 2015, in the U.S. District Court for the Eastern District of Pennsylvania, Fang Liwu (“Fang”) was convicted of violating the International Emergency Economic Powers Act (50 U.S.C. § 1701,
Section 766.25 of the Export Administration Regulations (“EAR” or “Regulations”)
BIS has received notice of Fang's conviction for violating IEEPA, and in accordance with Section 766.25 of the Regulations, BIS has provided notice and an opportunity for Fang to make a written submission to BIS. BIS has not received a submission from Fang.
Based upon my review and consultations with BIS's Office of Export Enforcement, including its Director, and the facts available to BIS, I have decided to deny Fang's export privileges under the Regulations for a period of 10 years from the date of Fang's conviction. I have also decided to revoke all licenses issued pursuant to the Act or Regulations in which Fang had an interest at the time of his conviction.
Accordingly, it is hereby ORDERED:
First, from the date of this Order until July 20, 2025, Fang Liwu, with a last known address of Nan Hu Xi Yuan 50505, Chai Yang District, Wang Ging, Beijing, China, and when acting for or on his behalf, his successors, assigns, employees, agents or representatives (the “Denied Person”), may not, directly or indirectly, participate in any way in any transaction involving any commodity, software or technology (hereinafter collectively referred to as “item”) exported or to be exported from the United States that is subject to the Regulations, including, but not limited to:
A. Applying for, obtaining, or using any license, License Exception, or export control document;
B. Carrying on negotiations concerning, or ordering, buying, receiving, using, selling, delivering, storing, disposing of, forwarding, transporting, financing, or otherwise servicing in any way, any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or in any other activity subject to the Regulations; or
C. Benefitting in any way from any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or in any other activity subject to the Regulations.
Second, no person may, directly or indirectly, do any of the following:
A. Export or reexport to or on behalf of the Denied Person any item subject to the Regulations;
B. Take any action that facilitates the acquisition or attempted acquisition by the Denied Person of the ownership, possession, or control of any item subject to the Regulations that has been or will be exported from the United States, including financing or other support activities related to a transaction whereby the Denied Person acquires or attempts to acquire such ownership, possession or control;
C. Take any action to acquire from or to facilitate the acquisition or attempted acquisition from the Denied Person of any item subject to the Regulations that has been exported from the United States;
D. Obtain from the Denied Person in the United States any item subject to the Regulations with knowledge or reason to know that the item will be, or is intended to be, exported from the United States; or
E. Engage in any transaction to service any item subject to the Regulations that has been or will be exported from the United States and which is owned, possessed or controlled by the Denied Person, or service any item, of whatever origin, that is owned, possessed or controlled by the Denied Person if such service involves the use of any item subject to the Regulations that has been or will be exported from the United States. For purposes of this paragraph, servicing means installation, maintenance, repair, modification or testing.
Third, after notice and opportunity for comment as provided in Section 766.23 of the Regulations, any other person, firm, corporation, or business organization related to Fang by ownership, control, position of responsibility, affiliation, or other connection in the conduct of trade or business may also be made subject to the provisions of this Order in order to prevent evasion of this Order.
Fourth, in accordance with Part 756 of the Regulations, Fang may file an appeal of this Order with the Under Secretary of Commerce for Industry and Security. The appeal must be filed within 45 days from the date of this Order and must comply with the provisions of Part 756 of the Regulations.
Fifth, a copy of this Order shall be delivered to the Fang. This Order shall be published in the
Sixth, this Order is effective immediately and shall remain in effect until July 20, 2025.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
On January 8, 2016, the Department of Commerce (“the Department”) published the preliminary results of the third administrative review (“AR”) of the antidumping duty (“AD”) order on multilayered wood flooring (“MLWF”) from the People's Republic of China (“the PRC”), in accordance with sections 751(a)(1)(B) and 751(a)(2)(B) of the Tariff Act of 1930, as amended (“the Act”).
Lilit Astvatsatrian or William Horn, AD/CVD Operations, Office IV, Enforcement and Compliance, International Trade Administration, Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-6412 or (202) 482-2615, respectively.
As noted above, on January 8, 2016, the Department published its
The merchandise covered by the order includes MLWF, subject to certain exceptions.
While HTSUS subheadings are provided for convenience and customs purposes, the written description of the subject merchandise is dispositive. For the full text of the scope of the order,
In the
All issues raised in the case and rebuttal briefs filed by parties in the AR are addressed in the Issues and Decision Memorandum. A list of the issues that parties raised and to which we responded in the Issues and Decision Memorandum follows as an appendix to this notice. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (“ACCESS”). ACCESS is available to registered users at
• We revised the calculation of surrogate financial ratios based on the notes in financial statement used in the preliminary results.
• We revised surrogate values for several lumber raw materials in calculation of the normal value for Fine Furniture.
• We deducted letter of credit expense from the surrogate value for brokerage and handling in the calculation of normal value for Fine Furniture.
• We corrected the application of certain adjustments by deducting them from international movement in calculation of the U.S. net price for Fine Furniture.
• We corrected the spelling of Baishan Huafeng Wooden Product Co., Ltd.'s name.
• We defined the members of Fusong Jinlong Group.
• We treated certain companies as separate rate respondents.
We determine that the following weighted-average dumping margins exist for the POR from December 1, 2013
The Department
If the Department determines that an exporter under review had no shipments of subject merchandise, any suspended entries that entered under that exporter's case number will be liquidated at the PRC-wide rate.
For the companies not selected for individual examination, we will instruct CBP to apply the rate listed above to the entries of subject merchandise exported by such companies and entered during the period from December 1, 2013 through November 30, 2014. This rate is the same as the rate for the one mandatory respondent with a weighted-average dumping margin that is above
The following cash deposit requirements will be effective upon publication of the final results of these reviews for shipments of the subject merchandise from the PRC entered, or withdrawn from warehouse, for consumption on or after the publication date in the
We intend to disclose the calculations performed regarding these AR final results within five days of the date of publication of this notice in this proceeding in accordance with 19 CFR 351.224(b).
This notice also serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this POR. Failure to comply with this requirement could result in the Department's presumption that reimbursement of antidumping duties has occurred and the subsequent assessment of doubled antidumping duties.
This notice also serves as a final reminder to parties subject to APO of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return or destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.
We are issuing and publishing this Administrative Review and notice in accordance with sections 751(a)(1), 751(a)(2)(B), and 777(i) of the Act.
International Trade Administration, U.S. Department of Commerce.
Notice of an open meeting.
The United States Manufacturing Council (Council) will hold an open meeting via livestream on Wednesday, August 3, 2016. The Council was established in April 2004 to advise the Secretary of Commerce on matters relating to the U.S. manufacturing industry. The purpose of the meeting is for Council members to review and deliberate a letter that summarizes the Council's recommendations and provides advice to the Secretary on the future of the Manufacturing Council. The final agenda will be posted on the Department of Commerce Web site for the Council at
Wednesday, August 3, 2016, 9:00 a.m.-12:00 p.m.
The United States Manufacturing Council meeting will be broadcast via live webcast on the Internet at
Archana Sahgal, U.S. Manufacturing Council, Room 4043, 1401 Constitution Avenue NW., Washington, DC 20230, telephone: 202-482-4501, email:
Submit statements electronically to Archana Sahgal, Executive Secretary, United States Manufacturing Council via email:
Send paper statements to Archana Sahgal, Executive Secretary, United States Manufacturing Council, Room 4043, 1401 Constitution Avenue NW., Washington, DC 20230. Statements will be posted on the United States Manufacturing Council website (
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (the Department) has completed its administrative review of the countervailing duty (CVD) order on crystalline silicon photovoltaic cells, whether or not assembled into modules (solar cells), from the People's Republic of China (the PRC) for the period of review (POR) covering January 1, 2013, through December 31, 2013. On January 8, 2016, we published the preliminary results of this review.
We provided interested parties with an opportunity to comment on the
Withdrawals of certain requests for review were timely filed and, as a result, we rescinded this administrative review with respect to certain companies, pursuant to 19 CFR 351.213(d)(1), and proceeded with the review of JA Solar, Changzhou Trina Solar Energy Co., Ltd. (Trina), and Wuxi Suntech Power Co., Ltd. (Suntech).
Effective Date: July 19, 2016.
David Lindgren, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone (202) 482-3870.
Following the
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. The product is currently classified under the Harmonized Tariff Schedule of the United States (HTSUS) item numbers 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 full description of the scope of the order is contained in the Issues and Decision Memorandum, which is hereby adopted by this notice.
All issues in the case briefs are addressed in the Issues and Decision Memorandum. A list of the issues raised is attached to this notice as Appendix I. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at
The Department conducted this review in accordance with section 751(a)(1)(A) of the Tariff Act of 1930, as amended (the Act). For each of the subsidy programs found countervailable, we determine that there is a subsidy,
In making these findings, we relied, in part, on facts available and, because the GOC did not act to the best of its ability in responding to the Department's requests for information, we drew an adverse inference in selecting from among the facts otherwise available.
In accordance with 19 CFR 351.221(b)(5), we determine a net countervailable subsidy rate of 19.20 percent
In accordance with 19 CFR 351.224(b), we will disclose the calculations performed within five days of the publication of this notice in the
In accordance with 19 CFR 351.212(b)(2), the Department intends to issue appropriate assessment instructions directly to U.S. Customs and Border Protection (CBP) 15 days after the date of publication of these final results, to liquidate shipments of subject merchandise by JA Solar, Trina and Suntech entered, or withdrawn from warehouse, for consumption on or after January 1, 2013, through December 31, 2013, at the percent rates, as listed above for each of the respective companies, of the entered value.
The Department also intends to instruct CBP to collect cash deposits of estimated CVDs in the amount shown above for shipments of subject merchandise by JA Solar, Trina and Suntech entered, or withdrawn from warehouse, for consumption on or after the date of publication of the final results of this review.
For non-reviewed firms, we will instruct CBP to collect cash deposits of estimated CVDs at the most recent company-specific or all-others rate applicable to the company. These cash deposit requirements, when imposed, shall remain in effect until further notice.
This notice serves as a reminder to parties subject to administrative protective order (APO) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.
We are issuing and publishing these results in accordance with sections 751(a)(1) and 777(i)(1) of the Act.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (“Department”) published its
Maisha Cryor, AD/CVD Operations, Office IV, Enforcement and Compliance, International Trade Administration, Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-5831.
For a complete description of the events that followed the publication of the
The merchandise covered by the order is multilayered wood flooring, which is composed of an assembly of two or more layers or plies of wood veneers
All issues raised in the case briefs by parties are addressed in the Issues and Decision Memorandum.
For the
For the foregoing reasons, the Department continues to find that Qingdao Barry's sale is not a
As the Department is rescinding this NSR, we have not calculated a company-specific dumping margin for Qingdao Barry. Qingdao Barry remains part of the PRC-wide entity and, accordingly, its entry will be assessed at the PRC-wide rate.
Effective upon publication of this notice of final rescission of the NSR of Qingdao Barry, the Department will instruct U.S. Customs and Border Protection to discontinue the option of posting a bond or security in lieu of a cash deposit for entries of subject merchandise from Qingdao Barry. Because we did not calculate a dumping margin for Qingdao Barry or otherwise find that Qingdao Barry is eligible for a separate rate in this review, Qingdao Barry continues to be part of the PRC-wide entity. The cash deposit rate for the PRC-wide entity is 25.62 percent. These cash deposit requirements shall remain in effect until further notice.
This notice also serves as a reminder to parties subject to Administrative Protective Order (“APO”) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305, which continues to govern business proprietary information in these segments of the proceeding. Timely written notification of the return or destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.
We are issuing and publishing this notice in accordance with sections 751(a)(2)(B) and 777(i) of the Tariff Act of 1930, as amended, and 19 CFR 351.214.
National Telecommunications and Information Administration, U.S. Department of Commerce.
Notice and request for comments.
The National Telecommunications and Information Administration (NTIA) publishes this Notice to provide preliminary guidance concerning how a qualified state may apply to NTIA for authority to enter into a spectrum capacity lease with the First Responder Network Authority (FirstNet) and receive a grant to construct its radio access network (RAN) should it opt to do so as allowed under the Middle Class Tax Relief and Job Creation Act of 2012 (Pub. L. 112-96, Title VI, 126 Stat. 256 (codified at 47 U.S.C. 1401
Submit written comments on or before August 18, 2016.
The public may submit written comments on issues addressed in this Notice. Written comments may be submitted electronically via email to:
Carolyn Dunn, Office of Public Safety Communications, National Telecommunications and Information Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Room 4078, Washington, DC 20230;
The Act requires FirstNet to take all actions necessary to ensure the deployment and operation of a nationwide public safety broadband network (NPSBN).
First, a state must submit its alternative plan for the construction, maintenance, operation and improvements of its RAN to the Federal Communications Commission (FCC) and meet specific interoperability criteria established by the FCC.
These three steps are fundamental to achieving a core goal of the Act, which is ensuring that the NPSBN, regardless whether FirstNet or a state assumes responsibility for the RAN, will interoperate, provide seamless broadband service across the nation, and be financially and technically sustainable. The Act directs NTIA to help determine whether a state, if it decides to pursue deploying and operating the RAN, can do so in a way that delivers these essential functionalities. NTIA's goal in reviewing state requests is to ensure that the nation has access to an interoperable, sustainable, technically sound, and cost-effective NPSBN. Accordingly, each state must ensure that its RAN functions as a fully interoperable, sustainable part of the NPSBN, and that it will do so in a manner that most effectively utilizes the limited federal fiscal resources and the spectrum allocated under the Act. Thus, for example, and as discussed more fully below, a state that proposes to utilize a “greenfield” build for its RAN will be unlikely to successfully demonstrate to NTIA that its alternative plan is cost-effective.
This Notice provides initial guidance on NTIA's process to review a state's application for authority to enter into a spectrum capacity lease with FirstNet and for optional grant funds to assist in the construction of its RAN. Section II discusses applicable provisions of the Act. Section III makes clear that NTIA will treat all such requests as requests for a grant under federal law. Section III also provides general parameters of each grant request (Lease Authority or a RAN Construction Grant). Finally, Section IV specifies the manner by which each state must demonstrate compliance with the Act's requirements in order to receive either grant. For each of the five demonstrations required of states under the Act, NTIA provides initial guidance on how to present such information and how NTIA will evaluate it.
NTIA provides this preliminary guidance to better inform states and other stakeholders as several important activities continue with regard to the future NPSBN buildout and operation. We feel that this information will be of use as states continue to consult with FirstNet on the NPSBN buildout in a given state or territory. Additionally, as FirstNet's procurement advances, we feel that other stakeholders will benefit from understanding the initial framework NTIA has developed with regard to the demonstrations a state must make to NTIA should it desire to bear the responsibility to conduct the RAN within that state. Future notices, including but not limited to a forthcoming Federal Funding Opportunity (FFO) notice, will provide more details on the application processes.
The Act requires the NPSBN to be composed of: (1) A core network consisting of national and regional data centers that connect to a RAN and the Internet/public switched network; and (2) a RAN consisting of cell site equipment, antennas, and backhaul equipment that is built and operated in consideration of state, local, and tribal consultation.
The Act requires FirstNet to develop and present to each state general details of the proposed buildout of the NPSBN, including its proposed plan for building the RAN in that state.
FirstNet has determined that a state may choose to adopt the FirstNet state plan by either: (1) Providing actual notice in writing to FirstNet within the Act's 90-day decision period; or (2) providing no notice at all within the 90-
If a state wishes to assume the responsibility to construct, operate, maintain, and improve its own RAN, NTIA must evaluate a state's demonstrations of specific criteria set forth in the Act, which address its ability to operate the RAN on technical, financial, interoperability, programmatic, and qualitative levels. If successful, NTIA will grant the: (1) Required authorization to enter into a spectrum capacity lease from FirstNet to operate its state RAN; and (2) optional eligibility to receive grant funds from NTIA to construct its state RAN.
1. The state has the technical capabilities to operate, and the funding to support, the state RAN;
2. The state has the ability to maintain ongoing RAN interoperability with the NPSBN;
3. The state has the ability to complete the RAN buildout within specified comparable timelines specific to the state;
4. The cost-effectiveness of the state alternative plan; and
5. The ability to provide RAN security, coverage, and quality of service comparable to that of the NPSBN.
FirstNet has interpreted some of the statutory provisions described above. These include the consequences of a state's failure to meet NTIA-reviewed criteria at least with respect to a state application for authority to enter into a spectrum capacity lease with FirstNet; the consequences of a state's failure to implement an FCC-approved alternative state plan; and any determination regarding the Act's Section 6302(g)(2) limitation of a state's use of revenues emanating from covered leasing agreements exclusively to RAN construction, maintenance, operations, and improvements.
As noted above, states must submit, and NTIA must review, requests by states whose state alternative plans are approved by the FCC for: (1) Grant of authority to enter into a spectrum capacity lease from FirstNet (Lease Authority); and (2) the optional request for RAN construction grant funding (RAN Construction Grant). The Act makes clear that a qualified state must request Lease Authority from NTIA so that the state may enter into an agreement to use spectrum licensed to FirstNet to operate the state's RAN.
As a threshold matter, NTIA has determined that each of these requests are grant requests under federal regulations, and that approval of such requests are grants of something of value provided by NTIA. We make this determination pursuant to the Federal Grants and Cooperative Agreement Act of 1977, which makes clear that “[a]n executive agency shall use a grant agreement as the legal instrument reflecting a relationship between the United States Government and a State, a local government, or other recipient when—(1) the principal purpose of the relationship is to transfer a thing of value to the State or local government or other recipient to carry out a public purpose of support or stimulation authorized by a law of the United States instead of acquiring (by purchase, lease, or barter) property or services for the direct benefit or use of the United States Government. . . .”
Such applications will be processed pursuant to a forthcoming FFO notice providing specific details on the application and grant program requirements.
NTIA must evaluate either grant request on the identical demonstration criteria set forth in 47 U.S.C. 1442(e)(3)(D). Below, we address procedural issues common to both types of requests and those distinct for each type of grant application pursuant to the Act.
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If the FCC approves a state's alternative plan, the state must request Lease Authority from NTIA to obtain from FirstNet the right to operate its RAN on the Band 14 spectrum licensed to FirstNet.
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5.
Central to the Act's provision of Lease Authority and a RAN Construction Grant is a detailed set of demonstrations a state must make to NTIA to establish eligibility for these grant opportunities.
NTIA interprets each of the criteria in 47 U.S.C. 1442(e)(3)(D) below to provide NTIA's preliminary view on how states should make the required demonstrations and how NTIA will evaluate each criterion. The forthcoming FFO notice will provide more specific, quantifiable, and finalized criteria and application questions.
Under this provision of the Act, a state must demonstrate: (1) That it can operate the state RAN on a technical level; and (2) that it has the financial resources to do so. We discuss how a state can effectively make each part of this demonstration below.
As a primary matter, a state must be able to demonstrate with specificity that it can operate its RAN on a technical level. To make such a demonstration, it must have a technical standard against which its demonstrations may be measured. As established in the Act, all components of the NPSBN, including the core network and the RAN, must be operated under common technical network policies.
From a resource management perspective, NTIA will require a state to identify the proposed management capabilities and organizational structure of its RAN project team.
In addition to this technical showing, 47 U.S.C. 1442(e)(3)(D)(i)(I) requires a state to demonstrate that it has the financial resources to build, operate, maintain, and improve the RAN for the duration of the requested authorized operation. In that context, a state will be required to provide its budgeting documents and staffing plan for its operations and must disclose its sources of funding for its RAN (
Under this requirement, a state must demonstrate that its RAN and other network attributes will be interoperable with the NPSBN on an “ongoing” basis. Consistent with the interoperability demonstration a state must make to the FCC in its state alternative plan, NTIA will determine interoperability with the NPSBN if a state demonstrates the ability to ensure that its RAN is capable of: 1) meeting the Interoperability Board Minimum Technical Requirements; and 2) interoperating with the NPSBN.
However, the 47 U.S.C. 1442(e)(3)(D)(i)(II) demonstration must include a state's ability to ensure ongoing interoperability with the NPSBN. Thus, a state must demonstrate that its entire operation as authorized by the FCC, insofar as it engages any RAN or core elements of the NPSBN, will be interoperable on an ongoing basis. For this reason, a state's demonstration must also show how, for example, any deployable RAN components and related applications the state intends to use will be interoperable with the NPSBN. This demonstration must include technical attributes and a plan for ensuring, through staffing and resources, the ability to meet those technical imperatives. Additionally, NTIA may require that a state demonstrate the ability to maintain ongoing interoperability with the NPSBN from a non-technical standpoint and require information on planned RAN governance models, standard operating procedures, training and exercises, and usage.
As a state must show capability of “ongoing” interoperability with the NPSBN, a state's demonstration must be forward looking and illustrate how its RAN and other network attributes will be interoperable with the NPSBN over time. Recognizing that the ongoing aspect of interoperability will largely be facilitated by a state's partner charged with constructing, operating, maintaining, and improving the RAN, NTIA will require that any state partnership agreement ensures the RAN will be interoperable with the NPSBN from deployment onward. Such a requirement may include demonstration of a partner's commitment to complying with FirstNet's evolving interoperability-based network policies.
Further, a state's RAN must be capable of interoperability with the NPSBN as it evolves and improves throughout the duration of the proposed RAN operation by the state, including compliance with new or evolving network policies. Such demonstrations should also include evidence that the state has the funding to fulfill these necessary elements for maintaining ongoing interoperability as detailed in Section IV. B.
FirstNet currently anticipates that its state plans will include timelines for NPSBN buildout as “minimum legally required contents of a FirstNet plan for a State” against which a state may present project completion time frames for comparison in its demonstration to NTIA.
NTIA will require that a state alternative plan, as submitted by a state to and approved by the FCC pursuant to the Act, is the plan at issue in this required demonstration. We believe every aspect of that plan as itemized in the Act—RAN construction, maintenance, operation, and improvement
In determining cost-effectiveness, NTIA may assess areas, including but not limited to, the proposed federal and state partner share of the RAN cost; the value, use, and revenue return of spectrum and other assets; and overall financial value of the proposed plan. For example, a state plan that proposes a “greenfield” build (one that does not leverage existing infrastructure and/or a public-private partnership and deploys a network solely consisting of new components) is not likely to demonstrate cost effectiveness. Additionally, the Act makes clear that a nationwide buildout can provide significant economies of scale across state boundaries that can leverage existing infrastructure when feasible and reduce the cost of NPSBN RAN construction in any given state or territory. NTIA will take these cross-border economies into account in the context of a state opt-out plan's cost effectiveness.
FirstNet anticipates including specific details on security, coverage, and quality of service in its proposed plan for the buildout of the NPSBN in a given state.
With respect to coverage, we note that the Act requires the NPSBN to include “substantial rural coverage milestones as part of each phase of the construction and deployment of the network.”
NTIA invites public comment on any and all issues identified in this Notice. Any non-public oral presentation to NTIA regarding the substance of this Notice will be considered an ex parte presentation, and the substance of the meeting will be placed on the public record and become part of this docket. No later than two (2) business days after an oral presentation or meeting, an interested party must submit a memorandum to NTIA summarizing the substance of the communication. NTIA reserves the right to supplement the memorandum with additional information as necessary, or to request that the party making the filing do so, if NTIA believes that important information was omitted or characterized incorrectly. Any written presentation provided in support of the oral communication or meeting will also be placed on the public record and become part of this docket. Such ex parte communications must be submitted to this docket as provided in the
Corporation for National and Community Service.
Notice.
The Corporation for National and Community Service (CNCS), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) (44 U.S.C. 3506(c)(2)(A)). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed.
Currently, CNCS is soliciting comments concerning its proposed new application instructions for AmeriCorps Affiliate.
Copies of the information collection request can be obtained by contacting the office listed in the
Written comments must be submitted to the individual and office listed in the
You may submit comments, identified by the title of the information collection activity, by any of the following methods:
(1)
(2) By hand delivery or by courier to the CNCS mailroom at Room 4200 at the mail address given in paragraph (1) above, between 9:00 a.m. and 4:00 p.m. Eastern Time, Monday through Friday, except Federal holidays.
(3) Electronically through
Individuals who use a telecommunications device for the deaf (TTY-TDD) may call 1-800-833-3722 between 8:00 a.m. and 8:00 p.m. Eastern Time, Monday through Friday.
Patti Stengel, 202-606-6745, or by email at
CNCS is particularly interested in comments that:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of CNCS, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are expected to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology (
Applicants for the AmeriCorps Affiliate program provide information through the use of the application instructions. Applicants use these application instructions to submit their application for Education Awards. This program provides only designations of positions as approved national service positions. CNCS may not award financial resources to applicants under this authority. The application information is collected electronically through the CNCS eGrants system.
This is a new information collection request. This new information collection would allow for an open competition to be an AmeriCorps Affiliate sponsor.
There are no current approved application instructions for the AmeriCorps Affiliate program.
Comments submitted in response to this notice will be summarized and/or included in the request for Office of Management and Budget approval of the information collection request; they will also become a matter of public record.
Department of the Army, DoD.
Notice of Advisory Committee meeting.
The Department of the Army is publishing this notice to announce the following Federal advisory committee meeting of the Board on Coastal Engineering Research. This meeting is open to the public.
The Board on Coastal Engineering Research will meet from 8:00 a.m. to 2:30 p.m. on August 9, 2016, and reconvene from 8:00 a.m. to 5:00 p.m. on August 10, 2016. The Executive Session of the Board will convene from 8:00 a.m. to 12:00 p.m. on August 11, 2016.
All sessions will be held at the Caribe Hilton San Cristobal Jr.
COL Bryan S. Green Designated Federal Officer (DFO), U.S. Army Engineer Research and Development Center, Waterways Experiment Station, 3909 Halls Ferry Road, Vicksburg, MS 39180-6199, phone 601-634-2513, or
The meeting is being held under the provisions of the Federal Advisory Committee Act (FACA) of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.150. The Board on Coastal Engineering Research provides broad policy guidance and reviews plans for the conduct of research and the development of research projects in consonance with the needs of the coastal engineering field and the objectives of the U.S. Army Chief of Engineers.
On Wednesday morning, August 10, 2016, the Board will reconvene to discuss Addressing Coastal Research Challenges. Presentations will include Challenges Characterizing Heterogeneous Coasts; Generation 2 Coastal Risk Model; Project Impacts Due to Deficient Processes Models; Puerto Rico Modeling Testbed, Waves, Surge, and Coral Reefs; State of Knowledge and Capability for Urban Flood Modeling; Modeling Storm Surge in Puerto Rico; and Integrated Watershed Infrastructure Interdependencies. Wednesday afternoon session continues with the Addressing Coastal Research Challenges panel. Presentations include Application of USACE Modeling Tools in Puerto Rico; CARICOOS: Ocean Observing in Support of Coastal Engineering and Navigation; Artificial Reef Systems in High Energy Environments; Coastal Dune Research; and Integrated Federal Coastal Nearshore Processes Research Implementation Plan.
The Board will meet in Executive Session to discuss ongoing initiatives and future actions on Thursday morning, August 11, 2016.
Oral participation by the public is scheduled for 3:45 p.m. on Wednesday, August 10, 2016. The Caribe Hilton Hotel is fully handicap accessible. For additional information about public access procedures, please contact COL Bryan S. Green, the Board's DFO, at the email address or telephone number listed in the
U.S. Department of Education, President's Board of Advisors on Historically Black Colleges and Universities, Office of Undersecretary, U.S. Department of Education.
Announcement of an open meeting.
This notice sets forth the agenda for the July 22, 2016, meeting of the President's Board of Advisors on Historically Black Colleges and Universities (PBA) and provides information to members of the public on submitting written comments and on the process as to how to request time to make oral comments at the meeting. The notice also describes the functions of the Board. Notice of the meeting is required by § 10(a)(2) of the Federal Advisory Committee Act and intended to notify the public of its opportunity to attend. This notice is being published less than 15 days due to ensuring five new Board members appointed by the President within the last two weeks were officially vetted in order to attend the meeting and establish quorum.
The PBA meeting will be held on July 22, 2016, from 9 a.m. to 2:00 p.m. E.D.T. in the Sky Room of the Beach House Hilton Head Island, 1 S. Forest Beach Drive, Hilton Head Island, South Carolina 29928.
Sedika Franklin, Associate Director, U.S. Department of Education, White House Initiative on Historically Black Colleges and Universities, 400 Maryland Avenue SW., Washington, DC 20204; telephone: (202) 453-5634 or (202) 453-5630, fax: (202) 453-5632, or email
The Board shall advise the President and the Secretary in the following areas: (i) Improving the identity, visibility, and distinctive capabilities and overall competitiveness of HBCUs; (ii) engaging the philanthropic, business, government, military, homeland-security, and education communities in a national dialogue regarding new HBCU programs and initiatives; (iii) improving the ability of HBCUs to remain fiscally secure institutions that can assist the nation in reaching its goal of having the highest proportion of college graduates by 2020; (iv) elevating the public awareness of HBCUs; and (v) encouraging public-private investments in HBCUs.
All oral comments made will become part of the official record of the Board. Similarly, written materials distributed during oral presentations will become part of the official record of the meeting.
You may also access documents of the Department published in the
Presidential Executive Order 13532, continued by Executive Order 13708.
Department of Energy.
Notice of open meeting.
This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Oak Ridge Reservation. The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires that public notice of this meeting be announced in the
Saturday, August 6, 2016, 9:00 a.m. to 2:30 p.m.
Tremont Lodge, 7726 East Lamar Alexander Parkway, Townsend, Tennessee 37882.
Melyssa P. Noe, Alternate Deputy Designated Federal Officer, U.S. Department of Energy, Oak Ridge Office of Environmental Management, P.O. Box 2001, EM-942, Oak Ridge, TN 37831. Phone (865) 241-3315; Fax (865) 241-6932; E-Mail:
• Welcome and Opening Remarks
• Comments from the Deputy Designated Federal Officer (DDFO)
• Comments from Oak Ridge SSAB (ORSSAB) Chair
• Discussion of Fiscal Year 2017 Work Plan Topics with Comments from DOE, Tennessee Department of Environment and Conservation, and Environmental Protection Agency Liaisons
Department of Energy, Office of Fossil Energy.
Notice of open meeting.
This notice announces a meeting of the National Petroleum Council. The Federal Advisory Committee Act (Public Law 92-463, 86 Stat. 770) requires that public notice of this meeting be announced in the
Friday, July 29, 2016; 9:00 a.m. to 11:30 a.m.
St. Regis Hotel, 923 16th and K Streets, NW., Washington, DC 20006.
Nancy Johnson, U.S. Department of Energy, Office of Oil and Natural Gas (FE-30), Washington, DC 20585; telephone (202) 586-5600 or facsimile (202) 586-6221.
• Call to Order and Introductory Remarks.
• Remarks by the Honorable Ernest Moniz, Secretary of Energy.
• Follow Up on the 2014 NPC Report on Emergency Preparedness for Natural Disasters.
• Remarks by the Honorable Elizabeth Sherwood-Randall, Deputy Secretary of Energy.
• Administrative Matters.
• Discussion of Any Other Business Properly Brought Before the National Petroleum Council.
• Adjournment.
Department of Energy, Office of Energy Efficiency and Renewable Energy.
Notice of open teleconference.
This notice announces a teleconference call of the State Energy Advisory Board (STEAB). The Federal Advisory Committee Act (Public Law 92-463; 86 Stat.770) requires that public notice of these meetings be announced in the
Thursday, August 18, 2016 from 3:30 p.m. to 4:30 p.m. (EDT). To receive the call-in number and passcode, please contact the Board's Designated Federal Officer at the address or phone number listed below.
Michael Li, Office of Energy Efficiency and Renewable Energy, US Department of Energy, 1000 Independence Ave SW., Washington, DC 20585. Phone number 202-287-5718, and email
Office of Nuclear Energy, Department of Energy.
Request for information (RFI).
The U.S. Department of Energy (DOE) is preparing for a potential new Secretarial Determination covering transfers of uranium for cleanup services at the Portsmouth Gaseous Diffusion Plant and for down-blending of highly-enriched uranium to low-enriched uranium (LEU). This RFI solicits information from the public about the uranium markets and domestic uranium industries, and the potential effects of DOE transfers in the uranium markets and possible consequences for the domestic uranium mining, conversion and enrichment industries. DOE will consider this information as part of its analysis to determine whether its transfers would have an adverse material impact on the domestic uranium mining, conversion, or enrichment industry.
DOE will accept comments, data, and information responding to this RFI submitted on or before August 18, 2016.
Interested persons may submit comments by any of the following methods.
1.
2.
3.
Requests for additional information may be sent to: Ms. Cheryl Moss Herman, U.S. Department of Energy, Office of Nuclear Energy, Mailstop B-409, 19901 Germantown Rd., Germantown, MD 20874-1290. Phone: (301) 903-1788. Email:
Title I, Chapters 6-7, 14, of the Atomic Energy Act of 1954 (42 U.S.C. 2011
In recent years, DOE has transferred uranium for cleanup services at the Portsmouth Gaseous Diffusion Plant and for down-blending of highly-enriched uranium to low-enriched uranium (LEU). In May 2015, the Secretary determined that certain transfers, described in the determination, would not have an adverse material impact on the domestic uranium mining, conversion, or enrichment industry (the “2015 Secretarial Determination”).
DOE is preparing for a new Secretarial Determination that would cover further transfers of uranium for cleanup services at the Portsmouth Gaseous Diffusion Plant and for down-blending of highly-enriched uranium to LEU upon expiration of the 2015 Secretarial Determination. DOE is initiating this process by publishing this RFI seeking information on the uranium markets and domestic uranium industries. DOE will evaluate comments received in response to this RFI, along with other information and analysis, to determine whether its future transfers would have an adverse material impact on the domestic uranium mining, conversion, or enrichment industry.
This RFI seeks information from interested parties on the uranium markets and domestic uranium industries, and the potential effects of DOE's transfers on the uranium markets and possible consequences for domestic uranium industries. DOE will use that information to help analyze and determine whether its transfers would have an adverse material impact on the domestic uranium mining, conversion, or enrichment industry. For all comments, DOE requests that interested parties fully explain any assumptions that underlie their reasoning. DOE also requests that commenters provide underlying data or other information sufficient to allow DOE to review and verify any of the assumptions, calculations or views expressed by the commenters.
DOE specifically invites public comment on the following questions:
(1) What are current and projected conditions in the uranium markets, and the domestic uranium mining, conversion and enrichment industries?
(2) What market effects and industry consequences could DOE expect from continued transfers at annual rates comparable to the transfers described in the 2015 Secretarial Determination?
(3) Would transfers at a lower annual rate or a higher annual rate significantly change these effects, and if so, how?
(4) Are there any anticipated changes in these markets that may significantly change how DOE transfers affect the domestic uranium industries?
Although comment is particularly welcome on the issues discussed above, DOE also requests comments on other topics that commenters consider significant in preparing for a potential new Secretarial Determination.
DOE invites all interested parties to submit, in writing by August 18, 2016, comments and information on matters addressed in this RFI. Any information that may be confidential and exempt by law from public disclosure should be submitted as described in section IV. Confidential Business Information. After the close of the comment period, DOE will continue collecting data, conducting analyses, and reviewing the public comments, as needed.
Pursuant to 10 CFR 1004.11, any person submitting information he or she believes to be confidential and exempt by law from public disclosure should submit via email, postal mail, or hand delivery/courier two well-marked copies: One copy of the document marked “confidential” including all the information believed to be confidential, and one copy of the document marked “non-confidential” with the information believed to be confidential deleted. Submit these documents via email. DOE will make its own determination about the confidential status of the information and treat it according to its determination. Factors of interest to DOE when evaluating requests to treat submitted information as confidential include: (1) A description of the items; (2) whether and why such items are customarily treated as confidential within the industry; (3) whether the information is generally known by or available from other sources; (4) whether the information has previously been made available to others without obligation concerning its confidentiality; (5) an explanation of the competitive injury to the submitting person which would result from public disclosure; (6) when such information might lose its confidential character due to the passage of time; and (7) why disclosure of the information would be contrary to the public interest.
Office of Fossil Energy, DOE.
Notice of application.
The Office of Fossil Energy (FE) of the Department of Energy (DOE) gives notice of receipt of an application, filed on December 23, 2015, amended on June 7, 2016 (Application), by Rio Grande LNG, LLC (Rio Grande LNG). Rio Grande LNG requests long-term, multi-contract authorization to export domestically produced liquefied natural gas (LNG) in a volume equivalent to approximately 1,318 billion cubic feet (Bcf) per year of natural gas (3.61 Bcf per day). Rio Grande LNG seeks to export the LNG by vessel from its proposed natural gas liquefaction and LNG export terminal to be located in Cameron County, Texas, along the north embankment of the Brownsville Ship Channel (Rio Grande LNG Project). Rio Grande LNG requests authorization to export this LNG to any country with
Protests, motions to intervene or notices of intervention, as applicable, requests for additional procedures, and written comments are to be filed using procedures detailed in the Public Comment Procedures section no later than 4:30 p.m., Eastern time, September 19, 2016.
The Application will be reviewed pursuant to section 3(a) of the NGA, 15 U.S.C. 717b(a), and DOE will consider any issues required by law or policy. To the extent determined to be relevant, these issues will include the domestic need for the natural gas proposed to be exported, the adequacy of domestic natural gas supply, and U.S. energy security. DOE may also consider other factors bearing on the public interest, including the impact of the proposed exports on the U.S. economy, international considerations, and whether the authorization is consistent with DOE's policy of promoting competition in the marketplace by allowing commercial parties to freely negotiate their own trade arrangements. As part of this analysis, DOE will consider the following two studies examining the cumulative impacts of exporting domestically produced LNG:
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•
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•
Parties that may oppose this Application should address these issues in their comments and/or protests, as well as other issues deemed relevant to the Application.
The National Environmental Policy Act (NEPA), 42 U.S.C. 4321
In response to this Notice, any person may file a protest, comments, or a motion to intervene or notice of intervention, as applicable. Due to the complexity of the issues raised by the Applicant, interested persons will be provided 60 days from the date of publication of this Notice in which to submit comments, protests, motions to intervene, or notices of intervention.
Any person wishing to become a party to the proceeding must file a motion to intervene or notice of intervention. The filing of comments or a protest with respect to the Application will not serve to make the commenter or protestant a party to the proceeding, although protests and comments received from persons who are not parties will be considered in determining the appropriate action to be taken on the Application. All protests, comments, motions to intervene, or notices of intervention must meet the requirements specified by the regulations in 10 CFR part 590.
Filings may be submitted using one of the following methods: (1) Emailing the filing to
A decisional record on the Application will be developed through responses to this notice by parties, including the parties' written comments and replies thereto. Additional procedures will be used as necessary to achieve a complete understanding of the facts and issues. If an additional procedure is scheduled, notice will be provided to all parties. If no party requests additional procedures, a final Opinion and Order may be issued based on the official record, including the Application and responses filed by parties pursuant to this notice, in accordance with 10 CFR 590.316.
The Application is available for inspection and copying in the Office of Regulation and International Engagement docket room, Room 3E-042, 1000 Independence Avenue SW., Washington, DC 20585. The docket room is open between the hours of 8:00 a.m. and 4:30 p.m., Monday through Friday, except Federal holidays.
The Application and any filed protests, motions to intervene or notice of interventions, and comments will also be available electronically by going to the following DOE/FE Web address:
In accordance with the National Environmental Policy Act of 1969 and the Federal Energy Regulatory Commission's (Commission or FERC's) regulations, 18 Code of Federal Regulations (CFR) Part 380 (Order No. 486, 52 Federal Register [FR] 47897), the Office of Energy Projects has reviewed Alaska Energy Authority's application for a non-capacity amendment to the license for the Bradley Lake Hydroelectric Project (FERC Project No. 8221), located on the south shore and near the head of Kachemak Bay, 22.5 miles east, northeast of the city of Homer, Kenai Peninsula Borough, Alaska. The project currently occupies a total of 5,498 acres of federal land administered by the Bureau of Land Management.
Staff prepared a final environmental assessment (EA), which analyzes the potential environmental effects of constructing and operating a new diversion on the West Fork of Upper Battle Creek that would divert water to Bradley Lake and thereby increase generation at the project. The final EA concludes that authorizing the amendment, with appropriate environmental protective measures, would not constitute a major federal action that would significantly affect the quality of the human environment.
A copy of the final EA is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
You may also register online at
For further information, contact Steven Sachs by telephone at 202-502-8666 or by email at
The following notice of meeting is published pursuant to section 3(a) of the government in the Sunshine Act (Pub. L. 94-409), 5 U.S.C. 552b:
Federal Energy Regulatory Commission.
July 21, 2016 10:00 a.m.
Room 2C, 888 First Street NE., Washington, DC 20426.
Open.
Agenda.
* NOTE—Items listed on the agenda may be deleted without further notice.
Kimberly D. Bose, Secretary, Telephone (202) 502-8400.
For a recorded message listing items struck from or added to the meeting, call (202) 502-8627.
This is a list of matters to be considered by the Commission. It does not include a listing of all documents relevant to the items on the agenda. All public documents, however, may be viewed on line at the Commission's Web site at
A free webcast of this event is available through
Immediately following the conclusion of the Commission Meeting, a press briefing will be held in the Commission Meeting Room. Members of the public may view this briefing in the designated overflow room. This statement is intended to notify the public that the press briefings that follow Commission meetings may now be viewed remotely at Commission headquarters, but will not be telecast through the Capitol Connection service.
Federal Communications Commission (FCC or Commission or Agency)
Notice of a new system of records.
The FCC proposes to add a new system of records, FCC/CGB-5, CGB Stakeholder Database, to its inventory of records systems subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended. This action is necessary to meet the requirements of the Privacy Act to publish in the
Written comments are due on or before August 18, 2016. This action will become effective on August 29, 2016 unless comments are received that require a contrary determination.
Send comments to Leslie F. Smith, Privacy Manager, Information Technology (IT), Room 1-C216, Federal Communications Commission, 445 12th Street SW., Washington, DC 20554, or via the Internet at
Leslie F. Smith, (202) 418-0217, or
The CGB Stakeholder Database allows CGB to fulfill its outreach responsibilities as set forth in 47 CFR 0.141. The database contains contact information for individuals who interact with the Bureau through electronic or in-person contact with the Bureau.
CGB Stakeholder Database.
The FCC's CIO will develop a security classification to this system of records based on NIST FIPS-199 standards.
Consumer and Governmental Affairs Bureau (CGB), Federal Communications Commission (FCC), 445 12th Street SW., Washington, DC 20554.
Members of the general public; representatives of federal, state, local and tribal governments; and representatives of public and private companies, trade groups, and interest groups.
The categories of records in this information system include the contact information that individuals have provided in their interactions with the Bureau, including: Personal contact information (including but not limited to, name, personal cell phone number, business cell phone number, home telephone number, business telephone number, personal and professional email address, personal and professional facsimile number, business and home mailing address, and social media contact information) and job-related data (including but not limited to organizational affiliation and title).
47 U.S.C. 151, 152, 155, 303; 47 CFR 0.141.
These records enable CGB personnel to contact interested parties concerning its public events,
In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act, all or a portion of the records or information contained in this system may be disclosed to authorized entities, as is determined to be relevant and necessary, outside the FCC as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows. In each of these cases, the FCC will determine whether disclosure of the records is compatible with the purpose(s) for which the records were collected.
1. Congressional Inquiries—To provide information to a congressional office from the record of an individual in response to an inquiry from that congressional office made at the request of that individual.
2. Contact Information Sharing—to share contact information for federal, state, local, or tribal governments; law enforcement; industry; advocacy groups; non-profit organizations; employment centers; faith-based organizations; libraries; policy organizations; media outlets; schools; seniors centers; veterans groups; national governmental associations; or tribal intergovernmental organizations with these entities, or members of the public, as part of CGB's outreach activities, but in no case will individual members of the public's contact information be provided to these entities without consent.
3. Government-wide Program Management and Oversight—To the National Archives and Records Administration for use in its records management inspections; to the Government Accountability Office (GAO) for oversight purposes; to the Department of Justice (DOJ) to obtain that department's advice regarding disclosure obligations under the Freedom of Information Act (FOIA); or to the Office of Management and Budget to obtain that office's advice regarding obligations under the Privacy Act.
4. Adjudication and Litigation—To the Department of Justice (DOJ), or other administrative body before which the FCC is authorized to appear, when: (a) The FCC or any component thereof; (b) any employee of the FCC in his or her official capacity; (c) any employee of the FCC in his or her individual capacity where DOJ or the FCC has agreed to represent the employee; or (d) the United States is a party to litigation or has an interest in such litigation, and the use of such records by DOJ or the FCC is deemed by the FCC to be relevant and necessary to the litigation.
5. Law Enforcement and Investigation—To disclose pertinent information to the appropriate Federal, State, or local agency responsible for investigating, prosecuting, enforcing, or implementing a statute, rule, regulation, or order, where the FCC becomes aware of an indication of a violation or potential violation of civil or criminal law or regulation; and
6. Breach Notification—To appropriate agencies, entities, and persons when (1) the Commission suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (2) the Commission 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 other systems or programs (whether maintained by the Commission 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 Commission's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
None.
The information in this system includes electronic data entered into the CGB Stakeholder Database that is maintained in the FCC's computer network.
Information in the CGB Stakeholder Database can be retrieved from the database by any element of an individual's contact information.
The electronic records are maintained in a database housed in the FCC computer network databases. The FCC's computer network is protected by the FCC's IT privacy safeguards, a comprehensive and dynamic set of IT safety and security protocols and features that are designed to meet all Federal IT privacy standards, including those required by the National Institute of Standard and Technology (NIST) and the Federal Information Security Management Act (FISMA). In addition, access to the information in the database is restricted to authorized CGB supervisors and staff and to authorized FCC Information Technology (IT) staff who maintain these computer databases. Other FCC employees and contractors may be granted access only on a “need-to-know” basis.
Physical documents containing information to be added into the CGB Stakeholders Database, such as business cards and sign-in sheets, are disposed of once the information is incorporated into the CGB Stakeholder Database and the physical records are no longer need for another business purpose. Before destruction of physical records, they are stored in CGB staff offices which are locked at the end of the business day.
The CGB Stakeholder Database will be retained by the FCC until a records schedule has been approved by NARA. Upon approval of a records schedule by NARA, the CGB Stakeholder Database will be retained and disposed of pursuant to that records schedule.
Individuals wishing to determine whether this system of records contains information about them may do so by writing to Leslie F. Smith, Privacy Manager, Information Technology (IT), Federal Communications Commission (FCC), 445 12th Street SW., Washington, DC 20554, or email
Individuals requesting access must also comply with the FCC's Privacy Act regulations regarding verification of identity and access to records (5 CFR part 0, subpart E).
The sources for information in the CGB Stakeholder Database include but are not limited to information provided by members of the general public, representatives of federal, state, local and tribal governments, representatives of public and private interest groups who:
1. Contact the Bureau through phone, letter, email, or social media communications;
2. Attend Bureau-hosted events and leave their information on a paper or electronic sign-in sheet;
3. Register for Bureau-hosted events through temporary “@fcc.gov” email addresses;
4. Voluntarily subscribe to
5. Are organizations whose publicly available information is used by the Bureau to initiate contact;
6. Attend non-FCC events and provide information to Bureau staff in attendance;
7. Electronically confirm attendance at Webinars or in-person meetings; and/or
8. Provide paper business cards to CGB staff.
None.
The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).
The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than August 3, 2016.
A. Federal Reserve Bank of Atlanta (Chapelle Davis, Assistant Vice President) 1000 Peachtree Street, NE., Atlanta, Georgia 30309. Comments can also be sent electronically to
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2.
The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).
The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than August 4, 2016.
A. Federal Reserve Bank of St. Louis (David L. Hubbard, Senior Manager) P.O. Box 442, St. Louis, Missouri 63166-2034. Comments can also be sent electronically to
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8:30 a.m. (Eastern Time) July 25, 2016.
10th Floor Board Meeting Room, 77 K Street NE., Washington, DC 20002.
Parts will be open to the public and parts will be closed to the public.
Information covered under 5 U.S.C. 552b(c)(9)(B) and (c)(10).
Kimberly Weaver, Director, Office of External Affairs, (202) 942-1640.
Centers for Medicare & Medicaid Services, HHS.
Notice.
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the
Comments on the collection(s) of information must be received by the OMB desk officer by August 18, 2016.
When commenting on the proposed information collections, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be received by the OMB desk officer via one of the following transmissions: OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: (202) 395-5806
To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:
1. Access CMS' Web site address at
2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to
3. Call the Reports Clearance Office at (410) 786-1326.
Reports Clearance Office at (410) 786-1326.
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the
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Centers for Medicare & Medicaid Services, HHS.
Notice.
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the
Comments must be received by September 19, 2016.
When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways:
1.
2.
To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:
1. Access CMS' Web site address at
2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to
3. Call the Reports Clearance Office at (410) 786-1326.
Reports Clearance Office at (410) 786-1326.
This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see
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. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the
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Administration for Community Living, HHS.
Notice.
The Administration for Community Living is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Submit written or electronic comments on the collection of information by September 19, 2016.
Submit written comments on the collection of information to Susan Jenkins at
Susan Jenkins, 202.795.7369
In compliance with PRA (44 U.S.C. 3501-3520), the Administration for Community Living (ACL, formerly the Administration for Aging) has submitted the following proposed collection of information to the Office of Management and Budget (OMB) for review and clearance. The Administration for Community Living/Administration on Aging (ACL/AoA) is requesting approval from the Office of Management and Budget (OMB) to complete data collection associated with the
The total burden estimate for the remaining data collection is: 144 hours. The proposed data collection tools may be found on the ACL Web site at:
Administration for Community Living, HHS.
Notice.
The President's Committee for People with Intellectual Disabilities (PCPID) will host a webinar/conference call for its members to discuss the potential topics of the Committee's 2017 Report to the President. All the PCPID meetings, in any format, are open to the public. This virtual meeting will be conducted in a discussion format.
Dr. MJ Karimi, PCPID Team Lead, 330 C Street SW., 1108A, Washington, DC 20201. Email:
The Committee held a conference call on May 2, 2016 to discuss and finalize the Committee's 2016 Report to the President. The purpose of this virtual meeting is to provide PCPID members with an update on submission of the 2016 Report to the President and to begin exploring the topics for the Committee's 2017 report.
1. Enter the following WebEx Link:
2. Click on the “join” button on the page
3. Enter your name and email address
4. Follow additional instructions as provided by WebEx. This WebEx does not require a password.
5. Please dial: (888) 469-0940; Pass Code: 5315454 (you should put your phone on mute during the meeting)
Administration for Community Living, HHS.
Notice.
The Administration for Community Living (ACL) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Submit written comments on the collection of information by August 18, 2016.
Submit written comments on the collection of information to Elena Fazio at 202-795-7343 or email:
Elena Fazio at 202-795-7343 or email:
In compliance with 44 U.S.C. 3507, ACL has submitted the following proposed collection of information to OMB for review and clearance.
The Older Americans Act (OAA) requires annual program performance reports from States, the District of Columbia, and Territories. In compliance with this OAA provision, ACL developed a State Program Report (SPR) in 1996 as part of its National Aging Program Information System (NAPIS). The SPR collects information about how State Agencies on Aging expend their OAA funds as well as funding from other sources for OAA authorized supportive services. The SPR also collects information on the demographic and functional status of the recipients, and is a key source for ACL performance measurement. This collection is an extension with no changes of the 2013 approved version. The proposed version will be in effect for the FY 2017 reporting year and thereafter. The proposed FY 2017 version may be found on the ACL Web site link entitled Renewal SPR Instrument for 2016 Extension With No Changes available at
Food and Drug Administration, HHS.
Notice of public workshop.
The Food and Drug Administration (FDA) is announcing a public workshop entitled “Pre-Clinical Evaluation of Red Blood Cells for Transfusion.” The purpose of the public workshop is to discuss new methodologies for pre-clinical evaluation of the safety and efficacy of red blood cell transfusion products. The workshop has been planned in partnership with the National Heart, Lung, and Blood Institute; National Institutes of Health (NIH); the Department of Defense; and the Office of the Assistant Secretary for Health, Department of Health and Human Services. The workshop will include presentations and panel discussions by experts from academic institutions, industry, and government Agencies.
The public workshop will be held on October 6, 2016, from 8 a.m. to 5 p.m. and on October 7 from 9 a.m. to 1 p.m. See the
The public workshop will be held at the Ruth Kirschstein
Matthew Morrison, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, rm. 3128, Silver Spring, MD 20993, 240-402-8126,
The purpose of the public workshop is to discuss new methodologies for pre-clinical evaluation of the safety and efficacy of red blood cell transfusion products including potential identification of biomarkers measurable during red cell storage that could predict the in vivo functionality of transfused red blood cells. The first day of the workshop will include presentations and panel discussions on the following topics: (1) Overview of red blood cells for transfusion; (2) methods for determining the suitability of red blood cells for transfusion; (3) new methods for detecting red blood cell processing and storage legions; and (4) the use of animal models of oxygen delivery as markers of red blood cell safety and efficacy in the acute bleeding and trauma resuscitation settings.
The second day of the workshop will include presentations and panel discussions on the potential mechanisms of red blood cell transfusion-associated toxicity and a summary of all workshop panel discussions, identified gaps, and future directions.
If you need special accommodations due to a disability, please contact Matthew Morrison (see
Food and Drug Administration, HHS.
Notice of public meeting; request for comments.
The Food and Drug Administration (FDA or Agency) is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FYs) 2018 through 2022. PDUFA authorizes FDA to collect fees and use them for the process for the review of human drug applications. The current legislative authority for PDUFA expires in September 2017. At that time, new legislation will be required for FDA to continue collecting prescription drug user fees in future fiscal years. Following discussions with the regulated industry and periodic consultations with public stakeholders, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) directs FDA to publish the recommendations for the reauthorized program in the
The public meeting will be held on August 15, 2016, from 9 a.m. to 2 p.m. Please register for the meeting by August 8, 2016, at
The meeting and workshop will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503, Section A), Silver Spring, MD 20993-0002. Participants must enter through Building 1 and undergo security screening. For more information on parking and security procedures, please refer to
You may submit comments as follows:
Submit electronic comments in the following way:
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• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• 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,
•
FDA will post the agenda approximately 5 days before the meeting at:
Graham Thompson, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993, 301-796-5003, FAX: 301-847-8443,
FDA is announcing a public meeting to discuss proposed recommendations for the reauthorization of PDUFA, the legislation that authorizes FDA to collect user fees and use them for the process for the review of human drug applications. The current authorization of the program (PDUFA V) expires in September 2017. Without new legislation, FDA will no longer be able to collect user fees for future fiscal years to fund the process for the review of human drug applications. Section 736B(d)(4) of the FD&C Act (21 U.S.C. 379h-2(d)(4)) requires that after FDA holds negotiations with regulated industry and periodic consultations with stakeholders, we do the following: (1) Present recommendations to the relevant Congressional committees, (2) publish recommendations in the
This notice, the 30-day comment period, and the public meeting will satisfy some of these requirements. After the public meeting, we will revise the recommendations as necessary and present our proposed recommendations to the Congressional committees.
The purpose of the meeting is to hear the public's views on the proposed recommendations for the reauthorized program (PDUFA VI). The following information is provided to help potential meeting participants better understand the history and evolution of the PDUFA program and the current status of the proposed PDUFA VI recommendations.
PDUFA is a law that authorizes FDA to collect fees from drug companies that submit marketing applications for certain human drug and biological products. PDUFA was originally enacted in 1992 as the Prescription Drug User Fee Act (Pub. L. 102-571) for a period of 5 years. In 1997, Congress passed the FDA Modernization Act (FDAMA, Pub. L. 105-115) that reauthorized the program (PDUFA II) for an additional 5 years. In 2002, Congress extended PDUFA again through FY 2007 (PDUFA III) in the Public Health Security and Bioterrorism Preparedness and Response Act (Pub. L. 107-188). In 2007, Title I of the Food and Drug Administration Amendments Act of 2007 (FDAAA, Pub. L. 110-85) reauthorized PDUFA through FY 2012 (PDUFA IV). Most recently, PDUFA was reauthorized through FY 2017 (PDUFA V) as Title I of the Food and Drug Administration Safety and Innovation Act (FDASIA, Pub. L. 112-144).
PDUFA's intent is to provide additional revenues so that FDA can hire more staff, improve systems, and establish a better-managed human drug review process to make important therapies available to patients sooner without compromising review quality or FDA's high standards for safety, efficacy, and quality. As part of FDA's agreement with industry during each reauthorization, the Agency agrees to certain performance goals. These goals apply to the process for the review of new human drug and biological product applications, resubmissions of original applications, and supplements to approved applications. During the first few years of PDUFA I, the additional funding enabled FDA to eliminate backlogs of original applications and supplements. Phased in over the 5 years of PDUFA I, the goals were to review and act on 90 percent of priority new drug applications (NDAs), biologics license applications (BLAs), and efficacy supplements within 6 months of submission of a complete application; to review and act on 90 percent of standard original NDAs, BLAs, and efficacy supplements within 12 months; and to review and act on resubmissions and manufacturing supplements within 6 months. Over the course of PDUFA I, FDA exceeded all of these performance goals and significantly reduced median review times of both priority and standard NDAs and BLAs.
Under PDUFA II, some of the review performance goals were shortened and new procedural goals were added to improve FDA's interactions with industry sponsors and to help facilitate the drug development process. The procedural goals, for example, articulated timeframes for scheduling sponsor-requested meetings intended to address issues or questions regarding specific drug development programs, as well as timeframes for the timely response to industry-submitted questions on special study protocols. FDA met or exceeded nearly all of the review and procedural goals under PDUFA II. However, concerns grew that overworked review teams often had to return applications as “approvable”
A sound financial footing and support for limited postmarket risk management were key themes of PDUFA III. Base user fee resources were significantly increased and a mechanism to account for changes in human drug review workload was adopted. PDUFA III also expanded the scope of user fee activities to include postmarket surveillance of new therapies for up to 3 years after marketing approval. FDA committed to the development of guidance for industry on risk assessment, risk management, and pharmacovigilance as well as guidance to review staff and industry on good review management principles and practices (GRMPs). Initiatives to improve application submissions and Agency-sponsored interactions during the drug development and application review processes were also adopted.
With PDUFA's reauthorization under FDAAA Title I (PDUFA IV), FDA obtained a significant increase in base fee funding and committed to full implementation of GRMPs, which includes providing a planned review timeline for premarket review, development of new guidance for industry on innovative clinical trials, modernization of postmarket safety, and elimination of the 3-year limitation on fee support for postmarket surveillance. Additional provisions in FDAAA (Titles IV, V, and IX) gave FDA additional statutory authority that increased the pre- and postmarket review process requirements, added new deadlines, and effectively increased review workload. Specifically, the new provisions expanded FDA's drug safety authorities such as the authority to require risk evaluation mitigation strategies, order safety labeling changes, and require postmarket studies.
With the current authorization of PDUFA under Title I of FDASIA, FDA implemented a new review program (“the Program”) to promote greater transparency and increase communication between the FDA review team and the applicant on the most innovative products reviewed by the Agency. The Program applies to all new molecular entity (NME) NDAs and original BLAs received by the Agency from October 1, 2012, through September 30, 2017. The Program adds new opportunities for communication between the FDA review team and the applicant during review of a marketing application, including mid-cycle communications and late-cycle meetings, while adding 60 days to the review clock to provide for this increased interaction and to address review issues for these complex applications. PDUFA V also required two assessments of the impact of the Program. The first of these, the interim assessment, is available on FDA's Web site at
In addition to continued commitment to a significant set of review, processing, and procedural goals, PDUFA V also included commitments related to enhancing regulatory science and expediting drug development, enhancing benefit-risk assessment in regulatory decisionmaking, modernizing the FDA drug safety system, and improving the efficiency of human drug application review by requiring electronic submissions and standardization of electronic drug application data. The PDUFA V Commitment Letter requires that FDA report on the progress in satisfying these commitments in the annual PDUFA performance report. The annual performance reports can be found at
In preparing the proposed recommendations to Congress for PDUFA reauthorization, FDA conducted discussions with the regulated industry and consulted with stakeholders, as required by the law. We began the PDUFA reauthorization process by publishing a notice in the
Following the July 2015 public meeting, FDA conducted negotiations with the regulated industry and held monthly consultations with stakeholders from September 2015 through February 2016. As directed by Congress, FDA posted minutes of these meetings on its Web site at
The proposed enhancements for PDUFA VI address many of the top priorities identified by public stakeholders, the regulated industry, and FDA. While some of the proposed enhancements are new, many either build on successful enhancements or refine elements from the existing program. The enhancements are proposed in the following areas: Premarket review, regulatory decision tools, postmarketing evaluation, electronic submissions and data standards, and administrative areas (hiring and financial management). The full text of the proposed PDUFA VI commitment letter can be found here at
The program for enhanced review transparency and communication for NME NDAs and original BLAs (the Program), first established in PDUFA V, provides for additional communication between FDA review teams and the applicants of NME NDAs or original BLAs in the form of pre-submission meetings, mid-cycle communications, and late-cycle meetings, while also adding 60 days to the review timeframe to accommodate this additional interaction. An interim assessment of the Program suggested that the Program has created conditions that enhance the ability of applicants and FDA reviewers to work toward application approval in the first cycle (see
For PDUFA VI, FDA proposes to maintain the Program with minor modifications to reduce administrative burden and increase flexibility to the benefit of FDA review teams and applicants. FDA proposes to provide an option for the FDA review team and the applicant to agree on a formal communication plan to govern interactions during the application review. The formal communication plan may or may not include Program elements (
This enhancement is described in section I.B. of the proposed PDUFA VI commitment letter.
Inspections late in the review process of inadequately identified manufacturing facilities can adversely impact FDA's ability to complete application review within the performance goal timeframes. FDA proposes to extend the goal date for an original application or an efficacy supplement when it identifies a need to inspect a facility that was not included in a comprehensive and readily located list of manufacturing facilities. This enhancement is described in section I.A.5.b of the proposed PDUFA VI commitment letter.
The number of requests for formal meetings between sponsors and the FDA is rapidly increasing; in FY 2015 alone, FDA received over 3,000 requests for formal PDUFA meetings with sponsors. The background packages for these meetings are increasingly complex which creates challenges for FDA to review and deliberate internally before providing advice to sponsors on complex drug development questions within current performance goal timeframes. To help address this issue, FDA proposes to create a new Type B End of Phase (EOP) meeting type for certain EOP 1 and EOP 2/pre-phase 3 meetings. The performance goal timeframes for responses to meeting requests, submission of meeting background packages, and FDA's issuance of preliminary responses for the Type B (EOP) meetings and the Type C meetings would be modified to provide adequate time for FDA review and response. Sponsors would receive preliminary responses to their questions no later than five calendar days before the scheduled meeting, providing the sponsor with time to evaluate whether an in-person meeting would still be necessary. Sponsors would also be able to request a Written Response Only for any meeting type. The language for meeting management is described in section I.H of the proposed PDUFA VI commitment letter.
The enhancements under this section focus on enhancing regulatory science and expediting drug development. Regulatory science, in this context, is the science of developing and applying new tools, standards, and approaches to assess the safety, effectiveness, quality, and performance of FDA-regulated drug products. The details of these enhancements can be found in section I.I of the proposed PDUFA VI commitment letter.
FDA recognizes that timely interactive communication with sponsors can help foster efficient and effective drug development. Under commitments in PDUFA V, FDA focused on improving communication between FDA and sponsors during drug development by establishing a dedicated drug development communications and training staff in the Center for Drug Evaluation and Research (CDER) and augmenting existing communications staff in the Center for Biologics Evaluation and Research (CBER). Under PDUFA VI, FDA proposes to build on this enhancement by conducting a third-party evaluation of current communication practices between FDA and sponsors during drug development, to convene a public workshop to discuss results of this evaluation, and then to update the guidance on “Best Practices for Communication Between IND Sponsors and FDA During Drug Development,” if necessary (available here:
FDASIA established a new designation, breakthrough therapy, for drugs intended to treat a serious or life threatening disease or condition where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. Utilization of the breakthrough therapy program has been higher than anticipated with over 300 requests for designation received, and over 100 granted (as of March 2016). Additional resources will enable the FDA to continue to work closely with sponsors throughout the development and review of breakthrough therapies. Both the FDA and the regulated industry are committed to ensuring the expedited development and review of innovative therapies for serious or life-threatening diseases by investing additional resources in the breakthrough therapy program during PDUFA VI.
FDA recognizes that early consultation can be important to an efficient development program when a sponsor intends to use a biomarker as a new surrogate endpoint that has never been used as the primary basis for product approval in the proposed context of use. Early consultation enables the FDA review team to consult with senior management to evaluate the sponsor's proposal before providing advice to the sponsor on a critical aspect of their development program. FDA proposes that these requests for early consultation in PDUFA VI be considered as Type C meeting requests. The purpose of the meeting will be to discuss the feasibility of the surrogate as a primary endpoint, any knowledge gaps, and how these gaps should be addressed before the surrogate endpoint could be used as the primary basis for approval. To qualify for this consultation, the meeting background package will be due at the time of the meeting request and must include preliminary human data indicating the impact of the drug on the biomarker.
In PDUFA VI, FDA proposes to build on the success of the Rare Disease Program (RDP) by continuing to advance and facilitate the development and timely approval of drugs and biologics for rare diseases, including diseases in children. In addition to providing training for review staff related to development and review of drugs for rare diseases and engaging in outreach to external stakeholders, the RDP staff in CDER will be integrated into review teams for rare disease development programs and application review, while the RDP Staff in CBER will ensure that CBER's review offices consider flexible and feasible approaches in review. The RDP will also continue to foster collaborations in the development of tools to support rare disease drug development and facilitate interactions
Under PDUFA VI FDA will pursue the opportunity to improve inter-center and intra-center combination review coordination and transparency for PDUFA-led products. FDA proposes to enhance staff capacity and capability across the relevant medical product centers and the Office of Combination Products to more efficiently, effectively, and consistently review drug and device-led combination products. FDA also proposes to streamline the process for combination product review and to improve the Agency's ability to track drug and device-led combination product review workload, including a third party assessment of current practices for combination drug product review.
Under this enhancement FDA will also establish new performance goals and submission procedures for the review of human factors protocols for PDUFA combination products. These goals will be to provide the sponsor with written comments on these protocols within 60 days of receipt. The goals to provide written comments within 60 days will begin at the 50 percent level in FY 2019, and increase to 90 percent by FY 2021.
In addition, FDA proposes to publish draft guidance or update previously published guidance on bridging studies and patient-oriented labeling.
FDA recognizes the potential value of utilizing “real-world” evidence in evaluating not only the safety of medications but also their effectiveness. To better understand how real-world evidence can be generated and used appropriately in product evaluation, FDA proposes to conduct one or more public workshops, as well as other appropriate activities (
The enhancements under this section focus on enhancing regulatory decision tools to support drug development and review. The details of these enhancements can be found in section I.J of the proposed PDUFA VI commitment letter.
In PDUFA V, FDA conducted a series of Patient-Focused Drug Development (PFDD) meetings with the aim to more systematically gather patients' perspectives on their condition and available therapies to treat their condition. Under PDUFA VI, FDA proposes to build on these efforts to bridge from PFDD meetings to fit-for-purpose tools to collect meaningful patient input that can be incorporated into regulatory review. FDA proposes to develop a series of guidance documents to advance the collection of meaningful patient input. The publication of each draft guidance will be preceded by a public workshop conducted by FDA to gather stakeholder input relevant to the topics that will be the focus of that guidance. FDA also proposes to publish a repository of publicly available tools on FDA's Web site as a resource for stakeholders, to update internal policies and procedures, as appropriate, to incorporate an increased focus on patient input, and to enhance staff capacity to facilitate development and use of patient-focused methods to inform drug development and regulatory decisions.
Ensuring the safety, effectiveness, and quality of drug products is an increasingly complicated regulatory task, requiring FDA's expert consideration of a multitude of complex factors. During PDUFA V, FDA implemented an enhanced structured approach to benefit-risk assessment in regulatory decisionmaking for drug products. In PDUFA VI, FDA proposes to publish an update to its benefit-risk framework implementation plan, to conduct an evaluation of the implementation of the benefit-risk framework, to develop guidance on benefit-risk assessments for new drugs and biologics, and to revise relevant policies and procedures to include new approaches that incorporate the benefit-risk framework into the human drug review program.
The development and application of exposure-based, biological, and statistical models derived from preclinical and clinical data sources can be used to inform regulatory decision-making, for example, in determining patient selection in clinical trials, individualized dosing for specific populations, or the need for post-marketing studies. To facilitate the development and application of these approaches during PDUFA VI, FDA proposes to convene a series of workshops to identify best practices for model-informed drug development (MIDD), to conduct a pilot program, to develop guidance on MIDD, and to update policies and procedures, as appropriate, to incorporate guidelines for the evaluation of MIDD approaches.
To facilitate the advancement and use of complex adaptive, Bayesian, and other novel clinical trial designs during PDUFA VI, FDA proposes to convene a public workshop on complex innovative trial designs, publish guidance on complex innovative trial designs, to conduct a pilot program, and to update policies and procedures as appropriate to incorporate guidelines on evaluating complex innovative trial designs.
As regulatory submissions are increasingly submitted in fully standard electronic format, it becomes increasingly important to ensure that analysis datasets are structured according to the standards to facilitate acceptance and analysis of the datasets. To support the enhancement of analysis data standards for product development and review in PDUFA VI, FDA proposes to enhance staff capacity to develop and update relevant standards, to support the efficient submission and review of analysis datasets, to convene a public workshop to advance the development and application of analysis data standards, to collaborate with external stakeholders on development of data standards, and to update, as appropriate, internal policies and procedures associated with the submission and utilization of standardized analysis datasets.
The Biomarker Qualification Program was established to support FDA's work with external partners to develop
The drug safety enhancements in PDUFA VI focus on expansion of the Sentinel System and enhancements to support the review, oversight, tracking, and communication of postmarketing drug safety issues. The enhancements are described in I.K of the proposed PDUFA VI commitment letter.
FDA's Sentinel Initiative is a long-term program designed to build and implement a national electronic system for monitoring the safety of FDA-approved medical products. FDA recently transitioned from the Mini-Sentinel pilot to the Sentinel System, but full utilization of the Sentinel System remains a work in progress. Continued development and integration of the Sentinel System is needed to realize the system's full value to the postmarketing safety review process. To help realize the full value of the Sentinel System during PDUFA VI, FDA proposes to continue to expand the systems' data sources and core capabilities, to systematically integrate Sentinel into postmarketing review activities, to enhance Sentinel communication practices with sponsors and the public, and to conduct an analysis of the impact of Sentinel expansion and integration for regulatory purposes.
During PDUFA VI, FDA proposes to continue to support the review, oversight, tracking, and communication of postmarketing drug safety issues. FDA proposes to make improvements to its current processes and information technology systems to enhance the management and oversight of postmarketing drug safety issues, to update policies and procedures to provide timely notification to a sponsor, to the extent practicable, when a serious safety signal is identified, and to conduct an assessment of how its data systems and processes support review, oversight, and communication of postmarketing drug safety issues.
FDA is committed to achieving the long-term goal of improving the predictability and consistency of the electronic submission process and enhancing transparency and accountability of FDA information technology related activities. During PDUFA VI, FDA proposes to publish submission documentation, metrics, submission status, and system and process changes, to hold quarterly meetings to share performance updates between FDA and the regulated industry, to hold annual public meetings to gather stakeholder input to inform the FDA information technology strategic plan, and to collaborate with standards development organizations and stakeholders to ensure the long-term sustainability of supported data standards. These enhancements are described in section IV of the proposed PDUFA VI commitment letter.
To speed and improve development of safe and effective new therapies for patients requires that FDA hire and retain sufficient numbers and types of technical and scientific experts to efficiently conduct reviews of human drug applications. In order to strengthen this core function during PDUFA VI, FDA proposes to commit to completing implementation of an full time equivalent staff (FTE)-based position management system capability, to complete implementation of an online position classification system, to complete implementation of corporate recruiting practices, to augment hiring capacity with expert contractor support, to complete establishment of a dedicated function to ensure needed scientific staffing for the human drug review program, to establish clear goals for human drug review program hiring, and to conduct a comprehensive and continuous assessment of hiring and retention performance. These enhancements are described in section III of the proposed PDUFA VI commitment letter.
FDA is committed to enhancing management of PDUFA resources and ensuring PDUFA user fee resources are administered, allocated, and reported in an efficient and transparent manner. In PDUFA VI, FDA proposes to establish a resource capacity planning function to improve its ability to analyze current resource needs and project future resource needs, to modernize its time reporting approach, to conduct an evaluation of PDUFA program resource management, to publish a 5-year PDUFA financial plan with annual updates, and to convene an annual public meeting, beginning in FY 2019, to discuss the financial plan and progress towards the financial management enhancements. These enhancements are described in section II of the proposed PDUFA VI commitment letter.
The current overall PDUFA fee structure and the fee setting process were established in 1993 for PDUFA I and have generally remained in place through four reauthorizations of PDUFA. Over the years, FDA and industry agreed that some elements of the fee structure and the fee setting process could be updated to enhance the predictability and stability of fee amounts and revenues in a manner to improve FDA's ability to engage in long-term financial planning. Additionally, some elements of the fee structure reduce the efficiency of administrative work without a corresponding benefit to the public or to the regulated industry. To address these issues, FDA proposes to shift a greater proportion of the target revenue allocation to more predictable fee-paying types (20 percent to applications; 80 percent to Program fees), to discontinue the establishment and supplement fees, to rename the product fee as the PDUFA Program fee, to modify the Program fee billing date to minimize the need for multiple billing cycles, to add a limitation that a sponsor shall not be assessed more than five PDUFA Program fees for a fiscal year for products identified in each distinct approved human drug application held by that sponsor, and to discontinue the Fees-Exceed-the-Costs waiver. FDA also proposes during PDUFA VI to replace the workload adjuster with a robust methodology for adjusting fees based on the capacity needs of the program, and to replace the fifth year offset provision and final year
To implement the proposed enhancements for PDUFA VI, funding for a cumulative total of 230 FTE staff is proposed to be phased in over the course of PDUFA VI. The new funding will be phased in as follows:
In addition, $8.73 million will be added in FY 2018 to provide for other additional direct costs associated with the PDUFA VI enhancements. This amount will be included for FYs 2019 through 2022 after being adjusted for inflation.
If you wish to attend this meeting, visit
The meeting will include a presentation by FDA and a series of invited panels representing different stakeholder groups identified in the statute (such as patient advocacy groups, consumer advocacy groups, health professionals, and regulated industry). We will also provide an opportunity for other organizations and individuals to make presentations at the meeting or to submit written comments to the docket before the meeting.
FDA will also hold an open public comment period at the meeting to give the public an opportunity to present their comments. Registration for open public comment will occur at the registration desk on the day of the meeting and workshop on a first-come, first-served basis.
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 September 19, 2016.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
•
FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20851,
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.
Part 50 (21 CFR part 50) applies to all clinical investigations regulated by FDA under sections 505(i) and 520(g) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i) and 360j(g), respectively), as well as clinical investigations that support applications for research or marketing permits for products regulated by FDA, including foods and dietary supplements that bear a nutrient content claim or a health claim, infant formulas, food and color additives, drugs for human use, medical devices for human use, biological products for human use, and electronic products. Compliance with part 50 is intended to protect the rights and safety of subjects involved in investigations filed with FDA under sections 403, 406, 409, 412, 413, 502, 503, 505, 510, 513-516, 518-520, 721, and 801 of the FD&C Act (21 U.S.C. 343, 346, 348, 350a, 350b, 352, 353, 355, 360, 360c-360f, 360h-360j, 379e, and 381, respectively) and sections 351 and 354-360F of the Public Health Service Act.
With few exceptions, no investigator may involve a human being as a subject in FDA-regulated research unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative (see § 50.20 (21 CFR 50.20)). In seeking informed consent, each subject must be provided with certain elements of informed consent. Those elements are listed in § 50.25. Informed consent shall be documented in writing as described in § 50.27.
An institutional review board (IRB) may approve emergency research without requiring the informed consent of all research subjects provided the IRB finds and documents that certain criteria are met as required in § 50.24. We estimate that about eight times per year an IRB is requested to review emergency research under § 50.24. We estimate, of the eight yearly requests for IRB review under § 50.24, a particular IRB will take about an hour during each of three separate fully convened IRB meetings to review the request under § 50.24 (one meeting occurring after community consultation). The total annual reporting burden for IRB review of emergency research under § 50.24 is estimated at 24 hours (see table 1).
The information requested in the regulations for exception from the general requirements for informed consent for medical devices (21 CFR 812.47), and the information requested in the regulations for exception from the general requirements of informed consent in § 50.23, paragraphs (a) through (c), and (e), is currently approved under OMB control number 0910-0586. The information requested in the investigational new drug (IND) regulations concerning exception from informed consent for emergency research under § 50.24 is currently approved under OMB control number 0910-0014. In addition, the information requested in the regulations for IND safety reporting requirements for human drug and biological products and safety reporting requirements for bioavailability and bioequivalence studies in humans (21 CFR 320.31(d), and 21 CFR 312.32(c)(1)(ii) and (iv)) is currently approved under OMB control number 0910-0672.
Some clinical investigations involving children, although otherwise not approvable, may present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children (see § 50.54). Certain clinical investigations involving children may proceed if the IRB finds and documents that the clinical investigation presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children and when the Commissioner of Food and Drugs, after consultation with a panel of experts in pertinent disciplines and following opportunity for public review and comment, makes a determination that certain conditions are met (see § 50.54(b)).
The information requested for clinical investigations in children of FDA-regulated products is covered by the collections of information in the IND regulations (part 312 (21 CFR part 312)), the investigational device exemption (IDE) regulations (part 812 (21 CFR part 812)), the IRB regulations (§ 56.115 (21 CFR 56.115)), the food additive petition and nutrient content claim petition regulations (21 CFR 101.69 and 101.70), and the infant formula regulations (parts 106 and 107 (21 CFR parts 106 and 107)), all of which are approved by OMB. Specifically, the information
Part 56 (21 CFR part 56) contains the general standards for the composition, operation, and responsibility of an IRB that reviews clinical investigations regulated by FDA under sections 505(i) and 520(g) of the FD&C Act, as well as clinical investigations that support applications for research or marketing permits for products regulated by FDA, including foods and dietary supplements that bear a nutrient content claim or a health claim, infant formulas, food and color additives, drugs for human use, medical devices for human use, biological products for human use, and electronic products. Compliance with part 56 is intended to protect the rights and welfare of human subjects involved in such investigations.
The information collected under the IRB regulations “Protection of Human Subjects—Recordkeeping and Reporting Requirements for Institutional Review Boards (part 56),” including the information collection activities in the provisions in § 56.108(a)(1) and (b), is currently approved under OMB control number 0910-0130. The information collected under the regulations for the registration of IRBs in § 56.106 is currently approved under OMB control number 0990-0279. The information collected for IRB review and approval for the IDE regulations (part 812) is currently approved under OMB control number 0910-0078. The information collected for premarket approval of medical devices (part 814 (21 CFR part 814)) is currently approved under OMB control number 0910-0231. The information collected under the regulations for IRB requirements for humanitarian use devices (part 814, subpart H) is currently approved under OMB control number 0910-0332. The information collected under the regulations for IRB review and approval of INDs (part 312) is currently approved under OMB control number 0910-0014.
This collection of information is limited to certain provisions in part 50, subpart B (Informed Consent of Human Subjects), and part 56 (Institutional Review Boards), currently approved under OMB control number 0910-0755.
This proposed extension applies to the following collections of information in part 50: §§ 50.24 (
In part 56, this proposed extension applies to the following collections of information: § 56.109(d) (written statement about research when documentation of informed consent is waived); § 56.109(e) (IRB written notification to approve or disapprove research); § 56.109(f) (continuing review of research); § 56.109(g) (IRB written statements to the sponsor about required public disclosures related to emergency research under § 50.24); § 56.113 (
In § 56.109(d), if an IRB has waived documentation of consent for research that (1) presents no more than minimal risk of harm to subjects and (2) involves no procedures for which consent is normally required outside of the research context, the IRB may nevertheless require the investigator to provide a written statement about the research to the subjects. We estimate that each IRB will review about two minimal risk FDA-regulated studies each year. Because the studies are minimal risk, the review can be fairly straightforward, and the written statement for the subjects would be brief. We estimate that IRB review of each written statement could be completed in less than 30 minutes (0.5 hours).
In § 56.109(f), the amount of time an IRB spends on the continuing review of a particular study will vary depending on the nature and complexity of the research, the amount and type of new information presented to the IRB, and whether the investigator is seeking approval of substantive changes to the research protocol or informed consent document. For many studies, continuing review can be fairly straightforward, and the IRB should be able to complete its deliberations and approve the research within a brief period of time.
In § 56.109(g), an IRB is required to provide the sponsor of a study involving an exception from informed consent for emergency research under § 50.24 with a written statement of information that has been publicly disclosed to the communities in which the investigation will be conducted and from which the subjects will be drawn. Public disclosure prior to initiation of the investigation would include the plans for the investigation and its risks and expected benefits. There must also be public disclosure of sufficient information following completion of the clinical investigation to apprise the community and researchers of the study, including the demographic characteristics of the research population, and its results. (See § 50.24(a)(7)(ii) and (iii).) The purpose of the IRB's written statements is to make the sponsor aware that public disclosure has occurred, so that the sponsor can provide copies of the information that has been disclosed to FDA, as required by 21 CFR 312.54(a) and 812.47(a).
We estimate that about eight requests to review emergency research under § 50.24 are submitted each year, and the IRBs that review those studies would prepare two public disclosure reports: One prior to initiation of the research and one following the study's completion. We estimate that it will take an IRB approximately 1 hour to prepare a written statement to the study sponsor describing each public disclosure, for a total of 2 hours per study. The total annual third party disclosure burden for IRBs to fulfill this requirement related to emergency research under § 50.24 is estimated at 16 hours (see table 2).
When an IRB or institution violates the regulations, FDA issues to the IRB or institution a noncompliance letter (see § 56.120(a)). The IRB or institution must respond to the noncompliance letter describing the corrective actions that will be taken by the IRB or institution. FDA estimates about seven IRBs or institutions will be issued a noncompliance letter annually. We estimate that the IRB's or institution's response will take about 10 hours to prepare, with an estimated total annual burden of 70 hours.
In 2016, FDA disqualified one IRB under § 56.121. To date, no IRB or institution has been reinstated or applied for reinstatement under § 56.123. For this reason, we estimate the annual reporting burden for one respondent only. We estimate a 5-hour burden per response, with an estimated total annual burden of 5 hours.
The regulatory provisions in parts 50 and 56 currently approved under this collection of information, OMB control number 0910-0755, and for which this extension is requested, are shown in table 1.
FDA estimates the burden of this collection of information as follows:
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is announcing the availability of guidances for industry entitled “E2C(R2) Periodic Benefit-Risk Evaluation” (E2C(R2) guidance) and “E2C(R2) Periodic Benefit-Risk Evaluation Report—Questions and Answers” (E2C(R2) Q&A guidance). These guidances were prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The E2C(R2) draft guidance, issued April 11, 2012, updated and combined two ICH guidances, “E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs” (E2C guidance) and “Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs” (addendum to the E2C guidance). The E2C(R2) guidance is intended to describe the format, content, and timing of a Periodic Benefit-Risk Evaluation Report (PBRER) for an approved drug or biologic, and it finalizes the draft guidance. The E2C(R2) Q&A guidance is a supplementary guidance that is intended to clarify key issues in the E2C(R2) guidance.
Submit either electronic or written comments on Agency guidances at any time.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked, and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Submit written requests for single copies of these guidances to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. The guidances may also be obtained by mail by calling CBER at 1-800-835-4709 or 240-402-8010. See the
In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. FDA has participated in many meetings designed to enhance harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies.
ICH was organized to provide an opportunity for harmonization initiatives to be developed with input from both regulatory and industry representatives. FDA also seeks input from consumer representatives and others. ICH is concerned with harmonization of technical requirements for the registration of pharmaceutical products for human use among regulators around the world. The six founding members of the ICH are the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; CDER and CBER, FDA; and the Pharmaceutical Research and Manufacturers of America. The Standing Members of the ICH Association include Health Canada and Swissmedic. Any party eligible as a Member in accordance with the ICH Articles of Association can apply for membership in writing to the ICH Secretariat. The ICH Secretariat, which coordinates the preparation of documentation, operates as an international nonprofit organization and is funded by the Members of the ICH Association.
The ICH Assembly is the overarching body of the Association and includes representatives from each of the ICH members and observers.
In the
After consideration of the comments received and revisions to the guidance, a final draft of the guidance was submitted to the ICH Steering Committee and endorsed by the regulatory agencies in November 2012.
The E2C(R2) guidance provides guidance on the format, content, and timing of a PBRER for an approved drug or biologic, and it finalizes the draft guidance. The PBRER will serve as a common standard for periodic reporting on approved drugs or biologics among the ICH regions. The harmonized PBRER is intended to promote a consistent approach to periodic postmarket safety reporting among the ICH regions and to enhance efficiency by reducing the number of reports
Since the E2C(R2) draft guidance was made available in 2012, ICH has identified questions linked to the interpretation and application of the E2C(R2) guidance. The E2C(R2) Q&A guidance is intended to clarify questions relating to implementation of the E2C(R2) guidance.
These guidances are being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidances represent the current thinking of FDA on the E2C(R2) PBRER. They do not establish any rights for any person and are not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
These guidances refer 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 (PRA) (44 U.S.C. 3501-3520). The collection of information in the “Guidance on Reporting in Accordance with International Council for Harmonisation—Periodic Benefit-Risk Evaluation Report (E2C(R2)) and Providing Waiver-Related Materials” has been approved under OMB control number 0910-0771. The guidances also reference other collections of information. The collection of information in 21 CFR 314.80 has been approved under OMB control number 0910-0230, and the collection of information in 21 CFR 600.80 has been approved under OMB control number 0910-0308.
Persons with access to the Internet may obtain the document at
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 August 18, 2016.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to
FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North 10A-12M, 11601 Landsdown Street, North Bethesda, MD 20852,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
In the
While most of the information collection burdens created by the final rule have now been incorporated into currently approved information collections supporting the applicable regulations, respondents to the collection may continue to seek an exemption from the bar code label requirement under § 201.25(d) (21 CFR 201.25(d)). Section 201.25(d) requires submission of a written request for an exemption and describes the information that must be included in such a request. Based on the number of exemption requests we have received previously, we estimate that approximately 2 exemption requests will be submitted annually and that each exemption request will require 24 hours to complete. This results in an annual reporting burden of 48 hours, as reflected below in Table 1.
In the
We estimate the burden of this collection of information as follows:
Food and Drug Administration, HHS.
Notice; Correction.
The Food and Drug Administration (FDA) is correcting a notice that appeared in the
Terrie L. Crescenzi, Office of Pediatric Therapeutics, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002,
In the
1. On page 39272, in the first column, in the first paragraph under the “Workshop Attendance and Participation” heading, the first sentence is corrected to read “If you wish to attend this workshop, visit
2. On page 39272, in the first column, in the second paragraph under the “Workshop Attendance and Participation” heading, the first sentence is corrected to read “Registration information, the agenda, and additional background materials can be found at
Health Resources and Services Administration, HHS.
Notice.
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c) (2) (A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Comments on this ICR should be received no later than September 19, 2016.
Submit your comments to
To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email
When submitting comments or requesting information, please include the information request collection title for reference.
OMB No. 0915-0149—Revision.
HRSA specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Health Resources and Services Administration, HHS.
Notice.
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Comments on this ICR should be received no later than August 18, 2016.
Submit your comments, including the ICR title, to the desk officer for HRSA, either by email to
To request a copy of the clearance requests submitted to OMB for review, email the HRSA Information Collection Clearance Officer at
OMB No. 0915-xxxx-New.
National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention, Department of Health and Human Services (HHS).
Notice.
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Idaho National Laboratory in Scoville, Idaho, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.
Stuart L. Hinnefeld, Director, Division of Compensation Analysis and Support, NIOSH, 1090 Tusculum Avenue, MS C-46, Cincinnati, OH 45226-1938, Telephone 877-222-7570. Information requests can also be submitted by email to
On June 3, 2016, as provided for under 42 U.S.C. 7384l(14)(C), the Secretary of HHS designated the following class of employees as an addition to the SEC:
All employees of the Department of Energy, its predecessor agencies, and their contractors and subcontractors who worked at the Idaho National Laboratory (INL) in Scoville, Idaho, and were monitored for external radiation at INL (
This designation became effective on July 3, 2016. Therefore, beginning on July 3, 2016, members of this class of employees, defined as reported in this notice, became members of the SEC.
National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention, Department of Health and Human Services (HHS).
Notice.
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Lawrence Livermore National Laboratory in Livermore, California, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.
Stuart L. Hinnefeld, Director, Division of Compensation Analysis and Support, NIOSH, 1090 Tusculum Avenue, MS C-46, Cincinnati, OH 45226-1938, Telephone 877-222-7570. Information requests can also be submitted by email to
42 U.S.C. 7384q(b). 42 U.S.C. 7384
On June 3, 2016, as provided for under 42 U.S.C. 7384l(14)(C), the Secretary of HHS designated the following class of employees as an addition to the SEC:
All employees of the Department of Energy, its predecessor agencies, and their contractors and subcontractors who worked in any area at the Lawrence Livermore National Laboratory in Livermore, California, during the period from January 1,1974, through December 31, 1989, for a number of work days aggregating at least 250 work days, occurring either solely under this employment, or in combination with work days within the parameters established for one or more other classes of employees in the Special Exposure Cohort.
This designation became effective on July 3, 2016. Therefore, beginning on July 3, 2016, members of this class of employees, defined as reported in this notice, became members of the SEC.
National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention, Department of Health and Human Services (HHS).
Notice.
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Argonne National Laboratory-West in Scoville, Idaho, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.
Stuart L. Hinnefeld, Director, Division of Compensation Analysis and Support, NIOSH, 1090 Tusculum Avenue, MS C-46, Cincinnati, OH 45226-1938, Telephone 877-222-7570. Information requests can also be submitted by email to
42 U.S.C. 7384q(b). 42 U.S.C. 7384
On June 3, 2016, as provided for under 42 U.S.C. 7384l(14)(C), the Secretary of HHS designated the following class of employees as an addition to the SEC:
All employees of the Department of Energy, its predecessor agencies, and their contractors and subcontractors who worked at the Argonne National Laboratory-West during the time period from April 10, 1951, through December 31, 1957, for a number of work days aggregating at least 250 work days, occurring either solely under this employment, or in combination with work days within the parameters established for one or more other classes of employees in the Special Exposure Cohort.
This designation became effective on July 3, 2016. Therefore, beginning on July 3, 2016, members of this class of employees, defined as reported in this notice, became members of the SEC.
Office of the Secretary, HHS.
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995,
To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, email your request, including your address, phone number, OMB number, to
Project Performance Site Location, Project Abstract, Key Contacts OMB Control Number 4040-0010.
3 Year Extension and assignment as a Common Form.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the 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 section 552b(c)(6), Title 5 U.S.C., as amended. The contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
U.S. Customs and Border Protection, Department of Homeland Security.
Notice of approval of SGS North America, Inc., as a commercial gauger.
Notice is hereby given, pursuant to CBP regulations, that SGS North America, Inc., has been approved to gauge petroleum and certain petroleum products for customs purposes for the next three years as of January 26, 2016.
The approval of SGS North America, Inc., as a commercial gauger became effective on January 26, 2016. The next triennial inspection date will be scheduled for January 2019.
Approved Gauger and Accredited Laboratories Manager, Laboratories and Scientific Services Directorate, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue NW., Suite 1500N, Washington, DC 20229, tel. 202-344-1060.
Notice is hereby given pursuant to 19 CFR 151.13, that SGS North America, Inc., 1740 West 4th St., Suite 108, Freeport, TX 77541, has been approved to gauge petroleum and certain petroleum products for customs purposes, in accordance with the provisions of 19 CFR 151.13. SGS North America, Inc., is approved for the following gauging procedures for petroleum and certain petroleum products set forth by the American Petroleum Institute (API):
Anyone wishing to employ this entity to conduct gauger services should request and receive written assurances from the entity that it is approved by the U.S. Customs and Border Protection to conduct the specific gauger service requested. Alternatively, inquiries regarding the specific gauger service this entity is approved to perform may be directed to the U.S. Customs and Border Protection by calling (202) 344-1060. The inquiry may also be sent to
U.S. Customs and Border Protection, Department of Homeland Security.
Notice of accreditation and approval of Camin Cargo Control, Inc., as a commercial gauger and laboratory.
Notice is hereby given, pursuant to CBP regulations, that Camin Cargo Control, Inc., has been approved to gauge and accredited to test petroleum and certain petroleum products for customs purposes for the next three years as of January 27, 2016.
Approved Gauger and Accredited Laboratories Manager, Laboratories and Scientific Services Directorate, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue NW., Suite 1500N, Washington, DC 20229, tel. 202-344-1060.
Notice is hereby given pursuant to 19 CFR 151.12 and 19 CFR 151.13, that Camin Cargo Control, Inc., 1550 Industrial Park Dr., Nederland, TX 77627, has been approved to gauge and accredited to test petroleum and certain petroleum products for customs purposes, in accordance with the provisions of 19 CFR 151.12 and 19 CFR 151.13. Camin Cargo Control, Inc., is approved for the following gauging procedures for petroleum and certain petroleum products set forth by the American Petroleum Institute (API):
Camin Cargo Control, Inc., is accredited for the following laboratory analysis procedures and methods for petroleum and certain petroleum products set forth by the U.S. Customs and Border Protection Laboratory
Anyone wishing to employ this entity to conduct laboratory analyses and gauger services should request and receive written assurances from the entity that it is accredited or approved by the U.S. Customs and Border Protection to conduct the specific test or gauger service requested. Alternatively, inquiries regarding the specific test or gauger service this entity is accredited or approved to perform may be directed to the U.S. Customs and Border Protection by calling (202) 344-1060. The inquiry may also be sent to
U.S. Customs and Border Protection, Department of Homeland Security.
Notice of accreditation and approval of Camin Cargo Control, Inc., as a commercial gauger and laboratory.
Notice is hereby given, pursuant to CBP regulations, that Camin Cargo Control, Inc., has been approved to gauge and accredited to test petroleum and certain petroleum products for customs purposes for the next three years as of July 15, 2015.
Approved Gauger and Accredited Laboratories Manager, Laboratories and Scientific Services Directorate, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue NW., Suite 1500N, Washington, DC 20229, tel. 202-344-1060.
Notice is hereby given pursuant to 19 CFR 151.12 and 19 CFR 151.13, that Camin Cargo Control, Inc., 471 Eastern Ave., Chelsea, MA 02150, has been approved to gauge and accredited to test petroleum and certain petroleum products for customs purposes, in accordance with the provisions of 19 CFR 151.12 and 19 CFR 151.13. Camin Cargo Control, Inc., is approved for the following gauging procedures for petroleum and certain petroleum products set forth by the American Petroleum Institute (API):
Camin Cargo Control, Inc., is accredited for the following laboratory analysis procedures and methods for petroleum and certain petroleum products set forth by the U.S. Customs and Border Protection Laboratory Methods (CBPL) and American Society for Testing and Materials (ASTM):
Anyone wishing to employ this entity to conduct laboratory analyses and gauger services should request and receive written assurances from the entity that it is accredited or approved by the U.S. Customs and Border Protection to conduct the specific test or gauger service requested. Alternatively, inquiries regarding the specific test or gauger service this entity is accredited or approved to perform may be directed to the U.S. Customs and Border Protection by calling (202) 344-1060. The inquiry may also be sent to
U.S. Customs and Border Protection, Department of Homeland Security.
Notice of approval of Marine Technical Surveyors, Inc., as a commercial gauger.
Notice is hereby given, pursuant to CBP regulations, that Marine Technical Surveyors, Inc., has been approved to gauge petroleum and certain petroleum products for customs purposes for the next three years as of June 16, 2015.
Approved Gauger and Accredited Laboratories Manager, Laboratories and Scientific Services Directorate, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue NW., Suite 1500N, Washington, DC 20229, tel. 202-344-1060.
Notice is hereby given pursuant to 19 CFR 151.13, that Marine Technical Surveyors, Inc., 2382 Highway 1 South, Donaldsonville, LA 70346, has been approved to gauge petroleum and certain petroleum products for customs purposes, in accordance with the provisions of 19 CFR 151.13. Marine Technical Surveyors, Inc., is approved for the following gauging procedures for petroleum and certain petroleum products set forth by the American Petroleum Institute (API):
Anyone wishing to employ this entity to conduct gauger services should request and receive written assurances from the entity that it is approved by the U.S. Customs and Border Protection to conduct the specific gauger service requested. Alternatively, inquiries regarding the specific gauger service this entity is approved to perform may be directed to the U.S. Customs and Border Protection by calling (202) 344-1060. The inquiry may also be sent to
U.S. Customs and Border Protection, Department of Homeland Security.
Notice of accreditation and approval of Camin Cargo Control, Inc., as a commercial gauger and laboratory.
Notice is hereby given, pursuant to CBP regulations, that Camin Cargo Control, Inc., has been approved to gauge and accredited to test petroleum and certain petroleum products for customs purposes for the next three years as of February 18, 2016.
Approved Gauger and Accredited Laboratories Manager, Laboratories and Scientific Services Directorate, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue NW., Suite 1500N, Washington, DC 20229, tel. 202-344-1060.
Notice is hereby given pursuant to 19 CFR 151.12 and 19 CFR 151.13, that Camin Cargo Control, Inc., 2844 Sharon Street, Suite B, Kenner, LA 70062, has been approved to gauge and accredited to test petroleum and certain petroleum products for customs purposes, in accordance with the provisions of 19 CFR 151.12 and 19 CFR 151.13. Camin Cargo Control, Inc., is approved for the following gauging procedures for petroleum and certain petroleum products set forth by the American Petroleum Institute (API):
Camin Cargo Control, Inc., is accredited for the following laboratory analysis procedures and methods for petroleum and certain petroleum products set forth by the U.S. Customs and Border Protection Laboratory Methods (CBPL) and American Society for Testing and Materials (ASTM):
Anyone wishing to employ this entity to conduct laboratory analyses and gauger services should request and receive written assurances from the entity that it is accredited or approved by the U.S. Customs and Border Protection to conduct the specific test or gauger service requested. Alternatively, inquiries regarding the specific test or gauger service this entity is accredited or approved to perform may be directed to the U.S. Customs and Border Protection by calling (202) 344-1060. The inquiry may also be sent to
U.S. Customs and Border Protection, Department of Homeland Security.
Notice of accreditation and approval of SGS North America, Inc., as a commercial gauger and laboratory.
Notice is hereby given, pursuant to CBP regulations, that SGS North America, Inc., has been approved to gauge and accredited to test petroleum and petroleum products for customs purposes for the next three years as of September 30, 2015.
Approved Gauger and Accredited Laboratories Manager, Laboratories and Scientific Services Directorate, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue NW., Suite 1500N, Washington, DC 20229, tel. 202-344-1060.
Notice is hereby given pursuant to 19 CFR 151.12 and 19 CFR 151.13, that SGS North America, Inc., 11729 Port Road, Seabrook, TX 77586, has been approved to gauge and accredited to test petroleum and petroleum products for customs purposes, in accordance with the provisions of 19 CFR 151.12 and 19 CFR 151.13. SGS North America, Inc., is approved for the following gauging procedures for petroleum and certain petroleum products set forth by the American Petroleum Institute (API):
SGS North America, Inc., is accredited for the following laboratory analysis procedures and methods for petroleum and certain petroleum products set forth by the U.S. Customs and Border Protection Laboratory Methods (CBPL) and American Society for Testing and Materials (ASTM):
Anyone wishing to employ this entity to conduct laboratory analyses and gauger services should request and receive written assurances from the entity that it is accredited or approved by the U.S. Customs and Border Protection to conduct the specific test or gauger service requested. Alternatively, inquiries regarding the specific test or gauger service this entity is accredited or approved to perform may be directed to the U.S. Customs and Border Protection by calling (202) 344-1060. The inquiry may also be sent to
U.S. Customs and Border Protection, Department of Homeland Security.
Notice of accreditation and approval of SGS North America, Inc., as a commercial gauger and laboratory.
Notice is hereby given, pursuant to CBP regulations, that SGS North America, Inc., has been approved to gauge and accredited to test petroleum and petroleum products for customs purposes for the next three years as of August 6, 2015.
Approved Gauger and Accredited Laboratories Manager, Laboratories and Scientific Services Directorate, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue NW., Suite 1500N, Washington, DC 20229, tel. 202-344-1060.
Notice is hereby given pursuant to 19 CFR 151.12 and 19 CFR 151.13, that SGS North America, Inc., 925 Corn Products Road, Corpus Christi, TX 78409, has been approved to gauge and accredited to test petroleum and petroleum products for customs purposes, in accordance with the provisions of 19 CFR 151.12 and 19 CFR 151.13. SGS North America, Inc., is approved for the following gauging procedures for petroleum and certain petroleum products set forth by the American Petroleum Institute (API):
SGS North America, Inc., is accredited for the following laboratory analysis procedures and methods for petroleum and certain petroleum products set forth by the U.S. Customs and Border Protection Laboratory Methods (CBPL) and American Society for Testing and Materials (ASTM):
Anyone wishing to employ this entity to conduct laboratory analyses and gauger services should request and receive written assurances from the entity that it is accredited or approved by the U.S. Customs and Border Protection to conduct the specific test or gauger service requested. Alternatively, inquiries regarding the specific test or gauger service this entity is accredited or approved to perform may be directed to the U.S. Customs and Border Protection by calling (202) 344-1060. The inquiry may also be sent to
U.S. Customs and Border Protection, Department of Homeland Security.
Notice of accreditation and approval of SGS North America, Inc., as a commercial gauger and laboratory.
Notice is hereby given, pursuant to CBP regulations, that SGS North America, Inc., has been approved to gauge and accredited to test petroleum and petroleum products for customs purposes for the next three years as of September 9, 2015.
Approved Gauger and Accredited Laboratories Manager, Laboratories and Scientific Services Directorate, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue NW., Suite 1500N, Washington, DC 20229, tel. 202-344-1060.
Notice is hereby given pursuant to 19 CFR 151.12 and 19 CFR 151.13, that SGS North America, Inc., 7315 S. 76th Ave., Bridgeview, IL 60455, has been approved to gauge and accredited to test petroleum and petroleum products for customs purposes, in accordance with the provisions of 19 CFR 151.12 and 19 CFR 151.13. SGS North America, Inc., is approved for the following gauging procedures for petroleum and certain petroleum products set forth by the American Petroleum Institute (API):
SGS North America, Inc., is accredited for the following laboratory analysis procedures and methods for petroleum and certain petroleum products set forth by the U.S. Customs and Border Protection Laboratory Methods (CBPL) and American Society for Testing and Materials (ASTM):
Anyone wishing to employ this entity to conduct laboratory analyses and gauger services should request and receive written assurances from the entity that it is accredited or approved by the U.S. Customs and Border Protection to conduct the specific test or gauger service requested. Alternatively, inquiries regarding the specific test or gauger service this entity is accredited or approved to perform may be directed to the U.S. Customs and Border Protection by calling (202) 344-1060. The inquiry may also be sent to
U.S. Customs and Border Protection, Department of Homeland Security.
Notice of accreditation and approval of SGS North America, Inc., as a commercial gauger and laboratory.
Notice is hereby given, pursuant to CBP regulations, that SGS North America, Inc., has been approved to gauge and accredited to test petroleum and petroleum products for customs purposes for the next three years as of April 13, 2016.
Approved Gauger and Accredited Laboratories Manager, Laboratories and Scientific Services Directorate, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue NW., Suite 1500N, Washington, DC 20229, tel. 202-344-1060.
Notice is hereby given pursuant to 19 CFR 151.12 and 19 CFR 151.13, that SGS North America, Inc., 1100 SE 24th St., Fort Lauderdale, FL 33316, has been approved to gauge and accredited to test petroleum and petroleum products for customs purposes, in accordance with the provisions of 19 CFR 151.12 and 19 CFR 151.13. SGS North America, Inc., is approved for the following gauging procedures for petroleum and certain petroleum products set forth by the American Petroleum Institute (API):
SGS North America, Inc., is accredited for the following laboratory analysis procedures and methods for petroleum and certain petroleum products set forth by the U.S. Customs and Border Protection Laboratory Methods (CBPL) and American Society for Testing and Materials (ASTM):
Anyone wishing to employ this entity to conduct laboratory analyses and gauger services should request and receive written assurances from the entity that it is accredited or approved by the U.S. Customs and Border Protection to conduct the specific test or gauger service requested. Alternatively, inquiries regarding the specific test or gauger service this entity is accredited or approved to perform may be directed to the U.S. Customs and Border Protection by calling (202) 344-1060. The inquiry may also be sent to
U.S. Customs and Border Protection, Department of Homeland Security.
Notice of approval of Barrios Measurement Services LLC, as a commercial gauger.
Notice is hereby given, pursuant to CBP regulations, that Barrios Measurement Services LLC, has been approved to gauge petroleum and petroleum products for customs purposes for the next three years as of March 31, 2016.
Approved Gauger and Accredited Laboratories Manager, Laboratories and Scientific Services Directorate, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue NW., Suite 1500N, Washington, DC 20229, tel. 202-344-1060.
Notice is hereby given pursuant to 19 CFR 151.13, that Barrios Measurement Services LLC, 228 West 133rd St., Cut Off, LA 70345, has been approved to gauge petroleum and petroleum products for customs purposes, in accordance with the provisions of 19 CFR 151.13. Barrios Measurement Services LLC, is approved for the following gauging procedures for petroleum and certain petroleum products set forth by the American Petroleum Institute (API):
Anyone wishing to employ this entity to conduct gauger services should request and receive written assurances from the entity that it is accredited or approved by the U.S. Customs and Border Protection to conduct the specific gauger service requested. Alternatively, inquiries regarding the specific gauger service this entity is accredited or approved to perform may be directed to the U.S. Customs and Border Protection by calling (202) 344-1060. The inquiry may also be sent to
U.S. Citizenship and Immigration Services, Department of Homeland Security.
60-Day notice.
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration (USCIS) invites the general public and other Federal agencies to comment upon this proposed extension of a currently approved collection of information or new collection of information. In accordance with the Paperwork Reduction Act (PRA) of 1995, the information collection notice is published in the
Comments are encouraged and will be accepted for 60 days until September 19, 2016.
All submissions received must include the OMB Control Number 1615-0009 in the subject box, the agency name and Docket ID USCIS-2005-0030. To avoid duplicate submissions, please use only
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USCIS, Office of Policy and Strategy, Regulatory Coordination Division, Samantha Deshommes, Chief, 20 Massachusetts Avenue NW.,
You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at:
Written comments and suggestions from the public and affected agencies should address one or more of the following four points:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
On December 31, 2015, USCIS published a Notice of Proposed Rulemaking (NPRM) in the
Under 5 CFR 1320.5(a), USCIS is required to evaluate comments received under § 1320.11. In addition, 5 CFR 1320.5(b) requires USCIS to ensure that Form I-129 displays a currently valid OMB control number. As USCIS continues its careful review and evaluation of the public comments received from 27,979 commenters, USCIS must ensure that Form I-129 continues to display a currently valid OMB control number. Currently, Form I-129 is set to expire on October 31, 2016. To ensure Form I-129 retains a valid OMB control number during review and evaluation of the public comments received from 27,979 commenters, USCIS must implement an Extension, Without Change, of a Currently Approved Collection.
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U.S. Citizenship and Immigration Services, Department of Homeland Security.
60-Day notice.
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration (USCIS) invites the general public and other Federal agencies to comment upon this proposed revision of a currently approved collection of information. In accordance with the Paperwork Reduction Act (PRA) of 1995, the information collection notice is published in the
Comments are encouraged and will be accepted for 60 days until September 19, 2016.
All submissions received must include the OMB Control Number 1615-0068 in the subject box, the agency name and Docket ID USCIS-2007-0036. To avoid duplicate submissions, please use only
(1)
(2)
(3)
USCIS, Office of Policy and Strategy, Regulatory Coordination Division, Samantha Deshommes, Chief, 20 Massachusetts Avenue NW., Washington, DC 20529-2140, telephone number 202-272-8377 (This is not a toll-free number. Comments are not accepted via telephone message). Please note contact information provided here is solely for questions regarding this notice. It is not for individual case status inquiries. Applicants seeking information about the status of their individual cases can check Case Status Online, available at the USCIS Web site at
You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at:
Written comments and suggestions from the public and affected agencies should address one or more of the following four points:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
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U.S. Geological Survey, Department of the Interior.
Notice of intent to grant an exclusive license.
The Notice is hereby given that the U.S. Geological Survey intends to grant to Induced Polarization Associates, LLC., 1124 NW. 53rd St., Seattle, WA 98107, an exclusive license to practice the following: A system and method, to utilize induced polarization to locate and detect minerals, and oil plumes below the surface water.
Comments must be received fifteen (15) days from the effective date of this notice.
Sharon Borland, Chief, Office of Policy and Analysis, U.S. Geological Survey, 12201 Sunrise Valley Dr., MS 153, Reston, VA 20192, 703-648-6723.
It is in the public interest to license this invention, as Induced Polarization Associates, LLC., submitted a complete and sufficient application for a license. The prospective exclusive license will be royalty-bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The prospective exclusive license may be granted unless, within fifteen (15) days from the date of this published Notice, the U.S. Geological Survey Office of Policy and Analysis receives written evidence and argument which establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7.
Bureau of Land Management, Interior
Notice.
Anadarko E&P Onshore, LLC and WPX Energy Rocky Mountain, LLC have filed a petition for reinstatement of competitive oil and gas lease WYW160587, which is located in Campbell County, Wyoming. The petition was filed on time and consistent with the Mineral Leasing Act of 1920. The lessee has paid the required rentals accruing from the date of termination. No leases that affect these lands were issued before the petition was filed.
Chris Hite, Chief of Fluid Minerals Adjudication, Bureau of Land Management, Wyoming State Office, 5353 Yellowstone Road, Cheyenne, Wyoming, 82009; phone 307-775-6176; email
In connection with this lease reinstatement, the lessees agreed to the amended lease terms for rentals and royalties specified in the applicable regulations—$10 per acre, or fraction thereof, per year and 16
Bureau of Land Management, Interior.
Notice.
Hilcorp Energy I, L.P. has filed a petition for reinstatement of competitive oil and gas lease WYW178491, which is located in Crook County, Wyoming. The petition was filed on time and consistent with the Mineral Leasing Act of 1920. The lessee has paid the required rentals accruing from the date of termination. No leases that affect these lands were issued before the petition was filed.
Chris Hite, Chief of Fluid Minerals Adjudication, Bureau of Land Management, Wyoming State Office, 5353 Yellowstone Road, Cheyenne, Wyoming, 82009; phone 307-775-6176; email
In connection with this lease reinstatement, the lessee agreed to the amended lease terms for rentals and royalties specified in the applicable regulations—$10 per acre, or fraction thereof, per year and 16
Bureau of Land Management, Interior.
60-Day notice and request for comments.
In compliance with the Paperwork Reduction Act, the Bureau of Land Management (BLM) invites public comments on, and plans to request approval to continue, the collection of information from those who wish to participate in the exploration, development, production, and utilization of geothermal resources on BLM-managed public lands, and on lands managed by other Federal agencies. The Office of Management and Budget (OMB) has assigned control number 1004-0132 to this information collection.
Please submit comments on the proposed information collection by September 19, 2016.
Comments may be submitted by mail, fax, or electronic mail.
Please indicate “Attn: 1004-0132” regardless of the form of your comments.
John Kalish at 202-912-7312. Persons who use a telecommunication device for the deaf may call the Federal Information Relay Service at 1-800-877-8339, to leave a message for Mr. Kalish.
OMB regulations at 5 CFR part 1320, which implement provisions of the Paperwork Reduction Act, 44 U.S.C. 3501-3521, require that interested members of the public and affected agencies be given an opportunity to comment on information collection and recordkeeping activities (see 5 CFR 1320.8 (d) and 1320.12(a)). This notice identifies an information collection that the BLM plans to submit to OMB for approval. The Paperwork Reduction Act provides that an agency may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number.
The BLM will request a 3-year term of approval for this information collection activity. Comments are invited on: (1) The need for the collection of information for the performance of the functions of the agency; (2) the accuracy of the agency's burden estimates; (3) ways to enhance the quality, utility and clarity of the information collection; and (4) ways to minimize the information collection burden on respondents, such as use of automated means of collection of the information. A summary of the public comments will accompany our submission of the information collection requests to OMB.
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
The following information pertains to this request:
• Form 3200-9, Notice of Intent to Conduct Geothermal Resource Exploration Operations;
• Form 3203-1, Nomination of Lands for Competitive Geothermal Leasing;
• Form 3260-2, Geothermal Drilling Permit;
• Form 3260-3, Geothermal Sundry Notice; and
• Form 3260-4; Geothermal Well Completion Report; and
• Form 3260-5; Monthly Report of Geothermal Operations.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has determined not to review an initial determination (“ID”) (Order No. 29) issued by the presiding administrative law judge (“ALJ”) granting a joint motion to terminate the investigation based on a settlement agreement.
Michael Liberman, Esq., Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-3115. Copies of non-confidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2000. General information concerning the Commission may also be obtained by accessing its Internet server at
The Commission instituted this investigation under section 337 of the Tariff Act of 1930, 19 U.S.C. 1337, on August 24, 2015, based on a complaint, as supplemented, filed by Trico Products Corporation of Rochester Hills, Michigan, alleging a violation of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain windscreen wipers and components thereof by reason of infringement of certain claims of U.S. Patent Nos. 6,836,925 and 6,799,348. 80 FR 51309 (Aug. 24, 2015). The respondents are Valeo North America, Inc. of Troy, Michigan, and Delmex de Juarez S. de R.L. de C.V. of Parque Industrial Intermex, Cd. Juarez, Chihuahua, Mexico.
On May 27, 2016, complainant and respondents filed a joint motion to terminate this investigation in its entirety based on a settlement agreement.
On June 20, 2016, the ALJ issued an ID (Order No. 29), granting the motion for termination. The ALJ found that the joint motion complies with the Commission Rules and that termination of the investigation will not adversely affect the public interest. No party petitioned for review of the subject ID. The Commission has determined not to review the ID.
The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in Part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).
By Order of the Commission.
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 September 19, 2016.
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 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 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 May 5, 2016, Cambrex Charles City, 1205 11th Street, Charles City, Iowa 50616 applied to be registered as a bulk manufacturer 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
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. Comments and requests for hearings 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 March 25, 2016, Rhodes Technologies, 498 Washington Street, Coventry, Rhode Island 02816 applied to be registered as an importer of the following basic classes of controlled substances:
The company plans to import opium, raw (9600) and poppy straw concentrate (9670) in order to bulk manufacture controlled substances in Active Pharmaceutical Ingredient (API) form. The company distributes the manufactured APIs in bulk to its customers. The company plans to import the other listed controlled substances for internal reference standards use only. The comparisons of foreign reference standards to the company's domestically manufacture API will allow the company to export domestically manufacture API to foreign markets.
Bureau of Prisons, Justice.
Notice.
The fee to cover the average cost of incarceration for Federal inmates in Fiscal Year 2015 was $31,977.65 ($87.61 per day). (
Office of General Counsel, Federal Bureau of Prisons, 320 First St. NW., Washington, DC 20534.
Sarah Qureshi, (202) 307-2105.
28 CFR part 505 allows for assessment and collection of a fee to cover the average cost of incarceration for Federal inmates. We calculate this fee by dividing the number representing Bureau of Prisons facilities' monetary obligation (excluding activation costs) by the number of inmate-days incurred for the preceding fiscal year, and then by multiplying the quotient by 365. Under § 505.2, the Director of the Bureau of Prisons determined that, based upon fiscal year 2015 data, the fee to cover the average cost of incarceration for Federal inmates in Fiscal Year 2015 was $31,977.65 ($87.61 per day). (
National Archives and Records Administration (NARA).
Privacy Act system of records notice (SORN) of a new system, NARA 45; Withdrawal.
The National Archives and Records Administration (NARA) published notice in the
This withdrawal notice is effective July 18, 2016.
National Archives and Records Administration; Regulations Comment Desk, Suite 4100; 8601 Adelphi Road; College Park, MD 20740.
Kimberly Keravuori, External Policy Program Manager, by email at
National Women's Business Council.
Notice of open public meeting.
The Public Meeting will be held on Tuesday, August 2nd, 2016 from 9:30 a.m. to 11:30 a.m. EST.
The meeting will be held in Atlanta, GA. Location details will be provided upon RSVP, as will information about teleconferencing and livestream options.
Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (5 U.S.C., Appendix 2), the U.S. Small Business Administration (SBA) announces the meeting of the National Women's Business Council. The National Women's Business Council conducts research on issues of importance and impact to women entrepreneurs and makes policy recommendations to the SBA, Congress, and the White House on how to improve the business climate for women.
This meeting is the 4th quarter meeting for Fiscal Year 2016. The program will include remarks from the Council Chair, Carla Harris; updates on research projects in progress, including: Women's participation in corporate supplier diversity programs, women's participation in accelerators and incubators, entrepreneurial ecosystems, and an upcoming report on the entrepreneurship amongst black women project; a recap of the Council's recent engagement efforts; and an announcement of the Council's FY2017 research portfolio. Time will be reserved at the end for audience participants to address Council Members directly with questions, comments, or feedback. Additional speakers will be promoted upon confirmation.
The meeting is open to the public however advance notice of attendance is requested. To RSVP and confirm attendance, the general public should email
For more information, please visit the National Women's Business Council Web site at
Nuclear Regulatory Commission.
Biweekly notice.
Pursuant to Section 189a.(2) of the Atomic Energy Act of 1954, as amended (the Act), the U.S. Nuclear Regulatory Commission (NRC) is publishing this regular biweekly notice. The Act requires the Commission to publish notice of any amendments issued, or proposed to be issued, and grants the Commission the authority to issue and make immediately effective any amendment to an operating license or combined license, as applicable, upon a determination by the Commission that such amendment involves no significant hazards consideration, notwithstanding the pendency before the Commission of a request for a hearing from any person.
This biweekly notice includes all notices of amendments issued, or proposed to be issued from June 21, 2016, to July 1, 2016. The last biweekly notice was published on July 5, 2016 (81 FR 43646).
Comments must be filed by August 18, 2016. A request for a hearing must be filed by September 19, 2016.
You may submit comments by any of the following methods (unless this document describes a different method for submitting comments on a specific subject):
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For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the
Lynn Ronewicz, Office of Nuclear Reactor Regulation,
Please refer to Docket ID: NRC-2016-0141 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:
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Please include Docket ID NRC-2016-0141, facility name, unit number(s), application date, and subject in your comment submission.
The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at
If you are requesting or aggregating comments from other persons for
The Commission has made a proposed determination that the following amendment requests involve no significant hazards consideration. Under the Commission's regulations in § 50.92 of title 10 of the
The Commission is seeking public comments on this proposed determination. Any comments received within 30 days after the date of publication of this notice will be considered in making any final determination.
Normally, the Commission will not issue the amendment until the expiration of 60 days after the date of publication of this notice. The Commission may issue the license amendment before expiration of the 60-day period provided that its final determination is that the amendment involves no significant hazards consideration. In addition, the Commission may issue the amendment prior to the expiration of the 30-day comment period if circumstances change during the 30-day comment period such that failure to act in a timely way would result, for example in derating or shutdown of the facility. If the Commission takes action prior to the expiration of either the comment period or the notice period, it will publish in the
Within 60 days after the date of publication of this notice, any person(s) whose interest may be affected by this action may file a request for a hearing and a petition to intervene with respect to issuance of the amendment to the subject facility operating license or combined license. Requests for a hearing and a petition for leave to intervene shall be filed in accordance with the Commission's “Agency Rules of Practice and Procedure” in 10 CFR part 2. Interested person(s) should consult a current copy of 10 CFR 2.309, which is available at the NRC's PDR, located at One White Flint North, Room O1-F21, 11555 Rockville Pike (first floor), Rockville, Maryland 20852. The NRC's regulations are accessible electronically from the NRC Library on the NRC's Web site at
As required by 10 CFR 2.309, a petition for leave to intervene shall set forth with particularity the interest of the petitioner in the proceeding, and how that interest may be affected by the results of the proceeding. The petition should specifically explain the reasons why intervention should be permitted with particular reference to the following general requirements: (1) The name, address, and telephone number of the requestor or petitioner; (2) the nature of the requestor's/petitioner's right under the Act to be made a party to the proceeding; (3) the nature and extent of the requestor's/petitioner's property, financial, or other interest in the proceeding; and (4) the possible effect of any decision or order which may be entered in the proceeding on the requestor's/petitioner's interest. The petition must also set forth the specific contentions which the requestor/petitioner seeks to have litigated at the proceeding.
Each contention must consist of a specific statement of the issue of law or fact to be raised or controverted. In addition, the requestor/petitioner shall provide a brief explanation of the bases for the contention and a concise statement of the alleged facts or expert opinion which support the contention and on which the requestor/petitioner intends to rely in proving the contention at the hearing. The requestor/petitioner must also provide references to those specific sources and documents of which the petitioner is aware and on which the requestor/petitioner intends to rely to establish those facts or expert opinion. The petition must include sufficient information to show that a genuine dispute exists with the applicant on a material issue of law or fact. Contentions shall be limited to matters within the scope of the amendment under consideration. The contention must be one which, if proven, would entitle the requestor/petitioner to relief. A requestor/petitioner who fails to satisfy these requirements with respect to at least one contention will not be permitted to participate as a party.
Those permitted to intervene become parties to the proceeding, subject to any limitations in the order granting leave to intervene, and have the opportunity to participate fully in the conduct of the hearing with respect to resolution of that person's admitted contentions, including the opportunity to present evidence and to submit a cross-examination plan for cross-examination of witnesses, consistent with NRC regulations, policies and procedures.
Petitions for leave to intervene must be filed no later than 60 days from the date of publication of this notice. Requests for hearing, petitions for leave to intervene, and motions for leave to file new or amended contentions that are filed after the 60-day deadline will not be entertained absent a determination by the presiding officer that the filing demonstrates good cause by satisfying the three factors in 10 CFR 2.309(c)(1)(i)-(iii). If a hearing is requested, and the Commission has not made a final determination on the issue of no significant hazards consideration, the Commission will make a final determination on the issue of no significant hazards consideration. The final determination will serve to decide when the hearing is held. If the final determination is that the amendment request involves no significant hazards consideration, the Commission may issue the amendment and make it immediately effective, notwithstanding the request for a hearing. Any hearing held would take place after issuance of the amendment. If the final determination is that the amendment request involves a significant hazards consideration, then any hearing held
A State, local governmental body, federally-recognized Indian Tribe, or agency thereof, may submit a petition to the Commission to participate as a party under 10 CFR 2.309(h)(1). The petition should state the nature and extent of the petitioner's interest in the proceeding. The petition should be submitted to the Commission by September 19, 2016. The petition must be filed in accordance with the filing instructions in the “Electronic Submissions (E-Filing)” section of this document, and should meet the requirements for petitions for leave to intervene set forth in this section, except that under § 2.309(h)(2) a State, local governmental body, or Federally-recognized Indian Tribe, or agency thereof does not need to address the standing requirements in 10 CFR 2.309(d) if the facility is located within its boundaries. A State, local governmental body, Federally-recognized Indian Tribe, or agency thereof may also have the opportunity to participate under 10 CFR 2.315(c).
If a hearing is granted, any person who does not wish, or is not qualified, to become a party to the proceeding may, in the discretion of the presiding officer, be permitted to make a limited appearance pursuant to the provisions of 10 CFR 2.315(a). A person making a limited appearance may make an oral or written statement of position on the issues, but may not otherwise participate in the proceeding. A limited appearance may be made at any session of the hearing or at any prehearing conference, subject to the limits and conditions as may be imposed by the presiding officer. Persons desiring to make a limited appearance are requested to inform the Secretary of the Commission by September 19, 2016.
All documents filed in NRC adjudicatory proceedings, including a request for hearing, a petition for leave to intervene, any motion or other document filed in the proceeding prior to the submission of a request for hearing or petition to intervene, and documents filed by interested governmental entities participating under 10 CFR 2.315(c), must be filed in accordance with the NRC's E-Filing rule (72 FR 49139; August 28, 2007). The E-Filing process requires participants to submit and serve all adjudicatory documents over the internet, or in some cases to mail copies on electronic storage media. Participants may not submit paper copies of their filings unless they seek an exemption in accordance with the procedures described below.
To comply with the procedural requirements of E-Filing, at least ten 10 days prior to the filing deadline, the participant should contact the Office of the Secretary by email at
Information about applying for a digital ID certificate is available on the NRC's public Web site at
If a participant is electronically submitting a document to the NRC in accordance with the E-Filing rule, the participant must file the document using the NRC's online, Web-based submission form. In order to serve documents through the Electronic Information Exchange System, users will be required to install a Web browser plug-in from the NRC's Web site. Further information on the Web-based submission form, including the installation of the Web browser plug-in, is available on the NRC's public Web site at
Once a participant has obtained a digital ID certificate and a docket has been created, the participant can then submit a request for hearing or petition for leave to intervene. Submissions should be in Portable Document Format (PDF) in accordance with NRC guidance available on the NRC's public Web site at
A person filing electronically using the NRC's adjudicatory E-Filing system may seek assistance by contacting the NRC Meta System Help Desk through the “Contact Us” link located on the NRC's public Web site at
Participants who believe that they have a good cause for not submitting documents electronically must file an exemption request, in accordance with 10 CFR 2.302(g), with their initial paper filing requesting authorization to continue to submit documents in paper format. Such filings must be submitted by: (1) First class mail addressed to the Office of the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemaking and Adjudications Staff; or (2) courier, express mail, or expedited delivery service to the Office of the Secretary, Sixteenth Floor, One White Flint North, 11555 Rockville Pike, Rockville, Maryland, 20852, Attention: Rulemaking and Adjudications Staff. Participants filing a document in this manner are responsible for serving the document on all other participants. Filing is considered complete by first-
Documents submitted in adjudicatory proceedings will appear in the NRC's electronic hearing docket which is available to the public at
For further details with respect these license amendment applications, see the application for amendment which is available for public inspection in ADAMS and at the NRC's PDR. For additional direction on accessing information related to this document, see the “Obtaining Information and Submitting Comments” section of this document.
1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?
The proposed amendment would modify the CR-3 facility operating license by revising the emergency plan and revising the EAL scheme. CR-3 has permanently ceased operation and is permanently defueled. The proposed amendment is conditioned on all spent nuclear fuel being removed from wet storage in the spent fuel pools and placed in dry storage within the ISFSI. Occurrence of postulated accidents associated with spent fuel stored in a spent fuel pool is no longer credible in a spent fuel pool devoid of such fuel. The proposed amendment has no effect on plant systems, structures, or components (SSC) and no effect on the capability of any plant SSC to perform its design function. The proposed amendment would not increase the likelihood of the malfunction of any plant SSC. The proposed amendment would have no effect on any of the previously evaluated accidents in the CR-3 Final Safety Analysis Report.
Since CR-3 has permanently ceased operation, the generation of fission products has ceased and the remaining source term continues to decay. This continues to significantly reduce the consequences of previously evaluated postulated accidents. Therefore, the proposed amendment does not involve a significant increase in the consequences of a previously evaluated accident.
2. Does the proposed change create the possibility of a new or different kind of accident from any accident previously evaluated?
The proposed amendment constitutes a revision of the emergency planning function commensurate with the ongoing and anticipated reduction in radiological source term at CR-3.
The proposed amendment does not involve a physical alteration of the plant. No new or different types of equipment will be installed and there are no physical modifications to existing equipment as a result of the proposed amendment. Similarly, the proposed amendment would not physically change any SSC involved in the mitigation of any postulated accidents. Thus, no new initiators or precursors of a new or different kind of accident are created. Furthermore, the proposed amendment does not create the possibility of a new failure mode associated with any equipment or personnel failures. The credible events for the ISFSI remain unchanged.
Therefore, the proposed amendment does not create the possibility of a new or different kind of accident from any previously evaluated.
3. Does the proposed amendment involve a significant reduction in a margin of safety?
Because the 10 CFR part 50 license for CR-3 no longer authorizes operation of the reactor or emplacement or retention of fuel into the reactor vessel, as specified in 10 CFR 50.82(a)(2), the occurrence of postulated accidents associated with reactor operation is no longer credible. With all spent nuclear fuel transferred out of wet storage from the spent fuel pools and placed in dry storage within the ISFSI, a fuel handling accident is no longer credible. There are no longer credible events that would result in radiological releases beyond the site boundary exceeding the EPA [Environmental Protection Agency] Protective Action Guide exposure levels, as detailed in the EPA's “Protective Action Guide and Planning Guidance for Radiological Incidents,” Draft for Interim Use and Public Comment dated March 2013 (PAG [Protective Action Guide] Manual).
The proposed amendment does not involve a change in the plant's design, configuration, or operation. The proposed amendment does not affect either the way in which the plant structures, systems, and components perform their safety function or their design margins. Because there is no change to the physical design of the plant, there is no change to these margins.
Therefore, the proposed amendment does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?
This proposed amendment has no influence on the probability or consequences of any accident previously evaluated. The lower safety setpoint tolerance change does not affect the operation of the SRVs and it does not affect the as-left setpoint tolerance band which is unchanged at ±3% of the lift setpoint of the SRVs. The change only affects the lower tolerance for opening of the SRVs. The proposed amendment does not affect the upper tolerance for SRVs safety setpoints, which is the limit that protects from overpressurization.
The proposed amendment does not involve any physical changes to the SRVs, nor does it change the safety function of the SRVs. The proposed TS revision involves no significant changes to the operation of any systems or components in normal or accident operating conditions as discussed in the technical evaluation for this [license amendment request]. Additionally, the proposed change does not involve any significant changes to existing structures, systems, or components.
The proposed amendment does not change any other behavior or operation of the SRVs, and, therefore, has no significant impact on reactor operation. It also has no significant impact on response to any perturbation of reactor operation including transients and accidents previously analyzed in the [Final Safety Analysis Report (FSAR)].
Therefore, the proposed amendment does not result in a significant increase in the probability or consequences of any previously evaluated accident.
2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?
The proposed change from −3% to −5% for the SRV safety setpoint lower tolerance only affects the criteria to determine when an as-found SRV test is considered acceptable. The proposed change does not affect the criteria for the setpoint upper tolerance for the SRVs.
The proposed change from −3% to −5% for the SRV safety setpoint lower tolerance does not adversely affect the operation of any safety-related components or equipment. Since the proposed amendment does not involve any hardware changes, significant changes to the operation of any systems or components, nor change to existing structures, systems, or components, there is no possibility that a new or different kind of accident is created.
The proposed change from −3% to −5% for the SRV safety setpoint lower tolerance does not involve any physical changes to the SRVs, nor does it change the safety function of the SRVs. The proposed change does not require any physical change or alteration of any existing plant equipment. No new or different equipment is being installed. No installed equipment is being operated in a new or different manner. There is no alteration to the parameters within which the plant is normally operated. This change does not alter the manner in which equipment operation is initiated, nor will the functional demands on credited equipment be changed. No alterations in the procedures that ensure the plant remains within analyzed limits are being proposed. No changes are being made to the procedures relied upon to respond to off-normal events as described in the FSAR are being proposed by this change. The proposed change does not alter assumptions made in the safety analysis and licensing basis.
Therefore, the proposed amendment does not create the possibility of a new or different kind of accident from any previously evaluated.
3. Does the proposed amendment involve a significant reduction in a margin of safety?
The proposed change from −3% to −5% for the SRV safety setpoint lower tolerance only affects the criteria to determine when an as-found SRV test is considered acceptable. This change does not affect the criteria for the SRV safety setpoint upper tolerance. The TS setpoints for the SRVs are not changed. The as-left setpoint tolerances are not changed by the proposed amendment and remain at ±3%.
The margin of safety is established through the design of the plant structures, systems, and components, the parameters within which the plant is operated, and the establishment of the setpoints for the actuation of equipment relied upon to respond to an event. The proposed change from −3% to −5% for the SRV safety setpoint lower tolerance does not significantly impact the condition or performance of structures, systems, and components relied upon for accident mitigation.
Therefore, the proposed change does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?
The proposed change relocates the volume of diesel lube oil required to support 7-day operation of each onsite diesel generator, and the volume equivalent to a 6-day supply, to licensee control. The specific volume of lube oil equivalent to a 7-day and 6-day supply is based on the diesel generator manufacturer's consumption values for the run time of the diesel generator. Because the requirement to maintain a 7-day supply of diesel lube oil is not changed and is consistent with the assumptions in the accident analyses, and the actions taken when the volume of lube oil is less than a 6-day supply have not changed, neither the probability nor the consequences of any accident previously evaluated will be affected.
Therefore, the proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed change create the possibility of a new or different kind of accident from any accident previously evaluated?
The change does not involve a physical alteration of the plant (
3. Does the proposed change involve a significant reduction in a margin of safety?
The proposed change relocates the volume of diesel lube oil required to support 7-day operation of each onsite diesel generator, and the volume equivalent to a 6-day supply, to licensee control. As the bases for the existing limits on diesel lube oil are not changed, no change is made to the accident analysis assumptions and no margin of safety is reduced as part of this change.
Therefore, the proposed change does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?
The proposed changes would not take effect until OCNGS has permanently ceased operation and entered a permanently defueled condition. The proposed changes would revise the OCNGS TS by deleting or modifying certain portions of the TS administrative controls described in Section 6.0 of the TS that are no longer applicable to a permanently shutdown and defueled facility.
The proposed changes do not involve any physical changes to plant Structures, Systems, and Components (SSCs) or the manner in which SSCs are operated, maintained, modified, tested, or inspected. The proposed changes do not involve a change to any safety limits, limiting safety system settings, limiting control settings, limiting conditions for operation, surveillance requirements, or design features.
The deletion and modification of provisions of the administrative controls do not directly affect the design of SSCs necessary for safe storage of spent irradiated fuel or the methods used for handling and storage of such fuel in the Spent Fuel Pool (SFP). The proposed changes are administrative in nature and do not affect any accidents applicable to the safe management of spent irradiated fuel or the permanently shutdown and defueled condition of the reactor.
In a permanently defueled condition, the only credible accidents are the Fuel Handling Accident (FHA), Radioactive Liquid Waste System Leak, and Postulated Radioactive Releases Due to Liquid Tank Failures. Other accidents such as Loss of Coolant Accident, Loss of Feedwater, and Reactivity and Power Distribution Anomalies will no longer be applicable to a permanently defueled reactor plant.
The probability of occurrence of previously evaluated accidents is not increased, since extended operation in a permanently defueled condition will be the only operation allowed, and therefore, bounded by the existing analyses. Additionally, the occurrence of postulated accidents associated with reactor operation is no longer credible in a permanently defueled reactor. This significantly reduces the scope of applicable accidents.
Therefore, the proposed changes do not involve a significant increase in the probability or consequence of an accident previously evaluated.
2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?
The proposed changes to delete and/or modify certain TS administrative controls have no impact on facility SSCs affecting the safe storage of spent irradiated fuel, or on the methods of operation of such SSCs, or on the handling and storage of spent irradiated fuel itself. The proposed changes do not result in different or more adverse failure modes or accidents than previously evaluated because the reactor will be permanently shut down and defueled and OCNGS will no longer be authorized to operate the reactor.
The proposed changes do not affect systems credited in the accident analysis for the FHA, Radioactive Liquid Waste System Leak, and Postulated Radioactive Releases Due to Liquid Tank Failures at OCNGS. The proposed changes will continue to require proper control and monitoring of safety significant parameters and activities. The proposed changes do not result in any new mechanisms that could initiate damage to the remaining relevant safety barriers in support of maintaining the plant in a permanently shutdown and defueled condition (
The proposed changes do not alter the protection system design, create new failure modes, or change any modes of operation. The proposed changes do not involve a physical alteration of the plant, and no new or different kind of equipment will be installed. Consequently, there are no new initiators that could result in a new or different kind of accident.
Therefore, the proposed changes do not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. Does the proposed amendment involve a significant reduction in a margin of safety?
The proposed changes involve deleting and/or modifying certain TS administrative controls once the OCNGS facility has been permanently shutdown and defueled. As specified in 10 CFR 50.82(a)(2), the 10 CFR 50 license for OCNGS will no longer authorize operation of the reactor or emplacement or retention of fuel into the reactor vessel following submittal of the certifications required by 10 CFR 50.82(a)(1). As a result, the occurrence of certain design basis postulated accidents are no longer considered credible when the reactor is permanently defueled.
The only remaining credible accident is a fuel handling accident (FHA). The proposed changes do not adversely affect the inputs or assumptions of any of the design basis analyses that impact the FHA.
The proposed changes are limited to those portions of the TS administrative controls that are related to the safe storage and maintenance of spent irradiated fuel. The requirements that are proposed to be revised and/or deleted from the OCNGS TS are not credited in the existing accident analysis for the remaining applicable postulated accident (
Therefore, the proposed changes do not involve a significant reduction in the margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?
The proposed change revises TS Chapter 5, “Administrative Controls,” Section 5.5, “Programs and Manuals,” by eliminating the “Inservice Testing Program” specification. Most requirements in the Inservice Testing Program are removed, as they are duplicative of requirements in the [American Society of Mechanical Engineers (ASME) Operations and Maintenance (OM) Code], as clarified by Code Case OMN-20, “Inservice Test Frequency.” The remaining requirements in the Section 5.5.8 [Inservice Testing (IST)] Program are eliminated because the NRC has determined their inclusion in the TS is contrary to regulations. A new defined term, “Inservice Testing Program,” is added to the TS, which references the requirements of 10 CFR 50.55a(f).
Performance of inservice testing is not an initiator to any accident previously evaluated. As a result, the probability of occurrence of an accident is not significantly affected by the proposed change. Inservice test frequencies under Code Case OMN-20 are equivalent to the current testing period allowed by the TS with the exception that testing frequencies greater than 2 years may be extended by up to 6 months to facilitate test scheduling and consideration of plant operating conditions that may not be suitable for performance of the required testing. The testing frequency extension will not affect the ability of the components to mitigate any accident previously evaluated as the components are required to be operable during the testing period extension. Performance of inservice tests utilizing allowances in OMN-20 will not significantly affect the reliability of the tested components. As a result, the availability of the affected components, as well as their ability to mitigate the consequences of accidents previously evaluated, is not affected.
Therefore, the proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?
The proposed change does not alter the design or configuration of the plant. The proposed change does not involve a physical alteration of the plant; no new or different kind of equipment will be installed. The proposed change does not alter the types of inservice testing performed. In most cases, the frequency of inservice testing is unchanged. However, the frequency of testing would not result in a new or different kind of accident from any previously evaluated since the testing methods are not altered.
Therefore, the proposed change does not create the possibility of a new or different kind of accident from any previously evaluated.
3. Does the proposed amendment involve a significant reduction in a margin of safety?
The proposed change eliminates some requirements from the TS in lieu of requirements in the ASME Code, as modified by use of Code Case OMN-20. Compliance with the ASME Code is required by 10 CFR 50.55a. The proposed change also allows inservice tests with frequencies greater than 2 years to be extended by 6 months to facilitate test scheduling and consideration of plant operating conditions that may not be suitable for performance of the required testing. The testing frequency extension will not affect the ability of the components to respond to an accident as the components are required to be operable during the testing period extension. The proposed change will eliminate existing TS SR 3.0.3 allowance to defer performance of missed inservice tests up to the duration of the specified testing frequency, and instead will require an assessment of the missed test on equipment operability. This assessment will consider the effect on a margin of safety (equipment operability). Should the component be inoperable, the Technical Specifications provide actions to ensure that the margin of safety is protected. The proposed change also eliminates a statement that nothing in the ASME Code should be construed to supersede the requirements of any TS. The NRC has determined that statement to be incorrect. However, elimination of the statement will have no effect on plant operation or safety.
Therefore, the proposed change does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?
The proposed amendment adopts the NRC-accepted guidelines of NEI 94-01, Revision 3-A, “Industry Guideline for Implementing Performance-Based Option of 10 CFR part 50, Appendix J,” for development of the Seabrook performance-based containment testing program. NEI 94-01 allows, based on risk and performance, an extension of Type A and Type C containment leak test intervals. Implementation of these guidelines continues to provide adequate assurance that during design basis accidents, the primary containment and its components will limit leakage rates to less than the values assumed in the plant safety analyses.
The findings of the Seabrook risk assessment confirm the general findings of previous studies that the risk impact with extending the containment leak rate is small. Per the guidance provided in Regulatory Guide 1.174, an extension of the leak test interval in accordance with NEI 94-01, Revision 3-A results in an estimated change within the small change region.
Since the change is implementing a performance-based containment testing
Therefore, the proposed changes do not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed change create the possibility of a new or different kind of accident from any previously evaluated?
The proposed change to implement a performance-based containment testing program, associated with integrated leakage rate test frequency, does not change the design or operation of structures, systems, or components of the plant.
The proposed changes would continue to ensure containment integrity and would ensure operation within the bounds of existing accident analyses. There are no accident initiators created or affected by these changes. Therefore, the proposed changes will not create the possibility of a new or different kind of accident from any accident previously evaluated.
Therefore, the proposed changes do not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. Does the proposed change involve a significant reduction in the margin of safety?
Margin of safety is related to confidence in the ability of the fission product barriers (fuel cladding, reactor coolant system, and primary containment) to perform their design functions during and following postulated accidents. The proposed change to implement a performance-based containment testing program, associated with integrated leakage rate test frequency, does not affect plant operations, design functions, or any analysis that verifies the capability of a structure, system, or component of the plant to perform a design function. In addition, this change does not affect safety limits, limiting safety system setpoints, or limiting conditions for operation.
The specific requirements and conditions of the TS Containment Leakage Rate Testing Program exist to ensure that the degree of containment structural integrity and leak-tightness that is considered in the plant safety analysis is maintained. The overall containment leak rate limit specified by TS is maintained. This ensures that the margin of safety in the plant safety analysis is maintained. The design, operation, testing methods and acceptance criteria for Type A, B, and C containment leakage tests specified in applicable codes and standards would continue to be met, with the acceptance of this proposed change, since these are not affected by implementation of a performance-based containment testing program.
Therefore, the proposed changes do not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?
The proposed TS change deletes Action Statement 3.4.2.1.b concerning safety/relief valves. The two (2) minute action represents detailed methods of responding to an event, and therefore, if eliminated, would not result in increasing the probability of the event, nor act as an initiator of an event. Limiting condition for operation 3.6.2.1, “Depressurization Systems—Suppression Chamber,” and plant procedures provide operators with appropriate direction for response to a suppression pool high temperature (which could be caused by a stuck open relief valve). Providing specific direction to close the valve within two (2) minutes does not provide additional plant protection beyond what is provided for in plant procedures and TS 3.6.2.1.
Therefore, this action can be eliminated, and will not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed change create the possibility of a new or different kind of accident from any accident previously evaluated?
The proposed TS change deletes Action Statement 3.4.2.1.b concerning safety/relief valves. This change does not change the design or configuration of the plant. No new operation or failure modes are created, nor is a system-level failure mode created that is different than those that already exist.
Therefore, it is concluded that this change does not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. Do the proposed changes involve a significant reduction in a margin of safety?
The proposed change does not involve a significant reduction in a margin of safety, nor does it affect any analytical limits. There are no changes to accident or transient core thermal hydraulic conditions, or fuel or reactor coolant boundary design limits, as a result of the proposed change. The proposed change will not alter the assumptions or results of the analysis contained in the Updated Final Safety Analysis Report (UFSAR).
Therefore, it is concluded that the proposed change does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?
As indicated in the UFSAR Subsection 3.8.4.1.2, the auxiliary building contains structural modules in the south side of the building that include the spent fuel pool, fuel transfer canal, and cask loading and washdown pits. The increase in tolerance associated with the concrete thickness of the concrete wall for the column line N from column line 2 to 4 and the deviation from ACI 349-01 does not involve any accident initiating components or events, thus leaving the probabilities of an accident unaltered. The increased tolerance does not adversely affect any safety-related structures or equipment nor does the increased tolerance reduce the effectiveness of a radioactive material barrier. Thus, the proposed changes would not affect any safety-related accident mitigating function served by the containment internal structures.
Therefore, the proposed amendment does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?
The proposed tolerance increase and code deviation from ACI 349-01 does not change the performance of the affected radiologically controlled portion of the auxiliary building. As demonstrated by the continued conformance to the other applicable codes and standards governing the design of the structures, and in conjunction with the analysis of a special system of construction in accordance with ACI 349-01 Section 1.4, the wall with an increased concrete thickness tolerance continues to withstand the same effects as previously evaluated. There is no change to the design function of the affected module and wall, and no new failure mechanisms are identified as the same types of accidents are presented to the wall before and after the change.
Therefore, the proposed amendment does not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. Does the proposed amendment involve a significant reduction in a margin of safety?
The proposed change to increase the concrete thickness tolerance for the column line N wall from column line 2 to 4 identified in COL Appendix C Table 3.3-1 does not alter any design function, design analysis, or safety analysis input or result, and sufficient margin exists to justify departure from the ACI 349-01 requirements for the wall. As such, because the system continues to respond to design basis accidents in the same manner as before without any changes to the expected response of the structure, no safety analysis or design basis acceptance limit/criterion is challenged or exceeded by the proposed changes. Accordingly, no safety margin is reduced by the increase of the wall concrete thickness tolerance.
Therefore, the proposed amendment does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?
The proposed changes do not affect the operation of any systems or equipment that initiate an analyzed accident or alter any structures, systems, and components (SSCs) accident initiator or initiating sequence of events. The proposed changes result from identifying PSX, RNS, and VFS piping lines required to be described in the licensing basis as ASME [American Society of Mechanical Engineers] Code Section III, evaluated to meet the LBB [leak-before-break] design criteria, or designed to withstand combined normal and seismic design basis loads without a loss of functional capability. Neither planned or inadvertent operation nor failure of the PXS, RNS, or VFS is an accident initiator or part of an initiating sequence of events for an accident previously evaluated. Therefore, the probabilities of the accidents evaluated in the UFSAR are not affected.
The proposed changes do not have an adverse impact on the ability of the PXS, RNS, or VFS to perform their design functions. The design of the PXS, RNS, and VFS continues to meet the same regulatory acceptance criteria, codes, and standards as required by the UFSAR. In addition, the changes ensure that the capabilities of the PXS, RNS, and VFS to mitigate the consequences of an accident meet the applicable regulatory acceptance criteria, and there is no adverse effect on any safety-related SSC or function used to mitigate an accident. The changes do not affect the prevention and mitigation of other abnormal events,
Therefore, the proposed amendment does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?
The proposed changes do not affect the operation of any systems or equipment that may initiate a new or different kind of accident, or alter any SSC such that a new accident initiator or initiating sequence of events is created. The proposed changes result from identifying PXS, RNS, and VFS piping lines required to be described in the licensing basis as ASME Code Section III, evaluated to meet the LBB design criteria, or designed to withstand combined normal and seismic design basis loads without a loss of functional capability. These proposed changes do not adversely affect any other PXS, RNS, VFS, or SSC design functions or methods of operation in a manner that results in a new failure mode, malfunction, or sequence of events that affect safety-related or nonsafety-related equipment. Therefore, this activity does not allow for a new fission product release path, result in a new fission product barrier failure mode, or create a new sequence of events that results in significant fuel cladding failures.
Therefore, the requested amendment does not create the possibility of a new or different
3. Does the proposed amendment involve a significant reduction in a margin of safety?
The proposed changes maintain existing safety margins. The proposed changes ensure that PXS, RNS, and VFS design requirements and design functions are met. The proposed changes maintain existing safety margin through continued application of the existing requirements of the UFSAR, while adding additional design features to ensure the PXS, RNS, and VFS perform the design functions required to meet the existing safety margins. Therefore, the proposed changes satisfy the same design functions in accordance with the same codes and standards as stated in the UFSAR. These changes do not adversely affect any design code, function, design analysis, safety analysis input or result, or design/safety margin. Because no safety analysis or design basis acceptance limit/criterion is challenged or exceeded by the proposed changes, no margin of safety is reduced.
Therefore, the requested amendment does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?
STPNOC has performed a multi-cycle assessment on previous Unit 1 reactor cores and evaluated the consequences associated with removal of Control Rod D-6. The assessment indicates that removal of Control Rod D-6 does impact reactivity parameters (
2. Does the proposed change create the possibility of a new or different kind of accident from any accident previously evaluated?
Operation of STP Unit 1 with Control Rod D-6 removed will not create the possibility of a new or different kind of accident from any accident previously evaluated. To preserve the reactor coolant system flow characteristics in the reactor core, a flow restrictor will be installed at the top of the D-6 guide tube housing. Installation of this component will not prevent the remaining 56 control rods from performing the required design function of providing adequate shutdown margin. No new operator actions are created as a result of the proposed change. Therefore, the proposed change does not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. Does the proposed change involve a significant reduction in a margin of safety?
Operation of STP Unit 1 with Control Rod D-6 removed will not involve a significant reduction in a margin of safety. The margin of safety is established by setting safety limits and operating within those limits. The proposed change does not alter a UFSAR design basis or safety limit and does not change any setpoint at which automatic actuations are initiated. STPNOC will continue to confirm all safety analysis limits remain bounding on a cycle-specific basis using an NRC-approved Westinghouse core reload evaluation methodology. Therefore, the proposed change does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the request for amendment involves no significant hazards consideration.
During the period since publication of the last biweekly notice, the Commission has issued the following amendments. The Commission has determined for each of these amendments that the application complies with the standards and requirements of the Atomic Energy Act of 1954, as amended (the Act), and the Commission's rules and regulations. The Commission has made appropriate findings as required by the Act and the Commission's rules and regulations in 10 CFR chapter I, which are set forth in the license amendment.
A notice of consideration of issuance of amendment to facility operating license or combined license, as applicable, proposed no significant hazards consideration determination, and opportunity for a hearing in connection with these actions, was published in the
Unless otherwise indicated, the Commission has determined that these amendments satisfy the criteria for categorical exclusion in accordance with 10 CFR 51.22. Therefore, pursuant to 10 CFR 51.22(b), no environmental impact statement or environmental assessment need be prepared for these amendments. If the Commission has prepared an environmental assessment under the special circumstances provision in 10 CFR 51.22(b) and has made a determination based on that assessment, it is so indicated.
For further details with respect to the action see (1) the applications for amendment, (2) the amendment, and (3) the Commission's related letter, Safety Evaluation, and/or Environmental Assessment as indicated. All of these items can be accessed as described in the “Obtaining Information and Submitting Comments” section of this document.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated June 23, 2016.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated June 21, 2016.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated June 21, 2016.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated June 21, 2016.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated June 27, 2016.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated June 28, 2016.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated June 20, 2016.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated June 21, 2016.
The Commission's related evaluation of the amendments and final no significant hazards consideration determination are contained in a Safety Evaluation dated June 29, 2016.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated June 23, 2016.
For the Nuclear Regulatory Commission.
July 18, 25, August 1, 8, 15, 22, 2016.
Commissioners' Conference Room, 11555 Rockville Pike, Rockville, Maryland.
Public and Closed.
This meeting will be webcast live at the Web address—
This meeting will be webcast live at the Web address—
9:00 a.m. Hearing on Combined Licenses for Levy Nuclear Plant, Units 1 and 2: Section 189a. of the Atomic Energy Act Proceeding (Public Meeting) (Contact: Donald Habib: 301-415-1035)
This meeting will be webcast live at the Web address—
There are no meetings scheduled for the week of August 1, 2016.
There are no meetings scheduled for the week of August 8, 2016.
There are no meetings scheduled for the week of August 15, 2016.
There are no meetings scheduled for the week of August 22, 2016.
The schedule for Commission meetings is subject to change on short notice. For more information or to verify the status of meetings, contact Denise McGovern at 301-415-0681 or via email at
The NRC Commission Meeting Schedule can be found on the Internet at:
The NRC provides reasonable accommodation to individuals with disabilities where appropriate. If you need a reasonable accommodation to participate in these public meetings, or need this meeting notice or the transcript or other information from the public meetings in another format (
Members of the public may request to receive this information electronically. If you would like to be added to the distribution, please contact the Nuclear Regulatory Commission, Office of the Secretary, Washington, DC 20555 (301-415-1969), or email
Nuclear Regulatory Commission.
Interim staff guidance; issuance.
The U.S. Nuclear Regulatory Commission (NRC) is issuing the final Japan Lessons-Learned Division Interim Staff Guidance (JLD-ISG), JLD-ISG-2016-01, “Guidance for Activities Related to Near-Term Task Force Recommendation 2.1, Flooding Hazard Reevaluation; Focused Evaluation and Integrated Assessment.” The JLD-ISG provides guidance and clarification to assist operating power reactor licensees and holders of construction permits under the NRC's regulations with the performance of the focused evaluations and revised integrated assessments for external flooding.
This guidance is effective on July 19, 2016.
Please refer to Docket ID NRC-2016-0084 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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Eric Bowman, Office of Nuclear Reactor, Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-2963; email:
Following the events at the Fukushima Dai-ichi nuclear power plant on March 11, 2011, the NRC established a senior-level agency task force referred to as the Near-Term Task Force (NTTF). The NTTF was tasked with conducting a systematic and methodical review of the NRC regulations and processes, and determining if the agency should make additional improvements to these programs in light of the events at Fukushima Dai-ichi. As a result of this review, the NTTF developed a comprehensive set of recommendations, documented in SECY-11-0093, “Recommendations for Enhancing Reactor Safety in the 21st Century, the Near-Term Task Force Review of Insights from the Fukushima Dai-ichi Accident,” dated July 12, 2011. These recommendations were enhanced by the NRC staff following interactions with stakeholders. Documentation of the staff's efforts is contained in SECY-11-0124, dated September 9, 2011, and SECY-11-0137, dated October 3, 2011.
As directed by the Commission's SRM for SECY-11-0093, the NRC staff reviewed the NTTF recommendations within the context of the NRC's existing regulatory framework and considered the various regulatory vehicles available to the NRC to implement the recommendations. In SECY-11-0124 and SECY-11-0137, the staff established the prioritization of the recommendations. After receiving the Commission's direction in SRM-SECY-11-0124 and SRM-SECY-11-0137, the NRC staff issued a request for information pursuant to section 50.54(f) of title 10 of the
In COMSECY-14-0037, dated November 21, 2014, the NRC staff requested that the Commission review and approve changes to revise the Recommendation 2.1 flooding assessments and integrate the Phase 2 decision-making into the development and implementation of mitigating strategies in accordance with Order EA-12-049 and the related Mitigation of Beyond-Design-Basis Events rulemaking.
In SRM-COMSECY-14-0037, the Commission disapproved this recommendation. Instead, the Commission instructed the staff to develop a closure plan for the flooding reevaluation activities and to reassess the existing guidance for performing a Phase 1 integrated assessment in order to focus on those plants with the most potential for safety benefits.
In COMSECY-15-0019, the staff provided revised guidance for performing a Phase 1 integrated assessment and described a modified process for identifying the list of plants that would be required to perform an integrated assessment. The process proposed by the staff included the development of a graded, risk-informed and performance-based approach consistent with Commission direction to focus on those plants with the greatest potential opportunity for safety enhancements. Specifically, the process included consideration and evaluation of local intense precipitation by performing a focused evaluation of the impact of the hazard and implementing any necessary programmatic, procedural, or plant modifications to address the hazard, taking into account available warning time. The process also considered flood protection and available physical margin, where licensees will confirm the capability of existing flood protection to address the hazard exceedance by performing a focused evaluation. For licensees where the reevaluated hazard cannot be addressed via existing or planned flood protection, the process also includes the performance of an integrated assessment, using revised guidance, in order to conduct more detailed evaluations of plant response capability. This revised integrated assessment will capture, among other information, quantitative characteristics about the effectiveness of various aspects of plant response (
In SRM-COMSECY-15-0019, the Commission approved the staff's plans to modify the approach for integrated assessments to implement a graded approach for determining the need for, and prioritization and scope of, plant-specific integrated assessments. As discussed in COMSECY-15-0019, the majority of sites with reevaluated flooding hazards exceeding the design-basis flood are expected to screen out from the integrated assessment process. The licensees will instead provide focused evaluations to ensure appropriate actions are taken and that these actions are effective and reasonable.
The Nuclear Energy Institute (NEI) submitted guidance NEI 16-05, “External Flooding Assessment Guidelines,” Revision 1, on June 10, 2016. The revised guidance is an industry-developed methodology that describes the flooding impact assessment process, which is intended to meet the requested information of an integrated assessment, as described in the document titled, “Request for Information Pursuant to Title 10 of the
On April 22, 2016 (81 FR 23758), the NRC requested public comments on draft JLD-ISG-2016-01. The NRC staff received comments from two stakeholders which were considered in the development of the final JLD-ISG-16-01. The questions, comments, and staff resolutions of those comments are contained in “NRC Responses to Public Comments: Revision to Japan Lessons-Learned Division Interim Staff Guidance JLD-ISG- 2016-01: Guidance for
This JLD-ISG is a rule as defined in the Congressional Review Act (5 U.S.C. 801-808). However, the Office of Management and Budget has not found it to be a major rule as defined in the Congressional Review Act.
The documents identified in the following table are available to interested persons through one or more of the following methods, as indicated.
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Extension of existing information collection; request for comment.
The U.S. Nuclear Regulatory Commission (NRC) invites public comment on the extension of Office of Management and Budget's (OMB) approval for an existing collection of information. The information collection is entitled NRC Form 314, “Certificate of Disposition of Materials.” The NRC Form 314 is submitted by a materials licensee who wishes to terminate its license. The form provides information needed by the NRC to determine whether the licensee has radioactive materials on hand which must be transferred or otherwise disposed of prior to expiration or termination of the license.
Submit comments by September 19, 2016. Comments received after this date will be considered if it is practical to do so, but the Commission is able to ensure consideration only for comments received on or before this date.
You may submit comments by any of the following methods:
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For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the
David Cullison, Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-2084; email:
Please refer to Docket ID NRC-2016-0132 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:
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Please include Docket ID NRC-2016-0132 in your comment submission.
The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at
If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the NRC is requesting public comment on its intention to request OMB's approval for the information collection summarized below.
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The NRC is seeking comments that address the following questions:
1. Is the proposed collection of information necessary for the NRC to properly perform its functions? Does the information have practical utility?
2. Is the estimate of the burden of the information collection accurate?
3. Is there a way to enhance the quality, utility, and clarity of the information to be collected?
4. How can the burden of the information collection on respondents be minimized, including the use of automated collection techniques or other forms of information technology?
For the Nuclear Regulatory Commission.
Pension Benefit Guaranty Corporation.
Notice of request for extension of OMB approval.
The Pension Benefit Guaranty Corporation (“PBGC”) is requesting that the Office of Management and Budget (“OMB”) extend approval without change, under the Paperwork Reduction Act, of a collection of information under its regulation on Rules for Administrative Review of Agency Decisions. This notice informs the public of PBGC's request and solicits public comment on the collection of information.
Comments should be submitted by August 18, 2016.
Comments should be sent to the Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for Pension Benefit Guaranty Corporation, via electronic mail at
Copies of the collection of information may also be obtained without charge by writing to the Disclosure Division of the Office of the General Counsel of PBGC at 1200 K Street NW., Washington, DC 20005-4026 or by visiting the Disclosure Division or calling 202-326-4400 ext. 3872 during normal business hours. (TTY and TDD users may call the Federal relay service toll-free at 1-800-877-8339 and ask to be connected to 202-326-4400 ext. 3872.) PBGC's regulation on Administrative Appeals may be accessed on PBGC's Web site at
Donald McCabe, Attorney, Regulatory Affairs Group, Office of the General Counsel, Pension Benefit Guaranty Corporation, 1200 K Street NW., Washington, DC 20005-4026, 202-326-4400 ext. 3872. (For TTY and TDD, call 800-877-8339 and request connection to 202-326-4400 ext. 3872).
PBGC's regulation on Rules for Administrative Review of Agency Decisions (29 CFR part 4003) prescribes rules governing the issuance of initial determinations by PBGC and the procedures for requesting and obtaining administrative review of initial determinations through reconsideration or appeal. Subpart A of
Any person aggrieved by an initial determination of PBGC under § 4003.1(b)(1) (determinations that a plan is covered by section 4021 of ERISA), § 4003.1(b)(2) (determinations concerning premiums, interest, and late payment penalties under section 4007 of ERISA), § 4003.1(b)(3) (determinations concerning voluntary terminations), § 4003.1(b)(4) (determinations concerning allocation of assets under section 4044 of ERISA), or § 4003.1(b)(5) (determinations with respect to penalties under section 4071 of ERISA) may request reconsideration of the initial determination. Requests for reconsideration must be in writing, be clearly designated as requests for reconsideration, contain a statement of the grounds for reconsideration and the relief sought, and contain or reference all pertinent information.
OMB has approved the reconsiderations collection of information under control number 1212-0063 through July 31, 2016. PBGC is requesting that OMB extend approval without change of this collection of information for three years. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
PBGC estimates that an average of about 226 appellants per year will respond to this collection of information. PBGC further estimates that the average annual burden of this collection of information is about one-half hour and about $626 per person, with an average total annual burden of about 112 hours and about $141,400.
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add Inbound Market Dominant Registered Service Agreement to the Market Dominant Product List.
Christopher C. Meyerson, (202) 268-7820.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642, on July 13, 2016, it filed with the Postal Regulatory Commission a Request of United States Postal Service to add Inbound Market Dominant Registered Service Agreement to the Market Dominant Product List. Documents are available at
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange filed a proposal to update Rule 13.4(a) regarding the public disclosure of the sources of data that the Exchange utilizes when performing: (i) Order handling; (ii) order routing; and (iii) related compliance processes to reflect the operation of the Investors Exchange LLC (“IEX”) as a registered national securities exchange
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.
On June 17, 2016, the Commission approved IEX's application to register as a national securities exchange.
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act,
The Exchange believes that its proposal to update Exchange Rule 13.4(a) to include IEX will ensure that the rule correctly identifies and publicly states on a market-by-market basis all of the specific network processor and proprietary data feeds that the Exchange utilizes for the handling, routing, and execution of orders, and for performing the regulatory compliance checks related to each of those functions. The proposed rule change also removes impediments to and perfects the mechanism of a free and open market and protects investors and the public interest because it provides additional specificity, clarity and transparency.
The Exchange believes its proposed rule change would not impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. To the contrary, the Exchange believes the proposal would enhance competition because including all of the exchanges enhances transparency and enables investors to better assess the quality of the Exchange's execution and routing services.
The Exchange has not solicited, and does not intend to solicit, comments on this proposed rule change. The Exchange has not received any unsolicited written comments from Members or other interested parties.
Because the foregoing proposed rule change does not: (A) Significantly affect the protection of investors or the public interest; (B) impose any significant burden on competition; and (C) by its terms, become operative for 30 days from the date on which it was filed or such shorter time as the Commission may designate it has become effective pursuant to Section 19(b)(3)(A) of the Act
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: (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 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 seeks to extend the pilots associated with the Automated Improvement Mechanism. The text of the proposed rule change is provided below.
Rule 6.74A. Automated Improvement Mechanism (“AIM”)
Notwithstanding the provisions of Rule 6.74, a Trading Permit Holder that represents agency orders may electronically execute an order it represents as agent (“Agency Order”) against principal interest or a solicited order provided it submits the Agency Order for electronic execution into the AIM auction (“Auction”) pursuant to this Rule.
(a)-(b) No change.
. . . Interpretations and Policies:
.01-.02 No change.
.03 Initially, and for at least a Pilot Period expiring on [July 18, 2016]
.04-.05 No change.
.06 Subparagraph (b)(2)(E) of this rule will be effective for a Pilot Period until [July 18, 2016]
.07-.08 No change.
Rule 24B.5A. FLEX Automated Improvement Mechanism
Notwithstanding the provisions of Rule 24B.5, a FLEX Trader that represents agency orders may electronically execute an order it represents as agent (“Agency Order”) against principal interest and/or against solicited orders provided it submits the Agency Order for execution into the automated improvement mechanism auction (“AIM A
(a)-(b) No change.
This rule supersedes Exchange Rule 6.74A.
. . . Interpretations and Policies:
.01-.02 No change.
.03 Initially, and for at least a Pilot Period expiring on [July 18, 2016]
.04-.07 No change.
The text of the proposed rule change is also available on the Exchange's Web site (
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
In February 2006, CBOE obtained approval from the Securities and Exchange Commission (the “Commission”) to adopt the AIM auction process.
The Commission approved two components of AIM on a pilot basis: (1) That there is no minimum size requirement for orders to be eligible for the auction; and (2) that the auction will conclude prematurely anytime there is a quote lock on the Exchange pursuant to Rule 6.45A(d).
Ten one-year extensions to the pilot programs have previously become effective.
Additionally, in March 2012, CBOE obtained approval from the Commission to adopt the AIM auction process for
The Commission approved on a pilot basis the component of AIM for FLEX Options that there is no minimum size requirement for orders to be eligible for the auction.
Four one-year extensions to the pilot program have previously become effective.
The Exchange also proposes to correct an inadvertent typographical error in Rule 24B.5A. On December 23, 2011 the Exchange filed a rule change to adopt Rule 24B.5A (FLEX Automated Improvement Mechanism).
The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
In particular, the proposed rule change protects investors and the public interest by allowing for an extension of the AIM and FLEX AIM pilot programs, and thus allowing additional time for the Commission to evaluate the pilot programs. The pilot programs will continue to allow (1) smaller non-FLEX option and FLEX Option orders to receive the opportunity for price improvement pursuant to the AIM auction, and (2) with respect to non-FLEX options, Agency Orders in AIM auctions that are concluded early because of quote lock on the Exchange to receive the benefit of the lock price. The additional data provided will help the Commission determine if there is evidence of meaningful competition for all size orders, significant price improvement for orders going through the AIM and FLEX AIM and an active and liquid market functioning on the Exchange outside of the AIM and FLEX AIM auctions.
CBOE does not believe that the proposed rule changes will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange does not believe the proposed rule changes impose any burden on intramarket competition because it applies to all Trading Permit Holders. All Trading Permit Holders that submit orders into an AIM or FLEX AIM auction are still subject to the same requirements. In addition, the Exchange does not believe the proposed rule changes will impose any burden on intermarket competition, as they merely extend the duration of an existing pilot programs, which are available to all market participants through Trading Permit Holders. AIM and FLEX AIM will continue to function in the same manner as they currently function for an extended period of time.
The Exchange neither solicited nor received comments on the proposed rule change.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act
A proposed rule change filed under Rule 19b-4(f)(6)
The Commission believes that waiving the 30-day operative delay is consistent with the protection of investors and the public interest, as it will allow the pilot programs to continue uninterrupted, thereby avoiding any potential investor confusion that could result from a temporary interruption in the pilot programs. Therefore, the Commission designates the proposed rule change to be operative on July 18, 2016.
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Section 17(a)(1) of the Exchange Act provides that broker-dealers registered with the Commission must make and keep records, furnish copies of the records, and make and disseminate reports as the Commission, by rule, prescribes. Pursuant to this authority, the Commission adopted Rule 17a-5 (17 CFR 240.17a-5), which is one of the primary financial and operational reporting rules for broker-dealers.
There are approximately 4,113 broker-dealers registered with the Commission. Based on staff experience, the Commission estimates that, on average, it would take a broker-dealer approximately 12 hours to complete and file Form Custody, for an annual industry-wide reporting burden of approximately 197,424 hours.
Written comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the Commission's estimate of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted in writing within 60 days of this publication.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information under the PRA unless it displays a currently valid OMB control number.
Please direct your written comments to: Pamela Dyson, Director/Chief Information Officer, Securities and Exchange Commission, c/o Remi Pavlik-Simon, 100 F Street NE., Washington, DC 20549, or send an email to:
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to adopt rules under Rule 3317 to implement the quoting and trading provisions of the Plan to Implement a Tick Size Pilot Program submitted to the Commission pursuant to Rule 608 of Regulation NMS
The text of the proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to establish rules to require its member organizations to comply with the requirements of the Plan, which is designed to study and assess the impact of increment conventions on the liquidity and trading of the common stocks of small capitalization companies. The Exchange proposes changes to its rules for a two-year pilot period that coincides with the pilot period for the Plan, which is currently scheduled as a two year pilot to begin on October 3, 2016.
On August 25, 2014, NYSE Group, Inc., on behalf of Bats BZX Exchange, Inc. (f/k/a BATS Exchange, Inc.), Bats BYX Exchange, Inc. (f/k/a BATS Y-Exchange, Inc.), Chicago Stock Exchange, Inc., EDGA Exchange, Inc., EDGX Exchange, Inc., the Exchange [sic], Financial Industry Regulatory Authority, Inc. (“FINRA”), NASDAQ OMX BX, Inc., NASDAQ OMX PHLX LLC, New York Stock Exchange LLC, the Exchange [sic] and NYSE Arca, Inc., and the NYSE MKT LLC, (collectively, “Participants”), filed with the Commission, pursuant to Section 11A of the Act
The Plan is designed to allow the Commission, market participants, and the public to study and assess the impact of increment conventions on the liquidity and trading of the common stocks of small capitalization companies. The Commission plans to use the Tick Size Pilot Program to assess whether wider tick sizes enhance the market quality of Pilot Securities for the benefit of issuers and investors. Each Participant is required to comply with, and to enforce compliance by its member organizations, as applicable, with the provisions of the Plan.
On October 9, 2015, the Operating Committee approved the Exchange's [sic] proposed rules as model Participant rules that would require compliance by a Participant's member organizations with the provisions of the Plan, as applicable, and would establish written policies and procedures reasonably designed to comply with applicable quoting and trading requirements specified in the Plan.
The Plan will include stocks of companies with $3 billion or less in market capitalization, an average daily trading volume of one million shares or less, and a volume weighted average price of at least $2.00 for every trading day. The Plan will consist of a control group of approximately 1,400 Pilot Securities and three test groups with 400 Pilot Securities in each selected by a stratified sampling.
The Plan also contains requirements for the collection and transmission of data to the Commission and the public. A variety of data generated during the Plan will be released publicly on an aggregated basis to assist in analyzing the impact of wider tick sizes on smaller capitalization stocks.
The Plan requires the Exchange to establish, maintain, and enforce written policies and procedures that are reasonably designed to comply with applicable quoting and trading requirements specified in the Plan.
Proposed paragraph (a)(1) of new Rule 3317 would establish the following defined terms:
• “Plan” means the Tick Size Pilot Plan submitted to the Commission pursuant to Rule 608(a)(3) of Regulation NMS under the Act.
• “Pilot Test Groups” means the three test groups established under the Plan, consisting of 400 Pilot Securities each, which satisfy the respective criteria established by the Plan for each such test group.
• “Trade-at Intermarket Sweep Order”
(i) When routed to a Trading Center, the limit order is identified as a Trade-at Intermarket Sweep Order; and
(ii) Simultaneously with the routing of the limit order identified as a Trade-at Intermarket Sweep Order, one or more additional limit orders, as necessary, are routed to execute against the full size of any protected bid, in the case of a limit order to sell, or the full displayed size of any protected offer, in the case of a limit order to buy, for the Pilot Security with a price that is better than or equal to the limit price of the limit order identified as a Trade-at Intermarket Sweep Order. These additional routed orders also must be marked as Trade-at Intermarket Sweep Orders.
• Paragraph (a)(1)(E) would provide that all capitalized terms not otherwise defined in this rule shall have the meanings set forth in the Plan, Regulation NMS under the Act, or Exchange rules, as applicable.
Proposed Paragraph (a)(2) would state that the Exchange is a Participant in, and subject to the applicable requirements of, the Plan; proposed Paragraph (a)(3) would require member organizations to establish, maintain and enforce written policies and procedures that are reasonably designed to comply with the applicable requirements of the Plan, which would allow the Exchange to enforce compliance by its member organizations with the provisions of the Plan, as required pursuant to Section II(B) of the Plan.
In addition, Paragraph (a)(4) would provide that Exchange systems would not display, quote or trade in violation of the applicable quoting and trading requirements for a Pilot Security specified in the Plan and this proposed rule, unless such quotation or transaction is specifically exempted under the Plan.
The Exchange also proposes to add Rule 3317(a)(5) to provide for the treatment of Pilot Securities that drop below a $1.00 value during the Pilot Period.
The Exchange proposes Rules 3317(c)(1)-(3), which would require member organizations to comply with the specific quoting and trading obligations for each Pilot Test Group under the Plan. With regard to Pilot Securities in Test Group One, proposed Rule 3317(c)(1) would provide that no member organization may display, rank, or accept from any person any displayable or non-displayable bids or offers, orders, or indications of interest in increments other than $0.05. However, orders priced to trade at the midpoint of the National Best Bid and National Best Offer (“NBBO”) or Best Protected Bid and Best Protected Offer (“PBBO”) and orders entered in a Participant-operated retail liquidity program
With regard to Pilot Securities in Test Group Two, proposed Rule 3317(c)(2)(A) would provide that such Pilot Securities would be subject to all of the same quoting requirements as described above for Pilot Securities in Test Group One, along with the applicable quoting exceptions. In addition, proposed Rule 3317(c)(2)(B) would provide that, absent one of the listed exceptions in proposed 3317(c)(2)(C) enumerated below, no member organization may execute orders in any Pilot Security in Test Group Two in price increments other than $0.05. The $0.05 trading increment would apply to all trades, including Brokered Cross Trades.
Paragraph (2)(C) would set forth further requirements for Pilot Securities in Test Group Two. Specifically, member organizations trading Pilot Securities in Test Group Two would be allowed to trade in increments less than $0.05 under the following circumstances:
(a) Except as provided herein, a member that accepts and holds an order in an equity security from its own customer or a customer of another broker-dealer without immediately executing the order is prohibited from trading that security on the same side of the market for its own account at a price that would satisfy the customer order, unless it immediately thereafter executes the customer order up to the size and at the same or better price at which it traded for its own account.
(b) A member must have a written methodology in place governing the execution and priority of all pending orders that is consistent with the requirements of this Rule and Rule 5310. A member also must ensure that this methodology is consistently applied.
The Exchange does not currently have a Manning rule analogous to FINRA Rule 5320, but will adopt such a rule in the near future. Once approved, the Exchange will amend Rules 3317(c)(2)(C)(iv) and (c)(3)(C)(iv), which are currently held in reserve, to reflect the availability of this additional circumstance by which a trade in increments less than $0.05.
(i) Trading may occur at the midpoint between the NBBO or PBBO;
(ii) Retail Investor Orders may be provided with price improvement that is at least $0.005 better than the PBBO; and
(iii) Negotiated Trades may trade in increments less than $0.05.
Paragraph (3)(A)-(3)(C) would set forth the requirements for Pilot Securities in Test Group Three. Member organizations quoting or trading such Pilot Securities would be subject to all of the same quoting and trading requirements as described above for Pilot Securities in Test Group Two, including the quoting and trading exceptions applicable to Pilot Securities in Test Group Two. In addition, proposed Paragraph (3)(D) would provide for an additional prohibition on Pilot Securities in Test Group Three referred to as the “Trade-at Prohibition.”
Proposed Rule 3317(c)(3)(D)(iii) would allow member organizations to execute a sell order for a Pilot Security in Test Group Three at the price of a Protected Bid or execute a buy order for a Pilot Security in Test Group Three at the price of a Protected Offer if any of the following circumstances exist:
a. The order is executed as agent or riskless principal by an independent trading unit, as defined under Rule 200(f) of Regulation SHO,
Independent trading unit aggregation is available if traders in an aggregation unit pursue only the particular trading objective(s) or strategy(s) of that aggregation unit and do not coordinate that strategy with any other aggregation unit. Therefore, a Trading Center cannot rely on quotations displayed by that broker dealer from a different independent trading unit. As an example, an agency desk of a broker-dealer cannot rely on the quotation of a proprietary desk in a separate independent trading unit at that same broker-dealer.
b. The order is executed by an independent trading unit, as defined under Rule 200(f) of Regulation SHO, of a Trading Center within a member organization that has a displayed quotation for the account of that Trading Center on a principal (excluding riskless principal
c. The order is of Block Size
A. An aggregation of non-block orders;
B. broken into orders smaller than Block Size prior to submitting the order to a Trading Center for execution; or
C. executed on multiple Trading Centers;
d. The order is a Retail Investor Order executed with at least $0.005 price improvement;
e. The order is executed when the Trading Center displaying the Protected Quotation that was traded at was experiencing a failure, material delay, or malfunction of its systems or equipment;
f. The order is executed as part of a transaction that was not a “regular way” contract;
g. The order is executed as part of a single-priced opening, reopening, or closing transaction on the Exchange;
h. The order is executed when a Protected Bid was priced higher than a Protected Offer in the Pilot Security in Test Group Three;
i. The order is identified as a Trade-at Intermarket Sweep Order;
The Exchange proposed an exemption to the Trade-at Prohibition for Trade-at ISOs to clarify that an ISO that is received by a Trading Center (and which could form the basis of an execution at the price of a Protected Quotation pursuant to Section VI(D)(8) of the Plan), is identified as a Trade-at ISO. Depending on whether Rule 611 of Regulation NMS or the Trade-at requirement applies, an ISO may mean that the sender of the ISO has swept better-priced Protected Quotations, so that the recipient of that ISO may trade through the price of the Protected Quotation (Rule 611 of Regulation NMS), or it could mean that the sender of the ISO has swept Protected Quotations at the same price that it wishes to execute at (in addition to any better-priced quotations), so the recipient of that ISO may trade at the price of the Protected Quotation (Trade-at). Given that the meaning of an ISO may differ under Rule 611 of Regulation NMS and Trade-at, the Exchange proposed an exemption to the Trade-at Prohibition for Trade-at ISOs so that the recipient of an ISO in a Test Group Three security would know, upon receipt of that ISO, that the Trading Center that sent the ISO had already executed against the full size of displayed quotations at that price,
j. The order is executed by a Trading Center that simultaneously routed Trade-at Intermarket Sweep Orders to execute against the full displayed size of the Protected Quotation that was traded at;
k. The order is executed as part of a Negotiated Trade;
l. The order is executed when the Trading Center displaying the Protected Quotation that was traded at had displayed, within one second prior to execution of the transaction that constituted the Trade-at, a Best Protected Bid or Best Protected Offer, as applicable, for the Pilot Security in Test Group Three with a price that was inferior to the price of the Trade-at transaction;
m. The order is executed by a Trading Center which, at the time of order receipt, the Trading Center had guaranteed an execution at no worse than a specified price (a “stopped order”), where:
A. The stopped order was for the account of a customer;
B. The customer agreed to the specified price on an order-by-order basis; and
C. The price of the Trade-at transaction was, for a stopped buy order, equal to or less than the National Best Bid in the Pilot Security in Test Group Three at the time of execution or, for a stopped sell order, equal to or greater than the National Best Offer in the Pilot Security in Test Group Three at the time of execution, as long as such order is priced at an acceptable increment;
To illustrate the application of the stopped order exemption as it currently operates under Rule 611 of Regulation NMS and as it is currently proposed for Trade-at, assume the National Best Bid is $10.00 and another protected quote is at $9.95. Under Rule 611 of Regulation NMS, a stopped order to buy can be filled at $9.95 and the firm does not have to send an ISO to access the protected quote at $10.00 since the price of the stopped order must be lower than the National Best Bid. For the stopped order to also be executed at $9.95 and satisfy the Trade-at requirements, the Trade-at exception would have to be revised to allow an order to execute at the price of a protected quote which, in this case, could be $9.95.
Based on the fact that a stopped order would be treated differently under the Rule 611 of Regulation NMS exception than under the Trade-at exception in the Plan, the Exchange believes that it is appropriate to amend the Trade-at stopped order exception in the Plan to ensure that the application of this exception would produce a consistent result under both Regulation NMS and the Plan. Therefore, the Exchange proposes in this proposed Rule 3317(c)(3)(D)(iii)m. to allow a transaction to satisfy the Trade-at requirement if the stopped order price, for a stopped buy order, is equal to or less than the National Best Bid, and for a stopped sell order, is equal to or greater than the National Best Offer, as long as such order is priced at an acceptable increment. The Commission granted
n. The order is for a fractional share of a Pilot Security in Test Group Three, provided that such fractional share order was not the result of breaking an order for one or more whole shares of a Pilot Security in Test Group Three into orders for fractional shares or was not otherwise effected to evade the requirements of the Trade-at Prohibition or any other provisions of the Plan; or
o. The order is to correct a bona fide error, which is recorded by the Trading Center in its error account.
Accordingly, the Exchange is proposing to exempt certain transactions to correct bona fide errors in the execution of customer orders from the Trade-at Prohibition, subject to the conditions set forth by the SEC's order exempting these transactions from Rule 611 of Regulation NMS. The Commission granted New York Stock Exchange LLC an exemption from Rule 608(c) related to this provision.
As with the corresponding exception under Rule 611 of Regulation NMS, the bona fide error would have to be evidenced by objective facts and circumstances, the Trading Center would have to maintain documentation of such facts and circumstances and record the transaction in its error account. To avail itself of the exemption, the Trading Center would have to establish, maintain, and enforce written policies and procedures reasonably designed to address the occurrence of errors and, in the event of an error, the use and terms of a transaction to correct the error in compliance with this exemption. Finally, the Trading Center would have to regularly surveil to ascertain the effectiveness of its policies and procedures to address errors and transactions to correct errors and take prompt action to remedy deficiencies in such policies and procedures.
A. The inaccurate conveyance or execution of any term of an order including, but not limited to, price, number of shares or other unit of trading; identification of the security; identification of the account for which securities are purchased or sold; lost or otherwise misplaced order tickets; short sales that were instead sold long or vice versa; or the execution of an order on the wrong side of a market;
B. The unauthorized or unintended purchase, sale, or allocation of securities, or the failure to follow specific client instructions;
C. The incorrect entry of data into relevant systems, including reliance on incorrect cash positions, withdrawals, or securities positions reflected in an account; or
D. A delay, outage, or failure of a communication system used to transmit market data prices or to facilitate the delivery or execution of an order.
Finally, proposed Rule 3317(c)(3)(D)(iv) would prevent member organizations from breaking an order into smaller orders or otherwise effecting or executing an order to evade the requirements of the Trade-at Prohibition or any other provisions of the Plan.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
Furthermore, the Exchange is a Participant under the Plan and subject, itself, to the provisions of the Plan. The proposed rule change ensures that the Exchange's systems would not display or execute trading interests outside the requirements specified in such Plan. The proposal would also help allow market participants to continue to trade NMS Stocks within quoting and trading requirements that are in compliance with the Plan, with certainty on how certain orders and trading interests would be treated. This, in turn, will help encourage market participants to continue to provide liquidity in the marketplace.
Because the Plan supports further examination and analysis on the impact of tick sizes on the trading and liquidity of the securities of small capitalization companies, and the Commission believes that altering tick sizes could result in significant market-wide benefits and improvements to liquidity and capital formation, adopting rules that enforce compliance by its member organizations with the provisions of the Plan would help promote liquidity in the marketplace and perfect the mechanism of a free and open market and national market system.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The proposed changes are being made to establish, maintain, and enforce written policies and procedures that are reasonably designed to comply with the trading and quoting requirements specified in the Plan, of which other equities exchanges are also Participants. Other competing national securities exchanges are subject to the same trading and quoting requirements specified in the Plan. Therefore, the proposed changes would not impose any burden on competition, while providing certainty of treatment and execution of trading interests on the Exchange to market participants in NMS Stocks that are acting in compliance with the requirements specified in the Plan.
No written comments were either solicited or received.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A)(iii) of the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is: (i) Necessary or appropriate in the public interest; (ii) for the protection of investors; or (iii) otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange filed a proposal to update Rule 13.4(a) regarding the public disclosure of the sources of data that the Exchange utilizes when performing: (i) Order handling; (ii) order routing; and (iii) related compliance processes to reflect the operation of the Investors Exchange LLC (“IEX”) as a registered national securities exchange
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.
On June 17, 2016, the Commission approved IEX's application to register as a national securities exchange.
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act,
The Exchange believes that its proposal to update Exchange Rule 13.4(a) to include IEX will ensure that the rule correctly identifies and publicly states on a market-by-market basis all of the specific network processor and proprietary data feeds that the Exchange utilizes for the handling, routing, and execution of orders, and for performing the regulatory compliance checks related to each of those functions. The proposed rule change also removes impediments to and perfects the mechanism of a free and open market and protects investors and the public interest because it provides additional specificity, clarity and transparency.
The Exchange believes its proposed rule change would not impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. To the contrary, the Exchange believes the proposal would enhance competition because including all of the exchanges enhances transparency and enables investors to better assess the quality of the Exchange's execution and routing services.
The Exchange has not solicited, and does not intend to solicit, comments on this proposed rule change. The Exchange has not received any unsolicited written comments from Members or other interested parties.
Because the foregoing proposed rule change does not: (A) Significantly affect the protection of investors or the public interest; (B) impose any significant burden on competition; and (C) by its terms, become operative for 30 days from the date on which it was filed or such shorter time as the Commission may designate it has become effective pursuant to Section 19(b)(3)(A) of the Act
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: (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 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 seeks to extend the pilot related to the Automated Improvement Mechanism. The text of the proposed rule change is provided below.
Rule 6.51. Automated Improvement Mechanism (“AIM”)
Notwithstanding the provisions of Rule 6.50, a Participant that represents agency orders may electronically execute an order it represents as agent (“Agency Order”) against principal interest or against a solicited order provided it submits the Agency Order for execution into the AIM auction (“Auction”) pursuant to this Rule.
(a)-(b) No change.
. . . Interpretations and Policies:
.01-.02 No change.
.03 Initially, and for at least a Pilot Period expiring on [July 18, 2016]
.04-.09 No change.
The text of the proposed rule change is also available on the Exchange's Web site (
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
In December 2009, the Securities and Exchange Commission (the “Commission”) approved adoption of C2's rules, including the AIM auction process.
The Commission approved on a pilot basis the component of AIM that there is no minimum size requirement for orders to be eligible for the auction. In connection with the pilot programs, the Exchange has submitted to the Commission reports providing AIM auction and order execution data. Five one-year extensions to the pilot program have previously become effective.
The proposed rule change merely extends the duration of the pilot program until January 18, 2017. Extending the pilot for an additional six months will allow the Commission more time to consider the potential impact of the pilot program on AIM order executions.
The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
In particular, the proposed rule change protects investors and the public interest by allowing for an extension of the AIM pilot program, and thus allowing additional time for the
C2 does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange does not believe the proposed rule change imposes any burden on intramarket competition because it applies to all Trading Permit Holders. All Trading Permit Holders that submit orders into an AIM auction are still subject to the same requirements. In addition, the Exchange does not believe the proposed rule change will impose any burden on intermarket competition, as it merely extends the duration of an existing pilot program, which is available to all market participants through Trading Permit Holders. AIM will continue to function in the same manner as it currently functions for an extended period of time.
The Exchange neither solicited nor received comments on the proposed rule change.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act
A proposed rule change filed under Rule 19b-4(f)(6)
The Commission believes that waiving the 30-day operative delay is consistent with the protection of investors and the public interest, as it will allow the pilot program to continue uninterrupted, thereby avoiding any potential investor confusion that could result from a temporary interruption in the pilot program. Therefore, the Commission designates the proposed rule change to be operative on July 18, 2016.
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Schedule 13E-4F (17 CFR 240.13e-102) may be used by an issuer that is incorporated or organized under the laws of Canada to make a cash tender or exchange offer for the issuer's own securities if less than 40 percent of the class of such issuer's securities outstanding that are the subject of the tender offer is held by U.S. holders. The information collected must be filed with the Commission and is publicly available. We estimate that it takes approximately 2 hours per response to prepare Schedule 13E-4F and that the information is filed by approximately 3 respondents annually for a total annual reporting burden of 6 hours (2 hours per response × 3 responses).
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 control number.
The public may view the background documentation for this information collection at the following Web site,
Notice is hereby given, pursuant to the provisions of the Government in the Sunshine Act, Public Law 94-409, that the Securities and Exchange Commission will hold an Open Meeting on Friday, July 22, 2016 at 10:30 a.m., in the Auditorium (L-002) at the Commission's headquarters building, to hear oral argument in an appeal from an initial decision of an administrative law judge by respondent Thomas C. Gonnella.
On November 13, 2014, the ALJ found that Respondent violated antifraud provisions, and aided and abetted and caused violations of recordkeeping provisions, of the securities laws while associated with Barclays, a dually registered broker-dealer and investment adviser. Specifically, the ALJ found that Respondent engaged in a fraudulent trading scheme in order to avoid aged-inventory charges that were implemented under Barclays's internal policy and yet retain the securities that were subject to the policy. The ALJ also found that Gonnella's failure to record the transactions properly caused Barclays's books and records to be incomplete and inaccurate and that Gonnella therefore aided and abetted and was a cause of recordkeeping violations.
For these violations, the ALJ suspended Respondent from the securities industry and from participation in penny stock offerings for twelve months, entered a cease-and-desist order, and assessed a civil money penalty of $82,500.
The Division of Enforcement appealed the suspension, and Respondent cross-appealed the findings of violations and sanctions imposed. The issues likely to be considered at oral argument include, among other things, whether Respondent violated the securities laws and, if so, what sanction, if any, is appropriate in the public interest.
For further information, please contact Brent J. Fields from the Office of the Secretary at (202) 551-5400.
By letter dated July 13, 2016 (the “Letter”), as supplemented by conversations with the staff of the Division of Trading and Markets, counsel for PowerShares Exchange-Traded Fund Trust II (the “Trust”), on behalf of the Trust, PowerShares DWA Momentum & Low Volatility Rotation Portfolio (the “Fund”), any national securities exchange on or through which shares issued by the Fund (“Shares”) may subsequently trade, Invesco Distributors, Inc. (the “Distributor”), and persons or entities engaging in transactions in Shares (collectively, the “Requestors”), requested exemptions, or interpretive or no-action relief, from Rule 10b-17 of the Securities Exchange Act of 1934, as amended (“Exchange Act”), and Rules 101 and 102 of Regulation M, in connection with secondary market transactions in Shares and the creation or redemption of aggregations of Shares of at least 50,000 shares (“Creation Units”).
The Trust is registered with the Securities and Exchange Commission (“Commission”) under the Investment Company Act of 1940, as amended (“1940 Act”), as an open-end management investment company. The Fund seeks to track the performance of the underlying index, the Dorsey Wright® Multi-Factor Global Equity Index (the “Index”). The Fund intends to operate as an “ETF of ETFs” by seeking to track the performance of its underlying Index through, under normal circumstances,
The Requestors represent, among other things, the following:
• Shares of the Fund will be issued by the Trust, an open-end management investment company that is registered with the Commission;
• The Trust will continuously redeem Creation Units at net asset value (“NAV”), and the secondary market price of the Shares should not vary substantially from the NAV of such Shares;
• Shares of the Fund will be listed and traded on the NASDAQ Stock Market LLC or another exchange in accordance with exchange listing standards that are, or will become, effective pursuant to Section 19(b) of the Exchange Act (the “Exchange”);
• All ETFs in which the Fund is invested will meet all conditions set forth in a relevant class relief letter, will have received individual relief from the Commission, or will be able to rely upon individual relief even though they are not named parties (for example, a no-action letter);
• At least 70% of the Fund is comprised of component securities that will meet the minimum public float and minimum average daily trading volume thresholds under the “actively-traded securities” definition found in Regulation M for excepted securities during each of the previous two months of trading prior to formation of the Fund;
• All of the components of the Index will have publicly available last sale trade information;
• The intra-day proxy value of the Fund per share and the value of the Index will be publicly disseminated by a major market data vendor throughout the trading day;
• On each business day before the opening of business on the Exchange, the Fund's custodian, through the National Securities Clearing Corporation, will make available the list of the names and the numbers of securities and other assets of the Fund's portfolio that will be applicable that day to creation and redemption requests;
• The Exchange or other market information provider will disseminate (i) continuously every 15 seconds throughout the trading day, through the facilities of the consolidated tape, the market value of a Share, and (ii) every 15 seconds throughout the trading day, a calculation of the intra-day indicative value of a Share;
• The arbitrage mechanism will be facilitated by the transparency of the Fund's portfolio and the availability of the intra-day indicative value, the liquidity of securities held by the Fund, and the ability to acquire such securities, as well as the arbitrageurs' ability to create workable hedges;
• The Fund will invest solely in liquid securities;
• The Fund will invest in securities that will facilitate an effective and efficient arbitrage mechanism and the ability to create workable hedges;
• The Trust believes that arbitrageurs are expected to take advantage of price variations between the Fund's market price and its NAV; and
• A close alignment between the market price of Shares and the Fund's NAV is expected.
While redeemable securities issued by an open-end management investment company are excepted from the provisions of Rules 101 and 102 of Regulation M, the Requestors may not rely upon those exceptions for the Shares.
Generally, Rule 101 of Regulation M is an anti-manipulation rule that, subject to certain exceptions, prohibits any “distribution participant” and its “affiliated purchasers” from bidding for, purchasing, or attempting to induce any person to bid for or purchase any security that is the subject of a distribution until after the applicable restricted period, except as specifically permitted in the Rule. Rule 100 of Regulation M defines “distribution” to mean any offering of securities that is distinguished from ordinary trading transactions by the magnitude of the offering and the presence of special selling efforts and selling methods. The provisions of Rule 101 of Regulation M apply to underwriters, prospective underwriters, brokers, dealers, or other persons who have agreed to participate or are participating in a distribution of securities. The Shares are in a continuous distribution, and, as such, the restricted period in which distribution participants and their affiliated purchasers are prohibited from bidding for, purchasing, or attempting to induce others to bid for or purchase extends indefinitely.
Based on the representations and the facts presented in the Letter, particularly that the Trust is a registered open-end management investment company that will continuously redeem at the NAV Creation Unit size aggregations of the Shares of the Fund and that a close alignment between the market price of Shares and the Fund's NAV is expected, the Commission finds that it is appropriate in the public interest, and consistent with the protection of investors to grant the Trust an exemption under paragraph (d) of Rule 101 of Regulation M with respect to the Fund, thus permitting persons participating in a distribution of Shares of the Fund to bid for or purchase such Shares during their participation in such distribution.
Rule 102 of Regulation M prohibits issuers, selling security holders, and any affiliated purchaser of such person from bidding for, purchasing, or attempting to induce any person to bid for or purchase a covered security during the applicable restricted period in connection with a distribution of securities effected by or on behalf of an issuer or selling security holder.
Based on the representations and the facts presented in the Letter, particularly that the Trust is a registered open-end management investment company that will redeem at the NAV Creation Unit size aggregations of Shares of the Fund and that a close alignment between the market price of Shares and the Fund's NAV is expected, the Commission finds that it is
Rule 10b-17, with certain exceptions, requires an issuer of a class of publicly traded securities to give notice of certain specified actions (for example, a dividend distribution) relating to such class of securities in accordance with Rule 10b-17(b). Based on the representations and the facts presented in the Letter, and subject to the conditions below, the Commission finds that it is appropriate in the public interest, and consistent with the protection of investors, to grant the Trust a conditional exemption from Rule 10b-17 because market participants will receive timely notification of the existence and timing of a pending distribution, and thus the concerns that the Commission raised in adopting Rule 10b-17 will not be implicated.
IT IS HEREBY ORDERED, pursuant to Rule 101(d) of Regulation M, that the Trust, based on the representations and facts presented in the Letter, is exempt from the requirements of Rule 101 with respect to the Fund, thus permitting persons who may be deemed to be participating in a distribution of Shares of the Fund to bid for or purchase such Shares during their participation in such distribution.
IT IS FURTHER ORDERED, pursuant to Rule 102(e) of Regulation M, that the Trust, based on the representations and the facts presented in the Letter, is exempt from the requirements of Rule 102 with respect to the Fund, thus permitting the Fund to redeem Shares of the Fund during the continuous offering of such Shares.
IT IS FURTHER ORDERED, pursuant to Rule 10b-17(b)(2), that the Trust, based on the representations and the facts presented in the Letter and subject to the conditions below, is exempt from the requirements of Rule 10b-17 with respect to the transactions in the Shares of the Fund.
This exemptive relief is subject to the following conditions:
• The Trust will comply with Rule 10b-17, except for Rule 10b-17(b)(1)(v)(a) and (b); and
• The Trust will provide the information required by Rule 10b-17(b)(1)(v)(a) and (b) to the Exchange as soon as practicable before trading begins on the ex-dividend date, but in no event later than the time when the Exchange last accepts information relating to distributions on the day before the ex-dividend date.
This exemptive relief is subject to modification or revocation at any time the Commission determines that such action is necessary or appropriate in furtherance of the purposes of the Exchange Act. This exemption is based on the facts presented and the representations made in the Letter. Any different facts or representations may require a different response. Persons relying upon this exemptive relief shall discontinue transactions involving the Shares of the Fund, pending presentation of the facts for the Commission's consideration, in the event that any material change occurs with respect to any of the facts or representations made by the Requestors, and as is the case with all preceding letters, particularly with respect to the close alignment between the market price of Shares and the Fund's NAV. In addition, persons relying on this exemption are directed to the anti-fraud and anti-manipulation provisions of the Exchange Act, particularly Sections 9(a), 10(b), and Rule 10b-5 thereunder.
Responsibility for compliance with these and any other applicable provisions of the federal securities laws must rest with the persons relying on this exemption. This Order should not be considered a view with respect to any other question that the proposed transactions may raise, including, but not limited to, the adequacy of the disclosure concerning, and the applicability of other federal or state laws to, the proposed transactions.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to introduce new risk protections on the Exchange and provide enhancements to current risk protections. The text of the proposed rule change is available from the principal office of the Exchange, at the Commission's Public Reference Room and also on the Exchange's Internet 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 these statements may be examined at the places specified in Item IV below. The self-regulatory organization has prepared summaries, set forth in Sections A, B, and C below, of the most significant aspects of such statements.
The purpose of the proposed rule change is to introduce new risk protections on the Exchange and provide enhancements to current risk protections designed to aid Participants in their risk management by supplementing current protections with new activity-based protections. In particular, the Exchange proposes to introduce new activity-based protections for orders and quotes, enhancements to the current protections available for Market Makers on the Exchange and provide maximum order and quote quantity.
The Exchange proposes to adopt Rule 7320 (Maximum Order and Quote Quantity) to provide an additional risk protection for orders and quotes entered on BOX. Specifically, the system will prevent orders or quotes from executing or being placed on the BOX Book if the size of the order or quote exceeds the size protection designated by the Participant submitting the order or quote. The size protection is the maximum size of an order or quote that will be accepted by the system and Participants may designate the size protection on a class-by-class basis for non-auction transactions. For auction transactions, the Participant may designate a size protection applicable to all auction types only. For Complex Orders, if any leg fails the validation, then the entire Complex Order is rejected.
In order to provide values for the size protection, Participants must contact the MOC.
The Exchange proposes to adopt Rule 7330 (Activity-Based Protections) to provide new risk protections. Specifically, the Exchange is proposing two new risk protections; one will cover executed orders and the other will cover executed orders and quotes.
The Exchange proposes to adopt Rule 7330(a) (Traded Order Protection) to provide new risk protections for orders executed by Participants on the Exchange. The risk protections the Exchange is proposing are similar to those already available on BOX for quotes.
When a Participant's order is executed, the system will look back over a specific period of time to determine whether the execution will cause the counters to be incremented. Specifically, if the difference between the time of the current trade and the time of the previous trade from the same Options Participant identification number (“Participant ID”) in the same class is greater than the Time Interval,
When a counter is triggered because it exceeds the maximum permissible value, all orders for that Participant ID in options on that class are cancelled unless such cancelation is not permitted under other rules.
The Exchange proposes to adopt Rule 7330(b) (Traded Activity Protection) to provide enhanced risk protections for orders and quotes. Specifically, the Exchange shall maintain traded activity counters for: (1) Maximum number of trades,
When a Participant's order and/or quote is executed, the system will look back over a specific period of time to determine whether the execution will cause the counters to be incremented. Specifically, if the difference between the time of the current trade and the time of the previous trade from the same Participant ID is greater than the Time Interval,
When a counter is triggered because it exceeds the maximum permissible value, all orders and quotes for that Participant ID in all classes are cancelled unless such cancelation is not permitted under other rules.
The Activity-based Protections are available to all Participants and are enabled when a Participant contacts the MOC and provides values for the parameters. The Exchange may also enable these features and provide default values for the parameters.
The last new protection mechanism that the Exchange is proposing is a Global Counter.
If multiple counters within the same category of protection are triggered by the same trade, the Global Counter will only be incremented by one. If, however, multiple counters from different categories of protection are triggered by the same trade, the Global Counter will be incremented by one for each category of protection, regardless of the number of counters within the same category of protection that were triggered. For example, if the maximum traded order volume counter for the Traded Order Protections and the maximum traded volume for the Trade Activity Protection are triggered by the same trade, then the Global Counter will only be incremented by one.
Participants will be allowed to provide a limit for the Global Counter (“Global Limit”) and the Exchange will also provide a default value for the Global Limit. If the Global Counter is triggered because it has reached or exceeded the Global Limit, the system will cancel all orders and/or quotes belonging to that Participant and the counter is reset. When determining if the Global Counter has been triggered, the system will use the most restrictive value for the Global Limit (
The Global Counter is available to all Participants and is enabled when a Participant contacts the MOC and provides values for the parameters. The Exchange may also enable this feature and provide default values for the parameters. The Exchange notes that the proposed Global Counter is not novel and another exchange has a similar counting program on its exchange.
Currently, the Exchange offers activity-based protections for Market Makers. Specifically, Rule 8130 (Automatic Quote Cancellation) provides activity-based protections for a Market Maker's quoting activity. The Automatic Quote Cancellation mechanism contains numerous triggering parameters for which a Market Maker can provide values. The Exchange is now proposing to amend the Automatic Quote Cancellation mechanism by adding an additional triggering parameter. Specifically, the Exchange is proposing to add a parameter that tracks the percentage of the Market Maker's quote that is traded. The Exchange notes that this is not a novel proposal and another exchange already has this feature.
Additionally, the Exchange is proposing to provide clarity on when the counters will be reset. Specifically, the counters in Rule 8130 are reset
The Exchange is proposing to amend Rule 8140 to provide that when a Market Maker is disconnected from the Trading Host, the Market Maker's quotes will be cancelled. As part of this proposed change, the Exchange is proposing to remove one of the triggering parameters currently in Rule 8130. Specifically, the Exchange is proposing to remove the first triggering parameter for when a Market Maker experiences a duration of no technical connectivity for between one and nine seconds. The Exchange believes that this parameter is no longer needed since the Exchange's proposed change for Rule 8140 will cover when a Market Maker is disconnected.
The Exchange will provide Participants with notice, via Information Circular, about the implementation date of these proposed enhancements to the protections offered by the Exchange. Additionally, any changes to any Exchange provided defaults will be communicated to Participants via Information Circular.
The Exchange believes that the proposal is consistent with the requirements of Section 6(b) of the Securities Exchange Act of 1934 (the “Act”),
The individual firm benefits of enhanced risk protections flow downstream to counterparties both at the Exchange and at other options exchanges, thereby increasing systemic protections as well. Additionally, because the Exchange offers these risk tools to all Participants, the Exchange believes it will encourage liquidity generally and remove impediments to and perfect the mechanism of a free and open market and a national market system, and protect investors and the public interest.
These risk protections, as noted above, will be offered to all Participants on BOX. The Exchange further represents that its proposal will operate consistently with the firm quote obligations of a broker-dealer pursuant to Rule 602 of Regulation NMS. Specifically, for a counter triggered for the resting order or quote side, action is taken following the complete processing of the incoming order or quote. Additionally, a Market Maker's obligation to provide continuous two-sided quotes on a daily basis is not diminished by the removal of such quotes through one of the risk protections. A Market Maker will be required to provide continuous two-sided quotes on a daily basis.
The Exchange believes that the proposed rule change will assist with the maintenance of a fair and orderly market by establishing new activity-based risk protections for orders and quotes. The Exchange believes that these proposed risk protections, in addition to the current risk protections available on the Exchange, will enable Participants to better manage their risk when trading on the Exchange. BOX believes the proposed risk controls will remove impediments to and perfect the mechanism of a free and open market by providing Participants with greater control over their activity.
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. BOX believes the proposal will provide market participants with additional protections while submitting orders and quotes to the Exchange. The Exchange does not believe the proposal will impose a burden on competition among the options exchanges, because of vigorous competition for order flow among the options exchanges. The Exchange competes with many other options exchanges. In this highly competitive market, market participants can easily and readily direct order flow to competing venues. The proposal does not impose an undue burden on intramarket competition because all Participants may avail themselves of the risk controls on the Exchange. Additionally, the proposed activity-based protections are similar to those available on competing exchanges.
The Exchange has neither solicited nor received comments on the proposed rule change.
The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act
A proposed rule change filed under Rule 19b-4(f)(6)
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate toecretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
The Commission will post all comments on the Commission's Internet Web site (
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice is hereby given, pursuant to the provisions of the Government in the Sunshine Act, Public Law 94-409, that the Securities and Exchange Commission will hold a Closed Meeting on Friday, July 22, 2016 at 11:30 a.m.
Commissioners, Counsel to the Commissioners, the Secretary to the Commission, and recording secretaries will attend the Closed Meeting. Certain staff members who have an interest in the matters also may be present.
The General Counsel of the Commission, or her designee, has certified that, in her opinion, one or more of the exemptions set forth in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR 200.402(a)(3), (5), (7), 9(ii) and (10), permit consideration of the scheduled matter at the Closed Meeting.
Commissioner Piwowar, as duty officer, voted to consider the items listed for the Closed Meeting in closed session.
The subject matter of the Closed Meeting will be:
At times, changes in Commission priorities require alterations in the scheduling of meeting items.
For further information and to ascertain what, if any, matters have been added, deleted or postponed, please contact Brent J. Fields from the Office of the Secretary at (202) 551-5400.
Office of the United States Trade Representative.
Notice.
Pursuant to section 181 of the Trade Act of 1974, as amended (19 U.S.C. 2241), the Office of the United States Trade Representative (USTR) is required to publish annually the National Trade Estimate Report on Foreign Trade Barriers (NTE). With this notice, the Trade Policy Staff Committee (TPSC) is requesting interested persons to submit comments to assist it in identifying significant barriers to U.S. exports of goods, services, and U.S. foreign direct investment for inclusion in the NTE. The TPSC invites written comments from the public on issues that USTR should examine in preparing the NTE.
Section 1377 of the Omnibus Trade and Competitiveness Act of 1988 (19 U.S.C. 3106) (“Section 1377”) requires the USTR to review annually the operation and effectiveness of all U.S. trade agreements regarding telecommunications products and services that are in force with respect to the United States. USTR is collecting information regarding the trade barriers pertinent to the conduct of the review called for in Section 1377 through this notice.
Public comments are due not later than 11:59 p.m., October 27, 2016.
Submissions should be made via the Internet at
Questions regarding this notice should be directed to Yvonne Jamison at (202) 395-3475.
The NTE sets out an inventory of the most important foreign barriers affecting U.S. exports of goods and services, U.S. foreign direct investment, and protection of intellectual property rights. The inventory facilitates U.S. negotiations aimed at reducing or eliminating these barriers. The report also provides a valuable tool in enforcing U.S. trade laws and strengthening the rules-based trading system. The 2016 NTE Report may be found on USTR's Internet Home Page (
(1) Import policies (
(2) Government procurement restrictions (
(3) Export subsidies (
(4) Lack of intellectual property protection (
(5) Services barriers (
(6) Investment barriers (
(7) Government-tolerated anticompetitive conduct of state-owned or private firms that restrict the sale or purchase of U.S. goods or services in the foreign country's markets;
(8) Trade restrictions affecting electronic commerce (
(9) Trade restrictions implemented through unwarranted Sanitary and Phytosanitary Measures, including unwarranted measures justified for purposes of protecting food safety, and animal and plant life or health;
(10) Trade restrictions implemented through unwarranted standards, conformity assessment procedures, or technical regulations (Technical Barriers to Trade) that may have as their objective protecting national security requirements, preventing deceptive practices, or protecting human health or safety, animal or plant life or health, or the environment, but that can be formulated or implemented in ways that create significant barriers to trade (including unnecessary or discriminatory technical regulations or standards for telecommunications products); and
(11) Other barriers (
In addition, Section 1377 of the Omnibus Trade and Competitiveness Act of 1988 (19 U.S.C. 3106) (“Section 1377”) requires the USTR to review annually the operation and effectiveness of all U.S. trade agreements regarding telecommunications products and services that are in force with respect to the United States. The purpose of the review is to determine whether any act, policy, or practice of a country that has entered into a trade agreement or other telecommunications trade agreement with the United States is inconsistent with the terms of such agreement or otherwise denies U.S. firms, within the context of the terms of such agreements, mutually advantageous market opportunities for telecommunications products and services. USTR is collecting the information with regard to the trade barriers pertinent to the Section 1377 review through this notice.
Furthermore, commenters are invited to identify those barriers covered in submissions that may operate as “localization barriers to trade”. Localization barriers are measures designed to protect, favor, or stimulate domestic industries, services providers, and or intellectual property at the expense of goods services or intellectual property from other countries, including the provision of subsidies linked to local production. For more information on localization barriers, please go to
In responding to this notice, commenters should place particular emphasis on any practices that may violate U.S. trade agreements. The TPSC is also interested in receiving new or updated information pertinent to the barriers covered in the 2016 NTE as well as information on new barriers. If USTR does not include in the NTE information that it receives pursuant to this notice, it will maintain the information for potential use in future discussions or negotiations with trading partners.
Estimate of Increase in Exports: Each comment should include an estimate of the potential increase in U.S. exports that would result from removing any foreign trade barrier the comment identifies, as well as a description of the methodology the commenter used to derive the estimate. Estimates should be expressed within the following value ranges: Less than $5 million; $5 to $25 million; $25 million to $50 million; $50 million to $100 million; $100 million to $500 million; or over $500 million. These estimates will help USTR conduct comparative analyses of a barrier's effect over a range of industries.
Requirements for Submissions: Commenters providing information on foreign trade barriers in more than one country should, whenever possible, provide a separate submission for each country. In order to ensure the timely receipt and consideration of comments, USTR strongly encourages commenters to make on-line submissions, using the
Comments should be submitted under docket number USTR 2016-0007. Persons submitting comments must do so in English and must identify (on the first page of the submission) “Comments Regarding Foreign Trade Barriers To U.S. Exports for 2017 Reporting.”
In order to be assured of consideration, comments should be submitted by 11:59 p.m., October 27, 2016. In order to ensure the timely receipt and consideration of comments, USTR strongly encourages commenters to make on-line submissions, using the
The
As noted, USTR strongly urges submitters to file comments through
Federal Aviation Administration (FAA), DOT.
Notice.
This notice contains a summary of a petition seeking relief from specified requirements of Title 14 of the Code of Federal Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Comments on this petition must identify the petition docket number and must be received on or before August 8, 2016.
Send comments identified by docket number FAA-2015-1533 using any of the following methods:
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Dan Ngo, (202) 267-4264, 800 Independence Avenue SW., Washington, DC 20591. This notice is published pursuant to 14 CFR 11.85.
Federal Aviation Administration (FAA), DOT.
Notice.
This notice contains a summary of a petition seeking relief from specified requirements of Title 14 of the Code of Federal Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process.
Comments on this petition must identify the petition docket number and must be received on or before August 8, 2016.
Send comments identified by docket number FAA-2015-3039 using any of the following methods:
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Dan Ngo, (202) 267-4264, 800 Independence Avenue SW., Washington, DC 20591. This notice is published pursuant to 14 CFR 11.85.
Federal Aviation Administration (FAA), DOT.
Notice.
This notice contains a summary of a petition seeking relief from specified requirements of Title 14 of the Code of Federal Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Comments on this petition must identify the petition docket number and must be received on or before August 8, 2016.
Send comments identified by docket number FAA-2015-7185 using any of the following methods:
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Dan Ngo, (202) 267-4264, 800 Independence Avenue SW., Washington, DC 20591. This notice is published pursuant to 14 CFR 11.85.
Federal Aviation Administration (FAA), DOT.
Notice.
This notice contains a summary of a petition seeking relief from specified requirements of Title 14 of the Code of Federal Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Comments on this petition must identify the petition docket number and must be received on or before August 8, 2016.
Send comments identified by docket number FAA-2015-7147 using any of the following methods:
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Dan Ngo, (202) 267-4264, 800 Independence Avenue SW., Washington, DC 20591. This notice is published pursuant to 14 CFR 11.85.
National Highway Traffic Safety Administration, DOT.
Receipt of petition.
This document announces receipt by the National Highway Traffic Safety Administration (NHTSA) of a petition for a decision that model year (MY) 2011 Ducati Multistrada Motorcycles (MCs) that were not originally manufactured to comply with all applicable Federal motor vehicle safety standards (FMVSS), are eligible for importation into the United States because they are substantially similar to vehicles that were originally manufactured for sale in the United States and that were certified by their manufacturer as complying with the safety standards (the U.S.-certified version of the 2011 Ducati Multistrada Motorcycles) and they are capable of being readily altered to conform to the standards.
The closing date for comments on the petition is August 18, 2016.
Comments should refer to the docket and notice numbers above and be submitted by any of the following methods:
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George Stevens, Office of Vehicle Safety Compliance, NHTSA (202-366-5308).
Under 49 U.S.C. 30141(a)(1)(A), a motor vehicle that was not originally manufactured to conform to all applicable FMVSS shall be refused admission into the United States unless NHTSA has decided that the motor vehicle is substantially similar to a motor vehicle originally manufactured for importation into and sale in the United States, certified under 49 U.S.C. 30115, and of the same model year as the model of the motor vehicle to be compared, and is capable of being readily altered to conform to all applicable FMVSS.
Petitions for eligibility decisions may be submitted by either manufacturers or importers who have registered with NHTSA pursuant to 49 CFR part 592. As specified in 49 CFR 593.7, NHTSA publishes notice in the
Skytop Rover Co. (Skytop), of Philadelphia, Pennsylvania (Registered Importer R-06-343) has petitioned NHTSA to decide whether nonconforming 2011 Ducati Multistrada MCs are eligible for importation into the United States. The vehicles which Skytop believes are substantially similar are MY 2011 Ducati Multistrada MCs sold in the United States and certified by their manufacturer as conforming to all applicable FMVSS.
The petitioner claims that it compared non-U.S. certified MY 2011 Ducati Multistrada MCs to their U.S.-certified counterparts, and found the vehicles to be substantially similar with respect to compliance with most FMVSS.
Skytop submitted information with its petition intended to demonstrate that non-U.S. certified MY 2011 Ducati Multistrada MCs, as originally manufactured, conform to many applicable FMVSS in the same manner as their U.S.-certified counterparts, or are capable of being readily altered to conform to those standards. Specifically, the petitioner claims that the non U.S.-certified MY 2011 Ducati Multistrada MCs, as originally manufactured, conform to: Standard Nos. 106
The petitioner also contends that the subject non-U.S certified vehicles are capable of being readily altered to meet the following standards, in the manner indicated:
All comments received before the close of business on the closing date indicated above will be considered, and will be available for examination in the docket at the above addresses both before and after that date. To the extent possible, comments filed after the closing date will also be considered. Notice of final action on the petition will be published in the
49 U.S.C. 30141(a)(1)(A), (a)(1)(B), and (b)(1); 49 CFR 593.7; delegation of authority at 49 CFR 1.95 and 501.8.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Announcement of public meeting.
NHTSA is announcing a public meeting to present the qualification and seating procedures for the Test Device for Human Occupant Restraint (THOR) 50th percentile male anthropomorphic test device (ATD). The meeting will include NHTSA presentations outlining the qualification and seating procedures the agency has been using and will provide opportunities for the attendees to ask questions on the technical aspects of the procedures.
NHTSA will hold the public meeting over two days. The first day will focus on seating procedures, and will begin at 9:00 a.m. and continue until 3:00 p.m. on Wednesday, August 31, 2016. The second day will focus on qualification procedures, and will begin at 9:00 a.m. and continue until 3:00 p.m. on Thursday, September 1, 2016. Each day will include two sessions: First, a technical information session that will occur in a conference room; second, a practical session which will take place in a lab environment. The public technical meeting will be held at the location indicated in the
The public meeting will be held at the National Highway Traffic Safety Administration Vehicle Research and Test Center, 10820 State Route 347—Bldg. 60, East Liberty, Ohio 43319.
If you would like to attend the public meeting, please contact Dr. Kevin Moorhouse by the date specified under
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The Test Device for Human Occupant Restraint 50th percentile male (THOR-50M) is an advanced anthropomorphic test device (ATD, or test dummy). It is designed to better represent the interaction of automotive occupants with modern and sophisticated restraint systems, such as force-limited three-point belts and air bags, which have become standard equipment. The purpose of this public meeting is to provide a demonstration of the qualification procedures and seating procedures for the THOR-50M ATD and answer questions that the public may have regarding the implementation of these procedures. Topics for discussion at the public meeting are limited to qualification procedures and seating procedures.
Registration is required for all attendees. Please see registration instructions under
Written comments can be submitted to the docket. See information under
There will be an opportunity for attendees to ask NHTSA questions related to the technical aspects of the qualification and seating procedures.
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 |